Original Research

Take-Home Points

• PRO data collection can provide feedback for improvements in patient care and physician performance.
• Many options exist for orthopedic physicians to establish clinical data registries.
• Registry systems can help improve patient follow-up with system monitoring and patient reminders.
• Clinical registries can offer many advantages to observational research.
• With registry use becoming more prevalent, work needs to be done to establish standards for validity and reliability.

In a 2012 review of database tools, Lubowitz and Smith¹ examined Internet-based applications that arthroscopic surgeons could use to record and monitor patient-reported outcome (PRO) data and potential adverse effects. In this article, we update orthopedic surgeons on the registries and monitoring software mentioned in that earlier publication and in other publications that have since become available.

Most orthopedic surgery candidates are seeking pain relief and improved function. Many patients expect their pain to be completely relieved by surgical intervention and their function to return to what it was before they became stricken.^2,3 Therefore, PRO measures (PROMs) are now standard in post-orthopedic surgery outcome reporting.⁴ PROMs, which include any measurement that assesses a patient’s health, illness, or benefits from the perspective of the patient, are often administered as a questionnaire or survey.⁵ The collection of PROMs continues to increase and evolve, creating a need for data storage and analysis. Registries, large collections of patient information and outcomes, allow for evaluation of patient outcomes, monitoring of adverse effects, identification of procedure incidence, understanding of predictors of prognosis, generation of feedback for quality of care, monitoring of the safety of implantable devices, and the conducting of hypothesis-driven scientific research.^6-9

Orthopedic surgery has registries at regional, national, and international levels. Although the United States has fallen well behind other countries in establishing a national registry,⁹ it has made some recent progress. The United States now has several national registries, including the American Joint Replacement Registry (AJRR), Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), the Kaiser Permanente National Total Joint Replacement Registry (TJRR), the Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs), and the National Trauma Data Bank (NTDB).⁹ AJRR currently has 960 hospitals participating and is tracking 1,084,664 hip and knee replacements.¹⁰

These orthopedic registries, however, are limited in 2 ways. First, the majority are joint replacement registries. Second, though registries are established to determine patterns of care and predict patient outcomes, many are not set up to report care data back to healthcare providers.⁷ For procedures other than joint arthroplasty and for providers interested in tracking their patients’ PROs, systems are available for establishing clinical quality registries in orthopedics.

Registry Systems

CareSense

CareSense (Medtrak) is an Internet-based care management and data collection system designed for patient engagement, which results in fewer missed appointments, increased patient adherence, enhanced patient education, and improved patient satisfaction.¹¹ CareSense features email/text reminders for data entry, custom and standard reports, import and export of electronic medical record (EMR) information, and tools for running research studies.¹² CareSense emphasizes care navigation by helping hospitals educate and guide patients through their care by sending exercise videos to patients for home rehabilitation, transferring messages from post-acute care facilities to surgeons and caregivers, and alerting the care team to any potential readmission symptoms.^11,13 CareSense is also a Centers for Medicare & Medicaid Services (CMS) approved qualified clinical data registry (QCDR). QCDRs collect data for Merit-Based Incentive Payment System (MIPS) clinicians and submit the data to CMS.¹²

KareOutcomes

KareOutcomes, a healthcare technology and support firm founded in 2009, advocates transparency and trust among providers and patients, and aims to optimize PROs.¹⁴ The KareOutcomes team incorporates patient follow-up personnel, administrators, engineers, physicians, software developers, and technicians. The KareOutcomes software, which is backed by a 6-month guarantee, includes system design and implementation, data collection and entry, methods of submitting data to statewide or nationwide registries and sending standardized and customized surveys, and accessible and meaningful data presentation. KareOutcomes allows patient follow-up through automated reminders by telephone, SMS text message, and email. Patients can respond to surveys or questionnaires whichever way is most convenient—by telephone, Internet, SMS text message, or on paper, either in the office or by mail.

Oberd

Oberd (Universal Research Solutions) offers a comprehensive package of solutions for collecting optimal PRO data. The package has several modules: outcomes, education, registry, operative notes, data import and export, and data reporting.¹⁵ Oberd Outcomes allows convenient and engaging data collection. For example, users can send both standardized and customized forms. Oberd Education allows patients to receive information in an interactive, narrated format that is specific to their physician’s techniques and practices. Oberd Registry allows users to input multiple datasets into a registry, compare data, and generate reports with visuals. Like CareSense, Oberd is a CMS-approved QCDR. Oberd’s MIPS Dashboard helps providers collect and report patients’ reported outcomes, and use that information to modify and improve their practice.

Ortech

Ortech is a web-based data registry system that allows physicians and administrators to mine the data they own, track key metrics in their data, and improve reporting.¹⁶ Users can collect PROMs, use them to measure and analyze patient progress, and add to their collection of information that helps support their evidence-based decision making. They can capture intraoperative and implant data through barcode scanning, which then registers the data in an implant product code library that allows quick identification of patients with a specific implant in the event of a product recall. Ortech also allows automatic generation of customized operative reports on data entered from the operating room and populated into the EMR. Ortech offers 2 versions of its data collection platform, phiDB and phiDB Lite. The phiDB Lite version is for smaller practices and focuses mainly on PROMs but lacks many of the other features that phiDB offers, such as operating room modules, automated operative reports, barcode scanning, and unlimited data reporting.

Socrates

Socrates (Standardised Orthopaedic Clinical Research and Treatment Evaluation Software; Ortholink) is dedicated orthopedic software that facilitates following patient outcomes and conducting high-quality research.¹⁷ Socrates is fully customizable to fit each user’s needs. It allows for tracking of outcome scores, intraoperative details, nonoperative procedures, clinical examinations, therapies, and adverse effects. Users can also create reports from this information, which is inputted to Socrates and can be exported into EMR. Socrates data are stored on the user’s server, on site; the software generates patient summaries, collective summaries, and follow-up reports through its built-in descriptive statistics module. Raw data can be extracted for statistical analysis. Socrates can catalogue images, radiographs, documents, and videos.

Surgical Outcomes System

Surgical Outcomes System (SOS; Arthrex) is a cloud-based orthopedic and sports medicine global registry that focuses on monitoring and evaluating the outcomes of various orthopedic and sports medicine surgical procedures, as well as nonoperative interventions, to contribute to evidence-based protocols for patient treatment.¹⁸ SOS can be fully customized with desired PROMs for arthroplasty and for surgical procedures for extremity joints and even the spine. SOS includes real-time reporting on PROs for individual patients, summary PROMs for all of the physician’s patients who are receiving the same treatment, and comparisons with all registry patients (from global de-identified registry data) who had the same treatment or surgery. This real-time analysis provides immediate patient and physician feedback on treatments and products used. A patient portal for education on surgical procedures is also available. SOS is approved for use in 21 countries and is a benefit included with Arthroscopy Association of North America (AANA) membership. SOS is listed on the National Quality Registry Network (NQRN) website and, as a specialized registry as defined by CMS, can accept data generated by EMR technology.

Discussion

Delaunay¹⁹ indicated that successful registry management depends on several factors, including “use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants.” The registry systems reviewed in this article are Internet based and allow healthcare providers to monitor the clinical outcomes of their patients in the hope of improving clinical decision-making and overall patient care. From the provider perspective, many registry systems allow for integration of outcome data reporting into EMRs, including generation of operative reports. In turn, registries can improve documentation efficiency, as it was estimated that a US physician without a registry spends more than 15 hours a week reporting quality measures,20 or almost 800 hours and $15 billion each year.^20,21 It remains to be seen whether registry systems will optimize the documentation process, but there is potential improvement in time and cost-efficiency with registry use.

Although the factors involved in management are important, clinical data registries must have systems in place to help ensure patient adherence and minimize selection bias, as adherence is crucial in data accuracy.³ What helps with adherence is the ability to send automated email or SMS text message reminders to patients. According to a review, email reminders increased the completion of PROM datasets by 26%.²² When the new national quality register (NQR) HAKIR (Handkirurgiskt kvalitetsregister) was established in Sweden, it was found that when only 1 type of reminder was used (SMS text message, in this case), only about 30% of participants completed their questionnaires.²³ However, after the system was changed to send both SMS text message and email reminders, the response rate increased from 50% to 60%. Using 2 types of automated reminders might minimize lost data more effectively than 1 type alone.

Another benefit of outcome monitoring through a registry is potential reduction of interviewer- related errors. Interviewer bias can occur in many different ways. Interviewers might not follow the same instructions or administer questionnaires or surveys the same way for different patients,²⁴ the interviewer’s presence might cause the patient to alter responses based on social norms,²⁵ and the patient might report better outcomes in the presence of a physician or interviewer.^26,27 Given that clinical registries allow electronic capture of self-administered surveys, interviewer bias is reduced because all patients receive a standardized set of questions and instructions. In addition, electronic questionnaires and surveys prompt users to add or fix missed or incorrectly completed items, further reducing potential data inaccuracies.

Healthcare costs continue to rise in the United States. In 2015, the total cost of healthcare expenditure in the United States was $3.2 trillion, or almost 18% of the US gross domestic product.²⁸ In addition, in the first half of 2016, an estimated 16.2% of people under age 65 years were in families that were struggling to pay medical bills.^29,30 Healthcare reform provides a financial incentive to healthcare providers to collaborate to reduce unnecessary costs and procedures and improve the quality of healthcare.³¹ Porter and Teisberg³² defined value as health outcomes achieved per dollar spent. Registry monitoring of PROMs, which are the numerator in this critical value formula, allows providers to track patient outcomes over time to determine which interventions produce the best outcomes.²² Therefore, clinical registries play an important role in improving health outcomes and reducing the cost of healthcare.⁷

Since the Swedish Knee Arthroplasty Register (SKAR) was established 40 years ago, NQRs have been commonplace in Scandinavian countries, Australia, and the United Kingdom.²³ Between 2001 and 2014, the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) documented a decline in the financial burden of hip and knee arthroplasty revision in Australia—in comparison with the United States, which did not have a full national registry at the time and showed a revision rate increase.²⁴ The economic benefit of reducing hip and knee arthroplasty revisions in Australia during that period was an estimated $65 million to $143 million.²⁴ Besides having financial benefits, national registries allow early identification of flawed implantation products and methods, leading to a further reduction in the burden associated with recall and future use of such defective implants—including patient harm.

In addition to monitoring existing techniques and devices, registries can also follow new techniques and, compared with publication in clinical journals, more expeditiously provide clinical data for outcome expectations and treatment methods. This timeliness is particularly valuable given that publication of clinical trials with the usual mandatory 2-year follow-up can take 4 years or longer.^33,34 For instance, in the expanding field of hip arthroscopy, data from registries in both Sweden and Denmark are being analyzed.^35,36 These data are important in new fields such as hip arthroscopy, in which clinical indications and treatment techniques may vary considerably between locations.³⁵ In 2012, the Danish Hip Arthroscopy Registry (DHAR) was started as a web-based prospective registry.³⁶ Between 2012 and December 2014, DHAR added 2000 procedures, which included all hip arthroscopy procedures performed at 11 centers in Denmark.³⁶ DHAR tracks PROM, surgical procedure, operative, and radiologic data.

Increased use of clinical registries has led to use of their data in clinical research. Registry-based randomized controlled trials (RCTs) are lower in cost than other types of research, allow for rapid enrollment of patients, offer larger population sizes and multi-institutional sampling, and can provide a more diverse patient population.^19,37 Although nonregistry RCTs remain the gold standard of clinical research, registry RCTs have several advantages given the abilities and structure of registries. Because of resources and cost, nonregistry RCTs are usually limited in the number of examined exposures and typically focus on only 2.6 Registry RCTs, on the other hand, can monitor multiple exposures, typically at minimal cost difference.⁶ Another disadvantage of nonregistry RCTs is that they are often performed at institutions providing care that might not be indicative of the quality most patients expect, as these institutions might be selected for a specific clinician or specialty service.

Registry RCTs also have their limitations with respect to clinical research. A major one is their lack of validity standards or accepted benchmarks for accuracy, adherence rates, registry completeness, and data collection.^37,38 In addition, lack of standardization across national and international registries could produce conflicting data. Another limitation is that data in most registries are not subjected to any third-party checks or independent auditing.^9,39 Furthermore, evaluating the impact of registries is difficult because it is difficult to find comparable outcome data on nonregistry patients.⁴⁰ A final limitation involves the ethics of including registry data in RCTs. Although data are often added to a registry without patient consent, should the same data be used for research without patient consent? Should patients be able to disallow use of their data for research, or require a notification each time their data are used? These issues must be addressed.

Review Limitations 

One limitation of this review of clinical Internet-based outcome systems is that it might not have identified comparable systems. In addition, specific costs associated with each system were not addressed, as they depend on PROM licensing fees, total institutional access, other proprietary costs, and other variables. Another limitation, in terms of creating a national or international registry, continues to be Internet access. The Pew Research Center estimated that 84% of US adults used the Internet in 2015.⁴¹ Although 84% represents most of the adult population, the other 16% typically is over age 65 years, where only 58% of adults reported using the Internet, or come from lower income households, where access was <75%. For registries in European countries and North America, where Internet usage typically is >70%, this is not a significant problem. However, worldwide, only 47% of the population used the Internet in 2016.⁴² Internet usage by Asian and Arab states citizens was 41.6% and 41.9%, respectively, and usage by African citizens was only 25.1%. As a significant benefit of registry use is that researchers can obtain larger sample sizes, it is a problem that some populations—elderly people, people of lower socioeconomic standing, people living where the Internet is unavailable—might be underrepresented in registry data.

As mentioned, patient adherence is an ongoing issue for clinical registries. As adherence tends to decrease as more time passes after a patient’s treatment date, it is important to account for and encourage continued patient participation with outcome monitoring. Missing data lessen the validity and accuracy of a registry, increasing the likelihood that certain groups will be underrepresented. Although registry systems can reduce the cost of following PROMs, doing so requires monitoring and following up on issues of patient adherence. In other words, many clinicians will need the help of a research assistant. Makhni and colleagues²¹ found that adding a research assistant for this task increased survey adherence from 65% to 94% before surgery, from 65% to 72% 6 months after surgery, and from 38% to 56% 12 months after surgery.

Even though studies continue to use clinical data from registries, there is not much research on the impact of these registries on improvement in healthcare. Again, many factors are involved: lack of standardized benchmarks for accuracy and adherence, lack of an accepted method of data auditing and validation, and difficulty evaluating the impact of registries owing to the difficulty obtaining comparable data on nonregistry patients. Registries must adopt accepted forms of standardization in order to allow better comparisons of registries, because comparing data across registries can be useful in determining the strengths and weaknesses of different registries.^27,43 As registries support decision making at clinical, institutional, and governmental levels, it is vital that their clinical data be accurate and reliable.³⁸

Conclusion

Rising healthcare costs, and government and third-party pressures are making patient outcomes collection a standard of care. Going forward, orthopedic surgeons must be proactive, and Internet -based registries provide technological advances that facilitate the process.

Take-Home Points

• PRO data collection can provide feedback for improvements in patient care and physician performance.
• Many options exist for orthopedic physicians to establish clinical data registries.
• Registry systems can help improve patient follow-up with system monitoring and patient reminders.
• Clinical registries can offer many advantages to observational research.
• With registry use becoming more prevalent, work needs to be done to establish standards for validity and reliability.

In a 2012 review of database tools, Lubowitz and Smith¹ examined Internet-based applications that arthroscopic surgeons could use to record and monitor patient-reported outcome (PRO) data and potential adverse effects. In this article, we update orthopedic surgeons on the registries and monitoring software mentioned in that earlier publication and in other publications that have since become available.

Most orthopedic surgery candidates are seeking pain relief and improved function. Many patients expect their pain to be completely relieved by surgical intervention and their function to return to what it was before they became stricken.^2,3 Therefore, PRO measures (PROMs) are now standard in post-orthopedic surgery outcome reporting.⁴ PROMs, which include any measurement that assesses a patient’s health, illness, or benefits from the perspective of the patient, are often administered as a questionnaire or survey.⁵ The collection of PROMs continues to increase and evolve, creating a need for data storage and analysis. Registries, large collections of patient information and outcomes, allow for evaluation of patient outcomes, monitoring of adverse effects, identification of procedure incidence, understanding of predictors of prognosis, generation of feedback for quality of care, monitoring of the safety of implantable devices, and the conducting of hypothesis-driven scientific research.^6-9

Orthopedic surgery has registries at regional, national, and international levels. Although the United States has fallen well behind other countries in establishing a national registry,⁹ it has made some recent progress. The United States now has several national registries, including the American Joint Replacement Registry (AJRR), Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), the Kaiser Permanente National Total Joint Replacement Registry (TJRR), the Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs), and the National Trauma Data Bank (NTDB).⁹ AJRR currently has 960 hospitals participating and is tracking 1,084,664 hip and knee replacements.¹⁰

These orthopedic registries, however, are limited in 2 ways. First, the majority are joint replacement registries. Second, though registries are established to determine patterns of care and predict patient outcomes, many are not set up to report care data back to healthcare providers.⁷ For procedures other than joint arthroplasty and for providers interested in tracking their patients’ PROs, systems are available for establishing clinical quality registries in orthopedics.

Registry Systems

CareSense

CareSense (Medtrak) is an Internet-based care management and data collection system designed for patient engagement, which results in fewer missed appointments, increased patient adherence, enhanced patient education, and improved patient satisfaction.¹¹ CareSense features email/text reminders for data entry, custom and standard reports, import and export of electronic medical record (EMR) information, and tools for running research studies.¹² CareSense emphasizes care navigation by helping hospitals educate and guide patients through their care by sending exercise videos to patients for home rehabilitation, transferring messages from post-acute care facilities to surgeons and caregivers, and alerting the care team to any potential readmission symptoms.^11,13 CareSense is also a Centers for Medicare & Medicaid Services (CMS) approved qualified clinical data registry (QCDR). QCDRs collect data for Merit-Based Incentive Payment System (MIPS) clinicians and submit the data to CMS.¹²

KareOutcomes

KareOutcomes, a healthcare technology and support firm founded in 2009, advocates transparency and trust among providers and patients, and aims to optimize PROs.¹⁴ The KareOutcomes team incorporates patient follow-up personnel, administrators, engineers, physicians, software developers, and technicians. The KareOutcomes software, which is backed by a 6-month guarantee, includes system design and implementation, data collection and entry, methods of submitting data to statewide or nationwide registries and sending standardized and customized surveys, and accessible and meaningful data presentation. KareOutcomes allows patient follow-up through automated reminders by telephone, SMS text message, and email. Patients can respond to surveys or questionnaires whichever way is most convenient—by telephone, Internet, SMS text message, or on paper, either in the office or by mail.

Oberd

Oberd (Universal Research Solutions) offers a comprehensive package of solutions for collecting optimal PRO data. The package has several modules: outcomes, education, registry, operative notes, data import and export, and data reporting.¹⁵ Oberd Outcomes allows convenient and engaging data collection. For example, users can send both standardized and customized forms. Oberd Education allows patients to receive information in an interactive, narrated format that is specific to their physician’s techniques and practices. Oberd Registry allows users to input multiple datasets into a registry, compare data, and generate reports with visuals. Like CareSense, Oberd is a CMS-approved QCDR. Oberd’s MIPS Dashboard helps providers collect and report patients’ reported outcomes, and use that information to modify and improve their practice.

Ortech

Ortech is a web-based data registry system that allows physicians and administrators to mine the data they own, track key metrics in their data, and improve reporting.¹⁶ Users can collect PROMs, use them to measure and analyze patient progress, and add to their collection of information that helps support their evidence-based decision making. They can capture intraoperative and implant data through barcode scanning, which then registers the data in an implant product code library that allows quick identification of patients with a specific implant in the event of a product recall. Ortech also allows automatic generation of customized operative reports on data entered from the operating room and populated into the EMR. Ortech offers 2 versions of its data collection platform, phiDB and phiDB Lite. The phiDB Lite version is for smaller practices and focuses mainly on PROMs but lacks many of the other features that phiDB offers, such as operating room modules, automated operative reports, barcode scanning, and unlimited data reporting.

Socrates

Socrates (Standardised Orthopaedic Clinical Research and Treatment Evaluation Software; Ortholink) is dedicated orthopedic software that facilitates following patient outcomes and conducting high-quality research.¹⁷ Socrates is fully customizable to fit each user’s needs. It allows for tracking of outcome scores, intraoperative details, nonoperative procedures, clinical examinations, therapies, and adverse effects. Users can also create reports from this information, which is inputted to Socrates and can be exported into EMR. Socrates data are stored on the user’s server, on site; the software generates patient summaries, collective summaries, and follow-up reports through its built-in descriptive statistics module. Raw data can be extracted for statistical analysis. Socrates can catalogue images, radiographs, documents, and videos.

Surgical Outcomes System

Surgical Outcomes System (SOS; Arthrex) is a cloud-based orthopedic and sports medicine global registry that focuses on monitoring and evaluating the outcomes of various orthopedic and sports medicine surgical procedures, as well as nonoperative interventions, to contribute to evidence-based protocols for patient treatment.¹⁸ SOS can be fully customized with desired PROMs for arthroplasty and for surgical procedures for extremity joints and even the spine. SOS includes real-time reporting on PROs for individual patients, summary PROMs for all of the physician’s patients who are receiving the same treatment, and comparisons with all registry patients (from global de-identified registry data) who had the same treatment or surgery. This real-time analysis provides immediate patient and physician feedback on treatments and products used. A patient portal for education on surgical procedures is also available. SOS is approved for use in 21 countries and is a benefit included with Arthroscopy Association of North America (AANA) membership. SOS is listed on the National Quality Registry Network (NQRN) website and, as a specialized registry as defined by CMS, can accept data generated by EMR technology.

Discussion

Delaunay¹⁹ indicated that successful registry management depends on several factors, including “use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants.” The registry systems reviewed in this article are Internet based and allow healthcare providers to monitor the clinical outcomes of their patients in the hope of improving clinical decision-making and overall patient care. From the provider perspective, many registry systems allow for integration of outcome data reporting into EMRs, including generation of operative reports. In turn, registries can improve documentation efficiency, as it was estimated that a US physician without a registry spends more than 15 hours a week reporting quality measures,20 or almost 800 hours and $15 billion each year.^20,21 It remains to be seen whether registry systems will optimize the documentation process, but there is potential improvement in time and cost-efficiency with registry use.

Although the factors involved in management are important, clinical data registries must have systems in place to help ensure patient adherence and minimize selection bias, as adherence is crucial in data accuracy.³ What helps with adherence is the ability to send automated email or SMS text message reminders to patients. According to a review, email reminders increased the completion of PROM datasets by 26%.²² When the new national quality register (NQR) HAKIR (Handkirurgiskt kvalitetsregister) was established in Sweden, it was found that when only 1 type of reminder was used (SMS text message, in this case), only about 30% of participants completed their questionnaires.²³ However, after the system was changed to send both SMS text message and email reminders, the response rate increased from 50% to 60%. Using 2 types of automated reminders might minimize lost data more effectively than 1 type alone.

Another benefit of outcome monitoring through a registry is potential reduction of interviewer- related errors. Interviewer bias can occur in many different ways. Interviewers might not follow the same instructions or administer questionnaires or surveys the same way for different patients,²⁴ the interviewer’s presence might cause the patient to alter responses based on social norms,²⁵ and the patient might report better outcomes in the presence of a physician or interviewer.^26,27 Given that clinical registries allow electronic capture of self-administered surveys, interviewer bias is reduced because all patients receive a standardized set of questions and instructions. In addition, electronic questionnaires and surveys prompt users to add or fix missed or incorrectly completed items, further reducing potential data inaccuracies.

Healthcare costs continue to rise in the United States. In 2015, the total cost of healthcare expenditure in the United States was $3.2 trillion, or almost 18% of the US gross domestic product.²⁸ In addition, in the first half of 2016, an estimated 16.2% of people under age 65 years were in families that were struggling to pay medical bills.^29,30 Healthcare reform provides a financial incentive to healthcare providers to collaborate to reduce unnecessary costs and procedures and improve the quality of healthcare.³¹ Porter and Teisberg³² defined value as health outcomes achieved per dollar spent. Registry monitoring of PROMs, which are the numerator in this critical value formula, allows providers to track patient outcomes over time to determine which interventions produce the best outcomes.²² Therefore, clinical registries play an important role in improving health outcomes and reducing the cost of healthcare.⁷

Since the Swedish Knee Arthroplasty Register (SKAR) was established 40 years ago, NQRs have been commonplace in Scandinavian countries, Australia, and the United Kingdom.²³ Between 2001 and 2014, the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) documented a decline in the financial burden of hip and knee arthroplasty revision in Australia—in comparison with the United States, which did not have a full national registry at the time and showed a revision rate increase.²⁴ The economic benefit of reducing hip and knee arthroplasty revisions in Australia during that period was an estimated $65 million to $143 million.²⁴ Besides having financial benefits, national registries allow early identification of flawed implantation products and methods, leading to a further reduction in the burden associated with recall and future use of such defective implants—including patient harm.

In addition to monitoring existing techniques and devices, registries can also follow new techniques and, compared with publication in clinical journals, more expeditiously provide clinical data for outcome expectations and treatment methods. This timeliness is particularly valuable given that publication of clinical trials with the usual mandatory 2-year follow-up can take 4 years or longer.^33,34 For instance, in the expanding field of hip arthroscopy, data from registries in both Sweden and Denmark are being analyzed.^35,36 These data are important in new fields such as hip arthroscopy, in which clinical indications and treatment techniques may vary considerably between locations.³⁵ In 2012, the Danish Hip Arthroscopy Registry (DHAR) was started as a web-based prospective registry.³⁶ Between 2012 and December 2014, DHAR added 2000 procedures, which included all hip arthroscopy procedures performed at 11 centers in Denmark.³⁶ DHAR tracks PROM, surgical procedure, operative, and radiologic data.

Increased use of clinical registries has led to use of their data in clinical research. Registry-based randomized controlled trials (RCTs) are lower in cost than other types of research, allow for rapid enrollment of patients, offer larger population sizes and multi-institutional sampling, and can provide a more diverse patient population.^19,37 Although nonregistry RCTs remain the gold standard of clinical research, registry RCTs have several advantages given the abilities and structure of registries. Because of resources and cost, nonregistry RCTs are usually limited in the number of examined exposures and typically focus on only 2.6 Registry RCTs, on the other hand, can monitor multiple exposures, typically at minimal cost difference.⁶ Another disadvantage of nonregistry RCTs is that they are often performed at institutions providing care that might not be indicative of the quality most patients expect, as these institutions might be selected for a specific clinician or specialty service.

Registry RCTs also have their limitations with respect to clinical research. A major one is their lack of validity standards or accepted benchmarks for accuracy, adherence rates, registry completeness, and data collection.^37,38 In addition, lack of standardization across national and international registries could produce conflicting data. Another limitation is that data in most registries are not subjected to any third-party checks or independent auditing.^9,39 Furthermore, evaluating the impact of registries is difficult because it is difficult to find comparable outcome data on nonregistry patients.⁴⁰ A final limitation involves the ethics of including registry data in RCTs. Although data are often added to a registry without patient consent, should the same data be used for research without patient consent? Should patients be able to disallow use of their data for research, or require a notification each time their data are used? These issues must be addressed.

Review Limitations 

One limitation of this review of clinical Internet-based outcome systems is that it might not have identified comparable systems. In addition, specific costs associated with each system were not addressed, as they depend on PROM licensing fees, total institutional access, other proprietary costs, and other variables. Another limitation, in terms of creating a national or international registry, continues to be Internet access. The Pew Research Center estimated that 84% of US adults used the Internet in 2015.⁴¹ Although 84% represents most of the adult population, the other 16% typically is over age 65 years, where only 58% of adults reported using the Internet, or come from lower income households, where access was <75%. For registries in European countries and North America, where Internet usage typically is >70%, this is not a significant problem. However, worldwide, only 47% of the population used the Internet in 2016.⁴² Internet usage by Asian and Arab states citizens was 41.6% and 41.9%, respectively, and usage by African citizens was only 25.1%. As a significant benefit of registry use is that researchers can obtain larger sample sizes, it is a problem that some populations—elderly people, people of lower socioeconomic standing, people living where the Internet is unavailable—might be underrepresented in registry data.

As mentioned, patient adherence is an ongoing issue for clinical registries. As adherence tends to decrease as more time passes after a patient’s treatment date, it is important to account for and encourage continued patient participation with outcome monitoring. Missing data lessen the validity and accuracy of a registry, increasing the likelihood that certain groups will be underrepresented. Although registry systems can reduce the cost of following PROMs, doing so requires monitoring and following up on issues of patient adherence. In other words, many clinicians will need the help of a research assistant. Makhni and colleagues²¹ found that adding a research assistant for this task increased survey adherence from 65% to 94% before surgery, from 65% to 72% 6 months after surgery, and from 38% to 56% 12 months after surgery.

Even though studies continue to use clinical data from registries, there is not much research on the impact of these registries on improvement in healthcare. Again, many factors are involved: lack of standardized benchmarks for accuracy and adherence, lack of an accepted method of data auditing and validation, and difficulty evaluating the impact of registries owing to the difficulty obtaining comparable data on nonregistry patients. Registries must adopt accepted forms of standardization in order to allow better comparisons of registries, because comparing data across registries can be useful in determining the strengths and weaknesses of different registries.^27,43 As registries support decision making at clinical, institutional, and governmental levels, it is vital that their clinical data be accurate and reliable.³⁸

Conclusion

Rising healthcare costs, and government and third-party pressures are making patient outcomes collection a standard of care. Going forward, orthopedic surgeons must be proactive, and Internet -based registries provide technological advances that facilitate the process.

Take-Home Points

• PRO data collection can provide feedback for improvements in patient care and physician performance.
• Many options exist for orthopedic physicians to establish clinical data registries.
• Registry systems can help improve patient follow-up with system monitoring and patient reminders.
• Clinical registries can offer many advantages to observational research.
• With registry use becoming more prevalent, work needs to be done to establish standards for validity and reliability.

In a 2012 review of database tools, Lubowitz and Smith¹ examined Internet-based applications that arthroscopic surgeons could use to record and monitor patient-reported outcome (PRO) data and potential adverse effects. In this article, we update orthopedic surgeons on the registries and monitoring software mentioned in that earlier publication and in other publications that have since become available.

Most orthopedic surgery candidates are seeking pain relief and improved function. Many patients expect their pain to be completely relieved by surgical intervention and their function to return to what it was before they became stricken.^2,3 Therefore, PRO measures (PROMs) are now standard in post-orthopedic surgery outcome reporting.⁴ PROMs, which include any measurement that assesses a patient’s health, illness, or benefits from the perspective of the patient, are often administered as a questionnaire or survey.⁵ The collection of PROMs continues to increase and evolve, creating a need for data storage and analysis. Registries, large collections of patient information and outcomes, allow for evaluation of patient outcomes, monitoring of adverse effects, identification of procedure incidence, understanding of predictors of prognosis, generation of feedback for quality of care, monitoring of the safety of implantable devices, and the conducting of hypothesis-driven scientific research.^6-9

Orthopedic surgery has registries at regional, national, and international levels. Although the United States has fallen well behind other countries in establishing a national registry,⁹ it has made some recent progress. The United States now has several national registries, including the American Joint Replacement Registry (AJRR), Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), the Kaiser Permanente National Total Joint Replacement Registry (TJRR), the Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs), and the National Trauma Data Bank (NTDB).⁹ AJRR currently has 960 hospitals participating and is tracking 1,084,664 hip and knee replacements.¹⁰

These orthopedic registries, however, are limited in 2 ways. First, the majority are joint replacement registries. Second, though registries are established to determine patterns of care and predict patient outcomes, many are not set up to report care data back to healthcare providers.⁷ For procedures other than joint arthroplasty and for providers interested in tracking their patients’ PROs, systems are available for establishing clinical quality registries in orthopedics.

Registry Systems

CareSense

CareSense (Medtrak) is an Internet-based care management and data collection system designed for patient engagement, which results in fewer missed appointments, increased patient adherence, enhanced patient education, and improved patient satisfaction.¹¹ CareSense features email/text reminders for data entry, custom and standard reports, import and export of electronic medical record (EMR) information, and tools for running research studies.¹² CareSense emphasizes care navigation by helping hospitals educate and guide patients through their care by sending exercise videos to patients for home rehabilitation, transferring messages from post-acute care facilities to surgeons and caregivers, and alerting the care team to any potential readmission symptoms.^11,13 CareSense is also a Centers for Medicare & Medicaid Services (CMS) approved qualified clinical data registry (QCDR). QCDRs collect data for Merit-Based Incentive Payment System (MIPS) clinicians and submit the data to CMS.¹²

KareOutcomes

KareOutcomes, a healthcare technology and support firm founded in 2009, advocates transparency and trust among providers and patients, and aims to optimize PROs.¹⁴ The KareOutcomes team incorporates patient follow-up personnel, administrators, engineers, physicians, software developers, and technicians. The KareOutcomes software, which is backed by a 6-month guarantee, includes system design and implementation, data collection and entry, methods of submitting data to statewide or nationwide registries and sending standardized and customized surveys, and accessible and meaningful data presentation. KareOutcomes allows patient follow-up through automated reminders by telephone, SMS text message, and email. Patients can respond to surveys or questionnaires whichever way is most convenient—by telephone, Internet, SMS text message, or on paper, either in the office or by mail.

Oberd

Oberd (Universal Research Solutions) offers a comprehensive package of solutions for collecting optimal PRO data. The package has several modules: outcomes, education, registry, operative notes, data import and export, and data reporting.¹⁵ Oberd Outcomes allows convenient and engaging data collection. For example, users can send both standardized and customized forms. Oberd Education allows patients to receive information in an interactive, narrated format that is specific to their physician’s techniques and practices. Oberd Registry allows users to input multiple datasets into a registry, compare data, and generate reports with visuals. Like CareSense, Oberd is a CMS-approved QCDR. Oberd’s MIPS Dashboard helps providers collect and report patients’ reported outcomes, and use that information to modify and improve their practice.

Ortech

Ortech is a web-based data registry system that allows physicians and administrators to mine the data they own, track key metrics in their data, and improve reporting.¹⁶ Users can collect PROMs, use them to measure and analyze patient progress, and add to their collection of information that helps support their evidence-based decision making. They can capture intraoperative and implant data through barcode scanning, which then registers the data in an implant product code library that allows quick identification of patients with a specific implant in the event of a product recall. Ortech also allows automatic generation of customized operative reports on data entered from the operating room and populated into the EMR. Ortech offers 2 versions of its data collection platform, phiDB and phiDB Lite. The phiDB Lite version is for smaller practices and focuses mainly on PROMs but lacks many of the other features that phiDB offers, such as operating room modules, automated operative reports, barcode scanning, and unlimited data reporting.

Socrates

Socrates (Standardised Orthopaedic Clinical Research and Treatment Evaluation Software; Ortholink) is dedicated orthopedic software that facilitates following patient outcomes and conducting high-quality research.¹⁷ Socrates is fully customizable to fit each user’s needs. It allows for tracking of outcome scores, intraoperative details, nonoperative procedures, clinical examinations, therapies, and adverse effects. Users can also create reports from this information, which is inputted to Socrates and can be exported into EMR. Socrates data are stored on the user’s server, on site; the software generates patient summaries, collective summaries, and follow-up reports through its built-in descriptive statistics module. Raw data can be extracted for statistical analysis. Socrates can catalogue images, radiographs, documents, and videos.

Surgical Outcomes System

Surgical Outcomes System (SOS; Arthrex) is a cloud-based orthopedic and sports medicine global registry that focuses on monitoring and evaluating the outcomes of various orthopedic and sports medicine surgical procedures, as well as nonoperative interventions, to contribute to evidence-based protocols for patient treatment.¹⁸ SOS can be fully customized with desired PROMs for arthroplasty and for surgical procedures for extremity joints and even the spine. SOS includes real-time reporting on PROs for individual patients, summary PROMs for all of the physician’s patients who are receiving the same treatment, and comparisons with all registry patients (from global de-identified registry data) who had the same treatment or surgery. This real-time analysis provides immediate patient and physician feedback on treatments and products used. A patient portal for education on surgical procedures is also available. SOS is approved for use in 21 countries and is a benefit included with Arthroscopy Association of North America (AANA) membership. SOS is listed on the National Quality Registry Network (NQRN) website and, as a specialized registry as defined by CMS, can accept data generated by EMR technology.

Discussion

Delaunay¹⁹ indicated that successful registry management depends on several factors, including “use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants.” The registry systems reviewed in this article are Internet based and allow healthcare providers to monitor the clinical outcomes of their patients in the hope of improving clinical decision-making and overall patient care. From the provider perspective, many registry systems allow for integration of outcome data reporting into EMRs, including generation of operative reports. In turn, registries can improve documentation efficiency, as it was estimated that a US physician without a registry spends more than 15 hours a week reporting quality measures,20 or almost 800 hours and $15 billion each year.^20,21 It remains to be seen whether registry systems will optimize the documentation process, but there is potential improvement in time and cost-efficiency with registry use.

Although the factors involved in management are important, clinical data registries must have systems in place to help ensure patient adherence and minimize selection bias, as adherence is crucial in data accuracy.³ What helps with adherence is the ability to send automated email or SMS text message reminders to patients. According to a review, email reminders increased the completion of PROM datasets by 26%.²² When the new national quality register (NQR) HAKIR (Handkirurgiskt kvalitetsregister) was established in Sweden, it was found that when only 1 type of reminder was used (SMS text message, in this case), only about 30% of participants completed their questionnaires.²³ However, after the system was changed to send both SMS text message and email reminders, the response rate increased from 50% to 60%. Using 2 types of automated reminders might minimize lost data more effectively than 1 type alone.

Another benefit of outcome monitoring through a registry is potential reduction of interviewer- related errors. Interviewer bias can occur in many different ways. Interviewers might not follow the same instructions or administer questionnaires or surveys the same way for different patients,²⁴ the interviewer’s presence might cause the patient to alter responses based on social norms,²⁵ and the patient might report better outcomes in the presence of a physician or interviewer.^26,27 Given that clinical registries allow electronic capture of self-administered surveys, interviewer bias is reduced because all patients receive a standardized set of questions and instructions. In addition, electronic questionnaires and surveys prompt users to add or fix missed or incorrectly completed items, further reducing potential data inaccuracies.

Healthcare costs continue to rise in the United States. In 2015, the total cost of healthcare expenditure in the United States was $3.2 trillion, or almost 18% of the US gross domestic product.²⁸ In addition, in the first half of 2016, an estimated 16.2% of people under age 65 years were in families that were struggling to pay medical bills.^29,30 Healthcare reform provides a financial incentive to healthcare providers to collaborate to reduce unnecessary costs and procedures and improve the quality of healthcare.³¹ Porter and Teisberg³² defined value as health outcomes achieved per dollar spent. Registry monitoring of PROMs, which are the numerator in this critical value formula, allows providers to track patient outcomes over time to determine which interventions produce the best outcomes.²² Therefore, clinical registries play an important role in improving health outcomes and reducing the cost of healthcare.⁷

Since the Swedish Knee Arthroplasty Register (SKAR) was established 40 years ago, NQRs have been commonplace in Scandinavian countries, Australia, and the United Kingdom.²³ Between 2001 and 2014, the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) documented a decline in the financial burden of hip and knee arthroplasty revision in Australia—in comparison with the United States, which did not have a full national registry at the time and showed a revision rate increase.²⁴ The economic benefit of reducing hip and knee arthroplasty revisions in Australia during that period was an estimated $65 million to $143 million.²⁴ Besides having financial benefits, national registries allow early identification of flawed implantation products and methods, leading to a further reduction in the burden associated with recall and future use of such defective implants—including patient harm.

In addition to monitoring existing techniques and devices, registries can also follow new techniques and, compared with publication in clinical journals, more expeditiously provide clinical data for outcome expectations and treatment methods. This timeliness is particularly valuable given that publication of clinical trials with the usual mandatory 2-year follow-up can take 4 years or longer.^33,34 For instance, in the expanding field of hip arthroscopy, data from registries in both Sweden and Denmark are being analyzed.^35,36 These data are important in new fields such as hip arthroscopy, in which clinical indications and treatment techniques may vary considerably between locations.³⁵ In 2012, the Danish Hip Arthroscopy Registry (DHAR) was started as a web-based prospective registry.³⁶ Between 2012 and December 2014, DHAR added 2000 procedures, which included all hip arthroscopy procedures performed at 11 centers in Denmark.³⁶ DHAR tracks PROM, surgical procedure, operative, and radiologic data.

Increased use of clinical registries has led to use of their data in clinical research. Registry-based randomized controlled trials (RCTs) are lower in cost than other types of research, allow for rapid enrollment of patients, offer larger population sizes and multi-institutional sampling, and can provide a more diverse patient population.^19,37 Although nonregistry RCTs remain the gold standard of clinical research, registry RCTs have several advantages given the abilities and structure of registries. Because of resources and cost, nonregistry RCTs are usually limited in the number of examined exposures and typically focus on only 2.6 Registry RCTs, on the other hand, can monitor multiple exposures, typically at minimal cost difference.⁶ Another disadvantage of nonregistry RCTs is that they are often performed at institutions providing care that might not be indicative of the quality most patients expect, as these institutions might be selected for a specific clinician or specialty service.

Registry RCTs also have their limitations with respect to clinical research. A major one is their lack of validity standards or accepted benchmarks for accuracy, adherence rates, registry completeness, and data collection.^37,38 In addition, lack of standardization across national and international registries could produce conflicting data. Another limitation is that data in most registries are not subjected to any third-party checks or independent auditing.^9,39 Furthermore, evaluating the impact of registries is difficult because it is difficult to find comparable outcome data on nonregistry patients.⁴⁰ A final limitation involves the ethics of including registry data in RCTs. Although data are often added to a registry without patient consent, should the same data be used for research without patient consent? Should patients be able to disallow use of their data for research, or require a notification each time their data are used? These issues must be addressed.

Review Limitations 

One limitation of this review of clinical Internet-based outcome systems is that it might not have identified comparable systems. In addition, specific costs associated with each system were not addressed, as they depend on PROM licensing fees, total institutional access, other proprietary costs, and other variables. Another limitation, in terms of creating a national or international registry, continues to be Internet access. The Pew Research Center estimated that 84% of US adults used the Internet in 2015.⁴¹ Although 84% represents most of the adult population, the other 16% typically is over age 65 years, where only 58% of adults reported using the Internet, or come from lower income households, where access was <75%. For registries in European countries and North America, where Internet usage typically is >70%, this is not a significant problem. However, worldwide, only 47% of the population used the Internet in 2016.⁴² Internet usage by Asian and Arab states citizens was 41.6% and 41.9%, respectively, and usage by African citizens was only 25.1%. As a significant benefit of registry use is that researchers can obtain larger sample sizes, it is a problem that some populations—elderly people, people of lower socioeconomic standing, people living where the Internet is unavailable—might be underrepresented in registry data.

As mentioned, patient adherence is an ongoing issue for clinical registries. As adherence tends to decrease as more time passes after a patient’s treatment date, it is important to account for and encourage continued patient participation with outcome monitoring. Missing data lessen the validity and accuracy of a registry, increasing the likelihood that certain groups will be underrepresented. Although registry systems can reduce the cost of following PROMs, doing so requires monitoring and following up on issues of patient adherence. In other words, many clinicians will need the help of a research assistant. Makhni and colleagues²¹ found that adding a research assistant for this task increased survey adherence from 65% to 94% before surgery, from 65% to 72% 6 months after surgery, and from 38% to 56% 12 months after surgery.

Even though studies continue to use clinical data from registries, there is not much research on the impact of these registries on improvement in healthcare. Again, many factors are involved: lack of standardized benchmarks for accuracy and adherence, lack of an accepted method of data auditing and validation, and difficulty evaluating the impact of registries owing to the difficulty obtaining comparable data on nonregistry patients. Registries must adopt accepted forms of standardization in order to allow better comparisons of registries, because comparing data across registries can be useful in determining the strengths and weaknesses of different registries.^27,43 As registries support decision making at clinical, institutional, and governmental levels, it is vital that their clinical data be accurate and reliable.³⁸

Conclusion

Rising healthcare costs, and government and third-party pressures are making patient outcomes collection a standard of care. Going forward, orthopedic surgeons must be proactive, and Internet -based registries provide technological advances that facilitate the process.

Take-Home Points

• The SCR is a viable treatment option for massive, irreparable RCTs.
• Arm position and exact measurement between anchors will help ensure proper graft tensioning.
• Anterior and posterior tension and margin convergence are critical to stabilizing the graft.
• Acromial-humeral distance, ASES, and VAS scores are improved and maintained over long-term follow-up.
• The dermal allograft should be 3.0 mm or thicker.

Conventional treatments for irreparable massive rotator cuff tears (RCTs) have ranged from nonoperative care to débridement and biceps tenotomy,^1,2 partial cuff repair,^3,4 bridging patch grafts,⁵ tendon transfers,^6,7 and reverse total shoulder arthroplasty (RTSA).^8,9 Superior capsular reconstruction (SCR), originally described by Mihata and colleagues,¹⁰ has been developed as an alternative to these interventions. Dr. Hirahara modified the technique to use dermal allograft instead of fascia lata autograft.^10,11

Biomechanical analysis has confirmed the integral role of the superior capsule in shoulder function.^10,12-14 In the presence of a massive RCT, the humeral head migrates superiorly, causing significant pain and functional deficits, such as pseudoparalysis. It is theorized that reestablishing this important stabilizer—centering the humeral head in the glenoid and allowing the larger muscles to move the arm about a proper fulcrum—improves function and decreases pain.

Using ultrasonography (US), radiography, magnetic resonance imaging (MRI), clinical outcome scores, and a visual analog scale (VAS) for pain, we prospectively evaluated minimum 2-year clinical outcomes of performing SCR with dermal allograft for irreparable RCTs.

Methods

Except where noted otherwise, all products mentioned in this section were made by Arthrex.

Surgical Technique

The surgical technique used here was described by Hirahara and Adams.¹¹ ArthroFlex dermal allograft was attached to the greater tuberosity and the glenoid, creating a superior restraint that replaced the anatomical superior capsule (Figures 1A, 1B). Some cases included biceps tenotomy, subscapularis repair, or infraspinatus repair.

Medial fixation was obtained with a PASTA (partial articular supraspinatus tendon avulsion) bridge-type construct¹⁵ that consisted of two 3.0-mm BioComposite SutureTak anchors (placed medially on the glenoid rim, medial to the labrum) and a 3.5-mm BioComposite Vented SwiveLock. In some cases, a significant amount of tissue was present medially, and the third anchor was not used; instead, a double surgeon knot was used to fixate the double pulley medially.

Posterior margin convergence (PMC) was performed in all cases. Anterior margin convergence (AMC) was performed in only 3 cases.

Clinical Evaluation

All patients who underwent SCR were followed prospectively, and all signed an informed consent form. Between 2014 and the time of this study, 9 patients had surgery with a minimum 2-year follow-up. Before surgery, all patients received a diagnosis of full-thickness RCT with decreased acromial-humeral distance (AHD). One patient had RTSA 18 months after surgery, did not reach the 2-year follow-up, and was excluded from the data analysis. Patients were clinically evaluated on the 100-point American Shoulder and Elbow Surgeons (ASES) shoulder index and on a 10-point VAS for pain—before surgery, monthly for the first 6 months after surgery, then every 6 months until 2 years after surgery, and yearly thereafter. These patients were compared with Dr. Hirahara’s historical control patients, who had undergone repair of massive RCTs. Mean graft size was calculated and reported. Cases were separated and analyzed on the basis of whether AMC was performed. Student t tests were used to determine statistical differences between study patients’ preoperative and postoperative scores, between study and historical control patients, and between patients who had AMC performed and those who did not (P < .05).

Imaging

For all SCR patients, preoperative and postoperative radiographs were obtained in 2 planes: anterior-posterior with arm in neutral rotation, and scapular Y. On anteroposterior radiographs, AHD was measured from the most proximal aspect of the humeral head in a vertical line to the most inferior portion of the acromion (Figures 2A, 2B).

Results

The Table provides an overview of the study results. Eight patients (6 men, 2 women) met the final inclusion criteria for postoperative ASES and VAS data analysis.

AHD was measured on a standard anteroposterior radiograph in neutral rotation. The Hamada grading scale16 was used to classify the massive RCTs before and after surgery. Before surgery, 4 were grade 4A, 1 grade 3, 2 grade 2, and 1 grade 1; immediately after surgery, all were grade 1 (AHD, ≥6 mm). Two years after surgery, 1 patient had an AHD of 4.6 mm after a failure caused by a fall. Mean (SD) preoperative AHD was 4.50 (2.25) mm (range, 1.7-7.9 mm). Radiographs obtained immediately (mean, 1.22 months; range, 1 day-2.73 months) after surgery showed AHD was significantly (P < .0008) increased (mean, 8.48 mm; SD, 1.25 mm; range, 6.0-10.0 mm) (Figure 5).

Mean graft size was 2.9 mm medial × 3.6 mm lateral × 5.4 mm anterior × 5.4 mm posterior. Three patients had AMC performed. There was a significant (P < .05) difference in ASES scores between patients who had AMC performed (93) and those who did not (77).

Ultrasonography

Two weeks to 2 months after surgery, all patients had an intact capsular graft and no pulsatile vessels on US. Between 4 months and 10 months, US showed the construct intact laterally in all cases, a pulsatile vessel in the graft at the tuberosity (evidence of blood flow) in 4 of 5 cases, and a pulsatile vessel hypertrophied in 2 cases (Figures 6A, 6B).

Magnetic Resonance Imaging

Before surgery, 4 patients had Goutallier¹⁷ stage 4 rotator cuff muscle degeneration, 2 had stage 3 degeneration, and 2 had stage 2 degeneration. Throughout the follow-up period, US was as effective as MRI in determining graft integrity, graft thickness, and greater tuberosity fixation. Therefore, the SCRs were assessed primarily with US. MRI was ordered only if a failure was suspected or if the patient had some form of trauma. A total of 7 MRIs were ordered for 5 of the 8 patients in the study. The graft was intact in 4 of the 5 (Figures 7A-7C) and ruptured in the fifth.

Discussion

Mihata and colleagues¹⁰ published 2-year data for their reconstructive procedure with fascia lata autograft. In a modification of their procedure, Dr. Hirahara used dermal allograft to recreate the superior capsule.¹¹ The results of the present 2-year study mirror the clinical outcomes reported by Mihata and colleagues¹⁰ and confirm that SCR improves functional outcomes and increases AHD regardless of graft type used.

The outcomes of the SCR patients in our study were significantly better than the outcomes of the historical control patients, who underwent repair of massive RCTs. Although there was no significant difference in the 2 groups’ ASES scores, the control patients had significantly higher postoperative VAS pain scores. We think that, as more patients undergo SCR and the population sample increases, we will see a significant difference in ASES scores as well (our SCR patients already showed a trend toward improved ASES scores).

Compared with RTSA, SCR has fewer risks and fewer complications and does not limit further surgical options.^8,9,18 The 9 patients who had surgery with a minimum 2-year follow-up in our study had 4 complications. Six months after surgery, 1 patient fell and tore the infraspinatus and subscapularis muscles. Outcomes continued to improve, and no issues were reported, despite a decrease in AHD, from 8 mm immediately after surgery to 4.6 mm 2 years after surgery.

Two patients were in motor vehicle accidents. In 1 case, the accident occurred about 2 months after surgery. This patient also sustained a possible injury in a fall after receiving general anesthesia for a dental procedure. After having done very well the preceding months, the patient now reported increasing pain and dysfunction. MRI showed loss of glenoid fixation. Improved ASES and VAS pain scores were maintained throughout the follow-up period. AHD was increased at 13 months and mildly decreased at 2 years. Glenoid fixation was obtained with 2 anchors and a double surgeon knot. When possible, however, it is best to add an anchor and double-row fixation, as 3 anchors and a double-row construct are biomechanically stronger.^19-24

The other motor vehicle accident occurred about 23 months after surgery. Two months later, a graft rupture was found on US and MRI, but the patient was maintaining full range of motion, AHD, and improved strength. The 1.5-mm graft in this patient was thinner than the 3.5-mm grafts in the rest of the study group. This was the only patient who developed a graft rupture rather than loss of fixation.

If only patients with graft thickness >3.0 mm are included in the data analysis, mean ASES score rises to 89.76, and mean VAS pain score drops to 0. Therefore, we argue against using a graft thinner than 3.5 mm. Our excellent study results indicate that larger grafts are unnecessary. Mihata and colleagues¹⁰ used fascia lata grafts of 6 mm to 8 mm. Ultimate load to failure is significantly higher for dermal allograft than for fascia lata graft.²⁵ In SCR, the stronger dermal allograft withstands applied forces and repeated deformations and has excellent clinical outcomes.

Only 1 patient had a failure that required RTSA. VAS pain scores were lower and ASES scores were improved the first year after surgery, but then function deteriorated. The patient said there was no specific precipitating incident. Computed tomography arthrogram, ordered to assess the construct, showed anterior and superior subluxation of the humeral head, even with an intact subscapularis tendon—an indication of underlying instability, which most likely caused the failure. Eighteen months after surgery, the patient was able to undergo RTSA. On further evaluation of this patient’s procedure, it was determined that the graft needed better fixation anteriorly.

Mihata and colleagues^10,12,14 indicated that AMC was unnecessary, and our procedure did not require it. However, data in our prospective evaluation began showing improved outcomes with AMC. As dermal allograft is more elastic than fascia lata autograft,²⁵ we concluded that graft tensioning is key to the success of this procedure. Graft tension depends on many factors, including exact measurement of the distances between the anchors to punch holes in the graft, arm position to set the relationship between the anchor distances, and AMC and PMC. We recommend placing the arm in neutral rotation, neutral flexion, and abduction with the patient at rest, based on the size of the patient’s latissimus dorsi. Too much abduction causes overtensioning, and excess rotation or flexion-extension changes the distance between the glenoid and the greater tuberosity asymmetrically, from anterior to posterior. With the arm in neutral position, distances between anchors are accurately measured, and these measurements are used to determine graft size.

Graft tension is also needed to control the amount of elasticity allowed by the graft and thereby maintain stability, as shown by the Poisson ratio, the ratio of transverse contraction to longitudinal extension on a material in the presence of a stretching force. As applied to SCR, it is the ratio of mediolateral elasticity to anteroposterior deformation or constraint. If the graft is appropriately secured in the anteroposterior direction by way of ACM and PMC, elongation in the medial-lateral direction will be limited—reducing the elasticity of the graft, improving overall stability, and ultimately producing better clinical outcomes. This issue was discussed by Burkhart and colleagues²⁶ with respect to the “rotator cable complex,” which now might be best described as the “rotator-capsule cable complex.” In our study, this phenomenon was evident in the finding that patients who had AMC performed did significantly better than patients who did not have AMC performed. The ability of dermal allograft to deform in these dimensions without failure while allowing excellent range of motion makes dermal allograft an exceptional choice for grafting during SCR. Mihata25 also found dermal allograft had a clear advantage in providing better range of motion, whereas fascia lata autograft resulted in a stiffer construct. 

Dermal allograft can also incorporate into the body and transform into host tissue. The literature has described musculoskeletal US as an effective diagnostic and interventional tool.^27-31 We used it to evaluate graft size, patency, and viability. As can be seen on US, the native rotator cuff does not have any pulsatile vessels and is fed by capillary flow. Dermal allograft has native vasculature built into the tissue. After 4 months to 8 months, presence of pulsatile vessels within the graft at the greater tuberosity indicates clear revascularization and incorporation of the tissue (Figure 6B). Disappearance of pulsatile vessels on US after 1 year indicates transformation to a stabilizing structure analogous to capsule or ligament with capillary flow. US also showed graft hypertrophy after 2 years, supporting a finding of integration and growth.

Conclusion

In the past, patients with irreparable massive RCTs had few good surgical management options, RTSA being the most definitive. SCR is technically challenging and requires use of specific implantation methods but can provide patients with outstanding relief. Our clinical data showed that technically well executed SCR effectively restores the superior restraints in the glenohumeral joint and thereby increases function and decreases pain in patients with irreparable massive RCTs, even after 2 years.

Take-Home Points

• The SCR is a viable treatment option for massive, irreparable RCTs.
• Arm position and exact measurement between anchors will help ensure proper graft tensioning.
• Anterior and posterior tension and margin convergence are critical to stabilizing the graft.
• Acromial-humeral distance, ASES, and VAS scores are improved and maintained over long-term follow-up.
• The dermal allograft should be 3.0 mm or thicker.

Conventional treatments for irreparable massive rotator cuff tears (RCTs) have ranged from nonoperative care to débridement and biceps tenotomy,^1,2 partial cuff repair,^3,4 bridging patch grafts,⁵ tendon transfers,^6,7 and reverse total shoulder arthroplasty (RTSA).^8,9 Superior capsular reconstruction (SCR), originally described by Mihata and colleagues,¹⁰ has been developed as an alternative to these interventions. Dr. Hirahara modified the technique to use dermal allograft instead of fascia lata autograft.^10,11

Biomechanical analysis has confirmed the integral role of the superior capsule in shoulder function.^10,12-14 In the presence of a massive RCT, the humeral head migrates superiorly, causing significant pain and functional deficits, such as pseudoparalysis. It is theorized that reestablishing this important stabilizer—centering the humeral head in the glenoid and allowing the larger muscles to move the arm about a proper fulcrum—improves function and decreases pain.

Using ultrasonography (US), radiography, magnetic resonance imaging (MRI), clinical outcome scores, and a visual analog scale (VAS) for pain, we prospectively evaluated minimum 2-year clinical outcomes of performing SCR with dermal allograft for irreparable RCTs.

Methods

Except where noted otherwise, all products mentioned in this section were made by Arthrex.

Surgical Technique

The surgical technique used here was described by Hirahara and Adams.¹¹ ArthroFlex dermal allograft was attached to the greater tuberosity and the glenoid, creating a superior restraint that replaced the anatomical superior capsule (Figures 1A, 1B). Some cases included biceps tenotomy, subscapularis repair, or infraspinatus repair.

Medial fixation was obtained with a PASTA (partial articular supraspinatus tendon avulsion) bridge-type construct¹⁵ that consisted of two 3.0-mm BioComposite SutureTak anchors (placed medially on the glenoid rim, medial to the labrum) and a 3.5-mm BioComposite Vented SwiveLock. In some cases, a significant amount of tissue was present medially, and the third anchor was not used; instead, a double surgeon knot was used to fixate the double pulley medially.

Posterior margin convergence (PMC) was performed in all cases. Anterior margin convergence (AMC) was performed in only 3 cases.

Clinical Evaluation

All patients who underwent SCR were followed prospectively, and all signed an informed consent form. Between 2014 and the time of this study, 9 patients had surgery with a minimum 2-year follow-up. Before surgery, all patients received a diagnosis of full-thickness RCT with decreased acromial-humeral distance (AHD). One patient had RTSA 18 months after surgery, did not reach the 2-year follow-up, and was excluded from the data analysis. Patients were clinically evaluated on the 100-point American Shoulder and Elbow Surgeons (ASES) shoulder index and on a 10-point VAS for pain—before surgery, monthly for the first 6 months after surgery, then every 6 months until 2 years after surgery, and yearly thereafter. These patients were compared with Dr. Hirahara’s historical control patients, who had undergone repair of massive RCTs. Mean graft size was calculated and reported. Cases were separated and analyzed on the basis of whether AMC was performed. Student t tests were used to determine statistical differences between study patients’ preoperative and postoperative scores, between study and historical control patients, and between patients who had AMC performed and those who did not (P < .05).

Imaging

For all SCR patients, preoperative and postoperative radiographs were obtained in 2 planes: anterior-posterior with arm in neutral rotation, and scapular Y. On anteroposterior radiographs, AHD was measured from the most proximal aspect of the humeral head in a vertical line to the most inferior portion of the acromion (Figures 2A, 2B).

Results

The Table provides an overview of the study results. Eight patients (6 men, 2 women) met the final inclusion criteria for postoperative ASES and VAS data analysis.

AHD was measured on a standard anteroposterior radiograph in neutral rotation. The Hamada grading scale16 was used to classify the massive RCTs before and after surgery. Before surgery, 4 were grade 4A, 1 grade 3, 2 grade 2, and 1 grade 1; immediately after surgery, all were grade 1 (AHD, ≥6 mm). Two years after surgery, 1 patient had an AHD of 4.6 mm after a failure caused by a fall. Mean (SD) preoperative AHD was 4.50 (2.25) mm (range, 1.7-7.9 mm). Radiographs obtained immediately (mean, 1.22 months; range, 1 day-2.73 months) after surgery showed AHD was significantly (P < .0008) increased (mean, 8.48 mm; SD, 1.25 mm; range, 6.0-10.0 mm) (Figure 5).

Mean graft size was 2.9 mm medial × 3.6 mm lateral × 5.4 mm anterior × 5.4 mm posterior. Three patients had AMC performed. There was a significant (P < .05) difference in ASES scores between patients who had AMC performed (93) and those who did not (77).

Ultrasonography

Two weeks to 2 months after surgery, all patients had an intact capsular graft and no pulsatile vessels on US. Between 4 months and 10 months, US showed the construct intact laterally in all cases, a pulsatile vessel in the graft at the tuberosity (evidence of blood flow) in 4 of 5 cases, and a pulsatile vessel hypertrophied in 2 cases (Figures 6A, 6B).

Magnetic Resonance Imaging

Before surgery, 4 patients had Goutallier¹⁷ stage 4 rotator cuff muscle degeneration, 2 had stage 3 degeneration, and 2 had stage 2 degeneration. Throughout the follow-up period, US was as effective as MRI in determining graft integrity, graft thickness, and greater tuberosity fixation. Therefore, the SCRs were assessed primarily with US. MRI was ordered only if a failure was suspected or if the patient had some form of trauma. A total of 7 MRIs were ordered for 5 of the 8 patients in the study. The graft was intact in 4 of the 5 (Figures 7A-7C) and ruptured in the fifth.

Discussion

Mihata and colleagues¹⁰ published 2-year data for their reconstructive procedure with fascia lata autograft. In a modification of their procedure, Dr. Hirahara used dermal allograft to recreate the superior capsule.¹¹ The results of the present 2-year study mirror the clinical outcomes reported by Mihata and colleagues¹⁰ and confirm that SCR improves functional outcomes and increases AHD regardless of graft type used.

The outcomes of the SCR patients in our study were significantly better than the outcomes of the historical control patients, who underwent repair of massive RCTs. Although there was no significant difference in the 2 groups’ ASES scores, the control patients had significantly higher postoperative VAS pain scores. We think that, as more patients undergo SCR and the population sample increases, we will see a significant difference in ASES scores as well (our SCR patients already showed a trend toward improved ASES scores).

Compared with RTSA, SCR has fewer risks and fewer complications and does not limit further surgical options.^8,9,18 The 9 patients who had surgery with a minimum 2-year follow-up in our study had 4 complications. Six months after surgery, 1 patient fell and tore the infraspinatus and subscapularis muscles. Outcomes continued to improve, and no issues were reported, despite a decrease in AHD, from 8 mm immediately after surgery to 4.6 mm 2 years after surgery.

Two patients were in motor vehicle accidents. In 1 case, the accident occurred about 2 months after surgery. This patient also sustained a possible injury in a fall after receiving general anesthesia for a dental procedure. After having done very well the preceding months, the patient now reported increasing pain and dysfunction. MRI showed loss of glenoid fixation. Improved ASES and VAS pain scores were maintained throughout the follow-up period. AHD was increased at 13 months and mildly decreased at 2 years. Glenoid fixation was obtained with 2 anchors and a double surgeon knot. When possible, however, it is best to add an anchor and double-row fixation, as 3 anchors and a double-row construct are biomechanically stronger.^19-24

The other motor vehicle accident occurred about 23 months after surgery. Two months later, a graft rupture was found on US and MRI, but the patient was maintaining full range of motion, AHD, and improved strength. The 1.5-mm graft in this patient was thinner than the 3.5-mm grafts in the rest of the study group. This was the only patient who developed a graft rupture rather than loss of fixation.

If only patients with graft thickness >3.0 mm are included in the data analysis, mean ASES score rises to 89.76, and mean VAS pain score drops to 0. Therefore, we argue against using a graft thinner than 3.5 mm. Our excellent study results indicate that larger grafts are unnecessary. Mihata and colleagues¹⁰ used fascia lata grafts of 6 mm to 8 mm. Ultimate load to failure is significantly higher for dermal allograft than for fascia lata graft.²⁵ In SCR, the stronger dermal allograft withstands applied forces and repeated deformations and has excellent clinical outcomes.

Only 1 patient had a failure that required RTSA. VAS pain scores were lower and ASES scores were improved the first year after surgery, but then function deteriorated. The patient said there was no specific precipitating incident. Computed tomography arthrogram, ordered to assess the construct, showed anterior and superior subluxation of the humeral head, even with an intact subscapularis tendon—an indication of underlying instability, which most likely caused the failure. Eighteen months after surgery, the patient was able to undergo RTSA. On further evaluation of this patient’s procedure, it was determined that the graft needed better fixation anteriorly.

Mihata and colleagues^10,12,14 indicated that AMC was unnecessary, and our procedure did not require it. However, data in our prospective evaluation began showing improved outcomes with AMC. As dermal allograft is more elastic than fascia lata autograft,²⁵ we concluded that graft tensioning is key to the success of this procedure. Graft tension depends on many factors, including exact measurement of the distances between the anchors to punch holes in the graft, arm position to set the relationship between the anchor distances, and AMC and PMC. We recommend placing the arm in neutral rotation, neutral flexion, and abduction with the patient at rest, based on the size of the patient’s latissimus dorsi. Too much abduction causes overtensioning, and excess rotation or flexion-extension changes the distance between the glenoid and the greater tuberosity asymmetrically, from anterior to posterior. With the arm in neutral position, distances between anchors are accurately measured, and these measurements are used to determine graft size.

Graft tension is also needed to control the amount of elasticity allowed by the graft and thereby maintain stability, as shown by the Poisson ratio, the ratio of transverse contraction to longitudinal extension on a material in the presence of a stretching force. As applied to SCR, it is the ratio of mediolateral elasticity to anteroposterior deformation or constraint. If the graft is appropriately secured in the anteroposterior direction by way of ACM and PMC, elongation in the medial-lateral direction will be limited—reducing the elasticity of the graft, improving overall stability, and ultimately producing better clinical outcomes. This issue was discussed by Burkhart and colleagues²⁶ with respect to the “rotator cable complex,” which now might be best described as the “rotator-capsule cable complex.” In our study, this phenomenon was evident in the finding that patients who had AMC performed did significantly better than patients who did not have AMC performed. The ability of dermal allograft to deform in these dimensions without failure while allowing excellent range of motion makes dermal allograft an exceptional choice for grafting during SCR. Mihata25 also found dermal allograft had a clear advantage in providing better range of motion, whereas fascia lata autograft resulted in a stiffer construct. 

Dermal allograft can also incorporate into the body and transform into host tissue. The literature has described musculoskeletal US as an effective diagnostic and interventional tool.^27-31 We used it to evaluate graft size, patency, and viability. As can be seen on US, the native rotator cuff does not have any pulsatile vessels and is fed by capillary flow. Dermal allograft has native vasculature built into the tissue. After 4 months to 8 months, presence of pulsatile vessels within the graft at the greater tuberosity indicates clear revascularization and incorporation of the tissue (Figure 6B). Disappearance of pulsatile vessels on US after 1 year indicates transformation to a stabilizing structure analogous to capsule or ligament with capillary flow. US also showed graft hypertrophy after 2 years, supporting a finding of integration and growth.

Conclusion

In the past, patients with irreparable massive RCTs had few good surgical management options, RTSA being the most definitive. SCR is technically challenging and requires use of specific implantation methods but can provide patients with outstanding relief. Our clinical data showed that technically well executed SCR effectively restores the superior restraints in the glenohumeral joint and thereby increases function and decreases pain in patients with irreparable massive RCTs, even after 2 years.

Take-Home Points

• The SCR is a viable treatment option for massive, irreparable RCTs.
• Arm position and exact measurement between anchors will help ensure proper graft tensioning.
• Anterior and posterior tension and margin convergence are critical to stabilizing the graft.
• Acromial-humeral distance, ASES, and VAS scores are improved and maintained over long-term follow-up.
• The dermal allograft should be 3.0 mm or thicker.

Conventional treatments for irreparable massive rotator cuff tears (RCTs) have ranged from nonoperative care to débridement and biceps tenotomy,^1,2 partial cuff repair,^3,4 bridging patch grafts,⁵ tendon transfers,^6,7 and reverse total shoulder arthroplasty (RTSA).^8,9 Superior capsular reconstruction (SCR), originally described by Mihata and colleagues,¹⁰ has been developed as an alternative to these interventions. Dr. Hirahara modified the technique to use dermal allograft instead of fascia lata autograft.^10,11

Biomechanical analysis has confirmed the integral role of the superior capsule in shoulder function.^10,12-14 In the presence of a massive RCT, the humeral head migrates superiorly, causing significant pain and functional deficits, such as pseudoparalysis. It is theorized that reestablishing this important stabilizer—centering the humeral head in the glenoid and allowing the larger muscles to move the arm about a proper fulcrum—improves function and decreases pain.

Using ultrasonography (US), radiography, magnetic resonance imaging (MRI), clinical outcome scores, and a visual analog scale (VAS) for pain, we prospectively evaluated minimum 2-year clinical outcomes of performing SCR with dermal allograft for irreparable RCTs.

Methods

Except where noted otherwise, all products mentioned in this section were made by Arthrex.

Surgical Technique

The surgical technique used here was described by Hirahara and Adams.¹¹ ArthroFlex dermal allograft was attached to the greater tuberosity and the glenoid, creating a superior restraint that replaced the anatomical superior capsule (Figures 1A, 1B). Some cases included biceps tenotomy, subscapularis repair, or infraspinatus repair.

Medial fixation was obtained with a PASTA (partial articular supraspinatus tendon avulsion) bridge-type construct¹⁵ that consisted of two 3.0-mm BioComposite SutureTak anchors (placed medially on the glenoid rim, medial to the labrum) and a 3.5-mm BioComposite Vented SwiveLock. In some cases, a significant amount of tissue was present medially, and the third anchor was not used; instead, a double surgeon knot was used to fixate the double pulley medially.

Posterior margin convergence (PMC) was performed in all cases. Anterior margin convergence (AMC) was performed in only 3 cases.

Clinical Evaluation

All patients who underwent SCR were followed prospectively, and all signed an informed consent form. Between 2014 and the time of this study, 9 patients had surgery with a minimum 2-year follow-up. Before surgery, all patients received a diagnosis of full-thickness RCT with decreased acromial-humeral distance (AHD). One patient had RTSA 18 months after surgery, did not reach the 2-year follow-up, and was excluded from the data analysis. Patients were clinically evaluated on the 100-point American Shoulder and Elbow Surgeons (ASES) shoulder index and on a 10-point VAS for pain—before surgery, monthly for the first 6 months after surgery, then every 6 months until 2 years after surgery, and yearly thereafter. These patients were compared with Dr. Hirahara’s historical control patients, who had undergone repair of massive RCTs. Mean graft size was calculated and reported. Cases were separated and analyzed on the basis of whether AMC was performed. Student t tests were used to determine statistical differences between study patients’ preoperative and postoperative scores, between study and historical control patients, and between patients who had AMC performed and those who did not (P < .05).

Imaging

For all SCR patients, preoperative and postoperative radiographs were obtained in 2 planes: anterior-posterior with arm in neutral rotation, and scapular Y. On anteroposterior radiographs, AHD was measured from the most proximal aspect of the humeral head in a vertical line to the most inferior portion of the acromion (Figures 2A, 2B).

Results

The Table provides an overview of the study results. Eight patients (6 men, 2 women) met the final inclusion criteria for postoperative ASES and VAS data analysis.

AHD was measured on a standard anteroposterior radiograph in neutral rotation. The Hamada grading scale16 was used to classify the massive RCTs before and after surgery. Before surgery, 4 were grade 4A, 1 grade 3, 2 grade 2, and 1 grade 1; immediately after surgery, all were grade 1 (AHD, ≥6 mm). Two years after surgery, 1 patient had an AHD of 4.6 mm after a failure caused by a fall. Mean (SD) preoperative AHD was 4.50 (2.25) mm (range, 1.7-7.9 mm). Radiographs obtained immediately (mean, 1.22 months; range, 1 day-2.73 months) after surgery showed AHD was significantly (P < .0008) increased (mean, 8.48 mm; SD, 1.25 mm; range, 6.0-10.0 mm) (Figure 5).

Mean graft size was 2.9 mm medial × 3.6 mm lateral × 5.4 mm anterior × 5.4 mm posterior. Three patients had AMC performed. There was a significant (P < .05) difference in ASES scores between patients who had AMC performed (93) and those who did not (77).

Ultrasonography

Two weeks to 2 months after surgery, all patients had an intact capsular graft and no pulsatile vessels on US. Between 4 months and 10 months, US showed the construct intact laterally in all cases, a pulsatile vessel in the graft at the tuberosity (evidence of blood flow) in 4 of 5 cases, and a pulsatile vessel hypertrophied in 2 cases (Figures 6A, 6B).

Magnetic Resonance Imaging

Before surgery, 4 patients had Goutallier¹⁷ stage 4 rotator cuff muscle degeneration, 2 had stage 3 degeneration, and 2 had stage 2 degeneration. Throughout the follow-up period, US was as effective as MRI in determining graft integrity, graft thickness, and greater tuberosity fixation. Therefore, the SCRs were assessed primarily with US. MRI was ordered only if a failure was suspected or if the patient had some form of trauma. A total of 7 MRIs were ordered for 5 of the 8 patients in the study. The graft was intact in 4 of the 5 (Figures 7A-7C) and ruptured in the fifth.

Discussion

Mihata and colleagues¹⁰ published 2-year data for their reconstructive procedure with fascia lata autograft. In a modification of their procedure, Dr. Hirahara used dermal allograft to recreate the superior capsule.¹¹ The results of the present 2-year study mirror the clinical outcomes reported by Mihata and colleagues¹⁰ and confirm that SCR improves functional outcomes and increases AHD regardless of graft type used.

The outcomes of the SCR patients in our study were significantly better than the outcomes of the historical control patients, who underwent repair of massive RCTs. Although there was no significant difference in the 2 groups’ ASES scores, the control patients had significantly higher postoperative VAS pain scores. We think that, as more patients undergo SCR and the population sample increases, we will see a significant difference in ASES scores as well (our SCR patients already showed a trend toward improved ASES scores).

Compared with RTSA, SCR has fewer risks and fewer complications and does not limit further surgical options.^8,9,18 The 9 patients who had surgery with a minimum 2-year follow-up in our study had 4 complications. Six months after surgery, 1 patient fell and tore the infraspinatus and subscapularis muscles. Outcomes continued to improve, and no issues were reported, despite a decrease in AHD, from 8 mm immediately after surgery to 4.6 mm 2 years after surgery.

Two patients were in motor vehicle accidents. In 1 case, the accident occurred about 2 months after surgery. This patient also sustained a possible injury in a fall after receiving general anesthesia for a dental procedure. After having done very well the preceding months, the patient now reported increasing pain and dysfunction. MRI showed loss of glenoid fixation. Improved ASES and VAS pain scores were maintained throughout the follow-up period. AHD was increased at 13 months and mildly decreased at 2 years. Glenoid fixation was obtained with 2 anchors and a double surgeon knot. When possible, however, it is best to add an anchor and double-row fixation, as 3 anchors and a double-row construct are biomechanically stronger.^19-24

The other motor vehicle accident occurred about 23 months after surgery. Two months later, a graft rupture was found on US and MRI, but the patient was maintaining full range of motion, AHD, and improved strength. The 1.5-mm graft in this patient was thinner than the 3.5-mm grafts in the rest of the study group. This was the only patient who developed a graft rupture rather than loss of fixation.

If only patients with graft thickness >3.0 mm are included in the data analysis, mean ASES score rises to 89.76, and mean VAS pain score drops to 0. Therefore, we argue against using a graft thinner than 3.5 mm. Our excellent study results indicate that larger grafts are unnecessary. Mihata and colleagues¹⁰ used fascia lata grafts of 6 mm to 8 mm. Ultimate load to failure is significantly higher for dermal allograft than for fascia lata graft.²⁵ In SCR, the stronger dermal allograft withstands applied forces and repeated deformations and has excellent clinical outcomes.

Only 1 patient had a failure that required RTSA. VAS pain scores were lower and ASES scores were improved the first year after surgery, but then function deteriorated. The patient said there was no specific precipitating incident. Computed tomography arthrogram, ordered to assess the construct, showed anterior and superior subluxation of the humeral head, even with an intact subscapularis tendon—an indication of underlying instability, which most likely caused the failure. Eighteen months after surgery, the patient was able to undergo RTSA. On further evaluation of this patient’s procedure, it was determined that the graft needed better fixation anteriorly.

Mihata and colleagues^10,12,14 indicated that AMC was unnecessary, and our procedure did not require it. However, data in our prospective evaluation began showing improved outcomes with AMC. As dermal allograft is more elastic than fascia lata autograft,²⁵ we concluded that graft tensioning is key to the success of this procedure. Graft tension depends on many factors, including exact measurement of the distances between the anchors to punch holes in the graft, arm position to set the relationship between the anchor distances, and AMC and PMC. We recommend placing the arm in neutral rotation, neutral flexion, and abduction with the patient at rest, based on the size of the patient’s latissimus dorsi. Too much abduction causes overtensioning, and excess rotation or flexion-extension changes the distance between the glenoid and the greater tuberosity asymmetrically, from anterior to posterior. With the arm in neutral position, distances between anchors are accurately measured, and these measurements are used to determine graft size.

Graft tension is also needed to control the amount of elasticity allowed by the graft and thereby maintain stability, as shown by the Poisson ratio, the ratio of transverse contraction to longitudinal extension on a material in the presence of a stretching force. As applied to SCR, it is the ratio of mediolateral elasticity to anteroposterior deformation or constraint. If the graft is appropriately secured in the anteroposterior direction by way of ACM and PMC, elongation in the medial-lateral direction will be limited—reducing the elasticity of the graft, improving overall stability, and ultimately producing better clinical outcomes. This issue was discussed by Burkhart and colleagues²⁶ with respect to the “rotator cable complex,” which now might be best described as the “rotator-capsule cable complex.” In our study, this phenomenon was evident in the finding that patients who had AMC performed did significantly better than patients who did not have AMC performed. The ability of dermal allograft to deform in these dimensions without failure while allowing excellent range of motion makes dermal allograft an exceptional choice for grafting during SCR. Mihata25 also found dermal allograft had a clear advantage in providing better range of motion, whereas fascia lata autograft resulted in a stiffer construct. 

Dermal allograft can also incorporate into the body and transform into host tissue. The literature has described musculoskeletal US as an effective diagnostic and interventional tool.^27-31 We used it to evaluate graft size, patency, and viability. As can be seen on US, the native rotator cuff does not have any pulsatile vessels and is fed by capillary flow. Dermal allograft has native vasculature built into the tissue. After 4 months to 8 months, presence of pulsatile vessels within the graft at the greater tuberosity indicates clear revascularization and incorporation of the tissue (Figure 6B). Disappearance of pulsatile vessels on US after 1 year indicates transformation to a stabilizing structure analogous to capsule or ligament with capillary flow. US also showed graft hypertrophy after 2 years, supporting a finding of integration and growth.

Conclusion

In the past, patients with irreparable massive RCTs had few good surgical management options, RTSA being the most definitive. SCR is technically challenging and requires use of specific implantation methods but can provide patients with outstanding relief. Our clinical data showed that technically well executed SCR effectively restores the superior restraints in the glenohumeral joint and thereby increases function and decreases pain in patients with irreparable massive RCTs, even after 2 years.

Take-Home Points

• The optimal centrifugation protocol for production of rat PRP is 1300 rpm for 5 minutes.
• PRP administration in RCR improves tendon biomechanics in a rat model.
• Administration of NSAIDs following RCR has no significant effect on tendon biomechanical properties.
• NSAIDs may be co-administered with PRP without reducing efficacy of PRP.
• The role of PRP and NSAIDs in human RCR remains unclear.

Rotator cuff tears are a common source of shoulder pain and disability among older adults and athletes. Full-thickness tears alone occur in up to 30% of adults older than 60 years.¹ Surgical repair is plagued by an unpredictable rate of recurrence (range, 11%-94%).^1-10 As a result of improved suture materials, knotting patterns, and anchor designs, hardware issues are no longer the primary cause of rotator cuff repair (RCR) failures; now the principal mode of failure is biologic.² Animal model studies have found that, after injury and subsequent healing, the tendon–bone interface remains abnormal.¹¹ Rotator cuff research therefore has focused largely on biological enhancement of tendon-to-bone healing.

One means of biological augmentation is autologous platelet-rich plasma (PRP), which has supraphysiologic concentrations of platelets and their secreted growth factors. Although there is no consensus on the long-term efficacy of PRP, some studies suggest PRP accelerates healing over short and intermediate terms, which may contribute to a more rapid decrease in pain and more rapid return to normal activities.^12-18 Similarly, systemic nonsteroidal anti-inflammatory drugs (NSAIDs) have long been used to treat musculoskeletal injuries, including rotator cuff pathology. However, NSAIDs inhibit cyclooxygenase activity, and clinical and experimental data have shown that cyclooxygenase 2 function is crucial in normal tendon-to-bone healing.^19-21

Comprehensive studies have been conducted on the efficacy of both PRP and NSAIDs, but the interaction of concurrently used PRP and NSAIDs has not been determined. As many physicians use both modalities in the treatment of soft-tissue injuries, it is important to study the potential interactions when coadministered. Prior studies in small animal models suggest NSAIDs may impair tendon-to-bone healing in RCR, but there is no evidence regarding the effect of NSAIDs on the efficacy of PRP treatment.²¹

We conducted a study to determine the interaction of PRP and NSAIDs when used as adjuncts to RCR in a rat model. We hypothesized that PRP would increase the strength of RCR and that NSAIDs would interfere with the effects of PRP. A preliminary study objective was to determine an appropriate centrifugation protocol for producing PRP from rat blood, for use in this study and in future rat-based studies of PRP.

Materials and Methods

Part A: Pretesting Determination of PRP Centrifugation Protocol

Fourteen adult male Fischer rats were used in part A of this study, which was conducted to determine an appropriate PRP centrifugation protocol. Traditional PRP centrifugation protocols are established for human blood, but rat red blood cells (RBCs) and human RBCs differ in size.²² In our preliminary study, we wanted to determine the adjusted centrifuge speed and duration for producing clinically optimal PRP from rats. Clinically optimal PRP has reduced levels of RBCs, which decrease platelet affinity. Although the role of leukocytes in PRP preparations is debated, reducing the number of white blood cells (WBCs) decreases the number of matrix metalloproteinases and reactive oxygen species that may lead to inflammation. We used the platelet index (ratio of platelets to WBCs) and the RBC count to quantify the quality of our PRP sample.

Each rat in part A was anesthetized while supine. We used the Autologous Conditioned Plasma (ACP) system (Arthrex), which requires only 1 centrifugation cycle to create PRP. About 9 mL or 10 mL of blood was obtained by cardiac aspiration using an ACP Double Syringe (Arthrex). After blood retrieval, a thoracotomy was performed to confirm each rat’s death.

Part B: Determining the Effects of PRP and NSAIDs on RCR in a Rat Model 

Operative Cohort. Of the 34 Fischer rats used in part B of this study, 6 were used as blood donors for PRP production, and the other 28 underwent bilateral rotator cuff surgeries. We used donor rats to maximize the amount of PRP retrieval, allocating about 1 donor rat per 5 operative rats. Fischer rats are an inbred strain, so the PRP from a donor Fischer rat simulates autologous blood in other Fischer rats. Use of allogenic blood is consistent with prior rat PRP studies.^23,24

Operative Technique. Each bilateral surgery was performed by a single board-certified shoulder surgeon, and the anesthetic and surgical protocols were followed as approved by the home institution’s Institutional Animal Care and Use Committee. Before surgery, blood was harvested for PRP production from donor rats, as described earlier, and centrifuged for 5 minutes × 1300 rpm. After anesthetic induction and skin incision, the deltoid muscle was cut to expose the acromion and underlying rotator cuff. The distal supraspinatus tendon was sharply detached from the greater tuberosity. A bone-tunnel RCR was performed by drilling a transverse tunnel across the greater tuberosity and affixing the tendon to its footprint with a 5-0 polypropylene suture (Prolene; Ethicon). Each rat was then randomly assigned to receive 50 µL of donor PRP injected in 1 operative shoulder and saline in the contralateral shoulder. Injections were made in the supraspinatus tendon at its attachment to the humerus. Deltoid and skin were closed with 4-0 polyglactin (Vicryl) suture (Ethicon) and staples, respectively.

Tendon Preparation. Immediately post mortem, each shoulder was grossly dissected to isolate the supraspinatus muscle attached to the humerus. Shoulders were then frozen in 0.15-M saline solution until specified biomechanical testing dates.

On day of dimensional/biomechanical testing, each specimen was thawed at room temperature and finely dissected under a microscope (Stemi 200-C; Car Zeiss). After dissection, the humeral shaft was embedded in polymethylmethacrylate within a test tube. The free end of the supraspinatus tendon was glued within a “tab” of waterproofed emery cloth, leaving about 2 mm of tendon between the tab and the greater tuberosity. 

Biomechanical Analysis. A 5848 MicroTester (Instron) was used for biomechanical testing. Each tabbed tendon, held by a pneumatic clamp attached to the MicroTester, was tested in a preconditioning phase and then a ramp-to-failure phase. A constant drip of 0.15-M saline was run through the apparatus to simulate physiologic hydration of tissue. After the embedded specimen was secure within the loading apparatus, an initial tensile preload of 0.2 N was applied. After preloading, the tendon was run through a preconditioning phase to account for viscoelastic relaxation. Immediately after preconditioning, each tendon was subjected to failure testing at a ramp rate of 0.1 mm/s. Force data were collected as a function of displacement, allowing for the calculation of 4 biomechanical parameters: failure force, tendon stiffness and normalized stiffness, energy to failure, and total energy. Tendon stiffness is the slope of a curve-fit line of the initial peak; failure force is the force of the highest peak; energy to failure is the area under the curve (AUC) to the highest peak; and total energy is the AUC from the start of failure ramping to the point at which the tendon is torn off completely. Two-way ANOVA was used to assess the differences between treatment groups and diet groups for all parameters. Statistical significance was set at P < .05.

A power analysis was performed to determine ability to detect differences between cohorts. For power of 80% and P = .05, a difference of 16% of the mean could be detected for failure force, 30% for energy to failure, 14% for total energy to failure, and 24% for stiffness. In addition, a difference of 4% of the mean could be detected for tendon length, 6% for width, and 10% for thickness.

Results

Across all collective treatment-diet groups and biomechanical parameters, there was only 1 statistically significant difference. Mean (SD) energy to failure was significantly higher (P = .03) in shoulders treated with PRP, 11.7 (7.3) N-mm, than in those treated without PRP, 8.7 (4.6) N-mm (Figure 4). There were no statistically significant differences between shoulders treated with indomethacin and those treated without indomethacin (Table 3), and no statistically significant relationships between treatment and drug for any other biomechanical parameter (Figures 5-7).

Discussion

Our preliminary objective in this study was to determine the optimal centrifugation protocol for producing rat-based PRP. Optimal PRP requires a dense concentration of platelets as well as reduced levels of RBCs and WBCs.²⁵ We used the platelet index to quantify the quality of our PRP samples, and we obtained the highest platelet index for the protocol of 5 minutes × 1300 rpm. This finding may be useful in later rat studies involving PRP.

The primary objective of this study was to assess the effect of the interaction of PRP and NSAIDs on RCR. PRP has been found to augment RCR,^12,26,27 but indomethacin may impair healing.^21,25 We hypothesized that shoulders treated with PRP would have more biomechanical strength than control shoulders and that indomethacin would decrease biomechanical strength. 

Our data showed increased energy to failure of the rotator cuff with PRP injections (P = .03). All other biomechanical parameters showed no significant differences with PRP treatment, though there were statistically insignificant trends of increased total energy, failure force, and stiffness in the PRP cohorts. There were no statistically significant differences between the indomethacin and no-indomethacin groups, and indomethacin had no effect on the efficacy of PRP treatment. It should be noted that the measurements of total energy, energy to failure, and failure force best reflect the strength of the tendon–bone interface. Other biomechanical measures, such as stiffness and normalized stiffness, are physical properties of the tendon itself and apply less to enthesis strength, which was the primary focus of this study.

Beck and colleagues²³ studied the effect of allogeneic PRP on RCR in a rat model. They tested biomechanical and histologic outcomes 7, 14, and 21 days after surgery. There was no significant difference in failure load between the 2 groups at any time point. Compared with failure strain in the control group, failure strain in the PRP group was decreased at 7 days, normalized at 14 days, and increased at 21 days. The authors hypothesized that increased tendon failure strain at 21 days may have reduced forces being transmitted to the suture fixation site, which may be clinically significant and warrants further investigation. In a similar study, by Dolkart and colleagues,²⁸ intraoperative PRP administration enhanced the maximal load-to-failure and stiffness of rats’ repaired rotator cuffs. On histologic examination, tendons treated with PRP (vs control tendons) had more organized collagen. Although these studies have limitations similar to our study, these results further support improved tendon-to-bone healing with PRP.

In clinical application, Barber and colleagues²⁶ found that, compared with controls, suturing PRP fibrin matrix into the rotator cuff during repair decreased the incidence of magnetic resonance imaging–detected retears. However, in 2 prospective, randomized trials, Castricini and colleagues²⁹ and Weber and colleagues³⁰ found that use of PRP in RCR did not improve outcomes. All 3 studies differ from ours in that they used fibrin matrix. However, Ersen and colleagues³¹ found no difference in the effects of PRP on rotator cuff healing between injection and fibrin matrix; PRP improved biomechanical properties of repaired rotator cuff independent of administration method. In a meta-analysis of PRP supplementation in RCR, Warth and colleagues³² found a statistically significant improvement in retear rates for tears >3 cm repaired with a double-row technique, but otherwise no overall improvement in retear rates or outcome scores with PRP. The authors acknowledged that the significant heterogeneity of the studies in their meta-analysis may have affected the quality of their data.

Although our study provides some insight into the effectiveness of PRP in tendon repair, the lack of standardization in PRP preparation and time points tested makes comparisons with similar studies difficult.³³ Recent reports have emphasized that not all PRP separation systems yield similar products.³³ Platelet concentrations, and therefore platelet-derived growth factor concentrations, differ between systems and may yield different clinical outcomes. Our decision to use leukocyte-reduced PRP is supported by a meta-analysis by Riboh and colleagues,³⁴ who reviewed the literature on the effect of leukocyte concentration on the efficacy of PRP products. They found that, in the treatment of knee osteoarthritis, use of leukocyte-poor PRP resulted in improved functional outcomes scores in comparison with placebo, but this improvement did not occur with leukocyte-rich PRP. However, there is still no consensus on optimal preparation, dosing, and route of administration of PRP, and preparations described in the literature vary.

This study also assessed the interaction of PRP and NSAIDs. Although there were no statistically significant differences between treatment and diet, shoulders treated with indomethacin alone showed a trend toward weaker biomechanical parameters in comparison with shoulders treated with saline alone, with PRP alone, or with both PRP and indomethacin. A larger sample would be needed to establish statistical significance. These trends are not surprising, as Cohen and colleagues²¹ found that NSAIDs, specifically indomethacin and celecoxib, significantly inhibited rotator cuff tendon-to-bone healing. The authors also found that a 2-week course of indomethacin was sufficient to significantly inhibit tendon-to-bone healing. In fact, although the drugs were discontinued after 14 days, biomechanical properties were negatively affected up to 8 weeks after repair. Our results differ from theirs even though the 2 studies used similar doses and administration protocols.

One strength of this study was that all surgeries were performed by a single board-certified surgeon using a standardized technique. In addition, a control group was established, and personnel and techniques for all fine dissections and biomechanical tests were consistent throughout. Blinded randomization and diet normalization, as well as adequate power for detecting significant effects, strengthened the study as well.

The study had several limitations. First, whereas most human rotator cuff tears are chronic, we used a model of acute injury and repair. As acute tears that are immediately repaired are more likely to heal, detection of differences between cohorts is less likely. However, using an acute model is still the most reliable strategy for inducing a controlled injury with reproducible severity. Second, we analyzed data at only 1 time point, which may not provide an accurate representation of long-term effects. Third, systemic administration of indomethacin did not allow for intra-rat shoulder comparisons of the different drug groups. Fourth, although it is possible that the dosage of NSAID was insufficient to produce significant differences in biomechanics, our dosage was consistent with that used in a study that found a significant effect on tendon healing.²¹

Conclusion

Our study found that the strength of the supraspinatus tendon enthesis as defined by energy to failure was increased with intratendinous PRP injection. Indomethacin showed no statistical effect, but there was a trend toward reduced strength after repair. However, the extent to which coadministration of indomethacin affects PRP remains unclear, and these data cannot necessarily be extrapolated to the typical human rotator cuff tear caused by chronic repetitive stress.

Take-Home Points

• The optimal centrifugation protocol for production of rat PRP is 1300 rpm for 5 minutes.
• PRP administration in RCR improves tendon biomechanics in a rat model.
• Administration of NSAIDs following RCR has no significant effect on tendon biomechanical properties.
• NSAIDs may be co-administered with PRP without reducing efficacy of PRP.
• The role of PRP and NSAIDs in human RCR remains unclear.

Rotator cuff tears are a common source of shoulder pain and disability among older adults and athletes. Full-thickness tears alone occur in up to 30% of adults older than 60 years.¹ Surgical repair is plagued by an unpredictable rate of recurrence (range, 11%-94%).^1-10 As a result of improved suture materials, knotting patterns, and anchor designs, hardware issues are no longer the primary cause of rotator cuff repair (RCR) failures; now the principal mode of failure is biologic.² Animal model studies have found that, after injury and subsequent healing, the tendon–bone interface remains abnormal.¹¹ Rotator cuff research therefore has focused largely on biological enhancement of tendon-to-bone healing.

One means of biological augmentation is autologous platelet-rich plasma (PRP), which has supraphysiologic concentrations of platelets and their secreted growth factors. Although there is no consensus on the long-term efficacy of PRP, some studies suggest PRP accelerates healing over short and intermediate terms, which may contribute to a more rapid decrease in pain and more rapid return to normal activities.^12-18 Similarly, systemic nonsteroidal anti-inflammatory drugs (NSAIDs) have long been used to treat musculoskeletal injuries, including rotator cuff pathology. However, NSAIDs inhibit cyclooxygenase activity, and clinical and experimental data have shown that cyclooxygenase 2 function is crucial in normal tendon-to-bone healing.^19-21

Comprehensive studies have been conducted on the efficacy of both PRP and NSAIDs, but the interaction of concurrently used PRP and NSAIDs has not been determined. As many physicians use both modalities in the treatment of soft-tissue injuries, it is important to study the potential interactions when coadministered. Prior studies in small animal models suggest NSAIDs may impair tendon-to-bone healing in RCR, but there is no evidence regarding the effect of NSAIDs on the efficacy of PRP treatment.²¹

We conducted a study to determine the interaction of PRP and NSAIDs when used as adjuncts to RCR in a rat model. We hypothesized that PRP would increase the strength of RCR and that NSAIDs would interfere with the effects of PRP. A preliminary study objective was to determine an appropriate centrifugation protocol for producing PRP from rat blood, for use in this study and in future rat-based studies of PRP.

Materials and Methods

Part A: Pretesting Determination of PRP Centrifugation Protocol

Fourteen adult male Fischer rats were used in part A of this study, which was conducted to determine an appropriate PRP centrifugation protocol. Traditional PRP centrifugation protocols are established for human blood, but rat red blood cells (RBCs) and human RBCs differ in size.²² In our preliminary study, we wanted to determine the adjusted centrifuge speed and duration for producing clinically optimal PRP from rats. Clinically optimal PRP has reduced levels of RBCs, which decrease platelet affinity. Although the role of leukocytes in PRP preparations is debated, reducing the number of white blood cells (WBCs) decreases the number of matrix metalloproteinases and reactive oxygen species that may lead to inflammation. We used the platelet index (ratio of platelets to WBCs) and the RBC count to quantify the quality of our PRP sample.

Each rat in part A was anesthetized while supine. We used the Autologous Conditioned Plasma (ACP) system (Arthrex), which requires only 1 centrifugation cycle to create PRP. About 9 mL or 10 mL of blood was obtained by cardiac aspiration using an ACP Double Syringe (Arthrex). After blood retrieval, a thoracotomy was performed to confirm each rat’s death.

Part B: Determining the Effects of PRP and NSAIDs on RCR in a Rat Model 

Operative Cohort. Of the 34 Fischer rats used in part B of this study, 6 were used as blood donors for PRP production, and the other 28 underwent bilateral rotator cuff surgeries. We used donor rats to maximize the amount of PRP retrieval, allocating about 1 donor rat per 5 operative rats. Fischer rats are an inbred strain, so the PRP from a donor Fischer rat simulates autologous blood in other Fischer rats. Use of allogenic blood is consistent with prior rat PRP studies.^23,24

Operative Technique. Each bilateral surgery was performed by a single board-certified shoulder surgeon, and the anesthetic and surgical protocols were followed as approved by the home institution’s Institutional Animal Care and Use Committee. Before surgery, blood was harvested for PRP production from donor rats, as described earlier, and centrifuged for 5 minutes × 1300 rpm. After anesthetic induction and skin incision, the deltoid muscle was cut to expose the acromion and underlying rotator cuff. The distal supraspinatus tendon was sharply detached from the greater tuberosity. A bone-tunnel RCR was performed by drilling a transverse tunnel across the greater tuberosity and affixing the tendon to its footprint with a 5-0 polypropylene suture (Prolene; Ethicon). Each rat was then randomly assigned to receive 50 µL of donor PRP injected in 1 operative shoulder and saline in the contralateral shoulder. Injections were made in the supraspinatus tendon at its attachment to the humerus. Deltoid and skin were closed with 4-0 polyglactin (Vicryl) suture (Ethicon) and staples, respectively.

Tendon Preparation. Immediately post mortem, each shoulder was grossly dissected to isolate the supraspinatus muscle attached to the humerus. Shoulders were then frozen in 0.15-M saline solution until specified biomechanical testing dates.

On day of dimensional/biomechanical testing, each specimen was thawed at room temperature and finely dissected under a microscope (Stemi 200-C; Car Zeiss). After dissection, the humeral shaft was embedded in polymethylmethacrylate within a test tube. The free end of the supraspinatus tendon was glued within a “tab” of waterproofed emery cloth, leaving about 2 mm of tendon between the tab and the greater tuberosity. 

Biomechanical Analysis. A 5848 MicroTester (Instron) was used for biomechanical testing. Each tabbed tendon, held by a pneumatic clamp attached to the MicroTester, was tested in a preconditioning phase and then a ramp-to-failure phase. A constant drip of 0.15-M saline was run through the apparatus to simulate physiologic hydration of tissue. After the embedded specimen was secure within the loading apparatus, an initial tensile preload of 0.2 N was applied. After preloading, the tendon was run through a preconditioning phase to account for viscoelastic relaxation. Immediately after preconditioning, each tendon was subjected to failure testing at a ramp rate of 0.1 mm/s. Force data were collected as a function of displacement, allowing for the calculation of 4 biomechanical parameters: failure force, tendon stiffness and normalized stiffness, energy to failure, and total energy. Tendon stiffness is the slope of a curve-fit line of the initial peak; failure force is the force of the highest peak; energy to failure is the area under the curve (AUC) to the highest peak; and total energy is the AUC from the start of failure ramping to the point at which the tendon is torn off completely. Two-way ANOVA was used to assess the differences between treatment groups and diet groups for all parameters. Statistical significance was set at P < .05.

A power analysis was performed to determine ability to detect differences between cohorts. For power of 80% and P = .05, a difference of 16% of the mean could be detected for failure force, 30% for energy to failure, 14% for total energy to failure, and 24% for stiffness. In addition, a difference of 4% of the mean could be detected for tendon length, 6% for width, and 10% for thickness.

Results

Across all collective treatment-diet groups and biomechanical parameters, there was only 1 statistically significant difference. Mean (SD) energy to failure was significantly higher (P = .03) in shoulders treated with PRP, 11.7 (7.3) N-mm, than in those treated without PRP, 8.7 (4.6) N-mm (Figure 4). There were no statistically significant differences between shoulders treated with indomethacin and those treated without indomethacin (Table 3), and no statistically significant relationships between treatment and drug for any other biomechanical parameter (Figures 5-7).

Discussion

Our preliminary objective in this study was to determine the optimal centrifugation protocol for producing rat-based PRP. Optimal PRP requires a dense concentration of platelets as well as reduced levels of RBCs and WBCs.²⁵ We used the platelet index to quantify the quality of our PRP samples, and we obtained the highest platelet index for the protocol of 5 minutes × 1300 rpm. This finding may be useful in later rat studies involving PRP.

The primary objective of this study was to assess the effect of the interaction of PRP and NSAIDs on RCR. PRP has been found to augment RCR,^12,26,27 but indomethacin may impair healing.^21,25 We hypothesized that shoulders treated with PRP would have more biomechanical strength than control shoulders and that indomethacin would decrease biomechanical strength. 

Our data showed increased energy to failure of the rotator cuff with PRP injections (P = .03). All other biomechanical parameters showed no significant differences with PRP treatment, though there were statistically insignificant trends of increased total energy, failure force, and stiffness in the PRP cohorts. There were no statistically significant differences between the indomethacin and no-indomethacin groups, and indomethacin had no effect on the efficacy of PRP treatment. It should be noted that the measurements of total energy, energy to failure, and failure force best reflect the strength of the tendon–bone interface. Other biomechanical measures, such as stiffness and normalized stiffness, are physical properties of the tendon itself and apply less to enthesis strength, which was the primary focus of this study.

Beck and colleagues²³ studied the effect of allogeneic PRP on RCR in a rat model. They tested biomechanical and histologic outcomes 7, 14, and 21 days after surgery. There was no significant difference in failure load between the 2 groups at any time point. Compared with failure strain in the control group, failure strain in the PRP group was decreased at 7 days, normalized at 14 days, and increased at 21 days. The authors hypothesized that increased tendon failure strain at 21 days may have reduced forces being transmitted to the suture fixation site, which may be clinically significant and warrants further investigation. In a similar study, by Dolkart and colleagues,²⁸ intraoperative PRP administration enhanced the maximal load-to-failure and stiffness of rats’ repaired rotator cuffs. On histologic examination, tendons treated with PRP (vs control tendons) had more organized collagen. Although these studies have limitations similar to our study, these results further support improved tendon-to-bone healing with PRP.

In clinical application, Barber and colleagues²⁶ found that, compared with controls, suturing PRP fibrin matrix into the rotator cuff during repair decreased the incidence of magnetic resonance imaging–detected retears. However, in 2 prospective, randomized trials, Castricini and colleagues²⁹ and Weber and colleagues³⁰ found that use of PRP in RCR did not improve outcomes. All 3 studies differ from ours in that they used fibrin matrix. However, Ersen and colleagues³¹ found no difference in the effects of PRP on rotator cuff healing between injection and fibrin matrix; PRP improved biomechanical properties of repaired rotator cuff independent of administration method. In a meta-analysis of PRP supplementation in RCR, Warth and colleagues³² found a statistically significant improvement in retear rates for tears >3 cm repaired with a double-row technique, but otherwise no overall improvement in retear rates or outcome scores with PRP. The authors acknowledged that the significant heterogeneity of the studies in their meta-analysis may have affected the quality of their data.

Although our study provides some insight into the effectiveness of PRP in tendon repair, the lack of standardization in PRP preparation and time points tested makes comparisons with similar studies difficult.³³ Recent reports have emphasized that not all PRP separation systems yield similar products.³³ Platelet concentrations, and therefore platelet-derived growth factor concentrations, differ between systems and may yield different clinical outcomes. Our decision to use leukocyte-reduced PRP is supported by a meta-analysis by Riboh and colleagues,³⁴ who reviewed the literature on the effect of leukocyte concentration on the efficacy of PRP products. They found that, in the treatment of knee osteoarthritis, use of leukocyte-poor PRP resulted in improved functional outcomes scores in comparison with placebo, but this improvement did not occur with leukocyte-rich PRP. However, there is still no consensus on optimal preparation, dosing, and route of administration of PRP, and preparations described in the literature vary.

This study also assessed the interaction of PRP and NSAIDs. Although there were no statistically significant differences between treatment and diet, shoulders treated with indomethacin alone showed a trend toward weaker biomechanical parameters in comparison with shoulders treated with saline alone, with PRP alone, or with both PRP and indomethacin. A larger sample would be needed to establish statistical significance. These trends are not surprising, as Cohen and colleagues²¹ found that NSAIDs, specifically indomethacin and celecoxib, significantly inhibited rotator cuff tendon-to-bone healing. The authors also found that a 2-week course of indomethacin was sufficient to significantly inhibit tendon-to-bone healing. In fact, although the drugs were discontinued after 14 days, biomechanical properties were negatively affected up to 8 weeks after repair. Our results differ from theirs even though the 2 studies used similar doses and administration protocols.

One strength of this study was that all surgeries were performed by a single board-certified surgeon using a standardized technique. In addition, a control group was established, and personnel and techniques for all fine dissections and biomechanical tests were consistent throughout. Blinded randomization and diet normalization, as well as adequate power for detecting significant effects, strengthened the study as well.

The study had several limitations. First, whereas most human rotator cuff tears are chronic, we used a model of acute injury and repair. As acute tears that are immediately repaired are more likely to heal, detection of differences between cohorts is less likely. However, using an acute model is still the most reliable strategy for inducing a controlled injury with reproducible severity. Second, we analyzed data at only 1 time point, which may not provide an accurate representation of long-term effects. Third, systemic administration of indomethacin did not allow for intra-rat shoulder comparisons of the different drug groups. Fourth, although it is possible that the dosage of NSAID was insufficient to produce significant differences in biomechanics, our dosage was consistent with that used in a study that found a significant effect on tendon healing.²¹

Conclusion

Our study found that the strength of the supraspinatus tendon enthesis as defined by energy to failure was increased with intratendinous PRP injection. Indomethacin showed no statistical effect, but there was a trend toward reduced strength after repair. However, the extent to which coadministration of indomethacin affects PRP remains unclear, and these data cannot necessarily be extrapolated to the typical human rotator cuff tear caused by chronic repetitive stress.

Take-Home Points

• The optimal centrifugation protocol for production of rat PRP is 1300 rpm for 5 minutes.
• PRP administration in RCR improves tendon biomechanics in a rat model.
• Administration of NSAIDs following RCR has no significant effect on tendon biomechanical properties.
• NSAIDs may be co-administered with PRP without reducing efficacy of PRP.
• The role of PRP and NSAIDs in human RCR remains unclear.

Rotator cuff tears are a common source of shoulder pain and disability among older adults and athletes. Full-thickness tears alone occur in up to 30% of adults older than 60 years.¹ Surgical repair is plagued by an unpredictable rate of recurrence (range, 11%-94%).^1-10 As a result of improved suture materials, knotting patterns, and anchor designs, hardware issues are no longer the primary cause of rotator cuff repair (RCR) failures; now the principal mode of failure is biologic.² Animal model studies have found that, after injury and subsequent healing, the tendon–bone interface remains abnormal.¹¹ Rotator cuff research therefore has focused largely on biological enhancement of tendon-to-bone healing.

One means of biological augmentation is autologous platelet-rich plasma (PRP), which has supraphysiologic concentrations of platelets and their secreted growth factors. Although there is no consensus on the long-term efficacy of PRP, some studies suggest PRP accelerates healing over short and intermediate terms, which may contribute to a more rapid decrease in pain and more rapid return to normal activities.^12-18 Similarly, systemic nonsteroidal anti-inflammatory drugs (NSAIDs) have long been used to treat musculoskeletal injuries, including rotator cuff pathology. However, NSAIDs inhibit cyclooxygenase activity, and clinical and experimental data have shown that cyclooxygenase 2 function is crucial in normal tendon-to-bone healing.^19-21

Comprehensive studies have been conducted on the efficacy of both PRP and NSAIDs, but the interaction of concurrently used PRP and NSAIDs has not been determined. As many physicians use both modalities in the treatment of soft-tissue injuries, it is important to study the potential interactions when coadministered. Prior studies in small animal models suggest NSAIDs may impair tendon-to-bone healing in RCR, but there is no evidence regarding the effect of NSAIDs on the efficacy of PRP treatment.²¹

We conducted a study to determine the interaction of PRP and NSAIDs when used as adjuncts to RCR in a rat model. We hypothesized that PRP would increase the strength of RCR and that NSAIDs would interfere with the effects of PRP. A preliminary study objective was to determine an appropriate centrifugation protocol for producing PRP from rat blood, for use in this study and in future rat-based studies of PRP.

Materials and Methods

Part A: Pretesting Determination of PRP Centrifugation Protocol

Fourteen adult male Fischer rats were used in part A of this study, which was conducted to determine an appropriate PRP centrifugation protocol. Traditional PRP centrifugation protocols are established for human blood, but rat red blood cells (RBCs) and human RBCs differ in size.²² In our preliminary study, we wanted to determine the adjusted centrifuge speed and duration for producing clinically optimal PRP from rats. Clinically optimal PRP has reduced levels of RBCs, which decrease platelet affinity. Although the role of leukocytes in PRP preparations is debated, reducing the number of white blood cells (WBCs) decreases the number of matrix metalloproteinases and reactive oxygen species that may lead to inflammation. We used the platelet index (ratio of platelets to WBCs) and the RBC count to quantify the quality of our PRP sample.

Each rat in part A was anesthetized while supine. We used the Autologous Conditioned Plasma (ACP) system (Arthrex), which requires only 1 centrifugation cycle to create PRP. About 9 mL or 10 mL of blood was obtained by cardiac aspiration using an ACP Double Syringe (Arthrex). After blood retrieval, a thoracotomy was performed to confirm each rat’s death.

Part B: Determining the Effects of PRP and NSAIDs on RCR in a Rat Model 

Operative Cohort. Of the 34 Fischer rats used in part B of this study, 6 were used as blood donors for PRP production, and the other 28 underwent bilateral rotator cuff surgeries. We used donor rats to maximize the amount of PRP retrieval, allocating about 1 donor rat per 5 operative rats. Fischer rats are an inbred strain, so the PRP from a donor Fischer rat simulates autologous blood in other Fischer rats. Use of allogenic blood is consistent with prior rat PRP studies.^23,24

Operative Technique. Each bilateral surgery was performed by a single board-certified shoulder surgeon, and the anesthetic and surgical protocols were followed as approved by the home institution’s Institutional Animal Care and Use Committee. Before surgery, blood was harvested for PRP production from donor rats, as described earlier, and centrifuged for 5 minutes × 1300 rpm. After anesthetic induction and skin incision, the deltoid muscle was cut to expose the acromion and underlying rotator cuff. The distal supraspinatus tendon was sharply detached from the greater tuberosity. A bone-tunnel RCR was performed by drilling a transverse tunnel across the greater tuberosity and affixing the tendon to its footprint with a 5-0 polypropylene suture (Prolene; Ethicon). Each rat was then randomly assigned to receive 50 µL of donor PRP injected in 1 operative shoulder and saline in the contralateral shoulder. Injections were made in the supraspinatus tendon at its attachment to the humerus. Deltoid and skin were closed with 4-0 polyglactin (Vicryl) suture (Ethicon) and staples, respectively.

Tendon Preparation. Immediately post mortem, each shoulder was grossly dissected to isolate the supraspinatus muscle attached to the humerus. Shoulders were then frozen in 0.15-M saline solution until specified biomechanical testing dates.

On day of dimensional/biomechanical testing, each specimen was thawed at room temperature and finely dissected under a microscope (Stemi 200-C; Car Zeiss). After dissection, the humeral shaft was embedded in polymethylmethacrylate within a test tube. The free end of the supraspinatus tendon was glued within a “tab” of waterproofed emery cloth, leaving about 2 mm of tendon between the tab and the greater tuberosity. 

Biomechanical Analysis. A 5848 MicroTester (Instron) was used for biomechanical testing. Each tabbed tendon, held by a pneumatic clamp attached to the MicroTester, was tested in a preconditioning phase and then a ramp-to-failure phase. A constant drip of 0.15-M saline was run through the apparatus to simulate physiologic hydration of tissue. After the embedded specimen was secure within the loading apparatus, an initial tensile preload of 0.2 N was applied. After preloading, the tendon was run through a preconditioning phase to account for viscoelastic relaxation. Immediately after preconditioning, each tendon was subjected to failure testing at a ramp rate of 0.1 mm/s. Force data were collected as a function of displacement, allowing for the calculation of 4 biomechanical parameters: failure force, tendon stiffness and normalized stiffness, energy to failure, and total energy. Tendon stiffness is the slope of a curve-fit line of the initial peak; failure force is the force of the highest peak; energy to failure is the area under the curve (AUC) to the highest peak; and total energy is the AUC from the start of failure ramping to the point at which the tendon is torn off completely. Two-way ANOVA was used to assess the differences between treatment groups and diet groups for all parameters. Statistical significance was set at P < .05.

A power analysis was performed to determine ability to detect differences between cohorts. For power of 80% and P = .05, a difference of 16% of the mean could be detected for failure force, 30% for energy to failure, 14% for total energy to failure, and 24% for stiffness. In addition, a difference of 4% of the mean could be detected for tendon length, 6% for width, and 10% for thickness.

Results

Across all collective treatment-diet groups and biomechanical parameters, there was only 1 statistically significant difference. Mean (SD) energy to failure was significantly higher (P = .03) in shoulders treated with PRP, 11.7 (7.3) N-mm, than in those treated without PRP, 8.7 (4.6) N-mm (Figure 4). There were no statistically significant differences between shoulders treated with indomethacin and those treated without indomethacin (Table 3), and no statistically significant relationships between treatment and drug for any other biomechanical parameter (Figures 5-7).

Discussion

Our preliminary objective in this study was to determine the optimal centrifugation protocol for producing rat-based PRP. Optimal PRP requires a dense concentration of platelets as well as reduced levels of RBCs and WBCs.²⁵ We used the platelet index to quantify the quality of our PRP samples, and we obtained the highest platelet index for the protocol of 5 minutes × 1300 rpm. This finding may be useful in later rat studies involving PRP.

The primary objective of this study was to assess the effect of the interaction of PRP and NSAIDs on RCR. PRP has been found to augment RCR,^12,26,27 but indomethacin may impair healing.^21,25 We hypothesized that shoulders treated with PRP would have more biomechanical strength than control shoulders and that indomethacin would decrease biomechanical strength. 

Our data showed increased energy to failure of the rotator cuff with PRP injections (P = .03). All other biomechanical parameters showed no significant differences with PRP treatment, though there were statistically insignificant trends of increased total energy, failure force, and stiffness in the PRP cohorts. There were no statistically significant differences between the indomethacin and no-indomethacin groups, and indomethacin had no effect on the efficacy of PRP treatment. It should be noted that the measurements of total energy, energy to failure, and failure force best reflect the strength of the tendon–bone interface. Other biomechanical measures, such as stiffness and normalized stiffness, are physical properties of the tendon itself and apply less to enthesis strength, which was the primary focus of this study.

Beck and colleagues²³ studied the effect of allogeneic PRP on RCR in a rat model. They tested biomechanical and histologic outcomes 7, 14, and 21 days after surgery. There was no significant difference in failure load between the 2 groups at any time point. Compared with failure strain in the control group, failure strain in the PRP group was decreased at 7 days, normalized at 14 days, and increased at 21 days. The authors hypothesized that increased tendon failure strain at 21 days may have reduced forces being transmitted to the suture fixation site, which may be clinically significant and warrants further investigation. In a similar study, by Dolkart and colleagues,²⁸ intraoperative PRP administration enhanced the maximal load-to-failure and stiffness of rats’ repaired rotator cuffs. On histologic examination, tendons treated with PRP (vs control tendons) had more organized collagen. Although these studies have limitations similar to our study, these results further support improved tendon-to-bone healing with PRP.

In clinical application, Barber and colleagues²⁶ found that, compared with controls, suturing PRP fibrin matrix into the rotator cuff during repair decreased the incidence of magnetic resonance imaging–detected retears. However, in 2 prospective, randomized trials, Castricini and colleagues²⁹ and Weber and colleagues³⁰ found that use of PRP in RCR did not improve outcomes. All 3 studies differ from ours in that they used fibrin matrix. However, Ersen and colleagues³¹ found no difference in the effects of PRP on rotator cuff healing between injection and fibrin matrix; PRP improved biomechanical properties of repaired rotator cuff independent of administration method. In a meta-analysis of PRP supplementation in RCR, Warth and colleagues³² found a statistically significant improvement in retear rates for tears >3 cm repaired with a double-row technique, but otherwise no overall improvement in retear rates or outcome scores with PRP. The authors acknowledged that the significant heterogeneity of the studies in their meta-analysis may have affected the quality of their data.

Although our study provides some insight into the effectiveness of PRP in tendon repair, the lack of standardization in PRP preparation and time points tested makes comparisons with similar studies difficult.³³ Recent reports have emphasized that not all PRP separation systems yield similar products.³³ Platelet concentrations, and therefore platelet-derived growth factor concentrations, differ between systems and may yield different clinical outcomes. Our decision to use leukocyte-reduced PRP is supported by a meta-analysis by Riboh and colleagues,³⁴ who reviewed the literature on the effect of leukocyte concentration on the efficacy of PRP products. They found that, in the treatment of knee osteoarthritis, use of leukocyte-poor PRP resulted in improved functional outcomes scores in comparison with placebo, but this improvement did not occur with leukocyte-rich PRP. However, there is still no consensus on optimal preparation, dosing, and route of administration of PRP, and preparations described in the literature vary.

This study also assessed the interaction of PRP and NSAIDs. Although there were no statistically significant differences between treatment and diet, shoulders treated with indomethacin alone showed a trend toward weaker biomechanical parameters in comparison with shoulders treated with saline alone, with PRP alone, or with both PRP and indomethacin. A larger sample would be needed to establish statistical significance. These trends are not surprising, as Cohen and colleagues²¹ found that NSAIDs, specifically indomethacin and celecoxib, significantly inhibited rotator cuff tendon-to-bone healing. The authors also found that a 2-week course of indomethacin was sufficient to significantly inhibit tendon-to-bone healing. In fact, although the drugs were discontinued after 14 days, biomechanical properties were negatively affected up to 8 weeks after repair. Our results differ from theirs even though the 2 studies used similar doses and administration protocols.

One strength of this study was that all surgeries were performed by a single board-certified surgeon using a standardized technique. In addition, a control group was established, and personnel and techniques for all fine dissections and biomechanical tests were consistent throughout. Blinded randomization and diet normalization, as well as adequate power for detecting significant effects, strengthened the study as well.

The study had several limitations. First, whereas most human rotator cuff tears are chronic, we used a model of acute injury and repair. As acute tears that are immediately repaired are more likely to heal, detection of differences between cohorts is less likely. However, using an acute model is still the most reliable strategy for inducing a controlled injury with reproducible severity. Second, we analyzed data at only 1 time point, which may not provide an accurate representation of long-term effects. Third, systemic administration of indomethacin did not allow for intra-rat shoulder comparisons of the different drug groups. Fourth, although it is possible that the dosage of NSAID was insufficient to produce significant differences in biomechanics, our dosage was consistent with that used in a study that found a significant effect on tendon healing.²¹

Conclusion

Our study found that the strength of the supraspinatus tendon enthesis as defined by energy to failure was increased with intratendinous PRP injection. Indomethacin showed no statistical effect, but there was a trend toward reduced strength after repair. However, the extent to which coadministration of indomethacin affects PRP remains unclear, and these data cannot necessarily be extrapolated to the typical human rotator cuff tear caused by chronic repetitive stress.

Take-Home Points

• The ulnohumeral joint can tolerate substantial articular surface loss without compromising stability.
• Consider BP as an alternative to AS in unreconstructable olecranon fractures.
• Both BP and AS of olecranon fractures maintain elbow stability.
• BP has the advantage of maintaining elbow range of motion.

Olecranon fractures constitute about 10% of all forearm fractures.¹ Many are low-energy fractures in osteoporotic bone in the elderly.^1,2 Unstable fractures require operative fixation in which the goal is restoration of articular congruity and stability.³ Various fixation methods are used to treat unstable olecranon fractures, and outcomes are good overall.^3-21 However, severely comminuted olecranon fractures, especially in osteoporotic bone, pose a unique challenge, where reconstruction may not be feasible.9 Although the articular surface can be reconstructed in most cases, reconstruction is not feasible with severe comminution or low bone mineral density. When articular congruity is no longer possible, the primary goal of fixation becomes elbow stability. Postoperative stability is linked to favorable outcomes, as it allows patients to engage in early range-of-motion (ROM) exercises, which improves joint function.^5,21,22

When treating these severely comminuted olecranon fractures, surgeons have 2 options: bridge plating (BP) and acute shortening (AS). In BP, a plate is used to restore the length of the olecranon. The plate is spanned over the comminuted segment with fixation at proximal and distal pieces but without open reduction of the comminuted pieces.⁸ This process may be performed with or without bone grafting.²¹ Although any bony defect between the proximal and distal pieces may be filled, there is now a gap in articular congruity within the sigmoid notch. One concern with this fixation method is that joint stability is lost when this gap becomes too large. Surgeons therefore may decide to forgo BP and perform AS instead, as long as the coronoid is intact.²¹ In AS, often referred to as olecranon excision, comminuted fragments are removed and the triceps muscle advanced distally. AS constructs, often reserved for older, less active patients, yield acceptable results in this population.⁵ However, the long-term effects of AS in young, active patients are unclear, and biomechanical studies suggest reduced triceps muscle strength.²³

Surgeons have had no studies guiding them in deciding which construct to use, BP or AS, in severely comminuted olecranon fractures in which the articular surface cannot be reconstructed.

We conducted a biomechanical study to determine the percentage loss of articular surface at which a BP construct becomes significantly clinically unstable. We also compared BP stability and AS stability for each percentage loss of articular surface and compared initial elbow ROM with the 2 methods. We hypothesized that, at a certain percentage loss of articular congruity, the BP construct would become too unstable and would require conversion to the AS construct.

Materials and Methods

Specimen Preparation

Eight fresh-frozen paired cadaveric upper limbs (2 male, 2 female; mean age, 61.8 years; age range, 56-74 years) were obtained from donors with no history of elbow trauma or prior surgery. Specimens were stored at –20°C, thawed to room temperature before testing, and, using clinical and radiographic evaluation, screened for abnormalities.

Each specimen was positioned with the arm draped in the lateral decubitus position, as in typical olecranon fracture surgery. A standard posterior approach to the olecranon was made with a midline posterior longitudinal skin incision. Subcutaneous flaps were developed, and the subcutaneous border of the proximal olecranon was exposed, preserving the medial and lateral collateral ligaments as well as the extensor mechanism. Baseline maximum flexion and extension of the elbow as well as olecranon length were measured with fluoroscopy (BV Pulsera, Philips) and ImageJ software (National Institutes of Health). 

To ensure reproducible anatomical reduction during plating, a 3.5-mm 4-hole nonlocking periarticular anatomically contoured plate (Zimmer Biomet) was applied posteriorly to the intact olecranon through a longitudinal slit in the distal triceps tendon. The plate was predrilled to house 4 nonlocking screws, 2 proximal and 2 distal.

Fracture Generation and Testing of Fixation Constructs

Analysis

ImageJ software was used to analyze the C-arm radiographs. Measurements were divided into 4 groups of joint surface loss caused by the resections: 0% to 20%, 20% to 40%, 40% to 60%, and >60%. Differences in ROM between the BP and AS constructs were analyzed with a Wilcoxon signed rank test with statistical significance set at P < .05 (Prism 6; GraphPad Software).

Results

As many as 6 serial resections were made before the proximal fragment of the olecranon was judged too small to be secured to a plate with at least 2 screws. Only 7 specimens were large enough for the fifth cut, and only 4 were large enough for the sixth cut. After the final resection, mean loss of olecranon length was 77.3% (range, 63.7%-88%; median, 80.6%). All elbow specimens remained stable to manual valgus and varus testing in full extension, 30° of flexion, and full flexion in both supination and pronation. There was no medial or lateral opening of the ulnohumeral joint on fluoroscopy throughout testing, for either the BP or the AS constructs. There was no anterior or posterior subluxation throughout the entire ROM.

Discussion

Our goal in this study was to determine the maximum articular surface loss that can be tolerated before a BP construct becomes unstable. This finding applies to situations in which the degree of comminution makes reconstruction of the articular surface impossible. Contrary to our hypothesis, the ulnohumeral joint remained stable despite extensive loss of congruity within the sigmoid notch. In 1 specimen, the joint remained stable at 88% loss of olecranon. However, the 2 constructs had different ROM results: ROM was significantly lower at more resections with AS but remained unchanged from baseline with BP.

Dorsal plating has become standard treatment for comminuted olecranon fractures, and many studies, both clinical and biomechanical, have reported favorable results, good functional outcomes, and acceptable ROM.^{3,7,10,13,18-20,25} However, the multiple studies on the use of various plates in comminuted olecranon fractures did not address whether articular congruity was maintained during reductions or how much articular surface was reconstructed. Although we may reasonably assume larger studies included cases with some unmeasured loss of articular congruity, it is difficult to directly compare our findings with those of other studies. In addition, it is possible those studies did not include fractures that were deemed unfit for BP (because of very severe comminution) and underwent AS instead. Only 1 case series has focused on BP without complete articular reconstruction.8 The cases in that series had good outcomes with good stability—consistent with our finding of extreme comminution in a worst-case scenario. 

Complete elbow stability after AS is consistent with findings in the literature.^4,6,12,14,16 As AS is reserved for severely comminuted fractures and bone resections,^21,23,26 our findings can be compared with the earlier findings. In AS, either the proximal pieces or the intermediate pieces are removed to create a smaller but congruent articular surface, with less concern for nonunion.²¹ When the proximal piece is removed, the triceps muscle is advanced to the ulnar shaft, creating a slinglike structure for the trochlea.^4,11,16,23 When the intermediate piece is removed, the proximal piece is advanced to the shaft along with the triceps.^12,14,27 In either technique, the triceps muscle is advanced distally, potentially affecting its extensibility and moment arm.²³

Although small in numbers, case series and retrospective reviews have found that AS has good outcomes,^4,14,16 whereas our study found significantly decreased ROM. A few patients in these studies lost ROM or triceps strength,^12,14,16 but the cause, AS or fracture severity, is unclear. It is possible only 0% to 20% of the olecranon was resected in those cases, whereas our study found no significant change in ROM. It is also possible that cadaveric muscles do not stretch as well as muscles in vivo. Biomechanical studies have demonstrated changes in triceps stretch and strength,^23,26 but perhaps these changes are subclinical or overcome with therapy and time.^12,14 There are no data regarding whether patients who undergo AS (vs another fixation method) need more physical therapy. In extreme resection, some reduction in ROM is expected.¹³

The ulnohumeral joint is a primary static stabilizer of the elbow joint.28-30 Recent studies on the role of the ulnohumeral joint in elbow stability have focused mainly on the coronoid process in the setting of dislocation.^28,29,31,32 According to these studies, 50% of the coronoid must remain intact for the elbow to be stable when all other stabilizers are intact.³² In our study, resections preserved the coronoid and the ligamentous stabilizers of the elbow. It is therefore possible that the elbow joint remained stable despite the considerable articular surface loss. Although the term ulnohumeral joint refers to both the coronoid and the remaining articular surface, our findings support the coronoid as a primary stabilizer and the remaining articular surface as a secondary static stabilizer.

This study had several limitations. First, its fractures were simulated by serial resection of only the middle portion of the olecranon. In reality, comminution could extend farther proximally or distally and involve the surrounding tissues, which help stabilize the elbow. However, our focus was on loss of articular surface and stability, so keeping surrounding structures intact avoided confounding factors that could contribute to stability. A second possible limitation is that the implant used here may be different from the implant used in a clinical setting. However, our focus was not on fixation quality, and stability alone should not be affected by plate type. Third, stability was measured not quantitatively but instead subjectively under manual stress and fluoroscopy. We chose this method because it mimics what happens during surgery and is the clinical standard for stability assessment.²⁴ Fourth, soft-tissue properties of the cadaver models used in this biomechanical study may differ from soft-tissue properties in vivo. This study could not evaluate possible long-term complications, such as posttraumatic arthritis and heterotopic ossification.^5,10 There are no long-term studies comparing BP and other olecranon fixation methods in terms of postoperative elbow arthritis.

Conclusion

The ulnohumeral joint can tolerate substantial articular surface loss without compromising stability. As a result, in the management of highly comminuted olecranon fractures, BP may be considered before AS is performed. Quality and amount of intact proximal bone, rather than degree of comminution, may be more important factors in deciding which fixation method to use.

This biomechanical study is the first to focus on olecranon fracture BP without complete reconstruction of the articular surface. When treating a highly comminuted olecranon fracture that has an unreconstructible articular surface, surgeons may consider BP with or without bone graft, as well as AS. Our study findings suggest that, though both constructs maintain elbow stability, BP may have the advantage of maintaining ROM too. BP can avoid effects on triceps and elbow ROM, which may be more important in younger, more active patients. Clinical correlates are needed to validate these findings, as overall outcomes may be affected by concurrent fractures and injuries to surrounding structures.

Take-Home Points

• The ulnohumeral joint can tolerate substantial articular surface loss without compromising stability.
• Consider BP as an alternative to AS in unreconstructable olecranon fractures.
• Both BP and AS of olecranon fractures maintain elbow stability.
• BP has the advantage of maintaining elbow range of motion.

Olecranon fractures constitute about 10% of all forearm fractures.¹ Many are low-energy fractures in osteoporotic bone in the elderly.^1,2 Unstable fractures require operative fixation in which the goal is restoration of articular congruity and stability.³ Various fixation methods are used to treat unstable olecranon fractures, and outcomes are good overall.^3-21 However, severely comminuted olecranon fractures, especially in osteoporotic bone, pose a unique challenge, where reconstruction may not be feasible.9 Although the articular surface can be reconstructed in most cases, reconstruction is not feasible with severe comminution or low bone mineral density. When articular congruity is no longer possible, the primary goal of fixation becomes elbow stability. Postoperative stability is linked to favorable outcomes, as it allows patients to engage in early range-of-motion (ROM) exercises, which improves joint function.^5,21,22

When treating these severely comminuted olecranon fractures, surgeons have 2 options: bridge plating (BP) and acute shortening (AS). In BP, a plate is used to restore the length of the olecranon. The plate is spanned over the comminuted segment with fixation at proximal and distal pieces but without open reduction of the comminuted pieces.⁸ This process may be performed with or without bone grafting.²¹ Although any bony defect between the proximal and distal pieces may be filled, there is now a gap in articular congruity within the sigmoid notch. One concern with this fixation method is that joint stability is lost when this gap becomes too large. Surgeons therefore may decide to forgo BP and perform AS instead, as long as the coronoid is intact.²¹ In AS, often referred to as olecranon excision, comminuted fragments are removed and the triceps muscle advanced distally. AS constructs, often reserved for older, less active patients, yield acceptable results in this population.⁵ However, the long-term effects of AS in young, active patients are unclear, and biomechanical studies suggest reduced triceps muscle strength.²³

Surgeons have had no studies guiding them in deciding which construct to use, BP or AS, in severely comminuted olecranon fractures in which the articular surface cannot be reconstructed.

We conducted a biomechanical study to determine the percentage loss of articular surface at which a BP construct becomes significantly clinically unstable. We also compared BP stability and AS stability for each percentage loss of articular surface and compared initial elbow ROM with the 2 methods. We hypothesized that, at a certain percentage loss of articular congruity, the BP construct would become too unstable and would require conversion to the AS construct.

Materials and Methods

Specimen Preparation

Eight fresh-frozen paired cadaveric upper limbs (2 male, 2 female; mean age, 61.8 years; age range, 56-74 years) were obtained from donors with no history of elbow trauma or prior surgery. Specimens were stored at –20°C, thawed to room temperature before testing, and, using clinical and radiographic evaluation, screened for abnormalities.

Each specimen was positioned with the arm draped in the lateral decubitus position, as in typical olecranon fracture surgery. A standard posterior approach to the olecranon was made with a midline posterior longitudinal skin incision. Subcutaneous flaps were developed, and the subcutaneous border of the proximal olecranon was exposed, preserving the medial and lateral collateral ligaments as well as the extensor mechanism. Baseline maximum flexion and extension of the elbow as well as olecranon length were measured with fluoroscopy (BV Pulsera, Philips) and ImageJ software (National Institutes of Health). 

To ensure reproducible anatomical reduction during plating, a 3.5-mm 4-hole nonlocking periarticular anatomically contoured plate (Zimmer Biomet) was applied posteriorly to the intact olecranon through a longitudinal slit in the distal triceps tendon. The plate was predrilled to house 4 nonlocking screws, 2 proximal and 2 distal.

Fracture Generation and Testing of Fixation Constructs

Analysis

ImageJ software was used to analyze the C-arm radiographs. Measurements were divided into 4 groups of joint surface loss caused by the resections: 0% to 20%, 20% to 40%, 40% to 60%, and >60%. Differences in ROM between the BP and AS constructs were analyzed with a Wilcoxon signed rank test with statistical significance set at P < .05 (Prism 6; GraphPad Software).

Results

As many as 6 serial resections were made before the proximal fragment of the olecranon was judged too small to be secured to a plate with at least 2 screws. Only 7 specimens were large enough for the fifth cut, and only 4 were large enough for the sixth cut. After the final resection, mean loss of olecranon length was 77.3% (range, 63.7%-88%; median, 80.6%). All elbow specimens remained stable to manual valgus and varus testing in full extension, 30° of flexion, and full flexion in both supination and pronation. There was no medial or lateral opening of the ulnohumeral joint on fluoroscopy throughout testing, for either the BP or the AS constructs. There was no anterior or posterior subluxation throughout the entire ROM.

Discussion

Our goal in this study was to determine the maximum articular surface loss that can be tolerated before a BP construct becomes unstable. This finding applies to situations in which the degree of comminution makes reconstruction of the articular surface impossible. Contrary to our hypothesis, the ulnohumeral joint remained stable despite extensive loss of congruity within the sigmoid notch. In 1 specimen, the joint remained stable at 88% loss of olecranon. However, the 2 constructs had different ROM results: ROM was significantly lower at more resections with AS but remained unchanged from baseline with BP.

Dorsal plating has become standard treatment for comminuted olecranon fractures, and many studies, both clinical and biomechanical, have reported favorable results, good functional outcomes, and acceptable ROM.^{3,7,10,13,18-20,25} However, the multiple studies on the use of various plates in comminuted olecranon fractures did not address whether articular congruity was maintained during reductions or how much articular surface was reconstructed. Although we may reasonably assume larger studies included cases with some unmeasured loss of articular congruity, it is difficult to directly compare our findings with those of other studies. In addition, it is possible those studies did not include fractures that were deemed unfit for BP (because of very severe comminution) and underwent AS instead. Only 1 case series has focused on BP without complete articular reconstruction.8 The cases in that series had good outcomes with good stability—consistent with our finding of extreme comminution in a worst-case scenario. 

Complete elbow stability after AS is consistent with findings in the literature.^4,6,12,14,16 As AS is reserved for severely comminuted fractures and bone resections,^21,23,26 our findings can be compared with the earlier findings. In AS, either the proximal pieces or the intermediate pieces are removed to create a smaller but congruent articular surface, with less concern for nonunion.²¹ When the proximal piece is removed, the triceps muscle is advanced to the ulnar shaft, creating a slinglike structure for the trochlea.^4,11,16,23 When the intermediate piece is removed, the proximal piece is advanced to the shaft along with the triceps.^12,14,27 In either technique, the triceps muscle is advanced distally, potentially affecting its extensibility and moment arm.²³

Although small in numbers, case series and retrospective reviews have found that AS has good outcomes,^4,14,16 whereas our study found significantly decreased ROM. A few patients in these studies lost ROM or triceps strength,^12,14,16 but the cause, AS or fracture severity, is unclear. It is possible only 0% to 20% of the olecranon was resected in those cases, whereas our study found no significant change in ROM. It is also possible that cadaveric muscles do not stretch as well as muscles in vivo. Biomechanical studies have demonstrated changes in triceps stretch and strength,^23,26 but perhaps these changes are subclinical or overcome with therapy and time.^12,14 There are no data regarding whether patients who undergo AS (vs another fixation method) need more physical therapy. In extreme resection, some reduction in ROM is expected.¹³

The ulnohumeral joint is a primary static stabilizer of the elbow joint.28-30 Recent studies on the role of the ulnohumeral joint in elbow stability have focused mainly on the coronoid process in the setting of dislocation.^28,29,31,32 According to these studies, 50% of the coronoid must remain intact for the elbow to be stable when all other stabilizers are intact.³² In our study, resections preserved the coronoid and the ligamentous stabilizers of the elbow. It is therefore possible that the elbow joint remained stable despite the considerable articular surface loss. Although the term ulnohumeral joint refers to both the coronoid and the remaining articular surface, our findings support the coronoid as a primary stabilizer and the remaining articular surface as a secondary static stabilizer.

This study had several limitations. First, its fractures were simulated by serial resection of only the middle portion of the olecranon. In reality, comminution could extend farther proximally or distally and involve the surrounding tissues, which help stabilize the elbow. However, our focus was on loss of articular surface and stability, so keeping surrounding structures intact avoided confounding factors that could contribute to stability. A second possible limitation is that the implant used here may be different from the implant used in a clinical setting. However, our focus was not on fixation quality, and stability alone should not be affected by plate type. Third, stability was measured not quantitatively but instead subjectively under manual stress and fluoroscopy. We chose this method because it mimics what happens during surgery and is the clinical standard for stability assessment.²⁴ Fourth, soft-tissue properties of the cadaver models used in this biomechanical study may differ from soft-tissue properties in vivo. This study could not evaluate possible long-term complications, such as posttraumatic arthritis and heterotopic ossification.^5,10 There are no long-term studies comparing BP and other olecranon fixation methods in terms of postoperative elbow arthritis.

Conclusion

The ulnohumeral joint can tolerate substantial articular surface loss without compromising stability. As a result, in the management of highly comminuted olecranon fractures, BP may be considered before AS is performed. Quality and amount of intact proximal bone, rather than degree of comminution, may be more important factors in deciding which fixation method to use.

This biomechanical study is the first to focus on olecranon fracture BP without complete reconstruction of the articular surface. When treating a highly comminuted olecranon fracture that has an unreconstructible articular surface, surgeons may consider BP with or without bone graft, as well as AS. Our study findings suggest that, though both constructs maintain elbow stability, BP may have the advantage of maintaining ROM too. BP can avoid effects on triceps and elbow ROM, which may be more important in younger, more active patients. Clinical correlates are needed to validate these findings, as overall outcomes may be affected by concurrent fractures and injuries to surrounding structures.

Take-Home Points

• The ulnohumeral joint can tolerate substantial articular surface loss without compromising stability.
• Consider BP as an alternative to AS in unreconstructable olecranon fractures.
• Both BP and AS of olecranon fractures maintain elbow stability.
• BP has the advantage of maintaining elbow range of motion.

Olecranon fractures constitute about 10% of all forearm fractures.¹ Many are low-energy fractures in osteoporotic bone in the elderly.^1,2 Unstable fractures require operative fixation in which the goal is restoration of articular congruity and stability.³ Various fixation methods are used to treat unstable olecranon fractures, and outcomes are good overall.^3-21 However, severely comminuted olecranon fractures, especially in osteoporotic bone, pose a unique challenge, where reconstruction may not be feasible.9 Although the articular surface can be reconstructed in most cases, reconstruction is not feasible with severe comminution or low bone mineral density. When articular congruity is no longer possible, the primary goal of fixation becomes elbow stability. Postoperative stability is linked to favorable outcomes, as it allows patients to engage in early range-of-motion (ROM) exercises, which improves joint function.^5,21,22

When treating these severely comminuted olecranon fractures, surgeons have 2 options: bridge plating (BP) and acute shortening (AS). In BP, a plate is used to restore the length of the olecranon. The plate is spanned over the comminuted segment with fixation at proximal and distal pieces but without open reduction of the comminuted pieces.⁸ This process may be performed with or without bone grafting.²¹ Although any bony defect between the proximal and distal pieces may be filled, there is now a gap in articular congruity within the sigmoid notch. One concern with this fixation method is that joint stability is lost when this gap becomes too large. Surgeons therefore may decide to forgo BP and perform AS instead, as long as the coronoid is intact.²¹ In AS, often referred to as olecranon excision, comminuted fragments are removed and the triceps muscle advanced distally. AS constructs, often reserved for older, less active patients, yield acceptable results in this population.⁵ However, the long-term effects of AS in young, active patients are unclear, and biomechanical studies suggest reduced triceps muscle strength.²³

Surgeons have had no studies guiding them in deciding which construct to use, BP or AS, in severely comminuted olecranon fractures in which the articular surface cannot be reconstructed.

We conducted a biomechanical study to determine the percentage loss of articular surface at which a BP construct becomes significantly clinically unstable. We also compared BP stability and AS stability for each percentage loss of articular surface and compared initial elbow ROM with the 2 methods. We hypothesized that, at a certain percentage loss of articular congruity, the BP construct would become too unstable and would require conversion to the AS construct.

Materials and Methods

Specimen Preparation

Eight fresh-frozen paired cadaveric upper limbs (2 male, 2 female; mean age, 61.8 years; age range, 56-74 years) were obtained from donors with no history of elbow trauma or prior surgery. Specimens were stored at –20°C, thawed to room temperature before testing, and, using clinical and radiographic evaluation, screened for abnormalities.

Each specimen was positioned with the arm draped in the lateral decubitus position, as in typical olecranon fracture surgery. A standard posterior approach to the olecranon was made with a midline posterior longitudinal skin incision. Subcutaneous flaps were developed, and the subcutaneous border of the proximal olecranon was exposed, preserving the medial and lateral collateral ligaments as well as the extensor mechanism. Baseline maximum flexion and extension of the elbow as well as olecranon length were measured with fluoroscopy (BV Pulsera, Philips) and ImageJ software (National Institutes of Health). 

To ensure reproducible anatomical reduction during plating, a 3.5-mm 4-hole nonlocking periarticular anatomically contoured plate (Zimmer Biomet) was applied posteriorly to the intact olecranon through a longitudinal slit in the distal triceps tendon. The plate was predrilled to house 4 nonlocking screws, 2 proximal and 2 distal.

Fracture Generation and Testing of Fixation Constructs

Analysis

ImageJ software was used to analyze the C-arm radiographs. Measurements were divided into 4 groups of joint surface loss caused by the resections: 0% to 20%, 20% to 40%, 40% to 60%, and >60%. Differences in ROM between the BP and AS constructs were analyzed with a Wilcoxon signed rank test with statistical significance set at P < .05 (Prism 6; GraphPad Software).

Results

As many as 6 serial resections were made before the proximal fragment of the olecranon was judged too small to be secured to a plate with at least 2 screws. Only 7 specimens were large enough for the fifth cut, and only 4 were large enough for the sixth cut. After the final resection, mean loss of olecranon length was 77.3% (range, 63.7%-88%; median, 80.6%). All elbow specimens remained stable to manual valgus and varus testing in full extension, 30° of flexion, and full flexion in both supination and pronation. There was no medial or lateral opening of the ulnohumeral joint on fluoroscopy throughout testing, for either the BP or the AS constructs. There was no anterior or posterior subluxation throughout the entire ROM.

Discussion

Our goal in this study was to determine the maximum articular surface loss that can be tolerated before a BP construct becomes unstable. This finding applies to situations in which the degree of comminution makes reconstruction of the articular surface impossible. Contrary to our hypothesis, the ulnohumeral joint remained stable despite extensive loss of congruity within the sigmoid notch. In 1 specimen, the joint remained stable at 88% loss of olecranon. However, the 2 constructs had different ROM results: ROM was significantly lower at more resections with AS but remained unchanged from baseline with BP.

Dorsal plating has become standard treatment for comminuted olecranon fractures, and many studies, both clinical and biomechanical, have reported favorable results, good functional outcomes, and acceptable ROM.^{3,7,10,13,18-20,25} However, the multiple studies on the use of various plates in comminuted olecranon fractures did not address whether articular congruity was maintained during reductions or how much articular surface was reconstructed. Although we may reasonably assume larger studies included cases with some unmeasured loss of articular congruity, it is difficult to directly compare our findings with those of other studies. In addition, it is possible those studies did not include fractures that were deemed unfit for BP (because of very severe comminution) and underwent AS instead. Only 1 case series has focused on BP without complete articular reconstruction.8 The cases in that series had good outcomes with good stability—consistent with our finding of extreme comminution in a worst-case scenario. 

Complete elbow stability after AS is consistent with findings in the literature.^4,6,12,14,16 As AS is reserved for severely comminuted fractures and bone resections,^21,23,26 our findings can be compared with the earlier findings. In AS, either the proximal pieces or the intermediate pieces are removed to create a smaller but congruent articular surface, with less concern for nonunion.²¹ When the proximal piece is removed, the triceps muscle is advanced to the ulnar shaft, creating a slinglike structure for the trochlea.^4,11,16,23 When the intermediate piece is removed, the proximal piece is advanced to the shaft along with the triceps.^12,14,27 In either technique, the triceps muscle is advanced distally, potentially affecting its extensibility and moment arm.²³

Although small in numbers, case series and retrospective reviews have found that AS has good outcomes,^4,14,16 whereas our study found significantly decreased ROM. A few patients in these studies lost ROM or triceps strength,^12,14,16 but the cause, AS or fracture severity, is unclear. It is possible only 0% to 20% of the olecranon was resected in those cases, whereas our study found no significant change in ROM. It is also possible that cadaveric muscles do not stretch as well as muscles in vivo. Biomechanical studies have demonstrated changes in triceps stretch and strength,^23,26 but perhaps these changes are subclinical or overcome with therapy and time.^12,14 There are no data regarding whether patients who undergo AS (vs another fixation method) need more physical therapy. In extreme resection, some reduction in ROM is expected.¹³

The ulnohumeral joint is a primary static stabilizer of the elbow joint.28-30 Recent studies on the role of the ulnohumeral joint in elbow stability have focused mainly on the coronoid process in the setting of dislocation.^28,29,31,32 According to these studies, 50% of the coronoid must remain intact for the elbow to be stable when all other stabilizers are intact.³² In our study, resections preserved the coronoid and the ligamentous stabilizers of the elbow. It is therefore possible that the elbow joint remained stable despite the considerable articular surface loss. Although the term ulnohumeral joint refers to both the coronoid and the remaining articular surface, our findings support the coronoid as a primary stabilizer and the remaining articular surface as a secondary static stabilizer.

This study had several limitations. First, its fractures were simulated by serial resection of only the middle portion of the olecranon. In reality, comminution could extend farther proximally or distally and involve the surrounding tissues, which help stabilize the elbow. However, our focus was on loss of articular surface and stability, so keeping surrounding structures intact avoided confounding factors that could contribute to stability. A second possible limitation is that the implant used here may be different from the implant used in a clinical setting. However, our focus was not on fixation quality, and stability alone should not be affected by plate type. Third, stability was measured not quantitatively but instead subjectively under manual stress and fluoroscopy. We chose this method because it mimics what happens during surgery and is the clinical standard for stability assessment.²⁴ Fourth, soft-tissue properties of the cadaver models used in this biomechanical study may differ from soft-tissue properties in vivo. This study could not evaluate possible long-term complications, such as posttraumatic arthritis and heterotopic ossification.^5,10 There are no long-term studies comparing BP and other olecranon fixation methods in terms of postoperative elbow arthritis.

Conclusion

The ulnohumeral joint can tolerate substantial articular surface loss without compromising stability. As a result, in the management of highly comminuted olecranon fractures, BP may be considered before AS is performed. Quality and amount of intact proximal bone, rather than degree of comminution, may be more important factors in deciding which fixation method to use.

This biomechanical study is the first to focus on olecranon fracture BP without complete reconstruction of the articular surface. When treating a highly comminuted olecranon fracture that has an unreconstructible articular surface, surgeons may consider BP with or without bone graft, as well as AS. Our study findings suggest that, though both constructs maintain elbow stability, BP may have the advantage of maintaining ROM too. BP can avoid effects on triceps and elbow ROM, which may be more important in younger, more active patients. Clinical correlates are needed to validate these findings, as overall outcomes may be affected by concurrent fractures and injuries to surrounding structures.

Take-Home Points

• Clinical and radiographic outcomes of patients treated with non-spanning external fixation are comparable to those treated with open reduction and internal volar locked plate fixation.
• Non-spanning external fixation can lead to satisfactory outcomes based on the following features: fragment specific fixation, subchondral support, fixed angle strength, limited dissection, distraction/length adjustment, joint distraction avoidance, and ability to perform early rehabilitation.
• Non-spanning external fixation should be considered as a treatment option for complicated unstable comminuted intra-articular distal radius fractures, specifically in the elderly.

In the United States, distal radius fractures (DRFs) are among the most common fractures, comprising about 15% of all extremity fractures.¹ With a DRF, the primary treatment goal is anatomical reduction with restoration of radiographic parameters and stable fixation of the fracture to restore wrist function.

This fracture type has a variety of treatment alternatives, including nonoperative closed reduction and casting of stable fractures, open reduction and internal fixation (ORIF) with dorsal or volar locking plates, and external fixation. Optimal surgical management of unstable DRFs remains controversial.² Closed reduction with percutaneous pinning or external fixation has become less common with a trend toward using volar locking plates for internal fixation.³

External fixation of DRFs traditionally has involved either spanning or simple nonspanning devices. Spanning fixation is particularly useful in open or highly comminuted fractures with an unstable soft-tissue envelope. In the past, nonspanning external fixation typically was reserved for fractures with a noncomminuted extra-articular distal fragment to which several large pins or Kirschner wires (K-wires) could be secured. The Non-Bridging External Fixator (NBX; Nutek Orthopaedics) may be used in cases that traditionally might be treated with locked plating or fragment-specific fixation. Specifically, this device is indicated for comminuted intra-articular DRFs in which bone quality may be less than ideal. The NBX, also suitable in open fractures with a stable soft-tissue envelope, can restore and maintain articular alignment by providing subchondral support and stability with fragment-specific fixation. A key advantage of this type of external fixation is that it involves percutaneous fixation and allows for early postoperative range of motion (ROM).

Numerous studies have found excellent outcomes of treating unstable DRFs with ORIF with volar locking plates.^4-6 However, few studies have compared the clinical and radiographic outcomes of ORIF with those of nonspanning external fixation in the treatment of unstable comminuted intra-articular DRFs. Windolf and colleagues⁷ found that, in cadaveric unstable intra-articular DRFs, nonspanning external fixation with multiplanar K-wires had biomechanical characteristics comparable to those of volar locking plates. Other suitable DRF treatment options have been found: an alternative nonbridging external fixator with multiplanar K-wires (Gradl and colleagues⁸) and the Cross-Pin Fixation system (A.M. Surgical) (Mirza and colleagues⁹).

We conducted a study to compare functional and radiographic outcomes of unstable comminuted intra-articular DRFs treated with a nonspanning external fixation device (NBX) with outcomes achieved with volar locking plates in a historical control group.

Materials and Methods

This retrospective case-control study was approved by our Institutional Review Board and conducted at 2 institutions. Included in the study were 25 consecutive patients (2 institutions) who underwent closed reduction and external fixation (CREF) with NBX as treatment for unstable DRFs (diagnosis based on radiographic parameters or inability to maintain acceptable alignment after closed reduction and casting). Of these 25 patients, 11 were available for clinical follow-up and medical records review; the other 14 were not available for followup but had their charts reviewed for radiographic data and treatment details. Six of the 14 patients declined to participate in the study, and the other 8 were lost to follow-up because of nonstandardized follow-up protocols. Patients were excluded from the study if their final follow-up had not occurred, or if it occurred before 6 months. For their participation in clinical follow-up, patients received nominal time compensation and mileage reimbursement through a grant from the NBX manufacturer.

The 25 patients underwent CREF with NBX between November 2008 and March 2013. Indications for external fixation consideration were intra-articular extension or significant comminution in patients with poor soft tissue or in patients who wanted to avoid invasive surgery or a permanent implant. Of the 11 patients who agreed to participate in the study, 7 were women and 4 were men; mean age was 64 years (range, 15-81 years). Of the 14 patients unable to follow up, 11 were women and 3 were men; mean age was 63 years (range, 26-89 years). At the last available follow-up, each of the 25 patients was doing well, was satisfied with treatment received and function regained, and had a healed DRF. In almost every case, the mechanism of injury was a fall onto an outstretched hand; most fractures were type C per AO (Arbeitsgemeinschaft für Osteosynthesefragen) classification (Table 1).

The surgical technique for this nonspanning external fixator involves closed reduction with longitudinal traction using ligamentotaxis to grossly align the fracture fragments, with small adjustments made throughout the procedure. A dorsally placed radiolucent fixator is used with fluoroscopic guidance to percutaneously affix a subchondral raft of smooth bicortical .062-inch K-wires. The fixator’s abundant pin holes allow for each specific distal fragment to be captured by pins that are a part of the external fixation construct. Furthermore, radially based pins that use a side bar allow for a “weave” of fixation. Radial length is then obtained and maintained by attaching the distal complex to proximal pins in the radial diaphysis. After pins are cut and wrist and digits are taken through full ROM to ensure smooth tracking, fluoroscopy is used to confirm final fracture fixation and alignment (Figure 1).

In ideal scenarios with good fixation, patients can begin gentle ROM exercises within 1 week after surgery. This regimen can progress to more aggressive motion exercises and even light strengthening (Figure 2).

The 11 clinical follow-up patients underwent directed clinical examination, including ROM and strength evaluation, by Dr. Dwyer and Dr. Crosby. Follow-up also included completion of questionnaires and review of radiographs.

During the clinical follow-up, a standard goniometer was used to evaluate active ROM (wrist flexion and extension and wrist radial and ulnar deviation, measured down the long axis of the forearm and the index ray), and forearm pronation and supination were measured from the 90° elbow flexion position using the humerus as the reference point with the shoulders in 0° of flexion, abduction, and external rotation. In addition, a calibrated dynamometer (Sammons Preston) was used to measure grip strength (position 3) and key pinch strength, and the average of 3 trials of each strength test was calculated. ROM and strength values were calculated as percentages of the contralateral (uninjured) side, as these ratios are more sensitive in detecting clinical changes.¹⁰ A 10% adjustment for dominant hand grip strength in right-handed patients was used for this comparison.¹¹

Union (osseous bridging across fracture site on 2 of 3 views), radial height, radial inclination, and volar tilt were measured on standard posteroanterior and lateral radiographs taken at several points: time of injury, postreduction and/or preoperative, initial postoperative, and final follow-up. All radiographic measurements were independently taken by Dr. Dwyer and Dr. Crosby, who used a digital goniometer and ruler (Siemens Medical Solutions) or, when necessary, manual instruments. Means of the original and independent measurements were used for calculations.

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, the Mayo wrist score, and the patient-rated wrist evaluation were used to assess activities of daily living, pain, and quality of life after surgery. Mayo wrist scores were adjusted for unemployed patients; work status was replaced with return to normal activities. 

Complications of surgical treatment were evaluated. Major complications evaluated were loss of reduction, malunion, nonunion, deep infection, neuropathy, and tendon rupture. Minor complication possibilities were transient extensor tendon irritation, superficial infection, and finger stiffness. Also noted were 1 patient who subsequently required another procedure and 7 patients who were immobilized after external fixation removal.

We compared our study group’s outcomes with those of historical control patients who underwent fixation with internal volar locking plates. The 2 groups had similar demographic characteristics. To obtain the historical controls, we used the key words distal, radi*, volar, and plat* in a PubMed search. From the 169 citations found, we removed biomechanical cadaver studies, studies that focused on patients with demographics and fracture types dissimilar from our patient population’s, and studies that focused on special circumstances, such as complications or patient characteristics. Eight studies remained for historical comparison.

Results

Radiographic Outcomes

On the injury radiographs, mean volar tilt was –16.7° (range, 2° to –42°), mean radial inclination was 14.1° (range, –1° to 44°), and mean radial height was 5.3 mm (range, –2 mm to 11 mm). Minor improvement after reduction was noted. All patients had intraoperative or postoperative radiographs with external fixation in place (Figure 3).

On the final (post-fixation removal) radiographs, mean volar tilt was 3.3° (range, –16° to 21°), mean radial inclination was 20.7° (range, 0° to 31°), and mean radial height was 7.5 mm (range, 0 mm to 13 mm). Comparison of the injury and final means revealed correction of ~20° for volar tilt, 6° for radial inclination, and 2 mm for radial height. All but 5 patients had type C fractures (AO classification).

Clinical Outcomes

Eleven patients underwent clinical evaluation (functional assessment, physical examination). Mean DASH score was 11.4 (SD, 10.5; range, 0-27.3), mean Mayo wrist score was 79.0 (SD, 12.2; range, 65-100), and mean patient-rated wrist evaluation was 12.2 (SD, 11.9; range, 0-25.5). There was no statistical difference in DASH scores between this group and the historical control group (Table 3). ROM was measured under active effort. In our group, mean wrist flexion was 69.3° (86% of contralateral side), and mean extension was 64.0° (94%). Mean radial deviation of the wrist was 47.4° (135% of relative normal for patient), and mean ulnar deviation was 29.2° (101%). Mean (SD) pronation was 84.6° (4.7°), and mean (SD) supination was 82.3° (8.5°), or about 100% of contralateral pronosupination.

For each hand, 3 grip strength values and 3 key pinch strength values were obtained. These values were averaged, and the injury and contralateral sides were compared. Mean grip strength was 49.6 pounds (85% of contralateral), and mean key pinch strength was 14.0 pounds (97%).

Complications

Of the 25 patients, 6 (24%) had a pin-tract infection treated with oral antibiotics. One of these infections resulted in the removal of the entire fixator. One (4%) of the 25 patients reported transient hypoesthesia of the dorsal first webspace, and 3 (12%) reported pain at the pin sites.

Although all fractures achieved complete bony union, 1 patient (4%) had a refracture on the same fracture line after a fall within 6 weeks after fixator removal; this refracture was successfully treated with a cast worn for 6 weeks. Of the 3 patients with complete follow-up (27%) who lost reduction with external fixation in place, 2 had radiographic parameters maintained within acceptable limits, and 1 (9%) had a malunion with –16° volar tilt.

Our study patients had no tendon rupture, tendon irritation, or stiffness. By contrast, fixation with volar locking plates has been associated with extensor tendon and flexor tendon injury, flexor pollicis rupture, carpal tunnel syndrome, complex regional pain syndrome, loss of reduction, and hardware failure.¹⁹ Flexor pollicis longus ruptures that occur after volar plate fixation of DRFs are often attributed to plate positioning.^20-22

Discussion

With volar locking plate internal fixation on the rise, CREF has become less widely used.³ This is especially true for comminuted and intra-articular fractures—most earlier external fixators required either spanning of the wrist or limited fixation in the distal articular fragment. Although many studies have found excellent outcomes of ORIF with volar locking plates in the treatment of unstable DRFs,^4,6 few studies have compared volar locking plate ORIF with nonspanning external fixation for unstable comminuted intra-articular DRFs. Both Gradl and colleagues,⁸ using a nonbridging external fixator with multiplanar K-wires, and Mirza and colleagues,9 using the Cross-Pin Fixation system, found wrist function, quality-of-life, and radiographic outcomes similar to those of volar plate fixation in the treatment of DRFs. A comparative meta-analysis by Margaliot and colleagues¹⁷ revealed no superiority of internal fixation over external fixation for unstable DRFs, given the similarity in wrist function, radiographic, and subjective outcomes.

At a mean follow-up of 12.8 months (range, 6-23 months), our retrospective study found that the functional and radiographic outcomes of treating unstable comminuted DRFs with a nonspanning external fixator were similar to those reported in similarly matched control studies. Although followup of >2 years has been shown to be unnecessary,^23-25 small differences may have been detected with interval results over these 2 years. The effect of selection bias on our study results should be considered in light of patients’ involvement in selecting fixation type. Our results parallel those of the temporal studies of Rozental and colleagues5 and Wei and colleagues¹² (Table 2) while allowing for patients to return to function with limited morbidity and complications, similar to Orbay and Fernandez¹⁵ though with a less invasive procedure.

Although we found patient-rated outcome measure values analogous to those of the volar plate fixation group and bridging external fixator group in the study by Wright and colleagues,⁶ we did not measure intra-articular step-off. Another variable not addressed here was operative time. The nonspanning external fixator treatment that we investigated should undergo further study. A randomized prospective study that includes the additional outcome measures of intra-articular step-off and operative time is warranted. 

We found that our study patients, who had their comminuted intra-articular DRFs treated with a nonspanning external fixator, and similar historical control patients, treated with volar locking plate internal fixation, had similar clinical and radiographic outcomes at final follow-up. There was no statistically significant difference in measured outcomes—wrist flexion and extension, radial deviation, pronation and supination, volar tilt, radial height, radial inclination, DASH scores—between the 2 groups. Compared with the historical control group, the external fixator group had significantly more postoperative ulnar deviation.

Given the functional and radiographic outcomes found at final follow-up in this study, we recommend considering a nonspanning external fixator in the treatment of unstable complex comminuted intra-articular DRFs, particularly those that occur in the elderly.

Take-Home Points

• Clinical and radiographic outcomes of patients treated with non-spanning external fixation are comparable to those treated with open reduction and internal volar locked plate fixation.
• Non-spanning external fixation can lead to satisfactory outcomes based on the following features: fragment specific fixation, subchondral support, fixed angle strength, limited dissection, distraction/length adjustment, joint distraction avoidance, and ability to perform early rehabilitation.
• Non-spanning external fixation should be considered as a treatment option for complicated unstable comminuted intra-articular distal radius fractures, specifically in the elderly.

In the United States, distal radius fractures (DRFs) are among the most common fractures, comprising about 15% of all extremity fractures.¹ With a DRF, the primary treatment goal is anatomical reduction with restoration of radiographic parameters and stable fixation of the fracture to restore wrist function.

This fracture type has a variety of treatment alternatives, including nonoperative closed reduction and casting of stable fractures, open reduction and internal fixation (ORIF) with dorsal or volar locking plates, and external fixation. Optimal surgical management of unstable DRFs remains controversial.² Closed reduction with percutaneous pinning or external fixation has become less common with a trend toward using volar locking plates for internal fixation.³

External fixation of DRFs traditionally has involved either spanning or simple nonspanning devices. Spanning fixation is particularly useful in open or highly comminuted fractures with an unstable soft-tissue envelope. In the past, nonspanning external fixation typically was reserved for fractures with a noncomminuted extra-articular distal fragment to which several large pins or Kirschner wires (K-wires) could be secured. The Non-Bridging External Fixator (NBX; Nutek Orthopaedics) may be used in cases that traditionally might be treated with locked plating or fragment-specific fixation. Specifically, this device is indicated for comminuted intra-articular DRFs in which bone quality may be less than ideal. The NBX, also suitable in open fractures with a stable soft-tissue envelope, can restore and maintain articular alignment by providing subchondral support and stability with fragment-specific fixation. A key advantage of this type of external fixation is that it involves percutaneous fixation and allows for early postoperative range of motion (ROM).

Numerous studies have found excellent outcomes of treating unstable DRFs with ORIF with volar locking plates.^4-6 However, few studies have compared the clinical and radiographic outcomes of ORIF with those of nonspanning external fixation in the treatment of unstable comminuted intra-articular DRFs. Windolf and colleagues⁷ found that, in cadaveric unstable intra-articular DRFs, nonspanning external fixation with multiplanar K-wires had biomechanical characteristics comparable to those of volar locking plates. Other suitable DRF treatment options have been found: an alternative nonbridging external fixator with multiplanar K-wires (Gradl and colleagues⁸) and the Cross-Pin Fixation system (A.M. Surgical) (Mirza and colleagues⁹).

We conducted a study to compare functional and radiographic outcomes of unstable comminuted intra-articular DRFs treated with a nonspanning external fixation device (NBX) with outcomes achieved with volar locking plates in a historical control group.

Materials and Methods

This retrospective case-control study was approved by our Institutional Review Board and conducted at 2 institutions. Included in the study were 25 consecutive patients (2 institutions) who underwent closed reduction and external fixation (CREF) with NBX as treatment for unstable DRFs (diagnosis based on radiographic parameters or inability to maintain acceptable alignment after closed reduction and casting). Of these 25 patients, 11 were available for clinical follow-up and medical records review; the other 14 were not available for followup but had their charts reviewed for radiographic data and treatment details. Six of the 14 patients declined to participate in the study, and the other 8 were lost to follow-up because of nonstandardized follow-up protocols. Patients were excluded from the study if their final follow-up had not occurred, or if it occurred before 6 months. For their participation in clinical follow-up, patients received nominal time compensation and mileage reimbursement through a grant from the NBX manufacturer.

The 25 patients underwent CREF with NBX between November 2008 and March 2013. Indications for external fixation consideration were intra-articular extension or significant comminution in patients with poor soft tissue or in patients who wanted to avoid invasive surgery or a permanent implant. Of the 11 patients who agreed to participate in the study, 7 were women and 4 were men; mean age was 64 years (range, 15-81 years). Of the 14 patients unable to follow up, 11 were women and 3 were men; mean age was 63 years (range, 26-89 years). At the last available follow-up, each of the 25 patients was doing well, was satisfied with treatment received and function regained, and had a healed DRF. In almost every case, the mechanism of injury was a fall onto an outstretched hand; most fractures were type C per AO (Arbeitsgemeinschaft für Osteosynthesefragen) classification (Table 1).

The surgical technique for this nonspanning external fixator involves closed reduction with longitudinal traction using ligamentotaxis to grossly align the fracture fragments, with small adjustments made throughout the procedure. A dorsally placed radiolucent fixator is used with fluoroscopic guidance to percutaneously affix a subchondral raft of smooth bicortical .062-inch K-wires. The fixator’s abundant pin holes allow for each specific distal fragment to be captured by pins that are a part of the external fixation construct. Furthermore, radially based pins that use a side bar allow for a “weave” of fixation. Radial length is then obtained and maintained by attaching the distal complex to proximal pins in the radial diaphysis. After pins are cut and wrist and digits are taken through full ROM to ensure smooth tracking, fluoroscopy is used to confirm final fracture fixation and alignment (Figure 1).

In ideal scenarios with good fixation, patients can begin gentle ROM exercises within 1 week after surgery. This regimen can progress to more aggressive motion exercises and even light strengthening (Figure 2).

The 11 clinical follow-up patients underwent directed clinical examination, including ROM and strength evaluation, by Dr. Dwyer and Dr. Crosby. Follow-up also included completion of questionnaires and review of radiographs.

During the clinical follow-up, a standard goniometer was used to evaluate active ROM (wrist flexion and extension and wrist radial and ulnar deviation, measured down the long axis of the forearm and the index ray), and forearm pronation and supination were measured from the 90° elbow flexion position using the humerus as the reference point with the shoulders in 0° of flexion, abduction, and external rotation. In addition, a calibrated dynamometer (Sammons Preston) was used to measure grip strength (position 3) and key pinch strength, and the average of 3 trials of each strength test was calculated. ROM and strength values were calculated as percentages of the contralateral (uninjured) side, as these ratios are more sensitive in detecting clinical changes.¹⁰ A 10% adjustment for dominant hand grip strength in right-handed patients was used for this comparison.¹¹

Union (osseous bridging across fracture site on 2 of 3 views), radial height, radial inclination, and volar tilt were measured on standard posteroanterior and lateral radiographs taken at several points: time of injury, postreduction and/or preoperative, initial postoperative, and final follow-up. All radiographic measurements were independently taken by Dr. Dwyer and Dr. Crosby, who used a digital goniometer and ruler (Siemens Medical Solutions) or, when necessary, manual instruments. Means of the original and independent measurements were used for calculations.

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, the Mayo wrist score, and the patient-rated wrist evaluation were used to assess activities of daily living, pain, and quality of life after surgery. Mayo wrist scores were adjusted for unemployed patients; work status was replaced with return to normal activities. 

Complications of surgical treatment were evaluated. Major complications evaluated were loss of reduction, malunion, nonunion, deep infection, neuropathy, and tendon rupture. Minor complication possibilities were transient extensor tendon irritation, superficial infection, and finger stiffness. Also noted were 1 patient who subsequently required another procedure and 7 patients who were immobilized after external fixation removal.

We compared our study group’s outcomes with those of historical control patients who underwent fixation with internal volar locking plates. The 2 groups had similar demographic characteristics. To obtain the historical controls, we used the key words distal, radi*, volar, and plat* in a PubMed search. From the 169 citations found, we removed biomechanical cadaver studies, studies that focused on patients with demographics and fracture types dissimilar from our patient population’s, and studies that focused on special circumstances, such as complications or patient characteristics. Eight studies remained for historical comparison.

Results

Radiographic Outcomes

On the injury radiographs, mean volar tilt was –16.7° (range, 2° to –42°), mean radial inclination was 14.1° (range, –1° to 44°), and mean radial height was 5.3 mm (range, –2 mm to 11 mm). Minor improvement after reduction was noted. All patients had intraoperative or postoperative radiographs with external fixation in place (Figure 3).

On the final (post-fixation removal) radiographs, mean volar tilt was 3.3° (range, –16° to 21°), mean radial inclination was 20.7° (range, 0° to 31°), and mean radial height was 7.5 mm (range, 0 mm to 13 mm). Comparison of the injury and final means revealed correction of ~20° for volar tilt, 6° for radial inclination, and 2 mm for radial height. All but 5 patients had type C fractures (AO classification).

Clinical Outcomes

Eleven patients underwent clinical evaluation (functional assessment, physical examination). Mean DASH score was 11.4 (SD, 10.5; range, 0-27.3), mean Mayo wrist score was 79.0 (SD, 12.2; range, 65-100), and mean patient-rated wrist evaluation was 12.2 (SD, 11.9; range, 0-25.5). There was no statistical difference in DASH scores between this group and the historical control group (Table 3). ROM was measured under active effort. In our group, mean wrist flexion was 69.3° (86% of contralateral side), and mean extension was 64.0° (94%). Mean radial deviation of the wrist was 47.4° (135% of relative normal for patient), and mean ulnar deviation was 29.2° (101%). Mean (SD) pronation was 84.6° (4.7°), and mean (SD) supination was 82.3° (8.5°), or about 100% of contralateral pronosupination.

For each hand, 3 grip strength values and 3 key pinch strength values were obtained. These values were averaged, and the injury and contralateral sides were compared. Mean grip strength was 49.6 pounds (85% of contralateral), and mean key pinch strength was 14.0 pounds (97%).

Complications

Of the 25 patients, 6 (24%) had a pin-tract infection treated with oral antibiotics. One of these infections resulted in the removal of the entire fixator. One (4%) of the 25 patients reported transient hypoesthesia of the dorsal first webspace, and 3 (12%) reported pain at the pin sites.

Although all fractures achieved complete bony union, 1 patient (4%) had a refracture on the same fracture line after a fall within 6 weeks after fixator removal; this refracture was successfully treated with a cast worn for 6 weeks. Of the 3 patients with complete follow-up (27%) who lost reduction with external fixation in place, 2 had radiographic parameters maintained within acceptable limits, and 1 (9%) had a malunion with –16° volar tilt.

Our study patients had no tendon rupture, tendon irritation, or stiffness. By contrast, fixation with volar locking plates has been associated with extensor tendon and flexor tendon injury, flexor pollicis rupture, carpal tunnel syndrome, complex regional pain syndrome, loss of reduction, and hardware failure.¹⁹ Flexor pollicis longus ruptures that occur after volar plate fixation of DRFs are often attributed to plate positioning.^20-22

Discussion

With volar locking plate internal fixation on the rise, CREF has become less widely used.³ This is especially true for comminuted and intra-articular fractures—most earlier external fixators required either spanning of the wrist or limited fixation in the distal articular fragment. Although many studies have found excellent outcomes of ORIF with volar locking plates in the treatment of unstable DRFs,^4,6 few studies have compared volar locking plate ORIF with nonspanning external fixation for unstable comminuted intra-articular DRFs. Both Gradl and colleagues,⁸ using a nonbridging external fixator with multiplanar K-wires, and Mirza and colleagues,9 using the Cross-Pin Fixation system, found wrist function, quality-of-life, and radiographic outcomes similar to those of volar plate fixation in the treatment of DRFs. A comparative meta-analysis by Margaliot and colleagues¹⁷ revealed no superiority of internal fixation over external fixation for unstable DRFs, given the similarity in wrist function, radiographic, and subjective outcomes.

At a mean follow-up of 12.8 months (range, 6-23 months), our retrospective study found that the functional and radiographic outcomes of treating unstable comminuted DRFs with a nonspanning external fixator were similar to those reported in similarly matched control studies. Although followup of >2 years has been shown to be unnecessary,^23-25 small differences may have been detected with interval results over these 2 years. The effect of selection bias on our study results should be considered in light of patients’ involvement in selecting fixation type. Our results parallel those of the temporal studies of Rozental and colleagues5 and Wei and colleagues¹² (Table 2) while allowing for patients to return to function with limited morbidity and complications, similar to Orbay and Fernandez¹⁵ though with a less invasive procedure.

Although we found patient-rated outcome measure values analogous to those of the volar plate fixation group and bridging external fixator group in the study by Wright and colleagues,⁶ we did not measure intra-articular step-off. Another variable not addressed here was operative time. The nonspanning external fixator treatment that we investigated should undergo further study. A randomized prospective study that includes the additional outcome measures of intra-articular step-off and operative time is warranted. 

We found that our study patients, who had their comminuted intra-articular DRFs treated with a nonspanning external fixator, and similar historical control patients, treated with volar locking plate internal fixation, had similar clinical and radiographic outcomes at final follow-up. There was no statistically significant difference in measured outcomes—wrist flexion and extension, radial deviation, pronation and supination, volar tilt, radial height, radial inclination, DASH scores—between the 2 groups. Compared with the historical control group, the external fixator group had significantly more postoperative ulnar deviation.

Given the functional and radiographic outcomes found at final follow-up in this study, we recommend considering a nonspanning external fixator in the treatment of unstable complex comminuted intra-articular DRFs, particularly those that occur in the elderly.

Take-Home Points

• Clinical and radiographic outcomes of patients treated with non-spanning external fixation are comparable to those treated with open reduction and internal volar locked plate fixation.
• Non-spanning external fixation can lead to satisfactory outcomes based on the following features: fragment specific fixation, subchondral support, fixed angle strength, limited dissection, distraction/length adjustment, joint distraction avoidance, and ability to perform early rehabilitation.
• Non-spanning external fixation should be considered as a treatment option for complicated unstable comminuted intra-articular distal radius fractures, specifically in the elderly.

In the United States, distal radius fractures (DRFs) are among the most common fractures, comprising about 15% of all extremity fractures.¹ With a DRF, the primary treatment goal is anatomical reduction with restoration of radiographic parameters and stable fixation of the fracture to restore wrist function.

This fracture type has a variety of treatment alternatives, including nonoperative closed reduction and casting of stable fractures, open reduction and internal fixation (ORIF) with dorsal or volar locking plates, and external fixation. Optimal surgical management of unstable DRFs remains controversial.² Closed reduction with percutaneous pinning or external fixation has become less common with a trend toward using volar locking plates for internal fixation.³

External fixation of DRFs traditionally has involved either spanning or simple nonspanning devices. Spanning fixation is particularly useful in open or highly comminuted fractures with an unstable soft-tissue envelope. In the past, nonspanning external fixation typically was reserved for fractures with a noncomminuted extra-articular distal fragment to which several large pins or Kirschner wires (K-wires) could be secured. The Non-Bridging External Fixator (NBX; Nutek Orthopaedics) may be used in cases that traditionally might be treated with locked plating or fragment-specific fixation. Specifically, this device is indicated for comminuted intra-articular DRFs in which bone quality may be less than ideal. The NBX, also suitable in open fractures with a stable soft-tissue envelope, can restore and maintain articular alignment by providing subchondral support and stability with fragment-specific fixation. A key advantage of this type of external fixation is that it involves percutaneous fixation and allows for early postoperative range of motion (ROM).

Numerous studies have found excellent outcomes of treating unstable DRFs with ORIF with volar locking plates.^4-6 However, few studies have compared the clinical and radiographic outcomes of ORIF with those of nonspanning external fixation in the treatment of unstable comminuted intra-articular DRFs. Windolf and colleagues⁷ found that, in cadaveric unstable intra-articular DRFs, nonspanning external fixation with multiplanar K-wires had biomechanical characteristics comparable to those of volar locking plates. Other suitable DRF treatment options have been found: an alternative nonbridging external fixator with multiplanar K-wires (Gradl and colleagues⁸) and the Cross-Pin Fixation system (A.M. Surgical) (Mirza and colleagues⁹).

We conducted a study to compare functional and radiographic outcomes of unstable comminuted intra-articular DRFs treated with a nonspanning external fixation device (NBX) with outcomes achieved with volar locking plates in a historical control group.

Materials and Methods

This retrospective case-control study was approved by our Institutional Review Board and conducted at 2 institutions. Included in the study were 25 consecutive patients (2 institutions) who underwent closed reduction and external fixation (CREF) with NBX as treatment for unstable DRFs (diagnosis based on radiographic parameters or inability to maintain acceptable alignment after closed reduction and casting). Of these 25 patients, 11 were available for clinical follow-up and medical records review; the other 14 were not available for followup but had their charts reviewed for radiographic data and treatment details. Six of the 14 patients declined to participate in the study, and the other 8 were lost to follow-up because of nonstandardized follow-up protocols. Patients were excluded from the study if their final follow-up had not occurred, or if it occurred before 6 months. For their participation in clinical follow-up, patients received nominal time compensation and mileage reimbursement through a grant from the NBX manufacturer.

The 25 patients underwent CREF with NBX between November 2008 and March 2013. Indications for external fixation consideration were intra-articular extension or significant comminution in patients with poor soft tissue or in patients who wanted to avoid invasive surgery or a permanent implant. Of the 11 patients who agreed to participate in the study, 7 were women and 4 were men; mean age was 64 years (range, 15-81 years). Of the 14 patients unable to follow up, 11 were women and 3 were men; mean age was 63 years (range, 26-89 years). At the last available follow-up, each of the 25 patients was doing well, was satisfied with treatment received and function regained, and had a healed DRF. In almost every case, the mechanism of injury was a fall onto an outstretched hand; most fractures were type C per AO (Arbeitsgemeinschaft für Osteosynthesefragen) classification (Table 1).

The surgical technique for this nonspanning external fixator involves closed reduction with longitudinal traction using ligamentotaxis to grossly align the fracture fragments, with small adjustments made throughout the procedure. A dorsally placed radiolucent fixator is used with fluoroscopic guidance to percutaneously affix a subchondral raft of smooth bicortical .062-inch K-wires. The fixator’s abundant pin holes allow for each specific distal fragment to be captured by pins that are a part of the external fixation construct. Furthermore, radially based pins that use a side bar allow for a “weave” of fixation. Radial length is then obtained and maintained by attaching the distal complex to proximal pins in the radial diaphysis. After pins are cut and wrist and digits are taken through full ROM to ensure smooth tracking, fluoroscopy is used to confirm final fracture fixation and alignment (Figure 1).

In ideal scenarios with good fixation, patients can begin gentle ROM exercises within 1 week after surgery. This regimen can progress to more aggressive motion exercises and even light strengthening (Figure 2).

The 11 clinical follow-up patients underwent directed clinical examination, including ROM and strength evaluation, by Dr. Dwyer and Dr. Crosby. Follow-up also included completion of questionnaires and review of radiographs.

During the clinical follow-up, a standard goniometer was used to evaluate active ROM (wrist flexion and extension and wrist radial and ulnar deviation, measured down the long axis of the forearm and the index ray), and forearm pronation and supination were measured from the 90° elbow flexion position using the humerus as the reference point with the shoulders in 0° of flexion, abduction, and external rotation. In addition, a calibrated dynamometer (Sammons Preston) was used to measure grip strength (position 3) and key pinch strength, and the average of 3 trials of each strength test was calculated. ROM and strength values were calculated as percentages of the contralateral (uninjured) side, as these ratios are more sensitive in detecting clinical changes.¹⁰ A 10% adjustment for dominant hand grip strength in right-handed patients was used for this comparison.¹¹

Union (osseous bridging across fracture site on 2 of 3 views), radial height, radial inclination, and volar tilt were measured on standard posteroanterior and lateral radiographs taken at several points: time of injury, postreduction and/or preoperative, initial postoperative, and final follow-up. All radiographic measurements were independently taken by Dr. Dwyer and Dr. Crosby, who used a digital goniometer and ruler (Siemens Medical Solutions) or, when necessary, manual instruments. Means of the original and independent measurements were used for calculations.

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, the Mayo wrist score, and the patient-rated wrist evaluation were used to assess activities of daily living, pain, and quality of life after surgery. Mayo wrist scores were adjusted for unemployed patients; work status was replaced with return to normal activities. 

Complications of surgical treatment were evaluated. Major complications evaluated were loss of reduction, malunion, nonunion, deep infection, neuropathy, and tendon rupture. Minor complication possibilities were transient extensor tendon irritation, superficial infection, and finger stiffness. Also noted were 1 patient who subsequently required another procedure and 7 patients who were immobilized after external fixation removal.

We compared our study group’s outcomes with those of historical control patients who underwent fixation with internal volar locking plates. The 2 groups had similar demographic characteristics. To obtain the historical controls, we used the key words distal, radi*, volar, and plat* in a PubMed search. From the 169 citations found, we removed biomechanical cadaver studies, studies that focused on patients with demographics and fracture types dissimilar from our patient population’s, and studies that focused on special circumstances, such as complications or patient characteristics. Eight studies remained for historical comparison.

Results

Radiographic Outcomes

On the injury radiographs, mean volar tilt was –16.7° (range, 2° to –42°), mean radial inclination was 14.1° (range, –1° to 44°), and mean radial height was 5.3 mm (range, –2 mm to 11 mm). Minor improvement after reduction was noted. All patients had intraoperative or postoperative radiographs with external fixation in place (Figure 3).

On the final (post-fixation removal) radiographs, mean volar tilt was 3.3° (range, –16° to 21°), mean radial inclination was 20.7° (range, 0° to 31°), and mean radial height was 7.5 mm (range, 0 mm to 13 mm). Comparison of the injury and final means revealed correction of ~20° for volar tilt, 6° for radial inclination, and 2 mm for radial height. All but 5 patients had type C fractures (AO classification).

Clinical Outcomes

Eleven patients underwent clinical evaluation (functional assessment, physical examination). Mean DASH score was 11.4 (SD, 10.5; range, 0-27.3), mean Mayo wrist score was 79.0 (SD, 12.2; range, 65-100), and mean patient-rated wrist evaluation was 12.2 (SD, 11.9; range, 0-25.5). There was no statistical difference in DASH scores between this group and the historical control group (Table 3). ROM was measured under active effort. In our group, mean wrist flexion was 69.3° (86% of contralateral side), and mean extension was 64.0° (94%). Mean radial deviation of the wrist was 47.4° (135% of relative normal for patient), and mean ulnar deviation was 29.2° (101%). Mean (SD) pronation was 84.6° (4.7°), and mean (SD) supination was 82.3° (8.5°), or about 100% of contralateral pronosupination.

For each hand, 3 grip strength values and 3 key pinch strength values were obtained. These values were averaged, and the injury and contralateral sides were compared. Mean grip strength was 49.6 pounds (85% of contralateral), and mean key pinch strength was 14.0 pounds (97%).

Complications

Of the 25 patients, 6 (24%) had a pin-tract infection treated with oral antibiotics. One of these infections resulted in the removal of the entire fixator. One (4%) of the 25 patients reported transient hypoesthesia of the dorsal first webspace, and 3 (12%) reported pain at the pin sites.

Although all fractures achieved complete bony union, 1 patient (4%) had a refracture on the same fracture line after a fall within 6 weeks after fixator removal; this refracture was successfully treated with a cast worn for 6 weeks. Of the 3 patients with complete follow-up (27%) who lost reduction with external fixation in place, 2 had radiographic parameters maintained within acceptable limits, and 1 (9%) had a malunion with –16° volar tilt.

Our study patients had no tendon rupture, tendon irritation, or stiffness. By contrast, fixation with volar locking plates has been associated with extensor tendon and flexor tendon injury, flexor pollicis rupture, carpal tunnel syndrome, complex regional pain syndrome, loss of reduction, and hardware failure.¹⁹ Flexor pollicis longus ruptures that occur after volar plate fixation of DRFs are often attributed to plate positioning.^20-22

Discussion

With volar locking plate internal fixation on the rise, CREF has become less widely used.³ This is especially true for comminuted and intra-articular fractures—most earlier external fixators required either spanning of the wrist or limited fixation in the distal articular fragment. Although many studies have found excellent outcomes of ORIF with volar locking plates in the treatment of unstable DRFs,^4,6 few studies have compared volar locking plate ORIF with nonspanning external fixation for unstable comminuted intra-articular DRFs. Both Gradl and colleagues,⁸ using a nonbridging external fixator with multiplanar K-wires, and Mirza and colleagues,9 using the Cross-Pin Fixation system, found wrist function, quality-of-life, and radiographic outcomes similar to those of volar plate fixation in the treatment of DRFs. A comparative meta-analysis by Margaliot and colleagues¹⁷ revealed no superiority of internal fixation over external fixation for unstable DRFs, given the similarity in wrist function, radiographic, and subjective outcomes.

At a mean follow-up of 12.8 months (range, 6-23 months), our retrospective study found that the functional and radiographic outcomes of treating unstable comminuted DRFs with a nonspanning external fixator were similar to those reported in similarly matched control studies. Although followup of >2 years has been shown to be unnecessary,^23-25 small differences may have been detected with interval results over these 2 years. The effect of selection bias on our study results should be considered in light of patients’ involvement in selecting fixation type. Our results parallel those of the temporal studies of Rozental and colleagues5 and Wei and colleagues¹² (Table 2) while allowing for patients to return to function with limited morbidity and complications, similar to Orbay and Fernandez¹⁵ though with a less invasive procedure.

Although we found patient-rated outcome measure values analogous to those of the volar plate fixation group and bridging external fixator group in the study by Wright and colleagues,⁶ we did not measure intra-articular step-off. Another variable not addressed here was operative time. The nonspanning external fixator treatment that we investigated should undergo further study. A randomized prospective study that includes the additional outcome measures of intra-articular step-off and operative time is warranted. 

We found that our study patients, who had their comminuted intra-articular DRFs treated with a nonspanning external fixator, and similar historical control patients, treated with volar locking plate internal fixation, had similar clinical and radiographic outcomes at final follow-up. There was no statistically significant difference in measured outcomes—wrist flexion and extension, radial deviation, pronation and supination, volar tilt, radial height, radial inclination, DASH scores—between the 2 groups. Compared with the historical control group, the external fixator group had significantly more postoperative ulnar deviation.

Given the functional and radiographic outcomes found at final follow-up in this study, we recommend considering a nonspanning external fixator in the treatment of unstable complex comminuted intra-articular DRFs, particularly those that occur in the elderly.

For more than a century, medical rounds have been a cornerstone of patient care and medical education in teaching hospitals. They remain critical activities for exposing generations of trainees to clinical decision making, coordination of care, and patient communication.¹

Despite this established importance within medical education and patient care, there is a relative paucity of research addressing the purpose of medical rounds in the 21st century. Medicine has evolved significantly since Osler’s day, and it is unclear whether the purpose of rounds has evolved along with it. Rounds, to Osler, were an important opportunity for future physicians to learn at the bedside from an attending physician. Increased duty hour restrictions, mandatory adoption of electronic medical records, and increasingly complex care have changed how rounds are performed, making it more difficult to achieve Osler’s ideals.^2,3 While several studies have aimed to quantify the changes to rounds and have demonstrated a significant decline in bedside teaching,^4-6 few studies have explored the purpose of rounds from the perspective of pertinent stakeholders, students, residents, and faculty. The authors have published the results of focus groups of resident stakeholders recently.⁷ We made the decision to combine the student/faculty data and describe it separately from the resident data to allow the most accurate and relevant discussion as it pertained to each group.

The aim of this study was to explore the perceptions of faculty and students of general inpatient rounds on internal medicine and pediatric rotations, and to identify any notable differences between these key stakeholders.

Between April 2014 and June 2014, we conducted 10 semistructured focus groups at 4 teaching hospitals: The University of Chicago Medical Center, Children’s National Health System, Georgetown University Medical Center, and the University of California, San Francisco Medical Center. A sample of eligible 3rd-year medical students and residents on pediatrics and internal medicine hospitalist services as well as hospitalist attendings in pediatrics and internal medicine were invited by e-mail to participate voluntarily without compensation. Identical semistructured focus groups were also conducted with pediatric and internal medicine interns (postgraduate year [PGY1]) and senior residents (PGY2 and PGY3), and those data have been published previously.⁷

Data Collection

Most focus groups had 6 to 8 participants, with 2 groups of 3 and 4. The groups were interviewed separately by training and specialty: 3rd-year medical students who had completed internal medicine and/or pediatrics rotations, hospitalist attendings in pediatrics, and hospitalist attendings in internal medicine. Attendings with training in medicine-pediatrics were included in the department in which they worked most frequently. The focus group script was informed by a literature review and expert input, and we used open-ended questions to explore perspectives on current and ideal purposes of rounds. Interviews were digitally recorded, transcribed, and names of speakers or references to specific patients were removed to preserve confidentiality and anonymity. The focus groups lasted between 30 and 60 minutes. The author (OH) conducted focus groups at 1 site, and trained facilitators conducted focus groups at the remaining 3 sites. The protocol was determined to be exempt by the institutional review boards at all participating sites. Prior to the focus groups, the definition of family-centered rounds was read aloud; after which, participants were asked to fill out a demographic survey.

Data Analysis

The authors employed a grounded theory approach to data collection and analysis,⁸ and data were analyzed by using the constant-comparative method.⁹ There was no a priori hypothesis. Four transcripts were independently reviewed by 2 authors (OH and RR) by using sentences and phrases as the units of data, which were coded with an identifier. The authors discussed initial codes and resolved discrepancies through deliberation and consensus to create codebooks. Themes, made up of multiple codes, were identified inductively and iteratively and were refined to reflect the evolving dataset. One author (OH) independently coded the remaining transcripts by using a revised codebook as a guide. A faculty author (JF) assessed the interrater reliability of the final codebook by reviewing 2 previously coded, randomly selected transcripts with no new codes emerging in the process, with a kappa coefficient of >0.8 indicating significant agreement.

What Do You Perceive the Purpose of Rounds to Be?

With respect to this prompt, we identified 4 themes, which represent 16 codes describing what attendings and medical students believed to be the purpose of rounds (Table 2). These themes are communication, medical education, patient care, and assessment.

Communication

Communication includes all comments addressing the role of rounds as it relates to communication between team members, patients, family members, and all those involved in patient care. There were 4 main codes, including coordination of patient care team, patient/family communication, establishing rapport with patients and/or family, and establishment of roles.

Coordination of patient care team identified rounds as a time “to make sure everyone is on the same page” and “to come together whenever possible,” so that everyone “had the same information of what was going on.” It also included comments related to interdisciplinary communication, with 1 participant describing rounds as “a time when your consulting team, or people with outside expertise, can weigh in on some medical issues.”

Medical Education

The theme of medical education is made up of 6 codes that encompass comments related to teaching and learning during rounds. These 6 codes include delivery of clinical education, exposure to clinical decision making, role modeling, student presentations, establishment of trainee autonomy, and providing a safe learning environment.

Delivery of clinical education included comments identifying rounds as a time for didactic teaching, teachable moments, “clinical pearls,” and bedside teaching of physical exam skills. Exposure to clinical decision making included comments by both medical students and attendings who described the purpose of rounds as a time for learning and teaching, specifically about how best to approach problems and decision making in a systematic manner, with 1 medical student explaining it as a time to “expose [trainees] to the way that people think about problems and how they decided to go about addressing them.”

Role modeling includes comments addressing rounds as a time for attendings to demonstrate appropriate behaviors and skills to trainees. One attending explained that “everybody learns from watching other people present and interact…so everybody has a chance to pick up things that they think, ‘Oh, this works well.’” Student presentations include comments, predominantly from students, that described rounds as an opportunity to practice presentations and receive feedback, with 1 student explaining it was a time “to learn how to present but also to be questioned and challenged.”

Establishing trainee autonomy is a code that identifies rounds as a time to encourage resident and student autonomy in order to achieve rounds that function with minimal input from the attending, with 1 attending describing how they “put resident leadership first as far as priorities… [and] fostering that because I usually let them decide what we’re going to do.”

Providing a safe learning environment identifies the purpose of rounds as being a space in which trainees can feel comfortable learning from their mistakes. One student described rounds as, “…a setting where it’s okay to be wrong and feel comfortable enough to know that it’s about a learning process.”

Assessment

Assessment is a theme composed of comments identifying the purpose of rounds as being related to observation, assessment, and feedback, and it includes 2 codes: attending observation, assessment, and feedback and establishment of expectations. Attending observation, assessment, and feedback includes comments from attendings and students alike who described rounds as a place for observation, evaluation, and provision of feedback regarding the skills and abilities of trainees. One attending explained that rounds gave him an “opportunity to observe trainees interacting with each other, with the patient, the patient’s family, and ancillary staff,” with another commenting it was time used “to assess how med students are gathering information, presenting information, and eventually their assessment and plan.” Establishment of expectations captures comments that describe rounds as a time for the establishment of expectations and goals of the team.

Patient Care

Patient care is a theme comprised of comments identifying the purpose of rounds as being directly related to the formation and delivery of the patient care plan, and it includes 2 codes: formation of the patient care plan and delivery of patient care. Formation of the patient care plan includes comments, which identified rounds as a time for discussing and forming the plan for the day, with an attending stating, “The purpose [of rounds] was to make a plan, a treatment plan, and to include the parents in making the treatment plan.” Delivery of patient care included comments identifying rounds as a means of ensuring timely, safe, and appropriate delivery of patient care occurred. One attending explained, “It can’t be undersold that the priority of rounds is patient care and the more eyes that look over information the less likely there are to be mistakes.”

What Do You Believe the Ideal Purpose of RoundsShould Be?

This study originally sought to compare responses to 2 different questions: “What do you perceive the purpose of rounds to be?” and “What do you believe the ideal purpose of rounds should be?” What became clear during the focus groups was that these were often interpreted to be the same question, and as such, responses to the latter question were truncated or were reiterations of what was previously said: “I think we’ve already discussed that, I think it’s no different than what we already kind of said, patient care, education, and communication,” explained 1 attending. Fifty-four responses to the question regarding the ideal purpose of rounds were coded and did not differ significantly from the previously noted results in terms of the domains represented and the frequency of representation.

Variation Among Respondents

Overall, there is a high level of concordance between the comments from medical students and attendings regarding the purpose of rounds, particularly in the medical education theme. However, medicine and pediatric attendings differ in their comments relating to the theme of communication, with 2 codes primarily accounting for this difference: pediatric attendings place more emphasis on time for patient/family communication and establishing rapport with patients than their internal medicine colleagues. Of note, all of the pediatric attendings involved in the study answered that they conducted family-centered rounds (FCR), compared with 22% of internal medicine attendings.¹⁰

Another notable discrepancy came up during focus groups involving comments from medical students who reiterated that the purpose of rounds was not fixed, but rather dependent on the attending that was running rounds. This theme was only identified in focus groups involving medical students. One student explained, “I think that it depends on the attending and if they actually want to teach,” and another commented that “it’s incredibly dependent on what the attending… is willing to invest.” No attendings identified student or attending variability as an important factor influencing the purpose of rounds.

This qualitative study is one of the first to explore the purpose of rounds from the perspective of both medical students and attendings. Reassuringly, our results indicate that medical student and attending perceptions are largely concordant. The 4 themes of communication, medical education, assessment, and patient care are in line with the findings of previous observational studies of internal medicine and pediatrics rounds.^1,11 The themes are similar to the findings of resident focus groups done at these same sites.⁷

Our results support that both medical students and attendings identify the importance of medical education during rounds. This is in contrast with findings in previous observational time-motion research by Stickrath that describes the focus on patient care related activities and the relative scarcity of education during rounds.¹ This stresses a divide between how medical students and attendings define the purpose of rounds and what other research suggests actually occurs on rounds. This distinction is an important one. It is possible that the way we, and others, define “medical education” and “patient care” may be at least partially responsible for these findings. This is supported by the ambiguous distinction between formal and informal educational activities on rounds and the challenges in characterizing the hidden curriculum and its role in medical student and resident education.¹¹ Attendings role modeling effective patient communication strategies, for example, highlights that patient care, medical education, and communication are frequently indistinguishable.¹² This hybridization of activities and dedication to diverse types of learning is an essential quality of rounds and is suggestive of why they have survived as a preeminent tool within the arsenal of medical education for the past century.

Yet, this finding does not excuse or adequately explain a well-documented disappearance of more formal educational activities during rounds. Recent observational studies have shown that the percentage of rounds dedicated to educational activities fell from 25% to 10% after the implementation of duty hour restrictions,^1,13,14 and a recent ethnographic study of pediatric attending rounds confirmed teaching during rounds, though seen as a pedagogical ideal, occurred infrequently and inconsistently in large part because of time pressures.¹⁵ In our attending focus groups, duty hours and time pressures were frequently cited as actively working against the purpose of rounds, specifically opportunities for teaching, with 1 attending explaining, “I just don’t think we achieve our [teaching] goals like we used to.” Another attending mentioned that, because of time pressures, “I often find myself apologizing. ‘I’m so sorry. I can’t resist. Can I just tell you this one thing? I’m so sorry to do teaching.’” This tension between time pressures and education on rounds is well documented in the literature.^4,16,17

Our results highlight that attendings and medical students still believe that medical education is a primary and important purpose of rounds even in the face of increasing time pressures. As such, efforts should be made to better align the many purposes of rounds with the realities of the modern day rounding environment. Increasing the presence of medical education on rounds need not be at the expense of time given that techniques like the 1-minute preceptor have been rated as both efficient and effective methods of teaching and delivering feedback.¹⁸ This is echoed in research that has found that faculty development with a focus on teaching significantly increased the rate of clinical education and interdisciplinary communication during rounds.¹ Opportunities for faculty development are increasingly accessible,¹⁹ including programs like the Advancing Pediatric Excellence Teaching Program, sponsored by the American Academy of Pediatrics Section on Hospital Medicine and the Academic Pediatric Association, and the Teaching Educators Across the Continuum of Healthcare program, sponsored by the Society for General Internal Medicine.^20,21

A testament to the adaptability of rounds can be seen in our findings that expose the increased emphasis with which pediatric attendings identify communication as a purpose of rounds, particularly within the themes of patient/family communication and establishing rapport with patients. This is likely due to the practice of FCR by 100% of the pediatric attendings in our focus groups, and is supported elsewhere in the literature.²² A key to family-centered rounds is communication, with active participation in the care discussion by patients and families as described and endorsed by a 2012 American Academy of Pediatrics (AAP) policy.^10,23

This emphasis could explain the increased frequency of comments made by pediatric attendings within the themes of patient/family communication and establishing rapport with patients. Furthermore, the AAP policy statement stresses the need to share information in a way that patients and families “effectively participate in care and decision making,” which could explain why pediatric attendings placed greater emphasis on the formation of the patient care plan in the theme of patient care.

As noted, the authors published a related study focusing on resident perceptions regarding the purpose of rounds. We initially undertook a separate analysis of the 3 groups: faculty, residents, and medical students. From that analysis, it became apparent that residents (PGY1-PGY3) viewed rounds differently than faculty and medical students. Where faculty and medical students were more focused on communication and medical education, the residents were more focused on the practical aspects of rounds (eg, “getting work done”). It was also noted that the residents’ focus aligned with the graduate medical education milestones, and framing the results within the milestones made the interpretation far more robust. In addition, the residents discussed their difficulties with patient and family involvement, especially in the context of family centered rounds, which is a topic that was rarely discussed by attendings or medical students.

Our study has a number of limitations. Only 4 university-based hospitals were included in the focus groups. This has the potential to limit the generalizability to the community hospital setting. Within the focus groups, the number of participants varied, and this may have had an impact on the flow and content of conversation. Facilitators were chosen to minimize potential bias and prior relationships with participants; however, this was not always possible, and as such, may have influenced responses. There may be a discrepancy between how people perceive rounds and how rounds actually function. Rounds were not standardized between institutions, departments, or attendings.

Rounds are an appropriate metaphor for medical education at large: they are time consuming, complex, and vary in quality, but are nevertheless essential to the goals of patients and learners alike because of their adaptability and hybridization of purpose. Our results highlight that rounds serve 4 critical purposes, including communication, medical education, patient care, and assessment. Importantly, both attendings and students agree on what they perceive to be the many purposes of rounds. Despite this agreement, a disconnect appears to exist between what people believe are the purposes of rounds and what is perceived to be happening during rounds. The causes of this gap are not well defined, and further efforts should be made to better understand the obstacles facing effective rounding. To improve rounds and adapt them to the needs of 21st century learners, it is critical that we better define the scope of medical education, both formal and informal, that occurs during rounds. In doing so, it will be possible to identify areas of development and training for faculty, residents, and medical students, which will ensure that rounds remain useful and critical tools for the development and education of future physicians.

Acknowledgments

The authors would like to acknowledge the following people who assisted on this project: Meghan Daly from The University of Chicago Pritzker School of Medicine, Shannon Martin, MD, MS, Assistant Professor of Medicine from the Department of Medicine at The University of Chicago, Joyce Campbell, BSN, MS, Senior Quality Manager at the Children’s National Medical Center, Benjamin Colburn from the University of California, San Francisco School of Medicine, Kelly Sanders from the University of California, San Francisco School of Medicine, and Alekist Quach from the University of California, San Francisco School of Medicine.

Disclosure 

The authors report no external funding source for this study. The authors declare no conflict of interest. The protocol was approved by the institutional review board at all participating institutions.

For more than a century, medical rounds have been a cornerstone of patient care and medical education in teaching hospitals. They remain critical activities for exposing generations of trainees to clinical decision making, coordination of care, and patient communication.¹

Despite this established importance within medical education and patient care, there is a relative paucity of research addressing the purpose of medical rounds in the 21st century. Medicine has evolved significantly since Osler’s day, and it is unclear whether the purpose of rounds has evolved along with it. Rounds, to Osler, were an important opportunity for future physicians to learn at the bedside from an attending physician. Increased duty hour restrictions, mandatory adoption of electronic medical records, and increasingly complex care have changed how rounds are performed, making it more difficult to achieve Osler’s ideals.^2,3 While several studies have aimed to quantify the changes to rounds and have demonstrated a significant decline in bedside teaching,^4-6 few studies have explored the purpose of rounds from the perspective of pertinent stakeholders, students, residents, and faculty. The authors have published the results of focus groups of resident stakeholders recently.⁷ We made the decision to combine the student/faculty data and describe it separately from the resident data to allow the most accurate and relevant discussion as it pertained to each group.

The aim of this study was to explore the perceptions of faculty and students of general inpatient rounds on internal medicine and pediatric rotations, and to identify any notable differences between these key stakeholders.

Between April 2014 and June 2014, we conducted 10 semistructured focus groups at 4 teaching hospitals: The University of Chicago Medical Center, Children’s National Health System, Georgetown University Medical Center, and the University of California, San Francisco Medical Center. A sample of eligible 3rd-year medical students and residents on pediatrics and internal medicine hospitalist services as well as hospitalist attendings in pediatrics and internal medicine were invited by e-mail to participate voluntarily without compensation. Identical semistructured focus groups were also conducted with pediatric and internal medicine interns (postgraduate year [PGY1]) and senior residents (PGY2 and PGY3), and those data have been published previously.⁷

Data Collection

Most focus groups had 6 to 8 participants, with 2 groups of 3 and 4. The groups were interviewed separately by training and specialty: 3rd-year medical students who had completed internal medicine and/or pediatrics rotations, hospitalist attendings in pediatrics, and hospitalist attendings in internal medicine. Attendings with training in medicine-pediatrics were included in the department in which they worked most frequently. The focus group script was informed by a literature review and expert input, and we used open-ended questions to explore perspectives on current and ideal purposes of rounds. Interviews were digitally recorded, transcribed, and names of speakers or references to specific patients were removed to preserve confidentiality and anonymity. The focus groups lasted between 30 and 60 minutes. The author (OH) conducted focus groups at 1 site, and trained facilitators conducted focus groups at the remaining 3 sites. The protocol was determined to be exempt by the institutional review boards at all participating sites. Prior to the focus groups, the definition of family-centered rounds was read aloud; after which, participants were asked to fill out a demographic survey.

Data Analysis

The authors employed a grounded theory approach to data collection and analysis,⁸ and data were analyzed by using the constant-comparative method.⁹ There was no a priori hypothesis. Four transcripts were independently reviewed by 2 authors (OH and RR) by using sentences and phrases as the units of data, which were coded with an identifier. The authors discussed initial codes and resolved discrepancies through deliberation and consensus to create codebooks. Themes, made up of multiple codes, were identified inductively and iteratively and were refined to reflect the evolving dataset. One author (OH) independently coded the remaining transcripts by using a revised codebook as a guide. A faculty author (JF) assessed the interrater reliability of the final codebook by reviewing 2 previously coded, randomly selected transcripts with no new codes emerging in the process, with a kappa coefficient of >0.8 indicating significant agreement.

What Do You Perceive the Purpose of Rounds to Be?

With respect to this prompt, we identified 4 themes, which represent 16 codes describing what attendings and medical students believed to be the purpose of rounds (Table 2). These themes are communication, medical education, patient care, and assessment.

Communication

Communication includes all comments addressing the role of rounds as it relates to communication between team members, patients, family members, and all those involved in patient care. There were 4 main codes, including coordination of patient care team, patient/family communication, establishing rapport with patients and/or family, and establishment of roles.

Coordination of patient care team identified rounds as a time “to make sure everyone is on the same page” and “to come together whenever possible,” so that everyone “had the same information of what was going on.” It also included comments related to interdisciplinary communication, with 1 participant describing rounds as “a time when your consulting team, or people with outside expertise, can weigh in on some medical issues.”

Medical Education

The theme of medical education is made up of 6 codes that encompass comments related to teaching and learning during rounds. These 6 codes include delivery of clinical education, exposure to clinical decision making, role modeling, student presentations, establishment of trainee autonomy, and providing a safe learning environment.

Delivery of clinical education included comments identifying rounds as a time for didactic teaching, teachable moments, “clinical pearls,” and bedside teaching of physical exam skills. Exposure to clinical decision making included comments by both medical students and attendings who described the purpose of rounds as a time for learning and teaching, specifically about how best to approach problems and decision making in a systematic manner, with 1 medical student explaining it as a time to “expose [trainees] to the way that people think about problems and how they decided to go about addressing them.”

Role modeling includes comments addressing rounds as a time for attendings to demonstrate appropriate behaviors and skills to trainees. One attending explained that “everybody learns from watching other people present and interact…so everybody has a chance to pick up things that they think, ‘Oh, this works well.’” Student presentations include comments, predominantly from students, that described rounds as an opportunity to practice presentations and receive feedback, with 1 student explaining it was a time “to learn how to present but also to be questioned and challenged.”

Establishing trainee autonomy is a code that identifies rounds as a time to encourage resident and student autonomy in order to achieve rounds that function with minimal input from the attending, with 1 attending describing how they “put resident leadership first as far as priorities… [and] fostering that because I usually let them decide what we’re going to do.”

Providing a safe learning environment identifies the purpose of rounds as being a space in which trainees can feel comfortable learning from their mistakes. One student described rounds as, “…a setting where it’s okay to be wrong and feel comfortable enough to know that it’s about a learning process.”

Assessment

Assessment is a theme composed of comments identifying the purpose of rounds as being related to observation, assessment, and feedback, and it includes 2 codes: attending observation, assessment, and feedback and establishment of expectations. Attending observation, assessment, and feedback includes comments from attendings and students alike who described rounds as a place for observation, evaluation, and provision of feedback regarding the skills and abilities of trainees. One attending explained that rounds gave him an “opportunity to observe trainees interacting with each other, with the patient, the patient’s family, and ancillary staff,” with another commenting it was time used “to assess how med students are gathering information, presenting information, and eventually their assessment and plan.” Establishment of expectations captures comments that describe rounds as a time for the establishment of expectations and goals of the team.

Patient Care

Patient care is a theme comprised of comments identifying the purpose of rounds as being directly related to the formation and delivery of the patient care plan, and it includes 2 codes: formation of the patient care plan and delivery of patient care. Formation of the patient care plan includes comments, which identified rounds as a time for discussing and forming the plan for the day, with an attending stating, “The purpose [of rounds] was to make a plan, a treatment plan, and to include the parents in making the treatment plan.” Delivery of patient care included comments identifying rounds as a means of ensuring timely, safe, and appropriate delivery of patient care occurred. One attending explained, “It can’t be undersold that the priority of rounds is patient care and the more eyes that look over information the less likely there are to be mistakes.”

What Do You Believe the Ideal Purpose of RoundsShould Be?

This study originally sought to compare responses to 2 different questions: “What do you perceive the purpose of rounds to be?” and “What do you believe the ideal purpose of rounds should be?” What became clear during the focus groups was that these were often interpreted to be the same question, and as such, responses to the latter question were truncated or were reiterations of what was previously said: “I think we’ve already discussed that, I think it’s no different than what we already kind of said, patient care, education, and communication,” explained 1 attending. Fifty-four responses to the question regarding the ideal purpose of rounds were coded and did not differ significantly from the previously noted results in terms of the domains represented and the frequency of representation.

Variation Among Respondents

Overall, there is a high level of concordance between the comments from medical students and attendings regarding the purpose of rounds, particularly in the medical education theme. However, medicine and pediatric attendings differ in their comments relating to the theme of communication, with 2 codes primarily accounting for this difference: pediatric attendings place more emphasis on time for patient/family communication and establishing rapport with patients than their internal medicine colleagues. Of note, all of the pediatric attendings involved in the study answered that they conducted family-centered rounds (FCR), compared with 22% of internal medicine attendings.¹⁰

Another notable discrepancy came up during focus groups involving comments from medical students who reiterated that the purpose of rounds was not fixed, but rather dependent on the attending that was running rounds. This theme was only identified in focus groups involving medical students. One student explained, “I think that it depends on the attending and if they actually want to teach,” and another commented that “it’s incredibly dependent on what the attending… is willing to invest.” No attendings identified student or attending variability as an important factor influencing the purpose of rounds.

This qualitative study is one of the first to explore the purpose of rounds from the perspective of both medical students and attendings. Reassuringly, our results indicate that medical student and attending perceptions are largely concordant. The 4 themes of communication, medical education, assessment, and patient care are in line with the findings of previous observational studies of internal medicine and pediatrics rounds.^1,11 The themes are similar to the findings of resident focus groups done at these same sites.⁷

Our results support that both medical students and attendings identify the importance of medical education during rounds. This is in contrast with findings in previous observational time-motion research by Stickrath that describes the focus on patient care related activities and the relative scarcity of education during rounds.¹ This stresses a divide between how medical students and attendings define the purpose of rounds and what other research suggests actually occurs on rounds. This distinction is an important one. It is possible that the way we, and others, define “medical education” and “patient care” may be at least partially responsible for these findings. This is supported by the ambiguous distinction between formal and informal educational activities on rounds and the challenges in characterizing the hidden curriculum and its role in medical student and resident education.¹¹ Attendings role modeling effective patient communication strategies, for example, highlights that patient care, medical education, and communication are frequently indistinguishable.¹² This hybridization of activities and dedication to diverse types of learning is an essential quality of rounds and is suggestive of why they have survived as a preeminent tool within the arsenal of medical education for the past century.

Yet, this finding does not excuse or adequately explain a well-documented disappearance of more formal educational activities during rounds. Recent observational studies have shown that the percentage of rounds dedicated to educational activities fell from 25% to 10% after the implementation of duty hour restrictions,^1,13,14 and a recent ethnographic study of pediatric attending rounds confirmed teaching during rounds, though seen as a pedagogical ideal, occurred infrequently and inconsistently in large part because of time pressures.¹⁵ In our attending focus groups, duty hours and time pressures were frequently cited as actively working against the purpose of rounds, specifically opportunities for teaching, with 1 attending explaining, “I just don’t think we achieve our [teaching] goals like we used to.” Another attending mentioned that, because of time pressures, “I often find myself apologizing. ‘I’m so sorry. I can’t resist. Can I just tell you this one thing? I’m so sorry to do teaching.’” This tension between time pressures and education on rounds is well documented in the literature.^4,16,17

Our results highlight that attendings and medical students still believe that medical education is a primary and important purpose of rounds even in the face of increasing time pressures. As such, efforts should be made to better align the many purposes of rounds with the realities of the modern day rounding environment. Increasing the presence of medical education on rounds need not be at the expense of time given that techniques like the 1-minute preceptor have been rated as both efficient and effective methods of teaching and delivering feedback.¹⁸ This is echoed in research that has found that faculty development with a focus on teaching significantly increased the rate of clinical education and interdisciplinary communication during rounds.¹ Opportunities for faculty development are increasingly accessible,¹⁹ including programs like the Advancing Pediatric Excellence Teaching Program, sponsored by the American Academy of Pediatrics Section on Hospital Medicine and the Academic Pediatric Association, and the Teaching Educators Across the Continuum of Healthcare program, sponsored by the Society for General Internal Medicine.^20,21

A testament to the adaptability of rounds can be seen in our findings that expose the increased emphasis with which pediatric attendings identify communication as a purpose of rounds, particularly within the themes of patient/family communication and establishing rapport with patients. This is likely due to the practice of FCR by 100% of the pediatric attendings in our focus groups, and is supported elsewhere in the literature.²² A key to family-centered rounds is communication, with active participation in the care discussion by patients and families as described and endorsed by a 2012 American Academy of Pediatrics (AAP) policy.^10,23

This emphasis could explain the increased frequency of comments made by pediatric attendings within the themes of patient/family communication and establishing rapport with patients. Furthermore, the AAP policy statement stresses the need to share information in a way that patients and families “effectively participate in care and decision making,” which could explain why pediatric attendings placed greater emphasis on the formation of the patient care plan in the theme of patient care.

As noted, the authors published a related study focusing on resident perceptions regarding the purpose of rounds. We initially undertook a separate analysis of the 3 groups: faculty, residents, and medical students. From that analysis, it became apparent that residents (PGY1-PGY3) viewed rounds differently than faculty and medical students. Where faculty and medical students were more focused on communication and medical education, the residents were more focused on the practical aspects of rounds (eg, “getting work done”). It was also noted that the residents’ focus aligned with the graduate medical education milestones, and framing the results within the milestones made the interpretation far more robust. In addition, the residents discussed their difficulties with patient and family involvement, especially in the context of family centered rounds, which is a topic that was rarely discussed by attendings or medical students.

Our study has a number of limitations. Only 4 university-based hospitals were included in the focus groups. This has the potential to limit the generalizability to the community hospital setting. Within the focus groups, the number of participants varied, and this may have had an impact on the flow and content of conversation. Facilitators were chosen to minimize potential bias and prior relationships with participants; however, this was not always possible, and as such, may have influenced responses. There may be a discrepancy between how people perceive rounds and how rounds actually function. Rounds were not standardized between institutions, departments, or attendings.

Rounds are an appropriate metaphor for medical education at large: they are time consuming, complex, and vary in quality, but are nevertheless essential to the goals of patients and learners alike because of their adaptability and hybridization of purpose. Our results highlight that rounds serve 4 critical purposes, including communication, medical education, patient care, and assessment. Importantly, both attendings and students agree on what they perceive to be the many purposes of rounds. Despite this agreement, a disconnect appears to exist between what people believe are the purposes of rounds and what is perceived to be happening during rounds. The causes of this gap are not well defined, and further efforts should be made to better understand the obstacles facing effective rounding. To improve rounds and adapt them to the needs of 21st century learners, it is critical that we better define the scope of medical education, both formal and informal, that occurs during rounds. In doing so, it will be possible to identify areas of development and training for faculty, residents, and medical students, which will ensure that rounds remain useful and critical tools for the development and education of future physicians.

Acknowledgments

The authors would like to acknowledge the following people who assisted on this project: Meghan Daly from The University of Chicago Pritzker School of Medicine, Shannon Martin, MD, MS, Assistant Professor of Medicine from the Department of Medicine at The University of Chicago, Joyce Campbell, BSN, MS, Senior Quality Manager at the Children’s National Medical Center, Benjamin Colburn from the University of California, San Francisco School of Medicine, Kelly Sanders from the University of California, San Francisco School of Medicine, and Alekist Quach from the University of California, San Francisco School of Medicine.

Disclosure 

The authors report no external funding source for this study. The authors declare no conflict of interest. The protocol was approved by the institutional review board at all participating institutions.

For more than a century, medical rounds have been a cornerstone of patient care and medical education in teaching hospitals. They remain critical activities for exposing generations of trainees to clinical decision making, coordination of care, and patient communication.¹

Despite this established importance within medical education and patient care, there is a relative paucity of research addressing the purpose of medical rounds in the 21st century. Medicine has evolved significantly since Osler’s day, and it is unclear whether the purpose of rounds has evolved along with it. Rounds, to Osler, were an important opportunity for future physicians to learn at the bedside from an attending physician. Increased duty hour restrictions, mandatory adoption of electronic medical records, and increasingly complex care have changed how rounds are performed, making it more difficult to achieve Osler’s ideals.^2,3 While several studies have aimed to quantify the changes to rounds and have demonstrated a significant decline in bedside teaching,^4-6 few studies have explored the purpose of rounds from the perspective of pertinent stakeholders, students, residents, and faculty. The authors have published the results of focus groups of resident stakeholders recently.⁷ We made the decision to combine the student/faculty data and describe it separately from the resident data to allow the most accurate and relevant discussion as it pertained to each group.

The aim of this study was to explore the perceptions of faculty and students of general inpatient rounds on internal medicine and pediatric rotations, and to identify any notable differences between these key stakeholders.

Between April 2014 and June 2014, we conducted 10 semistructured focus groups at 4 teaching hospitals: The University of Chicago Medical Center, Children’s National Health System, Georgetown University Medical Center, and the University of California, San Francisco Medical Center. A sample of eligible 3rd-year medical students and residents on pediatrics and internal medicine hospitalist services as well as hospitalist attendings in pediatrics and internal medicine were invited by e-mail to participate voluntarily without compensation. Identical semistructured focus groups were also conducted with pediatric and internal medicine interns (postgraduate year [PGY1]) and senior residents (PGY2 and PGY3), and those data have been published previously.⁷

Data Collection

Most focus groups had 6 to 8 participants, with 2 groups of 3 and 4. The groups were interviewed separately by training and specialty: 3rd-year medical students who had completed internal medicine and/or pediatrics rotations, hospitalist attendings in pediatrics, and hospitalist attendings in internal medicine. Attendings with training in medicine-pediatrics were included in the department in which they worked most frequently. The focus group script was informed by a literature review and expert input, and we used open-ended questions to explore perspectives on current and ideal purposes of rounds. Interviews were digitally recorded, transcribed, and names of speakers or references to specific patients were removed to preserve confidentiality and anonymity. The focus groups lasted between 30 and 60 minutes. The author (OH) conducted focus groups at 1 site, and trained facilitators conducted focus groups at the remaining 3 sites. The protocol was determined to be exempt by the institutional review boards at all participating sites. Prior to the focus groups, the definition of family-centered rounds was read aloud; after which, participants were asked to fill out a demographic survey.

Data Analysis

The authors employed a grounded theory approach to data collection and analysis,⁸ and data were analyzed by using the constant-comparative method.⁹ There was no a priori hypothesis. Four transcripts were independently reviewed by 2 authors (OH and RR) by using sentences and phrases as the units of data, which were coded with an identifier. The authors discussed initial codes and resolved discrepancies through deliberation and consensus to create codebooks. Themes, made up of multiple codes, were identified inductively and iteratively and were refined to reflect the evolving dataset. One author (OH) independently coded the remaining transcripts by using a revised codebook as a guide. A faculty author (JF) assessed the interrater reliability of the final codebook by reviewing 2 previously coded, randomly selected transcripts with no new codes emerging in the process, with a kappa coefficient of >0.8 indicating significant agreement.

What Do You Perceive the Purpose of Rounds to Be?

With respect to this prompt, we identified 4 themes, which represent 16 codes describing what attendings and medical students believed to be the purpose of rounds (Table 2). These themes are communication, medical education, patient care, and assessment.

Communication

Communication includes all comments addressing the role of rounds as it relates to communication between team members, patients, family members, and all those involved in patient care. There were 4 main codes, including coordination of patient care team, patient/family communication, establishing rapport with patients and/or family, and establishment of roles.

Coordination of patient care team identified rounds as a time “to make sure everyone is on the same page” and “to come together whenever possible,” so that everyone “had the same information of what was going on.” It also included comments related to interdisciplinary communication, with 1 participant describing rounds as “a time when your consulting team, or people with outside expertise, can weigh in on some medical issues.”

Medical Education

The theme of medical education is made up of 6 codes that encompass comments related to teaching and learning during rounds. These 6 codes include delivery of clinical education, exposure to clinical decision making, role modeling, student presentations, establishment of trainee autonomy, and providing a safe learning environment.

Delivery of clinical education included comments identifying rounds as a time for didactic teaching, teachable moments, “clinical pearls,” and bedside teaching of physical exam skills. Exposure to clinical decision making included comments by both medical students and attendings who described the purpose of rounds as a time for learning and teaching, specifically about how best to approach problems and decision making in a systematic manner, with 1 medical student explaining it as a time to “expose [trainees] to the way that people think about problems and how they decided to go about addressing them.”

Role modeling includes comments addressing rounds as a time for attendings to demonstrate appropriate behaviors and skills to trainees. One attending explained that “everybody learns from watching other people present and interact…so everybody has a chance to pick up things that they think, ‘Oh, this works well.’” Student presentations include comments, predominantly from students, that described rounds as an opportunity to practice presentations and receive feedback, with 1 student explaining it was a time “to learn how to present but also to be questioned and challenged.”

Establishing trainee autonomy is a code that identifies rounds as a time to encourage resident and student autonomy in order to achieve rounds that function with minimal input from the attending, with 1 attending describing how they “put resident leadership first as far as priorities… [and] fostering that because I usually let them decide what we’re going to do.”

Providing a safe learning environment identifies the purpose of rounds as being a space in which trainees can feel comfortable learning from their mistakes. One student described rounds as, “…a setting where it’s okay to be wrong and feel comfortable enough to know that it’s about a learning process.”

Assessment

Assessment is a theme composed of comments identifying the purpose of rounds as being related to observation, assessment, and feedback, and it includes 2 codes: attending observation, assessment, and feedback and establishment of expectations. Attending observation, assessment, and feedback includes comments from attendings and students alike who described rounds as a place for observation, evaluation, and provision of feedback regarding the skills and abilities of trainees. One attending explained that rounds gave him an “opportunity to observe trainees interacting with each other, with the patient, the patient’s family, and ancillary staff,” with another commenting it was time used “to assess how med students are gathering information, presenting information, and eventually their assessment and plan.” Establishment of expectations captures comments that describe rounds as a time for the establishment of expectations and goals of the team.

Patient Care

Patient care is a theme comprised of comments identifying the purpose of rounds as being directly related to the formation and delivery of the patient care plan, and it includes 2 codes: formation of the patient care plan and delivery of patient care. Formation of the patient care plan includes comments, which identified rounds as a time for discussing and forming the plan for the day, with an attending stating, “The purpose [of rounds] was to make a plan, a treatment plan, and to include the parents in making the treatment plan.” Delivery of patient care included comments identifying rounds as a means of ensuring timely, safe, and appropriate delivery of patient care occurred. One attending explained, “It can’t be undersold that the priority of rounds is patient care and the more eyes that look over information the less likely there are to be mistakes.”

What Do You Believe the Ideal Purpose of RoundsShould Be?

This study originally sought to compare responses to 2 different questions: “What do you perceive the purpose of rounds to be?” and “What do you believe the ideal purpose of rounds should be?” What became clear during the focus groups was that these were often interpreted to be the same question, and as such, responses to the latter question were truncated or were reiterations of what was previously said: “I think we’ve already discussed that, I think it’s no different than what we already kind of said, patient care, education, and communication,” explained 1 attending. Fifty-four responses to the question regarding the ideal purpose of rounds were coded and did not differ significantly from the previously noted results in terms of the domains represented and the frequency of representation.

Variation Among Respondents

Overall, there is a high level of concordance between the comments from medical students and attendings regarding the purpose of rounds, particularly in the medical education theme. However, medicine and pediatric attendings differ in their comments relating to the theme of communication, with 2 codes primarily accounting for this difference: pediatric attendings place more emphasis on time for patient/family communication and establishing rapport with patients than their internal medicine colleagues. Of note, all of the pediatric attendings involved in the study answered that they conducted family-centered rounds (FCR), compared with 22% of internal medicine attendings.¹⁰

Another notable discrepancy came up during focus groups involving comments from medical students who reiterated that the purpose of rounds was not fixed, but rather dependent on the attending that was running rounds. This theme was only identified in focus groups involving medical students. One student explained, “I think that it depends on the attending and if they actually want to teach,” and another commented that “it’s incredibly dependent on what the attending… is willing to invest.” No attendings identified student or attending variability as an important factor influencing the purpose of rounds.

This qualitative study is one of the first to explore the purpose of rounds from the perspective of both medical students and attendings. Reassuringly, our results indicate that medical student and attending perceptions are largely concordant. The 4 themes of communication, medical education, assessment, and patient care are in line with the findings of previous observational studies of internal medicine and pediatrics rounds.^1,11 The themes are similar to the findings of resident focus groups done at these same sites.⁷

Our results support that both medical students and attendings identify the importance of medical education during rounds. This is in contrast with findings in previous observational time-motion research by Stickrath that describes the focus on patient care related activities and the relative scarcity of education during rounds.¹ This stresses a divide between how medical students and attendings define the purpose of rounds and what other research suggests actually occurs on rounds. This distinction is an important one. It is possible that the way we, and others, define “medical education” and “patient care” may be at least partially responsible for these findings. This is supported by the ambiguous distinction between formal and informal educational activities on rounds and the challenges in characterizing the hidden curriculum and its role in medical student and resident education.¹¹ Attendings role modeling effective patient communication strategies, for example, highlights that patient care, medical education, and communication are frequently indistinguishable.¹² This hybridization of activities and dedication to diverse types of learning is an essential quality of rounds and is suggestive of why they have survived as a preeminent tool within the arsenal of medical education for the past century.

Yet, this finding does not excuse or adequately explain a well-documented disappearance of more formal educational activities during rounds. Recent observational studies have shown that the percentage of rounds dedicated to educational activities fell from 25% to 10% after the implementation of duty hour restrictions,^1,13,14 and a recent ethnographic study of pediatric attending rounds confirmed teaching during rounds, though seen as a pedagogical ideal, occurred infrequently and inconsistently in large part because of time pressures.¹⁵ In our attending focus groups, duty hours and time pressures were frequently cited as actively working against the purpose of rounds, specifically opportunities for teaching, with 1 attending explaining, “I just don’t think we achieve our [teaching] goals like we used to.” Another attending mentioned that, because of time pressures, “I often find myself apologizing. ‘I’m so sorry. I can’t resist. Can I just tell you this one thing? I’m so sorry to do teaching.’” This tension between time pressures and education on rounds is well documented in the literature.^4,16,17

Our results highlight that attendings and medical students still believe that medical education is a primary and important purpose of rounds even in the face of increasing time pressures. As such, efforts should be made to better align the many purposes of rounds with the realities of the modern day rounding environment. Increasing the presence of medical education on rounds need not be at the expense of time given that techniques like the 1-minute preceptor have been rated as both efficient and effective methods of teaching and delivering feedback.¹⁸ This is echoed in research that has found that faculty development with a focus on teaching significantly increased the rate of clinical education and interdisciplinary communication during rounds.¹ Opportunities for faculty development are increasingly accessible,¹⁹ including programs like the Advancing Pediatric Excellence Teaching Program, sponsored by the American Academy of Pediatrics Section on Hospital Medicine and the Academic Pediatric Association, and the Teaching Educators Across the Continuum of Healthcare program, sponsored by the Society for General Internal Medicine.^20,21

A testament to the adaptability of rounds can be seen in our findings that expose the increased emphasis with which pediatric attendings identify communication as a purpose of rounds, particularly within the themes of patient/family communication and establishing rapport with patients. This is likely due to the practice of FCR by 100% of the pediatric attendings in our focus groups, and is supported elsewhere in the literature.²² A key to family-centered rounds is communication, with active participation in the care discussion by patients and families as described and endorsed by a 2012 American Academy of Pediatrics (AAP) policy.^10,23

This emphasis could explain the increased frequency of comments made by pediatric attendings within the themes of patient/family communication and establishing rapport with patients. Furthermore, the AAP policy statement stresses the need to share information in a way that patients and families “effectively participate in care and decision making,” which could explain why pediatric attendings placed greater emphasis on the formation of the patient care plan in the theme of patient care.

As noted, the authors published a related study focusing on resident perceptions regarding the purpose of rounds. We initially undertook a separate analysis of the 3 groups: faculty, residents, and medical students. From that analysis, it became apparent that residents (PGY1-PGY3) viewed rounds differently than faculty and medical students. Where faculty and medical students were more focused on communication and medical education, the residents were more focused on the practical aspects of rounds (eg, “getting work done”). It was also noted that the residents’ focus aligned with the graduate medical education milestones, and framing the results within the milestones made the interpretation far more robust. In addition, the residents discussed their difficulties with patient and family involvement, especially in the context of family centered rounds, which is a topic that was rarely discussed by attendings or medical students.

Our study has a number of limitations. Only 4 university-based hospitals were included in the focus groups. This has the potential to limit the generalizability to the community hospital setting. Within the focus groups, the number of participants varied, and this may have had an impact on the flow and content of conversation. Facilitators were chosen to minimize potential bias and prior relationships with participants; however, this was not always possible, and as such, may have influenced responses. There may be a discrepancy between how people perceive rounds and how rounds actually function. Rounds were not standardized between institutions, departments, or attendings.

Rounds are an appropriate metaphor for medical education at large: they are time consuming, complex, and vary in quality, but are nevertheless essential to the goals of patients and learners alike because of their adaptability and hybridization of purpose. Our results highlight that rounds serve 4 critical purposes, including communication, medical education, patient care, and assessment. Importantly, both attendings and students agree on what they perceive to be the many purposes of rounds. Despite this agreement, a disconnect appears to exist between what people believe are the purposes of rounds and what is perceived to be happening during rounds. The causes of this gap are not well defined, and further efforts should be made to better understand the obstacles facing effective rounding. To improve rounds and adapt them to the needs of 21st century learners, it is critical that we better define the scope of medical education, both formal and informal, that occurs during rounds. In doing so, it will be possible to identify areas of development and training for faculty, residents, and medical students, which will ensure that rounds remain useful and critical tools for the development and education of future physicians.

Acknowledgments

The authors would like to acknowledge the following people who assisted on this project: Meghan Daly from The University of Chicago Pritzker School of Medicine, Shannon Martin, MD, MS, Assistant Professor of Medicine from the Department of Medicine at The University of Chicago, Joyce Campbell, BSN, MS, Senior Quality Manager at the Children’s National Medical Center, Benjamin Colburn from the University of California, San Francisco School of Medicine, Kelly Sanders from the University of California, San Francisco School of Medicine, and Alekist Quach from the University of California, San Francisco School of Medicine.

Disclosure 

The authors report no external funding source for this study. The authors declare no conflict of interest. The protocol was approved by the institutional review board at all participating institutions.

Fatigue is the most common clinical symptom of anemia and is a significant concern to patients.^1,2 In ambulatory patients, lower hemoglobin (Hb) concentration is associated with increased fatigue.^2,3 Accordingly, therapies that treat anemia by increasing Hb concentration, such as erythropoiesis stimulating agents,^4-7 often use fatigue as an outcome measure.

In hospitalized patients, transfusion of red blood cell increases Hb concentration and is the primary treatment for anemia. However, the extent to which transfusion and changes in Hb concentration affect hospitalized patients’ fatigue levels is not well established. Guidelines support transfusing patients with symptoms of anemia, such as fatigue, on the assumption that the increased oxygen delivery will improve the symptoms of anemia. While transfusion studies in hospitalized patients have consistently reported that transfusion at lower or “restrictive” Hb concentrations is safe compared with transfusion at higher Hb concentrations,^8-10 these studies have mainly used cardiac events and mortality as outcomes rather than patient symptoms, such as fatigue. Nevertheless, they have resulted in hospitals increasingly adopting restrictive transfusion policies that discourage transfusion at higher Hb levels.^11,12 Consequently, the rate of transfusion in hospitalized patients has decreased,¹³ raising questions of whether some patients with lower Hb concentrations may experience increased fatigue as a result of restrictive transfusion policies. Fatigue among hospitalized patients is important not only because it is an adverse symptom but because it may result in decreased activity levels, deconditioning, and losses in functional status.^14,15While the effect of alternative transfusion policies on fatigue in hospitalized patients could be answered by a randomized clinical trial using fatigue and functional status as outcomes, an important first step is to assess whether the Hb concentration of hospitalized patients is associated with their fatigue level during hospitalization. Because hospitalized patients often have acute illnesses that can cause fatigue in and of themselves, it is possible that anemia is not associated with fatigue in hospitalized patients despite anemia’s association with fatigue in ambulatory patients. Additionally, Hb concentration varies during hospitalization,¹⁶ raising the question of what measures of Hb during hospitalization might be most associated with anemia-related fatigue.

The objective of this study is to explore multiple Hb measures in hospitalized medical patients with anemia and test whether any of these Hb measures are associated with patients’ fatigue level.

Study Design

We performed a prospective, observational study of hospitalized patients with anemia on the general medicine services at The University of Chicago Medical Center (UCMC). The institutional review board approved the study procedures, and all study subjects provided informed consent.

Study Eligibility

Between April 2014 and June 2015, all general medicine inpatients were approached for written consent for The University of Chicago Hospitalist Project,¹⁷ a research infrastructure at UCMC. Among patients consenting to participate in the Hospitalist Project, patients were eligible if they had Hb <9 g/dL at any point during their hospitalization and were age ≥50 years. Hb concentration of <9 g/dL was chosen to include the range of Hb values covered by most restrictive transfusion policies.^8-10,18 Age ≥50 years was an inclusion criteria because anemia is more strongly associated with poor outcomes, including functional impairment, among older patients compared with younger patients.^14,19-21 If patients were not eligible for inclusion at the time of consent for the Hospitalist Project, their Hb values were reviewed twice daily until hospital discharge to assess if their Hb was <9 g/dL. Proxies were sought to answer questions for patients who failed the Short Portable Mental Status Questionnaire.²²

Patient Demographic Data Collection

Research assistants abstracted patient age and sex from the electronic health record (EHR), and asked patients to self-identify their race. The individual comorbidities included as part of the Charlson Comorbidity Index were identified using International Classification of Diseases, 9th Revision codes from hospital administrative data for each encounter and specifically included the following: myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatic disease, peptic ulcer disease, liver disease, diabetes, hemiplegia and/or paraplegia, renal disease, cancer, and human immunodeficiency virus/acquired immunodeficiency syndrome.²³ We also used Healthcare Cost and Utilization Project (www.hcup-us.ahrq.gov/toolssoftware/ccs/ccs.jsp) diagnosis categories to identify whether patients had sickle cell (SC) anemia, gastrointestinal bleeding (GIB), or a depressive disorder (DD) because these conditions are associated with anemia (SC and GIB) and fatigue (DD).²⁴

Measuring Anemia

Hb measures were available only when hospital providers ordered them as part of routine practice. The first Hb concentration <9 g/dL during a patient’s hospitalization, which made them eligible for study participation, was obtained through manual review of the EHR. All additional Hb values during the patient’s hospitalization were obtained from the hospital’s administrative data mart. All Hb values collected for each patient during the hospitalization were used to calculate summary measures of Hb during the hospitalization, including the mean Hb, median Hb, minimum Hb, maximum Hb, admission (first recorded) Hb, and discharge (last recorded) Hb. Hb measures were analyzed both as a continuous variable and as a categorical variable created by dividing the continuous Hb measures into integer ranges of 3 groups of approximately the same size.

Measuring Fatigue

Our primary outcome was patients’ level of fatigue reported during hospitalization, measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Anemia questionnaire. Fatigue was measured using a 13-question fatigue subscale,^1,2,25 which measures fatigue within the past 7 days. Scores on the fatigue subscale range from 0 to 52, with lower scores reflecting greater levels of fatigue. As soon as patients met the eligibility criteria for study participation during their hospitalization (age ≥50 years and Hb <9 g/dL), they were approached to answer the FACIT questions. Values for missing data in the fatigue subscale for individual subjects were filled in using a prorated score from their answered questions as long as >50% of the items in the fatigue subscale were answered, in accordance with recommendations for addressing missing data in the FACIT.²⁶ Fatigue was analyzed as a continuous variable and as a dichotomous variable created by dividing the sample into high (FACIT <27) and low (FACIT ≥27) levels of fatigue based on the median FACIT score of the population. Previous literature has shown a FACIT fatigue subscale score between 23 and 26 to be associated with an Eastern Cooperative Oncology Group (ECOG)²⁷ C Performance Status rating of 2 to 3³ compared to scores ≥27.

Statistical Analysis

Statistical analysis was performed using Stata statistical software (StataCorp, College Station, Texas). Descriptive statistics were used to characterize patient demographics. Analysis of variance was used to test for differences in the mean fatigue levels across Hb measures. χ² tests were performed to test for associations between high fatigue levels and the Hb measures. Multivariable analysis, including both linear and logistic regression models, were used to test the association of Hb concentration and fatigue. P values <0.05 using a 2-tailed test were deemed statistically significant.

Patient Characteristics

During the study period, 8559 patients were admitted to the general medicine service. Of those, 5073 (59%) consented for participation in the Hospitalist Project, and 3670 (72%) completed the Hospitalist Project inpatient interview. Of these patients, 1292 (35%) had Hb <9 g/dL, and 784 (61%) were 50 years or older and completed the FACIT questionnaire.

Table 1 reports the demographic characteristics and comorbidities for the sample, the mean (standard deviation [SD]) for the 6 Hb measures, and mean (SD) and median FACIT scores.

Bivariate Association of Fatigue and Hb

Categorizing patients into low, middle, or high Hb for each of the 6 Hb measures, minimum Hb was strongly associated with fatigue, with a weaker association for mean Hb and no statistically significant association for the other measures.

Minimum Hb

Patients with a minimum Hb <7 g/dL and patients with Hb 7-8 g/dL had higher fatigue levels (FACIT = 25 for each) than patients with a minimum Hb ≥8 g/dL (FACIT = 29; P < 0.001; Table 2). When excluding patients with SC and/or GIB because their average minimum Hb differed from the average minimum Hb of the full population (P < 0.001), patients with a minimum Hb <7 g/dL or 7-8 g/dL had even higher fatigue levels (FACIT = 23 and FACIT = 24, respectively), with no change in the fatigue level of patients with a minimum Hb ≥8 g/dL (FACIT = 29; P < 0.001; Table 2). Lower minimum Hb continued to be associated with higher fatigue levels when analyzed in 0.5 g/dL increments (Figure).

Mean Hb and Other Measures

Fatigue levels were high for 47% of patients with a mean Hb <8g /dL and 53% of patients with a mean Hb 8-9 g/dL compared with 43% of patients with a mean Hb ≥9 g/dL (P = 0.05). However, the association between high fatigue and mean Hb was not statistically significant when patients with SC and/or GIB were excluded (Table 2). None of the other 4 Hb measures was significantly associated with fatigue.

Linear Regression of Fatigue on Hb

In linear regression models, minimum Hb consistently predicted patient fatigue, mean Hb had a less robust association with fatigue, and the other Hb measures were not associated with patient fatigue. Increases in minimum Hb (analyzed as a continuous variable) were associated with reduced fatigue (higher FACIT score; β = 1.4; P = 0.005). In models in which minimum Hb was a categorical variable, patients with a minimum Hb of <7 g/dL or 7-8 g/dL had greater fatigue (lower FACIT score) than patients whose minimum Hb was ≥8 g/dL (Hb <7 g/dL: β = −4.2; P ≤ 0.001; Hb 7-8 g/dL: β = −4.1; P < 0.001). These results control for patients’ age, sex, individual comorbidities, and whether their minimum Hb occurred before or after the measurement of fatigue during hospitalization (Model 1), and the results are unchanged when also controlling for the number of Hb laboratory draws patients had during their hospitalization (Model 2; Table 3). In a stratified analysis excluding patients with either SC and/or GIB, changes in minimum Hb were associated with larger changes in patient fatigue levels (Supplemental Table 1). We also stratified our analysis to include only patients whose minimum Hb occurred before the measurement of their fatigue level during hospitalization to avoid a spurious association of fatigue with minimum Hb occurring after fatigue was measured. In both Models 1 and 2, minimum Hb remained a predictor of patients’ fatigue levels with similar effect sizes, although in Model 2, the results did not quite reach a statistically significant level, in part due to larger confidence intervals from the smaller sample size of this stratified analysis (Supplemental Table 2a). We further stratified this analysis to include only patients whose transfusion, if they received one, occurred after their minimum Hb and the measurement of their fatigue level to account for the possibility that a transfusion could affect the fatigue level patients report. In this analysis, most of the estimates of the effect of minimum Hb on fatigue were larger than those seen when only analyzing patients whose minimum Hb occurred before the measurement of their fatigue level, although again, the smaller sample size of this additional stratified analysis does produce larger confidence intervals for these estimates (Supplemental Table 2b).

Logistic Regression of High Fatigue Level on Hb

Using logistic regression, minimum Hb analyzed as a categorical variable predicted increased odds of a high fatigue level. Patients with a minimum Hb <7 g/dL were 50% (odds ratio [OR] = 1.5; P = 0.03) more likely to have high fatigue and patients with a minimum Hb 7-8 g/dL were 90% (OR = 1.9; P < 0.001) more likely to have high fatigue compared with patients with a minimum Hb ≥8 g/dL in Model 1. These results were similar in Model 2, although the effect was only statistically significant in the 7-8 g/dL Hb group (Table 3). When excluding SC and/or GIB patients, the odds of having high fatigue as minimum Hb decreased were the same or higher for both models compared to the full population of patients. However, again, in Model 2, the effect was only statistically significant in the 7-8 g/dL Hb group (Supplemental Table 1).

Patients with a mean Hb <8 g/dL were 20% to 30% more likely to have high fatigue and patients with mean Hb 8-9 g/dL were 50% more likely to have high fatigue compared with patients with a mean Hb ≥9 g/dL, but the effects were only statistically significant for patients with a mean Hb 8-9 g/dL in both Models 1 and 2 (Table 3). These results were similar when excluding patients with SC and/or GIB, but they were only significant for patients with a mean Hb 8-9 g/dL in Model 1 and patients with a mean Hb <8 g/dL in the Model 2 (Supplemental Table 3).

These results demonstrate that minimum Hb during hospitalization is associated with fatigue in hospitalized patients age ≥50 years, and the association is stronger among patients without SC and/or GIB as comorbidities. The analysis of Hb as a continuous and categorical variable and the use of both linear and logistic regression models support the robustness of these associations and illuminate their clinical significance. For example, in linear regression with minimum Hb a continuous variable, the coefficient of 1.4 suggests that an increase of 2 g/dL in Hb, as might be expected from transfusion of 2 units of red blood cells, would be associated with about a 3-point improvement in fatigue. Additionally, as a categorical variable, a minimum Hb ≥8 g/dL compared with a minimum Hb <7 g/dL or 7-8 g/dL is associated with a 3- to 4-point improvement in fatigue. Previous literature suggests that a difference of 3 in the FACIT score is the minimum clinically important difference in fatigue,³ and changes in minimum Hb in either model predict changes in fatigue that are in the range of potential clinical significance.

The clinical significance of the findings is also reflected in the results of the logistic regressions, which may be mapped to potential effects on functional status. Specifically, the odds of having a high fatigue level (FACIT <27) increase 90% for persons with a minimum Hb 7–8 g/dL compared with persons with a minimum Hb ≥8 g/dL. For persons with a minimum Hb <7 g/dL, point estimates suggest a smaller (50%) increase in the odds of high fatigue, but the 95% confidence interval overlaps heavily with the estimate of patients whose minimum Hb is 7-8 g/dL. While it might be expected that patients with a minimum Hb <7 g/dL have greater levels of fatigue compared with patients with a minimum Hb 7-8 g/dL, we did not observe such a pattern. One reason may be that the confidence intervals of our estimated effects are wide enough that we cannot exclude such a pattern. Another possible explanation is that in both groups, the fatigue levels are sufficiently severe, such that the difference in their fatigue levels may not be clinically meaningful. For example, a FACIT score of 23 to 26 has been shown to be associated with an ECOG performance status of 2 to 3, requiring bed rest for at least part of the day.³ Therefore, patients with a minimum Hb 7-8 g/dL (mean FACIT score = 24; Table 2) or a minimum Hb of <7 g/dL (mean FACIT score = 23; Table 2) are already functionally limited to the point of being partially bed bound, such that further decreases in their Hb may not produce additional fatigue in part because they reduce their activity sufficiently to prevent an increase in fatigue. In such cases, the potential benefits of increased Hb may be better assessed by measuring fatigue in response to a specific and provoked activity level, a concept known as fatigability.²⁰

That minimum Hb is more strongly associated with fatigue than any other measure of Hb during hospitalization may not be surprising. Mean, median, maximum, and discharge Hb may all be affected by transfusion during hospitalization that could affect fatigue. Admission Hb may not reflect true oxygen-carrying capacity because of hemoconcentration.

The association between Hb and fatigue in hospitalized patients is important because increased fatigue could contribute to slower clinical recovery in hospitalized patients. Additionally, increased fatigue during hospitalization and at hospital discharge could exacerbate the known deleterious consequences of fatigue on patients and their health outcomes^14,15 after hospital discharge. Although one previous study, the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)⁸ trial, did not report differences in patients’ fatigue levels at 30 and 60 days postdischarge when transfused at restrictive (8 g/dL) compared with liberal (10 g/dL) Hb thresholds, confidence in the validity of this finding is reduced by the fact that more than half of the patients were lost to follow-up at the 30- and 60-day time points. Further, patients in the restrictive transfusion arm of FOCUS were transfused to maintain Hb levels at or above 8 g/dL. This transfusion threshold of 8 g/dL may have mitigated the high levels of fatigue that are seen in our study when patients’ Hb drops below 8 g/dL, and maintaining a Hb level of 7 g/dL is now the standard of care in stable hospitalized patients. Lastly, FOCUS was limited to postoperative hip fracture patients, and the generalizability of FOCUS to hospitalized medicine patients with anemia is limited.

Therefore, our results support guideline suggestions that practitioners incorporate the presence of patient symptoms such as fatigue into transfusion decisions, particularly if patients’ Hb is <8 g/dL.¹⁸ Though reasonable, the suggestion to incorporate symptoms such as fatigue into transfusion decisions has not been strongly supported by evidence so far, and it may often be neglected in practice. Definitive evidence to support such recommendations would benefit from study through an optimal trial¹⁸ that incorporates symptoms into decision making. Our findings add support for a study of transfusion strategies that incorporates patients’ fatigue level in addition to Hb concentration.

This study has several limitations. Although our sample size is large and includes patients with a range of comorbidities that we believe are representative of hospitalized general medicine patients, as a single-center, observational study, our results may not be generalizable to other centers. Additionally, although these data support a reliable association between hospitalized patients’ minimum Hb and fatigue level, the observational design of this study cannot prove that this relationship is causal. Also, patients’ Hb values were measured at the discretion of their clinician, and therefore, the measures of Hb were not uniformly measured for participating patients. In addition, fatigue was only measured at one time point during a patient’s hospitalization, and it is possible that patients’ fatigue levels change during hospitalization in relation to variables we did not consider. Finally, our study was not designed to assess the association of Hb with longer-term functional outcomes, which may be of greater concern than fatigue.

In hospitalized patients ≥50 years old, minimum Hb is reliably associated with patients’ fatigue level. Patients whose minimum Hb is <8 g/dL experience higher fatigue levels compared to patients whose minimum Hb is ≥8 g/dL. Additional studies are warranted to understand if patients may benefit from improved fatigue levels by correcting their anemia through transfusion.

Disclosure 

Dr. Prochaska is supported by an Agency for Healthcare Research and Quality Patient-Centered Outcomes Research Institutional K12 Award (1K12HS023007-01, principal investigator Meltzer). Dr. Meltzer is supported by a National Institutes of Health Clinical and Translational Science Award (2UL1TR000430-06, principal investigator Solway) and a grant from the Patient-Centered Outcomes Research Network in support of the Chicago Patient-Centered Outcomes Research Network. The authors report no conflicts of interest.

Fatigue is the most common clinical symptom of anemia and is a significant concern to patients.^1,2 In ambulatory patients, lower hemoglobin (Hb) concentration is associated with increased fatigue.^2,3 Accordingly, therapies that treat anemia by increasing Hb concentration, such as erythropoiesis stimulating agents,^4-7 often use fatigue as an outcome measure.

In hospitalized patients, transfusion of red blood cell increases Hb concentration and is the primary treatment for anemia. However, the extent to which transfusion and changes in Hb concentration affect hospitalized patients’ fatigue levels is not well established. Guidelines support transfusing patients with symptoms of anemia, such as fatigue, on the assumption that the increased oxygen delivery will improve the symptoms of anemia. While transfusion studies in hospitalized patients have consistently reported that transfusion at lower or “restrictive” Hb concentrations is safe compared with transfusion at higher Hb concentrations,^8-10 these studies have mainly used cardiac events and mortality as outcomes rather than patient symptoms, such as fatigue. Nevertheless, they have resulted in hospitals increasingly adopting restrictive transfusion policies that discourage transfusion at higher Hb levels.^11,12 Consequently, the rate of transfusion in hospitalized patients has decreased,¹³ raising questions of whether some patients with lower Hb concentrations may experience increased fatigue as a result of restrictive transfusion policies. Fatigue among hospitalized patients is important not only because it is an adverse symptom but because it may result in decreased activity levels, deconditioning, and losses in functional status.^14,15While the effect of alternative transfusion policies on fatigue in hospitalized patients could be answered by a randomized clinical trial using fatigue and functional status as outcomes, an important first step is to assess whether the Hb concentration of hospitalized patients is associated with their fatigue level during hospitalization. Because hospitalized patients often have acute illnesses that can cause fatigue in and of themselves, it is possible that anemia is not associated with fatigue in hospitalized patients despite anemia’s association with fatigue in ambulatory patients. Additionally, Hb concentration varies during hospitalization,¹⁶ raising the question of what measures of Hb during hospitalization might be most associated with anemia-related fatigue.

The objective of this study is to explore multiple Hb measures in hospitalized medical patients with anemia and test whether any of these Hb measures are associated with patients’ fatigue level.

Study Design

We performed a prospective, observational study of hospitalized patients with anemia on the general medicine services at The University of Chicago Medical Center (UCMC). The institutional review board approved the study procedures, and all study subjects provided informed consent.

Study Eligibility

Between April 2014 and June 2015, all general medicine inpatients were approached for written consent for The University of Chicago Hospitalist Project,¹⁷ a research infrastructure at UCMC. Among patients consenting to participate in the Hospitalist Project, patients were eligible if they had Hb <9 g/dL at any point during their hospitalization and were age ≥50 years. Hb concentration of <9 g/dL was chosen to include the range of Hb values covered by most restrictive transfusion policies.^8-10,18 Age ≥50 years was an inclusion criteria because anemia is more strongly associated with poor outcomes, including functional impairment, among older patients compared with younger patients.^14,19-21 If patients were not eligible for inclusion at the time of consent for the Hospitalist Project, their Hb values were reviewed twice daily until hospital discharge to assess if their Hb was <9 g/dL. Proxies were sought to answer questions for patients who failed the Short Portable Mental Status Questionnaire.²²

Patient Demographic Data Collection

Research assistants abstracted patient age and sex from the electronic health record (EHR), and asked patients to self-identify their race. The individual comorbidities included as part of the Charlson Comorbidity Index were identified using International Classification of Diseases, 9th Revision codes from hospital administrative data for each encounter and specifically included the following: myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatic disease, peptic ulcer disease, liver disease, diabetes, hemiplegia and/or paraplegia, renal disease, cancer, and human immunodeficiency virus/acquired immunodeficiency syndrome.²³ We also used Healthcare Cost and Utilization Project (www.hcup-us.ahrq.gov/toolssoftware/ccs/ccs.jsp) diagnosis categories to identify whether patients had sickle cell (SC) anemia, gastrointestinal bleeding (GIB), or a depressive disorder (DD) because these conditions are associated with anemia (SC and GIB) and fatigue (DD).²⁴

Measuring Anemia

Hb measures were available only when hospital providers ordered them as part of routine practice. The first Hb concentration <9 g/dL during a patient’s hospitalization, which made them eligible for study participation, was obtained through manual review of the EHR. All additional Hb values during the patient’s hospitalization were obtained from the hospital’s administrative data mart. All Hb values collected for each patient during the hospitalization were used to calculate summary measures of Hb during the hospitalization, including the mean Hb, median Hb, minimum Hb, maximum Hb, admission (first recorded) Hb, and discharge (last recorded) Hb. Hb measures were analyzed both as a continuous variable and as a categorical variable created by dividing the continuous Hb measures into integer ranges of 3 groups of approximately the same size.

Measuring Fatigue

Our primary outcome was patients’ level of fatigue reported during hospitalization, measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Anemia questionnaire. Fatigue was measured using a 13-question fatigue subscale,^1,2,25 which measures fatigue within the past 7 days. Scores on the fatigue subscale range from 0 to 52, with lower scores reflecting greater levels of fatigue. As soon as patients met the eligibility criteria for study participation during their hospitalization (age ≥50 years and Hb <9 g/dL), they were approached to answer the FACIT questions. Values for missing data in the fatigue subscale for individual subjects were filled in using a prorated score from their answered questions as long as >50% of the items in the fatigue subscale were answered, in accordance with recommendations for addressing missing data in the FACIT.²⁶ Fatigue was analyzed as a continuous variable and as a dichotomous variable created by dividing the sample into high (FACIT <27) and low (FACIT ≥27) levels of fatigue based on the median FACIT score of the population. Previous literature has shown a FACIT fatigue subscale score between 23 and 26 to be associated with an Eastern Cooperative Oncology Group (ECOG)²⁷ C Performance Status rating of 2 to 3³ compared to scores ≥27.

Statistical Analysis

Statistical analysis was performed using Stata statistical software (StataCorp, College Station, Texas). Descriptive statistics were used to characterize patient demographics. Analysis of variance was used to test for differences in the mean fatigue levels across Hb measures. χ² tests were performed to test for associations between high fatigue levels and the Hb measures. Multivariable analysis, including both linear and logistic regression models, were used to test the association of Hb concentration and fatigue. P values <0.05 using a 2-tailed test were deemed statistically significant.

Patient Characteristics

During the study period, 8559 patients were admitted to the general medicine service. Of those, 5073 (59%) consented for participation in the Hospitalist Project, and 3670 (72%) completed the Hospitalist Project inpatient interview. Of these patients, 1292 (35%) had Hb <9 g/dL, and 784 (61%) were 50 years or older and completed the FACIT questionnaire.

Table 1 reports the demographic characteristics and comorbidities for the sample, the mean (standard deviation [SD]) for the 6 Hb measures, and mean (SD) and median FACIT scores.

Bivariate Association of Fatigue and Hb

Categorizing patients into low, middle, or high Hb for each of the 6 Hb measures, minimum Hb was strongly associated with fatigue, with a weaker association for mean Hb and no statistically significant association for the other measures.

Minimum Hb

Patients with a minimum Hb <7 g/dL and patients with Hb 7-8 g/dL had higher fatigue levels (FACIT = 25 for each) than patients with a minimum Hb ≥8 g/dL (FACIT = 29; P < 0.001; Table 2). When excluding patients with SC and/or GIB because their average minimum Hb differed from the average minimum Hb of the full population (P < 0.001), patients with a minimum Hb <7 g/dL or 7-8 g/dL had even higher fatigue levels (FACIT = 23 and FACIT = 24, respectively), with no change in the fatigue level of patients with a minimum Hb ≥8 g/dL (FACIT = 29; P < 0.001; Table 2). Lower minimum Hb continued to be associated with higher fatigue levels when analyzed in 0.5 g/dL increments (Figure).

Mean Hb and Other Measures

Fatigue levels were high for 47% of patients with a mean Hb <8g /dL and 53% of patients with a mean Hb 8-9 g/dL compared with 43% of patients with a mean Hb ≥9 g/dL (P = 0.05). However, the association between high fatigue and mean Hb was not statistically significant when patients with SC and/or GIB were excluded (Table 2). None of the other 4 Hb measures was significantly associated with fatigue.

Linear Regression of Fatigue on Hb

In linear regression models, minimum Hb consistently predicted patient fatigue, mean Hb had a less robust association with fatigue, and the other Hb measures were not associated with patient fatigue. Increases in minimum Hb (analyzed as a continuous variable) were associated with reduced fatigue (higher FACIT score; β = 1.4; P = 0.005). In models in which minimum Hb was a categorical variable, patients with a minimum Hb of <7 g/dL or 7-8 g/dL had greater fatigue (lower FACIT score) than patients whose minimum Hb was ≥8 g/dL (Hb <7 g/dL: β = −4.2; P ≤ 0.001; Hb 7-8 g/dL: β = −4.1; P < 0.001). These results control for patients’ age, sex, individual comorbidities, and whether their minimum Hb occurred before or after the measurement of fatigue during hospitalization (Model 1), and the results are unchanged when also controlling for the number of Hb laboratory draws patients had during their hospitalization (Model 2; Table 3). In a stratified analysis excluding patients with either SC and/or GIB, changes in minimum Hb were associated with larger changes in patient fatigue levels (Supplemental Table 1). We also stratified our analysis to include only patients whose minimum Hb occurred before the measurement of their fatigue level during hospitalization to avoid a spurious association of fatigue with minimum Hb occurring after fatigue was measured. In both Models 1 and 2, minimum Hb remained a predictor of patients’ fatigue levels with similar effect sizes, although in Model 2, the results did not quite reach a statistically significant level, in part due to larger confidence intervals from the smaller sample size of this stratified analysis (Supplemental Table 2a). We further stratified this analysis to include only patients whose transfusion, if they received one, occurred after their minimum Hb and the measurement of their fatigue level to account for the possibility that a transfusion could affect the fatigue level patients report. In this analysis, most of the estimates of the effect of minimum Hb on fatigue were larger than those seen when only analyzing patients whose minimum Hb occurred before the measurement of their fatigue level, although again, the smaller sample size of this additional stratified analysis does produce larger confidence intervals for these estimates (Supplemental Table 2b).

Logistic Regression of High Fatigue Level on Hb

Using logistic regression, minimum Hb analyzed as a categorical variable predicted increased odds of a high fatigue level. Patients with a minimum Hb <7 g/dL were 50% (odds ratio [OR] = 1.5; P = 0.03) more likely to have high fatigue and patients with a minimum Hb 7-8 g/dL were 90% (OR = 1.9; P < 0.001) more likely to have high fatigue compared with patients with a minimum Hb ≥8 g/dL in Model 1. These results were similar in Model 2, although the effect was only statistically significant in the 7-8 g/dL Hb group (Table 3). When excluding SC and/or GIB patients, the odds of having high fatigue as minimum Hb decreased were the same or higher for both models compared to the full population of patients. However, again, in Model 2, the effect was only statistically significant in the 7-8 g/dL Hb group (Supplemental Table 1).

Patients with a mean Hb <8 g/dL were 20% to 30% more likely to have high fatigue and patients with mean Hb 8-9 g/dL were 50% more likely to have high fatigue compared with patients with a mean Hb ≥9 g/dL, but the effects were only statistically significant for patients with a mean Hb 8-9 g/dL in both Models 1 and 2 (Table 3). These results were similar when excluding patients with SC and/or GIB, but they were only significant for patients with a mean Hb 8-9 g/dL in Model 1 and patients with a mean Hb <8 g/dL in the Model 2 (Supplemental Table 3).

These results demonstrate that minimum Hb during hospitalization is associated with fatigue in hospitalized patients age ≥50 years, and the association is stronger among patients without SC and/or GIB as comorbidities. The analysis of Hb as a continuous and categorical variable and the use of both linear and logistic regression models support the robustness of these associations and illuminate their clinical significance. For example, in linear regression with minimum Hb a continuous variable, the coefficient of 1.4 suggests that an increase of 2 g/dL in Hb, as might be expected from transfusion of 2 units of red blood cells, would be associated with about a 3-point improvement in fatigue. Additionally, as a categorical variable, a minimum Hb ≥8 g/dL compared with a minimum Hb <7 g/dL or 7-8 g/dL is associated with a 3- to 4-point improvement in fatigue. Previous literature suggests that a difference of 3 in the FACIT score is the minimum clinically important difference in fatigue,³ and changes in minimum Hb in either model predict changes in fatigue that are in the range of potential clinical significance.

The clinical significance of the findings is also reflected in the results of the logistic regressions, which may be mapped to potential effects on functional status. Specifically, the odds of having a high fatigue level (FACIT <27) increase 90% for persons with a minimum Hb 7–8 g/dL compared with persons with a minimum Hb ≥8 g/dL. For persons with a minimum Hb <7 g/dL, point estimates suggest a smaller (50%) increase in the odds of high fatigue, but the 95% confidence interval overlaps heavily with the estimate of patients whose minimum Hb is 7-8 g/dL. While it might be expected that patients with a minimum Hb <7 g/dL have greater levels of fatigue compared with patients with a minimum Hb 7-8 g/dL, we did not observe such a pattern. One reason may be that the confidence intervals of our estimated effects are wide enough that we cannot exclude such a pattern. Another possible explanation is that in both groups, the fatigue levels are sufficiently severe, such that the difference in their fatigue levels may not be clinically meaningful. For example, a FACIT score of 23 to 26 has been shown to be associated with an ECOG performance status of 2 to 3, requiring bed rest for at least part of the day.³ Therefore, patients with a minimum Hb 7-8 g/dL (mean FACIT score = 24; Table 2) or a minimum Hb of <7 g/dL (mean FACIT score = 23; Table 2) are already functionally limited to the point of being partially bed bound, such that further decreases in their Hb may not produce additional fatigue in part because they reduce their activity sufficiently to prevent an increase in fatigue. In such cases, the potential benefits of increased Hb may be better assessed by measuring fatigue in response to a specific and provoked activity level, a concept known as fatigability.²⁰

That minimum Hb is more strongly associated with fatigue than any other measure of Hb during hospitalization may not be surprising. Mean, median, maximum, and discharge Hb may all be affected by transfusion during hospitalization that could affect fatigue. Admission Hb may not reflect true oxygen-carrying capacity because of hemoconcentration.

The association between Hb and fatigue in hospitalized patients is important because increased fatigue could contribute to slower clinical recovery in hospitalized patients. Additionally, increased fatigue during hospitalization and at hospital discharge could exacerbate the known deleterious consequences of fatigue on patients and their health outcomes^14,15 after hospital discharge. Although one previous study, the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)⁸ trial, did not report differences in patients’ fatigue levels at 30 and 60 days postdischarge when transfused at restrictive (8 g/dL) compared with liberal (10 g/dL) Hb thresholds, confidence in the validity of this finding is reduced by the fact that more than half of the patients were lost to follow-up at the 30- and 60-day time points. Further, patients in the restrictive transfusion arm of FOCUS were transfused to maintain Hb levels at or above 8 g/dL. This transfusion threshold of 8 g/dL may have mitigated the high levels of fatigue that are seen in our study when patients’ Hb drops below 8 g/dL, and maintaining a Hb level of 7 g/dL is now the standard of care in stable hospitalized patients. Lastly, FOCUS was limited to postoperative hip fracture patients, and the generalizability of FOCUS to hospitalized medicine patients with anemia is limited.

Therefore, our results support guideline suggestions that practitioners incorporate the presence of patient symptoms such as fatigue into transfusion decisions, particularly if patients’ Hb is <8 g/dL.¹⁸ Though reasonable, the suggestion to incorporate symptoms such as fatigue into transfusion decisions has not been strongly supported by evidence so far, and it may often be neglected in practice. Definitive evidence to support such recommendations would benefit from study through an optimal trial¹⁸ that incorporates symptoms into decision making. Our findings add support for a study of transfusion strategies that incorporates patients’ fatigue level in addition to Hb concentration.

This study has several limitations. Although our sample size is large and includes patients with a range of comorbidities that we believe are representative of hospitalized general medicine patients, as a single-center, observational study, our results may not be generalizable to other centers. Additionally, although these data support a reliable association between hospitalized patients’ minimum Hb and fatigue level, the observational design of this study cannot prove that this relationship is causal. Also, patients’ Hb values were measured at the discretion of their clinician, and therefore, the measures of Hb were not uniformly measured for participating patients. In addition, fatigue was only measured at one time point during a patient’s hospitalization, and it is possible that patients’ fatigue levels change during hospitalization in relation to variables we did not consider. Finally, our study was not designed to assess the association of Hb with longer-term functional outcomes, which may be of greater concern than fatigue.

In hospitalized patients ≥50 years old, minimum Hb is reliably associated with patients’ fatigue level. Patients whose minimum Hb is <8 g/dL experience higher fatigue levels compared to patients whose minimum Hb is ≥8 g/dL. Additional studies are warranted to understand if patients may benefit from improved fatigue levels by correcting their anemia through transfusion.

Disclosure 

Dr. Prochaska is supported by an Agency for Healthcare Research and Quality Patient-Centered Outcomes Research Institutional K12 Award (1K12HS023007-01, principal investigator Meltzer). Dr. Meltzer is supported by a National Institutes of Health Clinical and Translational Science Award (2UL1TR000430-06, principal investigator Solway) and a grant from the Patient-Centered Outcomes Research Network in support of the Chicago Patient-Centered Outcomes Research Network. The authors report no conflicts of interest.

Fatigue is the most common clinical symptom of anemia and is a significant concern to patients.^1,2 In ambulatory patients, lower hemoglobin (Hb) concentration is associated with increased fatigue.^2,3 Accordingly, therapies that treat anemia by increasing Hb concentration, such as erythropoiesis stimulating agents,^4-7 often use fatigue as an outcome measure.

In hospitalized patients, transfusion of red blood cell increases Hb concentration and is the primary treatment for anemia. However, the extent to which transfusion and changes in Hb concentration affect hospitalized patients’ fatigue levels is not well established. Guidelines support transfusing patients with symptoms of anemia, such as fatigue, on the assumption that the increased oxygen delivery will improve the symptoms of anemia. While transfusion studies in hospitalized patients have consistently reported that transfusion at lower or “restrictive” Hb concentrations is safe compared with transfusion at higher Hb concentrations,^8-10 these studies have mainly used cardiac events and mortality as outcomes rather than patient symptoms, such as fatigue. Nevertheless, they have resulted in hospitals increasingly adopting restrictive transfusion policies that discourage transfusion at higher Hb levels.^11,12 Consequently, the rate of transfusion in hospitalized patients has decreased,¹³ raising questions of whether some patients with lower Hb concentrations may experience increased fatigue as a result of restrictive transfusion policies. Fatigue among hospitalized patients is important not only because it is an adverse symptom but because it may result in decreased activity levels, deconditioning, and losses in functional status.^14,15While the effect of alternative transfusion policies on fatigue in hospitalized patients could be answered by a randomized clinical trial using fatigue and functional status as outcomes, an important first step is to assess whether the Hb concentration of hospitalized patients is associated with their fatigue level during hospitalization. Because hospitalized patients often have acute illnesses that can cause fatigue in and of themselves, it is possible that anemia is not associated with fatigue in hospitalized patients despite anemia’s association with fatigue in ambulatory patients. Additionally, Hb concentration varies during hospitalization,¹⁶ raising the question of what measures of Hb during hospitalization might be most associated with anemia-related fatigue.

The objective of this study is to explore multiple Hb measures in hospitalized medical patients with anemia and test whether any of these Hb measures are associated with patients’ fatigue level.

Study Design

We performed a prospective, observational study of hospitalized patients with anemia on the general medicine services at The University of Chicago Medical Center (UCMC). The institutional review board approved the study procedures, and all study subjects provided informed consent.

Study Eligibility

Between April 2014 and June 2015, all general medicine inpatients were approached for written consent for The University of Chicago Hospitalist Project,¹⁷ a research infrastructure at UCMC. Among patients consenting to participate in the Hospitalist Project, patients were eligible if they had Hb <9 g/dL at any point during their hospitalization and were age ≥50 years. Hb concentration of <9 g/dL was chosen to include the range of Hb values covered by most restrictive transfusion policies.^8-10,18 Age ≥50 years was an inclusion criteria because anemia is more strongly associated with poor outcomes, including functional impairment, among older patients compared with younger patients.^14,19-21 If patients were not eligible for inclusion at the time of consent for the Hospitalist Project, their Hb values were reviewed twice daily until hospital discharge to assess if their Hb was <9 g/dL. Proxies were sought to answer questions for patients who failed the Short Portable Mental Status Questionnaire.²²

Patient Demographic Data Collection

Research assistants abstracted patient age and sex from the electronic health record (EHR), and asked patients to self-identify their race. The individual comorbidities included as part of the Charlson Comorbidity Index were identified using International Classification of Diseases, 9th Revision codes from hospital administrative data for each encounter and specifically included the following: myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatic disease, peptic ulcer disease, liver disease, diabetes, hemiplegia and/or paraplegia, renal disease, cancer, and human immunodeficiency virus/acquired immunodeficiency syndrome.²³ We also used Healthcare Cost and Utilization Project (www.hcup-us.ahrq.gov/toolssoftware/ccs/ccs.jsp) diagnosis categories to identify whether patients had sickle cell (SC) anemia, gastrointestinal bleeding (GIB), or a depressive disorder (DD) because these conditions are associated with anemia (SC and GIB) and fatigue (DD).²⁴

Measuring Anemia

Hb measures were available only when hospital providers ordered them as part of routine practice. The first Hb concentration <9 g/dL during a patient’s hospitalization, which made them eligible for study participation, was obtained through manual review of the EHR. All additional Hb values during the patient’s hospitalization were obtained from the hospital’s administrative data mart. All Hb values collected for each patient during the hospitalization were used to calculate summary measures of Hb during the hospitalization, including the mean Hb, median Hb, minimum Hb, maximum Hb, admission (first recorded) Hb, and discharge (last recorded) Hb. Hb measures were analyzed both as a continuous variable and as a categorical variable created by dividing the continuous Hb measures into integer ranges of 3 groups of approximately the same size.

Measuring Fatigue

Our primary outcome was patients’ level of fatigue reported during hospitalization, measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Anemia questionnaire. Fatigue was measured using a 13-question fatigue subscale,^1,2,25 which measures fatigue within the past 7 days. Scores on the fatigue subscale range from 0 to 52, with lower scores reflecting greater levels of fatigue. As soon as patients met the eligibility criteria for study participation during their hospitalization (age ≥50 years and Hb <9 g/dL), they were approached to answer the FACIT questions. Values for missing data in the fatigue subscale for individual subjects were filled in using a prorated score from their answered questions as long as >50% of the items in the fatigue subscale were answered, in accordance with recommendations for addressing missing data in the FACIT.²⁶ Fatigue was analyzed as a continuous variable and as a dichotomous variable created by dividing the sample into high (FACIT <27) and low (FACIT ≥27) levels of fatigue based on the median FACIT score of the population. Previous literature has shown a FACIT fatigue subscale score between 23 and 26 to be associated with an Eastern Cooperative Oncology Group (ECOG)²⁷ C Performance Status rating of 2 to 3³ compared to scores ≥27.

Statistical Analysis

Statistical analysis was performed using Stata statistical software (StataCorp, College Station, Texas). Descriptive statistics were used to characterize patient demographics. Analysis of variance was used to test for differences in the mean fatigue levels across Hb measures. χ² tests were performed to test for associations between high fatigue levels and the Hb measures. Multivariable analysis, including both linear and logistic regression models, were used to test the association of Hb concentration and fatigue. P values <0.05 using a 2-tailed test were deemed statistically significant.

Patient Characteristics

During the study period, 8559 patients were admitted to the general medicine service. Of those, 5073 (59%) consented for participation in the Hospitalist Project, and 3670 (72%) completed the Hospitalist Project inpatient interview. Of these patients, 1292 (35%) had Hb <9 g/dL, and 784 (61%) were 50 years or older and completed the FACIT questionnaire.

Table 1 reports the demographic characteristics and comorbidities for the sample, the mean (standard deviation [SD]) for the 6 Hb measures, and mean (SD) and median FACIT scores.

Bivariate Association of Fatigue and Hb

Categorizing patients into low, middle, or high Hb for each of the 6 Hb measures, minimum Hb was strongly associated with fatigue, with a weaker association for mean Hb and no statistically significant association for the other measures.

Minimum Hb

Patients with a minimum Hb <7 g/dL and patients with Hb 7-8 g/dL had higher fatigue levels (FACIT = 25 for each) than patients with a minimum Hb ≥8 g/dL (FACIT = 29; P < 0.001; Table 2). When excluding patients with SC and/or GIB because their average minimum Hb differed from the average minimum Hb of the full population (P < 0.001), patients with a minimum Hb <7 g/dL or 7-8 g/dL had even higher fatigue levels (FACIT = 23 and FACIT = 24, respectively), with no change in the fatigue level of patients with a minimum Hb ≥8 g/dL (FACIT = 29; P < 0.001; Table 2). Lower minimum Hb continued to be associated with higher fatigue levels when analyzed in 0.5 g/dL increments (Figure).

Mean Hb and Other Measures

Fatigue levels were high for 47% of patients with a mean Hb <8g /dL and 53% of patients with a mean Hb 8-9 g/dL compared with 43% of patients with a mean Hb ≥9 g/dL (P = 0.05). However, the association between high fatigue and mean Hb was not statistically significant when patients with SC and/or GIB were excluded (Table 2). None of the other 4 Hb measures was significantly associated with fatigue.

Linear Regression of Fatigue on Hb

In linear regression models, minimum Hb consistently predicted patient fatigue, mean Hb had a less robust association with fatigue, and the other Hb measures were not associated with patient fatigue. Increases in minimum Hb (analyzed as a continuous variable) were associated with reduced fatigue (higher FACIT score; β = 1.4; P = 0.005). In models in which minimum Hb was a categorical variable, patients with a minimum Hb of <7 g/dL or 7-8 g/dL had greater fatigue (lower FACIT score) than patients whose minimum Hb was ≥8 g/dL (Hb <7 g/dL: β = −4.2; P ≤ 0.001; Hb 7-8 g/dL: β = −4.1; P < 0.001). These results control for patients’ age, sex, individual comorbidities, and whether their minimum Hb occurred before or after the measurement of fatigue during hospitalization (Model 1), and the results are unchanged when also controlling for the number of Hb laboratory draws patients had during their hospitalization (Model 2; Table 3). In a stratified analysis excluding patients with either SC and/or GIB, changes in minimum Hb were associated with larger changes in patient fatigue levels (Supplemental Table 1). We also stratified our analysis to include only patients whose minimum Hb occurred before the measurement of their fatigue level during hospitalization to avoid a spurious association of fatigue with minimum Hb occurring after fatigue was measured. In both Models 1 and 2, minimum Hb remained a predictor of patients’ fatigue levels with similar effect sizes, although in Model 2, the results did not quite reach a statistically significant level, in part due to larger confidence intervals from the smaller sample size of this stratified analysis (Supplemental Table 2a). We further stratified this analysis to include only patients whose transfusion, if they received one, occurred after their minimum Hb and the measurement of their fatigue level to account for the possibility that a transfusion could affect the fatigue level patients report. In this analysis, most of the estimates of the effect of minimum Hb on fatigue were larger than those seen when only analyzing patients whose minimum Hb occurred before the measurement of their fatigue level, although again, the smaller sample size of this additional stratified analysis does produce larger confidence intervals for these estimates (Supplemental Table 2b).

Logistic Regression of High Fatigue Level on Hb

Using logistic regression, minimum Hb analyzed as a categorical variable predicted increased odds of a high fatigue level. Patients with a minimum Hb <7 g/dL were 50% (odds ratio [OR] = 1.5; P = 0.03) more likely to have high fatigue and patients with a minimum Hb 7-8 g/dL were 90% (OR = 1.9; P < 0.001) more likely to have high fatigue compared with patients with a minimum Hb ≥8 g/dL in Model 1. These results were similar in Model 2, although the effect was only statistically significant in the 7-8 g/dL Hb group (Table 3). When excluding SC and/or GIB patients, the odds of having high fatigue as minimum Hb decreased were the same or higher for both models compared to the full population of patients. However, again, in Model 2, the effect was only statistically significant in the 7-8 g/dL Hb group (Supplemental Table 1).

Patients with a mean Hb <8 g/dL were 20% to 30% more likely to have high fatigue and patients with mean Hb 8-9 g/dL were 50% more likely to have high fatigue compared with patients with a mean Hb ≥9 g/dL, but the effects were only statistically significant for patients with a mean Hb 8-9 g/dL in both Models 1 and 2 (Table 3). These results were similar when excluding patients with SC and/or GIB, but they were only significant for patients with a mean Hb 8-9 g/dL in Model 1 and patients with a mean Hb <8 g/dL in the Model 2 (Supplemental Table 3).

These results demonstrate that minimum Hb during hospitalization is associated with fatigue in hospitalized patients age ≥50 years, and the association is stronger among patients without SC and/or GIB as comorbidities. The analysis of Hb as a continuous and categorical variable and the use of both linear and logistic regression models support the robustness of these associations and illuminate their clinical significance. For example, in linear regression with minimum Hb a continuous variable, the coefficient of 1.4 suggests that an increase of 2 g/dL in Hb, as might be expected from transfusion of 2 units of red blood cells, would be associated with about a 3-point improvement in fatigue. Additionally, as a categorical variable, a minimum Hb ≥8 g/dL compared with a minimum Hb <7 g/dL or 7-8 g/dL is associated with a 3- to 4-point improvement in fatigue. Previous literature suggests that a difference of 3 in the FACIT score is the minimum clinically important difference in fatigue,³ and changes in minimum Hb in either model predict changes in fatigue that are in the range of potential clinical significance.

The clinical significance of the findings is also reflected in the results of the logistic regressions, which may be mapped to potential effects on functional status. Specifically, the odds of having a high fatigue level (FACIT <27) increase 90% for persons with a minimum Hb 7–8 g/dL compared with persons with a minimum Hb ≥8 g/dL. For persons with a minimum Hb <7 g/dL, point estimates suggest a smaller (50%) increase in the odds of high fatigue, but the 95% confidence interval overlaps heavily with the estimate of patients whose minimum Hb is 7-8 g/dL. While it might be expected that patients with a minimum Hb <7 g/dL have greater levels of fatigue compared with patients with a minimum Hb 7-8 g/dL, we did not observe such a pattern. One reason may be that the confidence intervals of our estimated effects are wide enough that we cannot exclude such a pattern. Another possible explanation is that in both groups, the fatigue levels are sufficiently severe, such that the difference in their fatigue levels may not be clinically meaningful. For example, a FACIT score of 23 to 26 has been shown to be associated with an ECOG performance status of 2 to 3, requiring bed rest for at least part of the day.³ Therefore, patients with a minimum Hb 7-8 g/dL (mean FACIT score = 24; Table 2) or a minimum Hb of <7 g/dL (mean FACIT score = 23; Table 2) are already functionally limited to the point of being partially bed bound, such that further decreases in their Hb may not produce additional fatigue in part because they reduce their activity sufficiently to prevent an increase in fatigue. In such cases, the potential benefits of increased Hb may be better assessed by measuring fatigue in response to a specific and provoked activity level, a concept known as fatigability.²⁰

That minimum Hb is more strongly associated with fatigue than any other measure of Hb during hospitalization may not be surprising. Mean, median, maximum, and discharge Hb may all be affected by transfusion during hospitalization that could affect fatigue. Admission Hb may not reflect true oxygen-carrying capacity because of hemoconcentration.

The association between Hb and fatigue in hospitalized patients is important because increased fatigue could contribute to slower clinical recovery in hospitalized patients. Additionally, increased fatigue during hospitalization and at hospital discharge could exacerbate the known deleterious consequences of fatigue on patients and their health outcomes^14,15 after hospital discharge. Although one previous study, the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)⁸ trial, did not report differences in patients’ fatigue levels at 30 and 60 days postdischarge when transfused at restrictive (8 g/dL) compared with liberal (10 g/dL) Hb thresholds, confidence in the validity of this finding is reduced by the fact that more than half of the patients were lost to follow-up at the 30- and 60-day time points. Further, patients in the restrictive transfusion arm of FOCUS were transfused to maintain Hb levels at or above 8 g/dL. This transfusion threshold of 8 g/dL may have mitigated the high levels of fatigue that are seen in our study when patients’ Hb drops below 8 g/dL, and maintaining a Hb level of 7 g/dL is now the standard of care in stable hospitalized patients. Lastly, FOCUS was limited to postoperative hip fracture patients, and the generalizability of FOCUS to hospitalized medicine patients with anemia is limited.

Therefore, our results support guideline suggestions that practitioners incorporate the presence of patient symptoms such as fatigue into transfusion decisions, particularly if patients’ Hb is <8 g/dL.¹⁸ Though reasonable, the suggestion to incorporate symptoms such as fatigue into transfusion decisions has not been strongly supported by evidence so far, and it may often be neglected in practice. Definitive evidence to support such recommendations would benefit from study through an optimal trial¹⁸ that incorporates symptoms into decision making. Our findings add support for a study of transfusion strategies that incorporates patients’ fatigue level in addition to Hb concentration.

This study has several limitations. Although our sample size is large and includes patients with a range of comorbidities that we believe are representative of hospitalized general medicine patients, as a single-center, observational study, our results may not be generalizable to other centers. Additionally, although these data support a reliable association between hospitalized patients’ minimum Hb and fatigue level, the observational design of this study cannot prove that this relationship is causal. Also, patients’ Hb values were measured at the discretion of their clinician, and therefore, the measures of Hb were not uniformly measured for participating patients. In addition, fatigue was only measured at one time point during a patient’s hospitalization, and it is possible that patients’ fatigue levels change during hospitalization in relation to variables we did not consider. Finally, our study was not designed to assess the association of Hb with longer-term functional outcomes, which may be of greater concern than fatigue.

In hospitalized patients ≥50 years old, minimum Hb is reliably associated with patients’ fatigue level. Patients whose minimum Hb is <8 g/dL experience higher fatigue levels compared to patients whose minimum Hb is ≥8 g/dL. Additional studies are warranted to understand if patients may benefit from improved fatigue levels by correcting their anemia through transfusion.

Disclosure 

Dr. Prochaska is supported by an Agency for Healthcare Research and Quality Patient-Centered Outcomes Research Institutional K12 Award (1K12HS023007-01, principal investigator Meltzer). Dr. Meltzer is supported by a National Institutes of Health Clinical and Translational Science Award (2UL1TR000430-06, principal investigator Solway) and a grant from the Patient-Centered Outcomes Research Network in support of the Chicago Patient-Centered Outcomes Research Network. The authors report no conflicts of interest.

Acute viral bronchiolitis is the most common cause of hospitalization for children less than 1 year of age.¹ Overuse of ineffective therapies has persisted despite the existence of the evidence-based American Academy of Pediatrics (AAP) clinical practice guideline (CPG), which recommends primarily supportive care.^2-8 Adherence to the AAP CPG recommendations for management of bronchiolitis improved significantly through the AAP’s Bronchiolitis Quality Improvement Project (BQIP), a 12-month, multiinstitutional collaborative of community and free-standing children’s hospitals.⁹ This subsequent study investigates if these improvements were sustained after completion of the formal 12-month project.

Published multiinstitutional bronchiolitis quality improvement (QI) work is limited to 1 study⁵ that describes the results of a single intervention season at academic medical centers. Multiyear bronchiolitis QI projects are limited to single-center studies, and results have been mixed.^5,6,8,10-13 One study¹¹ observed continued improvement in bronchodilator use in subsequent seasons, whereas a second study¹⁰ observed a return to baseline bronchodilator use in the following season. Mittal⁶ observed inconsistent improvements in key bronchiolitis measures during postintervention seasons.

Our specific aim was to assess the sustainability of improvements in bronchiolitis management at participating institutions 1 year following completion of the AAP BQIP collaborative.⁹ Because no studies demonstrate the most effective way to support long-term improvement through a QI collaborative, we hypothesized that the initial collaborative activities, which were designed to build the capacity of local interdisciplinary teams while providing standardized evidence-based care pathways, would lead to performance in the subsequent season at levels similar to or better than those observed during the active phase of the collaborative, without additional project interventions.

Study Design and Setting

This was a follow-up study of the AAP Quality Improvement Innovation Networks project entitled “A Quality Collaborative for Improving Hospital Compliance with the AAP Bronchiolitis Guideline” (BQIP).⁹ The AAP Institutional Review Board approved this project.

Twenty-one multidisciplinary, hospital-based teams participated in the BQIP collaborative and provided monthly data during the January through March bronchiolitis season. Teams submitted 2013 baseline data and 2014 intervention data. Nine sites provided 2015 sustainability data following the completion of the collaborative.

Participants

Hospital encounters with a primary diagnosis of acute viral bronchiolitis were eligible for inclusion among patients from 1 month to 2 years of age. Encounters were excluded for prematurity (<35 weeks gestational age), congenital heart disease, bronchopulmonary dysplasia, genetic, congenital or neuromuscular abnormalities, and pediatric intensive-care admission.

Data Collection

Hospital characteristics were collected, including hospital type (academic, community), bed size, location (urban, rural), hospital distributions of race/ethnicity and public payer, cases of bronchiolitis per year, presence of an electronic medical record and a pediatric respiratory therapist, and self-rated QI knowledge of the multidisciplinary team (very knowledgeable, knowledgeable, and somewhat knowledgeable). A trained member at each site collected data through structured chart review in baseline, intervention, and sustainability bronchiolitis seasons for January, February, and March. Site members reviewed the first 20 charts per month that met the inclusion criteria or all charts if there were fewer than 20 eligible encounters. Sites input data about key quality measures into the AAP’s Quality Improvement Data Aggregator, a web-based data repository.

Intervention

The BQIP project was designed as a virtual collaborative consisting of monthly education webinars about QI methods and bronchiolitis management, opportunities for collaboration via teleconference and e-mail listserv, and individual site-coaching by e-mail or telephone.⁹ A change package was shared with sites that included examples of evidence-based pathways, ordersets, a respiratory scoring tool, communication tools for parents and referring physicians, and slide sets for individual site education efforts. Following completion of the collaborative, written resources remained available to participants, although virtual collaboration ceased and no additional project interventions to promote sustainability were introduced.

Bronchiolitis Process and Outcome Measures

Process measures following admission included the following: severity assessment using a respiratory score, respiratory score use to assess response to bronchodilators, bronchodilator use, bronchodilator doses, steroid doses per patient encounter, chest radiographs per encounter, and presence of an order to transition to intermittent pulse oximetry monitoring. Outcome measures included length of stay and readmissions within 72 hours.

Analysis

Changes among baseline-, intervention-, and sustainability-season data were assessed using generalized linear mixed-effects models with random effect for study sites. Negative binomial models were used for count variables to allow for overdispersion. Length of stay was log-transformed to achieve a normal distribution. We also analyzed each site individually to assess whether sustained improvements were the result of broad sustainability across all sites or whether they represented an aggregation of some sites that continued to improve while other sites actually worsened.

To address any bias introduced by the voluntary and incomplete participation of sites in the sustainability season, we planned a priori to conduct 3 additional analyses. First, we compared the characteristics of sites that did participate in the sustainability season with those that did not participate by using Chi-squared tests for differences in proportions and t tests for differences in means. Second, we determined whether the baseline-season process and outcome measures were different between sites that did and did not participate using descriptive statistics. Third, we assessed whether improvements between the baseline and intervention seasons were different between sites that did and did not participate using a linear mixed-effects model for normally distributed outcomes and generalized linear mixed-effects model with site-specific random effects for nonnormally distributed outcomes. All study outcomes were summarized in terms of model-adjusted means along with the corresponding 95% confidence intervals. All P values are 2-sided, and P < 0.05 was used to define statistical significance. Data analyses were conducted using SAS software (SAS Institute Inc., Cary, North Carolina) version 9.4.

To our knowledge, this is the first report of sustained improvements in care achieved through a multiinstitutional QI collaborative of community and academic hospitals focused on bronchiolitis care. We found that overall sites participating in a national bronchiolitis QI project sustained improvements in key bronchiolitis quality measures for 1 year following the project’s completion. For the aggregate group no measures worsened, and one measure, orders for intermittent pulse oximetry monitoring, continued to increase during the sustainability season. Furthermore, the sustained improvements were primarily the result of consistent sustained performance of each individual site, as opposed to averages wherein some sites worsened while others improved (Appendix 1a). These findings suggest that designing a collaborative approach, which provides an evidence-based best-practice toolkit while building the QI capacity of local interdisciplinary teams, can support performance gains that persist beyond the project’s active phase.

There are a number of possible reasons why improvements were sustained following the collaborative. The BQIP requirement for institutional leadership buy-in may have motivated accountability to local leaders in subsequent bronchiolitis seasons at each site. We suspect that culture change such as flattened hierarchies through multidisciplinary teams,¹⁴ which empowered nurse and respiratory therapy staff, may have facilitated consistent use of tools created locally. The synergy of interdisciplinary teams composed of physician, nurse, and respiratory therapy champions may have created accountability to perpetuate the previous year’s efforts.¹⁵ In addition, the sites adopted elements of the evidence-based toolkit, such as pathways,^16,17 forcing function tools^13,18 and order sets that limited management decision options and bronchodilator use contingent on respiratory scores,^9,19 which may have driven desired behaviors.

Moreover, the 2014 AAP CPG for the management of bronchiolitis,²⁰ released prior to the sustainability bronchiolitis season, may have underscored the key concepts of the collaborative. Similarly, national exposure of best practices for bronchiolitis management, including the 3 widespread Choosing Wisely recommendations related to bronchiolitis,²¹ might have been a compelling reason for sites to maintain their improvement efforts and contribute to secular trends toward decreasing interventions in bronchiolitis management nationally.³ Lastly, the mechanisms developed for local data collection may have created opportunities at each site to conduct ongoing evaluation of performance on key bronchiolitis quality measures through data-driven feedback systems.²² Our study highlights the need for additional research in order to understand why improvements are or are not sustained.

Even with substantial, sustained improvements in this initiative, further reduction in unnecessary care may be possible. Findings from previous studies suggest that even multifaceted QI interventions, including provider education, guidelines and use of respiratory scores, may only modestly reduce bronchodilators, steroids, and chest radiograph use.^8,13 To achieve continued improvements in bronchiolitis care, additional active efforts may be needed to develop new interventions that target root causes for areas of overuse at individual sites.

Future multiinstitutional collaboratives might benefit their participants if they include a focus on helping sites develop skills to ensure that local improvement activities continue after the collaborative phases are completed. Proactively scheduling intermittent check-ins with collaborative members to discuss experiences with both sustainability and ongoing improvement may be valuable and likely needs to be incorporated into the initial collaborative planning.

As these sustainability data represent a subset of 9 of the original 21 BQIP sites, there is concern for potential selection bias related to factors that could have motivated sites to participate in the sustainability season’s data collection and simultaneously influenced their performance. These concerns were mitigated to some extent through 3 specific analyses: finding limited differences in hospital characteristics, baseline performance in key bronchiolitis measures, and performance change from baseline to intervention seasons between sites that did and did not participate in the sustainability season.

Notably, sites that participated in the sustainability phase actually had lower baseline respiratory score use and fewer orders for intermittent pulse oximetry at baseline. Theoretically, if participation in the collaborative highlighted this disparity for these sites, it could have been a motivating factor for their continued participation and sustained performance across these measures. Similarly, sites that recognized their higher baseline performance through participation in the collaborative might have felt less motivation to participate in ongoing data collection during the sustainability season. Whether they might have also sustained, declined, or continued improving is not known. Additionally, the magnitude of improvement in the collaborative period might have also motivated ongoing participation during the sustainability phase. For example, although all sites improved in score use during the collaborative, sites participating in the sustainability season demonstrated significantly more improvement in these measures. Sites with a higher magnitude of improvement in collaborative measures might have more enthusiasm about the project, more commitment to the project activities, or feel a sense of obligation to respond to requests for additional data collection.

This work has several limitations. Selection bias may limit generalizability of the results, as sites that did not participate in the sustainability season may have had different results than those that did participate. It is unknown whether sites that regressed toward their baseline were deterred from participating in the sustainability season. The analyses that we were able to preform, however, suggest that the 2 groups were similar in their characteristics as well as in their baseline and improvement performance.

We have limited knowledge of the local improvement work that sites conducted between the completion of the collaborative and the sustainability season. Site-specific factors may have influenced improvement sustainability. For example, qualitative research with the original group found that team engagement had a quantitative association with better performance, but only for the bronchodilator use measure.²³ Sites were responsible for their own data collection, and despite attempts to centralize and standardize the process, data collection inconsistencies may have occurred. For instance, it is unknown how closely that orders for intermittent pulse oximetry correlate with intermittent use at the bedside. Lastly, the absence of a control group limits examination of the causal relationships of interventions and the influence of secular trends.

Improvements gained during the BQIP collaborative were sustained at 1 year following completion of the collaborative. These findings are encouraging, as national QI collaborative efforts are increasingly common. Our findings suggest that opportunities exist to even further reduce unnecessary care in the management of bronchiolitis. Such opportunities highlight the importance of integrating strategies to both measure sustainability and plan for ongoing independent local activities after completion of the collaborative. Future efforts should focus on supporting local sites to continue individual practice-improvement as they transition from collaborative to independent quality initiatives.

Acknowledgments

The authors thank the 21 hospitals that participated in the BQIP collaborative, and in particular the 9 hospital teams that contributed sustainability data for their ongoing dedication. There was no external funding for this manuscript.

Disclosure

The authors report no financial conflicts of interest.

Acute viral bronchiolitis is the most common cause of hospitalization for children less than 1 year of age.¹ Overuse of ineffective therapies has persisted despite the existence of the evidence-based American Academy of Pediatrics (AAP) clinical practice guideline (CPG), which recommends primarily supportive care.^2-8 Adherence to the AAP CPG recommendations for management of bronchiolitis improved significantly through the AAP’s Bronchiolitis Quality Improvement Project (BQIP), a 12-month, multiinstitutional collaborative of community and free-standing children’s hospitals.⁹ This subsequent study investigates if these improvements were sustained after completion of the formal 12-month project.

Published multiinstitutional bronchiolitis quality improvement (QI) work is limited to 1 study⁵ that describes the results of a single intervention season at academic medical centers. Multiyear bronchiolitis QI projects are limited to single-center studies, and results have been mixed.^5,6,8,10-13 One study¹¹ observed continued improvement in bronchodilator use in subsequent seasons, whereas a second study¹⁰ observed a return to baseline bronchodilator use in the following season. Mittal⁶ observed inconsistent improvements in key bronchiolitis measures during postintervention seasons.

Our specific aim was to assess the sustainability of improvements in bronchiolitis management at participating institutions 1 year following completion of the AAP BQIP collaborative.⁹ Because no studies demonstrate the most effective way to support long-term improvement through a QI collaborative, we hypothesized that the initial collaborative activities, which were designed to build the capacity of local interdisciplinary teams while providing standardized evidence-based care pathways, would lead to performance in the subsequent season at levels similar to or better than those observed during the active phase of the collaborative, without additional project interventions.

Study Design and Setting

This was a follow-up study of the AAP Quality Improvement Innovation Networks project entitled “A Quality Collaborative for Improving Hospital Compliance with the AAP Bronchiolitis Guideline” (BQIP).⁹ The AAP Institutional Review Board approved this project.

Twenty-one multidisciplinary, hospital-based teams participated in the BQIP collaborative and provided monthly data during the January through March bronchiolitis season. Teams submitted 2013 baseline data and 2014 intervention data. Nine sites provided 2015 sustainability data following the completion of the collaborative.

Participants

Hospital encounters with a primary diagnosis of acute viral bronchiolitis were eligible for inclusion among patients from 1 month to 2 years of age. Encounters were excluded for prematurity (<35 weeks gestational age), congenital heart disease, bronchopulmonary dysplasia, genetic, congenital or neuromuscular abnormalities, and pediatric intensive-care admission.

Data Collection

Hospital characteristics were collected, including hospital type (academic, community), bed size, location (urban, rural), hospital distributions of race/ethnicity and public payer, cases of bronchiolitis per year, presence of an electronic medical record and a pediatric respiratory therapist, and self-rated QI knowledge of the multidisciplinary team (very knowledgeable, knowledgeable, and somewhat knowledgeable). A trained member at each site collected data through structured chart review in baseline, intervention, and sustainability bronchiolitis seasons for January, February, and March. Site members reviewed the first 20 charts per month that met the inclusion criteria or all charts if there were fewer than 20 eligible encounters. Sites input data about key quality measures into the AAP’s Quality Improvement Data Aggregator, a web-based data repository.

Intervention

The BQIP project was designed as a virtual collaborative consisting of monthly education webinars about QI methods and bronchiolitis management, opportunities for collaboration via teleconference and e-mail listserv, and individual site-coaching by e-mail or telephone.⁹ A change package was shared with sites that included examples of evidence-based pathways, ordersets, a respiratory scoring tool, communication tools for parents and referring physicians, and slide sets for individual site education efforts. Following completion of the collaborative, written resources remained available to participants, although virtual collaboration ceased and no additional project interventions to promote sustainability were introduced.

Bronchiolitis Process and Outcome Measures

Process measures following admission included the following: severity assessment using a respiratory score, respiratory score use to assess response to bronchodilators, bronchodilator use, bronchodilator doses, steroid doses per patient encounter, chest radiographs per encounter, and presence of an order to transition to intermittent pulse oximetry monitoring. Outcome measures included length of stay and readmissions within 72 hours.

Analysis

Changes among baseline-, intervention-, and sustainability-season data were assessed using generalized linear mixed-effects models with random effect for study sites. Negative binomial models were used for count variables to allow for overdispersion. Length of stay was log-transformed to achieve a normal distribution. We also analyzed each site individually to assess whether sustained improvements were the result of broad sustainability across all sites or whether they represented an aggregation of some sites that continued to improve while other sites actually worsened.

To address any bias introduced by the voluntary and incomplete participation of sites in the sustainability season, we planned a priori to conduct 3 additional analyses. First, we compared the characteristics of sites that did participate in the sustainability season with those that did not participate by using Chi-squared tests for differences in proportions and t tests for differences in means. Second, we determined whether the baseline-season process and outcome measures were different between sites that did and did not participate using descriptive statistics. Third, we assessed whether improvements between the baseline and intervention seasons were different between sites that did and did not participate using a linear mixed-effects model for normally distributed outcomes and generalized linear mixed-effects model with site-specific random effects for nonnormally distributed outcomes. All study outcomes were summarized in terms of model-adjusted means along with the corresponding 95% confidence intervals. All P values are 2-sided, and P < 0.05 was used to define statistical significance. Data analyses were conducted using SAS software (SAS Institute Inc., Cary, North Carolina) version 9.4.

To our knowledge, this is the first report of sustained improvements in care achieved through a multiinstitutional QI collaborative of community and academic hospitals focused on bronchiolitis care. We found that overall sites participating in a national bronchiolitis QI project sustained improvements in key bronchiolitis quality measures for 1 year following the project’s completion. For the aggregate group no measures worsened, and one measure, orders for intermittent pulse oximetry monitoring, continued to increase during the sustainability season. Furthermore, the sustained improvements were primarily the result of consistent sustained performance of each individual site, as opposed to averages wherein some sites worsened while others improved (Appendix 1a). These findings suggest that designing a collaborative approach, which provides an evidence-based best-practice toolkit while building the QI capacity of local interdisciplinary teams, can support performance gains that persist beyond the project’s active phase.

There are a number of possible reasons why improvements were sustained following the collaborative. The BQIP requirement for institutional leadership buy-in may have motivated accountability to local leaders in subsequent bronchiolitis seasons at each site. We suspect that culture change such as flattened hierarchies through multidisciplinary teams,¹⁴ which empowered nurse and respiratory therapy staff, may have facilitated consistent use of tools created locally. The synergy of interdisciplinary teams composed of physician, nurse, and respiratory therapy champions may have created accountability to perpetuate the previous year’s efforts.¹⁵ In addition, the sites adopted elements of the evidence-based toolkit, such as pathways,^16,17 forcing function tools^13,18 and order sets that limited management decision options and bronchodilator use contingent on respiratory scores,^9,19 which may have driven desired behaviors.

Moreover, the 2014 AAP CPG for the management of bronchiolitis,²⁰ released prior to the sustainability bronchiolitis season, may have underscored the key concepts of the collaborative. Similarly, national exposure of best practices for bronchiolitis management, including the 3 widespread Choosing Wisely recommendations related to bronchiolitis,²¹ might have been a compelling reason for sites to maintain their improvement efforts and contribute to secular trends toward decreasing interventions in bronchiolitis management nationally.³ Lastly, the mechanisms developed for local data collection may have created opportunities at each site to conduct ongoing evaluation of performance on key bronchiolitis quality measures through data-driven feedback systems.²² Our study highlights the need for additional research in order to understand why improvements are or are not sustained.

Even with substantial, sustained improvements in this initiative, further reduction in unnecessary care may be possible. Findings from previous studies suggest that even multifaceted QI interventions, including provider education, guidelines and use of respiratory scores, may only modestly reduce bronchodilators, steroids, and chest radiograph use.^8,13 To achieve continued improvements in bronchiolitis care, additional active efforts may be needed to develop new interventions that target root causes for areas of overuse at individual sites.

Future multiinstitutional collaboratives might benefit their participants if they include a focus on helping sites develop skills to ensure that local improvement activities continue after the collaborative phases are completed. Proactively scheduling intermittent check-ins with collaborative members to discuss experiences with both sustainability and ongoing improvement may be valuable and likely needs to be incorporated into the initial collaborative planning.

As these sustainability data represent a subset of 9 of the original 21 BQIP sites, there is concern for potential selection bias related to factors that could have motivated sites to participate in the sustainability season’s data collection and simultaneously influenced their performance. These concerns were mitigated to some extent through 3 specific analyses: finding limited differences in hospital characteristics, baseline performance in key bronchiolitis measures, and performance change from baseline to intervention seasons between sites that did and did not participate in the sustainability season.

Notably, sites that participated in the sustainability phase actually had lower baseline respiratory score use and fewer orders for intermittent pulse oximetry at baseline. Theoretically, if participation in the collaborative highlighted this disparity for these sites, it could have been a motivating factor for their continued participation and sustained performance across these measures. Similarly, sites that recognized their higher baseline performance through participation in the collaborative might have felt less motivation to participate in ongoing data collection during the sustainability season. Whether they might have also sustained, declined, or continued improving is not known. Additionally, the magnitude of improvement in the collaborative period might have also motivated ongoing participation during the sustainability phase. For example, although all sites improved in score use during the collaborative, sites participating in the sustainability season demonstrated significantly more improvement in these measures. Sites with a higher magnitude of improvement in collaborative measures might have more enthusiasm about the project, more commitment to the project activities, or feel a sense of obligation to respond to requests for additional data collection.

This work has several limitations. Selection bias may limit generalizability of the results, as sites that did not participate in the sustainability season may have had different results than those that did participate. It is unknown whether sites that regressed toward their baseline were deterred from participating in the sustainability season. The analyses that we were able to preform, however, suggest that the 2 groups were similar in their characteristics as well as in their baseline and improvement performance.

We have limited knowledge of the local improvement work that sites conducted between the completion of the collaborative and the sustainability season. Site-specific factors may have influenced improvement sustainability. For example, qualitative research with the original group found that team engagement had a quantitative association with better performance, but only for the bronchodilator use measure.²³ Sites were responsible for their own data collection, and despite attempts to centralize and standardize the process, data collection inconsistencies may have occurred. For instance, it is unknown how closely that orders for intermittent pulse oximetry correlate with intermittent use at the bedside. Lastly, the absence of a control group limits examination of the causal relationships of interventions and the influence of secular trends.

Improvements gained during the BQIP collaborative were sustained at 1 year following completion of the collaborative. These findings are encouraging, as national QI collaborative efforts are increasingly common. Our findings suggest that opportunities exist to even further reduce unnecessary care in the management of bronchiolitis. Such opportunities highlight the importance of integrating strategies to both measure sustainability and plan for ongoing independent local activities after completion of the collaborative. Future efforts should focus on supporting local sites to continue individual practice-improvement as they transition from collaborative to independent quality initiatives.

Acknowledgments

The authors thank the 21 hospitals that participated in the BQIP collaborative, and in particular the 9 hospital teams that contributed sustainability data for their ongoing dedication. There was no external funding for this manuscript.

Disclosure

The authors report no financial conflicts of interest.

Acute viral bronchiolitis is the most common cause of hospitalization for children less than 1 year of age.¹ Overuse of ineffective therapies has persisted despite the existence of the evidence-based American Academy of Pediatrics (AAP) clinical practice guideline (CPG), which recommends primarily supportive care.^2-8 Adherence to the AAP CPG recommendations for management of bronchiolitis improved significantly through the AAP’s Bronchiolitis Quality Improvement Project (BQIP), a 12-month, multiinstitutional collaborative of community and free-standing children’s hospitals.⁹ This subsequent study investigates if these improvements were sustained after completion of the formal 12-month project.

Published multiinstitutional bronchiolitis quality improvement (QI) work is limited to 1 study⁵ that describes the results of a single intervention season at academic medical centers. Multiyear bronchiolitis QI projects are limited to single-center studies, and results have been mixed.^5,6,8,10-13 One study¹¹ observed continued improvement in bronchodilator use in subsequent seasons, whereas a second study¹⁰ observed a return to baseline bronchodilator use in the following season. Mittal⁶ observed inconsistent improvements in key bronchiolitis measures during postintervention seasons.

Our specific aim was to assess the sustainability of improvements in bronchiolitis management at participating institutions 1 year following completion of the AAP BQIP collaborative.⁹ Because no studies demonstrate the most effective way to support long-term improvement through a QI collaborative, we hypothesized that the initial collaborative activities, which were designed to build the capacity of local interdisciplinary teams while providing standardized evidence-based care pathways, would lead to performance in the subsequent season at levels similar to or better than those observed during the active phase of the collaborative, without additional project interventions.

Study Design and Setting

This was a follow-up study of the AAP Quality Improvement Innovation Networks project entitled “A Quality Collaborative for Improving Hospital Compliance with the AAP Bronchiolitis Guideline” (BQIP).⁹ The AAP Institutional Review Board approved this project.

Twenty-one multidisciplinary, hospital-based teams participated in the BQIP collaborative and provided monthly data during the January through March bronchiolitis season. Teams submitted 2013 baseline data and 2014 intervention data. Nine sites provided 2015 sustainability data following the completion of the collaborative.

Participants

Hospital encounters with a primary diagnosis of acute viral bronchiolitis were eligible for inclusion among patients from 1 month to 2 years of age. Encounters were excluded for prematurity (<35 weeks gestational age), congenital heart disease, bronchopulmonary dysplasia, genetic, congenital or neuromuscular abnormalities, and pediatric intensive-care admission.

Data Collection

Hospital characteristics were collected, including hospital type (academic, community), bed size, location (urban, rural), hospital distributions of race/ethnicity and public payer, cases of bronchiolitis per year, presence of an electronic medical record and a pediatric respiratory therapist, and self-rated QI knowledge of the multidisciplinary team (very knowledgeable, knowledgeable, and somewhat knowledgeable). A trained member at each site collected data through structured chart review in baseline, intervention, and sustainability bronchiolitis seasons for January, February, and March. Site members reviewed the first 20 charts per month that met the inclusion criteria or all charts if there were fewer than 20 eligible encounters. Sites input data about key quality measures into the AAP’s Quality Improvement Data Aggregator, a web-based data repository.

Intervention

The BQIP project was designed as a virtual collaborative consisting of monthly education webinars about QI methods and bronchiolitis management, opportunities for collaboration via teleconference and e-mail listserv, and individual site-coaching by e-mail or telephone.⁹ A change package was shared with sites that included examples of evidence-based pathways, ordersets, a respiratory scoring tool, communication tools for parents and referring physicians, and slide sets for individual site education efforts. Following completion of the collaborative, written resources remained available to participants, although virtual collaboration ceased and no additional project interventions to promote sustainability were introduced.

Bronchiolitis Process and Outcome Measures

Process measures following admission included the following: severity assessment using a respiratory score, respiratory score use to assess response to bronchodilators, bronchodilator use, bronchodilator doses, steroid doses per patient encounter, chest radiographs per encounter, and presence of an order to transition to intermittent pulse oximetry monitoring. Outcome measures included length of stay and readmissions within 72 hours.

Analysis

Changes among baseline-, intervention-, and sustainability-season data were assessed using generalized linear mixed-effects models with random effect for study sites. Negative binomial models were used for count variables to allow for overdispersion. Length of stay was log-transformed to achieve a normal distribution. We also analyzed each site individually to assess whether sustained improvements were the result of broad sustainability across all sites or whether they represented an aggregation of some sites that continued to improve while other sites actually worsened.

To address any bias introduced by the voluntary and incomplete participation of sites in the sustainability season, we planned a priori to conduct 3 additional analyses. First, we compared the characteristics of sites that did participate in the sustainability season with those that did not participate by using Chi-squared tests for differences in proportions and t tests for differences in means. Second, we determined whether the baseline-season process and outcome measures were different between sites that did and did not participate using descriptive statistics. Third, we assessed whether improvements between the baseline and intervention seasons were different between sites that did and did not participate using a linear mixed-effects model for normally distributed outcomes and generalized linear mixed-effects model with site-specific random effects for nonnormally distributed outcomes. All study outcomes were summarized in terms of model-adjusted means along with the corresponding 95% confidence intervals. All P values are 2-sided, and P < 0.05 was used to define statistical significance. Data analyses were conducted using SAS software (SAS Institute Inc., Cary, North Carolina) version 9.4.

To our knowledge, this is the first report of sustained improvements in care achieved through a multiinstitutional QI collaborative of community and academic hospitals focused on bronchiolitis care. We found that overall sites participating in a national bronchiolitis QI project sustained improvements in key bronchiolitis quality measures for 1 year following the project’s completion. For the aggregate group no measures worsened, and one measure, orders for intermittent pulse oximetry monitoring, continued to increase during the sustainability season. Furthermore, the sustained improvements were primarily the result of consistent sustained performance of each individual site, as opposed to averages wherein some sites worsened while others improved (Appendix 1a). These findings suggest that designing a collaborative approach, which provides an evidence-based best-practice toolkit while building the QI capacity of local interdisciplinary teams, can support performance gains that persist beyond the project’s active phase.

There are a number of possible reasons why improvements were sustained following the collaborative. The BQIP requirement for institutional leadership buy-in may have motivated accountability to local leaders in subsequent bronchiolitis seasons at each site. We suspect that culture change such as flattened hierarchies through multidisciplinary teams,¹⁴ which empowered nurse and respiratory therapy staff, may have facilitated consistent use of tools created locally. The synergy of interdisciplinary teams composed of physician, nurse, and respiratory therapy champions may have created accountability to perpetuate the previous year’s efforts.¹⁵ In addition, the sites adopted elements of the evidence-based toolkit, such as pathways,^16,17 forcing function tools^13,18 and order sets that limited management decision options and bronchodilator use contingent on respiratory scores,^9,19 which may have driven desired behaviors.

Moreover, the 2014 AAP CPG for the management of bronchiolitis,²⁰ released prior to the sustainability bronchiolitis season, may have underscored the key concepts of the collaborative. Similarly, national exposure of best practices for bronchiolitis management, including the 3 widespread Choosing Wisely recommendations related to bronchiolitis,²¹ might have been a compelling reason for sites to maintain their improvement efforts and contribute to secular trends toward decreasing interventions in bronchiolitis management nationally.³ Lastly, the mechanisms developed for local data collection may have created opportunities at each site to conduct ongoing evaluation of performance on key bronchiolitis quality measures through data-driven feedback systems.²² Our study highlights the need for additional research in order to understand why improvements are or are not sustained.

Even with substantial, sustained improvements in this initiative, further reduction in unnecessary care may be possible. Findings from previous studies suggest that even multifaceted QI interventions, including provider education, guidelines and use of respiratory scores, may only modestly reduce bronchodilators, steroids, and chest radiograph use.^8,13 To achieve continued improvements in bronchiolitis care, additional active efforts may be needed to develop new interventions that target root causes for areas of overuse at individual sites.

Future multiinstitutional collaboratives might benefit their participants if they include a focus on helping sites develop skills to ensure that local improvement activities continue after the collaborative phases are completed. Proactively scheduling intermittent check-ins with collaborative members to discuss experiences with both sustainability and ongoing improvement may be valuable and likely needs to be incorporated into the initial collaborative planning.

As these sustainability data represent a subset of 9 of the original 21 BQIP sites, there is concern for potential selection bias related to factors that could have motivated sites to participate in the sustainability season’s data collection and simultaneously influenced their performance. These concerns were mitigated to some extent through 3 specific analyses: finding limited differences in hospital characteristics, baseline performance in key bronchiolitis measures, and performance change from baseline to intervention seasons between sites that did and did not participate in the sustainability season.

Notably, sites that participated in the sustainability phase actually had lower baseline respiratory score use and fewer orders for intermittent pulse oximetry at baseline. Theoretically, if participation in the collaborative highlighted this disparity for these sites, it could have been a motivating factor for their continued participation and sustained performance across these measures. Similarly, sites that recognized their higher baseline performance through participation in the collaborative might have felt less motivation to participate in ongoing data collection during the sustainability season. Whether they might have also sustained, declined, or continued improving is not known. Additionally, the magnitude of improvement in the collaborative period might have also motivated ongoing participation during the sustainability phase. For example, although all sites improved in score use during the collaborative, sites participating in the sustainability season demonstrated significantly more improvement in these measures. Sites with a higher magnitude of improvement in collaborative measures might have more enthusiasm about the project, more commitment to the project activities, or feel a sense of obligation to respond to requests for additional data collection.

This work has several limitations. Selection bias may limit generalizability of the results, as sites that did not participate in the sustainability season may have had different results than those that did participate. It is unknown whether sites that regressed toward their baseline were deterred from participating in the sustainability season. The analyses that we were able to preform, however, suggest that the 2 groups were similar in their characteristics as well as in their baseline and improvement performance.

We have limited knowledge of the local improvement work that sites conducted between the completion of the collaborative and the sustainability season. Site-specific factors may have influenced improvement sustainability. For example, qualitative research with the original group found that team engagement had a quantitative association with better performance, but only for the bronchodilator use measure.²³ Sites were responsible for their own data collection, and despite attempts to centralize and standardize the process, data collection inconsistencies may have occurred. For instance, it is unknown how closely that orders for intermittent pulse oximetry correlate with intermittent use at the bedside. Lastly, the absence of a control group limits examination of the causal relationships of interventions and the influence of secular trends.

Improvements gained during the BQIP collaborative were sustained at 1 year following completion of the collaborative. These findings are encouraging, as national QI collaborative efforts are increasingly common. Our findings suggest that opportunities exist to even further reduce unnecessary care in the management of bronchiolitis. Such opportunities highlight the importance of integrating strategies to both measure sustainability and plan for ongoing independent local activities after completion of the collaborative. Future efforts should focus on supporting local sites to continue individual practice-improvement as they transition from collaborative to independent quality initiatives.

Acknowledgments

The authors thank the 21 hospitals that participated in the BQIP collaborative, and in particular the 9 hospital teams that contributed sustainability data for their ongoing dedication. There was no external funding for this manuscript.

Disclosure

The authors report no financial conflicts of interest.

A special concern since the institution of hospital readmission penalties¹ is the transitions in care of a patient from one care setting to another, often at hospital discharge. Burke et al.² proposed a framework for an ideal transition in care (ITC) to study and improve transitions from the hospital to home. The features in the ITC were identified based upon their inclusion in the interventions that improved discharge outcomes.^3-5 Inspired by the ITC and other patient risk tools,⁶ we identified 10 domains of transitional care needs ([TCN] specified below), which we define as patient-centered risk factors that should be addressed to foster a safe and effective transition in care.⁷

One particularly important risk factor in patient self-management at transition points is health literacy, a patient’s ability to obtain, understand, and use basic health information and services. Low health literacy affects approximately 26% to 36% of adults in the United States.^8,9 Health literacy is associated with many factors that may affect successful navigation of care transitions, including doctor-patient communication,^10,11 understanding of the medication regimen,¹² and self-management.^13-15 Research has also demonstrated an association between low health literacy and poor outcomes after hospital discharge, including medication errors,¹⁶ 30-day hospital readmission,¹⁷ and mortality.¹⁸ Transitional care initiatives have begun to incorporate health literacy into patient risk assessments⁶ and provide specific attention to low health literacy in interventions to reduce adverse drug events and readmission.^4,19 Training programs for medical students and nurses advise teaching skills in health literacy as part of fostering effective transitions in care.^20,21

Although low health literacy is generally recognized as a barrier to patient education and self-management, little is known about whether patients with low health literacy are more likely to have other risk factors that could further increase their risk for poor transitions in care. A better understanding of associated risks would inform and improve patient care. We hypothesized that TCNs are more common among patients with low health literacy, as compared with those with adequate health literacy. We also aimed to describe the relationship between low health literacy and specific TCNs in order to guide clinical care and future interventions.

Setting

The present study is a cross-sectional analysis of data from a quality improvement (QI) intervention that was performed at Vanderbilt University Medical Center, a tertiary care facility in Nashville, Tennessee. The QI intervention, My Health Team (MHT), was funded by the Centers for Medicare and Medicaid Services Innovation Award program. The overall MHT program included outpatient care coordination for chronic disease management as well as a transitional care program that was designed to reduce hospital readmission. The latter included an inpatient needs assessment (which provided data for the present analysis), inpatient intervention, and postdischarge phone follow-up. The MHT initiative was reviewed by the institutional review board (IRB), which deemed it a QI program and granted a waiver of informed consent. The present secondary data analysis was reviewed and approved by the IRB.

Sample

Patients were identified for inclusion in the MHT transitions of care program if the presenting problem for hospital admission was pneumonia, chronic obstructive pulmonary disease (COPD) exacerbation, or decompensated heart failure, as determined by the review of clinical documentation by nurse transition care coordinators (TCCs). Adults over the age of 18 years were eligible, though priority was given to patients aged 65 years or older. This study includes the first inpatient encounter between June 2013 and December 31, 2014, for patients having a completed needs assessment and documentation of health literacy data in the medical record.

Data Collection

TCN assessment was developed from published patient risk tools and the ITC framework.^2,6,22 The assessment has 10 domains composed of 49 individual items as follows: (1) caregiver support (caregiver support not sufficient for patient needs), (2) transportation (relies on public or others for transportation and misses medical care because of transportation), (3) health care utilization (no primary care physician, unplanned hospitalization in the last year, emergency department [ED] visit in the last 6 months, or home health services in the last 60 days), (4) high-risk medical comorbidities (malnutrition or body mass index <18.5, renal failure, chronic pain, diabetes, heart failure, COPD, or stroke), (5) medication management provider or caregiver concern (cannot provide medication list, >10 preadmission medications, high-risk medications [eg, insulin, warfarin], poor medication understanding, or adherence issue identified), (6) medical devices (vascular access, urinary catheter, wounds, or home supplemental oxygen), (7) functional status (weakness of extremities, limited extremity range of motion, difficulty with mobility, falls at home, or activities of daily living challenges), (8) mental health comorbidities (over the past month has felt down, depressed, or hopeless or over the past month has felt little interest or pleasure in doing things, high-risk alcohol use, or high-risk substance use), (9) communication (limited English proficiency or at risk for limited health literacy), and (10) financial resources (no health insurance, skips or rations medicines because of cost, misses medical care because of cost, or misses medical care because of job).

The 49 items of the TCN assessment were documented as being present or absent by nurse TCCs at the time patients were enrolled in the transitional care program, based on patient and family interview and chart review, and the items were later extracted for analysis. Patients were determined to have a domain-level need if they reported a need on any individual item within that domain, resulting in a binary score (any need present, absent) for each of the 10 TCN domains.

Health literacy was assessed by using the Brief Health Literacy Screen (BHLS), which is administered routinely by nurses at hospital intake and documented in the medical record, with completion rates of approximately 90%.²³ The BHLS is a 3-question subjective health literacy assessment (scoring range 3-15) that has been validated against longer objective measures²⁴ and shown to predict disease control and mortality.^18,25 To improve the stability of scores (for patients who completed the BHLS more than once because of repeat hospitalizations) and to reduce missing values, we calculated the patient’s mean BHLS score for assessments obtained between January 1, 2013, and December 31, 2014. Patients were then categorized as having inadequate health literacy (BHLS ≤ 9) or adequate health literacy (BHLS > 9).^18,25 Demographic information was extracted from patient records and included age, sex (male/female), marital status (married/without a partner), race (white/nonwhite), and years of education. Income level and primary language were not available for analysis.

Statistical Analysis

Patient characteristics and TCNs were summarized by using the frequency and percentages for categorical variables and the mean and standard deviation (SD) for continuous variables. We compared patient characteristics (age, sex, marital status, race, and education) between health literacy groups (inadequate vs adequate) by using χ² or analysis of variance as appropriate. We assessed Pearson correlations among the 10 TCN domains, and we examined differences in reported needs for each of 10 TCN domains by the level of health literacy by using the χ² test. Because the TCN domain of communication included low health literacy as one of its items, we excluded this domain from subsequent analyses. We then compared differences in the number of TCNs documented (scoring range 0-9) by using an independent samples Student t test.

Multivariate logistic regression models were then constructed to examine the independent association of inadequate health literacy with 8 TCN domains while controlling for age, sex, marital status, race, and education. Patients with incomplete demographic data were excluded from these models. Additionally, these analyses excluded 2 TCN domains: the communication domain for reasons noted above and the high-risk medical comorbidity domain because it ended up being positive in 98.4% of patients. Statistical significance was set at an alpha of 0.05. All analyses were performed by using SPSS Statistics for Mac, version 23.0 (IBM Corp., Armonk, New York)

A structured patient risk factor assessment derived from literature was used to record TCNs in preparation for hospital discharge. On average, patients had needs in about half of the TCN domains (4.6 of 9). The most common areas identified were related to the presence of high-risk comorbidities (98.4%), frequent or prior healthcare utilization (76.6%), medication management (76.3%), functional status (54.9%), and transportation (48.7%). Many of the TCNs were significantly correlated with one another. The prevalence of these needs highlights the importance of using a structured assessment to identify patient concerns so that they may be addressed through discharge planning and follow-up. In addition, using a standardized TCN instrument based on a framework for ITC promotes further research in understanding patient needs and in developing personalized interventions to address them.

As hypothesized, we found that TCNs were more common in patients with inadequate health literacy. After adjustment for demographic factors, inadequate health literacy was significantly associated with transportation barriers and inadequate caregiver support. Analyses also suggested a relationship with needs related to medical devices, functional status, and mental health comorbidities. A review of the literature substantiates a link between inadequate health literacy and these needs and also suggests solutions to address these barriers.

The association with inadequate caregiver support is concerning because there is often a high degree of reliance on caregivers at transitions in care.^3-5 Caregivers are routinely called upon to provide assistance with activities that may be difficult for patients with low health literacy, including medication adherence, provider communication, and self-care activities.^26,27 Our finding that patients with inadequate health literacy are more likely to have inadequate caregiver support indicates additional vulnerability. This may be because of the absence of a caregiver, or in many cases, the presence of a caregiver who is underprepared to assist with care. Prior research has shown that when caregivers are present, up to 33% have low health literacy, even when they are paid nonfamilial caregivers.^26,28 Other studies have noted the inadequacy of information and patient training for caregivers.^29,30 Transitional care programs to improve caregiver understanding have been developed³¹ and have been demonstrated to lower rehospitalization and ED visits.³²

Patients with inadequate health literacy were also more likely to have transportation barriers. Lack of transportation has been recorded as a factor in early hospital readmission in patients with chronic disease,³³ and it has been shown to have a negative effect on a variety of health outcomes.³⁴ A likely link between readmission and lack of transportation is poor follow-up care. Wheeler et al.³⁵ found that 59% of patients expected difficulty keeping postdischarge appointments because of transportation needs. Instead of expecting patients to navigate their own transportation, the Agency for Healthcare Research and Quality recommends identifying community resources for patients with low health literacy.³⁶

In this sample, inadequate health literacy also had near significant associations with TCNs in the use of medical devices, lower functional status, and mental health comorbidities. The use of a medical device, such as home oxygen, is a risk factor for readmission,³⁷ and early reports suggest that interventions, including education related to home oxygen use, can dramatically reduce these readmissions.³⁸ Lower functional capacity and faster functional decline are associated with inadequate health literacy,³⁹ which may have to do with the inability to appropriately utilize health resources.⁴⁰ If so, structured discharge planning could alleviate the known connection between functional impairment and hospital readmissions.⁴¹ A relationship between low health literacy and depression has been demonstrated repeatedly,⁴² with worsened symptoms in those with addiction.⁴³ As has been shown in other domains where health literacy is a factor, literacy-focused interventions provide greater benefits to these depressed patients.⁴⁴

The TCN assessment worked well overall, but certain domains proved less valuable and could be removed in the future. First, it was not useful to separately identify communication barriers, because doing so did not add to information beyond the measurement of health literacy. Second, high-risk comorbidities were ubiquitous within the sample and therefore unhelpful for group comparisons. In hindsight, this is unsurprising because the sample was comprised primarily of elderly patients admitted to medical services. Still, in a younger population or a surgical setting, identifying patients with high-risk medical comorbidities may be more useful.

We acknowledge several limitations of this study. First, the study was performed at a single center, and the TCN assessments were conducted by a small number of registered nurses who received training. Therefore, the results may not generalize to the profile of patient needs at other settings, and the instrument may perform differently when scaled across an organization. Second, the needs assessment was developed for this QI initiative and did not undergo formal validation, although it was developed from published frameworks and similar assessments. Third, for the measure of health literacy, we relied on data collected by nurses as part of their normal workflow. As is often the case with data collected during routine care, the scores are imperfect,⁴⁵ but they have proven to be a valuable and valid indicator of health literacy in our previous research.^18,24,25,46 Fourth, we chose to declare a domain as positive if any item in that domain was positive and to perform a domain-level analysis (for greater clarity). We did not take into account the variable number of items within each domain or attempt to grade their severity, as this would be a subjective exercise and impractical in the discharge planning process. Finally, we were unable to address associations among socioeconomic status,⁴⁷ primary language,⁴⁸ and health literacy, because relevant data were not available for this analysis.

In this sample of hospitalized patients who were administered a structured needs assessment, patients commonly had needs that placed them at a higher risk of adverse outcomes, such as hospital readmission. Patients with low health literacy had more TCNs that extended beyond the areas that we normally associate with low health literacy, namely patient education and self-management. Healthcare professionals should be aware of the greater likelihood of transportation barriers and inadequate caregiver support among patients with low health literacy. Screening for health literacy and TCN at admission or as part of the discharge planning process will elevate such risks, better positioning clinicians and hospitals to address them as a part of the efforts to ensure a quality transition of care.

Disclosure 

This work was funded by the Centers for Medicare and Medicaid Services (1C1CMS330979) and in part by the National Center for Advancing Translational Sciences (2 UL1 TR000445-06). The content is solely the responsibility of the authors and does not necessarily represent official views of the funding agencies, which did not participate in the planning, collection, analysis, or interpretation of data or in the decision to submit for publication.

Dr. Dittus reports personal fees as a board member of the Robert Wood Johnson Foundation Medical Faculty Scholars Program National Advisory Committee; consultancy fees from the University of Virginia, Indiana University, University of Michigan, Northwestern University, Montana State University, and Purdue University; has grants/grants pending from NIH (research grants), PCORI (research grant), CME (innovation award), VA (training grant); payment for lectures including service on speakers bureaus from Corporate Parity (conference organizer) for the Global Hospital Management & Innovation Summit; and other from Medical Decision Making, Inc. (passive owner); all outside the submitted work. Dr. Kripalani has grants from NIH (research grant), PCORI (research grant), and CMS (QI grant); outside the submitted work. All other authors have nothing to disclose.

A special concern since the institution of hospital readmission penalties¹ is the transitions in care of a patient from one care setting to another, often at hospital discharge. Burke et al.² proposed a framework for an ideal transition in care (ITC) to study and improve transitions from the hospital to home. The features in the ITC were identified based upon their inclusion in the interventions that improved discharge outcomes.^3-5 Inspired by the ITC and other patient risk tools,⁶ we identified 10 domains of transitional care needs ([TCN] specified below), which we define as patient-centered risk factors that should be addressed to foster a safe and effective transition in care.⁷

One particularly important risk factor in patient self-management at transition points is health literacy, a patient’s ability to obtain, understand, and use basic health information and services. Low health literacy affects approximately 26% to 36% of adults in the United States.^8,9 Health literacy is associated with many factors that may affect successful navigation of care transitions, including doctor-patient communication,^10,11 understanding of the medication regimen,¹² and self-management.^13-15 Research has also demonstrated an association between low health literacy and poor outcomes after hospital discharge, including medication errors,¹⁶ 30-day hospital readmission,¹⁷ and mortality.¹⁸ Transitional care initiatives have begun to incorporate health literacy into patient risk assessments⁶ and provide specific attention to low health literacy in interventions to reduce adverse drug events and readmission.^4,19 Training programs for medical students and nurses advise teaching skills in health literacy as part of fostering effective transitions in care.^20,21

Although low health literacy is generally recognized as a barrier to patient education and self-management, little is known about whether patients with low health literacy are more likely to have other risk factors that could further increase their risk for poor transitions in care. A better understanding of associated risks would inform and improve patient care. We hypothesized that TCNs are more common among patients with low health literacy, as compared with those with adequate health literacy. We also aimed to describe the relationship between low health literacy and specific TCNs in order to guide clinical care and future interventions.

Setting

The present study is a cross-sectional analysis of data from a quality improvement (QI) intervention that was performed at Vanderbilt University Medical Center, a tertiary care facility in Nashville, Tennessee. The QI intervention, My Health Team (MHT), was funded by the Centers for Medicare and Medicaid Services Innovation Award program. The overall MHT program included outpatient care coordination for chronic disease management as well as a transitional care program that was designed to reduce hospital readmission. The latter included an inpatient needs assessment (which provided data for the present analysis), inpatient intervention, and postdischarge phone follow-up. The MHT initiative was reviewed by the institutional review board (IRB), which deemed it a QI program and granted a waiver of informed consent. The present secondary data analysis was reviewed and approved by the IRB.

Sample

Patients were identified for inclusion in the MHT transitions of care program if the presenting problem for hospital admission was pneumonia, chronic obstructive pulmonary disease (COPD) exacerbation, or decompensated heart failure, as determined by the review of clinical documentation by nurse transition care coordinators (TCCs). Adults over the age of 18 years were eligible, though priority was given to patients aged 65 years or older. This study includes the first inpatient encounter between June 2013 and December 31, 2014, for patients having a completed needs assessment and documentation of health literacy data in the medical record.

Data Collection

TCN assessment was developed from published patient risk tools and the ITC framework.^2,6,22 The assessment has 10 domains composed of 49 individual items as follows: (1) caregiver support (caregiver support not sufficient for patient needs), (2) transportation (relies on public or others for transportation and misses medical care because of transportation), (3) health care utilization (no primary care physician, unplanned hospitalization in the last year, emergency department [ED] visit in the last 6 months, or home health services in the last 60 days), (4) high-risk medical comorbidities (malnutrition or body mass index <18.5, renal failure, chronic pain, diabetes, heart failure, COPD, or stroke), (5) medication management provider or caregiver concern (cannot provide medication list, >10 preadmission medications, high-risk medications [eg, insulin, warfarin], poor medication understanding, or adherence issue identified), (6) medical devices (vascular access, urinary catheter, wounds, or home supplemental oxygen), (7) functional status (weakness of extremities, limited extremity range of motion, difficulty with mobility, falls at home, or activities of daily living challenges), (8) mental health comorbidities (over the past month has felt down, depressed, or hopeless or over the past month has felt little interest or pleasure in doing things, high-risk alcohol use, or high-risk substance use), (9) communication (limited English proficiency or at risk for limited health literacy), and (10) financial resources (no health insurance, skips or rations medicines because of cost, misses medical care because of cost, or misses medical care because of job).

The 49 items of the TCN assessment were documented as being present or absent by nurse TCCs at the time patients were enrolled in the transitional care program, based on patient and family interview and chart review, and the items were later extracted for analysis. Patients were determined to have a domain-level need if they reported a need on any individual item within that domain, resulting in a binary score (any need present, absent) for each of the 10 TCN domains.

Health literacy was assessed by using the Brief Health Literacy Screen (BHLS), which is administered routinely by nurses at hospital intake and documented in the medical record, with completion rates of approximately 90%.²³ The BHLS is a 3-question subjective health literacy assessment (scoring range 3-15) that has been validated against longer objective measures²⁴ and shown to predict disease control and mortality.^18,25 To improve the stability of scores (for patients who completed the BHLS more than once because of repeat hospitalizations) and to reduce missing values, we calculated the patient’s mean BHLS score for assessments obtained between January 1, 2013, and December 31, 2014. Patients were then categorized as having inadequate health literacy (BHLS ≤ 9) or adequate health literacy (BHLS > 9).^18,25 Demographic information was extracted from patient records and included age, sex (male/female), marital status (married/without a partner), race (white/nonwhite), and years of education. Income level and primary language were not available for analysis.

Statistical Analysis

Patient characteristics and TCNs were summarized by using the frequency and percentages for categorical variables and the mean and standard deviation (SD) for continuous variables. We compared patient characteristics (age, sex, marital status, race, and education) between health literacy groups (inadequate vs adequate) by using χ² or analysis of variance as appropriate. We assessed Pearson correlations among the 10 TCN domains, and we examined differences in reported needs for each of 10 TCN domains by the level of health literacy by using the χ² test. Because the TCN domain of communication included low health literacy as one of its items, we excluded this domain from subsequent analyses. We then compared differences in the number of TCNs documented (scoring range 0-9) by using an independent samples Student t test.

Multivariate logistic regression models were then constructed to examine the independent association of inadequate health literacy with 8 TCN domains while controlling for age, sex, marital status, race, and education. Patients with incomplete demographic data were excluded from these models. Additionally, these analyses excluded 2 TCN domains: the communication domain for reasons noted above and the high-risk medical comorbidity domain because it ended up being positive in 98.4% of patients. Statistical significance was set at an alpha of 0.05. All analyses were performed by using SPSS Statistics for Mac, version 23.0 (IBM Corp., Armonk, New York)

A structured patient risk factor assessment derived from literature was used to record TCNs in preparation for hospital discharge. On average, patients had needs in about half of the TCN domains (4.6 of 9). The most common areas identified were related to the presence of high-risk comorbidities (98.4%), frequent or prior healthcare utilization (76.6%), medication management (76.3%), functional status (54.9%), and transportation (48.7%). Many of the TCNs were significantly correlated with one another. The prevalence of these needs highlights the importance of using a structured assessment to identify patient concerns so that they may be addressed through discharge planning and follow-up. In addition, using a standardized TCN instrument based on a framework for ITC promotes further research in understanding patient needs and in developing personalized interventions to address them.

As hypothesized, we found that TCNs were more common in patients with inadequate health literacy. After adjustment for demographic factors, inadequate health literacy was significantly associated with transportation barriers and inadequate caregiver support. Analyses also suggested a relationship with needs related to medical devices, functional status, and mental health comorbidities. A review of the literature substantiates a link between inadequate health literacy and these needs and also suggests solutions to address these barriers.

The association with inadequate caregiver support is concerning because there is often a high degree of reliance on caregivers at transitions in care.^3-5 Caregivers are routinely called upon to provide assistance with activities that may be difficult for patients with low health literacy, including medication adherence, provider communication, and self-care activities.^26,27 Our finding that patients with inadequate health literacy are more likely to have inadequate caregiver support indicates additional vulnerability. This may be because of the absence of a caregiver, or in many cases, the presence of a caregiver who is underprepared to assist with care. Prior research has shown that when caregivers are present, up to 33% have low health literacy, even when they are paid nonfamilial caregivers.^26,28 Other studies have noted the inadequacy of information and patient training for caregivers.^29,30 Transitional care programs to improve caregiver understanding have been developed³¹ and have been demonstrated to lower rehospitalization and ED visits.³²

Patients with inadequate health literacy were also more likely to have transportation barriers. Lack of transportation has been recorded as a factor in early hospital readmission in patients with chronic disease,³³ and it has been shown to have a negative effect on a variety of health outcomes.³⁴ A likely link between readmission and lack of transportation is poor follow-up care. Wheeler et al.³⁵ found that 59% of patients expected difficulty keeping postdischarge appointments because of transportation needs. Instead of expecting patients to navigate their own transportation, the Agency for Healthcare Research and Quality recommends identifying community resources for patients with low health literacy.³⁶

In this sample, inadequate health literacy also had near significant associations with TCNs in the use of medical devices, lower functional status, and mental health comorbidities. The use of a medical device, such as home oxygen, is a risk factor for readmission,³⁷ and early reports suggest that interventions, including education related to home oxygen use, can dramatically reduce these readmissions.³⁸ Lower functional capacity and faster functional decline are associated with inadequate health literacy,³⁹ which may have to do with the inability to appropriately utilize health resources.⁴⁰ If so, structured discharge planning could alleviate the known connection between functional impairment and hospital readmissions.⁴¹ A relationship between low health literacy and depression has been demonstrated repeatedly,⁴² with worsened symptoms in those with addiction.⁴³ As has been shown in other domains where health literacy is a factor, literacy-focused interventions provide greater benefits to these depressed patients.⁴⁴

The TCN assessment worked well overall, but certain domains proved less valuable and could be removed in the future. First, it was not useful to separately identify communication barriers, because doing so did not add to information beyond the measurement of health literacy. Second, high-risk comorbidities were ubiquitous within the sample and therefore unhelpful for group comparisons. In hindsight, this is unsurprising because the sample was comprised primarily of elderly patients admitted to medical services. Still, in a younger population or a surgical setting, identifying patients with high-risk medical comorbidities may be more useful.

We acknowledge several limitations of this study. First, the study was performed at a single center, and the TCN assessments were conducted by a small number of registered nurses who received training. Therefore, the results may not generalize to the profile of patient needs at other settings, and the instrument may perform differently when scaled across an organization. Second, the needs assessment was developed for this QI initiative and did not undergo formal validation, although it was developed from published frameworks and similar assessments. Third, for the measure of health literacy, we relied on data collected by nurses as part of their normal workflow. As is often the case with data collected during routine care, the scores are imperfect,⁴⁵ but they have proven to be a valuable and valid indicator of health literacy in our previous research.^18,24,25,46 Fourth, we chose to declare a domain as positive if any item in that domain was positive and to perform a domain-level analysis (for greater clarity). We did not take into account the variable number of items within each domain or attempt to grade their severity, as this would be a subjective exercise and impractical in the discharge planning process. Finally, we were unable to address associations among socioeconomic status,⁴⁷ primary language,⁴⁸ and health literacy, because relevant data were not available for this analysis.

In this sample of hospitalized patients who were administered a structured needs assessment, patients commonly had needs that placed them at a higher risk of adverse outcomes, such as hospital readmission. Patients with low health literacy had more TCNs that extended beyond the areas that we normally associate with low health literacy, namely patient education and self-management. Healthcare professionals should be aware of the greater likelihood of transportation barriers and inadequate caregiver support among patients with low health literacy. Screening for health literacy and TCN at admission or as part of the discharge planning process will elevate such risks, better positioning clinicians and hospitals to address them as a part of the efforts to ensure a quality transition of care.

Disclosure 

This work was funded by the Centers for Medicare and Medicaid Services (1C1CMS330979) and in part by the National Center for Advancing Translational Sciences (2 UL1 TR000445-06). The content is solely the responsibility of the authors and does not necessarily represent official views of the funding agencies, which did not participate in the planning, collection, analysis, or interpretation of data or in the decision to submit for publication.

Dr. Dittus reports personal fees as a board member of the Robert Wood Johnson Foundation Medical Faculty Scholars Program National Advisory Committee; consultancy fees from the University of Virginia, Indiana University, University of Michigan, Northwestern University, Montana State University, and Purdue University; has grants/grants pending from NIH (research grants), PCORI (research grant), CME (innovation award), VA (training grant); payment for lectures including service on speakers bureaus from Corporate Parity (conference organizer) for the Global Hospital Management & Innovation Summit; and other from Medical Decision Making, Inc. (passive owner); all outside the submitted work. Dr. Kripalani has grants from NIH (research grant), PCORI (research grant), and CMS (QI grant); outside the submitted work. All other authors have nothing to disclose.

A special concern since the institution of hospital readmission penalties¹ is the transitions in care of a patient from one care setting to another, often at hospital discharge. Burke et al.² proposed a framework for an ideal transition in care (ITC) to study and improve transitions from the hospital to home. The features in the ITC were identified based upon their inclusion in the interventions that improved discharge outcomes.^3-5 Inspired by the ITC and other patient risk tools,⁶ we identified 10 domains of transitional care needs ([TCN] specified below), which we define as patient-centered risk factors that should be addressed to foster a safe and effective transition in care.⁷

One particularly important risk factor in patient self-management at transition points is health literacy, a patient’s ability to obtain, understand, and use basic health information and services. Low health literacy affects approximately 26% to 36% of adults in the United States.^8,9 Health literacy is associated with many factors that may affect successful navigation of care transitions, including doctor-patient communication,^10,11 understanding of the medication regimen,¹² and self-management.^13-15 Research has also demonstrated an association between low health literacy and poor outcomes after hospital discharge, including medication errors,¹⁶ 30-day hospital readmission,¹⁷ and mortality.¹⁸ Transitional care initiatives have begun to incorporate health literacy into patient risk assessments⁶ and provide specific attention to low health literacy in interventions to reduce adverse drug events and readmission.^4,19 Training programs for medical students and nurses advise teaching skills in health literacy as part of fostering effective transitions in care.^20,21

Although low health literacy is generally recognized as a barrier to patient education and self-management, little is known about whether patients with low health literacy are more likely to have other risk factors that could further increase their risk for poor transitions in care. A better understanding of associated risks would inform and improve patient care. We hypothesized that TCNs are more common among patients with low health literacy, as compared with those with adequate health literacy. We also aimed to describe the relationship between low health literacy and specific TCNs in order to guide clinical care and future interventions.

Setting

The present study is a cross-sectional analysis of data from a quality improvement (QI) intervention that was performed at Vanderbilt University Medical Center, a tertiary care facility in Nashville, Tennessee. The QI intervention, My Health Team (MHT), was funded by the Centers for Medicare and Medicaid Services Innovation Award program. The overall MHT program included outpatient care coordination for chronic disease management as well as a transitional care program that was designed to reduce hospital readmission. The latter included an inpatient needs assessment (which provided data for the present analysis), inpatient intervention, and postdischarge phone follow-up. The MHT initiative was reviewed by the institutional review board (IRB), which deemed it a QI program and granted a waiver of informed consent. The present secondary data analysis was reviewed and approved by the IRB.

Sample

Patients were identified for inclusion in the MHT transitions of care program if the presenting problem for hospital admission was pneumonia, chronic obstructive pulmonary disease (COPD) exacerbation, or decompensated heart failure, as determined by the review of clinical documentation by nurse transition care coordinators (TCCs). Adults over the age of 18 years were eligible, though priority was given to patients aged 65 years or older. This study includes the first inpatient encounter between June 2013 and December 31, 2014, for patients having a completed needs assessment and documentation of health literacy data in the medical record.

Data Collection

TCN assessment was developed from published patient risk tools and the ITC framework.^2,6,22 The assessment has 10 domains composed of 49 individual items as follows: (1) caregiver support (caregiver support not sufficient for patient needs), (2) transportation (relies on public or others for transportation and misses medical care because of transportation), (3) health care utilization (no primary care physician, unplanned hospitalization in the last year, emergency department [ED] visit in the last 6 months, or home health services in the last 60 days), (4) high-risk medical comorbidities (malnutrition or body mass index <18.5, renal failure, chronic pain, diabetes, heart failure, COPD, or stroke), (5) medication management provider or caregiver concern (cannot provide medication list, >10 preadmission medications, high-risk medications [eg, insulin, warfarin], poor medication understanding, or adherence issue identified), (6) medical devices (vascular access, urinary catheter, wounds, or home supplemental oxygen), (7) functional status (weakness of extremities, limited extremity range of motion, difficulty with mobility, falls at home, or activities of daily living challenges), (8) mental health comorbidities (over the past month has felt down, depressed, or hopeless or over the past month has felt little interest or pleasure in doing things, high-risk alcohol use, or high-risk substance use), (9) communication (limited English proficiency or at risk for limited health literacy), and (10) financial resources (no health insurance, skips or rations medicines because of cost, misses medical care because of cost, or misses medical care because of job).

The 49 items of the TCN assessment were documented as being present or absent by nurse TCCs at the time patients were enrolled in the transitional care program, based on patient and family interview and chart review, and the items were later extracted for analysis. Patients were determined to have a domain-level need if they reported a need on any individual item within that domain, resulting in a binary score (any need present, absent) for each of the 10 TCN domains.

Health literacy was assessed by using the Brief Health Literacy Screen (BHLS), which is administered routinely by nurses at hospital intake and documented in the medical record, with completion rates of approximately 90%.²³ The BHLS is a 3-question subjective health literacy assessment (scoring range 3-15) that has been validated against longer objective measures²⁴ and shown to predict disease control and mortality.^18,25 To improve the stability of scores (for patients who completed the BHLS more than once because of repeat hospitalizations) and to reduce missing values, we calculated the patient’s mean BHLS score for assessments obtained between January 1, 2013, and December 31, 2014. Patients were then categorized as having inadequate health literacy (BHLS ≤ 9) or adequate health literacy (BHLS > 9).^18,25 Demographic information was extracted from patient records and included age, sex (male/female), marital status (married/without a partner), race (white/nonwhite), and years of education. Income level and primary language were not available for analysis.

Statistical Analysis

Patient characteristics and TCNs were summarized by using the frequency and percentages for categorical variables and the mean and standard deviation (SD) for continuous variables. We compared patient characteristics (age, sex, marital status, race, and education) between health literacy groups (inadequate vs adequate) by using χ² or analysis of variance as appropriate. We assessed Pearson correlations among the 10 TCN domains, and we examined differences in reported needs for each of 10 TCN domains by the level of health literacy by using the χ² test. Because the TCN domain of communication included low health literacy as one of its items, we excluded this domain from subsequent analyses. We then compared differences in the number of TCNs documented (scoring range 0-9) by using an independent samples Student t test.

Multivariate logistic regression models were then constructed to examine the independent association of inadequate health literacy with 8 TCN domains while controlling for age, sex, marital status, race, and education. Patients with incomplete demographic data were excluded from these models. Additionally, these analyses excluded 2 TCN domains: the communication domain for reasons noted above and the high-risk medical comorbidity domain because it ended up being positive in 98.4% of patients. Statistical significance was set at an alpha of 0.05. All analyses were performed by using SPSS Statistics for Mac, version 23.0 (IBM Corp., Armonk, New York)

A structured patient risk factor assessment derived from literature was used to record TCNs in preparation for hospital discharge. On average, patients had needs in about half of the TCN domains (4.6 of 9). The most common areas identified were related to the presence of high-risk comorbidities (98.4%), frequent or prior healthcare utilization (76.6%), medication management (76.3%), functional status (54.9%), and transportation (48.7%). Many of the TCNs were significantly correlated with one another. The prevalence of these needs highlights the importance of using a structured assessment to identify patient concerns so that they may be addressed through discharge planning and follow-up. In addition, using a standardized TCN instrument based on a framework for ITC promotes further research in understanding patient needs and in developing personalized interventions to address them.

As hypothesized, we found that TCNs were more common in patients with inadequate health literacy. After adjustment for demographic factors, inadequate health literacy was significantly associated with transportation barriers and inadequate caregiver support. Analyses also suggested a relationship with needs related to medical devices, functional status, and mental health comorbidities. A review of the literature substantiates a link between inadequate health literacy and these needs and also suggests solutions to address these barriers.

The association with inadequate caregiver support is concerning because there is often a high degree of reliance on caregivers at transitions in care.^3-5 Caregivers are routinely called upon to provide assistance with activities that may be difficult for patients with low health literacy, including medication adherence, provider communication, and self-care activities.^26,27 Our finding that patients with inadequate health literacy are more likely to have inadequate caregiver support indicates additional vulnerability. This may be because of the absence of a caregiver, or in many cases, the presence of a caregiver who is underprepared to assist with care. Prior research has shown that when caregivers are present, up to 33% have low health literacy, even when they are paid nonfamilial caregivers.^26,28 Other studies have noted the inadequacy of information and patient training for caregivers.^29,30 Transitional care programs to improve caregiver understanding have been developed³¹ and have been demonstrated to lower rehospitalization and ED visits.³²

Patients with inadequate health literacy were also more likely to have transportation barriers. Lack of transportation has been recorded as a factor in early hospital readmission in patients with chronic disease,³³ and it has been shown to have a negative effect on a variety of health outcomes.³⁴ A likely link between readmission and lack of transportation is poor follow-up care. Wheeler et al.³⁵ found that 59% of patients expected difficulty keeping postdischarge appointments because of transportation needs. Instead of expecting patients to navigate their own transportation, the Agency for Healthcare Research and Quality recommends identifying community resources for patients with low health literacy.³⁶

In this sample, inadequate health literacy also had near significant associations with TCNs in the use of medical devices, lower functional status, and mental health comorbidities. The use of a medical device, such as home oxygen, is a risk factor for readmission,³⁷ and early reports suggest that interventions, including education related to home oxygen use, can dramatically reduce these readmissions.³⁸ Lower functional capacity and faster functional decline are associated with inadequate health literacy,³⁹ which may have to do with the inability to appropriately utilize health resources.⁴⁰ If so, structured discharge planning could alleviate the known connection between functional impairment and hospital readmissions.⁴¹ A relationship between low health literacy and depression has been demonstrated repeatedly,⁴² with worsened symptoms in those with addiction.⁴³ As has been shown in other domains where health literacy is a factor, literacy-focused interventions provide greater benefits to these depressed patients.⁴⁴

The TCN assessment worked well overall, but certain domains proved less valuable and could be removed in the future. First, it was not useful to separately identify communication barriers, because doing so did not add to information beyond the measurement of health literacy. Second, high-risk comorbidities were ubiquitous within the sample and therefore unhelpful for group comparisons. In hindsight, this is unsurprising because the sample was comprised primarily of elderly patients admitted to medical services. Still, in a younger population or a surgical setting, identifying patients with high-risk medical comorbidities may be more useful.

We acknowledge several limitations of this study. First, the study was performed at a single center, and the TCN assessments were conducted by a small number of registered nurses who received training. Therefore, the results may not generalize to the profile of patient needs at other settings, and the instrument may perform differently when scaled across an organization. Second, the needs assessment was developed for this QI initiative and did not undergo formal validation, although it was developed from published frameworks and similar assessments. Third, for the measure of health literacy, we relied on data collected by nurses as part of their normal workflow. As is often the case with data collected during routine care, the scores are imperfect,⁴⁵ but they have proven to be a valuable and valid indicator of health literacy in our previous research.^18,24,25,46 Fourth, we chose to declare a domain as positive if any item in that domain was positive and to perform a domain-level analysis (for greater clarity). We did not take into account the variable number of items within each domain or attempt to grade their severity, as this would be a subjective exercise and impractical in the discharge planning process. Finally, we were unable to address associations among socioeconomic status,⁴⁷ primary language,⁴⁸ and health literacy, because relevant data were not available for this analysis.

In this sample of hospitalized patients who were administered a structured needs assessment, patients commonly had needs that placed them at a higher risk of adverse outcomes, such as hospital readmission. Patients with low health literacy had more TCNs that extended beyond the areas that we normally associate with low health literacy, namely patient education and self-management. Healthcare professionals should be aware of the greater likelihood of transportation barriers and inadequate caregiver support among patients with low health literacy. Screening for health literacy and TCN at admission or as part of the discharge planning process will elevate such risks, better positioning clinicians and hospitals to address them as a part of the efforts to ensure a quality transition of care.

Disclosure 

This work was funded by the Centers for Medicare and Medicaid Services (1C1CMS330979) and in part by the National Center for Advancing Translational Sciences (2 UL1 TR000445-06). The content is solely the responsibility of the authors and does not necessarily represent official views of the funding agencies, which did not participate in the planning, collection, analysis, or interpretation of data or in the decision to submit for publication.

Dr. Dittus reports personal fees as a board member of the Robert Wood Johnson Foundation Medical Faculty Scholars Program National Advisory Committee; consultancy fees from the University of Virginia, Indiana University, University of Michigan, Northwestern University, Montana State University, and Purdue University; has grants/grants pending from NIH (research grants), PCORI (research grant), CME (innovation award), VA (training grant); payment for lectures including service on speakers bureaus from Corporate Parity (conference organizer) for the Global Hospital Management & Innovation Summit; and other from Medical Decision Making, Inc. (passive owner); all outside the submitted work. Dr. Kripalani has grants from NIH (research grant), PCORI (research grant), and CMS (QI grant); outside the submitted work. All other authors have nothing to disclose.

When seniors are discharged from the hospital, many will require additional support and therapy to regain their independence and return safely home.^1,2 Most seniors do not understand what their support needs will entail or the differences between therapy choices.³ To complicate the issue, seniors are often incapacitated and unable to make discharge selections for themselves.

Consequently, discharge planners and social workers often explain options to family members and loved ones, who frequently feel overwhelmed.^4,5 While often balancing jobs, loved ones are divided between wanting to stay with the senior in the hospital and driving to area skilled nursing facilities (SNFs) for consideration. Discharges are delayed waiting for families to make visits and choose an SNF. Longer lengths of stay are detrimental to seniors due to the increased risks of infection, functional loss, and cognitive decline.⁶

Although seniors comprised only 12% of the US population in 2003,⁷ they accounted for one-third of all hospitalizations, over 13.2 million hospital stays.⁸ Hospital stays for seniors resulted in hospital charges totaling nearly $329 billion, or 43.6% of national hospital bills in 2003.⁷ Seniors are also high consumers of postacute care services. By 2050, the number of individuals using long-term care services in any setting (eg, at home, assisted living, or SNFs) will be close to 27 million.^9-11 With the knowledge that many seniors will be hospitalized and subsequently require services thereafter, we sought to assist seniors in planning for their hospital discharge needs before they were hospitalized.

Our team developed PlanYourLifespan.org (PYL) to facilitate this planning for postdischarge needs and fill the knowledge gap in understanding postdischarge options. With funding from the Patient Centered Outcomes Research Institute, we aimed to test the effectiveness of PYL on improving knowledge of hospital discharge resources among seniors.

PlanYourLifespan.org

PlanYourLifespan.org (PYL) educates users on the health crises that often occur with age and connects them to posthospital and home-based resources available locally and nationally. PYL is personalized, dynamic, and adaptable in that all the information can be changed per the senior’s wishes or changing health needs.

Content of PYL

Previously, we conducted focus groups with seniors about current and perceived home needs and aging-in-place. Major themes of what advanced life events (ALEs) would impact aging-in-place were identified as follows: hospitalizations, falls, and Alzheimer’s.¹² We organized PYL around these health-related ALEs. Our multidisciplinary team of researchers, seniors, social workers, caregiver agencies, and Area Agencies on Aging representatives then determined what information and resources should be included.

Each section of PYL starts with a video of a senior discussing their real-life personal experiences, with subsections providing interactive information on what seniors can expect, types of resources available to support home needs, and choices to be made. Descriptions of types of settings for therapy, options available, and links to national/local resources (eg, quality indicators for SNFs) are also included. For example, by entering their zip code, users can identify their neighborhood SNFs, closest Area Agency on Aging, and what home caregiver agencies exist in their area.

Users can save their preferences and revisit their choices at any time. To support communication between seniors and their loved ones, a summary of their choices can be printed or e-mailed to relevant parties. For example, a senior uses PYL and can e-mail these choices to family members, which can stimulate a conversation about future posthospital care expectations.

As inadequate health literacy and cognitive impairment are prevalent among seniors, PYL presents information understandable at all levels of health literacy and sensitive to cognitive load.⁹ There is simplified, large-font, no mouse scrolling and audio available for the visually impaired.

Study Design and Randomization

To test PYL, a 2-armed (attention control [AC] and PYL intervention), parallel, randomized controlled trial was conducted. Participants were randomly assigned to 1 of the 2 conditions via a pregenerated central randomization list using equal (1:1) allocation and random permuted block design to ensure relatively equal allocation throughout the study. The AC condition exposed participants to the National Institute on Aging-sponsored website, Go4Life.nia.nih.gov, an educational website on physical activity for seniors. This website has comparable design and layout to PYL but does not include information about advanced planning. The AC condition controlled for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.

The trial was conducted from October 2014 to September 2015 in Chicago, Illinois; Fort Wayne, Indiana; and Houston, Texas. Inclusion criteria were as follows: age 65 and older, English-speaking, scoring ≥4 questions correctly on the Brief Cognitive Screen,¹⁴ and current self-reported use of a computer or smartphone with internet. Participants were excluded if they had previously participated in the focus groups or beta testing of the PYL website. Community-based patient partners/stakeholders drove subject recruitment in their communities through word of mouth, e-mail bursts, newsletters, and flyers. At the Area Agency on Aging and community centers where services such as food vouchers and case management are provided, participants were recruited on-site and given study information. At the clinical sites, staff referred potential participants. Study materials such as flyers and information sheets were also located in the clinic waiting rooms. The Villages, nonprofit, grassroots, membership organizations that are redefining aging by being a key resource to community members wishing to age in place, heavily relied on electronic recruitment using their regular e-newsletters and e-mail lists to recruit potential participants. Potential subjects were also recruited by distributing flyers at local senior centers and senior housing buildings. Interested seniors contacted research staff who explained the study and assessed their eligibility. If eligible, subjects were scheduled for a face-to-face interview.

At the face-to-face encounter, all study subjects completed a written consent, answered baseline questions, and were randomized to either arm. Next, research staff introduced all study subjects to the website to which they were randomized and provided instructions on its use. Staff were present to assist with questions as needed on navigation but did not assist with decision making for either website. A minimum of 15 minutes and a maximum of 45 minutes was allotted for navigating either website. After navigating their website, participants were administered an immediate in-person posttest survey. One month and 3 months after the face-to-face encounter, research staff contacted all study participants over the phone to complete a follow-up survey. Staff attempted to reach participants up to 3 times by phone. Data were entered into Research Electronic Data Capture survey software.¹⁵ This study was approved by the Northwestern University Institutional Review Board.

Understanding of Posthospital Discharge and Home Services

As part of the larger trial, which included behavioural outcomes that will be reported elsewhere, we sought to explore the effects of PYL on participants’ knowledge and understanding of posthospital discharge and home services (UHS). Participants were asked to respond to 6 questions at baseline, immediate posttest, and at the 1- and 3-month follow-up time points. Knowledge items were developed by the study team in conjunction with the patient/partner stakeholders. UHS scores were calculated as the sum of the 6 questions (each scored 0 if incorrect and 1 if correct) with a possible range of 0-6.

Covariates

Demographic information, self-reported health, importance of religion, and existence of a power of attorney, living will, advanced directive (eg, Physician Orders for Life-Sustaining Treatment) were obtained via self-report. Participants were asked about their general and social self-efficacy using the validated Self-efficacy Scale¹⁶ and their social support using the Lubben Social Network Scale–6.¹⁷ Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine–Short Form.¹⁸ To measure burden of disease, participant comorbidities were measured using a nonvalidated 9-item dichotomous response condition list, which included some items adapted from the Charlson Comorbidity Index and the Elixhauser Comorbidity Index.

Statistical Analysis

Data analysis included all available data in the intention-to-treat dataset. As UHS was collected at multiple time points up to 3 months postintervention, we employed linear- mixed modeling with random participant effect and fixed arm, time, and time-by-arm interaction terms. The time-by-arm interaction allows for comparison of UHS slopes (or trajectories) across arms. Analyses explored multiple potential covariates, including current utilization of services, physical function, comorbidities, social support, health literacy, self-efficacy, and sociodemographics. Those covariates found to have a significant association (P < 0.05) with outcome were considered for inclusion in the overall model selection process. Ultimately, we developed a final parsimonious, adjusted longitudinal model with primary predictors of time, arm, and their interaction, controlling for only significant baseline variables following a manual backward selection method. All analyses were conducted in SAS software (version 9.4, copyright 2012, The SAS Institute Inc., Cary, North Carolina).

The results of our study show that among seniors, PYL improved their understanding of home-based services and the services that may be required following a hospitalization. Educating seniors about what to expect regarding the transition home from a hospital before a hospitalization even occurs may enable seniors and their families to plan ahead instead of reacting to a hospitalization. PYL, a national, publicly available tool with links to local resources may potentially help in advancing transitional discharge care to prior to a hospitalization.

To our knowledge, this is one of the first websites and trials devoted to planning for seniors’ health trajectory as they age into their 70s, 80s, 90s, and 100s. Clinicians regularly discuss code status and powers of attorney during their end-of-life discussions with patients. We encourage clinicians to ask patients, “What about the 10 to 20 years before you die? Have you considered what you will do if you get sick or need help at home?” While not replacing a social worker, the ability of PYL to connect seniors to local resources makes it somewhat of a “virtual social worker.” With many physician practices unable to afford social workers, PYL provides a free-of-charge means of connecting seniors to area resources.

Acknowledgments

This work was supported through a Patient-Centered Outcomes Research Institute Award (IH-12-11-4259). Dr. Lindquist and Dr. Ciolino had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Research reported in this publication was also supported, in part, by the National Institutes of Health’s National Center for Advancing Translational Sciences, Grant Number UL1TR000150.

Disclaimer 

All statements in this manuscript, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its Board of Governors or Methodology Committee, or the National Institutes of Health.

Disclosure: The authors have nothing to report.

When seniors are discharged from the hospital, many will require additional support and therapy to regain their independence and return safely home.^1,2 Most seniors do not understand what their support needs will entail or the differences between therapy choices.³ To complicate the issue, seniors are often incapacitated and unable to make discharge selections for themselves.

Consequently, discharge planners and social workers often explain options to family members and loved ones, who frequently feel overwhelmed.^4,5 While often balancing jobs, loved ones are divided between wanting to stay with the senior in the hospital and driving to area skilled nursing facilities (SNFs) for consideration. Discharges are delayed waiting for families to make visits and choose an SNF. Longer lengths of stay are detrimental to seniors due to the increased risks of infection, functional loss, and cognitive decline.⁶

Although seniors comprised only 12% of the US population in 2003,⁷ they accounted for one-third of all hospitalizations, over 13.2 million hospital stays.⁸ Hospital stays for seniors resulted in hospital charges totaling nearly $329 billion, or 43.6% of national hospital bills in 2003.⁷ Seniors are also high consumers of postacute care services. By 2050, the number of individuals using long-term care services in any setting (eg, at home, assisted living, or SNFs) will be close to 27 million.^9-11 With the knowledge that many seniors will be hospitalized and subsequently require services thereafter, we sought to assist seniors in planning for their hospital discharge needs before they were hospitalized.

Our team developed PlanYourLifespan.org (PYL) to facilitate this planning for postdischarge needs and fill the knowledge gap in understanding postdischarge options. With funding from the Patient Centered Outcomes Research Institute, we aimed to test the effectiveness of PYL on improving knowledge of hospital discharge resources among seniors.

PlanYourLifespan.org

PlanYourLifespan.org (PYL) educates users on the health crises that often occur with age and connects them to posthospital and home-based resources available locally and nationally. PYL is personalized, dynamic, and adaptable in that all the information can be changed per the senior’s wishes or changing health needs.

Content of PYL

Previously, we conducted focus groups with seniors about current and perceived home needs and aging-in-place. Major themes of what advanced life events (ALEs) would impact aging-in-place were identified as follows: hospitalizations, falls, and Alzheimer’s.¹² We organized PYL around these health-related ALEs. Our multidisciplinary team of researchers, seniors, social workers, caregiver agencies, and Area Agencies on Aging representatives then determined what information and resources should be included.

Each section of PYL starts with a video of a senior discussing their real-life personal experiences, with subsections providing interactive information on what seniors can expect, types of resources available to support home needs, and choices to be made. Descriptions of types of settings for therapy, options available, and links to national/local resources (eg, quality indicators for SNFs) are also included. For example, by entering their zip code, users can identify their neighborhood SNFs, closest Area Agency on Aging, and what home caregiver agencies exist in their area.

Users can save their preferences and revisit their choices at any time. To support communication between seniors and their loved ones, a summary of their choices can be printed or e-mailed to relevant parties. For example, a senior uses PYL and can e-mail these choices to family members, which can stimulate a conversation about future posthospital care expectations.

As inadequate health literacy and cognitive impairment are prevalent among seniors, PYL presents information understandable at all levels of health literacy and sensitive to cognitive load.⁹ There is simplified, large-font, no mouse scrolling and audio available for the visually impaired.

Study Design and Randomization

To test PYL, a 2-armed (attention control [AC] and PYL intervention), parallel, randomized controlled trial was conducted. Participants were randomly assigned to 1 of the 2 conditions via a pregenerated central randomization list using equal (1:1) allocation and random permuted block design to ensure relatively equal allocation throughout the study. The AC condition exposed participants to the National Institute on Aging-sponsored website, Go4Life.nia.nih.gov, an educational website on physical activity for seniors. This website has comparable design and layout to PYL but does not include information about advanced planning. The AC condition controlled for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.

The trial was conducted from October 2014 to September 2015 in Chicago, Illinois; Fort Wayne, Indiana; and Houston, Texas. Inclusion criteria were as follows: age 65 and older, English-speaking, scoring ≥4 questions correctly on the Brief Cognitive Screen,¹⁴ and current self-reported use of a computer or smartphone with internet. Participants were excluded if they had previously participated in the focus groups or beta testing of the PYL website. Community-based patient partners/stakeholders drove subject recruitment in their communities through word of mouth, e-mail bursts, newsletters, and flyers. At the Area Agency on Aging and community centers where services such as food vouchers and case management are provided, participants were recruited on-site and given study information. At the clinical sites, staff referred potential participants. Study materials such as flyers and information sheets were also located in the clinic waiting rooms. The Villages, nonprofit, grassroots, membership organizations that are redefining aging by being a key resource to community members wishing to age in place, heavily relied on electronic recruitment using their regular e-newsletters and e-mail lists to recruit potential participants. Potential subjects were also recruited by distributing flyers at local senior centers and senior housing buildings. Interested seniors contacted research staff who explained the study and assessed their eligibility. If eligible, subjects were scheduled for a face-to-face interview.

At the face-to-face encounter, all study subjects completed a written consent, answered baseline questions, and were randomized to either arm. Next, research staff introduced all study subjects to the website to which they were randomized and provided instructions on its use. Staff were present to assist with questions as needed on navigation but did not assist with decision making for either website. A minimum of 15 minutes and a maximum of 45 minutes was allotted for navigating either website. After navigating their website, participants were administered an immediate in-person posttest survey. One month and 3 months after the face-to-face encounter, research staff contacted all study participants over the phone to complete a follow-up survey. Staff attempted to reach participants up to 3 times by phone. Data were entered into Research Electronic Data Capture survey software.¹⁵ This study was approved by the Northwestern University Institutional Review Board.

Understanding of Posthospital Discharge and Home Services

As part of the larger trial, which included behavioural outcomes that will be reported elsewhere, we sought to explore the effects of PYL on participants’ knowledge and understanding of posthospital discharge and home services (UHS). Participants were asked to respond to 6 questions at baseline, immediate posttest, and at the 1- and 3-month follow-up time points. Knowledge items were developed by the study team in conjunction with the patient/partner stakeholders. UHS scores were calculated as the sum of the 6 questions (each scored 0 if incorrect and 1 if correct) with a possible range of 0-6.

Covariates

Demographic information, self-reported health, importance of religion, and existence of a power of attorney, living will, advanced directive (eg, Physician Orders for Life-Sustaining Treatment) were obtained via self-report. Participants were asked about their general and social self-efficacy using the validated Self-efficacy Scale¹⁶ and their social support using the Lubben Social Network Scale–6.¹⁷ Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine–Short Form.¹⁸ To measure burden of disease, participant comorbidities were measured using a nonvalidated 9-item dichotomous response condition list, which included some items adapted from the Charlson Comorbidity Index and the Elixhauser Comorbidity Index.

Statistical Analysis

Data analysis included all available data in the intention-to-treat dataset. As UHS was collected at multiple time points up to 3 months postintervention, we employed linear- mixed modeling with random participant effect and fixed arm, time, and time-by-arm interaction terms. The time-by-arm interaction allows for comparison of UHS slopes (or trajectories) across arms. Analyses explored multiple potential covariates, including current utilization of services, physical function, comorbidities, social support, health literacy, self-efficacy, and sociodemographics. Those covariates found to have a significant association (P < 0.05) with outcome were considered for inclusion in the overall model selection process. Ultimately, we developed a final parsimonious, adjusted longitudinal model with primary predictors of time, arm, and their interaction, controlling for only significant baseline variables following a manual backward selection method. All analyses were conducted in SAS software (version 9.4, copyright 2012, The SAS Institute Inc., Cary, North Carolina).

The results of our study show that among seniors, PYL improved their understanding of home-based services and the services that may be required following a hospitalization. Educating seniors about what to expect regarding the transition home from a hospital before a hospitalization even occurs may enable seniors and their families to plan ahead instead of reacting to a hospitalization. PYL, a national, publicly available tool with links to local resources may potentially help in advancing transitional discharge care to prior to a hospitalization.

To our knowledge, this is one of the first websites and trials devoted to planning for seniors’ health trajectory as they age into their 70s, 80s, 90s, and 100s. Clinicians regularly discuss code status and powers of attorney during their end-of-life discussions with patients. We encourage clinicians to ask patients, “What about the 10 to 20 years before you die? Have you considered what you will do if you get sick or need help at home?” While not replacing a social worker, the ability of PYL to connect seniors to local resources makes it somewhat of a “virtual social worker.” With many physician practices unable to afford social workers, PYL provides a free-of-charge means of connecting seniors to area resources.

Acknowledgments

This work was supported through a Patient-Centered Outcomes Research Institute Award (IH-12-11-4259). Dr. Lindquist and Dr. Ciolino had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Research reported in this publication was also supported, in part, by the National Institutes of Health’s National Center for Advancing Translational Sciences, Grant Number UL1TR000150.

Disclaimer 

All statements in this manuscript, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its Board of Governors or Methodology Committee, or the National Institutes of Health.

Disclosure: The authors have nothing to report.

When seniors are discharged from the hospital, many will require additional support and therapy to regain their independence and return safely home.^1,2 Most seniors do not understand what their support needs will entail or the differences between therapy choices.³ To complicate the issue, seniors are often incapacitated and unable to make discharge selections for themselves.

Consequently, discharge planners and social workers often explain options to family members and loved ones, who frequently feel overwhelmed.^4,5 While often balancing jobs, loved ones are divided between wanting to stay with the senior in the hospital and driving to area skilled nursing facilities (SNFs) for consideration. Discharges are delayed waiting for families to make visits and choose an SNF. Longer lengths of stay are detrimental to seniors due to the increased risks of infection, functional loss, and cognitive decline.⁶

Although seniors comprised only 12% of the US population in 2003,⁷ they accounted for one-third of all hospitalizations, over 13.2 million hospital stays.⁸ Hospital stays for seniors resulted in hospital charges totaling nearly $329 billion, or 43.6% of national hospital bills in 2003.⁷ Seniors are also high consumers of postacute care services. By 2050, the number of individuals using long-term care services in any setting (eg, at home, assisted living, or SNFs) will be close to 27 million.^9-11 With the knowledge that many seniors will be hospitalized and subsequently require services thereafter, we sought to assist seniors in planning for their hospital discharge needs before they were hospitalized.

Our team developed PlanYourLifespan.org (PYL) to facilitate this planning for postdischarge needs and fill the knowledge gap in understanding postdischarge options. With funding from the Patient Centered Outcomes Research Institute, we aimed to test the effectiveness of PYL on improving knowledge of hospital discharge resources among seniors.

PlanYourLifespan.org

PlanYourLifespan.org (PYL) educates users on the health crises that often occur with age and connects them to posthospital and home-based resources available locally and nationally. PYL is personalized, dynamic, and adaptable in that all the information can be changed per the senior’s wishes or changing health needs.

Content of PYL

Previously, we conducted focus groups with seniors about current and perceived home needs and aging-in-place. Major themes of what advanced life events (ALEs) would impact aging-in-place were identified as follows: hospitalizations, falls, and Alzheimer’s.¹² We organized PYL around these health-related ALEs. Our multidisciplinary team of researchers, seniors, social workers, caregiver agencies, and Area Agencies on Aging representatives then determined what information and resources should be included.

Each section of PYL starts with a video of a senior discussing their real-life personal experiences, with subsections providing interactive information on what seniors can expect, types of resources available to support home needs, and choices to be made. Descriptions of types of settings for therapy, options available, and links to national/local resources (eg, quality indicators for SNFs) are also included. For example, by entering their zip code, users can identify their neighborhood SNFs, closest Area Agency on Aging, and what home caregiver agencies exist in their area.

Users can save their preferences and revisit their choices at any time. To support communication between seniors and their loved ones, a summary of their choices can be printed or e-mailed to relevant parties. For example, a senior uses PYL and can e-mail these choices to family members, which can stimulate a conversation about future posthospital care expectations.

As inadequate health literacy and cognitive impairment are prevalent among seniors, PYL presents information understandable at all levels of health literacy and sensitive to cognitive load.⁹ There is simplified, large-font, no mouse scrolling and audio available for the visually impaired.

Study Design and Randomization

To test PYL, a 2-armed (attention control [AC] and PYL intervention), parallel, randomized controlled trial was conducted. Participants were randomly assigned to 1 of the 2 conditions via a pregenerated central randomization list using equal (1:1) allocation and random permuted block design to ensure relatively equal allocation throughout the study. The AC condition exposed participants to the National Institute on Aging-sponsored website, Go4Life.nia.nih.gov, an educational website on physical activity for seniors. This website has comparable design and layout to PYL but does not include information about advanced planning. The AC condition controlled for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.

The trial was conducted from October 2014 to September 2015 in Chicago, Illinois; Fort Wayne, Indiana; and Houston, Texas. Inclusion criteria were as follows: age 65 and older, English-speaking, scoring ≥4 questions correctly on the Brief Cognitive Screen,¹⁴ and current self-reported use of a computer or smartphone with internet. Participants were excluded if they had previously participated in the focus groups or beta testing of the PYL website. Community-based patient partners/stakeholders drove subject recruitment in their communities through word of mouth, e-mail bursts, newsletters, and flyers. At the Area Agency on Aging and community centers where services such as food vouchers and case management are provided, participants were recruited on-site and given study information. At the clinical sites, staff referred potential participants. Study materials such as flyers and information sheets were also located in the clinic waiting rooms. The Villages, nonprofit, grassroots, membership organizations that are redefining aging by being a key resource to community members wishing to age in place, heavily relied on electronic recruitment using their regular e-newsletters and e-mail lists to recruit potential participants. Potential subjects were also recruited by distributing flyers at local senior centers and senior housing buildings. Interested seniors contacted research staff who explained the study and assessed their eligibility. If eligible, subjects were scheduled for a face-to-face interview.

At the face-to-face encounter, all study subjects completed a written consent, answered baseline questions, and were randomized to either arm. Next, research staff introduced all study subjects to the website to which they were randomized and provided instructions on its use. Staff were present to assist with questions as needed on navigation but did not assist with decision making for either website. A minimum of 15 minutes and a maximum of 45 minutes was allotted for navigating either website. After navigating their website, participants were administered an immediate in-person posttest survey. One month and 3 months after the face-to-face encounter, research staff contacted all study participants over the phone to complete a follow-up survey. Staff attempted to reach participants up to 3 times by phone. Data were entered into Research Electronic Data Capture survey software.¹⁵ This study was approved by the Northwestern University Institutional Review Board.

Understanding of Posthospital Discharge and Home Services

As part of the larger trial, which included behavioural outcomes that will be reported elsewhere, we sought to explore the effects of PYL on participants’ knowledge and understanding of posthospital discharge and home services (UHS). Participants were asked to respond to 6 questions at baseline, immediate posttest, and at the 1- and 3-month follow-up time points. Knowledge items were developed by the study team in conjunction with the patient/partner stakeholders. UHS scores were calculated as the sum of the 6 questions (each scored 0 if incorrect and 1 if correct) with a possible range of 0-6.

Covariates

Demographic information, self-reported health, importance of religion, and existence of a power of attorney, living will, advanced directive (eg, Physician Orders for Life-Sustaining Treatment) were obtained via self-report. Participants were asked about their general and social self-efficacy using the validated Self-efficacy Scale¹⁶ and their social support using the Lubben Social Network Scale–6.¹⁷ Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine–Short Form.¹⁸ To measure burden of disease, participant comorbidities were measured using a nonvalidated 9-item dichotomous response condition list, which included some items adapted from the Charlson Comorbidity Index and the Elixhauser Comorbidity Index.