PHM 2021 session

Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion

Presenter

Julie Silver, MD

Session summary

Gender inequity in medicine has been well documented and further highlighted by the tremendous impact of the COVID-19 pandemic on women in medicine. While more women than men are entering medical schools across the U.S., women still struggle to reach the highest levels of academic rank, achieve leadership positions of power and influence, receive fair equitable pay, attain leadership roles in national societies, and receive funding from national agencies. They also continue to face discrimination and implicit and explicit biases. Women of color or from other minority backgrounds face even greater barriers and biases. Despite being a specialty in which women represent almost 70% of the workforce, pediatrics is not immune to these disparities.

In her PHM21 plenary on Aug. 3, 2021, Dr. Julie Silver, a national expert in gender equity disparities, detailed the landscape for women in medicine and proposed some solutions to accelerate systemic change for gender equity. In order to understand and mitigate gender inequity, Dr. Silver encouraged the PHM community to identify influential “gatekeepers” of promotion, advancement, and salary compensation. In academic medicine medical schools, funding agencies, professional societies, and journals are the gatekeepers to advancement and compensation for women. Women are traditionally underrepresented as members and influential leaders of these gatekeeping organizations and in their recognition structures, therefore their advancement, compensation, and wellbeing are hindered.

Key takeaways

• Critical mass theory will not help alleviate gender inequity in medicine, as women make up a critical mass in pediatrics and are still experiencing stark inequities. Critical actor leaders are needed to highlight disparities and drive change even once a critical mass is reached.
• Our current diversity, equity, and inclusion (DEI) efforts are ineffective and are creating an “illusion of fairness that causes majority group members to become less sensitive to recognizing discrimination against minorities.” Many of the activities that are considered citizenship, including committees focused on DEI efforts, should be counted as scholarship, and appropriately compensated to ensure promotion of our women and minority colleagues.
• Male allies are critical to documenting, disseminating, and addressing gender inequality. Without the support of men in the field, we will see little progress.
• While there are numerous advocacy angles we can take when advocating for gender equity, the most effective will be the financial angle. Gender pay gaps at the start of a career can lead to roughly 2 million dollars of salary loss for a woman over the course of her career. In order to alleviate those salary pay gaps our institutions must not expect women to negotiate for fair pay, make salary benchmarks transparent, continue to monitor and conduct research on compensation disparities, and attempt to alleviate the weight of educational debt.
• COVID-19 is causing immense stress on women in medicine, and the impact could be disastrous. We must recognize and reward the “4th shift” women are working for COVID-19–related activities at home and at work, and put measures in place to #GiveHerAReasonToStay in health care.
• Men and other women leaders have a responsibility to sponsor the many and well-qualified women in medicine for awards, committees, and speaking engagements. These opportunities are key markers of success in academic medicine and are critical to advancement and salary compensation.

Dr. Casillas is the internal medicine-pediatric chief resident for the University of Cincinnati/Cincinnati Children’s Internal Medicine-Pediatric program. His career goal is to serve as a hospitalist for children and adults, and he is interested in health equity and Latinx health. Dr. O’Toole is a pediatric and adult hospitalist at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center, and a professor of pediatrics and internal medicine at the University of Cincinnati College of Medicine. She serves as program director of Cincinnati’s Combined Internal Medicine and Pediatrics Residency Program.

PHM 2021 session

Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion

Presenter

Julie Silver, MD

Session summary

Gender inequity in medicine has been well documented and further highlighted by the tremendous impact of the COVID-19 pandemic on women in medicine. While more women than men are entering medical schools across the U.S., women still struggle to reach the highest levels of academic rank, achieve leadership positions of power and influence, receive fair equitable pay, attain leadership roles in national societies, and receive funding from national agencies. They also continue to face discrimination and implicit and explicit biases. Women of color or from other minority backgrounds face even greater barriers and biases. Despite being a specialty in which women represent almost 70% of the workforce, pediatrics is not immune to these disparities.

In her PHM21 plenary on Aug. 3, 2021, Dr. Julie Silver, a national expert in gender equity disparities, detailed the landscape for women in medicine and proposed some solutions to accelerate systemic change for gender equity. In order to understand and mitigate gender inequity, Dr. Silver encouraged the PHM community to identify influential “gatekeepers” of promotion, advancement, and salary compensation. In academic medicine medical schools, funding agencies, professional societies, and journals are the gatekeepers to advancement and compensation for women. Women are traditionally underrepresented as members and influential leaders of these gatekeeping organizations and in their recognition structures, therefore their advancement, compensation, and wellbeing are hindered.

Key takeaways

• Critical mass theory will not help alleviate gender inequity in medicine, as women make up a critical mass in pediatrics and are still experiencing stark inequities. Critical actor leaders are needed to highlight disparities and drive change even once a critical mass is reached.
• Our current diversity, equity, and inclusion (DEI) efforts are ineffective and are creating an “illusion of fairness that causes majority group members to become less sensitive to recognizing discrimination against minorities.” Many of the activities that are considered citizenship, including committees focused on DEI efforts, should be counted as scholarship, and appropriately compensated to ensure promotion of our women and minority colleagues.
• Male allies are critical to documenting, disseminating, and addressing gender inequality. Without the support of men in the field, we will see little progress.
• While there are numerous advocacy angles we can take when advocating for gender equity, the most effective will be the financial angle. Gender pay gaps at the start of a career can lead to roughly 2 million dollars of salary loss for a woman over the course of her career. In order to alleviate those salary pay gaps our institutions must not expect women to negotiate for fair pay, make salary benchmarks transparent, continue to monitor and conduct research on compensation disparities, and attempt to alleviate the weight of educational debt.
• COVID-19 is causing immense stress on women in medicine, and the impact could be disastrous. We must recognize and reward the “4th shift” women are working for COVID-19–related activities at home and at work, and put measures in place to #GiveHerAReasonToStay in health care.
• Men and other women leaders have a responsibility to sponsor the many and well-qualified women in medicine for awards, committees, and speaking engagements. These opportunities are key markers of success in academic medicine and are critical to advancement and salary compensation.

Dr. Casillas is the internal medicine-pediatric chief resident for the University of Cincinnati/Cincinnati Children’s Internal Medicine-Pediatric program. His career goal is to serve as a hospitalist for children and adults, and he is interested in health equity and Latinx health. Dr. O’Toole is a pediatric and adult hospitalist at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center, and a professor of pediatrics and internal medicine at the University of Cincinnati College of Medicine. She serves as program director of Cincinnati’s Combined Internal Medicine and Pediatrics Residency Program.

PHM 2021 session

Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion

Presenter

Julie Silver, MD

Session summary

Gender inequity in medicine has been well documented and further highlighted by the tremendous impact of the COVID-19 pandemic on women in medicine. While more women than men are entering medical schools across the U.S., women still struggle to reach the highest levels of academic rank, achieve leadership positions of power and influence, receive fair equitable pay, attain leadership roles in national societies, and receive funding from national agencies. They also continue to face discrimination and implicit and explicit biases. Women of color or from other minority backgrounds face even greater barriers and biases. Despite being a specialty in which women represent almost 70% of the workforce, pediatrics is not immune to these disparities.

In her PHM21 plenary on Aug. 3, 2021, Dr. Julie Silver, a national expert in gender equity disparities, detailed the landscape for women in medicine and proposed some solutions to accelerate systemic change for gender equity. In order to understand and mitigate gender inequity, Dr. Silver encouraged the PHM community to identify influential “gatekeepers” of promotion, advancement, and salary compensation. In academic medicine medical schools, funding agencies, professional societies, and journals are the gatekeepers to advancement and compensation for women. Women are traditionally underrepresented as members and influential leaders of these gatekeeping organizations and in their recognition structures, therefore their advancement, compensation, and wellbeing are hindered.

Key takeaways

• Critical mass theory will not help alleviate gender inequity in medicine, as women make up a critical mass in pediatrics and are still experiencing stark inequities. Critical actor leaders are needed to highlight disparities and drive change even once a critical mass is reached.
• Our current diversity, equity, and inclusion (DEI) efforts are ineffective and are creating an “illusion of fairness that causes majority group members to become less sensitive to recognizing discrimination against minorities.” Many of the activities that are considered citizenship, including committees focused on DEI efforts, should be counted as scholarship, and appropriately compensated to ensure promotion of our women and minority colleagues.
• Male allies are critical to documenting, disseminating, and addressing gender inequality. Without the support of men in the field, we will see little progress.
• While there are numerous advocacy angles we can take when advocating for gender equity, the most effective will be the financial angle. Gender pay gaps at the start of a career can lead to roughly 2 million dollars of salary loss for a woman over the course of her career. In order to alleviate those salary pay gaps our institutions must not expect women to negotiate for fair pay, make salary benchmarks transparent, continue to monitor and conduct research on compensation disparities, and attempt to alleviate the weight of educational debt.
• COVID-19 is causing immense stress on women in medicine, and the impact could be disastrous. We must recognize and reward the “4th shift” women are working for COVID-19–related activities at home and at work, and put measures in place to #GiveHerAReasonToStay in health care.
• Men and other women leaders have a responsibility to sponsor the many and well-qualified women in medicine for awards, committees, and speaking engagements. These opportunities are key markers of success in academic medicine and are critical to advancement and salary compensation.

Dr. Casillas is the internal medicine-pediatric chief resident for the University of Cincinnati/Cincinnati Children’s Internal Medicine-Pediatric program. His career goal is to serve as a hospitalist for children and adults, and he is interested in health equity and Latinx health. Dr. O’Toole is a pediatric and adult hospitalist at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center, and a professor of pediatrics and internal medicine at the University of Cincinnati College of Medicine. She serves as program director of Cincinnati’s Combined Internal Medicine and Pediatrics Residency Program.

In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.

©daoleduc/ThinkStock.com

Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.
 

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.
 

Shared responsibility

According to the JAMA commentary, the SAFER guides were developed “to help health care organizations and EHR developers conduct voluntary self-assessments to help eliminate or minimize EHR-related safety risks and hazards.”

In response to a query from this news organization, ONC confirmed that the SAFER guides were intended for use by developers as well as practitioners. ONC said it supports CMS’s approach to incentivize collaborations between EHR vendors and health care organizations. It noted that some entities have already teamed up to the meet the SAFER guides’ recommendations.

Hospitals and EHR developers must share responsibility for safety, Dr. Sittig and Dr. Singh argue, because many SAFER recommendations are based on EHR features that have to be programmed by developers.

For example, one recommendation is that patient identification information be displayed on all portions of the EHR user interface, wristbands, and printouts. Hospitals can’t implement this feature if the developer hasn’t built it into its product.

Dr. Sittig and Dr. Singh suggest three strategies to complement CMS’s new regulation:

• Because in their view, ONC’s EHR certification criteria are insufficient to address many patient safety concerns, CMS should require EHR developers to assess their products annually.
• ONC should conduct annual reviews of the SAFER recommendations with input from EHR developers and safety experts.
• EHR vendors should disseminate guidance to their customers on how to address safety practices, perhaps including EHR configuration guides related to safety.

Safety in EHR certification

At a recent press conference that ONC held to update reporters on its current plans, officials were asked to comment on Dr. Sittig’s and Dr. Singh’s proposition that EHR developers, as well as hospitals, do more to ensure system safety.

Steve Posnack, deputy national coordinator of health IT, noted that the ONC-supervised certification process requires developers to pay attention to how they “implement and integrate safety practices in their software design. We have certification criteria ... around what’s called safety-enhanced design – specific capabilities in the EHR that are sensitive to safety in areas like e-prescribing, medication, and high-risk events, where you want to make sure there’s more attention paid to the safety-related dynamics.”

After the conference, ONC told this news organization that among the safety-related certification criteria is one on user-centered design, which must be used in programming certain EHR features. Another is on the use of a quality management system to guide the creation of each EHR capability.

Nevertheless, there is evidence that not all EHR developers have paid sufficient attention to safety in their products. This is shown in the corporate integrity agreements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) that developers eClinicalWorks and Greenway agreed to sign because, according to the government, they had not met all of the certification criteria they’d claimed to satisfy.

Under these agreements, the vendors agreed to follow “relevant standards, checklists, self-assessment tools, and other practices identified in the ONC SAFER guides and the ICE Report(s) to optimize the safety and safe use of EHRs” in a number of specific areas.

Even if all EHRs conformed to the certification requirements for safety, they would fall short of the SAFER recommendations, Dr. Sittig says. “Those certification criteria are pretty general and not as comprehensive as the SAFER guides. Some SAFER guide recommendations are in existing certification requirements, like you’re supposed to have drug-drug interaction checking capabilities, and they’re supposed to be on. But it doesn’t say you need to have the patient’s identification on every screen. It’s easy to assume good software design, development, and testing principles are a given, but our experience suggests otherwise.”
 

Configuration problems

A handful of vendors are working on what the JAMA article suggests, but there are about 1,000 EHR developers, Dr. Sittig notes. Moreover, there are configuration problems in the design of many EHRs, even if the products have the recommended features.

“For example, it’s often possible to meet the SAFER recommendations, but not all the vendors make that the default setting. That’s one of the things our paper says they should do,” Dr. Sittig says.

Conversely, some hospitals turn off certain features because they annoy doctors, he notes. For instance, the SAFER guides recommend that allergies, problem list entries, and diagnostic test results be entered and stored using standard, coded data elements in the EHR, but often the EHR makes it easier to enter free text data.

Default settings can be wiped out during system upgrades, he added. That has happened with drug interaction checkers. “If you don’t test the system after upgrades and reassess it annually, you might go several months without your drug-drug interaction checker on. And your doctors aren’t complaining about not getting alerts. Those kinds of mistakes are hard to catch.”

Some errors in an EHR may be caught fairly quickly, but in a health system that treats thousands of patients at any given time, those mistakes can still cause a lot of potential patient harm, Dr. Sittig points out. Some vendors, he says, are building tools to help health care organizations catch those errors through what is called “anomaly detection.” This is similar to what credit card companies do when they notice you’ve bought a carpet in Saudi Arabia, although you’ve never traveled abroad, he notes.

“You can look at alert firing data and notice that all of a sudden an alert fired 500 times today when it usually fires 10 times, or it stopped firing,” Dr. Sittig observes. “Those kinds of things should be built into all EHRs. That would be an excellent step forward.”

A version of this article first appeared on Medscape.com.

In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.

©daoleduc/ThinkStock.com

Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.
 

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.
 

Shared responsibility

According to the JAMA commentary, the SAFER guides were developed “to help health care organizations and EHR developers conduct voluntary self-assessments to help eliminate or minimize EHR-related safety risks and hazards.”

In response to a query from this news organization, ONC confirmed that the SAFER guides were intended for use by developers as well as practitioners. ONC said it supports CMS’s approach to incentivize collaborations between EHR vendors and health care organizations. It noted that some entities have already teamed up to the meet the SAFER guides’ recommendations.

Hospitals and EHR developers must share responsibility for safety, Dr. Sittig and Dr. Singh argue, because many SAFER recommendations are based on EHR features that have to be programmed by developers.

For example, one recommendation is that patient identification information be displayed on all portions of the EHR user interface, wristbands, and printouts. Hospitals can’t implement this feature if the developer hasn’t built it into its product.

Dr. Sittig and Dr. Singh suggest three strategies to complement CMS’s new regulation:

• Because in their view, ONC’s EHR certification criteria are insufficient to address many patient safety concerns, CMS should require EHR developers to assess their products annually.
• ONC should conduct annual reviews of the SAFER recommendations with input from EHR developers and safety experts.
• EHR vendors should disseminate guidance to their customers on how to address safety practices, perhaps including EHR configuration guides related to safety.

Safety in EHR certification

At a recent press conference that ONC held to update reporters on its current plans, officials were asked to comment on Dr. Sittig’s and Dr. Singh’s proposition that EHR developers, as well as hospitals, do more to ensure system safety.

Steve Posnack, deputy national coordinator of health IT, noted that the ONC-supervised certification process requires developers to pay attention to how they “implement and integrate safety practices in their software design. We have certification criteria ... around what’s called safety-enhanced design – specific capabilities in the EHR that are sensitive to safety in areas like e-prescribing, medication, and high-risk events, where you want to make sure there’s more attention paid to the safety-related dynamics.”

After the conference, ONC told this news organization that among the safety-related certification criteria is one on user-centered design, which must be used in programming certain EHR features. Another is on the use of a quality management system to guide the creation of each EHR capability.

Nevertheless, there is evidence that not all EHR developers have paid sufficient attention to safety in their products. This is shown in the corporate integrity agreements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) that developers eClinicalWorks and Greenway agreed to sign because, according to the government, they had not met all of the certification criteria they’d claimed to satisfy.

Under these agreements, the vendors agreed to follow “relevant standards, checklists, self-assessment tools, and other practices identified in the ONC SAFER guides and the ICE Report(s) to optimize the safety and safe use of EHRs” in a number of specific areas.

Even if all EHRs conformed to the certification requirements for safety, they would fall short of the SAFER recommendations, Dr. Sittig says. “Those certification criteria are pretty general and not as comprehensive as the SAFER guides. Some SAFER guide recommendations are in existing certification requirements, like you’re supposed to have drug-drug interaction checking capabilities, and they’re supposed to be on. But it doesn’t say you need to have the patient’s identification on every screen. It’s easy to assume good software design, development, and testing principles are a given, but our experience suggests otherwise.”
 

Configuration problems

A handful of vendors are working on what the JAMA article suggests, but there are about 1,000 EHR developers, Dr. Sittig notes. Moreover, there are configuration problems in the design of many EHRs, even if the products have the recommended features.

“For example, it’s often possible to meet the SAFER recommendations, but not all the vendors make that the default setting. That’s one of the things our paper says they should do,” Dr. Sittig says.

Conversely, some hospitals turn off certain features because they annoy doctors, he notes. For instance, the SAFER guides recommend that allergies, problem list entries, and diagnostic test results be entered and stored using standard, coded data elements in the EHR, but often the EHR makes it easier to enter free text data.

Default settings can be wiped out during system upgrades, he added. That has happened with drug interaction checkers. “If you don’t test the system after upgrades and reassess it annually, you might go several months without your drug-drug interaction checker on. And your doctors aren’t complaining about not getting alerts. Those kinds of mistakes are hard to catch.”

Some errors in an EHR may be caught fairly quickly, but in a health system that treats thousands of patients at any given time, those mistakes can still cause a lot of potential patient harm, Dr. Sittig points out. Some vendors, he says, are building tools to help health care organizations catch those errors through what is called “anomaly detection.” This is similar to what credit card companies do when they notice you’ve bought a carpet in Saudi Arabia, although you’ve never traveled abroad, he notes.

“You can look at alert firing data and notice that all of a sudden an alert fired 500 times today when it usually fires 10 times, or it stopped firing,” Dr. Sittig observes. “Those kinds of things should be built into all EHRs. That would be an excellent step forward.”

A version of this article first appeared on Medscape.com.

In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.

©daoleduc/ThinkStock.com

Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.
 

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.
 

Shared responsibility

According to the JAMA commentary, the SAFER guides were developed “to help health care organizations and EHR developers conduct voluntary self-assessments to help eliminate or minimize EHR-related safety risks and hazards.”

In response to a query from this news organization, ONC confirmed that the SAFER guides were intended for use by developers as well as practitioners. ONC said it supports CMS’s approach to incentivize collaborations between EHR vendors and health care organizations. It noted that some entities have already teamed up to the meet the SAFER guides’ recommendations.

Hospitals and EHR developers must share responsibility for safety, Dr. Sittig and Dr. Singh argue, because many SAFER recommendations are based on EHR features that have to be programmed by developers.

For example, one recommendation is that patient identification information be displayed on all portions of the EHR user interface, wristbands, and printouts. Hospitals can’t implement this feature if the developer hasn’t built it into its product.

Dr. Sittig and Dr. Singh suggest three strategies to complement CMS’s new regulation:

• Because in their view, ONC’s EHR certification criteria are insufficient to address many patient safety concerns, CMS should require EHR developers to assess their products annually.
• ONC should conduct annual reviews of the SAFER recommendations with input from EHR developers and safety experts.
• EHR vendors should disseminate guidance to their customers on how to address safety practices, perhaps including EHR configuration guides related to safety.

Safety in EHR certification

At a recent press conference that ONC held to update reporters on its current plans, officials were asked to comment on Dr. Sittig’s and Dr. Singh’s proposition that EHR developers, as well as hospitals, do more to ensure system safety.

Steve Posnack, deputy national coordinator of health IT, noted that the ONC-supervised certification process requires developers to pay attention to how they “implement and integrate safety practices in their software design. We have certification criteria ... around what’s called safety-enhanced design – specific capabilities in the EHR that are sensitive to safety in areas like e-prescribing, medication, and high-risk events, where you want to make sure there’s more attention paid to the safety-related dynamics.”

After the conference, ONC told this news organization that among the safety-related certification criteria is one on user-centered design, which must be used in programming certain EHR features. Another is on the use of a quality management system to guide the creation of each EHR capability.

Nevertheless, there is evidence that not all EHR developers have paid sufficient attention to safety in their products. This is shown in the corporate integrity agreements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) that developers eClinicalWorks and Greenway agreed to sign because, according to the government, they had not met all of the certification criteria they’d claimed to satisfy.

Under these agreements, the vendors agreed to follow “relevant standards, checklists, self-assessment tools, and other practices identified in the ONC SAFER guides and the ICE Report(s) to optimize the safety and safe use of EHRs” in a number of specific areas.

Even if all EHRs conformed to the certification requirements for safety, they would fall short of the SAFER recommendations, Dr. Sittig says. “Those certification criteria are pretty general and not as comprehensive as the SAFER guides. Some SAFER guide recommendations are in existing certification requirements, like you’re supposed to have drug-drug interaction checking capabilities, and they’re supposed to be on. But it doesn’t say you need to have the patient’s identification on every screen. It’s easy to assume good software design, development, and testing principles are a given, but our experience suggests otherwise.”
 

Configuration problems

A handful of vendors are working on what the JAMA article suggests, but there are about 1,000 EHR developers, Dr. Sittig notes. Moreover, there are configuration problems in the design of many EHRs, even if the products have the recommended features.

“For example, it’s often possible to meet the SAFER recommendations, but not all the vendors make that the default setting. That’s one of the things our paper says they should do,” Dr. Sittig says.

Conversely, some hospitals turn off certain features because they annoy doctors, he notes. For instance, the SAFER guides recommend that allergies, problem list entries, and diagnostic test results be entered and stored using standard, coded data elements in the EHR, but often the EHR makes it easier to enter free text data.

Default settings can be wiped out during system upgrades, he added. That has happened with drug interaction checkers. “If you don’t test the system after upgrades and reassess it annually, you might go several months without your drug-drug interaction checker on. And your doctors aren’t complaining about not getting alerts. Those kinds of mistakes are hard to catch.”

Some errors in an EHR may be caught fairly quickly, but in a health system that treats thousands of patients at any given time, those mistakes can still cause a lot of potential patient harm, Dr. Sittig points out. Some vendors, he says, are building tools to help health care organizations catch those errors through what is called “anomaly detection.” This is similar to what credit card companies do when they notice you’ve bought a carpet in Saudi Arabia, although you’ve never traveled abroad, he notes.

“You can look at alert firing data and notice that all of a sudden an alert fired 500 times today when it usually fires 10 times, or it stopped firing,” Dr. Sittig observes. “Those kinds of things should be built into all EHRs. That would be an excellent step forward.”

A version of this article first appeared on Medscape.com.

Another study has shown an association between antibiotic use and an increased risk for colon cancer.

The latest data come from a Swedish population study. Investigators analyzed data from more than 40,000 colorectal cancer patients and 200,000 cancer-free control persons.

Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0

They found that moderate use of antibiotics increased the risk for proximal colon cancer by 9% and that very high antibiotic use increased the risk by 17%.

In contrast, the risk for rectal cancer was reduced by 4% with moderate use and 9% with very high use, but this association was confined to women.

Antibiotic use was categorized as no use (no reported use of antibiotics during the study period), low (use during a period of 1-10 days), moderate (11-60 days), high (61-180 days), and very high (>180 days).

The study, led by Sophia Harlid, PhD, department of radiation sciences, oncology, Umeå University, Sweden, was published online on Sept. 1 in the Journal of the National Cancer Institute.

The results complement findings from a recent study from Scotland, which found that a history of antibiotic use among individuals younger than 50 appeared to increase the risk of developing colon cancer but not rectal cancer by 49%.

The new data from Sweden “strengthen prior evidence and provide new insights into site-specific carcinogenesis as well as indirect support for the role of gut microbiota,” lead author Dr. Dr. Harlid commented in an interview.

“The positive associations between antibiotics use and proximal colon cancer began at the lowest level of antibiotics use, providing a potential justification for reducing antibiotics prescriptions in clinical practice,” she added.

In their article, the team suggests that the increased risk could be a result of antibiotics having a “disruptive effect” on the gut microbiome.

The finding of an increased risk for cancer in the proximal colon but not further along the alimentary tract “is consistent with a high microbial impact in the proximal colon and a decreasing concentration of short-chain fatty acids along the colon,” the authors comment.

This results “in higher bacterial activity, biofilm formation, and fermentation in the proximal compared with the distal colon and rectum.”

A further analysis showed that the use of quinolones and sulfonamides and/or trimethoprims was associated with an increased risk for proximal colon cancer, whereas use of nitrofurantoins, macrolides and/or lincosamides, and metronidazoles and/or tinidazoles was inversely associated with rectal cancer.

Details of the study findings

For their study, the team analyzed complete-population data from Swedish national registers for the period July 1, 2005 to Dec. 31, 2016.

They matched case patients who were diagnosed with colorectal cancer from Jan. 1, 2010 to Dec. 31, 2016 with cancer-free control persons in a 1:5 ratio. Data on antibiotic use were extracted from the Swedish Prescribed Drug Register.

Other variables, such as socioeconomic factors and health care utilization, were obtained from the Swedish Inpatient Register and the Longitudinal Integration Database for Health Insurance and Labor Market Studies.

The team identified 40,545 patients with colorectal cancer cases; there were 202,720 control persons. Just over half (52.9%) of the participants were men; the mean age at cancer diagnosis was 72 years. Among the cases, 36.4% were proximal colon cancers, 29.3% were distal colon cancers, and 33.0% rectal cancers.

Control patients were more likely to have been prescribed no antibiotics, at 22.4% versus 18.7% for case patients. Case patients were more likely than control persons to have used antibiotics for more than 2 months, at 20.8% versus 19.3% (P < .001).

Overall, antibiotic use was positively associated with colorectal cancer. In comparison with no use, the odds ratio for moderate use was 1.15; for very high use, it was 1.17 (P < .001 for trend).

Excluding all antibiotic use during the 2 years prior to a colorectal cancer diagnosis attenuated the association, such that it was no longer significant for very high use versus no antibiotic use.

Applying this cutoff to the remaining analyses, the team found that the dose-response relationship between antibiotic use and colorectal cancer was largely confined to proximal colon cancer, at an odds ratio of 1.09 for moderate use and 1.17 for very high use in comparison with no use (P < .001 for trend).

For distal colon cancer, the relationship was “close to null.”

There was a slight inverse relationship between rectal cancer and antibiotic use, at an odds rate of 0.96 for moderate use and 0.91 for very high use versus no use (P < .001 for trend). This association was found in women only, whereas the other associations were seen in both men and women.

The study was supported by the Lion’s Cancer Research Foundation, Umeå University, and Region Västerbotten. Dr. Harlid has disclosed no relevant financial relationships. Three coauthors report various relationships with industry, as noted in the original article.

A version of this article first appeared on Medscape.com.

Another study has shown an association between antibiotic use and an increased risk for colon cancer.

The latest data come from a Swedish population study. Investigators analyzed data from more than 40,000 colorectal cancer patients and 200,000 cancer-free control persons.

Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0

They found that moderate use of antibiotics increased the risk for proximal colon cancer by 9% and that very high antibiotic use increased the risk by 17%.

In contrast, the risk for rectal cancer was reduced by 4% with moderate use and 9% with very high use, but this association was confined to women.

Antibiotic use was categorized as no use (no reported use of antibiotics during the study period), low (use during a period of 1-10 days), moderate (11-60 days), high (61-180 days), and very high (>180 days).

The study, led by Sophia Harlid, PhD, department of radiation sciences, oncology, Umeå University, Sweden, was published online on Sept. 1 in the Journal of the National Cancer Institute.

The results complement findings from a recent study from Scotland, which found that a history of antibiotic use among individuals younger than 50 appeared to increase the risk of developing colon cancer but not rectal cancer by 49%.

The new data from Sweden “strengthen prior evidence and provide new insights into site-specific carcinogenesis as well as indirect support for the role of gut microbiota,” lead author Dr. Dr. Harlid commented in an interview.

“The positive associations between antibiotics use and proximal colon cancer began at the lowest level of antibiotics use, providing a potential justification for reducing antibiotics prescriptions in clinical practice,” she added.

In their article, the team suggests that the increased risk could be a result of antibiotics having a “disruptive effect” on the gut microbiome.

The finding of an increased risk for cancer in the proximal colon but not further along the alimentary tract “is consistent with a high microbial impact in the proximal colon and a decreasing concentration of short-chain fatty acids along the colon,” the authors comment.

This results “in higher bacterial activity, biofilm formation, and fermentation in the proximal compared with the distal colon and rectum.”

A further analysis showed that the use of quinolones and sulfonamides and/or trimethoprims was associated with an increased risk for proximal colon cancer, whereas use of nitrofurantoins, macrolides and/or lincosamides, and metronidazoles and/or tinidazoles was inversely associated with rectal cancer.

Details of the study findings

For their study, the team analyzed complete-population data from Swedish national registers for the period July 1, 2005 to Dec. 31, 2016.

They matched case patients who were diagnosed with colorectal cancer from Jan. 1, 2010 to Dec. 31, 2016 with cancer-free control persons in a 1:5 ratio. Data on antibiotic use were extracted from the Swedish Prescribed Drug Register.

Other variables, such as socioeconomic factors and health care utilization, were obtained from the Swedish Inpatient Register and the Longitudinal Integration Database for Health Insurance and Labor Market Studies.

The team identified 40,545 patients with colorectal cancer cases; there were 202,720 control persons. Just over half (52.9%) of the participants were men; the mean age at cancer diagnosis was 72 years. Among the cases, 36.4% were proximal colon cancers, 29.3% were distal colon cancers, and 33.0% rectal cancers.

Control patients were more likely to have been prescribed no antibiotics, at 22.4% versus 18.7% for case patients. Case patients were more likely than control persons to have used antibiotics for more than 2 months, at 20.8% versus 19.3% (P < .001).

Overall, antibiotic use was positively associated with colorectal cancer. In comparison with no use, the odds ratio for moderate use was 1.15; for very high use, it was 1.17 (P < .001 for trend).

Excluding all antibiotic use during the 2 years prior to a colorectal cancer diagnosis attenuated the association, such that it was no longer significant for very high use versus no antibiotic use.

Applying this cutoff to the remaining analyses, the team found that the dose-response relationship between antibiotic use and colorectal cancer was largely confined to proximal colon cancer, at an odds ratio of 1.09 for moderate use and 1.17 for very high use in comparison with no use (P < .001 for trend).

For distal colon cancer, the relationship was “close to null.”

There was a slight inverse relationship between rectal cancer and antibiotic use, at an odds rate of 0.96 for moderate use and 0.91 for very high use versus no use (P < .001 for trend). This association was found in women only, whereas the other associations were seen in both men and women.

The study was supported by the Lion’s Cancer Research Foundation, Umeå University, and Region Västerbotten. Dr. Harlid has disclosed no relevant financial relationships. Three coauthors report various relationships with industry, as noted in the original article.

A version of this article first appeared on Medscape.com.

Another study has shown an association between antibiotic use and an increased risk for colon cancer.

The latest data come from a Swedish population study. Investigators analyzed data from more than 40,000 colorectal cancer patients and 200,000 cancer-free control persons.

Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0

They found that moderate use of antibiotics increased the risk for proximal colon cancer by 9% and that very high antibiotic use increased the risk by 17%.

In contrast, the risk for rectal cancer was reduced by 4% with moderate use and 9% with very high use, but this association was confined to women.

Antibiotic use was categorized as no use (no reported use of antibiotics during the study period), low (use during a period of 1-10 days), moderate (11-60 days), high (61-180 days), and very high (>180 days).

The study, led by Sophia Harlid, PhD, department of radiation sciences, oncology, Umeå University, Sweden, was published online on Sept. 1 in the Journal of the National Cancer Institute.

The results complement findings from a recent study from Scotland, which found that a history of antibiotic use among individuals younger than 50 appeared to increase the risk of developing colon cancer but not rectal cancer by 49%.

The new data from Sweden “strengthen prior evidence and provide new insights into site-specific carcinogenesis as well as indirect support for the role of gut microbiota,” lead author Dr. Dr. Harlid commented in an interview.

“The positive associations between antibiotics use and proximal colon cancer began at the lowest level of antibiotics use, providing a potential justification for reducing antibiotics prescriptions in clinical practice,” she added.

In their article, the team suggests that the increased risk could be a result of antibiotics having a “disruptive effect” on the gut microbiome.

The finding of an increased risk for cancer in the proximal colon but not further along the alimentary tract “is consistent with a high microbial impact in the proximal colon and a decreasing concentration of short-chain fatty acids along the colon,” the authors comment.

This results “in higher bacterial activity, biofilm formation, and fermentation in the proximal compared with the distal colon and rectum.”

A further analysis showed that the use of quinolones and sulfonamides and/or trimethoprims was associated with an increased risk for proximal colon cancer, whereas use of nitrofurantoins, macrolides and/or lincosamides, and metronidazoles and/or tinidazoles was inversely associated with rectal cancer.

Details of the study findings

For their study, the team analyzed complete-population data from Swedish national registers for the period July 1, 2005 to Dec. 31, 2016.

They matched case patients who were diagnosed with colorectal cancer from Jan. 1, 2010 to Dec. 31, 2016 with cancer-free control persons in a 1:5 ratio. Data on antibiotic use were extracted from the Swedish Prescribed Drug Register.

Other variables, such as socioeconomic factors and health care utilization, were obtained from the Swedish Inpatient Register and the Longitudinal Integration Database for Health Insurance and Labor Market Studies.

The team identified 40,545 patients with colorectal cancer cases; there were 202,720 control persons. Just over half (52.9%) of the participants were men; the mean age at cancer diagnosis was 72 years. Among the cases, 36.4% were proximal colon cancers, 29.3% were distal colon cancers, and 33.0% rectal cancers.

Control patients were more likely to have been prescribed no antibiotics, at 22.4% versus 18.7% for case patients. Case patients were more likely than control persons to have used antibiotics for more than 2 months, at 20.8% versus 19.3% (P < .001).

Overall, antibiotic use was positively associated with colorectal cancer. In comparison with no use, the odds ratio for moderate use was 1.15; for very high use, it was 1.17 (P < .001 for trend).

Excluding all antibiotic use during the 2 years prior to a colorectal cancer diagnosis attenuated the association, such that it was no longer significant for very high use versus no antibiotic use.

Applying this cutoff to the remaining analyses, the team found that the dose-response relationship between antibiotic use and colorectal cancer was largely confined to proximal colon cancer, at an odds ratio of 1.09 for moderate use and 1.17 for very high use in comparison with no use (P < .001 for trend).

For distal colon cancer, the relationship was “close to null.”

There was a slight inverse relationship between rectal cancer and antibiotic use, at an odds rate of 0.96 for moderate use and 0.91 for very high use versus no use (P < .001 for trend). This association was found in women only, whereas the other associations were seen in both men and women.

The study was supported by the Lion’s Cancer Research Foundation, Umeå University, and Region Västerbotten. Dr. Harlid has disclosed no relevant financial relationships. Three coauthors report various relationships with industry, as noted in the original article.

A version of this article first appeared on Medscape.com.

The family of an Alabama man used his obituary to plead with people to become vaccinated against COVID-19.

Ray Martin DeMonia, 73, of Cullman, Alabama, ran an antiques business for 40 years and served as an auctioneer at charity events, the obituary said.

He had a stroke in 2020 during the first months of the COVID pandemic and made sure to get vaccinated, his daughter, Raven DeMonia, told The Washington Post.

“He knew what the vaccine meant for his health and what it meant to staying alive,” she said. “He said, ‘I just want to get back to shaking hands with people, selling stuff, and talking antiques.’”

His daughter told the Post that her father went to Cullman Regional Medical Center on Aug. 23 with heart problems.

About 12 hours after he was admitted, her mother got a call from the hospital saying they’d called 43 hospitals and were unable to find a “specialized cardiac ICU bed” for him, Ms. DeMonia told the Post.

He was finally airlifted to Rush Foundation Hospital in Meridian, Mississippi, almost 200 miles from his home, but died there Sept. 1. His family decided to make a plea for increased vaccinations in his obituary.

“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” the obit said. “Due to COVID 19, CRMC emergency staff contacted 43 hospitals in 3 states in search of a Cardiac ICU bed and finally located one in Meridian, MS. He would not want any other family to go through what his did.”

Mr. DeMonia is survived by his wife, daughter, grandson, and other family members.

The Alabama Hospital Association says state hospitals are still short of ICU beds. On Sept. 12, the AHA website said the state had 1,530 staffed ICU beds to accommodate 1,541 ICU patients.

The AHA said 83% of COVID patients in ICU had not been vaccinated against COVID, 4% were partially vaccinated, and 13% were fully vaccinated. Alabama trails other states in vaccination rates. Newsweek, citing CDC data, said 53.7% of people in Alabama were fully vaccinated. In comparison, 53.8% of all Americans nationally are fully vaccinated.

A version of this article first appeared on WebMD.com.

The family of an Alabama man used his obituary to plead with people to become vaccinated against COVID-19.

Ray Martin DeMonia, 73, of Cullman, Alabama, ran an antiques business for 40 years and served as an auctioneer at charity events, the obituary said.

He had a stroke in 2020 during the first months of the COVID pandemic and made sure to get vaccinated, his daughter, Raven DeMonia, told The Washington Post.

“He knew what the vaccine meant for his health and what it meant to staying alive,” she said. “He said, ‘I just want to get back to shaking hands with people, selling stuff, and talking antiques.’”

His daughter told the Post that her father went to Cullman Regional Medical Center on Aug. 23 with heart problems.

About 12 hours after he was admitted, her mother got a call from the hospital saying they’d called 43 hospitals and were unable to find a “specialized cardiac ICU bed” for him, Ms. DeMonia told the Post.

He was finally airlifted to Rush Foundation Hospital in Meridian, Mississippi, almost 200 miles from his home, but died there Sept. 1. His family decided to make a plea for increased vaccinations in his obituary.

“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” the obit said. “Due to COVID 19, CRMC emergency staff contacted 43 hospitals in 3 states in search of a Cardiac ICU bed and finally located one in Meridian, MS. He would not want any other family to go through what his did.”

Mr. DeMonia is survived by his wife, daughter, grandson, and other family members.

The Alabama Hospital Association says state hospitals are still short of ICU beds. On Sept. 12, the AHA website said the state had 1,530 staffed ICU beds to accommodate 1,541 ICU patients.

The AHA said 83% of COVID patients in ICU had not been vaccinated against COVID, 4% were partially vaccinated, and 13% were fully vaccinated. Alabama trails other states in vaccination rates. Newsweek, citing CDC data, said 53.7% of people in Alabama were fully vaccinated. In comparison, 53.8% of all Americans nationally are fully vaccinated.

A version of this article first appeared on WebMD.com.

The family of an Alabama man used his obituary to plead with people to become vaccinated against COVID-19.

Ray Martin DeMonia, 73, of Cullman, Alabama, ran an antiques business for 40 years and served as an auctioneer at charity events, the obituary said.

He had a stroke in 2020 during the first months of the COVID pandemic and made sure to get vaccinated, his daughter, Raven DeMonia, told The Washington Post.

“He knew what the vaccine meant for his health and what it meant to staying alive,” she said. “He said, ‘I just want to get back to shaking hands with people, selling stuff, and talking antiques.’”

His daughter told the Post that her father went to Cullman Regional Medical Center on Aug. 23 with heart problems.

About 12 hours after he was admitted, her mother got a call from the hospital saying they’d called 43 hospitals and were unable to find a “specialized cardiac ICU bed” for him, Ms. DeMonia told the Post.

He was finally airlifted to Rush Foundation Hospital in Meridian, Mississippi, almost 200 miles from his home, but died there Sept. 1. His family decided to make a plea for increased vaccinations in his obituary.

“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” the obit said. “Due to COVID 19, CRMC emergency staff contacted 43 hospitals in 3 states in search of a Cardiac ICU bed and finally located one in Meridian, MS. He would not want any other family to go through what his did.”

Mr. DeMonia is survived by his wife, daughter, grandson, and other family members.

The Alabama Hospital Association says state hospitals are still short of ICU beds. On Sept. 12, the AHA website said the state had 1,530 staffed ICU beds to accommodate 1,541 ICU patients.

The AHA said 83% of COVID patients in ICU had not been vaccinated against COVID, 4% were partially vaccinated, and 13% were fully vaccinated. Alabama trails other states in vaccination rates. Newsweek, citing CDC data, said 53.7% of people in Alabama were fully vaccinated. In comparison, 53.8% of all Americans nationally are fully vaccinated.

A version of this article first appeared on WebMD.com.

The SGLT2 inhibitor dapagliflozin scored a clear win in a randomized, controlled trial with more than 300 U.S. patients with heart failure with preserved ejection fraction (HFpEF), showing a significant and clinically meaningful benefit for the primary endpoint, a KCCQ measure of symptoms and physical limitations, after 12 weeks of treatment.

These results in the PRESERVED-HF study follow closely on the heals of the initial report from the EMPEROR-Preserved trial that showed a benefit from a different sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (Jardiance) in nearly 6,000 randomized patients for the primary endpoint of preventing cardiovascular death or hospitalizations for heart failure.

In PRESERVED-HF, patients with HFpEF who received a standard, once-daily dose of dapagliflozin (Farxiga) had an average 5.8-point improvement in their condition as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS), the study’s primary endpoint.

This is “the first study to demonstrate that an SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Mikhail N. Kosiborod, MD, reported at the annual scientific meeting of the Heart Failure Society of America. The secondary endpoint of 6-minute walking distance “has been very difficult to improve in many previous studies of other treatments” tested in patients with HFpEF, noted Dr. Kosiborod, a cardiologist and codirector of the Cardiometabolic Center of Excellence at Saint Luke’s Mid-America Heart Institute.

The results are “highly complementary” to the findings from large outcome trials, such as the findings from EMPEROR-Preserved, he said, and collectively the recent findings from these studies of SGLT2 inhibitors in patients with HFpEF identify drugs in this class as a “new treatment option” for patients with a disorder that until now had no treatment with unequivocally proven efficacy and safety.
 

‘Impressive and unprecedented’ findings

The findings are “really impressive and unprecedented,” said Milton Packer, MD, a cardiologist at Baylor University Medical Center in Dallas who was not involved in the study. “This is the largest KCCQ benefit ever seen in either patients with HFpEF or in patients with heart failure with reduced ejection fraction,” said Dr. Packer, one of the investigators who led the EMPEROR-Preserved trial.

MDedge News

PRESERVED-HF randomized 324 patients diagnosed with heart failure and with a left ventricular ejection fraction of 45% or higher at any of 26 U.S. centers, with 304 patients completing the planned final analysis after 12 weeks on treatment. Patients could be in New York Heart Association (NYHA) functional class II-IV, they had to have a baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) level of at least 225 pg/mL (or higher if they also had atrial fibrillation), and they required at least one of three markers of established heart failure: recent hospitalization for heart failure or an urgent outpatient visit that required treatment with an IV diuretic, elevated filling pressure measured by left or right catheterization, or structural heart disease detected by echocardiography.

The average age of the enrolled patients was 70 years, and they had been diagnosed with heart failure for about 3 years; 57% were women, 30% were African American, and their median body mass index was 35 kg/m². Roughly 42% had NYHA class III or IV disease, 56% had type 2 diabetes, their median estimated glomerular filtration rate was about 55 mL/min per 1.73m², their median KCCQ-CS score at baseline was about 62, and their average 6-minute walk distance was 244 m.

These and other features of the enrolled population define a distinctly U.S. patient population, stressed Dr. Kosiborod, professor of medicine at the University of Missouri–Kansas City.

“The patients we enrolled are the patients we see in U.S. clinical practice,” he said in an interview. Importantly, the patient profile of a median BMI of 35 kg/m², a median KCCQ-CS score of 62 – “quite low,” noted Dr. Kosiborod – and having more than 40% of patients in NYHA functional class III defines a study population with a substantially greater burden of obesity, symptoms, and functional impairment compared with those enrolled in prior trials involving patients with HFpEF such as EMPEROR-Preserved.
 

Results complement findings from larger trials

PRESERVED-HF was an investigator-initiated study designed to inform clinical practice, not as a pivotal trial like EMPEROR-Preserved, which aims to gather evidence to support a new indication for regulatory approval. (On Sept. 9, 2021, the Food and Drug Administration granted empagliflozin “breakthrough therapy” status for treating HFpEF based on the EMPEROR-Preserved results, which will fast-track the agency’s decision on this indication.)

Dr. Kosiborod noted that he and his associates designed PRESERVED-HF with adequate patient numbers to power a statistically valid assessment of effect on KCCQ-CS score. While the new findings will not by themselves lead to a new indication for dapagliflozin to treat patients with HFpEF, they will potentially complement the pending results of another trial, DELIVER, by showing efficacy and safety in a uniquely U.S. patient population. DELIVER is a pivotal, global trial of dapagliflozin in more than 6,000 patients with HFpEF that’s on track to report findings in 2022.

Dr. Kosiborod also stressed that dapagliflozin has U.S.-approved indications for treating patients with type 2 diabetes, and for patients with chronic kidney disease, and that a majority of patients enrolled in PRESERVED-HF had one or both of these conditions. That makes the new findings especially compelling for patients with either type 2 diabetes or chronic kidney disease and HFpEF who are not already receiving an SGLT2 inhibitor.

Other findings that he reported showed a range of benefits consistent with the primary endpoint, including the KCCQ overall summary score, which also showed a significant 4.5-point average increase over placebo after 12 weeks. Analysis by the percentage of patients achieving at least a 5-point improvement in the KCCQ clinical summary score (the threshold for a clinically meaningful improvement) showed that about 45% of patients treated with dapagliflozin reached this mark compared with roughly 35% of patients in the placebo arm, indicating a number needed to treat of nine to have one additional patient achieve this threshold after 12 weeks. Average improvement in 6-minute walk distance was about 20 m with dapagliflozin compared with placebo.

No heterogeneity of effect by baseline ejection fraction.

Subgroup analyses showed no heterogeneity of response across 12 different ways of subdividing the study population, including age, sex, race, diabetes status, and BMI. The median left ventricular ejection fraction among enrolled patients was 60%, and the findings showed identical KCCQ improvements among patients with ejection fractions less than the median and those with an ejection fraction above the median.

This last finding was especially relevant because the EMPEROR-Preserved results showed a possible signal of heterogeneity by ejection fraction and an attenuated effect among patients with HFpEF and an ejection fraction above the 60%-65% range, although the certainty of this finding is currently controversial.

The impact of empagliflozin on KCCQ clinical summary score in EMPEROR-Preserved showed an average incremental improvement of 1.32 points compared with placebo, a significant difference, but more modest than the increment from dapagliflozin treatment seen in PRESERVED-HF. Dr. Kosiborod hypothesized that this difference might be mostly because of the different patient populations enrolled in the two studies.

Dr. Kosiborod noted that a report on the PRESERVED-HF results will soon appear in Nature Medicine.

PRESERVED-HF was funded by AstraZeneca, which markets dapagliflozin (Farxiga), but the trials’ design and conduct were independent of this funding source. Dr. Kosiborod has been a consultant to AstraZeneca and numerous other companies, and he has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Packer has had financial relationships with AstraZeneca and numerous other companies.

mzoler@mdedge.com

The SGLT2 inhibitor dapagliflozin scored a clear win in a randomized, controlled trial with more than 300 U.S. patients with heart failure with preserved ejection fraction (HFpEF), showing a significant and clinically meaningful benefit for the primary endpoint, a KCCQ measure of symptoms and physical limitations, after 12 weeks of treatment.

These results in the PRESERVED-HF study follow closely on the heals of the initial report from the EMPEROR-Preserved trial that showed a benefit from a different sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (Jardiance) in nearly 6,000 randomized patients for the primary endpoint of preventing cardiovascular death or hospitalizations for heart failure.

In PRESERVED-HF, patients with HFpEF who received a standard, once-daily dose of dapagliflozin (Farxiga) had an average 5.8-point improvement in their condition as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS), the study’s primary endpoint.

This is “the first study to demonstrate that an SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Mikhail N. Kosiborod, MD, reported at the annual scientific meeting of the Heart Failure Society of America. The secondary endpoint of 6-minute walking distance “has been very difficult to improve in many previous studies of other treatments” tested in patients with HFpEF, noted Dr. Kosiborod, a cardiologist and codirector of the Cardiometabolic Center of Excellence at Saint Luke’s Mid-America Heart Institute.

The results are “highly complementary” to the findings from large outcome trials, such as the findings from EMPEROR-Preserved, he said, and collectively the recent findings from these studies of SGLT2 inhibitors in patients with HFpEF identify drugs in this class as a “new treatment option” for patients with a disorder that until now had no treatment with unequivocally proven efficacy and safety.
 

‘Impressive and unprecedented’ findings

The findings are “really impressive and unprecedented,” said Milton Packer, MD, a cardiologist at Baylor University Medical Center in Dallas who was not involved in the study. “This is the largest KCCQ benefit ever seen in either patients with HFpEF or in patients with heart failure with reduced ejection fraction,” said Dr. Packer, one of the investigators who led the EMPEROR-Preserved trial.

MDedge News

PRESERVED-HF randomized 324 patients diagnosed with heart failure and with a left ventricular ejection fraction of 45% or higher at any of 26 U.S. centers, with 304 patients completing the planned final analysis after 12 weeks on treatment. Patients could be in New York Heart Association (NYHA) functional class II-IV, they had to have a baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) level of at least 225 pg/mL (or higher if they also had atrial fibrillation), and they required at least one of three markers of established heart failure: recent hospitalization for heart failure or an urgent outpatient visit that required treatment with an IV diuretic, elevated filling pressure measured by left or right catheterization, or structural heart disease detected by echocardiography.

The average age of the enrolled patients was 70 years, and they had been diagnosed with heart failure for about 3 years; 57% were women, 30% were African American, and their median body mass index was 35 kg/m². Roughly 42% had NYHA class III or IV disease, 56% had type 2 diabetes, their median estimated glomerular filtration rate was about 55 mL/min per 1.73m², their median KCCQ-CS score at baseline was about 62, and their average 6-minute walk distance was 244 m.

These and other features of the enrolled population define a distinctly U.S. patient population, stressed Dr. Kosiborod, professor of medicine at the University of Missouri–Kansas City.

“The patients we enrolled are the patients we see in U.S. clinical practice,” he said in an interview. Importantly, the patient profile of a median BMI of 35 kg/m², a median KCCQ-CS score of 62 – “quite low,” noted Dr. Kosiborod – and having more than 40% of patients in NYHA functional class III defines a study population with a substantially greater burden of obesity, symptoms, and functional impairment compared with those enrolled in prior trials involving patients with HFpEF such as EMPEROR-Preserved.
 

Results complement findings from larger trials

PRESERVED-HF was an investigator-initiated study designed to inform clinical practice, not as a pivotal trial like EMPEROR-Preserved, which aims to gather evidence to support a new indication for regulatory approval. (On Sept. 9, 2021, the Food and Drug Administration granted empagliflozin “breakthrough therapy” status for treating HFpEF based on the EMPEROR-Preserved results, which will fast-track the agency’s decision on this indication.)

Dr. Kosiborod noted that he and his associates designed PRESERVED-HF with adequate patient numbers to power a statistically valid assessment of effect on KCCQ-CS score. While the new findings will not by themselves lead to a new indication for dapagliflozin to treat patients with HFpEF, they will potentially complement the pending results of another trial, DELIVER, by showing efficacy and safety in a uniquely U.S. patient population. DELIVER is a pivotal, global trial of dapagliflozin in more than 6,000 patients with HFpEF that’s on track to report findings in 2022.

Dr. Kosiborod also stressed that dapagliflozin has U.S.-approved indications for treating patients with type 2 diabetes, and for patients with chronic kidney disease, and that a majority of patients enrolled in PRESERVED-HF had one or both of these conditions. That makes the new findings especially compelling for patients with either type 2 diabetes or chronic kidney disease and HFpEF who are not already receiving an SGLT2 inhibitor.

Other findings that he reported showed a range of benefits consistent with the primary endpoint, including the KCCQ overall summary score, which also showed a significant 4.5-point average increase over placebo after 12 weeks. Analysis by the percentage of patients achieving at least a 5-point improvement in the KCCQ clinical summary score (the threshold for a clinically meaningful improvement) showed that about 45% of patients treated with dapagliflozin reached this mark compared with roughly 35% of patients in the placebo arm, indicating a number needed to treat of nine to have one additional patient achieve this threshold after 12 weeks. Average improvement in 6-minute walk distance was about 20 m with dapagliflozin compared with placebo.

No heterogeneity of effect by baseline ejection fraction.

Subgroup analyses showed no heterogeneity of response across 12 different ways of subdividing the study population, including age, sex, race, diabetes status, and BMI. The median left ventricular ejection fraction among enrolled patients was 60%, and the findings showed identical KCCQ improvements among patients with ejection fractions less than the median and those with an ejection fraction above the median.

This last finding was especially relevant because the EMPEROR-Preserved results showed a possible signal of heterogeneity by ejection fraction and an attenuated effect among patients with HFpEF and an ejection fraction above the 60%-65% range, although the certainty of this finding is currently controversial.

The impact of empagliflozin on KCCQ clinical summary score in EMPEROR-Preserved showed an average incremental improvement of 1.32 points compared with placebo, a significant difference, but more modest than the increment from dapagliflozin treatment seen in PRESERVED-HF. Dr. Kosiborod hypothesized that this difference might be mostly because of the different patient populations enrolled in the two studies.

Dr. Kosiborod noted that a report on the PRESERVED-HF results will soon appear in Nature Medicine.

PRESERVED-HF was funded by AstraZeneca, which markets dapagliflozin (Farxiga), but the trials’ design and conduct were independent of this funding source. Dr. Kosiborod has been a consultant to AstraZeneca and numerous other companies, and he has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Packer has had financial relationships with AstraZeneca and numerous other companies.

mzoler@mdedge.com

The SGLT2 inhibitor dapagliflozin scored a clear win in a randomized, controlled trial with more than 300 U.S. patients with heart failure with preserved ejection fraction (HFpEF), showing a significant and clinically meaningful benefit for the primary endpoint, a KCCQ measure of symptoms and physical limitations, after 12 weeks of treatment.

These results in the PRESERVED-HF study follow closely on the heals of the initial report from the EMPEROR-Preserved trial that showed a benefit from a different sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (Jardiance) in nearly 6,000 randomized patients for the primary endpoint of preventing cardiovascular death or hospitalizations for heart failure.

In PRESERVED-HF, patients with HFpEF who received a standard, once-daily dose of dapagliflozin (Farxiga) had an average 5.8-point improvement in their condition as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS), the study’s primary endpoint.

This is “the first study to demonstrate that an SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Mikhail N. Kosiborod, MD, reported at the annual scientific meeting of the Heart Failure Society of America. The secondary endpoint of 6-minute walking distance “has been very difficult to improve in many previous studies of other treatments” tested in patients with HFpEF, noted Dr. Kosiborod, a cardiologist and codirector of the Cardiometabolic Center of Excellence at Saint Luke’s Mid-America Heart Institute.

The results are “highly complementary” to the findings from large outcome trials, such as the findings from EMPEROR-Preserved, he said, and collectively the recent findings from these studies of SGLT2 inhibitors in patients with HFpEF identify drugs in this class as a “new treatment option” for patients with a disorder that until now had no treatment with unequivocally proven efficacy and safety.
 

‘Impressive and unprecedented’ findings

The findings are “really impressive and unprecedented,” said Milton Packer, MD, a cardiologist at Baylor University Medical Center in Dallas who was not involved in the study. “This is the largest KCCQ benefit ever seen in either patients with HFpEF or in patients with heart failure with reduced ejection fraction,” said Dr. Packer, one of the investigators who led the EMPEROR-Preserved trial.

MDedge News

PRESERVED-HF randomized 324 patients diagnosed with heart failure and with a left ventricular ejection fraction of 45% or higher at any of 26 U.S. centers, with 304 patients completing the planned final analysis after 12 weeks on treatment. Patients could be in New York Heart Association (NYHA) functional class II-IV, they had to have a baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) level of at least 225 pg/mL (or higher if they also had atrial fibrillation), and they required at least one of three markers of established heart failure: recent hospitalization for heart failure or an urgent outpatient visit that required treatment with an IV diuretic, elevated filling pressure measured by left or right catheterization, or structural heart disease detected by echocardiography.

The average age of the enrolled patients was 70 years, and they had been diagnosed with heart failure for about 3 years; 57% were women, 30% were African American, and their median body mass index was 35 kg/m². Roughly 42% had NYHA class III or IV disease, 56% had type 2 diabetes, their median estimated glomerular filtration rate was about 55 mL/min per 1.73m², their median KCCQ-CS score at baseline was about 62, and their average 6-minute walk distance was 244 m.

These and other features of the enrolled population define a distinctly U.S. patient population, stressed Dr. Kosiborod, professor of medicine at the University of Missouri–Kansas City.

“The patients we enrolled are the patients we see in U.S. clinical practice,” he said in an interview. Importantly, the patient profile of a median BMI of 35 kg/m², a median KCCQ-CS score of 62 – “quite low,” noted Dr. Kosiborod – and having more than 40% of patients in NYHA functional class III defines a study population with a substantially greater burden of obesity, symptoms, and functional impairment compared with those enrolled in prior trials involving patients with HFpEF such as EMPEROR-Preserved.
 

Results complement findings from larger trials

PRESERVED-HF was an investigator-initiated study designed to inform clinical practice, not as a pivotal trial like EMPEROR-Preserved, which aims to gather evidence to support a new indication for regulatory approval. (On Sept. 9, 2021, the Food and Drug Administration granted empagliflozin “breakthrough therapy” status for treating HFpEF based on the EMPEROR-Preserved results, which will fast-track the agency’s decision on this indication.)

Dr. Kosiborod noted that he and his associates designed PRESERVED-HF with adequate patient numbers to power a statistically valid assessment of effect on KCCQ-CS score. While the new findings will not by themselves lead to a new indication for dapagliflozin to treat patients with HFpEF, they will potentially complement the pending results of another trial, DELIVER, by showing efficacy and safety in a uniquely U.S. patient population. DELIVER is a pivotal, global trial of dapagliflozin in more than 6,000 patients with HFpEF that’s on track to report findings in 2022.

Dr. Kosiborod also stressed that dapagliflozin has U.S.-approved indications for treating patients with type 2 diabetes, and for patients with chronic kidney disease, and that a majority of patients enrolled in PRESERVED-HF had one or both of these conditions. That makes the new findings especially compelling for patients with either type 2 diabetes or chronic kidney disease and HFpEF who are not already receiving an SGLT2 inhibitor.

Other findings that he reported showed a range of benefits consistent with the primary endpoint, including the KCCQ overall summary score, which also showed a significant 4.5-point average increase over placebo after 12 weeks. Analysis by the percentage of patients achieving at least a 5-point improvement in the KCCQ clinical summary score (the threshold for a clinically meaningful improvement) showed that about 45% of patients treated with dapagliflozin reached this mark compared with roughly 35% of patients in the placebo arm, indicating a number needed to treat of nine to have one additional patient achieve this threshold after 12 weeks. Average improvement in 6-minute walk distance was about 20 m with dapagliflozin compared with placebo.

No heterogeneity of effect by baseline ejection fraction.

Subgroup analyses showed no heterogeneity of response across 12 different ways of subdividing the study population, including age, sex, race, diabetes status, and BMI. The median left ventricular ejection fraction among enrolled patients was 60%, and the findings showed identical KCCQ improvements among patients with ejection fractions less than the median and those with an ejection fraction above the median.

This last finding was especially relevant because the EMPEROR-Preserved results showed a possible signal of heterogeneity by ejection fraction and an attenuated effect among patients with HFpEF and an ejection fraction above the 60%-65% range, although the certainty of this finding is currently controversial.

The impact of empagliflozin on KCCQ clinical summary score in EMPEROR-Preserved showed an average incremental improvement of 1.32 points compared with placebo, a significant difference, but more modest than the increment from dapagliflozin treatment seen in PRESERVED-HF. Dr. Kosiborod hypothesized that this difference might be mostly because of the different patient populations enrolled in the two studies.

Dr. Kosiborod noted that a report on the PRESERVED-HF results will soon appear in Nature Medicine.

PRESERVED-HF was funded by AstraZeneca, which markets dapagliflozin (Farxiga), but the trials’ design and conduct were independent of this funding source. Dr. Kosiborod has been a consultant to AstraZeneca and numerous other companies, and he has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Packer has had financial relationships with AstraZeneca and numerous other companies.

mzoler@mdedge.com

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest.

Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma.

They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal.

“In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress.
 

Unmeasured confounding

The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization.

“While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said.

Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr. Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results.

In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score.

The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.
 

Alphabet soup

Dr. Longo and colleagues analyzed data on a total 1,511 children enrolled in four observational studies (PACMAN, PAGES, HPR, CLARA) and one cohort study (ALSPAC).

They included children with an asthma diagnosis who used ICS and had available information on both BMI and genetics.

The Mendelian randomization analysis was based on a weighted allele score based on 97 SNPs predictive of BMI based on large-scale genomewide association studies. The exposure for the analysis was age- and sex-adjusted BMI z scores based on World Health Organization growth charts for children.

They found that using the Mendelian randomization approach, for each standard deviation increase in BMI, the OR for any parent-reported asthma exacerbations, including urgent care visits or use of oral corticosteroids, was 2.31 (95% confidence interval, 1.26-4.25).

In contrast, if the traditional observational model had been used, the OR would be a nonsignificant 1.10 (95% CI, 0.99-1.22).

“Treatment guidelines recommend steroids for children with asthma who have a higher-than-normal BMI,” Dr. Longo said in a statement. “Our research group felt that the one-size fits-all approach to treating children with asthma with inhaled steroids as their first-line treatment, particularly those with excess weight, warrants revision. At the very least, research identifying potential alternative treatments should be encouraged and prioritized, especially since 30% of children with asthma are also obese. With the childhood obesity epidemic rising, we expect this percentage to increase meaning this problem of poor control will be seen more frequently in routine clinical practice.”

Christopher E. Brightling, PhD, professor of respiratory medicine at the University of Leicester (England), commented that “this is very good and fascinating research with findings that are important and novel.

“It sheds light on the complex interplay between genes, weight, and response to inhaled corticosteroids, underscoring the need to combine drug treatments with lifestyle and diet modifications. Policy makers, health care providers and families need to do much more to tackle the growing obesity epidemic in young people,” he said.

Dr. Brightling was not involved in the study.

The study was supported by the ERS and the European Union’s H2020 research and innovation program. Dr. Longo was a Horizon 2020 Marie-Sklodowska Cure Respire-3 fellow. Dr. Brightling reported no relevant disclosures.

Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest.

Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma.

They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal.

“In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress.
 

Unmeasured confounding

The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization.

“While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said.

Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr. Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results.

In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score.

The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.
 

Alphabet soup

Dr. Longo and colleagues analyzed data on a total 1,511 children enrolled in four observational studies (PACMAN, PAGES, HPR, CLARA) and one cohort study (ALSPAC).

They included children with an asthma diagnosis who used ICS and had available information on both BMI and genetics.

The Mendelian randomization analysis was based on a weighted allele score based on 97 SNPs predictive of BMI based on large-scale genomewide association studies. The exposure for the analysis was age- and sex-adjusted BMI z scores based on World Health Organization growth charts for children.

They found that using the Mendelian randomization approach, for each standard deviation increase in BMI, the OR for any parent-reported asthma exacerbations, including urgent care visits or use of oral corticosteroids, was 2.31 (95% confidence interval, 1.26-4.25).

In contrast, if the traditional observational model had been used, the OR would be a nonsignificant 1.10 (95% CI, 0.99-1.22).

“Treatment guidelines recommend steroids for children with asthma who have a higher-than-normal BMI,” Dr. Longo said in a statement. “Our research group felt that the one-size fits-all approach to treating children with asthma with inhaled steroids as their first-line treatment, particularly those with excess weight, warrants revision. At the very least, research identifying potential alternative treatments should be encouraged and prioritized, especially since 30% of children with asthma are also obese. With the childhood obesity epidemic rising, we expect this percentage to increase meaning this problem of poor control will be seen more frequently in routine clinical practice.”

Christopher E. Brightling, PhD, professor of respiratory medicine at the University of Leicester (England), commented that “this is very good and fascinating research with findings that are important and novel.

“It sheds light on the complex interplay between genes, weight, and response to inhaled corticosteroids, underscoring the need to combine drug treatments with lifestyle and diet modifications. Policy makers, health care providers and families need to do much more to tackle the growing obesity epidemic in young people,” he said.

Dr. Brightling was not involved in the study.

The study was supported by the ERS and the European Union’s H2020 research and innovation program. Dr. Longo was a Horizon 2020 Marie-Sklodowska Cure Respire-3 fellow. Dr. Brightling reported no relevant disclosures.

Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest.

Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma.

They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal.

“In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress.
 

Unmeasured confounding

The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization.

“While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said.

Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr. Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results.

In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score.

The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.
 

Alphabet soup

Dr. Longo and colleagues analyzed data on a total 1,511 children enrolled in four observational studies (PACMAN, PAGES, HPR, CLARA) and one cohort study (ALSPAC).

They included children with an asthma diagnosis who used ICS and had available information on both BMI and genetics.

The Mendelian randomization analysis was based on a weighted allele score based on 97 SNPs predictive of BMI based on large-scale genomewide association studies. The exposure for the analysis was age- and sex-adjusted BMI z scores based on World Health Organization growth charts for children.

They found that using the Mendelian randomization approach, for each standard deviation increase in BMI, the OR for any parent-reported asthma exacerbations, including urgent care visits or use of oral corticosteroids, was 2.31 (95% confidence interval, 1.26-4.25).

In contrast, if the traditional observational model had been used, the OR would be a nonsignificant 1.10 (95% CI, 0.99-1.22).

“Treatment guidelines recommend steroids for children with asthma who have a higher-than-normal BMI,” Dr. Longo said in a statement. “Our research group felt that the one-size fits-all approach to treating children with asthma with inhaled steroids as their first-line treatment, particularly those with excess weight, warrants revision. At the very least, research identifying potential alternative treatments should be encouraged and prioritized, especially since 30% of children with asthma are also obese. With the childhood obesity epidemic rising, we expect this percentage to increase meaning this problem of poor control will be seen more frequently in routine clinical practice.”

Christopher E. Brightling, PhD, professor of respiratory medicine at the University of Leicester (England), commented that “this is very good and fascinating research with findings that are important and novel.

“It sheds light on the complex interplay between genes, weight, and response to inhaled corticosteroids, underscoring the need to combine drug treatments with lifestyle and diet modifications. Policy makers, health care providers and families need to do much more to tackle the growing obesity epidemic in young people,” he said.

Dr. Brightling was not involved in the study.

The study was supported by the ERS and the European Union’s H2020 research and innovation program. Dr. Longo was a Horizon 2020 Marie-Sklodowska Cure Respire-3 fellow. Dr. Brightling reported no relevant disclosures.

The U.S. Preventive Services Task Force has updated its 2014 statement on screening asymptomatic individuals for chlamydia and gonorrhea infection.

Published online in JAMA, the 2021 version recommends that all sexually active women aged 24 years or younger and at-risk women 25 years or older should be screened for chlamydia and gonorrhea.

As in 2014, the task force made no screening recommendation for men owing to inconclusive evidence of benefit.

With cases of sexually transmitted infections reaching all-time highs, Amy G. Cantor, MD, MPH, of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues noted that chlamydia and gonorrhea are among the most common STIs in this country. According to the Centers for Disease Control and Prevention, 2019 saw approximately 1.8 million reported cases of chlamydia and more than 600,000 of gonorrhea.

In the current analysis of 27 observational and randomized studies comprising 179,515 patients, the USPSTF panel found that, compared with no screening, chlamydia screening was significantly associated with a reduced risk of pelvic inflammatory disease (PID) in young women in 2 out of 4 trials.

The authors cautioned, however, that the magnitude of benefit was relatively small. No studies reported on screening effectiveness in men, except for one reporting rates of epididymitis, and no studies were done on pregnant women for any outcome.

The largest and newest study, the Australian Chlamydia Control Effectiveness Pilot trial of 2018, assessed chlamydia screening against usual care in 180,355 men and women aged 16-29 years in 130 rural Australian primary care clinics. Screening was associated with a reduced risk of hospital-diagnosed PID: the absolute risk was 0.24% for screening versus 0.38% for usual care (unadjusted risk ratio, 0.6; 95% confidence interval, 0.4-1.0). It was not, however, significantly associated with a reduced risk of clinic-diagnosed PID, with an absolute risk of 0.45% versus 0.39% (RR, 1.1; 95% CI, 0.7-18). Nor did it correlate with a risk reduction for clinic-diagnosed epididymitis: 0.26% vs. 0.27% (RR, 0.9; 95% CI, 0.6-1.4).

While risk prediction criteria apart from age were only minimally accurate, testing for asymptomatic chlamydial and gonococcal infections was highly accurate at most anatomical sites, including urine and self-collected specimens, the investigators observed. Age 22 years or younger alone versus multi-item risk criteria demonstrated similar discrimination in a study that included symptomatic and asymptomatic women.

Sensitivity of chlamydial testing was similar at endocervical (89%-100%) and self- and clinician-collected vaginal (90%-100%) sites for women and at meatal (100%), urethral (99%), and rectal (92%) sites for men. It was lower, however, at pharyngeal sites (69.2%) for men who have sex with men (MSM).

Sensitivity of gonococcal testing was 89% or greater for all anatomical samples. False-positive and false-negative testing rates were low across anatomical sites and collection methods.

“Effectiveness of screening in men and during pregnancy, optimal screening intervals, and adverse effects of screening require further evaluation, Dr. Cantor and associates concluded.

In an accompanying editorial, Jeanne Marrazzo, MD, MPH, and Jodie Dionne-Odom, MD, MSPH, of the division of infectious diseases at the University of Alabama at Birmingham, called the guidelines “timely” and “powerful agents of change” that “influence a wide spectrum of health-based metrics, from quality assurance measures to criteria for financial reimbursement.”

They pointed out that men who have sex with men are experiencing historically high rates of gonorrhea, with most infections occurring extragenitally at the pharynx or rectum. In 2019 CDC data, MSM had substantially higher rates of gonorrhea than men who had sex only with women. They recommended that guidelines for men consider STI risk because of sexual relations with men, women, or both.

“Comprehensive screening guidelines for common STIs like chlamydia and gonorrhea could incorporate the limited evidence base for MSM, whether it is regular practice or not,” they wrote, with the same approach for women who have sex with women but may be at risk for chlamydia, particularly if they also have sex with men.

In their view, these latest guidelines appropriately prioritize high-level clinically based data. They pointed, however, to recent progress in understanding the pathogenesis of upper reproductive tract infection in women and the sexual networks behind the current resurgence of STIs in the United States in the failure to manage exposed sex partners.

“Considering these critical advances in the evolution of clinic-based screening guidelines is a work in progress,” they wrote, “the dialogue among basic scientists, clinical trial investigators, and public health professionals to inform the next version of updated USPSTF chlamydia and gonorrhea screening guidelines should start now.”

In the opinion of Jennifer L. Reed, MD, MS, a professor of pediatrics and an emergency medicine physician at Cincinnati Children’s Hospital Medical Center and not involved in the updated statement, the recommendations are very reasonable. “The highest rates of infection occur in females 15-24 years of age, and therefore asymptomatic screening for chlamydia and gonorrhea is imperative at least annually or more often if they are high risk,” she said in an interview.

“I would hope that providers increase their asymptomatic screening as a result of these recommendations and highly consider it in the younger men,” Dr. Reed added. “I see a very high rate of gonorrhea and chlamydia infections.” Her center is studying the implementation of gonorrhea and chlamydia asymptomatic screening for adolescents in the pediatric emergency department, a high-risk patient population that will benefit from STI screening opportunities in nontraditional settings.

This research was funded by the Agency for Healthcare Research and Quality and the Department of Health & Human Services under a contract to support the USPSTF. One statement coauthor reported personal fees from Insmed, Paratek, RedHill, and Spero, as well as grants from Insmed. No other disclosures were reported. Dr. Dionne-Odom reported grants from the National Institutes of Health/National Institute of Child Health and Development. Dr. Reed reported a grant from NIH/NICHD for a pragmatic trial of improving STI detection in the pediatric ED.
 

The U.S. Preventive Services Task Force has updated its 2014 statement on screening asymptomatic individuals for chlamydia and gonorrhea infection.

Published online in JAMA, the 2021 version recommends that all sexually active women aged 24 years or younger and at-risk women 25 years or older should be screened for chlamydia and gonorrhea.

As in 2014, the task force made no screening recommendation for men owing to inconclusive evidence of benefit.

With cases of sexually transmitted infections reaching all-time highs, Amy G. Cantor, MD, MPH, of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues noted that chlamydia and gonorrhea are among the most common STIs in this country. According to the Centers for Disease Control and Prevention, 2019 saw approximately 1.8 million reported cases of chlamydia and more than 600,000 of gonorrhea.

In the current analysis of 27 observational and randomized studies comprising 179,515 patients, the USPSTF panel found that, compared with no screening, chlamydia screening was significantly associated with a reduced risk of pelvic inflammatory disease (PID) in young women in 2 out of 4 trials.

The authors cautioned, however, that the magnitude of benefit was relatively small. No studies reported on screening effectiveness in men, except for one reporting rates of epididymitis, and no studies were done on pregnant women for any outcome.

The largest and newest study, the Australian Chlamydia Control Effectiveness Pilot trial of 2018, assessed chlamydia screening against usual care in 180,355 men and women aged 16-29 years in 130 rural Australian primary care clinics. Screening was associated with a reduced risk of hospital-diagnosed PID: the absolute risk was 0.24% for screening versus 0.38% for usual care (unadjusted risk ratio, 0.6; 95% confidence interval, 0.4-1.0). It was not, however, significantly associated with a reduced risk of clinic-diagnosed PID, with an absolute risk of 0.45% versus 0.39% (RR, 1.1; 95% CI, 0.7-18). Nor did it correlate with a risk reduction for clinic-diagnosed epididymitis: 0.26% vs. 0.27% (RR, 0.9; 95% CI, 0.6-1.4).

While risk prediction criteria apart from age were only minimally accurate, testing for asymptomatic chlamydial and gonococcal infections was highly accurate at most anatomical sites, including urine and self-collected specimens, the investigators observed. Age 22 years or younger alone versus multi-item risk criteria demonstrated similar discrimination in a study that included symptomatic and asymptomatic women.

Sensitivity of chlamydial testing was similar at endocervical (89%-100%) and self- and clinician-collected vaginal (90%-100%) sites for women and at meatal (100%), urethral (99%), and rectal (92%) sites for men. It was lower, however, at pharyngeal sites (69.2%) for men who have sex with men (MSM).

Sensitivity of gonococcal testing was 89% or greater for all anatomical samples. False-positive and false-negative testing rates were low across anatomical sites and collection methods.

“Effectiveness of screening in men and during pregnancy, optimal screening intervals, and adverse effects of screening require further evaluation, Dr. Cantor and associates concluded.

In an accompanying editorial, Jeanne Marrazzo, MD, MPH, and Jodie Dionne-Odom, MD, MSPH, of the division of infectious diseases at the University of Alabama at Birmingham, called the guidelines “timely” and “powerful agents of change” that “influence a wide spectrum of health-based metrics, from quality assurance measures to criteria for financial reimbursement.”

They pointed out that men who have sex with men are experiencing historically high rates of gonorrhea, with most infections occurring extragenitally at the pharynx or rectum. In 2019 CDC data, MSM had substantially higher rates of gonorrhea than men who had sex only with women. They recommended that guidelines for men consider STI risk because of sexual relations with men, women, or both.

“Comprehensive screening guidelines for common STIs like chlamydia and gonorrhea could incorporate the limited evidence base for MSM, whether it is regular practice or not,” they wrote, with the same approach for women who have sex with women but may be at risk for chlamydia, particularly if they also have sex with men.

In their view, these latest guidelines appropriately prioritize high-level clinically based data. They pointed, however, to recent progress in understanding the pathogenesis of upper reproductive tract infection in women and the sexual networks behind the current resurgence of STIs in the United States in the failure to manage exposed sex partners.

“Considering these critical advances in the evolution of clinic-based screening guidelines is a work in progress,” they wrote, “the dialogue among basic scientists, clinical trial investigators, and public health professionals to inform the next version of updated USPSTF chlamydia and gonorrhea screening guidelines should start now.”

In the opinion of Jennifer L. Reed, MD, MS, a professor of pediatrics and an emergency medicine physician at Cincinnati Children’s Hospital Medical Center and not involved in the updated statement, the recommendations are very reasonable. “The highest rates of infection occur in females 15-24 years of age, and therefore asymptomatic screening for chlamydia and gonorrhea is imperative at least annually or more often if they are high risk,” she said in an interview.

“I would hope that providers increase their asymptomatic screening as a result of these recommendations and highly consider it in the younger men,” Dr. Reed added. “I see a very high rate of gonorrhea and chlamydia infections.” Her center is studying the implementation of gonorrhea and chlamydia asymptomatic screening for adolescents in the pediatric emergency department, a high-risk patient population that will benefit from STI screening opportunities in nontraditional settings.

This research was funded by the Agency for Healthcare Research and Quality and the Department of Health & Human Services under a contract to support the USPSTF. One statement coauthor reported personal fees from Insmed, Paratek, RedHill, and Spero, as well as grants from Insmed. No other disclosures were reported. Dr. Dionne-Odom reported grants from the National Institutes of Health/National Institute of Child Health and Development. Dr. Reed reported a grant from NIH/NICHD for a pragmatic trial of improving STI detection in the pediatric ED.
 

The U.S. Preventive Services Task Force has updated its 2014 statement on screening asymptomatic individuals for chlamydia and gonorrhea infection.

Published online in JAMA, the 2021 version recommends that all sexually active women aged 24 years or younger and at-risk women 25 years or older should be screened for chlamydia and gonorrhea.

As in 2014, the task force made no screening recommendation for men owing to inconclusive evidence of benefit.

With cases of sexually transmitted infections reaching all-time highs, Amy G. Cantor, MD, MPH, of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues noted that chlamydia and gonorrhea are among the most common STIs in this country. According to the Centers for Disease Control and Prevention, 2019 saw approximately 1.8 million reported cases of chlamydia and more than 600,000 of gonorrhea.

In the current analysis of 27 observational and randomized studies comprising 179,515 patients, the USPSTF panel found that, compared with no screening, chlamydia screening was significantly associated with a reduced risk of pelvic inflammatory disease (PID) in young women in 2 out of 4 trials.

The authors cautioned, however, that the magnitude of benefit was relatively small. No studies reported on screening effectiveness in men, except for one reporting rates of epididymitis, and no studies were done on pregnant women for any outcome.

The largest and newest study, the Australian Chlamydia Control Effectiveness Pilot trial of 2018, assessed chlamydia screening against usual care in 180,355 men and women aged 16-29 years in 130 rural Australian primary care clinics. Screening was associated with a reduced risk of hospital-diagnosed PID: the absolute risk was 0.24% for screening versus 0.38% for usual care (unadjusted risk ratio, 0.6; 95% confidence interval, 0.4-1.0). It was not, however, significantly associated with a reduced risk of clinic-diagnosed PID, with an absolute risk of 0.45% versus 0.39% (RR, 1.1; 95% CI, 0.7-18). Nor did it correlate with a risk reduction for clinic-diagnosed epididymitis: 0.26% vs. 0.27% (RR, 0.9; 95% CI, 0.6-1.4).

While risk prediction criteria apart from age were only minimally accurate, testing for asymptomatic chlamydial and gonococcal infections was highly accurate at most anatomical sites, including urine and self-collected specimens, the investigators observed. Age 22 years or younger alone versus multi-item risk criteria demonstrated similar discrimination in a study that included symptomatic and asymptomatic women.

Sensitivity of chlamydial testing was similar at endocervical (89%-100%) and self- and clinician-collected vaginal (90%-100%) sites for women and at meatal (100%), urethral (99%), and rectal (92%) sites for men. It was lower, however, at pharyngeal sites (69.2%) for men who have sex with men (MSM).

Sensitivity of gonococcal testing was 89% or greater for all anatomical samples. False-positive and false-negative testing rates were low across anatomical sites and collection methods.

“Effectiveness of screening in men and during pregnancy, optimal screening intervals, and adverse effects of screening require further evaluation, Dr. Cantor and associates concluded.

In an accompanying editorial, Jeanne Marrazzo, MD, MPH, and Jodie Dionne-Odom, MD, MSPH, of the division of infectious diseases at the University of Alabama at Birmingham, called the guidelines “timely” and “powerful agents of change” that “influence a wide spectrum of health-based metrics, from quality assurance measures to criteria for financial reimbursement.”

They pointed out that men who have sex with men are experiencing historically high rates of gonorrhea, with most infections occurring extragenitally at the pharynx or rectum. In 2019 CDC data, MSM had substantially higher rates of gonorrhea than men who had sex only with women. They recommended that guidelines for men consider STI risk because of sexual relations with men, women, or both.

“Comprehensive screening guidelines for common STIs like chlamydia and gonorrhea could incorporate the limited evidence base for MSM, whether it is regular practice or not,” they wrote, with the same approach for women who have sex with women but may be at risk for chlamydia, particularly if they also have sex with men.

In their view, these latest guidelines appropriately prioritize high-level clinically based data. They pointed, however, to recent progress in understanding the pathogenesis of upper reproductive tract infection in women and the sexual networks behind the current resurgence of STIs in the United States in the failure to manage exposed sex partners.

“Considering these critical advances in the evolution of clinic-based screening guidelines is a work in progress,” they wrote, “the dialogue among basic scientists, clinical trial investigators, and public health professionals to inform the next version of updated USPSTF chlamydia and gonorrhea screening guidelines should start now.”

In the opinion of Jennifer L. Reed, MD, MS, a professor of pediatrics and an emergency medicine physician at Cincinnati Children’s Hospital Medical Center and not involved in the updated statement, the recommendations are very reasonable. “The highest rates of infection occur in females 15-24 years of age, and therefore asymptomatic screening for chlamydia and gonorrhea is imperative at least annually or more often if they are high risk,” she said in an interview.

“I would hope that providers increase their asymptomatic screening as a result of these recommendations and highly consider it in the younger men,” Dr. Reed added. “I see a very high rate of gonorrhea and chlamydia infections.” Her center is studying the implementation of gonorrhea and chlamydia asymptomatic screening for adolescents in the pediatric emergency department, a high-risk patient population that will benefit from STI screening opportunities in nontraditional settings.

This research was funded by the Agency for Healthcare Research and Quality and the Department of Health & Human Services under a contract to support the USPSTF. One statement coauthor reported personal fees from Insmed, Paratek, RedHill, and Spero, as well as grants from Insmed. No other disclosures were reported. Dr. Dionne-Odom reported grants from the National Institutes of Health/National Institute of Child Health and Development. Dr. Reed reported a grant from NIH/NICHD for a pragmatic trial of improving STI detection in the pediatric ED.
 

Women cardiologists receive dramatically smaller payments from the U.S. Centers for Medicare & Medicaid Services (CMS) than their male counterparts, new research suggests.

An analysis of 2016 claims data revealed male cardiologists received on average 45% more reimbursement than women in the inpatient setting, with the median payment 39% higher ($62,897 vs. $45,288).

In the outpatient setting, men received on average 62% more annual CMS payments, with the median payment 75% higher ($91,053 vs. $51,975; P < .001 for both).

The difference remained significant after the exclusion of the top and bottom 2.5% of earning physicians and cardiology subspecialties, like electrophysiology and interventional cardiology, with high procedural volumes and greater gender imbalances.

“This is one study among others which demonstrates a wage gap between men and women in medicine in cardiology,” lead author Inbar Raber, MD, Beth Israel Deaconess Medical Center, Boston, said in an interview. “I hope by increasing awareness [and] understanding of possible etiologies, it will enable some sustainable solutions, and those include access to additional support staff and equitable models surrounding parental leave and childcare support.”

The study, published online September 8 in JAMA Cardiology, comes on the heels of a recent cross-sectional analysis that put cardiology at the bottom of 13 internal medicine subspecialties with just 21% female faculty representation and one of only three specialties in which women’s median salaries did not reach 90% of men’s.

The new findings build on a 2017 report that showed Medicare payments to women physicians in 2013 were 55% of those to male physicians across all specialties.  

“It can be disheartening, especially as an early career woman cardiologist, seeing these differences, but I think the responsibility on all of us is to take these observations and really try to understand more deeply why they exist,” Nosheen Reza, MD, from the University of Pennsylvania, Philadelphia, and coauthor of the cross-sectional analysis, told this news organization.

Several factors could be contributing to the disparity, but “it’s not gender discrimination from Medicare,” Dr. Raber said. “The gap in reimbursement is really driven by the types and the volume of charges submitted.”

Indeed, a direct comparison of the three most common inpatient and outpatient billing codes showed no difference in payments between the sexes.

Men, however, submitted 24% more median inpatient charges to CMS than women (1,190 vs. 959), and 94% more outpatient charges (1,685 vs. 870).

Men also submitted slightly more unique billing codes (median inpatient, 10 vs. 9; median outpatient, 11 vs. 8).

Notably, women made up just 13% of the 17,524 cardiologists who received CMS payments in the inpatient setting in 2016 and 13% of the 16,929 cardiologists who did so in the outpatient setting.

Louisiana had the dubious distinction of having the largest gender gap in mean CMS payments, with male cardiologists earning $145,323 (235%) more than women, whereas women cardiologists in Vermont out-earned men by $31,483 (38%).

Overall, male cardiologists had more years in practice than women cardiologists and cared for slightly older Medicare beneficiaries.

Differences in CMS payments persisted, however, after adjustment for years since graduation, physician subspecialty, number of charges, number of unique billing codes, and patient complexity. The resulting β coefficient was -0.06, which translates into women receiving an average of 94% of the CMS payments received by men.

“The first takeaway, if you were really crass and focused on the bottom line, might be: ‘Hey, let me get a few more male cardiologists because they’re going to bring more into the organization.’ But we shouldn’t do that because, unless you link these data with quality outcomes, they’re an interesting observation and hypothesis-generating,” said Sharonne Hayes, MD, coauthor of the 2017 report and professor of cardiovascular medicine at Mayo Clinic in Rochester, Minn., where she has served as director of diversity and inclusion for a decade.

She noted that there are multiple examples that the style of medicine women practice, on average, may be more effective, may be more outcomes based, and may save lives, as suggested by a recent analysis of hospitalized Medicare beneficiaries.

“The gap was not much different, like within 1% or so, but when you take that over the literally millions of Medicare patients cared for each year by hospitalists, that’s a substantial number of people,” Dr. Hayes said. “So, I think we need to take a step back, and we have to include these observations on studies like this and better understand the compensation gaps.”

She pointed out that the present study lacks data on full-time-equivalent status but that female physicians are more likely to work part-time, thus reducing the volume of claims.

Women might also care for different patient populations. “I practice in a women’s heart clinic and take care of [spontaneous coronary artery dissection] SCAD patients where the average age of SCAD is 42. So, the vast majority of patients I see on a day-to-day basis aren’t going to be Medicare age,” observed Dr. Hayes.

The differences in charges might also reflect the increased obligations in nonreimbursed work that women can have, Dr. Raber said. These can be things like mentoring, teaching roles, and serving on committees, which is a hypothesis supported by a 2021 study that showed women physicians spend more time on these “citizenship tasks” than men.

Finally, there could be organizational barriers that affect women’s clinical volumes, including less access to support from health care personnel. Added support is especially important, though, amid a 100-year pandemic, the women agreed.

“Within the first year of the pandemic, we saw women leaving the workforce in droves across all sectors, including medicine, including academic medicine. And, as the pandemic goes on without any signs of abatement, those threats continue to exist and continue to be amplified,” Dr. Reza said.

The groundswell of support surrounding the importance of diversity, equity, and inclusion initiatives across the board has helped bring attention to the issue, she said. Some institutions, including the National Institutes of Health, are making efforts to extend relief to women with young families, caregivers, or those in academic medicine who, for example, need extensions on grants or bridge funding.

“There’s certainly a lot left to do, but I do think within the last year, there’s been an acceleration of literature that has come out, not only pointing out the disparities, but pointing out that perhaps women physicians do have better outcomes and are better liked by their patients and that losing women in the workforce would be a huge detriment to the field overall,” Dr. Reza said.

Dr. Raber, Dr. Reza, and Dr. Hayes reports no relevant financial relationships. Coauthor conflict of interest disclosures are listed in the paper.

A version of this article first appeared on Medscape.com.

Women cardiologists receive dramatically smaller payments from the U.S. Centers for Medicare & Medicaid Services (CMS) than their male counterparts, new research suggests.

An analysis of 2016 claims data revealed male cardiologists received on average 45% more reimbursement than women in the inpatient setting, with the median payment 39% higher ($62,897 vs. $45,288).

In the outpatient setting, men received on average 62% more annual CMS payments, with the median payment 75% higher ($91,053 vs. $51,975; P < .001 for both).

The difference remained significant after the exclusion of the top and bottom 2.5% of earning physicians and cardiology subspecialties, like electrophysiology and interventional cardiology, with high procedural volumes and greater gender imbalances.

“This is one study among others which demonstrates a wage gap between men and women in medicine in cardiology,” lead author Inbar Raber, MD, Beth Israel Deaconess Medical Center, Boston, said in an interview. “I hope by increasing awareness [and] understanding of possible etiologies, it will enable some sustainable solutions, and those include access to additional support staff and equitable models surrounding parental leave and childcare support.”

The study, published online September 8 in JAMA Cardiology, comes on the heels of a recent cross-sectional analysis that put cardiology at the bottom of 13 internal medicine subspecialties with just 21% female faculty representation and one of only three specialties in which women’s median salaries did not reach 90% of men’s.

The new findings build on a 2017 report that showed Medicare payments to women physicians in 2013 were 55% of those to male physicians across all specialties.  

“It can be disheartening, especially as an early career woman cardiologist, seeing these differences, but I think the responsibility on all of us is to take these observations and really try to understand more deeply why they exist,” Nosheen Reza, MD, from the University of Pennsylvania, Philadelphia, and coauthor of the cross-sectional analysis, told this news organization.

Several factors could be contributing to the disparity, but “it’s not gender discrimination from Medicare,” Dr. Raber said. “The gap in reimbursement is really driven by the types and the volume of charges submitted.”

Indeed, a direct comparison of the three most common inpatient and outpatient billing codes showed no difference in payments between the sexes.

Men, however, submitted 24% more median inpatient charges to CMS than women (1,190 vs. 959), and 94% more outpatient charges (1,685 vs. 870).

Men also submitted slightly more unique billing codes (median inpatient, 10 vs. 9; median outpatient, 11 vs. 8).

Notably, women made up just 13% of the 17,524 cardiologists who received CMS payments in the inpatient setting in 2016 and 13% of the 16,929 cardiologists who did so in the outpatient setting.

Louisiana had the dubious distinction of having the largest gender gap in mean CMS payments, with male cardiologists earning $145,323 (235%) more than women, whereas women cardiologists in Vermont out-earned men by $31,483 (38%).

Overall, male cardiologists had more years in practice than women cardiologists and cared for slightly older Medicare beneficiaries.

Differences in CMS payments persisted, however, after adjustment for years since graduation, physician subspecialty, number of charges, number of unique billing codes, and patient complexity. The resulting β coefficient was -0.06, which translates into women receiving an average of 94% of the CMS payments received by men.

“The first takeaway, if you were really crass and focused on the bottom line, might be: ‘Hey, let me get a few more male cardiologists because they’re going to bring more into the organization.’ But we shouldn’t do that because, unless you link these data with quality outcomes, they’re an interesting observation and hypothesis-generating,” said Sharonne Hayes, MD, coauthor of the 2017 report and professor of cardiovascular medicine at Mayo Clinic in Rochester, Minn., where she has served as director of diversity and inclusion for a decade.

She noted that there are multiple examples that the style of medicine women practice, on average, may be more effective, may be more outcomes based, and may save lives, as suggested by a recent analysis of hospitalized Medicare beneficiaries.

“The gap was not much different, like within 1% or so, but when you take that over the literally millions of Medicare patients cared for each year by hospitalists, that’s a substantial number of people,” Dr. Hayes said. “So, I think we need to take a step back, and we have to include these observations on studies like this and better understand the compensation gaps.”

She pointed out that the present study lacks data on full-time-equivalent status but that female physicians are more likely to work part-time, thus reducing the volume of claims.

Women might also care for different patient populations. “I practice in a women’s heart clinic and take care of [spontaneous coronary artery dissection] SCAD patients where the average age of SCAD is 42. So, the vast majority of patients I see on a day-to-day basis aren’t going to be Medicare age,” observed Dr. Hayes.

The differences in charges might also reflect the increased obligations in nonreimbursed work that women can have, Dr. Raber said. These can be things like mentoring, teaching roles, and serving on committees, which is a hypothesis supported by a 2021 study that showed women physicians spend more time on these “citizenship tasks” than men.

Finally, there could be organizational barriers that affect women’s clinical volumes, including less access to support from health care personnel. Added support is especially important, though, amid a 100-year pandemic, the women agreed.

“Within the first year of the pandemic, we saw women leaving the workforce in droves across all sectors, including medicine, including academic medicine. And, as the pandemic goes on without any signs of abatement, those threats continue to exist and continue to be amplified,” Dr. Reza said.

The groundswell of support surrounding the importance of diversity, equity, and inclusion initiatives across the board has helped bring attention to the issue, she said. Some institutions, including the National Institutes of Health, are making efforts to extend relief to women with young families, caregivers, or those in academic medicine who, for example, need extensions on grants or bridge funding.

“There’s certainly a lot left to do, but I do think within the last year, there’s been an acceleration of literature that has come out, not only pointing out the disparities, but pointing out that perhaps women physicians do have better outcomes and are better liked by their patients and that losing women in the workforce would be a huge detriment to the field overall,” Dr. Reza said.

Dr. Raber, Dr. Reza, and Dr. Hayes reports no relevant financial relationships. Coauthor conflict of interest disclosures are listed in the paper.

A version of this article first appeared on Medscape.com.

Women cardiologists receive dramatically smaller payments from the U.S. Centers for Medicare & Medicaid Services (CMS) than their male counterparts, new research suggests.

An analysis of 2016 claims data revealed male cardiologists received on average 45% more reimbursement than women in the inpatient setting, with the median payment 39% higher ($62,897 vs. $45,288).

In the outpatient setting, men received on average 62% more annual CMS payments, with the median payment 75% higher ($91,053 vs. $51,975; P < .001 for both).

The difference remained significant after the exclusion of the top and bottom 2.5% of earning physicians and cardiology subspecialties, like electrophysiology and interventional cardiology, with high procedural volumes and greater gender imbalances.

“This is one study among others which demonstrates a wage gap between men and women in medicine in cardiology,” lead author Inbar Raber, MD, Beth Israel Deaconess Medical Center, Boston, said in an interview. “I hope by increasing awareness [and] understanding of possible etiologies, it will enable some sustainable solutions, and those include access to additional support staff and equitable models surrounding parental leave and childcare support.”

The study, published online September 8 in JAMA Cardiology, comes on the heels of a recent cross-sectional analysis that put cardiology at the bottom of 13 internal medicine subspecialties with just 21% female faculty representation and one of only three specialties in which women’s median salaries did not reach 90% of men’s.

The new findings build on a 2017 report that showed Medicare payments to women physicians in 2013 were 55% of those to male physicians across all specialties.  

“It can be disheartening, especially as an early career woman cardiologist, seeing these differences, but I think the responsibility on all of us is to take these observations and really try to understand more deeply why they exist,” Nosheen Reza, MD, from the University of Pennsylvania, Philadelphia, and coauthor of the cross-sectional analysis, told this news organization.

Several factors could be contributing to the disparity, but “it’s not gender discrimination from Medicare,” Dr. Raber said. “The gap in reimbursement is really driven by the types and the volume of charges submitted.”

Indeed, a direct comparison of the three most common inpatient and outpatient billing codes showed no difference in payments between the sexes.

Men, however, submitted 24% more median inpatient charges to CMS than women (1,190 vs. 959), and 94% more outpatient charges (1,685 vs. 870).

Men also submitted slightly more unique billing codes (median inpatient, 10 vs. 9; median outpatient, 11 vs. 8).

Notably, women made up just 13% of the 17,524 cardiologists who received CMS payments in the inpatient setting in 2016 and 13% of the 16,929 cardiologists who did so in the outpatient setting.

Louisiana had the dubious distinction of having the largest gender gap in mean CMS payments, with male cardiologists earning $145,323 (235%) more than women, whereas women cardiologists in Vermont out-earned men by $31,483 (38%).

Overall, male cardiologists had more years in practice than women cardiologists and cared for slightly older Medicare beneficiaries.

Differences in CMS payments persisted, however, after adjustment for years since graduation, physician subspecialty, number of charges, number of unique billing codes, and patient complexity. The resulting β coefficient was -0.06, which translates into women receiving an average of 94% of the CMS payments received by men.

“The first takeaway, if you were really crass and focused on the bottom line, might be: ‘Hey, let me get a few more male cardiologists because they’re going to bring more into the organization.’ But we shouldn’t do that because, unless you link these data with quality outcomes, they’re an interesting observation and hypothesis-generating,” said Sharonne Hayes, MD, coauthor of the 2017 report and professor of cardiovascular medicine at Mayo Clinic in Rochester, Minn., where she has served as director of diversity and inclusion for a decade.

She noted that there are multiple examples that the style of medicine women practice, on average, may be more effective, may be more outcomes based, and may save lives, as suggested by a recent analysis of hospitalized Medicare beneficiaries.

“The gap was not much different, like within 1% or so, but when you take that over the literally millions of Medicare patients cared for each year by hospitalists, that’s a substantial number of people,” Dr. Hayes said. “So, I think we need to take a step back, and we have to include these observations on studies like this and better understand the compensation gaps.”

She pointed out that the present study lacks data on full-time-equivalent status but that female physicians are more likely to work part-time, thus reducing the volume of claims.

Women might also care for different patient populations. “I practice in a women’s heart clinic and take care of [spontaneous coronary artery dissection] SCAD patients where the average age of SCAD is 42. So, the vast majority of patients I see on a day-to-day basis aren’t going to be Medicare age,” observed Dr. Hayes.

The differences in charges might also reflect the increased obligations in nonreimbursed work that women can have, Dr. Raber said. These can be things like mentoring, teaching roles, and serving on committees, which is a hypothesis supported by a 2021 study that showed women physicians spend more time on these “citizenship tasks” than men.

Finally, there could be organizational barriers that affect women’s clinical volumes, including less access to support from health care personnel. Added support is especially important, though, amid a 100-year pandemic, the women agreed.

“Within the first year of the pandemic, we saw women leaving the workforce in droves across all sectors, including medicine, including academic medicine. And, as the pandemic goes on without any signs of abatement, those threats continue to exist and continue to be amplified,” Dr. Reza said.

The groundswell of support surrounding the importance of diversity, equity, and inclusion initiatives across the board has helped bring attention to the issue, she said. Some institutions, including the National Institutes of Health, are making efforts to extend relief to women with young families, caregivers, or those in academic medicine who, for example, need extensions on grants or bridge funding.

“There’s certainly a lot left to do, but I do think within the last year, there’s been an acceleration of literature that has come out, not only pointing out the disparities, but pointing out that perhaps women physicians do have better outcomes and are better liked by their patients and that losing women in the workforce would be a huge detriment to the field overall,” Dr. Reza said.

Dr. Raber, Dr. Reza, and Dr. Hayes reports no relevant financial relationships. Coauthor conflict of interest disclosures are listed in the paper.

A version of this article first appeared on Medscape.com.

The new guideline on management of heart failure (HF) from the European Society of Cardiology seemed to bear an asterisk or footnote even before its full unveiling in the early hours of ESC Congress 2021.

frankpeters/Getty Images

The document would offer little new in the arena of HF with preserved ejection fraction (HFpEF), so understandably the fast-approaching presentation of a major HFpEF trial – arguably the conference’s marquee event – would feel to some like the elephant in the room.

“I’d like to highlight this unfortunate timing of the guideline, because it’s an hour or 2 before we hear the full story from EMPEROR-Preserved, which I’m sure will change the guidelines,” Faiez Zannad, MD, PhD, University of Lorraine, Vandoeuvre-Les-Nancy, France, said wryly.

Anticipation of the trial’s full presentation was intense as the ESC congress got underway, in part because the top-line and incomplete message from EMPEROR-Preserved had already been released: Patients with HFpEF treated with the sodium-glucose cotransporter 2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) showed a significant benefit for the primary endpoint of cardiovascular (CV) death or HF hospitalization.

Although empagliflozin is the first medication to achieve that status in a major HFpEF trial, conspicuously absent from the early announcement were the magnitude of “benefit” and any data. Still, the tantalizing top-line results mean that technically, at least, “we have a drug which is effective in reduced and preserved ejection fraction,” Dr. Zannad said.

But the new guideline, published online Aug. 27, 2021, in the European Heart Journal and comprehensively described that day at the congress, was never really expected to consider results from EMPEROR-Reduced. “These new indications do need to go through the regulatory authorities,” such as the European Medicines Agency and the U.S. Food and Drug Administration, observed Carlos Aguiar, MD, Hospital Santa Cruz, Carnaxide, Portugal.

“It does take some time for the whole process to be concluded and, finally, as physicians, being able to implement it in clinical practice,” Dr. Aguiar said as moderator of press briefing prior to the ESC congress.

The ESC guideline’s next iteration or update could well include an SGLT2 inhibitor recommendation that applies beyond the ejection fraction limits of HFrEF. Still, the document summarized that day reflects a number of pivotal concepts with profound treatment implications. Among them are the field’s latest paradigm for medical therapy of HFrEF and the increasingly accepted division of traditional HFpEF into two entities: HF with mildly reduced ejection fraction (HFmrEF); and HFpEF, with its left ventricular ejection fraction (LVEF) threshold raised to 50%.

In fact, HFmrEF in the new document is a drug-therapy indication that barely existed a few years ago but grew in prominence after secondary findings from trials like TOPCAT for spironolactone and PARAGON-HF for sacubitril-valsartan (Entresto, Novartis), an angiotensin-receptor/neprilysin inhibitor (ARNI). Still, the HFmrEF recommendations come with different class and level-of-evidence designations.

Those new guideline features and others in the realm of pharmacologic therapy were summarized by the document’s authors at the 2021 Heart Failure Association of the European Society of Cardiology (ESC-HFA) meeting, and covered at the time by this news organization

The ‘fantastic four’

One of the document’s central recommendations specifies which contemporary drug classes should be initiated, and when, in patients with HFrEF. An ACE inhibitor or ARNI, a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor collectively earned a class I recommendation, “given the importance of these key HFrEF therapies, some of which have been shown to improve outcomes within a month of initiation,” observed Roy S. Gardner, MBChB, MD.

An agent from each of the four classes is to be “commenced and up-titrated as quickly and as safely as possible, whilst using the lowest effective dose of loop diuretic to relieve congestion,” said Dr. Gardner, from Golden Jubilee National Hospital, Clydebank, Scotland, when presenting the full HFrEF portion of the guidelines.

The oral soluble guanylate-cyclase receptor stimulator vericiguat (Verquvo, Merck), which recently emerged from the VICTORIA trial as a modest success for patients with HFrEF and a previous HF hospitalization, gained a class IIb recommendation.

The document’s “simplified algorithm” for managing such patients overall and the advent of SGLT2 inhibitors are new twists in ESC guidelines for HF. But the way the four drug classes are started in patients is key and could take some practitioners time to get used to. There is no prespecified order of initiation.

“We’ve left the door open for clinicians to evaluate the evidence to make sure these four drugs are started, and to tailor how to do it according to the patient,” based on clinical considerations such as blood pressure or renal function, said Theresa A. McDonagh, MD, King’s College London, cochair of the guideline task force.

“The SGLT2 inhibitor trials were done on top of therapy with ACE inhibitors or ARNI, beta-blockers, and MRAs, so some people no doubt will choose to follow a sequenced approach,” Dr. McDonagh said. Other practitioners will consider each patient and attempt to get all four started “as quickly and safely as possible based on the phenotype.”

Importantly, clinicians “should not wait for weeks, months, or years until you have the four drugs in the patient, but you should do this within weeks,” cautioned Johann Bauersachs, MD, Hannover (Germany) Medical School, a discussant for the guideline presentation who is listed as a reviewer on the document.

Although angiotensin-receptor blockers (ARBs) and ACE inhibitors are sometimes thought of as interchangeable, the new guideline does not give them the same weight. “The angiotensin-receptor blocker valsartan is a constituent of the ARNI,” Dr. McDonagh noted. “So, the place of ARBs in heart failure has been downgraded in HFrEF. They are really for those who are intolerant of an ACE inhibitor or an ARNI.”

In practice, ARBs are likely to be used as first-line therapy in some circumstances, observed Dr. Bauersachs. They are “the default option in, unfortunately, many low-income countries that may not afford sacubitril-valsartan. And I know that there are many of them.”
 

Tweaks to device recommendations

The new document contains several new wrinkles in the recommendations for HF device therapy, which should usually be considered only if still appropriate after at least 3 months of optimal medical therapy, Dr. Gardner said.

For example, use of an implantable cardioverter-defibrillator (ICD) has been demoted from its previous class I recommendation to class II, level of evidence A, in patients with nonischemic cardiomyopathy “in light of the data from the DANISH study,” Dr. Gardner said.

The 2016 DANISH trial was noteworthy for questioning the survival benefits of ICDs in patients with nonischemic cardiomyopathy, whether or not they were also receiving cardiac resynchronization therapy (CRT).

The new document also puts greater emphasis on a range of specific CRT patient-selection criteria. Beyond the conventional recommended standards of an LVEF of 35% or less, QRS of at least 150 ms, and left-bundle-branch block on optimal meds, consideration can be given to CRT if the QRS is only 130 ms or greater. “And where it’s appropriate to do so, an ICD could be an option,” Dr. Gardner said.

It also recommends CRT as a replacement for right ventricular pacing in patients with high-degree atrioventricular block. “And this, for the first time, includes patients with atrial fibrillation,” he said. “The previous indications for CRT were in individuals in sinus rhythm.”

The new document recommends that HF in any patient be classified as HFrEF, defined by an LVEF of ≤40%; HFmrEF, defined by an LVEF of 41%-49%; or HFpEF, defined by an LVEF of at least 50%. “Importantly, for all forms, the presence of the clinical syndrome of heart failure is a prerequisite,” observed Carolyn S.P. Lam, MBBS, PhD, Duke-NUS Graduate Medical School, Singapore, at the presentation.

In a critical update from previous guidelines, the term HF with “mid-range” ejection fraction was replaced by the term specifying “mildly reduced” ejection fraction, Dr. Lam noted. The shift retains the acronym but now reflects growing appreciation that HFmrEF patients can benefit from treatments also used in HFrEF, including ACE inhibitors, ARBs, beta-blockers, MRAs, and sacubitril-valsartan, she said.

Support for that relationship comes largely from post hoc subgroup analyses of trials that featured some patients with LVEF 40%-49%. That includes most HFpEF trials represented in the guideline document, but also EMPEROR-Preserved, which saw gains for the primary outcome across the entire range of LVEF above 40%.

The LVEF-based definitions are consistent with a recent HF classification proposal endorsed by the ESC and subspecialty societies in Europe, North America, Japan, India, Australia, New Zealand, and China.

The document doesn’t update recommendations for HFpEF, in which “no treatment has been shown to convincingly reduce mortality or morbidity,” Dr. Lam observed. Still, she noted, the guideline task force “acknowledges that treatment options for HFpEF are being revised even as the guidelines have been published.”

That could be a reference to empagliflozin in EMPEROR-Preserved, but it also refers to the strikingly broad wording of an expanded indication for sacubitril-valsartan in the United States – “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure” – without specific restrictions on the basis of LVEF. The new indication was announced in early 2021, too late to be considered in the new guidelines.
 

Whither LVEF-based definitions?

During discussion after the guideline presentation, Dr. Zannad speculated on the future of HF classifications based on ventricular function, given trial evidence in recent years that some agents – notably spironolactone, sacubitril-valsartan, and now, apparently, empagliflozin – might be effective in HFpEF as well as HFrEF.

Will the field continue with “LVEF-centric” distinctions across the range of HF, or transition to “some definition in which drug therapies can be used independently across the full spectrum of ejection fraction?” Dr. Zannad posed.

“I think we need to wait and see what some of these trials with the SGLT2 inhibitors are going to show in heart failure with preserved ejection fraction,” Dr. McDonagh replied. “And I think that will be a step for the next guideline, completely redefining heart failure.”

A version of this article first appeared on Medscape.com.

The new guideline on management of heart failure (HF) from the European Society of Cardiology seemed to bear an asterisk or footnote even before its full unveiling in the early hours of ESC Congress 2021.

frankpeters/Getty Images

The document would offer little new in the arena of HF with preserved ejection fraction (HFpEF), so understandably the fast-approaching presentation of a major HFpEF trial – arguably the conference’s marquee event – would feel to some like the elephant in the room.

“I’d like to highlight this unfortunate timing of the guideline, because it’s an hour or 2 before we hear the full story from EMPEROR-Preserved, which I’m sure will change the guidelines,” Faiez Zannad, MD, PhD, University of Lorraine, Vandoeuvre-Les-Nancy, France, said wryly.

Anticipation of the trial’s full presentation was intense as the ESC congress got underway, in part because the top-line and incomplete message from EMPEROR-Preserved had already been released: Patients with HFpEF treated with the sodium-glucose cotransporter 2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) showed a significant benefit for the primary endpoint of cardiovascular (CV) death or HF hospitalization.

Although empagliflozin is the first medication to achieve that status in a major HFpEF trial, conspicuously absent from the early announcement were the magnitude of “benefit” and any data. Still, the tantalizing top-line results mean that technically, at least, “we have a drug which is effective in reduced and preserved ejection fraction,” Dr. Zannad said.

But the new guideline, published online Aug. 27, 2021, in the European Heart Journal and comprehensively described that day at the congress, was never really expected to consider results from EMPEROR-Reduced. “These new indications do need to go through the regulatory authorities,” such as the European Medicines Agency and the U.S. Food and Drug Administration, observed Carlos Aguiar, MD, Hospital Santa Cruz, Carnaxide, Portugal.

“It does take some time for the whole process to be concluded and, finally, as physicians, being able to implement it in clinical practice,” Dr. Aguiar said as moderator of press briefing prior to the ESC congress.

The ESC guideline’s next iteration or update could well include an SGLT2 inhibitor recommendation that applies beyond the ejection fraction limits of HFrEF. Still, the document summarized that day reflects a number of pivotal concepts with profound treatment implications. Among them are the field’s latest paradigm for medical therapy of HFrEF and the increasingly accepted division of traditional HFpEF into two entities: HF with mildly reduced ejection fraction (HFmrEF); and HFpEF, with its left ventricular ejection fraction (LVEF) threshold raised to 50%.

In fact, HFmrEF in the new document is a drug-therapy indication that barely existed a few years ago but grew in prominence after secondary findings from trials like TOPCAT for spironolactone and PARAGON-HF for sacubitril-valsartan (Entresto, Novartis), an angiotensin-receptor/neprilysin inhibitor (ARNI). Still, the HFmrEF recommendations come with different class and level-of-evidence designations.

Those new guideline features and others in the realm of pharmacologic therapy were summarized by the document’s authors at the 2021 Heart Failure Association of the European Society of Cardiology (ESC-HFA) meeting, and covered at the time by this news organization

The ‘fantastic four’

One of the document’s central recommendations specifies which contemporary drug classes should be initiated, and when, in patients with HFrEF. An ACE inhibitor or ARNI, a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor collectively earned a class I recommendation, “given the importance of these key HFrEF therapies, some of which have been shown to improve outcomes within a month of initiation,” observed Roy S. Gardner, MBChB, MD.

An agent from each of the four classes is to be “commenced and up-titrated as quickly and as safely as possible, whilst using the lowest effective dose of loop diuretic to relieve congestion,” said Dr. Gardner, from Golden Jubilee National Hospital, Clydebank, Scotland, when presenting the full HFrEF portion of the guidelines.

The oral soluble guanylate-cyclase receptor stimulator vericiguat (Verquvo, Merck), which recently emerged from the VICTORIA trial as a modest success for patients with HFrEF and a previous HF hospitalization, gained a class IIb recommendation.

The document’s “simplified algorithm” for managing such patients overall and the advent of SGLT2 inhibitors are new twists in ESC guidelines for HF. But the way the four drug classes are started in patients is key and could take some practitioners time to get used to. There is no prespecified order of initiation.

“We’ve left the door open for clinicians to evaluate the evidence to make sure these four drugs are started, and to tailor how to do it according to the patient,” based on clinical considerations such as blood pressure or renal function, said Theresa A. McDonagh, MD, King’s College London, cochair of the guideline task force.

“The SGLT2 inhibitor trials were done on top of therapy with ACE inhibitors or ARNI, beta-blockers, and MRAs, so some people no doubt will choose to follow a sequenced approach,” Dr. McDonagh said. Other practitioners will consider each patient and attempt to get all four started “as quickly and safely as possible based on the phenotype.”

Importantly, clinicians “should not wait for weeks, months, or years until you have the four drugs in the patient, but you should do this within weeks,” cautioned Johann Bauersachs, MD, Hannover (Germany) Medical School, a discussant for the guideline presentation who is listed as a reviewer on the document.

Although angiotensin-receptor blockers (ARBs) and ACE inhibitors are sometimes thought of as interchangeable, the new guideline does not give them the same weight. “The angiotensin-receptor blocker valsartan is a constituent of the ARNI,” Dr. McDonagh noted. “So, the place of ARBs in heart failure has been downgraded in HFrEF. They are really for those who are intolerant of an ACE inhibitor or an ARNI.”

In practice, ARBs are likely to be used as first-line therapy in some circumstances, observed Dr. Bauersachs. They are “the default option in, unfortunately, many low-income countries that may not afford sacubitril-valsartan. And I know that there are many of them.”
 

Tweaks to device recommendations

The new document contains several new wrinkles in the recommendations for HF device therapy, which should usually be considered only if still appropriate after at least 3 months of optimal medical therapy, Dr. Gardner said.

For example, use of an implantable cardioverter-defibrillator (ICD) has been demoted from its previous class I recommendation to class II, level of evidence A, in patients with nonischemic cardiomyopathy “in light of the data from the DANISH study,” Dr. Gardner said.

The 2016 DANISH trial was noteworthy for questioning the survival benefits of ICDs in patients with nonischemic cardiomyopathy, whether or not they were also receiving cardiac resynchronization therapy (CRT).

The new document also puts greater emphasis on a range of specific CRT patient-selection criteria. Beyond the conventional recommended standards of an LVEF of 35% or less, QRS of at least 150 ms, and left-bundle-branch block on optimal meds, consideration can be given to CRT if the QRS is only 130 ms or greater. “And where it’s appropriate to do so, an ICD could be an option,” Dr. Gardner said.

It also recommends CRT as a replacement for right ventricular pacing in patients with high-degree atrioventricular block. “And this, for the first time, includes patients with atrial fibrillation,” he said. “The previous indications for CRT were in individuals in sinus rhythm.”

The new document recommends that HF in any patient be classified as HFrEF, defined by an LVEF of ≤40%; HFmrEF, defined by an LVEF of 41%-49%; or HFpEF, defined by an LVEF of at least 50%. “Importantly, for all forms, the presence of the clinical syndrome of heart failure is a prerequisite,” observed Carolyn S.P. Lam, MBBS, PhD, Duke-NUS Graduate Medical School, Singapore, at the presentation.

In a critical update from previous guidelines, the term HF with “mid-range” ejection fraction was replaced by the term specifying “mildly reduced” ejection fraction, Dr. Lam noted. The shift retains the acronym but now reflects growing appreciation that HFmrEF patients can benefit from treatments also used in HFrEF, including ACE inhibitors, ARBs, beta-blockers, MRAs, and sacubitril-valsartan, she said.

Support for that relationship comes largely from post hoc subgroup analyses of trials that featured some patients with LVEF 40%-49%. That includes most HFpEF trials represented in the guideline document, but also EMPEROR-Preserved, which saw gains for the primary outcome across the entire range of LVEF above 40%.

The LVEF-based definitions are consistent with a recent HF classification proposal endorsed by the ESC and subspecialty societies in Europe, North America, Japan, India, Australia, New Zealand, and China.

The document doesn’t update recommendations for HFpEF, in which “no treatment has been shown to convincingly reduce mortality or morbidity,” Dr. Lam observed. Still, she noted, the guideline task force “acknowledges that treatment options for HFpEF are being revised even as the guidelines have been published.”

That could be a reference to empagliflozin in EMPEROR-Preserved, but it also refers to the strikingly broad wording of an expanded indication for sacubitril-valsartan in the United States – “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure” – without specific restrictions on the basis of LVEF. The new indication was announced in early 2021, too late to be considered in the new guidelines.
 

Whither LVEF-based definitions?

During discussion after the guideline presentation, Dr. Zannad speculated on the future of HF classifications based on ventricular function, given trial evidence in recent years that some agents – notably spironolactone, sacubitril-valsartan, and now, apparently, empagliflozin – might be effective in HFpEF as well as HFrEF.

Will the field continue with “LVEF-centric” distinctions across the range of HF, or transition to “some definition in which drug therapies can be used independently across the full spectrum of ejection fraction?” Dr. Zannad posed.

“I think we need to wait and see what some of these trials with the SGLT2 inhibitors are going to show in heart failure with preserved ejection fraction,” Dr. McDonagh replied. “And I think that will be a step for the next guideline, completely redefining heart failure.”

A version of this article first appeared on Medscape.com.

The new guideline on management of heart failure (HF) from the European Society of Cardiology seemed to bear an asterisk or footnote even before its full unveiling in the early hours of ESC Congress 2021.

frankpeters/Getty Images

The document would offer little new in the arena of HF with preserved ejection fraction (HFpEF), so understandably the fast-approaching presentation of a major HFpEF trial – arguably the conference’s marquee event – would feel to some like the elephant in the room.

“I’d like to highlight this unfortunate timing of the guideline, because it’s an hour or 2 before we hear the full story from EMPEROR-Preserved, which I’m sure will change the guidelines,” Faiez Zannad, MD, PhD, University of Lorraine, Vandoeuvre-Les-Nancy, France, said wryly.

Anticipation of the trial’s full presentation was intense as the ESC congress got underway, in part because the top-line and incomplete message from EMPEROR-Preserved had already been released: Patients with HFpEF treated with the sodium-glucose cotransporter 2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) showed a significant benefit for the primary endpoint of cardiovascular (CV) death or HF hospitalization.

Although empagliflozin is the first medication to achieve that status in a major HFpEF trial, conspicuously absent from the early announcement were the magnitude of “benefit” and any data. Still, the tantalizing top-line results mean that technically, at least, “we have a drug which is effective in reduced and preserved ejection fraction,” Dr. Zannad said.

But the new guideline, published online Aug. 27, 2021, in the European Heart Journal and comprehensively described that day at the congress, was never really expected to consider results from EMPEROR-Reduced. “These new indications do need to go through the regulatory authorities,” such as the European Medicines Agency and the U.S. Food and Drug Administration, observed Carlos Aguiar, MD, Hospital Santa Cruz, Carnaxide, Portugal.

“It does take some time for the whole process to be concluded and, finally, as physicians, being able to implement it in clinical practice,” Dr. Aguiar said as moderator of press briefing prior to the ESC congress.

The ESC guideline’s next iteration or update could well include an SGLT2 inhibitor recommendation that applies beyond the ejection fraction limits of HFrEF. Still, the document summarized that day reflects a number of pivotal concepts with profound treatment implications. Among them are the field’s latest paradigm for medical therapy of HFrEF and the increasingly accepted division of traditional HFpEF into two entities: HF with mildly reduced ejection fraction (HFmrEF); and HFpEF, with its left ventricular ejection fraction (LVEF) threshold raised to 50%.

In fact, HFmrEF in the new document is a drug-therapy indication that barely existed a few years ago but grew in prominence after secondary findings from trials like TOPCAT for spironolactone and PARAGON-HF for sacubitril-valsartan (Entresto, Novartis), an angiotensin-receptor/neprilysin inhibitor (ARNI). Still, the HFmrEF recommendations come with different class and level-of-evidence designations.

Those new guideline features and others in the realm of pharmacologic therapy were summarized by the document’s authors at the 2021 Heart Failure Association of the European Society of Cardiology (ESC-HFA) meeting, and covered at the time by this news organization

The ‘fantastic four’

One of the document’s central recommendations specifies which contemporary drug classes should be initiated, and when, in patients with HFrEF. An ACE inhibitor or ARNI, a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor collectively earned a class I recommendation, “given the importance of these key HFrEF therapies, some of which have been shown to improve outcomes within a month of initiation,” observed Roy S. Gardner, MBChB, MD.

An agent from each of the four classes is to be “commenced and up-titrated as quickly and as safely as possible, whilst using the lowest effective dose of loop diuretic to relieve congestion,” said Dr. Gardner, from Golden Jubilee National Hospital, Clydebank, Scotland, when presenting the full HFrEF portion of the guidelines.

The oral soluble guanylate-cyclase receptor stimulator vericiguat (Verquvo, Merck), which recently emerged from the VICTORIA trial as a modest success for patients with HFrEF and a previous HF hospitalization, gained a class IIb recommendation.

The document’s “simplified algorithm” for managing such patients overall and the advent of SGLT2 inhibitors are new twists in ESC guidelines for HF. But the way the four drug classes are started in patients is key and could take some practitioners time to get used to. There is no prespecified order of initiation.

“We’ve left the door open for clinicians to evaluate the evidence to make sure these four drugs are started, and to tailor how to do it according to the patient,” based on clinical considerations such as blood pressure or renal function, said Theresa A. McDonagh, MD, King’s College London, cochair of the guideline task force.

“The SGLT2 inhibitor trials were done on top of therapy with ACE inhibitors or ARNI, beta-blockers, and MRAs, so some people no doubt will choose to follow a sequenced approach,” Dr. McDonagh said. Other practitioners will consider each patient and attempt to get all four started “as quickly and safely as possible based on the phenotype.”

Importantly, clinicians “should not wait for weeks, months, or years until you have the four drugs in the patient, but you should do this within weeks,” cautioned Johann Bauersachs, MD, Hannover (Germany) Medical School, a discussant for the guideline presentation who is listed as a reviewer on the document.

Although angiotensin-receptor blockers (ARBs) and ACE inhibitors are sometimes thought of as interchangeable, the new guideline does not give them the same weight. “The angiotensin-receptor blocker valsartan is a constituent of the ARNI,” Dr. McDonagh noted. “So, the place of ARBs in heart failure has been downgraded in HFrEF. They are really for those who are intolerant of an ACE inhibitor or an ARNI.”

In practice, ARBs are likely to be used as first-line therapy in some circumstances, observed Dr. Bauersachs. They are “the default option in, unfortunately, many low-income countries that may not afford sacubitril-valsartan. And I know that there are many of them.”
 

Tweaks to device recommendations

The new document contains several new wrinkles in the recommendations for HF device therapy, which should usually be considered only if still appropriate after at least 3 months of optimal medical therapy, Dr. Gardner said.

For example, use of an implantable cardioverter-defibrillator (ICD) has been demoted from its previous class I recommendation to class II, level of evidence A, in patients with nonischemic cardiomyopathy “in light of the data from the DANISH study,” Dr. Gardner said.

The 2016 DANISH trial was noteworthy for questioning the survival benefits of ICDs in patients with nonischemic cardiomyopathy, whether or not they were also receiving cardiac resynchronization therapy (CRT).

The new document also puts greater emphasis on a range of specific CRT patient-selection criteria. Beyond the conventional recommended standards of an LVEF of 35% or less, QRS of at least 150 ms, and left-bundle-branch block on optimal meds, consideration can be given to CRT if the QRS is only 130 ms or greater. “And where it’s appropriate to do so, an ICD could be an option,” Dr. Gardner said.

It also recommends CRT as a replacement for right ventricular pacing in patients with high-degree atrioventricular block. “And this, for the first time, includes patients with atrial fibrillation,” he said. “The previous indications for CRT were in individuals in sinus rhythm.”

The new document recommends that HF in any patient be classified as HFrEF, defined by an LVEF of ≤40%; HFmrEF, defined by an LVEF of 41%-49%; or HFpEF, defined by an LVEF of at least 50%. “Importantly, for all forms, the presence of the clinical syndrome of heart failure is a prerequisite,” observed Carolyn S.P. Lam, MBBS, PhD, Duke-NUS Graduate Medical School, Singapore, at the presentation.

In a critical update from previous guidelines, the term HF with “mid-range” ejection fraction was replaced by the term specifying “mildly reduced” ejection fraction, Dr. Lam noted. The shift retains the acronym but now reflects growing appreciation that HFmrEF patients can benefit from treatments also used in HFrEF, including ACE inhibitors, ARBs, beta-blockers, MRAs, and sacubitril-valsartan, she said.

Support for that relationship comes largely from post hoc subgroup analyses of trials that featured some patients with LVEF 40%-49%. That includes most HFpEF trials represented in the guideline document, but also EMPEROR-Preserved, which saw gains for the primary outcome across the entire range of LVEF above 40%.

The LVEF-based definitions are consistent with a recent HF classification proposal endorsed by the ESC and subspecialty societies in Europe, North America, Japan, India, Australia, New Zealand, and China.

The document doesn’t update recommendations for HFpEF, in which “no treatment has been shown to convincingly reduce mortality or morbidity,” Dr. Lam observed. Still, she noted, the guideline task force “acknowledges that treatment options for HFpEF are being revised even as the guidelines have been published.”

That could be a reference to empagliflozin in EMPEROR-Preserved, but it also refers to the strikingly broad wording of an expanded indication for sacubitril-valsartan in the United States – “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure” – without specific restrictions on the basis of LVEF. The new indication was announced in early 2021, too late to be considered in the new guidelines.
 

Whither LVEF-based definitions?

During discussion after the guideline presentation, Dr. Zannad speculated on the future of HF classifications based on ventricular function, given trial evidence in recent years that some agents – notably spironolactone, sacubitril-valsartan, and now, apparently, empagliflozin – might be effective in HFpEF as well as HFrEF.

Will the field continue with “LVEF-centric” distinctions across the range of HF, or transition to “some definition in which drug therapies can be used independently across the full spectrum of ejection fraction?” Dr. Zannad posed.

“I think we need to wait and see what some of these trials with the SGLT2 inhibitors are going to show in heart failure with preserved ejection fraction,” Dr. McDonagh replied. “And I think that will be a step for the next guideline, completely redefining heart failure.”

A version of this article first appeared on Medscape.com.