Patient Safety in Transitions of Care: Addressing Discharge Communication Gaps and the Potential of the Teach-Back Method

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Patient Safety in Transitions of Care: Addressing Discharge Communication Gaps and the Potential of the Teach-Back Method

Study 1 Overview (Trivedi et al)

Objective: This observational quality improvement study aimed to evaluate the discharge communication practices in internal medicine services at 2 urban academic teaching hospitals, specifically focusing on patient education and counseling in 6 key discharge communication domains.

Design: Observations were conducted over a 13-month period from September 2018 through October 2019, following the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.

Setting and participants: The study involved a total of 33 English- and Spanish-speaking patients purposefully selected from the “discharge before noon” list at 2 urban tertiary-care teaching hospitals. A total of 155 observation hours were accumulated, with an average observation time of 4.7 hours per patient on the day of discharge.

Main outcome measures: The study assessed 6 discharge communication domains: (1) the name and function of medication changes, (2) the purpose of postdischarge appointments, (3) disease self-management, (4) red flags or warning signs for complications, (5) teach-back techniques to confirm patient understanding, and (6) staff solicitation of patient questions or concerns.

Main results: The study found several gaps in discharge communication practices. Among the 29 patients with medication changes, 28% were not informed about the name and basic function of the changes, while 59% did not receive counseling on the purpose for the medication change. In terms of postdischarge appointments, 48% of patients were not told the purpose of these appointments. Moreover, 54% of patients did not receive counseling on self-management of their primary discharge diagnosis or other diagnoses, and 73% were not informed about symptom expectations or the expected course of their illness after leaving the hospital. Most patients (82%) were not counseled on red-flag signs and symptoms that should prompt immediate return to care.

Teach-back techniques, which are critical for ensuring patient understanding, were used in only 3% of cases, and 85% of patients were not asked by health care providers if there might be barriers to following the care plan. Less than half (42%) of the patients were asked if they had any questions, with most questions being logistical and often deferred to another team member or met with uncertainty. Of note, among the 33 patients, only 2 patients received extensive information that covered 5 or 6 out of 6 discharge communication domains.

The study found variable roles in who communicated what aspects of discharge education, with most domains being communicated in an ad hoc manner and no clear pattern of responsibility. However, 2 exceptions were observed: nurses were more likely to provide information about new or changed medications and follow-up appointments, and the only example of teach-back was conducted by an attending physician.

Conclusion: The study highlights a significant need for improved discharge techniques to enhance patient safety and quality of care upon leaving the hospital. Interventions should focus on increasing transparency in patient education and understanding, clarifying assumptions of roles among the interprofessional team, and implementing effective communication strategies and system redesigns that foster patient-centered discharge education. Also, the study revealed that some patients received more robust discharge education than others, indicating systemic inequality in the patient experience. Further studies are needed to explore the development and assessment of such interventions to ensure optimal patient outcomes and equal care following hospital discharge.

 

 

Study 2 Overview (Marks et al)

Objective: This study aimed to investigate the impact of a nurse-led discharge medication education program, Teaching Important Medication Effects (TIME), on patients’ new medication knowledge at discharge and 48 to 72 hours post discharge. The specific objectives were to identify patients’ priority learning needs, evaluate the influence of TIME on patients’ new medication knowledge before and after discharge, and assess the effect of TIME on patients’ experience and satisfaction with medication education.

Design: The study employed a longitudinal pretest/post-test, 2-group design involving 107 randomly selected medical-surgical patients from an academic hospital. Participants were interviewed before and within 72 hours after discharge following administration of medication instructions. Bivariate analyses were performed to assess demographic and outcome variable differences between groups.

Setting and participants: Conducted on a 24-bed medical-surgical unit at a large Magnet® hospital over 18 months (2018-2019), the study included patients with at least 1 new medication, aged 18 years or older, able to read and speak English or Spanish, admitted from home with a minimum 1 overnight stay, and planning to return home post discharge. Excluded were cognitively impaired patients, those assigned to a resource pool nurse without TIME training, and those having a research team member assigned. Participants were randomly selected from a computerized list of patients scheduled for discharge.

Main outcome measures: Primary outcome measures included patients’ new medication knowledge before and after discharge and patients’ experience and satisfaction with medication education.

Main results: The usual care (n = 52) and TIME (n = 55) patients had similar baseline demographic characteristics. The study revealed that almost all patients in both usual care and TIME groups were aware of their new medication and its purpose at discharge. However, differences were observed in medication side effect responses, with 72.5% of the usual-care group knowing side effects compared to 94.3% of the TIME group (P = .003). Additionally, 81.5% of the usual-care group understood the medication purpose compared to 100% of the TIME group (P = .02). During the 48- to 72-hour postdischarge calls, consistent responses were found from both groups regarding knowledge of new medication, medication name, and medication purpose. Similar to discharge results, differences in medication side effect responses were observed, with 75.8% of the usual care group correctly identifying at least 1 medication side effect compared to 93.9% of the TIME group (P = .04). TIME was associated with higher satisfaction with medication education compared to usual care (97% vs. 46.9%, P < .001).

Conclusion: The nurse-led discharge medication education program TIME effectively enhanced patients’ new medication knowledge at discharge and 48 to 72 hours after discharge. The program also significantly improved patients’ experience and satisfaction with medication education. These findings indicate that TIME is a valuable tool for augmenting patient education and medication adherence in a hospital setting. By incorporating the teach-back method, TIME offers a structured approach to educating patients about their medications at hospital discharge, leading to improved care transitions.

 

 

Commentary

Suboptimal communication between patients, caregivers, and providers upon hospital discharge is a major contributor to patients’ inadequate understanding of postdischarge care plans. This inadequate understanding leads to preventable harms, such as medication errors, adverse events, emergency room visits, and costly hospital readmissions.1 The issue is further exacerbated by a lack of clarity among health care team members’ respective roles in providing information that optimizes care transitions during the discharge communication process. Moreover, low health literacy, particularly prevalent among seniors, those from disadvantaged backgrouds, and those with lower education attainment or chronic illnesses, create additional barriers to effective discharge communication. A potential solution to this problem is the adoption of effective teaching strategies, specifically the teach-back method. This method employs techniques that ensure patients’ understanding and recall of new information regardless of health literacy, and places accountability on clinicians rather than patients. By closing communication gaps between clinicians and patients, the teach-back method can reduce hospital readmissions, hospital-acquired conditions, and mortality rates, while improving patient satisfaction with health care instructions and the overall hospital experience.2

Study 1, by Trivedi et al, and study 2, by Marks et al, aimed to identify and address problems related to poor communication between patients and health care team members at hospital discharge. Specifically, study 1 examined routine discharge communication practices to determine communication gaps, while study 2 evaluated a nurse-led teach-back intervention program designed to improve patients’ medication knowledge and satisfaction. These distinct objectives and designs reflected the unique ways each study approached the challenges associated with care transitions at the time of hospital discharge.

Study 1 used direct observation of patient-practitioner interactions to evaluate routine discharge communication practices in internal medicine services at 2 urban academic teaching hospitals. In the 33 patients observed, significant gaps in discharge communication practices were identified in the domains of medication changes, postdischarge appointments, disease self-management, and red flags or warning signs. Unsurprisingly, most of these domains were communicated in an ad hoc manner by members of the health care team without a clear pattern of responsibility in reference to patient discharge education, and teach-back was seldom used. These findings underscore the need for improved discharge techniques, effective communication strategies, and clarification of roles among the interprofessional team to enhance the safety, quality of care, and overall patient experience during hospital discharge.

Study 2 aimed to augment the hospital discharge communication process by implementing a nurse-led discharge medication education program (TIME), which targeted patients’ priority learning needs, new medication knowledge, and satisfaction with medication education. In the 107 patients assessed, this teach-back method enhanced patients’ new medication knowledge at discharge and 48 to 72 hours after discharge, as well as improved patients’ experience and satisfaction with medication education. These results suggest that a teach-back method such as the TIME program could be a solution to care transition problems identified in the Trivedi et al study by providing a structured approach to patient education and enhancing communication practices during the hospital discharge process. Thus, by implementing the TIME program, hospitals may improve patient outcomes, safety, and overall quality of care upon leaving the hospital.

Applications for Clinical Practice and System Implementation

Care transition at the time of hospital discharge is a particularly pivotal period in the care of vulnerable individuals. There is growing literature, including studies discussed in this review, to indicate that by focusing on improving patient-practitioner communication during the discharge process and using strategies such as the teach-back method, health care professionals can better prepare patients for self-management in the post-acute period and help them make informed decisions about their care. This emphasis on care-transition communication strategies may lead to a reduction in medication errors, adverse events, and hospital readmissions, ultimately improving patient outcomes and satisfaction. Barriers to system implementation of such strategies may include competing demands and responsibilities of busy practitioners as well as the inherent complexities associated with hospital discharge. Creative solutions, such as the utilization of telehealth and early transition-of-care visits, represent some potential approaches to counter these barriers.

While both studies illustrated barriers and facilitators of hospital discharge communication, each study had limitations that impacted their generalizability to real-world clinical practice. Limitations in study 1 included a small sample size, purposive sampling method, and a focus on planned discharges in a teaching hospital, which may introduce selection bias. The study’s findings may not be generalizable to unplanned discharges, patients who do not speak English or Spanish, or nonteaching hospitals. Additionally, the data were collected before the COVID-19 pandemic, which could have further impacted discharge education practices. The study also revealed that some patients received more robust discharge education than others, which indicated systemic inequality in the patient experience. Further research is required to address this discrepancy. Limitations in study 2 included a relatively small and homogeneous sample, with most participants being younger, non-Hispanic White, English-speaking, and well-educated. This lack of diversity may limit the generalizability of the findings. Furthermore, the study did not evaluate the patients’ knowledge of medication dosage and focused only on new medications. Future studies should examine the effect of teach-back on a broader range of self-management topics in preparation for discharge, while also including a more diverse population to account for factors related to social determinants of health. Taken together, further research is needed to address these limitations and ensure more generalizable results that can more broadly improve discharge education and care transitions that bridge acute and post-acute care.

Practice Points

  • There is a significant need for improved discharge strategies to enhance patient safety and quality of care upon leaving the hospital.
  • Teach-back method may offer a structured approach to educating patients about their medications at hospital discharge and improve care transitions.

–Yuka Shichijo, MD, and Fred Ko, MD, Mount Sinai Beth Israel Hospital, New York, NY

References

1. Snow V, Beck D, Budnitz T, Miller DC, Potter J, Wears RL, Weiss KB, Williams MV; American College of Physicians; Society of General Internal Medicine; Society of Hospital Medicine; American Geriatrics Society; American College of Emergency Physicians; Society of Academic Emergency Medicine. Transitions of care consensus policy statement American College of Physicians-Society of General Internal Medicine-Society of Hospital Medicine-American Geriatrics Society-American College of Emergency Physicians-Society of Academic Emergency Medicine. J Gen Intern Med. 2009;24(8):971-976. doi:10.1007/s11606-009-0969-x

2. Yen PH, Leasure AR. Use and effectiveness of the teach-back method in patient education and health outcomes. Fed. Pract. 2019;36(6):284-289.

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Study 1 Overview (Trivedi et al)

Objective: This observational quality improvement study aimed to evaluate the discharge communication practices in internal medicine services at 2 urban academic teaching hospitals, specifically focusing on patient education and counseling in 6 key discharge communication domains.

Design: Observations were conducted over a 13-month period from September 2018 through October 2019, following the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.

Setting and participants: The study involved a total of 33 English- and Spanish-speaking patients purposefully selected from the “discharge before noon” list at 2 urban tertiary-care teaching hospitals. A total of 155 observation hours were accumulated, with an average observation time of 4.7 hours per patient on the day of discharge.

Main outcome measures: The study assessed 6 discharge communication domains: (1) the name and function of medication changes, (2) the purpose of postdischarge appointments, (3) disease self-management, (4) red flags or warning signs for complications, (5) teach-back techniques to confirm patient understanding, and (6) staff solicitation of patient questions or concerns.

Main results: The study found several gaps in discharge communication practices. Among the 29 patients with medication changes, 28% were not informed about the name and basic function of the changes, while 59% did not receive counseling on the purpose for the medication change. In terms of postdischarge appointments, 48% of patients were not told the purpose of these appointments. Moreover, 54% of patients did not receive counseling on self-management of their primary discharge diagnosis or other diagnoses, and 73% were not informed about symptom expectations or the expected course of their illness after leaving the hospital. Most patients (82%) were not counseled on red-flag signs and symptoms that should prompt immediate return to care.

Teach-back techniques, which are critical for ensuring patient understanding, were used in only 3% of cases, and 85% of patients were not asked by health care providers if there might be barriers to following the care plan. Less than half (42%) of the patients were asked if they had any questions, with most questions being logistical and often deferred to another team member or met with uncertainty. Of note, among the 33 patients, only 2 patients received extensive information that covered 5 or 6 out of 6 discharge communication domains.

The study found variable roles in who communicated what aspects of discharge education, with most domains being communicated in an ad hoc manner and no clear pattern of responsibility. However, 2 exceptions were observed: nurses were more likely to provide information about new or changed medications and follow-up appointments, and the only example of teach-back was conducted by an attending physician.

Conclusion: The study highlights a significant need for improved discharge techniques to enhance patient safety and quality of care upon leaving the hospital. Interventions should focus on increasing transparency in patient education and understanding, clarifying assumptions of roles among the interprofessional team, and implementing effective communication strategies and system redesigns that foster patient-centered discharge education. Also, the study revealed that some patients received more robust discharge education than others, indicating systemic inequality in the patient experience. Further studies are needed to explore the development and assessment of such interventions to ensure optimal patient outcomes and equal care following hospital discharge.

 

 

Study 2 Overview (Marks et al)

Objective: This study aimed to investigate the impact of a nurse-led discharge medication education program, Teaching Important Medication Effects (TIME), on patients’ new medication knowledge at discharge and 48 to 72 hours post discharge. The specific objectives were to identify patients’ priority learning needs, evaluate the influence of TIME on patients’ new medication knowledge before and after discharge, and assess the effect of TIME on patients’ experience and satisfaction with medication education.

Design: The study employed a longitudinal pretest/post-test, 2-group design involving 107 randomly selected medical-surgical patients from an academic hospital. Participants were interviewed before and within 72 hours after discharge following administration of medication instructions. Bivariate analyses were performed to assess demographic and outcome variable differences between groups.

Setting and participants: Conducted on a 24-bed medical-surgical unit at a large Magnet® hospital over 18 months (2018-2019), the study included patients with at least 1 new medication, aged 18 years or older, able to read and speak English or Spanish, admitted from home with a minimum 1 overnight stay, and planning to return home post discharge. Excluded were cognitively impaired patients, those assigned to a resource pool nurse without TIME training, and those having a research team member assigned. Participants were randomly selected from a computerized list of patients scheduled for discharge.

Main outcome measures: Primary outcome measures included patients’ new medication knowledge before and after discharge and patients’ experience and satisfaction with medication education.

Main results: The usual care (n = 52) and TIME (n = 55) patients had similar baseline demographic characteristics. The study revealed that almost all patients in both usual care and TIME groups were aware of their new medication and its purpose at discharge. However, differences were observed in medication side effect responses, with 72.5% of the usual-care group knowing side effects compared to 94.3% of the TIME group (P = .003). Additionally, 81.5% of the usual-care group understood the medication purpose compared to 100% of the TIME group (P = .02). During the 48- to 72-hour postdischarge calls, consistent responses were found from both groups regarding knowledge of new medication, medication name, and medication purpose. Similar to discharge results, differences in medication side effect responses were observed, with 75.8% of the usual care group correctly identifying at least 1 medication side effect compared to 93.9% of the TIME group (P = .04). TIME was associated with higher satisfaction with medication education compared to usual care (97% vs. 46.9%, P < .001).

Conclusion: The nurse-led discharge medication education program TIME effectively enhanced patients’ new medication knowledge at discharge and 48 to 72 hours after discharge. The program also significantly improved patients’ experience and satisfaction with medication education. These findings indicate that TIME is a valuable tool for augmenting patient education and medication adherence in a hospital setting. By incorporating the teach-back method, TIME offers a structured approach to educating patients about their medications at hospital discharge, leading to improved care transitions.

 

 

Commentary

Suboptimal communication between patients, caregivers, and providers upon hospital discharge is a major contributor to patients’ inadequate understanding of postdischarge care plans. This inadequate understanding leads to preventable harms, such as medication errors, adverse events, emergency room visits, and costly hospital readmissions.1 The issue is further exacerbated by a lack of clarity among health care team members’ respective roles in providing information that optimizes care transitions during the discharge communication process. Moreover, low health literacy, particularly prevalent among seniors, those from disadvantaged backgrouds, and those with lower education attainment or chronic illnesses, create additional barriers to effective discharge communication. A potential solution to this problem is the adoption of effective teaching strategies, specifically the teach-back method. This method employs techniques that ensure patients’ understanding and recall of new information regardless of health literacy, and places accountability on clinicians rather than patients. By closing communication gaps between clinicians and patients, the teach-back method can reduce hospital readmissions, hospital-acquired conditions, and mortality rates, while improving patient satisfaction with health care instructions and the overall hospital experience.2

Study 1, by Trivedi et al, and study 2, by Marks et al, aimed to identify and address problems related to poor communication between patients and health care team members at hospital discharge. Specifically, study 1 examined routine discharge communication practices to determine communication gaps, while study 2 evaluated a nurse-led teach-back intervention program designed to improve patients’ medication knowledge and satisfaction. These distinct objectives and designs reflected the unique ways each study approached the challenges associated with care transitions at the time of hospital discharge.

Study 1 used direct observation of patient-practitioner interactions to evaluate routine discharge communication practices in internal medicine services at 2 urban academic teaching hospitals. In the 33 patients observed, significant gaps in discharge communication practices were identified in the domains of medication changes, postdischarge appointments, disease self-management, and red flags or warning signs. Unsurprisingly, most of these domains were communicated in an ad hoc manner by members of the health care team without a clear pattern of responsibility in reference to patient discharge education, and teach-back was seldom used. These findings underscore the need for improved discharge techniques, effective communication strategies, and clarification of roles among the interprofessional team to enhance the safety, quality of care, and overall patient experience during hospital discharge.

Study 2 aimed to augment the hospital discharge communication process by implementing a nurse-led discharge medication education program (TIME), which targeted patients’ priority learning needs, new medication knowledge, and satisfaction with medication education. In the 107 patients assessed, this teach-back method enhanced patients’ new medication knowledge at discharge and 48 to 72 hours after discharge, as well as improved patients’ experience and satisfaction with medication education. These results suggest that a teach-back method such as the TIME program could be a solution to care transition problems identified in the Trivedi et al study by providing a structured approach to patient education and enhancing communication practices during the hospital discharge process. Thus, by implementing the TIME program, hospitals may improve patient outcomes, safety, and overall quality of care upon leaving the hospital.

Applications for Clinical Practice and System Implementation

Care transition at the time of hospital discharge is a particularly pivotal period in the care of vulnerable individuals. There is growing literature, including studies discussed in this review, to indicate that by focusing on improving patient-practitioner communication during the discharge process and using strategies such as the teach-back method, health care professionals can better prepare patients for self-management in the post-acute period and help them make informed decisions about their care. This emphasis on care-transition communication strategies may lead to a reduction in medication errors, adverse events, and hospital readmissions, ultimately improving patient outcomes and satisfaction. Barriers to system implementation of such strategies may include competing demands and responsibilities of busy practitioners as well as the inherent complexities associated with hospital discharge. Creative solutions, such as the utilization of telehealth and early transition-of-care visits, represent some potential approaches to counter these barriers.

While both studies illustrated barriers and facilitators of hospital discharge communication, each study had limitations that impacted their generalizability to real-world clinical practice. Limitations in study 1 included a small sample size, purposive sampling method, and a focus on planned discharges in a teaching hospital, which may introduce selection bias. The study’s findings may not be generalizable to unplanned discharges, patients who do not speak English or Spanish, or nonteaching hospitals. Additionally, the data were collected before the COVID-19 pandemic, which could have further impacted discharge education practices. The study also revealed that some patients received more robust discharge education than others, which indicated systemic inequality in the patient experience. Further research is required to address this discrepancy. Limitations in study 2 included a relatively small and homogeneous sample, with most participants being younger, non-Hispanic White, English-speaking, and well-educated. This lack of diversity may limit the generalizability of the findings. Furthermore, the study did not evaluate the patients’ knowledge of medication dosage and focused only on new medications. Future studies should examine the effect of teach-back on a broader range of self-management topics in preparation for discharge, while also including a more diverse population to account for factors related to social determinants of health. Taken together, further research is needed to address these limitations and ensure more generalizable results that can more broadly improve discharge education and care transitions that bridge acute and post-acute care.

Practice Points

  • There is a significant need for improved discharge strategies to enhance patient safety and quality of care upon leaving the hospital.
  • Teach-back method may offer a structured approach to educating patients about their medications at hospital discharge and improve care transitions.

–Yuka Shichijo, MD, and Fred Ko, MD, Mount Sinai Beth Israel Hospital, New York, NY

Study 1 Overview (Trivedi et al)

Objective: This observational quality improvement study aimed to evaluate the discharge communication practices in internal medicine services at 2 urban academic teaching hospitals, specifically focusing on patient education and counseling in 6 key discharge communication domains.

Design: Observations were conducted over a 13-month period from September 2018 through October 2019, following the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.

Setting and participants: The study involved a total of 33 English- and Spanish-speaking patients purposefully selected from the “discharge before noon” list at 2 urban tertiary-care teaching hospitals. A total of 155 observation hours were accumulated, with an average observation time of 4.7 hours per patient on the day of discharge.

Main outcome measures: The study assessed 6 discharge communication domains: (1) the name and function of medication changes, (2) the purpose of postdischarge appointments, (3) disease self-management, (4) red flags or warning signs for complications, (5) teach-back techniques to confirm patient understanding, and (6) staff solicitation of patient questions or concerns.

Main results: The study found several gaps in discharge communication practices. Among the 29 patients with medication changes, 28% were not informed about the name and basic function of the changes, while 59% did not receive counseling on the purpose for the medication change. In terms of postdischarge appointments, 48% of patients were not told the purpose of these appointments. Moreover, 54% of patients did not receive counseling on self-management of their primary discharge diagnosis or other diagnoses, and 73% were not informed about symptom expectations or the expected course of their illness after leaving the hospital. Most patients (82%) were not counseled on red-flag signs and symptoms that should prompt immediate return to care.

Teach-back techniques, which are critical for ensuring patient understanding, were used in only 3% of cases, and 85% of patients were not asked by health care providers if there might be barriers to following the care plan. Less than half (42%) of the patients were asked if they had any questions, with most questions being logistical and often deferred to another team member or met with uncertainty. Of note, among the 33 patients, only 2 patients received extensive information that covered 5 or 6 out of 6 discharge communication domains.

The study found variable roles in who communicated what aspects of discharge education, with most domains being communicated in an ad hoc manner and no clear pattern of responsibility. However, 2 exceptions were observed: nurses were more likely to provide information about new or changed medications and follow-up appointments, and the only example of teach-back was conducted by an attending physician.

Conclusion: The study highlights a significant need for improved discharge techniques to enhance patient safety and quality of care upon leaving the hospital. Interventions should focus on increasing transparency in patient education and understanding, clarifying assumptions of roles among the interprofessional team, and implementing effective communication strategies and system redesigns that foster patient-centered discharge education. Also, the study revealed that some patients received more robust discharge education than others, indicating systemic inequality in the patient experience. Further studies are needed to explore the development and assessment of such interventions to ensure optimal patient outcomes and equal care following hospital discharge.

 

 

Study 2 Overview (Marks et al)

Objective: This study aimed to investigate the impact of a nurse-led discharge medication education program, Teaching Important Medication Effects (TIME), on patients’ new medication knowledge at discharge and 48 to 72 hours post discharge. The specific objectives were to identify patients’ priority learning needs, evaluate the influence of TIME on patients’ new medication knowledge before and after discharge, and assess the effect of TIME on patients’ experience and satisfaction with medication education.

Design: The study employed a longitudinal pretest/post-test, 2-group design involving 107 randomly selected medical-surgical patients from an academic hospital. Participants were interviewed before and within 72 hours after discharge following administration of medication instructions. Bivariate analyses were performed to assess demographic and outcome variable differences between groups.

Setting and participants: Conducted on a 24-bed medical-surgical unit at a large Magnet® hospital over 18 months (2018-2019), the study included patients with at least 1 new medication, aged 18 years or older, able to read and speak English or Spanish, admitted from home with a minimum 1 overnight stay, and planning to return home post discharge. Excluded were cognitively impaired patients, those assigned to a resource pool nurse without TIME training, and those having a research team member assigned. Participants were randomly selected from a computerized list of patients scheduled for discharge.

Main outcome measures: Primary outcome measures included patients’ new medication knowledge before and after discharge and patients’ experience and satisfaction with medication education.

Main results: The usual care (n = 52) and TIME (n = 55) patients had similar baseline demographic characteristics. The study revealed that almost all patients in both usual care and TIME groups were aware of their new medication and its purpose at discharge. However, differences were observed in medication side effect responses, with 72.5% of the usual-care group knowing side effects compared to 94.3% of the TIME group (P = .003). Additionally, 81.5% of the usual-care group understood the medication purpose compared to 100% of the TIME group (P = .02). During the 48- to 72-hour postdischarge calls, consistent responses were found from both groups regarding knowledge of new medication, medication name, and medication purpose. Similar to discharge results, differences in medication side effect responses were observed, with 75.8% of the usual care group correctly identifying at least 1 medication side effect compared to 93.9% of the TIME group (P = .04). TIME was associated with higher satisfaction with medication education compared to usual care (97% vs. 46.9%, P < .001).

Conclusion: The nurse-led discharge medication education program TIME effectively enhanced patients’ new medication knowledge at discharge and 48 to 72 hours after discharge. The program also significantly improved patients’ experience and satisfaction with medication education. These findings indicate that TIME is a valuable tool for augmenting patient education and medication adherence in a hospital setting. By incorporating the teach-back method, TIME offers a structured approach to educating patients about their medications at hospital discharge, leading to improved care transitions.

 

 

Commentary

Suboptimal communication between patients, caregivers, and providers upon hospital discharge is a major contributor to patients’ inadequate understanding of postdischarge care plans. This inadequate understanding leads to preventable harms, such as medication errors, adverse events, emergency room visits, and costly hospital readmissions.1 The issue is further exacerbated by a lack of clarity among health care team members’ respective roles in providing information that optimizes care transitions during the discharge communication process. Moreover, low health literacy, particularly prevalent among seniors, those from disadvantaged backgrouds, and those with lower education attainment or chronic illnesses, create additional barriers to effective discharge communication. A potential solution to this problem is the adoption of effective teaching strategies, specifically the teach-back method. This method employs techniques that ensure patients’ understanding and recall of new information regardless of health literacy, and places accountability on clinicians rather than patients. By closing communication gaps between clinicians and patients, the teach-back method can reduce hospital readmissions, hospital-acquired conditions, and mortality rates, while improving patient satisfaction with health care instructions and the overall hospital experience.2

Study 1, by Trivedi et al, and study 2, by Marks et al, aimed to identify and address problems related to poor communication between patients and health care team members at hospital discharge. Specifically, study 1 examined routine discharge communication practices to determine communication gaps, while study 2 evaluated a nurse-led teach-back intervention program designed to improve patients’ medication knowledge and satisfaction. These distinct objectives and designs reflected the unique ways each study approached the challenges associated with care transitions at the time of hospital discharge.

Study 1 used direct observation of patient-practitioner interactions to evaluate routine discharge communication practices in internal medicine services at 2 urban academic teaching hospitals. In the 33 patients observed, significant gaps in discharge communication practices were identified in the domains of medication changes, postdischarge appointments, disease self-management, and red flags or warning signs. Unsurprisingly, most of these domains were communicated in an ad hoc manner by members of the health care team without a clear pattern of responsibility in reference to patient discharge education, and teach-back was seldom used. These findings underscore the need for improved discharge techniques, effective communication strategies, and clarification of roles among the interprofessional team to enhance the safety, quality of care, and overall patient experience during hospital discharge.

Study 2 aimed to augment the hospital discharge communication process by implementing a nurse-led discharge medication education program (TIME), which targeted patients’ priority learning needs, new medication knowledge, and satisfaction with medication education. In the 107 patients assessed, this teach-back method enhanced patients’ new medication knowledge at discharge and 48 to 72 hours after discharge, as well as improved patients’ experience and satisfaction with medication education. These results suggest that a teach-back method such as the TIME program could be a solution to care transition problems identified in the Trivedi et al study by providing a structured approach to patient education and enhancing communication practices during the hospital discharge process. Thus, by implementing the TIME program, hospitals may improve patient outcomes, safety, and overall quality of care upon leaving the hospital.

Applications for Clinical Practice and System Implementation

Care transition at the time of hospital discharge is a particularly pivotal period in the care of vulnerable individuals. There is growing literature, including studies discussed in this review, to indicate that by focusing on improving patient-practitioner communication during the discharge process and using strategies such as the teach-back method, health care professionals can better prepare patients for self-management in the post-acute period and help them make informed decisions about their care. This emphasis on care-transition communication strategies may lead to a reduction in medication errors, adverse events, and hospital readmissions, ultimately improving patient outcomes and satisfaction. Barriers to system implementation of such strategies may include competing demands and responsibilities of busy practitioners as well as the inherent complexities associated with hospital discharge. Creative solutions, such as the utilization of telehealth and early transition-of-care visits, represent some potential approaches to counter these barriers.

While both studies illustrated barriers and facilitators of hospital discharge communication, each study had limitations that impacted their generalizability to real-world clinical practice. Limitations in study 1 included a small sample size, purposive sampling method, and a focus on planned discharges in a teaching hospital, which may introduce selection bias. The study’s findings may not be generalizable to unplanned discharges, patients who do not speak English or Spanish, or nonteaching hospitals. Additionally, the data were collected before the COVID-19 pandemic, which could have further impacted discharge education practices. The study also revealed that some patients received more robust discharge education than others, which indicated systemic inequality in the patient experience. Further research is required to address this discrepancy. Limitations in study 2 included a relatively small and homogeneous sample, with most participants being younger, non-Hispanic White, English-speaking, and well-educated. This lack of diversity may limit the generalizability of the findings. Furthermore, the study did not evaluate the patients’ knowledge of medication dosage and focused only on new medications. Future studies should examine the effect of teach-back on a broader range of self-management topics in preparation for discharge, while also including a more diverse population to account for factors related to social determinants of health. Taken together, further research is needed to address these limitations and ensure more generalizable results that can more broadly improve discharge education and care transitions that bridge acute and post-acute care.

Practice Points

  • There is a significant need for improved discharge strategies to enhance patient safety and quality of care upon leaving the hospital.
  • Teach-back method may offer a structured approach to educating patients about their medications at hospital discharge and improve care transitions.

–Yuka Shichijo, MD, and Fred Ko, MD, Mount Sinai Beth Israel Hospital, New York, NY

References

1. Snow V, Beck D, Budnitz T, Miller DC, Potter J, Wears RL, Weiss KB, Williams MV; American College of Physicians; Society of General Internal Medicine; Society of Hospital Medicine; American Geriatrics Society; American College of Emergency Physicians; Society of Academic Emergency Medicine. Transitions of care consensus policy statement American College of Physicians-Society of General Internal Medicine-Society of Hospital Medicine-American Geriatrics Society-American College of Emergency Physicians-Society of Academic Emergency Medicine. J Gen Intern Med. 2009;24(8):971-976. doi:10.1007/s11606-009-0969-x

2. Yen PH, Leasure AR. Use and effectiveness of the teach-back method in patient education and health outcomes. Fed. Pract. 2019;36(6):284-289.

References

1. Snow V, Beck D, Budnitz T, Miller DC, Potter J, Wears RL, Weiss KB, Williams MV; American College of Physicians; Society of General Internal Medicine; Society of Hospital Medicine; American Geriatrics Society; American College of Emergency Physicians; Society of Academic Emergency Medicine. Transitions of care consensus policy statement American College of Physicians-Society of General Internal Medicine-Society of Hospital Medicine-American Geriatrics Society-American College of Emergency Physicians-Society of Academic Emergency Medicine. J Gen Intern Med. 2009;24(8):971-976. doi:10.1007/s11606-009-0969-x

2. Yen PH, Leasure AR. Use and effectiveness of the teach-back method in patient education and health outcomes. Fed. Pract. 2019;36(6):284-289.

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Unveiling sexual dysfunction: Clinicians can do more

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. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

  • Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
  • Advise. Make sure your patient knows many women struggle with the problem they have raised.
  • Assess. Ask a set of standardized assessment questions.
  • Assist. Tell your patient about treatment options.
  • Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetinefluvoxaminesertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

 

 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desireby Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

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

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. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

  • Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
  • Advise. Make sure your patient knows many women struggle with the problem they have raised.
  • Assess. Ask a set of standardized assessment questions.
  • Assist. Tell your patient about treatment options.
  • Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetinefluvoxaminesertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

 

 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desireby Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

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

. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

  • Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
  • Advise. Make sure your patient knows many women struggle with the problem they have raised.
  • Assess. Ask a set of standardized assessment questions.
  • Assist. Tell your patient about treatment options.
  • Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetinefluvoxaminesertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

 

 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desireby Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

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

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AI at the office: Are clinicians prepared?

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Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

 

 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

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

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Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

 

 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

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

Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

 

 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

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

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Pop this question to improve medication adherence

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Mon, 05/22/2023 - 08:42

How often do you talk with patients about how to lower their out-of-pocket costs for medical care?

For most clinicians, the answer is: not often enough. But having those conversations can improve medication adherence and strengthen the patient-clinician relationship, according to panelists at the annual meeting of the Society of General Internal Medicine.

The inverse association between out-of-pocket expenditures and fidelity to prescriptions is clear. A 2020 study by the IQVIA Institute for Human Data Science, for example, found that rates of prescription abandonment are less than 5% when a given medication carries no out-of-pocket cost for patients. That figure rises to 45% when the cost is more than $125, and to 60% when it exceeds $500. One in five Americans said cost prevented them from adhering to medication regimens, according to a new study in JAMA Network Open.

The researchers surveyed more than 2,000 men and women, 40.4% of whom were aged 75 or older. They found that nearly 90% of respondents said they would not be uncomfortable being asked about drug costs before a visit with a physician. A similar share (89.5%) said they would welcome the use by their physician of a real-time tool to determine the cost of their medication.

But the survey results contained a note of warning for clinicians: A significant number of respondents said they would be “extremely” upset if the cost of their medication exceeded the estimate from the pricing tool. And many also said they would be “moderately” or “extremely” angry if their physician used a pricing tool but failed to share the results with them.

“Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use,” the authors write. “However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.”

While having conversations about cost can be difficult for both clinicians and patients, studies have shown that patients who discuss cost concerns with their doctors feel as if they have stronger relationships as a result.

Clinicians often avoid conversations about out-of-pocket expenses because they don’t know specific price information, they lack solutions to address cost, or they are uncomfortable bringing up the issue.

One member of the audience at the SGIM meeting recalled a patient who worked in a warehouse for a large company. The man, who had type 2 diabetes, had medical insurance, but even with insurance, insulin was going to cost him $150 per month. He struggled to afford the necessary treatment.

“He looked at me and said, ‘What do they want me to do? Do they want me to actually not be able to work for them and not manage my diabetes?’ ”

The clinician said he offered empathy in the moment but felt he could do little else.

Panelists acknowledged that clinicians are crunched on time when seeing patients, but being willing to initiate conversations about cost with patients and to offer resources can help patients get necessary treatment.
 

Start the conversation

Panel member Caroline Sloan, MD, an assistant professor of medicine at Duke University, Durham, N.C., said making patients aware that you know cost can make a big difference.

The American College of Physicians advises clinicians to ask patients whether they are worried about the cost of care and to not assume which patients may have concerns.

The conversation could be started like this: “I’d like to discuss any concerns you might have about the cost of your health care.”

Normalize the concern by making it more general, and reassure your patient that your goal is to get them the best care. Say something like, “I’ve heard from many patients the cost of medications or tests is becoming hard to manage.”

Once a patient’s concerns are clear, you can direct them to resources for assistance in reducing their costs, Dr. Sloan said, such as ClearHealthCosts, FAIR Health, Healthcare Bluebook, New Choice Health, GoodRx, PharmacyChecker, HealthWell Foundation, Patient Advocate Foundation, Good Days, Good Health Will, Mercy Medical Angels, and the American Association of Family Physicians Neighborhood Navigator.

Dr. Sloan said she knows clinicians don’t have time to understand every insurance plan and other issues related to cost. “But at least know to ask about costs,” she said. “Practice, practice, practice. It feels awkward at first, but it gets easier every time.”

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

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How often do you talk with patients about how to lower their out-of-pocket costs for medical care?

For most clinicians, the answer is: not often enough. But having those conversations can improve medication adherence and strengthen the patient-clinician relationship, according to panelists at the annual meeting of the Society of General Internal Medicine.

The inverse association between out-of-pocket expenditures and fidelity to prescriptions is clear. A 2020 study by the IQVIA Institute for Human Data Science, for example, found that rates of prescription abandonment are less than 5% when a given medication carries no out-of-pocket cost for patients. That figure rises to 45% when the cost is more than $125, and to 60% when it exceeds $500. One in five Americans said cost prevented them from adhering to medication regimens, according to a new study in JAMA Network Open.

The researchers surveyed more than 2,000 men and women, 40.4% of whom were aged 75 or older. They found that nearly 90% of respondents said they would not be uncomfortable being asked about drug costs before a visit with a physician. A similar share (89.5%) said they would welcome the use by their physician of a real-time tool to determine the cost of their medication.

But the survey results contained a note of warning for clinicians: A significant number of respondents said they would be “extremely” upset if the cost of their medication exceeded the estimate from the pricing tool. And many also said they would be “moderately” or “extremely” angry if their physician used a pricing tool but failed to share the results with them.

“Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use,” the authors write. “However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.”

While having conversations about cost can be difficult for both clinicians and patients, studies have shown that patients who discuss cost concerns with their doctors feel as if they have stronger relationships as a result.

Clinicians often avoid conversations about out-of-pocket expenses because they don’t know specific price information, they lack solutions to address cost, or they are uncomfortable bringing up the issue.

One member of the audience at the SGIM meeting recalled a patient who worked in a warehouse for a large company. The man, who had type 2 diabetes, had medical insurance, but even with insurance, insulin was going to cost him $150 per month. He struggled to afford the necessary treatment.

“He looked at me and said, ‘What do they want me to do? Do they want me to actually not be able to work for them and not manage my diabetes?’ ”

The clinician said he offered empathy in the moment but felt he could do little else.

Panelists acknowledged that clinicians are crunched on time when seeing patients, but being willing to initiate conversations about cost with patients and to offer resources can help patients get necessary treatment.
 

Start the conversation

Panel member Caroline Sloan, MD, an assistant professor of medicine at Duke University, Durham, N.C., said making patients aware that you know cost can make a big difference.

The American College of Physicians advises clinicians to ask patients whether they are worried about the cost of care and to not assume which patients may have concerns.

The conversation could be started like this: “I’d like to discuss any concerns you might have about the cost of your health care.”

Normalize the concern by making it more general, and reassure your patient that your goal is to get them the best care. Say something like, “I’ve heard from many patients the cost of medications or tests is becoming hard to manage.”

Once a patient’s concerns are clear, you can direct them to resources for assistance in reducing their costs, Dr. Sloan said, such as ClearHealthCosts, FAIR Health, Healthcare Bluebook, New Choice Health, GoodRx, PharmacyChecker, HealthWell Foundation, Patient Advocate Foundation, Good Days, Good Health Will, Mercy Medical Angels, and the American Association of Family Physicians Neighborhood Navigator.

Dr. Sloan said she knows clinicians don’t have time to understand every insurance plan and other issues related to cost. “But at least know to ask about costs,” she said. “Practice, practice, practice. It feels awkward at first, but it gets easier every time.”

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

How often do you talk with patients about how to lower their out-of-pocket costs for medical care?

For most clinicians, the answer is: not often enough. But having those conversations can improve medication adherence and strengthen the patient-clinician relationship, according to panelists at the annual meeting of the Society of General Internal Medicine.

The inverse association between out-of-pocket expenditures and fidelity to prescriptions is clear. A 2020 study by the IQVIA Institute for Human Data Science, for example, found that rates of prescription abandonment are less than 5% when a given medication carries no out-of-pocket cost for patients. That figure rises to 45% when the cost is more than $125, and to 60% when it exceeds $500. One in five Americans said cost prevented them from adhering to medication regimens, according to a new study in JAMA Network Open.

The researchers surveyed more than 2,000 men and women, 40.4% of whom were aged 75 or older. They found that nearly 90% of respondents said they would not be uncomfortable being asked about drug costs before a visit with a physician. A similar share (89.5%) said they would welcome the use by their physician of a real-time tool to determine the cost of their medication.

But the survey results contained a note of warning for clinicians: A significant number of respondents said they would be “extremely” upset if the cost of their medication exceeded the estimate from the pricing tool. And many also said they would be “moderately” or “extremely” angry if their physician used a pricing tool but failed to share the results with them.

“Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use,” the authors write. “However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.”

While having conversations about cost can be difficult for both clinicians and patients, studies have shown that patients who discuss cost concerns with their doctors feel as if they have stronger relationships as a result.

Clinicians often avoid conversations about out-of-pocket expenses because they don’t know specific price information, they lack solutions to address cost, or they are uncomfortable bringing up the issue.

One member of the audience at the SGIM meeting recalled a patient who worked in a warehouse for a large company. The man, who had type 2 diabetes, had medical insurance, but even with insurance, insulin was going to cost him $150 per month. He struggled to afford the necessary treatment.

“He looked at me and said, ‘What do they want me to do? Do they want me to actually not be able to work for them and not manage my diabetes?’ ”

The clinician said he offered empathy in the moment but felt he could do little else.

Panelists acknowledged that clinicians are crunched on time when seeing patients, but being willing to initiate conversations about cost with patients and to offer resources can help patients get necessary treatment.
 

Start the conversation

Panel member Caroline Sloan, MD, an assistant professor of medicine at Duke University, Durham, N.C., said making patients aware that you know cost can make a big difference.

The American College of Physicians advises clinicians to ask patients whether they are worried about the cost of care and to not assume which patients may have concerns.

The conversation could be started like this: “I’d like to discuss any concerns you might have about the cost of your health care.”

Normalize the concern by making it more general, and reassure your patient that your goal is to get them the best care. Say something like, “I’ve heard from many patients the cost of medications or tests is becoming hard to manage.”

Once a patient’s concerns are clear, you can direct them to resources for assistance in reducing their costs, Dr. Sloan said, such as ClearHealthCosts, FAIR Health, Healthcare Bluebook, New Choice Health, GoodRx, PharmacyChecker, HealthWell Foundation, Patient Advocate Foundation, Good Days, Good Health Will, Mercy Medical Angels, and the American Association of Family Physicians Neighborhood Navigator.

Dr. Sloan said she knows clinicians don’t have time to understand every insurance plan and other issues related to cost. “But at least know to ask about costs,” she said. “Practice, practice, practice. It feels awkward at first, but it gets easier every time.”

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

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How primary care fails new mothers

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Sun, 05/21/2023 - 15:10

. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.

The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.

You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?

This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.

“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”

When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.

“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”

Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.

“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
 

Starting point

Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.

“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”

Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.

Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.

Women who experience preeclampsia have two to four times the risk for coronary heart disease.

Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
 

 

 

More questions

Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.

Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.

“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.

Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.

She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
 

Follow-up care

“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”

For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.

Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.

“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”

No relevant financial relationships were reported.



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

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. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.

The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.

You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?

This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.

“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”

When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.

“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”

Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.

“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
 

Starting point

Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.

“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”

Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.

Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.

Women who experience preeclampsia have two to four times the risk for coronary heart disease.

Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
 

 

 

More questions

Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.

Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.

“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.

Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.

She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
 

Follow-up care

“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”

For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.

Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.

“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”

No relevant financial relationships were reported.



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

. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.

The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.

You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?

This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.

“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”

When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.

“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”

Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.

“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
 

Starting point

Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.

“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”

Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.

Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.

Women who experience preeclampsia have two to four times the risk for coronary heart disease.

Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
 

 

 

More questions

Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.

Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.

“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.

Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.

She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
 

Follow-up care

“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”

For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.

Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.

“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”

No relevant financial relationships were reported.



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

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HFpEF: New guidelines are pertinent for primary care

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Mon, 05/22/2023 - 10:52

This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today we are going to talk about the 2023 American College of Cardiology Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction (HFpEF). The incidence of HFpEF is increasing, yet it’s underrecognized. Now that there are evidence-based treatment approaches that improve outcomes, we’ve started to look for this condition and are diagnosing it more often. HFpEF is commonly encountered in primary care.

We should be thinking about HFpEF when we see adults with shortness of breath and/or fatigue and reduced exercise capacity, particularly in the settings of obesity, hypertension, or diabetes. It may not be simple deconditioning; it could be HFpEF.  

I’ll organize this discussion into three topics: when to think about HFpEF, how to diagnosis it. and how to treat it.

When to think about HFpEF. When we see a person with risk factors (e.g., older age, obesity, diabetes, hypertension) experiencing dyspnea or fatigue with physical activity, their symptoms are not always from simple deconditioning. HFpEF should be on our differential as well as chronic obstructive pulmonary disease (COPD).

Making the diagnosis. HFpEF is defined as a clinical diagnosis of HR with left ventricular EF (LVEF) greater than 50%. Remember, in HF with reduced EF (HFrEF), the EF is less than 40%, and the EF in midrange HF is 40%-50%. See this recent HF review for more details on reduced and midrange ejection fractions.

For practical purposes, to diagnose HFpEF, check for an elevated N-terminal pro B-type natriuretic  peptide (NT-proBNP) (> 125 pg/mL) and evidence of diastolic dysfunction on echocardiogram. Be aware that patients with obesity and HFpEF have lower BNP concentrations than those without obesity, and one professional society has suggested that a 50% reduction in BNP cutoff values should be used when making the diagnosis in patients with obesity.

Of course, we evaluate for other causes of dyspnea and/or edema including lung (most commonly COPD), liver, or kidney disease. When the diagnosis of HFpEF is made, consider whether further evaluation is warranted for specific underlying causes of HFpEF, such as amyloidosis, sarcoid, hemochromatosis, or hypertrophic cardiomyopathy.

Treatment. The evolution of the management of HFpEF has been intriguing. I recommend that people take a look at the guidelines and read the supporting trials. Finding effective therapies has taken longer than it did for HFrEF, but finally, an effective therapy for HFpEF is available.

To quote the guidelines, diuretics should be used “judiciously as needed” to reduce pulmonary congestion and improve symptoms. But here’s the big deal. The mainstays of treatment for HFpEF are the sodium-glucose cotransporter 2 (SGLT2) inhibitors on the basis of the findings of two trials: DELIVER (dapagliflozin) and EMPEROR-Preserved (empagliflozin), both of which have shown very impressive levels of benefit.

Both trials lasted a little over 2 years and found a statistically significant approximately 30% decline in HF hospitalizations and a numerical reduction of about 10% in cardiovascular death, which was statistically significant in meta-analysis. That’s over 2 years! That’s a large level of effect. They also showed improvements in symptoms and health status. Therefore, SGLT2 inhibitors are first-line treatment for all individuals with HFpEF, currently graded as a Class 2a (moderate) recommendation, but likely soon to be upgraded to Class 1 (strong) recommendation.

After the SGLT2 inhibitors, treatment is based on evidence which is not as strong and the recommendations are graded as Class 2b (weak) recommendations. In men with an LVEF less than 55%-60% and for women with any EF, use of a mineralocorticoid antagonist (MRA), an angiotensin receptor-neprilysin inhibitor, or if an ARN inhibitor is not feasible, an angiotensin receptor blocker (ARB) may be considered.

Nonpharmacologic management is also important. Exercise and weight loss (if the patient is overweight) can improve symptoms and quality of life. A new intervention, an implantable ambulatory pulmonary artery sensor, called CardioMEMS, has been evaluated in two trials, showing a decrease in HF hospitalizations. This may be considered for those who experience hospitalizations for HF and continue to experience New York Heart Association functional Class 3 symptoms despite optimal guideline-directed medical therapy or those who have lability in volume status or other medical problems (such as obesity or COPD) that make it difficult to tell whether their symptoms are from HFpEF or a comorbid condition.

In summary:

  • Have a low threshold to evaluate for HFpEF in any patients who have shortness of breath, fatigue with exertion, or fluid overload.
  • Initially evaluate with an NT-proBNP level and an echocardiogram.
  • First-line treatment is an evidence-based SGLT2 inhibitor along with exercise and perhaps weight loss if needed. A loop diuretic can be used as needed to control volume status. Then you can consider, based on symptoms and details discussed above, an MRA, ARN inhibitor, or ARB.

This is important information for a diagnosis that is common in primary care, HFpEF, and for which we now have impressive, effective treatment.

Dr. Skolnik is a professor in the department of family medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the department of family medicine at Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim; Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

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

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This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today we are going to talk about the 2023 American College of Cardiology Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction (HFpEF). The incidence of HFpEF is increasing, yet it’s underrecognized. Now that there are evidence-based treatment approaches that improve outcomes, we’ve started to look for this condition and are diagnosing it more often. HFpEF is commonly encountered in primary care.

We should be thinking about HFpEF when we see adults with shortness of breath and/or fatigue and reduced exercise capacity, particularly in the settings of obesity, hypertension, or diabetes. It may not be simple deconditioning; it could be HFpEF.  

I’ll organize this discussion into three topics: when to think about HFpEF, how to diagnosis it. and how to treat it.

When to think about HFpEF. When we see a person with risk factors (e.g., older age, obesity, diabetes, hypertension) experiencing dyspnea or fatigue with physical activity, their symptoms are not always from simple deconditioning. HFpEF should be on our differential as well as chronic obstructive pulmonary disease (COPD).

Making the diagnosis. HFpEF is defined as a clinical diagnosis of HR with left ventricular EF (LVEF) greater than 50%. Remember, in HF with reduced EF (HFrEF), the EF is less than 40%, and the EF in midrange HF is 40%-50%. See this recent HF review for more details on reduced and midrange ejection fractions.

For practical purposes, to diagnose HFpEF, check for an elevated N-terminal pro B-type natriuretic  peptide (NT-proBNP) (> 125 pg/mL) and evidence of diastolic dysfunction on echocardiogram. Be aware that patients with obesity and HFpEF have lower BNP concentrations than those without obesity, and one professional society has suggested that a 50% reduction in BNP cutoff values should be used when making the diagnosis in patients with obesity.

Of course, we evaluate for other causes of dyspnea and/or edema including lung (most commonly COPD), liver, or kidney disease. When the diagnosis of HFpEF is made, consider whether further evaluation is warranted for specific underlying causes of HFpEF, such as amyloidosis, sarcoid, hemochromatosis, or hypertrophic cardiomyopathy.

Treatment. The evolution of the management of HFpEF has been intriguing. I recommend that people take a look at the guidelines and read the supporting trials. Finding effective therapies has taken longer than it did for HFrEF, but finally, an effective therapy for HFpEF is available.

To quote the guidelines, diuretics should be used “judiciously as needed” to reduce pulmonary congestion and improve symptoms. But here’s the big deal. The mainstays of treatment for HFpEF are the sodium-glucose cotransporter 2 (SGLT2) inhibitors on the basis of the findings of two trials: DELIVER (dapagliflozin) and EMPEROR-Preserved (empagliflozin), both of which have shown very impressive levels of benefit.

Both trials lasted a little over 2 years and found a statistically significant approximately 30% decline in HF hospitalizations and a numerical reduction of about 10% in cardiovascular death, which was statistically significant in meta-analysis. That’s over 2 years! That’s a large level of effect. They also showed improvements in symptoms and health status. Therefore, SGLT2 inhibitors are first-line treatment for all individuals with HFpEF, currently graded as a Class 2a (moderate) recommendation, but likely soon to be upgraded to Class 1 (strong) recommendation.

After the SGLT2 inhibitors, treatment is based on evidence which is not as strong and the recommendations are graded as Class 2b (weak) recommendations. In men with an LVEF less than 55%-60% and for women with any EF, use of a mineralocorticoid antagonist (MRA), an angiotensin receptor-neprilysin inhibitor, or if an ARN inhibitor is not feasible, an angiotensin receptor blocker (ARB) may be considered.

Nonpharmacologic management is also important. Exercise and weight loss (if the patient is overweight) can improve symptoms and quality of life. A new intervention, an implantable ambulatory pulmonary artery sensor, called CardioMEMS, has been evaluated in two trials, showing a decrease in HF hospitalizations. This may be considered for those who experience hospitalizations for HF and continue to experience New York Heart Association functional Class 3 symptoms despite optimal guideline-directed medical therapy or those who have lability in volume status or other medical problems (such as obesity or COPD) that make it difficult to tell whether their symptoms are from HFpEF or a comorbid condition.

In summary:

  • Have a low threshold to evaluate for HFpEF in any patients who have shortness of breath, fatigue with exertion, or fluid overload.
  • Initially evaluate with an NT-proBNP level and an echocardiogram.
  • First-line treatment is an evidence-based SGLT2 inhibitor along with exercise and perhaps weight loss if needed. A loop diuretic can be used as needed to control volume status. Then you can consider, based on symptoms and details discussed above, an MRA, ARN inhibitor, or ARB.

This is important information for a diagnosis that is common in primary care, HFpEF, and for which we now have impressive, effective treatment.

Dr. Skolnik is a professor in the department of family medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the department of family medicine at Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim; Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

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

This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today we are going to talk about the 2023 American College of Cardiology Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction (HFpEF). The incidence of HFpEF is increasing, yet it’s underrecognized. Now that there are evidence-based treatment approaches that improve outcomes, we’ve started to look for this condition and are diagnosing it more often. HFpEF is commonly encountered in primary care.

We should be thinking about HFpEF when we see adults with shortness of breath and/or fatigue and reduced exercise capacity, particularly in the settings of obesity, hypertension, or diabetes. It may not be simple deconditioning; it could be HFpEF.  

I’ll organize this discussion into three topics: when to think about HFpEF, how to diagnosis it. and how to treat it.

When to think about HFpEF. When we see a person with risk factors (e.g., older age, obesity, diabetes, hypertension) experiencing dyspnea or fatigue with physical activity, their symptoms are not always from simple deconditioning. HFpEF should be on our differential as well as chronic obstructive pulmonary disease (COPD).

Making the diagnosis. HFpEF is defined as a clinical diagnosis of HR with left ventricular EF (LVEF) greater than 50%. Remember, in HF with reduced EF (HFrEF), the EF is less than 40%, and the EF in midrange HF is 40%-50%. See this recent HF review for more details on reduced and midrange ejection fractions.

For practical purposes, to diagnose HFpEF, check for an elevated N-terminal pro B-type natriuretic  peptide (NT-proBNP) (> 125 pg/mL) and evidence of diastolic dysfunction on echocardiogram. Be aware that patients with obesity and HFpEF have lower BNP concentrations than those without obesity, and one professional society has suggested that a 50% reduction in BNP cutoff values should be used when making the diagnosis in patients with obesity.

Of course, we evaluate for other causes of dyspnea and/or edema including lung (most commonly COPD), liver, or kidney disease. When the diagnosis of HFpEF is made, consider whether further evaluation is warranted for specific underlying causes of HFpEF, such as amyloidosis, sarcoid, hemochromatosis, or hypertrophic cardiomyopathy.

Treatment. The evolution of the management of HFpEF has been intriguing. I recommend that people take a look at the guidelines and read the supporting trials. Finding effective therapies has taken longer than it did for HFrEF, but finally, an effective therapy for HFpEF is available.

To quote the guidelines, diuretics should be used “judiciously as needed” to reduce pulmonary congestion and improve symptoms. But here’s the big deal. The mainstays of treatment for HFpEF are the sodium-glucose cotransporter 2 (SGLT2) inhibitors on the basis of the findings of two trials: DELIVER (dapagliflozin) and EMPEROR-Preserved (empagliflozin), both of which have shown very impressive levels of benefit.

Both trials lasted a little over 2 years and found a statistically significant approximately 30% decline in HF hospitalizations and a numerical reduction of about 10% in cardiovascular death, which was statistically significant in meta-analysis. That’s over 2 years! That’s a large level of effect. They also showed improvements in symptoms and health status. Therefore, SGLT2 inhibitors are first-line treatment for all individuals with HFpEF, currently graded as a Class 2a (moderate) recommendation, but likely soon to be upgraded to Class 1 (strong) recommendation.

After the SGLT2 inhibitors, treatment is based on evidence which is not as strong and the recommendations are graded as Class 2b (weak) recommendations. In men with an LVEF less than 55%-60% and for women with any EF, use of a mineralocorticoid antagonist (MRA), an angiotensin receptor-neprilysin inhibitor, or if an ARN inhibitor is not feasible, an angiotensin receptor blocker (ARB) may be considered.

Nonpharmacologic management is also important. Exercise and weight loss (if the patient is overweight) can improve symptoms and quality of life. A new intervention, an implantable ambulatory pulmonary artery sensor, called CardioMEMS, has been evaluated in two trials, showing a decrease in HF hospitalizations. This may be considered for those who experience hospitalizations for HF and continue to experience New York Heart Association functional Class 3 symptoms despite optimal guideline-directed medical therapy or those who have lability in volume status or other medical problems (such as obesity or COPD) that make it difficult to tell whether their symptoms are from HFpEF or a comorbid condition.

In summary:

  • Have a low threshold to evaluate for HFpEF in any patients who have shortness of breath, fatigue with exertion, or fluid overload.
  • Initially evaluate with an NT-proBNP level and an echocardiogram.
  • First-line treatment is an evidence-based SGLT2 inhibitor along with exercise and perhaps weight loss if needed. A loop diuretic can be used as needed to control volume status. Then you can consider, based on symptoms and details discussed above, an MRA, ARN inhibitor, or ARB.

This is important information for a diagnosis that is common in primary care, HFpEF, and for which we now have impressive, effective treatment.

Dr. Skolnik is a professor in the department of family medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the department of family medicine at Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim; Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

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

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No expiration date for sex

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Mon, 05/22/2023 - 16:42

For health professionals, the thought that our parents and grandparents don’t have sex – or didn’t – might be comforting.

The reality is that, for a significant proportion of our older patients, sex has no use-by date. Humans are sexual beings throughout their lives, yet the culture has concealed that fact.

According to Rome, the purpose of sex is to make children. According to Hollywood, sex is only for the young, the healthy, and the beautiful. For the medical profession, sex consists mainly of risks or dysfunctions.

The results of these biases? Many middle-aged people fear their later sexual life. And medical professionals rarely ask about sexuality. That failing can be harmful. Sexuality and intimacy are essential elements for quality of life, with clear physical, emotional, and relational benefits.

Let’s look at the data when researchers dared to ask seniors about their sexuality.

We start with the 2015 U.K. national research on sexuality. The study found a link between age and a decline in various aspects of sexual activity – but not a zeroing-out. For example, among men aged 70-79, 59% reported having had sex in the past year, with 19% having intercourse at least twice a month and 18% masturbating at least that often. Above age 80, those numbers dropped to 39%, 6%, and 5%, respectively. The reason behind the declines? A combination of taboo, fear of disease, use of medications or other interventions that disrupt sexual function or cause disfigurement, and a little bit of age itself.

What about women? Among women ages 70-79, 39% said they’d had sex in the past year, with 6% having intercourse at least twice per month and 5% masturbating two times or more monthly. Above age 80, those numbers were 10%, 4.5%, and 1%, respectively. Driving the falloff in women were the same factors as for men, plus the sad reality that many heterosexual women become widowed because their older male partners die earlier.

The male-female difference also reflects lower levels of testosterone in women. And, because women say they value intimacy more than performance, we have two explanations for their lower frequency of masturbation. After all, a lot of intimacy occurs without either intercourse or masturbation.

Surprising and relevant is the amount of distress – or rather, their relative lack thereof – older patients report because of sexual problems. At age 18-44, 11% of U.S. women indicated sexual distress; at age 45-64, the figure was 15%; and at age 65 and up, 9%.

For clinicians, those figures should prompt us to look more closely at alternative forms of sexual expression – those not involving intercourse or masturbation – in the aged, a field physicians typically do not consider.

Although dyspareunia or erectile problems affect many in long-standing relationships, neither is a reason to abstain from sexual pleasure. Indeed, in many couples, oral sex will replace vaginal intercourse, and if urinary, fecal, or flatal incontinence intrude, couples often waive oral sex in favor of more cuddling, kissing, digital stimulation, and other forms of sexual pleasure.
 

What about the expiry date for sex?

Fascinating research from Nils Beckman, PhD, and colleagues found that the sex drive persists even as people (and men in particular) reach their 100th year. Dr. Beckman’s group interviewed 269 Swedish seniors, all without dementia, at age 97. Sexual desire was affirmed by 27% of men and 5% of women in the survey. Among the men, 32% said they still had sexual thoughts, compared with 18% of women. Meanwhile, 26% of the men and 15% of the women said they missed sexual activity.

What should clinicians do with this information? First, we could start talking about sex with our older patients. According to the 97-year-old Swedes, most want us to! More than 8 in 10 of both women and men in the survey expressed positive views about questions on sexuality. And please don’t be scared to address the subject in the single senior. They, too, can have a sexual or relationship issue and are happy when we raise the subject. They’re not scared to talk about masturbation, either.

When caring for those with chronic diseases, cancer, in the course of physical rehabilitation, and even in the last phase of life, the clinical experience indicates that our patients are happy when we address sexuality and intimacy. Doing so can open the door to the admission of a problem and a corresponding solution, a lubricant or a PDE5 inhibitor.

But sometimes the solution is the conversation itself: Roughly 25% of patients are sufficiently helped simply by talking about sex. Addressing the importance of sexual pleasure is nearly always valuable.

Here are a few ice-breakers I find helpful:

  • Did taking this medication change aspects of sexuality? If so, does that bother you?
  • Knowing that continuing intimacy is healthy, do you mind if I address that subject?
  • We know that aspects of sexuality and intimacy are healthy. Without a partner, some people become sexually isolated. Would you like to talk about that?’

If addressing sexuality has benefits, what about sex itself?

We are gradually learning more about the many short-, intermediate-, and long-term health benefits of solo and joint sexual activity. Short-term benefits include muscle relaxation, pain relief (even, perhaps ironically, for headaches), and better sleep – all pretty valuable for older adults. Examples of intermediate-term benefits include stress relief and less depression. Research from the United States has found that hugging can reduce the concentrations of proinflammatory cytokines, and kissing positively influences cholesterol levels.

Finally, while the long-term benefits of sex might be less relevant for seniors, they do exist.

Among them are delayed onset of dementia and a substantial reduction in cardiovascular and cerebrovascular problems in men. More sex has been linked to longevity, with men benefiting a bit more than women from going through the entire process, including an orgasm, whereas women appear to gain from having a “satisfying” sex life, which does not always require an orgasm.

Let us not forget that these benefits apply to both patients and clinicians alike. Addressing intimacy and sexuality can ease eventual sexual concerns and potentially create a stronger clinician-patient relationship.

Dr. Gianotten, MD is emeritus senior lecturer in medical sexology, Erasmus University Medical Centre, Rotterdam, the Netherlands. He reported no conflicts of interest.

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

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For health professionals, the thought that our parents and grandparents don’t have sex – or didn’t – might be comforting.

The reality is that, for a significant proportion of our older patients, sex has no use-by date. Humans are sexual beings throughout their lives, yet the culture has concealed that fact.

According to Rome, the purpose of sex is to make children. According to Hollywood, sex is only for the young, the healthy, and the beautiful. For the medical profession, sex consists mainly of risks or dysfunctions.

The results of these biases? Many middle-aged people fear their later sexual life. And medical professionals rarely ask about sexuality. That failing can be harmful. Sexuality and intimacy are essential elements for quality of life, with clear physical, emotional, and relational benefits.

Let’s look at the data when researchers dared to ask seniors about their sexuality.

We start with the 2015 U.K. national research on sexuality. The study found a link between age and a decline in various aspects of sexual activity – but not a zeroing-out. For example, among men aged 70-79, 59% reported having had sex in the past year, with 19% having intercourse at least twice a month and 18% masturbating at least that often. Above age 80, those numbers dropped to 39%, 6%, and 5%, respectively. The reason behind the declines? A combination of taboo, fear of disease, use of medications or other interventions that disrupt sexual function or cause disfigurement, and a little bit of age itself.

What about women? Among women ages 70-79, 39% said they’d had sex in the past year, with 6% having intercourse at least twice per month and 5% masturbating two times or more monthly. Above age 80, those numbers were 10%, 4.5%, and 1%, respectively. Driving the falloff in women were the same factors as for men, plus the sad reality that many heterosexual women become widowed because their older male partners die earlier.

The male-female difference also reflects lower levels of testosterone in women. And, because women say they value intimacy more than performance, we have two explanations for their lower frequency of masturbation. After all, a lot of intimacy occurs without either intercourse or masturbation.

Surprising and relevant is the amount of distress – or rather, their relative lack thereof – older patients report because of sexual problems. At age 18-44, 11% of U.S. women indicated sexual distress; at age 45-64, the figure was 15%; and at age 65 and up, 9%.

For clinicians, those figures should prompt us to look more closely at alternative forms of sexual expression – those not involving intercourse or masturbation – in the aged, a field physicians typically do not consider.

Although dyspareunia or erectile problems affect many in long-standing relationships, neither is a reason to abstain from sexual pleasure. Indeed, in many couples, oral sex will replace vaginal intercourse, and if urinary, fecal, or flatal incontinence intrude, couples often waive oral sex in favor of more cuddling, kissing, digital stimulation, and other forms of sexual pleasure.
 

What about the expiry date for sex?

Fascinating research from Nils Beckman, PhD, and colleagues found that the sex drive persists even as people (and men in particular) reach their 100th year. Dr. Beckman’s group interviewed 269 Swedish seniors, all without dementia, at age 97. Sexual desire was affirmed by 27% of men and 5% of women in the survey. Among the men, 32% said they still had sexual thoughts, compared with 18% of women. Meanwhile, 26% of the men and 15% of the women said they missed sexual activity.

What should clinicians do with this information? First, we could start talking about sex with our older patients. According to the 97-year-old Swedes, most want us to! More than 8 in 10 of both women and men in the survey expressed positive views about questions on sexuality. And please don’t be scared to address the subject in the single senior. They, too, can have a sexual or relationship issue and are happy when we raise the subject. They’re not scared to talk about masturbation, either.

When caring for those with chronic diseases, cancer, in the course of physical rehabilitation, and even in the last phase of life, the clinical experience indicates that our patients are happy when we address sexuality and intimacy. Doing so can open the door to the admission of a problem and a corresponding solution, a lubricant or a PDE5 inhibitor.

But sometimes the solution is the conversation itself: Roughly 25% of patients are sufficiently helped simply by talking about sex. Addressing the importance of sexual pleasure is nearly always valuable.

Here are a few ice-breakers I find helpful:

  • Did taking this medication change aspects of sexuality? If so, does that bother you?
  • Knowing that continuing intimacy is healthy, do you mind if I address that subject?
  • We know that aspects of sexuality and intimacy are healthy. Without a partner, some people become sexually isolated. Would you like to talk about that?’

If addressing sexuality has benefits, what about sex itself?

We are gradually learning more about the many short-, intermediate-, and long-term health benefits of solo and joint sexual activity. Short-term benefits include muscle relaxation, pain relief (even, perhaps ironically, for headaches), and better sleep – all pretty valuable for older adults. Examples of intermediate-term benefits include stress relief and less depression. Research from the United States has found that hugging can reduce the concentrations of proinflammatory cytokines, and kissing positively influences cholesterol levels.

Finally, while the long-term benefits of sex might be less relevant for seniors, they do exist.

Among them are delayed onset of dementia and a substantial reduction in cardiovascular and cerebrovascular problems in men. More sex has been linked to longevity, with men benefiting a bit more than women from going through the entire process, including an orgasm, whereas women appear to gain from having a “satisfying” sex life, which does not always require an orgasm.

Let us not forget that these benefits apply to both patients and clinicians alike. Addressing intimacy and sexuality can ease eventual sexual concerns and potentially create a stronger clinician-patient relationship.

Dr. Gianotten, MD is emeritus senior lecturer in medical sexology, Erasmus University Medical Centre, Rotterdam, the Netherlands. He reported no conflicts of interest.

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

For health professionals, the thought that our parents and grandparents don’t have sex – or didn’t – might be comforting.

The reality is that, for a significant proportion of our older patients, sex has no use-by date. Humans are sexual beings throughout their lives, yet the culture has concealed that fact.

According to Rome, the purpose of sex is to make children. According to Hollywood, sex is only for the young, the healthy, and the beautiful. For the medical profession, sex consists mainly of risks or dysfunctions.

The results of these biases? Many middle-aged people fear their later sexual life. And medical professionals rarely ask about sexuality. That failing can be harmful. Sexuality and intimacy are essential elements for quality of life, with clear physical, emotional, and relational benefits.

Let’s look at the data when researchers dared to ask seniors about their sexuality.

We start with the 2015 U.K. national research on sexuality. The study found a link between age and a decline in various aspects of sexual activity – but not a zeroing-out. For example, among men aged 70-79, 59% reported having had sex in the past year, with 19% having intercourse at least twice a month and 18% masturbating at least that often. Above age 80, those numbers dropped to 39%, 6%, and 5%, respectively. The reason behind the declines? A combination of taboo, fear of disease, use of medications or other interventions that disrupt sexual function or cause disfigurement, and a little bit of age itself.

What about women? Among women ages 70-79, 39% said they’d had sex in the past year, with 6% having intercourse at least twice per month and 5% masturbating two times or more monthly. Above age 80, those numbers were 10%, 4.5%, and 1%, respectively. Driving the falloff in women were the same factors as for men, plus the sad reality that many heterosexual women become widowed because their older male partners die earlier.

The male-female difference also reflects lower levels of testosterone in women. And, because women say they value intimacy more than performance, we have two explanations for their lower frequency of masturbation. After all, a lot of intimacy occurs without either intercourse or masturbation.

Surprising and relevant is the amount of distress – or rather, their relative lack thereof – older patients report because of sexual problems. At age 18-44, 11% of U.S. women indicated sexual distress; at age 45-64, the figure was 15%; and at age 65 and up, 9%.

For clinicians, those figures should prompt us to look more closely at alternative forms of sexual expression – those not involving intercourse or masturbation – in the aged, a field physicians typically do not consider.

Although dyspareunia or erectile problems affect many in long-standing relationships, neither is a reason to abstain from sexual pleasure. Indeed, in many couples, oral sex will replace vaginal intercourse, and if urinary, fecal, or flatal incontinence intrude, couples often waive oral sex in favor of more cuddling, kissing, digital stimulation, and other forms of sexual pleasure.
 

What about the expiry date for sex?

Fascinating research from Nils Beckman, PhD, and colleagues found that the sex drive persists even as people (and men in particular) reach their 100th year. Dr. Beckman’s group interviewed 269 Swedish seniors, all without dementia, at age 97. Sexual desire was affirmed by 27% of men and 5% of women in the survey. Among the men, 32% said they still had sexual thoughts, compared with 18% of women. Meanwhile, 26% of the men and 15% of the women said they missed sexual activity.

What should clinicians do with this information? First, we could start talking about sex with our older patients. According to the 97-year-old Swedes, most want us to! More than 8 in 10 of both women and men in the survey expressed positive views about questions on sexuality. And please don’t be scared to address the subject in the single senior. They, too, can have a sexual or relationship issue and are happy when we raise the subject. They’re not scared to talk about masturbation, either.

When caring for those with chronic diseases, cancer, in the course of physical rehabilitation, and even in the last phase of life, the clinical experience indicates that our patients are happy when we address sexuality and intimacy. Doing so can open the door to the admission of a problem and a corresponding solution, a lubricant or a PDE5 inhibitor.

But sometimes the solution is the conversation itself: Roughly 25% of patients are sufficiently helped simply by talking about sex. Addressing the importance of sexual pleasure is nearly always valuable.

Here are a few ice-breakers I find helpful:

  • Did taking this medication change aspects of sexuality? If so, does that bother you?
  • Knowing that continuing intimacy is healthy, do you mind if I address that subject?
  • We know that aspects of sexuality and intimacy are healthy. Without a partner, some people become sexually isolated. Would you like to talk about that?’

If addressing sexuality has benefits, what about sex itself?

We are gradually learning more about the many short-, intermediate-, and long-term health benefits of solo and joint sexual activity. Short-term benefits include muscle relaxation, pain relief (even, perhaps ironically, for headaches), and better sleep – all pretty valuable for older adults. Examples of intermediate-term benefits include stress relief and less depression. Research from the United States has found that hugging can reduce the concentrations of proinflammatory cytokines, and kissing positively influences cholesterol levels.

Finally, while the long-term benefits of sex might be less relevant for seniors, they do exist.

Among them are delayed onset of dementia and a substantial reduction in cardiovascular and cerebrovascular problems in men. More sex has been linked to longevity, with men benefiting a bit more than women from going through the entire process, including an orgasm, whereas women appear to gain from having a “satisfying” sex life, which does not always require an orgasm.

Let us not forget that these benefits apply to both patients and clinicians alike. Addressing intimacy and sexuality can ease eventual sexual concerns and potentially create a stronger clinician-patient relationship.

Dr. Gianotten, MD is emeritus senior lecturer in medical sexology, Erasmus University Medical Centre, Rotterdam, the Netherlands. He reported no conflicts of interest.

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

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Drug shortages in U.S. at 10-year high

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Mon, 05/22/2023 - 12:31

Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), said in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

As of early May, there were 15 oncology drugs on the official Food and Drug Administration drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Dr. Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes,” she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply: carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers; fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia; dacarbazine injection for treatment of skin cancer; amifostine injection; azacitidine injection; capecitabine tablets; cisplatin injection; cytarabine injection; dexamethasone sodium phosphate injection; hydrocortisone sodium succinate injection; leucovorin calcium lyophilized powder for injection; Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection; methotrexate injection; pentostatin injection; and streptozocin (Zanosar) sterile powder.

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.
 

Two decades of shortages

Drug shortages in the United States have been a chronic problem for more than 2 decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

A 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Dr. Knudsen noted that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

“ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages,” she said. “In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients’ treatments are not delayed.”
 

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

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Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), said in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

As of early May, there were 15 oncology drugs on the official Food and Drug Administration drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Dr. Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes,” she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply: carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers; fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia; dacarbazine injection for treatment of skin cancer; amifostine injection; azacitidine injection; capecitabine tablets; cisplatin injection; cytarabine injection; dexamethasone sodium phosphate injection; hydrocortisone sodium succinate injection; leucovorin calcium lyophilized powder for injection; Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection; methotrexate injection; pentostatin injection; and streptozocin (Zanosar) sterile powder.

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.
 

Two decades of shortages

Drug shortages in the United States have been a chronic problem for more than 2 decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

A 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Dr. Knudsen noted that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

“ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages,” she said. “In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients’ treatments are not delayed.”
 

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

Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), said in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

As of early May, there were 15 oncology drugs on the official Food and Drug Administration drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Dr. Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes,” she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply: carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers; fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia; dacarbazine injection for treatment of skin cancer; amifostine injection; azacitidine injection; capecitabine tablets; cisplatin injection; cytarabine injection; dexamethasone sodium phosphate injection; hydrocortisone sodium succinate injection; leucovorin calcium lyophilized powder for injection; Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection; methotrexate injection; pentostatin injection; and streptozocin (Zanosar) sterile powder.

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.
 

Two decades of shortages

Drug shortages in the United States have been a chronic problem for more than 2 decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

A 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Dr. Knudsen noted that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

“ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages,” she said. “In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients’ treatments are not delayed.”
 

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

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New guidance on neurological complications of long COVID

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Changed
Mon, 05/22/2023 - 08:36

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) has issued new consensus guidance on the assessment and treatment of neurologic sequelae in patients with long COVID, also known as postacute sequelae of SARS-CoV-2 infection (PASC).

The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.

Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.

Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.

“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.

According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.

“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.

Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.

The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.

She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”

Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.

While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.

The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.

Experts also recommend clinicians do the following:

  • Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
  • Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
  • Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
  • Work with physical, occupational, and speech therapists to increase function and independence.
  • Refer patients to counseling and community resources for risk factor modification.
 

 

The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.

The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.

“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”

The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.

The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.

For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.

The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
 

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

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The American Academy of Physical Medicine and Rehabilitation (AAPM&R) has issued new consensus guidance on the assessment and treatment of neurologic sequelae in patients with long COVID, also known as postacute sequelae of SARS-CoV-2 infection (PASC).

The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.

Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.

Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.

“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.

According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.

“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.

Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.

The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.

She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”

Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.

While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.

The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.

Experts also recommend clinicians do the following:

  • Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
  • Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
  • Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
  • Work with physical, occupational, and speech therapists to increase function and independence.
  • Refer patients to counseling and community resources for risk factor modification.
 

 

The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.

The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.

“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”

The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.

The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.

For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.

The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
 

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

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) has issued new consensus guidance on the assessment and treatment of neurologic sequelae in patients with long COVID, also known as postacute sequelae of SARS-CoV-2 infection (PASC).

The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.

Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.

Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.

“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.

According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.

“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.

Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.

The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.

She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”

Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.

While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.

The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.

Experts also recommend clinicians do the following:

  • Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
  • Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
  • Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
  • Work with physical, occupational, and speech therapists to increase function and independence.
  • Refer patients to counseling and community resources for risk factor modification.
 

 

The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.

The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.

“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”

The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.

The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.

For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.

The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
 

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

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‘Robust evidence’ that exercise cuts Parkinson’s risk in women

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Mon, 05/22/2023 - 08:42

Physical activity has been tied to a significantly decreased risk of Parkinson’s disease (PD) in women, results of a large, long-term prospective study show.

Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.

The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.

This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.

“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.

The study was published online in Neurology.
 

Direct protective effect?

Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.

The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.

To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.

The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.

In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.

Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.

Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.

The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.

In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).

The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”

Analyses that included 15-year and 20-year lag times had similar findings.

Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.

“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.

Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.

Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.

The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
 

 

 

Robust evidence

In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.

“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.

The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.

Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.

Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.

Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”

Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”

The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.

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

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Physical activity has been tied to a significantly decreased risk of Parkinson’s disease (PD) in women, results of a large, long-term prospective study show.

Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.

The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.

This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.

“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.

The study was published online in Neurology.
 

Direct protective effect?

Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.

The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.

To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.

The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.

In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.

Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.

Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.

The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.

In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).

The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”

Analyses that included 15-year and 20-year lag times had similar findings.

Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.

“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.

Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.

Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.

The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
 

 

 

Robust evidence

In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.

“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.

The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.

Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.

Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.

Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”

Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”

The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.

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

Physical activity has been tied to a significantly decreased risk of Parkinson’s disease (PD) in women, results of a large, long-term prospective study show.

Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.

The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.

This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.

“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.

The study was published online in Neurology.
 

Direct protective effect?

Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.

The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.

To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.

The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.

In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.

Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.

Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.

The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.

In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).

The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”

Analyses that included 15-year and 20-year lag times had similar findings.

Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.

“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.

Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.

Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.

The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
 

 

 

Robust evidence

In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.

“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.

The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.

Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.

Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.

Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”

Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”

The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.

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

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