Health Policy

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.¹ Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.² The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.^3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.^5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.⁷ T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.⁸

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.^9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,¹⁵ including those with complex cases.¹⁶ Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).¹⁷ Additional studies, like those conducted by Phillip et al,¹⁸ confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.¹⁹

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.^3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.^29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.³¹ In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.³² The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.³³

Health Equity

While inequities across various health outcomes have been well documented for years,³⁴ the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.^23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).³⁶ One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.³⁷ There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.³⁸ A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.³⁹ The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.⁴⁰

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).⁴¹ Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.⁴² This effort has been expanded and will continue in 2022 and beyond,⁴³ and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.⁴⁴

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.^45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.⁴⁸ These systems support reduced hypoglycemia and improved time in range.⁴⁹

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs^50,51 and even a patch to deliver insulin without the burden of injections.⁵² As barriers to diabetes technology persist,⁵³ innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.^53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.⁵⁶ Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.⁵⁷ Other recent advances include stem cell replacement therapy for patients with T1D.⁵⁸ The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.⁵⁹

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.^60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.⁶² Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,⁶³ advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,⁶⁴ and 20 states passed legislation capping insulin pricing.⁶² Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.⁶⁵

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.⁶⁶ Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.⁶⁷

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: amungmode@t1dexchange.org

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.¹ Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.² The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.^3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.^5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.⁷ T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.⁸

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.^9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,¹⁵ including those with complex cases.¹⁶ Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).¹⁷ Additional studies, like those conducted by Phillip et al,¹⁸ confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.¹⁹

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.^3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.^29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.³¹ In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.³² The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.³³

Health Equity

While inequities across various health outcomes have been well documented for years,³⁴ the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.^23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).³⁶ One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.³⁷ There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.³⁸ A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.³⁹ The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.⁴⁰

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).⁴¹ Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.⁴² This effort has been expanded and will continue in 2022 and beyond,⁴³ and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.⁴⁴

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.^45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.⁴⁸ These systems support reduced hypoglycemia and improved time in range.⁴⁹

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs^50,51 and even a patch to deliver insulin without the burden of injections.⁵² As barriers to diabetes technology persist,⁵³ innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.^53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.⁵⁶ Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.⁵⁷ Other recent advances include stem cell replacement therapy for patients with T1D.⁵⁸ The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.⁵⁹

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.^60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.⁶² Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,⁶³ advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,⁶⁴ and 20 states passed legislation capping insulin pricing.⁶² Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.⁶⁵

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.⁶⁶ Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.⁶⁷

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: amungmode@t1dexchange.org

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.¹ Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.² The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.^3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.^5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.⁷ T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.⁸

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.^9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,¹⁵ including those with complex cases.¹⁶ Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).¹⁷ Additional studies, like those conducted by Phillip et al,¹⁸ confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.¹⁹

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.^3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.^29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.³¹ In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.³² The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.³³

Health Equity

While inequities across various health outcomes have been well documented for years,³⁴ the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.^23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).³⁶ One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.³⁷ There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.³⁸ A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.³⁹ The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.⁴⁰

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).⁴¹ Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.⁴² This effort has been expanded and will continue in 2022 and beyond,⁴³ and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.⁴⁴

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.^45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.⁴⁸ These systems support reduced hypoglycemia and improved time in range.⁴⁹

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs^50,51 and even a patch to deliver insulin without the burden of injections.⁵² As barriers to diabetes technology persist,⁵³ innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.^53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.⁵⁶ Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.⁵⁷ Other recent advances include stem cell replacement therapy for patients with T1D.⁵⁸ The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.⁵⁹

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.^60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.⁶² Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,⁶³ advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,⁶⁴ and 20 states passed legislation capping insulin pricing.⁶² Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.⁶⁵

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.⁶⁶ Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.⁶⁷

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: amungmode@t1dexchange.org

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

Study 1 Overview (Bayliss et al)

Objective: To examine the effect of a deprescribing educational intervention on medication use in older adults with cognitive impairment.

Design: This was a pragmatic, cluster randomized trial conducted in 8 primary care clinics that are part of a nonprofit health care system.

Setting and participants: The primary care clinic populations ranged from 170 to 1125 patients per clinic. The primary care clinics were randomly assigned to intervention or control using a uniform distribution in blocks by clinic size. Eligibility criteria for participants at those practices included age 65 years or older; health plan enrollment at least 1 year prior to intervention; diagnosis of Alzheimer disease and related dementia (ADRD) or mild cognitive impairment (MCI) by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code or from problem list; 1 or more chronic conditions from those in the Chronic Conditions Warehouse; and 5 or more long-term medications. Those who scheduled a visit at their primary care clinic in advance were eligible for the intervention. Primary care clinicians in intervention clinics were eligible to receive the clinician portion of the intervention. A total of 1433 participants were enrolled in the intervention group, and 1579 participants were enrolled in the control group.

Intervention: The intervention included 2 components: a patient and family component with materials mailed in advance of their primary care visits and a clinician component comprising monthly educational materials on deprescribing and notification in the electronic health record about visits with patient participants. The patient and family component consisted of a brochure titled “Managing Medication” and a questionnaire on attitudes toward deprescribing intended to educate patients and family about deprescribing. Clinicians at intervention clinics received an educational presentation at a monthly clinician meeting as well as tip sheets and a poster on deprescribing topics, and they also were notified of upcoming appointments with patients who received the patient component of the intervention. For the control group, patients and family did not receive any materials, and clinicians did not receive intervention materials or notification of participants enrolled in the trial. Usual care in both intervention and control groups included medication reconciliation and electronic health record alerts for potentially high-risk medications.

Main outcome measures: The primary outcomes of the study were the number of long-term medications per individual and the proportion of patients prescribed 1 or more potentially inappropriate medications. Outcome measurements were extracted from the electronic clinical data, and outcomes were assessed at 6 months, which involved comparing counts of medications at baseline with medications at 6 months. Long-term medications were defined as medications that are prescribed for 28 days or more based on pharmacy dispensing data. Potentially inappropriate medications (PIMs) were defined using the Beers list of medications to avoid in those with cognitive impairment and opioid medications. Analyses were conducted as intention to treat.

Main results: In the intervention group and control group, 56.2% and 54.4% of participants were women, and the mean age was 80.1 years (SD, 7.2) and 79.9 years (SD, 7.5), respectively. At baseline, the mean number of long-term medications was 7.0 (SD, 2.1) in the intervention group and 7.0 (SD, 2.2) in the control group. The proportion of patients taking any PIMs was 30.5% in the intervention group and 29.6% in the control group. At 6 months, the mean number of long-term medications was 6.4 in the intervention group and 6.5 in the control group, with an adjusted difference of –0.1 (95% CI, –0.2 to 0.04; P = .14); the proportion of patients with any PIMs was 17.8% in the intervention group and 20.9% in the control group, with an adjusted difference of –3.2% (95% CI, –6.2 to 0.4; P = .08). Preplanned analyses to examine subgroup differences for those with a higher number of medications (7+ vs 5 or 6 medications) did not find different effects of the intervention.

Conclusion: This educational intervention on deprescribing did not result in reductions in the number of medications or the use of PIMs in patients with cognitive impairment.

Study 2 Overview (Gedde et al)

Objective: To examine the effect of a deprescribing intervention (COSMOS) on medication use for nursing home residents.

Design: This was a randomized clinical trial.

Setting and participants: This trial was conducted in 67 units in 33 nursing homes in Norway. Participants were nursing home residents recruited from August 2014 to March 2015. Inclusion criteria included adults aged 65 years and older with at least 2 years of residency in nursing homes. Exclusion criteria included diagnosis of schizophrenia and a life expectancy of 6 months or less. Participants were followed for 4 months; participants were considered lost to follow-up if they died or moved from the nursing home unit. The analyses were per protocol and did not include those lost to follow-up or those who did not undergo a medication review in the intervention group. A total of 217 and 211 residents were included in the intervention and control groups, respectively.

Intervention: The intervention contained 5 components: communication and advance care planning, systematic pain management, medication reviews with collegial mentoring, organization of activities adjusted to needs and preferences, and safety. For medication review, the nursing home physician reviewed medications together with a nurse and study physicians who provided mentoring. The medication review involved a structured process that used assessment tools for behavioral and psychological symptoms of dementia (BPSD), activities of daily living (ADL), pain, cognitive status, well-being and quality of life, and clinical metrics of blood pressure, pulse, and body mass index. The study utilized the START/STOPP criteria¹ for medication use in addition to a list of medications with anticholinergic properties for the medication review. In addition, drug interactions were documented through a drug interaction database; the team also incorporated patient wishes and concerns in the medication reviews. The nursing home physician made final decisions on medications. For the control group, nursing home residents received usual care without this intervention.

Main outcome measures: The primary outcome of the study was the mean change in the number of prescribed psychotropic medications, both regularly scheduled and total medications (which also included on-demand drugs) received at 4 months when compared to baseline. Psychotropic medications included antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs. Secondary outcomes included mean changes in BPSD using the Neuropsychiatric Inventory-Nursing home version (NPI-NH) and the Cornell Scale for Depression for Dementia (CSDD) and ADL using the Physical Self Maintenance Scale (PSMS).

Main results: In both the intervention and control groups, 76% of participants were women, and mean age was 86.3 years (SD, 7.95) in the intervention group and 86.6 years (SD, 7.21) in the control group. At baseline, the mean number of total medications was 10.9 (SD, 4.6) in the intervention group and 10.9 (SD, 4.7) in the control group, and the mean number of psychotropic medications was 2.2 (SD, 1.6) and 2.2 (SD, 1.7) in the intervention and control groups, respectively. At 4 months, the mean change from baseline of total psychotropic medications was –0.34 in the intervention group and 0.01 in the control group (P < .001), and the mean change of regularly scheduled psychotropic medications was –0.21 in the intervention group and 0.02 in the control group (P < .001). Measures of BPSD and depression did not differ between intervention and control groups, and ADL showed a small improvement in the intervention group.

Conclusion: This intervention reduced the use of psychotropic medications in nursing home residents without worsening BPSD or depression and may have yielded improvements in ADL.

Commentary

Polypharmacy is common among older adults, as many of them have multiple chronic conditions and often take multiple medications for managing them. Polypharmacy increases the risk of drug interactions and adverse effects from medications; older adults who are frail and/or who have cognitive impairment are especially at risk. Reducing medication use, especially medications likely to cause adverse effects such as those with anticholinergic properties, has the potential to yield beneficial effects while reducing the burden of taking medications. A large randomized trial found that a pharmacist-led education intervention can be effective in reducing PIM use in community-dwelling older adults,² and that targeting patient motivation and capacity to deprescribe could be effective.³ This study by Bayliss and colleagues (Study 1), however, fell short of the effects seen in the earlier D-PRESCRIBE trial. One of the reasons for these findings may be that the clinician portion of the intervention was less intensive than that used in the earlier trial; specifically, in the present study, clinicians were not provided with or expected to utilize tools for structured medication review or deprescribing. Although the intervention primes the patient and family for discussions around deprescribing through the use of a brochure and questionnaire, the clinician portion of the intervention was less structured. Another example of an effective intervention that provided a more structured deprescribing intervention beyond education of clinicians utilized electronic decision-support to assist with deprescribing.⁴

The findings from the Gedde et al study (Study 2) are comparable to those of prior studies in the nursing home population,⁵ where participants are likely to take a large number of medications, including psychotropic medications, and are more likely to be frail. However, Gedde and colleagues employed a bundled intervention⁶ that included other components besides medication review, and thus it is unclear whether the effect on ADL can be attributed to the deprescribing of medications alone. Gedde et al’s finding that deprescribing can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression is an important contribution to our knowledge about polypharmacy and deprescribing in older patients. Thus, nursing home residents, their families, and clinicians could expect that the deprescribing of psychotropic medications does not lead to worsening symptoms. Of note, the clinician portion of the intervention in the Gedde et al study was quite structured, and this structure may have contributed to the observed effects.

Applications for Clinical Practice and System Implementation

Both studies add to the literature on deprescribing and may offer options for researchers and clinicians who are considering potential components of an effective deprescribing intervention. Patient activation for deprescribing via the methods used in these 2 studies may help to prime patients for conversations about deprescribing; however, as shown by the Bayliss et al study, a more structured approach to clinical encounters may be needed when deprescribing, such as the use of tools in the electronic health record, in order to reduce the use of medication deemed unnecessary or potentially harmful. Further studies should examine the effect of deprescribing on medication use, but perhaps even more importantly, how deprescribing impacts patient outcomes both in terms of risks and benefits.

Practice Points

• A more structured approach to clinical encounters (eg, the use of tools in the electronic health record) may be needed when deprescribing unnecessary or potentially harmful medications in older patients in community settings.
• In the nursing home setting, structured deprescribing intervention can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression.

–William W. Hung, MD, MPH

Study 1 Overview (Bayliss et al)

Objective: To examine the effect of a deprescribing educational intervention on medication use in older adults with cognitive impairment.

Design: This was a pragmatic, cluster randomized trial conducted in 8 primary care clinics that are part of a nonprofit health care system.

Setting and participants: The primary care clinic populations ranged from 170 to 1125 patients per clinic. The primary care clinics were randomly assigned to intervention or control using a uniform distribution in blocks by clinic size. Eligibility criteria for participants at those practices included age 65 years or older; health plan enrollment at least 1 year prior to intervention; diagnosis of Alzheimer disease and related dementia (ADRD) or mild cognitive impairment (MCI) by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code or from problem list; 1 or more chronic conditions from those in the Chronic Conditions Warehouse; and 5 or more long-term medications. Those who scheduled a visit at their primary care clinic in advance were eligible for the intervention. Primary care clinicians in intervention clinics were eligible to receive the clinician portion of the intervention. A total of 1433 participants were enrolled in the intervention group, and 1579 participants were enrolled in the control group.

Intervention: The intervention included 2 components: a patient and family component with materials mailed in advance of their primary care visits and a clinician component comprising monthly educational materials on deprescribing and notification in the electronic health record about visits with patient participants. The patient and family component consisted of a brochure titled “Managing Medication” and a questionnaire on attitudes toward deprescribing intended to educate patients and family about deprescribing. Clinicians at intervention clinics received an educational presentation at a monthly clinician meeting as well as tip sheets and a poster on deprescribing topics, and they also were notified of upcoming appointments with patients who received the patient component of the intervention. For the control group, patients and family did not receive any materials, and clinicians did not receive intervention materials or notification of participants enrolled in the trial. Usual care in both intervention and control groups included medication reconciliation and electronic health record alerts for potentially high-risk medications.

Main outcome measures: The primary outcomes of the study were the number of long-term medications per individual and the proportion of patients prescribed 1 or more potentially inappropriate medications. Outcome measurements were extracted from the electronic clinical data, and outcomes were assessed at 6 months, which involved comparing counts of medications at baseline with medications at 6 months. Long-term medications were defined as medications that are prescribed for 28 days or more based on pharmacy dispensing data. Potentially inappropriate medications (PIMs) were defined using the Beers list of medications to avoid in those with cognitive impairment and opioid medications. Analyses were conducted as intention to treat.

Main results: In the intervention group and control group, 56.2% and 54.4% of participants were women, and the mean age was 80.1 years (SD, 7.2) and 79.9 years (SD, 7.5), respectively. At baseline, the mean number of long-term medications was 7.0 (SD, 2.1) in the intervention group and 7.0 (SD, 2.2) in the control group. The proportion of patients taking any PIMs was 30.5% in the intervention group and 29.6% in the control group. At 6 months, the mean number of long-term medications was 6.4 in the intervention group and 6.5 in the control group, with an adjusted difference of –0.1 (95% CI, –0.2 to 0.04; P = .14); the proportion of patients with any PIMs was 17.8% in the intervention group and 20.9% in the control group, with an adjusted difference of –3.2% (95% CI, –6.2 to 0.4; P = .08). Preplanned analyses to examine subgroup differences for those with a higher number of medications (7+ vs 5 or 6 medications) did not find different effects of the intervention.

Conclusion: This educational intervention on deprescribing did not result in reductions in the number of medications or the use of PIMs in patients with cognitive impairment.

Study 2 Overview (Gedde et al)

Objective: To examine the effect of a deprescribing intervention (COSMOS) on medication use for nursing home residents.

Design: This was a randomized clinical trial.

Setting and participants: This trial was conducted in 67 units in 33 nursing homes in Norway. Participants were nursing home residents recruited from August 2014 to March 2015. Inclusion criteria included adults aged 65 years and older with at least 2 years of residency in nursing homes. Exclusion criteria included diagnosis of schizophrenia and a life expectancy of 6 months or less. Participants were followed for 4 months; participants were considered lost to follow-up if they died or moved from the nursing home unit. The analyses were per protocol and did not include those lost to follow-up or those who did not undergo a medication review in the intervention group. A total of 217 and 211 residents were included in the intervention and control groups, respectively.

Intervention: The intervention contained 5 components: communication and advance care planning, systematic pain management, medication reviews with collegial mentoring, organization of activities adjusted to needs and preferences, and safety. For medication review, the nursing home physician reviewed medications together with a nurse and study physicians who provided mentoring. The medication review involved a structured process that used assessment tools for behavioral and psychological symptoms of dementia (BPSD), activities of daily living (ADL), pain, cognitive status, well-being and quality of life, and clinical metrics of blood pressure, pulse, and body mass index. The study utilized the START/STOPP criteria¹ for medication use in addition to a list of medications with anticholinergic properties for the medication review. In addition, drug interactions were documented through a drug interaction database; the team also incorporated patient wishes and concerns in the medication reviews. The nursing home physician made final decisions on medications. For the control group, nursing home residents received usual care without this intervention.

Main outcome measures: The primary outcome of the study was the mean change in the number of prescribed psychotropic medications, both regularly scheduled and total medications (which also included on-demand drugs) received at 4 months when compared to baseline. Psychotropic medications included antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs. Secondary outcomes included mean changes in BPSD using the Neuropsychiatric Inventory-Nursing home version (NPI-NH) and the Cornell Scale for Depression for Dementia (CSDD) and ADL using the Physical Self Maintenance Scale (PSMS).

Main results: In both the intervention and control groups, 76% of participants were women, and mean age was 86.3 years (SD, 7.95) in the intervention group and 86.6 years (SD, 7.21) in the control group. At baseline, the mean number of total medications was 10.9 (SD, 4.6) in the intervention group and 10.9 (SD, 4.7) in the control group, and the mean number of psychotropic medications was 2.2 (SD, 1.6) and 2.2 (SD, 1.7) in the intervention and control groups, respectively. At 4 months, the mean change from baseline of total psychotropic medications was –0.34 in the intervention group and 0.01 in the control group (P < .001), and the mean change of regularly scheduled psychotropic medications was –0.21 in the intervention group and 0.02 in the control group (P < .001). Measures of BPSD and depression did not differ between intervention and control groups, and ADL showed a small improvement in the intervention group.

Conclusion: This intervention reduced the use of psychotropic medications in nursing home residents without worsening BPSD or depression and may have yielded improvements in ADL.

Commentary

Polypharmacy is common among older adults, as many of them have multiple chronic conditions and often take multiple medications for managing them. Polypharmacy increases the risk of drug interactions and adverse effects from medications; older adults who are frail and/or who have cognitive impairment are especially at risk. Reducing medication use, especially medications likely to cause adverse effects such as those with anticholinergic properties, has the potential to yield beneficial effects while reducing the burden of taking medications. A large randomized trial found that a pharmacist-led education intervention can be effective in reducing PIM use in community-dwelling older adults,² and that targeting patient motivation and capacity to deprescribe could be effective.³ This study by Bayliss and colleagues (Study 1), however, fell short of the effects seen in the earlier D-PRESCRIBE trial. One of the reasons for these findings may be that the clinician portion of the intervention was less intensive than that used in the earlier trial; specifically, in the present study, clinicians were not provided with or expected to utilize tools for structured medication review or deprescribing. Although the intervention primes the patient and family for discussions around deprescribing through the use of a brochure and questionnaire, the clinician portion of the intervention was less structured. Another example of an effective intervention that provided a more structured deprescribing intervention beyond education of clinicians utilized electronic decision-support to assist with deprescribing.⁴

The findings from the Gedde et al study (Study 2) are comparable to those of prior studies in the nursing home population,⁵ where participants are likely to take a large number of medications, including psychotropic medications, and are more likely to be frail. However, Gedde and colleagues employed a bundled intervention⁶ that included other components besides medication review, and thus it is unclear whether the effect on ADL can be attributed to the deprescribing of medications alone. Gedde et al’s finding that deprescribing can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression is an important contribution to our knowledge about polypharmacy and deprescribing in older patients. Thus, nursing home residents, their families, and clinicians could expect that the deprescribing of psychotropic medications does not lead to worsening symptoms. Of note, the clinician portion of the intervention in the Gedde et al study was quite structured, and this structure may have contributed to the observed effects.

Applications for Clinical Practice and System Implementation

Both studies add to the literature on deprescribing and may offer options for researchers and clinicians who are considering potential components of an effective deprescribing intervention. Patient activation for deprescribing via the methods used in these 2 studies may help to prime patients for conversations about deprescribing; however, as shown by the Bayliss et al study, a more structured approach to clinical encounters may be needed when deprescribing, such as the use of tools in the electronic health record, in order to reduce the use of medication deemed unnecessary or potentially harmful. Further studies should examine the effect of deprescribing on medication use, but perhaps even more importantly, how deprescribing impacts patient outcomes both in terms of risks and benefits.

Practice Points

• A more structured approach to clinical encounters (eg, the use of tools in the electronic health record) may be needed when deprescribing unnecessary or potentially harmful medications in older patients in community settings.
• In the nursing home setting, structured deprescribing intervention can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression.

–William W. Hung, MD, MPH

Study 1 Overview (Bayliss et al)

Objective: To examine the effect of a deprescribing educational intervention on medication use in older adults with cognitive impairment.

Design: This was a pragmatic, cluster randomized trial conducted in 8 primary care clinics that are part of a nonprofit health care system.

Setting and participants: The primary care clinic populations ranged from 170 to 1125 patients per clinic. The primary care clinics were randomly assigned to intervention or control using a uniform distribution in blocks by clinic size. Eligibility criteria for participants at those practices included age 65 years or older; health plan enrollment at least 1 year prior to intervention; diagnosis of Alzheimer disease and related dementia (ADRD) or mild cognitive impairment (MCI) by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code or from problem list; 1 or more chronic conditions from those in the Chronic Conditions Warehouse; and 5 or more long-term medications. Those who scheduled a visit at their primary care clinic in advance were eligible for the intervention. Primary care clinicians in intervention clinics were eligible to receive the clinician portion of the intervention. A total of 1433 participants were enrolled in the intervention group, and 1579 participants were enrolled in the control group.

Intervention: The intervention included 2 components: a patient and family component with materials mailed in advance of their primary care visits and a clinician component comprising monthly educational materials on deprescribing and notification in the electronic health record about visits with patient participants. The patient and family component consisted of a brochure titled “Managing Medication” and a questionnaire on attitudes toward deprescribing intended to educate patients and family about deprescribing. Clinicians at intervention clinics received an educational presentation at a monthly clinician meeting as well as tip sheets and a poster on deprescribing topics, and they also were notified of upcoming appointments with patients who received the patient component of the intervention. For the control group, patients and family did not receive any materials, and clinicians did not receive intervention materials or notification of participants enrolled in the trial. Usual care in both intervention and control groups included medication reconciliation and electronic health record alerts for potentially high-risk medications.

Main outcome measures: The primary outcomes of the study were the number of long-term medications per individual and the proportion of patients prescribed 1 or more potentially inappropriate medications. Outcome measurements were extracted from the electronic clinical data, and outcomes were assessed at 6 months, which involved comparing counts of medications at baseline with medications at 6 months. Long-term medications were defined as medications that are prescribed for 28 days or more based on pharmacy dispensing data. Potentially inappropriate medications (PIMs) were defined using the Beers list of medications to avoid in those with cognitive impairment and opioid medications. Analyses were conducted as intention to treat.

Main results: In the intervention group and control group, 56.2% and 54.4% of participants were women, and the mean age was 80.1 years (SD, 7.2) and 79.9 years (SD, 7.5), respectively. At baseline, the mean number of long-term medications was 7.0 (SD, 2.1) in the intervention group and 7.0 (SD, 2.2) in the control group. The proportion of patients taking any PIMs was 30.5% in the intervention group and 29.6% in the control group. At 6 months, the mean number of long-term medications was 6.4 in the intervention group and 6.5 in the control group, with an adjusted difference of –0.1 (95% CI, –0.2 to 0.04; P = .14); the proportion of patients with any PIMs was 17.8% in the intervention group and 20.9% in the control group, with an adjusted difference of –3.2% (95% CI, –6.2 to 0.4; P = .08). Preplanned analyses to examine subgroup differences for those with a higher number of medications (7+ vs 5 or 6 medications) did not find different effects of the intervention.

Conclusion: This educational intervention on deprescribing did not result in reductions in the number of medications or the use of PIMs in patients with cognitive impairment.

Study 2 Overview (Gedde et al)

Objective: To examine the effect of a deprescribing intervention (COSMOS) on medication use for nursing home residents.

Design: This was a randomized clinical trial.

Setting and participants: This trial was conducted in 67 units in 33 nursing homes in Norway. Participants were nursing home residents recruited from August 2014 to March 2015. Inclusion criteria included adults aged 65 years and older with at least 2 years of residency in nursing homes. Exclusion criteria included diagnosis of schizophrenia and a life expectancy of 6 months or less. Participants were followed for 4 months; participants were considered lost to follow-up if they died or moved from the nursing home unit. The analyses were per protocol and did not include those lost to follow-up or those who did not undergo a medication review in the intervention group. A total of 217 and 211 residents were included in the intervention and control groups, respectively.

Intervention: The intervention contained 5 components: communication and advance care planning, systematic pain management, medication reviews with collegial mentoring, organization of activities adjusted to needs and preferences, and safety. For medication review, the nursing home physician reviewed medications together with a nurse and study physicians who provided mentoring. The medication review involved a structured process that used assessment tools for behavioral and psychological symptoms of dementia (BPSD), activities of daily living (ADL), pain, cognitive status, well-being and quality of life, and clinical metrics of blood pressure, pulse, and body mass index. The study utilized the START/STOPP criteria¹ for medication use in addition to a list of medications with anticholinergic properties for the medication review. In addition, drug interactions were documented through a drug interaction database; the team also incorporated patient wishes and concerns in the medication reviews. The nursing home physician made final decisions on medications. For the control group, nursing home residents received usual care without this intervention.

Main outcome measures: The primary outcome of the study was the mean change in the number of prescribed psychotropic medications, both regularly scheduled and total medications (which also included on-demand drugs) received at 4 months when compared to baseline. Psychotropic medications included antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs. Secondary outcomes included mean changes in BPSD using the Neuropsychiatric Inventory-Nursing home version (NPI-NH) and the Cornell Scale for Depression for Dementia (CSDD) and ADL using the Physical Self Maintenance Scale (PSMS).

Main results: In both the intervention and control groups, 76% of participants were women, and mean age was 86.3 years (SD, 7.95) in the intervention group and 86.6 years (SD, 7.21) in the control group. At baseline, the mean number of total medications was 10.9 (SD, 4.6) in the intervention group and 10.9 (SD, 4.7) in the control group, and the mean number of psychotropic medications was 2.2 (SD, 1.6) and 2.2 (SD, 1.7) in the intervention and control groups, respectively. At 4 months, the mean change from baseline of total psychotropic medications was –0.34 in the intervention group and 0.01 in the control group (P < .001), and the mean change of regularly scheduled psychotropic medications was –0.21 in the intervention group and 0.02 in the control group (P < .001). Measures of BPSD and depression did not differ between intervention and control groups, and ADL showed a small improvement in the intervention group.

Conclusion: This intervention reduced the use of psychotropic medications in nursing home residents without worsening BPSD or depression and may have yielded improvements in ADL.

Commentary

Polypharmacy is common among older adults, as many of them have multiple chronic conditions and often take multiple medications for managing them. Polypharmacy increases the risk of drug interactions and adverse effects from medications; older adults who are frail and/or who have cognitive impairment are especially at risk. Reducing medication use, especially medications likely to cause adverse effects such as those with anticholinergic properties, has the potential to yield beneficial effects while reducing the burden of taking medications. A large randomized trial found that a pharmacist-led education intervention can be effective in reducing PIM use in community-dwelling older adults,² and that targeting patient motivation and capacity to deprescribe could be effective.³ This study by Bayliss and colleagues (Study 1), however, fell short of the effects seen in the earlier D-PRESCRIBE trial. One of the reasons for these findings may be that the clinician portion of the intervention was less intensive than that used in the earlier trial; specifically, in the present study, clinicians were not provided with or expected to utilize tools for structured medication review or deprescribing. Although the intervention primes the patient and family for discussions around deprescribing through the use of a brochure and questionnaire, the clinician portion of the intervention was less structured. Another example of an effective intervention that provided a more structured deprescribing intervention beyond education of clinicians utilized electronic decision-support to assist with deprescribing.⁴

The findings from the Gedde et al study (Study 2) are comparable to those of prior studies in the nursing home population,⁵ where participants are likely to take a large number of medications, including psychotropic medications, and are more likely to be frail. However, Gedde and colleagues employed a bundled intervention⁶ that included other components besides medication review, and thus it is unclear whether the effect on ADL can be attributed to the deprescribing of medications alone. Gedde et al’s finding that deprescribing can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression is an important contribution to our knowledge about polypharmacy and deprescribing in older patients. Thus, nursing home residents, their families, and clinicians could expect that the deprescribing of psychotropic medications does not lead to worsening symptoms. Of note, the clinician portion of the intervention in the Gedde et al study was quite structured, and this structure may have contributed to the observed effects.

Applications for Clinical Practice and System Implementation

Both studies add to the literature on deprescribing and may offer options for researchers and clinicians who are considering potential components of an effective deprescribing intervention. Patient activation for deprescribing via the methods used in these 2 studies may help to prime patients for conversations about deprescribing; however, as shown by the Bayliss et al study, a more structured approach to clinical encounters may be needed when deprescribing, such as the use of tools in the electronic health record, in order to reduce the use of medication deemed unnecessary or potentially harmful. Further studies should examine the effect of deprescribing on medication use, but perhaps even more importantly, how deprescribing impacts patient outcomes both in terms of risks and benefits.

Practice Points

• A more structured approach to clinical encounters (eg, the use of tools in the electronic health record) may be needed when deprescribing unnecessary or potentially harmful medications in older patients in community settings.
• In the nursing home setting, structured deprescribing intervention can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression.

–William W. Hung, MD, MPH

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

THE CASE

Louise T* is a 42-year-old woman who presented to her family medicine office for a routine annual visit. During the exam, her physician noticed bruises on Ms. T’s arms and back. Upon further inquiry, Ms. T reported that she and her husband had argued the night before the appointment. With some hesitancy, she went on to say that this was not the first time this had happened. She said that she and her husband had been arguing frequently for several years and that 6 months earlier, when he lost his job, he began hitting and pushing her.

● How would you proceed with this patient?

*The patient’s name has been changed to protect her identity.

Intimate partner violence (IPV) includes physical, sexual, or psychological aggression or stalking perpetrated by a current or former relationship partner.¹ IPV affects more than 12 million men and women living in the United States each year.² According to a national survey of IPV, approximately one-third (35.6%) of women and one-quarter (28.5%) of men living in the United States experience rape, physical violence, or stalking by an intimate partner during their lifetime.² Lifetime exposure to psychological IPV is even more prevalent, affecting nearly half of women and men (48.4% and 48.8%, respectively).²

Lifetime prevalence of any form of IPV is higher among women who identify as bisexual (59.8%) and lesbian (46.3%) compared with those who identify as heterosexual (37.2%); rates are comparable among men who identify as heterosexual (31.9%), bisexual (35.3%), and gay (35.1%).³ Preliminary data suggest that IPV may have increased in frequency and severity during the COVID-19 pandemic, particularly in the context of mandated shelter-in-place and stay-at-home orders.^4-6

IPV is associated with numerous negative health consequences. They include fear and concern for safety, mental health disorders such as posttraumatic stress disorder (PTSD), and physical health problems including physical injury, chronic pain, sleep disturbance, and frequent headaches.² IPV is also associated with a greater number of missed days from school and work and increased utilization of legal, health care, and housing services.^2,7 The overall annual cost of IPV against women is estimated at $5.8 billion, with health care costs accounting for approximately $4.1 billion.⁷ Family physicians can play an important role in curbing the devastating effects of IPV by screening patients and providing resources when needed.

Facilitate disclosure using screening tools and protocol

In Ms. T’s case, evidence of violence was clearly visible. However, not all instances of IPV leave physical marks. The US Preventive Services Task Force (USPSTF) recommends that all women of childbearing age be screened for IPV, whether or not they exhibit signs of violence.⁸ While the USPSTF has only published recommendations regarding screening women for IPV, there has been a recent push to screen all patients given that men also experience high rates of IPV.⁹

It’s helpful to ask questions such as: “Do arguments [with your partner] ever result in hitting, kicking, or pushing?” and “How often does your partner scream or curse at you?”

Utilize a brief screening tool. Directly ask patients about IPV; this can help reduce stigma, facilitate disclosure, and initiate the process of connecting patients to potentially lifesaving resources. The USPSTF lists several brief screening measures that can be used in primary care settings to assess exposure to IPV (TABLE 1^8,10-17). The brevity of these screening tools makes them well suited for busy physicians; cutoff scores facilitate the rapid identification of positive screens. While the USPSTF has not made specific recommendations regarding a screening interval, many studies examining the utility of these measures have reported on annual screenings.⁸ While there is limited evidence that brief screening alone leads to reductions in IPV,⁸ discussing IPV in a supportive and empathic manner and connecting patients to resources, such as supportive counseling, does have an important benefit: It can reduce symptoms of depression.¹⁸

Continue to: Screen patients in private; this protocol can help

Screen patients in private; this protocol can help. Given the sensitive nature of IPV and the potential danger some patients may be facing, it is important to screen patients in a safe and supportive environment.^19,20 Screening should be conducted by the primary care clinician, ideally when a trusting relationship already has been formed. Screen patients only when they are alone in a private room; avoid screening in public spaces such as clinic waiting rooms or in the vicinity of the patient’s partner or children older than age 2 years.^19,20

To provide all patients with an opportunity for private and safe IPV screening, clinics are encouraged to develop a clinic-wide policy whereby patients are routinely escorted to the exam room alone for the first portion of their visit, after which any accompanying individuals may be invited to join.²¹ Clinic staff can inform patients and accompanying individuals of this policy when they first arrive. Once in the exam room, and before the screening process begins, clearly state reporting requirements to ensure that patients can make an informed decision about whether to disclose IPV.¹⁹

Set a receptive tone. The manner in which clinicians discuss IPV with their patients is just as important as the setting. Demonstrating sensitivity and genuine concern for the patient’s safety and well-being may increase the patient’s comfort level throughout the screening process and may facilitate disclosures of IPV.^19,22 When screening patients for IPV, sit face to face rather than standing over them, maintain warm and open body language, and speak in a soft tone of voice.²²

Patients may feel more comfortable if you ask screening questions in a straightforward, nonjudgmental manner, as this helps to normalize the screening experience. We also recommend using behaviorally specific language (eg, “Do arguments [with your partner] ever result in hitting, kicking, or pushing?”¹⁶ or “How often does your partner scream or curse at you?”),¹³ as some patients who have experienced IPV will not label their experiences as “abuse” or “violence.” Not every patient who experiences IPV will be ready to disclose these events; however, maintaining a positive and supportive relationship during routine IPV screening and throughout the remainder of the medical visit may help facilitate future disclosures if, and when, a patient is ready to seek support.¹⁹

CRITICAL INTERVENTION ELEMENTS: EMPATHY AND SAFETY

A physician’s response to an IPV disclosure can have a lasting impact on the patient. We encourage family physicians to respond to IPV disclosures with empathy. Maintain eye contact and warm body language, validate the patient’s experiences (“I am sorry this happened to you,” “that must have been terrifying”), tell the patient that the violence was not their fault, and thank the patient for disclosing.²³

Continue to: Assess patient safety

Assess patient safety. Another critical component of intervention is to assess the patient’s safety and engage in safety planning. If the patient agrees to this next step, you may wish to provide a warm handoff to a trained social worker, nurse, or psychologist in the clinic who can spend more time covering this information with the patient. Some key components of a safety assessment include determining whether the violence or threat of violence is ongoing and identifying who lives in the home (eg, the partner, children, and any pets). You and the patient can also discuss red flags that would indicate elevated risk. You should discuss red flags that are unique to the patient’s relationship as well as common factors that have been found to heighten risk for IPV (eg, partner engaging in heavy alcohol use).¹

With the patient’s permission, collaboratively construct a safety plan that details how the patient can stay safe on a daily basis and how to safely leave should a dangerous situation arise (TABLE 2^9,24). The interactive safety planning tool available on the National Domestic Violence Hotline’s website can be a valuable resource (www.thehotline.org/plan-for-safety/).²⁴ Finally, if a patient is experiencing mental health concerns associated with IPV (eg, PTSD, depression, substance misuse, suicidal ideation), consider a referral to a domestic violence counseling center or mental health provider.

Move at the patient’s pace. Even if patients are willing to disclose IPV, they will differ in their readiness to discuss psychoeducation, safety planning, and referrals. Similarly, even if a patient is experiencing severe violence, they may not be ready to leave the relationship. Thus, it’s important to ask the patient for permission before initiating each successive step of the follow-up intervention. You and the patient may wish to schedule additional appointments to discuss this information at a pace the patient finds appropriate.

You may need to spend some time helping the patient recognize the severity of their situation and to feel empowered to take action. In addition, offer information and resources to all patients, even those who do not disclose IPV. Some patients may want to receive this information even if they do not feel comfortable sharing their experiences during the appointment.²⁰ You can also inform patients that they are welcome to bring up issues related to IPV at any future appointments in order to leave the door open to future disclosures.

THE CASE

The physician determined that Ms. T had been experiencing physical and psychological IPV in her current relationship. After responding empathically and obtaining the patient’s consent, the physician provided a warm handoff to the psychologist in the clinic. With Ms. T’s permission, the psychologist provided psychoeducation about IPV, and they discussed Ms. T’s current situation and risk level. They determined that Ms. T was at risk for subsequent episodes of IPV and they collaborated on a safety plan, making sure to discuss contact information for local and national crisis resources.

Continue to: Ms. T saved the phone number...

Ms. T saved the phone number for her local domestic violence shelter in her phone under a false name in case her husband looked through her phone. She said she planned to work on several safety plan items when her husband was away from the house and it was safe to do so. For example, she planned to identify additional ways to exit the house in an emergency and she was going to put together a bag with a change of clothes and some money and drop it off at a trusted friend’s house.

Ms. T and the psychologist agreed to follow up with an office visit in 1 week to discuss any additional safety concerns and to determine whether Ms. T could benefit from a referral to domestic violence counseling services or mental health treatment. The psychologist provided a summary of the topics she and Ms. T had discussed to the physician. The physician scheduled a follow-up appointment with Ms. T in 3 weeks to assess her current safety, troubleshoot any difficulties in implementing her safety plan, and offer additional resources, as needed.

CORRESPONDENCE
Andrea Massa, PhD, 125 Doughty Street, Suite 300, Charleston, SC 29403; massa@musc.edu

THE CASE

Louise T* is a 42-year-old woman who presented to her family medicine office for a routine annual visit. During the exam, her physician noticed bruises on Ms. T’s arms and back. Upon further inquiry, Ms. T reported that she and her husband had argued the night before the appointment. With some hesitancy, she went on to say that this was not the first time this had happened. She said that she and her husband had been arguing frequently for several years and that 6 months earlier, when he lost his job, he began hitting and pushing her.

● How would you proceed with this patient?

*The patient’s name has been changed to protect her identity.

Intimate partner violence (IPV) includes physical, sexual, or psychological aggression or stalking perpetrated by a current or former relationship partner.¹ IPV affects more than 12 million men and women living in the United States each year.² According to a national survey of IPV, approximately one-third (35.6%) of women and one-quarter (28.5%) of men living in the United States experience rape, physical violence, or stalking by an intimate partner during their lifetime.² Lifetime exposure to psychological IPV is even more prevalent, affecting nearly half of women and men (48.4% and 48.8%, respectively).²

Lifetime prevalence of any form of IPV is higher among women who identify as bisexual (59.8%) and lesbian (46.3%) compared with those who identify as heterosexual (37.2%); rates are comparable among men who identify as heterosexual (31.9%), bisexual (35.3%), and gay (35.1%).³ Preliminary data suggest that IPV may have increased in frequency and severity during the COVID-19 pandemic, particularly in the context of mandated shelter-in-place and stay-at-home orders.^4-6

IPV is associated with numerous negative health consequences. They include fear and concern for safety, mental health disorders such as posttraumatic stress disorder (PTSD), and physical health problems including physical injury, chronic pain, sleep disturbance, and frequent headaches.² IPV is also associated with a greater number of missed days from school and work and increased utilization of legal, health care, and housing services.^2,7 The overall annual cost of IPV against women is estimated at $5.8 billion, with health care costs accounting for approximately $4.1 billion.⁷ Family physicians can play an important role in curbing the devastating effects of IPV by screening patients and providing resources when needed.

Facilitate disclosure using screening tools and protocol

In Ms. T’s case, evidence of violence was clearly visible. However, not all instances of IPV leave physical marks. The US Preventive Services Task Force (USPSTF) recommends that all women of childbearing age be screened for IPV, whether or not they exhibit signs of violence.⁸ While the USPSTF has only published recommendations regarding screening women for IPV, there has been a recent push to screen all patients given that men also experience high rates of IPV.⁹

It’s helpful to ask questions such as: “Do arguments [with your partner] ever result in hitting, kicking, or pushing?” and “How often does your partner scream or curse at you?”

Utilize a brief screening tool. Directly ask patients about IPV; this can help reduce stigma, facilitate disclosure, and initiate the process of connecting patients to potentially lifesaving resources. The USPSTF lists several brief screening measures that can be used in primary care settings to assess exposure to IPV (TABLE 1^8,10-17). The brevity of these screening tools makes them well suited for busy physicians; cutoff scores facilitate the rapid identification of positive screens. While the USPSTF has not made specific recommendations regarding a screening interval, many studies examining the utility of these measures have reported on annual screenings.⁸ While there is limited evidence that brief screening alone leads to reductions in IPV,⁸ discussing IPV in a supportive and empathic manner and connecting patients to resources, such as supportive counseling, does have an important benefit: It can reduce symptoms of depression.¹⁸

Continue to: Screen patients in private; this protocol can help

Screen patients in private; this protocol can help. Given the sensitive nature of IPV and the potential danger some patients may be facing, it is important to screen patients in a safe and supportive environment.^19,20 Screening should be conducted by the primary care clinician, ideally when a trusting relationship already has been formed. Screen patients only when they are alone in a private room; avoid screening in public spaces such as clinic waiting rooms or in the vicinity of the patient’s partner or children older than age 2 years.^19,20

To provide all patients with an opportunity for private and safe IPV screening, clinics are encouraged to develop a clinic-wide policy whereby patients are routinely escorted to the exam room alone for the first portion of their visit, after which any accompanying individuals may be invited to join.²¹ Clinic staff can inform patients and accompanying individuals of this policy when they first arrive. Once in the exam room, and before the screening process begins, clearly state reporting requirements to ensure that patients can make an informed decision about whether to disclose IPV.¹⁹

Set a receptive tone. The manner in which clinicians discuss IPV with their patients is just as important as the setting. Demonstrating sensitivity and genuine concern for the patient’s safety and well-being may increase the patient’s comfort level throughout the screening process and may facilitate disclosures of IPV.^19,22 When screening patients for IPV, sit face to face rather than standing over them, maintain warm and open body language, and speak in a soft tone of voice.²²

Patients may feel more comfortable if you ask screening questions in a straightforward, nonjudgmental manner, as this helps to normalize the screening experience. We also recommend using behaviorally specific language (eg, “Do arguments [with your partner] ever result in hitting, kicking, or pushing?”¹⁶ or “How often does your partner scream or curse at you?”),¹³ as some patients who have experienced IPV will not label their experiences as “abuse” or “violence.” Not every patient who experiences IPV will be ready to disclose these events; however, maintaining a positive and supportive relationship during routine IPV screening and throughout the remainder of the medical visit may help facilitate future disclosures if, and when, a patient is ready to seek support.¹⁹

CRITICAL INTERVENTION ELEMENTS: EMPATHY AND SAFETY

A physician’s response to an IPV disclosure can have a lasting impact on the patient. We encourage family physicians to respond to IPV disclosures with empathy. Maintain eye contact and warm body language, validate the patient’s experiences (“I am sorry this happened to you,” “that must have been terrifying”), tell the patient that the violence was not their fault, and thank the patient for disclosing.²³

Continue to: Assess patient safety

Assess patient safety. Another critical component of intervention is to assess the patient’s safety and engage in safety planning. If the patient agrees to this next step, you may wish to provide a warm handoff to a trained social worker, nurse, or psychologist in the clinic who can spend more time covering this information with the patient. Some key components of a safety assessment include determining whether the violence or threat of violence is ongoing and identifying who lives in the home (eg, the partner, children, and any pets). You and the patient can also discuss red flags that would indicate elevated risk. You should discuss red flags that are unique to the patient’s relationship as well as common factors that have been found to heighten risk for IPV (eg, partner engaging in heavy alcohol use).¹

With the patient’s permission, collaboratively construct a safety plan that details how the patient can stay safe on a daily basis and how to safely leave should a dangerous situation arise (TABLE 2^9,24). The interactive safety planning tool available on the National Domestic Violence Hotline’s website can be a valuable resource (www.thehotline.org/plan-for-safety/).²⁴ Finally, if a patient is experiencing mental health concerns associated with IPV (eg, PTSD, depression, substance misuse, suicidal ideation), consider a referral to a domestic violence counseling center or mental health provider.

Move at the patient’s pace. Even if patients are willing to disclose IPV, they will differ in their readiness to discuss psychoeducation, safety planning, and referrals. Similarly, even if a patient is experiencing severe violence, they may not be ready to leave the relationship. Thus, it’s important to ask the patient for permission before initiating each successive step of the follow-up intervention. You and the patient may wish to schedule additional appointments to discuss this information at a pace the patient finds appropriate.

You may need to spend some time helping the patient recognize the severity of their situation and to feel empowered to take action. In addition, offer information and resources to all patients, even those who do not disclose IPV. Some patients may want to receive this information even if they do not feel comfortable sharing their experiences during the appointment.²⁰ You can also inform patients that they are welcome to bring up issues related to IPV at any future appointments in order to leave the door open to future disclosures.

THE CASE

The physician determined that Ms. T had been experiencing physical and psychological IPV in her current relationship. After responding empathically and obtaining the patient’s consent, the physician provided a warm handoff to the psychologist in the clinic. With Ms. T’s permission, the psychologist provided psychoeducation about IPV, and they discussed Ms. T’s current situation and risk level. They determined that Ms. T was at risk for subsequent episodes of IPV and they collaborated on a safety plan, making sure to discuss contact information for local and national crisis resources.

Continue to: Ms. T saved the phone number...

Ms. T saved the phone number for her local domestic violence shelter in her phone under a false name in case her husband looked through her phone. She said she planned to work on several safety plan items when her husband was away from the house and it was safe to do so. For example, she planned to identify additional ways to exit the house in an emergency and she was going to put together a bag with a change of clothes and some money and drop it off at a trusted friend’s house.

Ms. T and the psychologist agreed to follow up with an office visit in 1 week to discuss any additional safety concerns and to determine whether Ms. T could benefit from a referral to domestic violence counseling services or mental health treatment. The psychologist provided a summary of the topics she and Ms. T had discussed to the physician. The physician scheduled a follow-up appointment with Ms. T in 3 weeks to assess her current safety, troubleshoot any difficulties in implementing her safety plan, and offer additional resources, as needed.

CORRESPONDENCE
Andrea Massa, PhD, 125 Doughty Street, Suite 300, Charleston, SC 29403; massa@musc.edu

THE CASE

Louise T* is a 42-year-old woman who presented to her family medicine office for a routine annual visit. During the exam, her physician noticed bruises on Ms. T’s arms and back. Upon further inquiry, Ms. T reported that she and her husband had argued the night before the appointment. With some hesitancy, she went on to say that this was not the first time this had happened. She said that she and her husband had been arguing frequently for several years and that 6 months earlier, when he lost his job, he began hitting and pushing her.

● How would you proceed with this patient?

*The patient’s name has been changed to protect her identity.

Intimate partner violence (IPV) includes physical, sexual, or psychological aggression or stalking perpetrated by a current or former relationship partner.¹ IPV affects more than 12 million men and women living in the United States each year.² According to a national survey of IPV, approximately one-third (35.6%) of women and one-quarter (28.5%) of men living in the United States experience rape, physical violence, or stalking by an intimate partner during their lifetime.² Lifetime exposure to psychological IPV is even more prevalent, affecting nearly half of women and men (48.4% and 48.8%, respectively).²

Lifetime prevalence of any form of IPV is higher among women who identify as bisexual (59.8%) and lesbian (46.3%) compared with those who identify as heterosexual (37.2%); rates are comparable among men who identify as heterosexual (31.9%), bisexual (35.3%), and gay (35.1%).³ Preliminary data suggest that IPV may have increased in frequency and severity during the COVID-19 pandemic, particularly in the context of mandated shelter-in-place and stay-at-home orders.^4-6

IPV is associated with numerous negative health consequences. They include fear and concern for safety, mental health disorders such as posttraumatic stress disorder (PTSD), and physical health problems including physical injury, chronic pain, sleep disturbance, and frequent headaches.² IPV is also associated with a greater number of missed days from school and work and increased utilization of legal, health care, and housing services.^2,7 The overall annual cost of IPV against women is estimated at $5.8 billion, with health care costs accounting for approximately $4.1 billion.⁷ Family physicians can play an important role in curbing the devastating effects of IPV by screening patients and providing resources when needed.

Facilitate disclosure using screening tools and protocol

In Ms. T’s case, evidence of violence was clearly visible. However, not all instances of IPV leave physical marks. The US Preventive Services Task Force (USPSTF) recommends that all women of childbearing age be screened for IPV, whether or not they exhibit signs of violence.⁸ While the USPSTF has only published recommendations regarding screening women for IPV, there has been a recent push to screen all patients given that men also experience high rates of IPV.⁹

It’s helpful to ask questions such as: “Do arguments [with your partner] ever result in hitting, kicking, or pushing?” and “How often does your partner scream or curse at you?”

Utilize a brief screening tool. Directly ask patients about IPV; this can help reduce stigma, facilitate disclosure, and initiate the process of connecting patients to potentially lifesaving resources. The USPSTF lists several brief screening measures that can be used in primary care settings to assess exposure to IPV (TABLE 1^8,10-17). The brevity of these screening tools makes them well suited for busy physicians; cutoff scores facilitate the rapid identification of positive screens. While the USPSTF has not made specific recommendations regarding a screening interval, many studies examining the utility of these measures have reported on annual screenings.⁸ While there is limited evidence that brief screening alone leads to reductions in IPV,⁸ discussing IPV in a supportive and empathic manner and connecting patients to resources, such as supportive counseling, does have an important benefit: It can reduce symptoms of depression.¹⁸

Continue to: Screen patients in private; this protocol can help

Screen patients in private; this protocol can help. Given the sensitive nature of IPV and the potential danger some patients may be facing, it is important to screen patients in a safe and supportive environment.^19,20 Screening should be conducted by the primary care clinician, ideally when a trusting relationship already has been formed. Screen patients only when they are alone in a private room; avoid screening in public spaces such as clinic waiting rooms or in the vicinity of the patient’s partner or children older than age 2 years.^19,20

To provide all patients with an opportunity for private and safe IPV screening, clinics are encouraged to develop a clinic-wide policy whereby patients are routinely escorted to the exam room alone for the first portion of their visit, after which any accompanying individuals may be invited to join.²¹ Clinic staff can inform patients and accompanying individuals of this policy when they first arrive. Once in the exam room, and before the screening process begins, clearly state reporting requirements to ensure that patients can make an informed decision about whether to disclose IPV.¹⁹

Set a receptive tone. The manner in which clinicians discuss IPV with their patients is just as important as the setting. Demonstrating sensitivity and genuine concern for the patient’s safety and well-being may increase the patient’s comfort level throughout the screening process and may facilitate disclosures of IPV.^19,22 When screening patients for IPV, sit face to face rather than standing over them, maintain warm and open body language, and speak in a soft tone of voice.²²

Patients may feel more comfortable if you ask screening questions in a straightforward, nonjudgmental manner, as this helps to normalize the screening experience. We also recommend using behaviorally specific language (eg, “Do arguments [with your partner] ever result in hitting, kicking, or pushing?”¹⁶ or “How often does your partner scream or curse at you?”),¹³ as some patients who have experienced IPV will not label their experiences as “abuse” or “violence.” Not every patient who experiences IPV will be ready to disclose these events; however, maintaining a positive and supportive relationship during routine IPV screening and throughout the remainder of the medical visit may help facilitate future disclosures if, and when, a patient is ready to seek support.¹⁹

CRITICAL INTERVENTION ELEMENTS: EMPATHY AND SAFETY

A physician’s response to an IPV disclosure can have a lasting impact on the patient. We encourage family physicians to respond to IPV disclosures with empathy. Maintain eye contact and warm body language, validate the patient’s experiences (“I am sorry this happened to you,” “that must have been terrifying”), tell the patient that the violence was not their fault, and thank the patient for disclosing.²³

Continue to: Assess patient safety

Assess patient safety. Another critical component of intervention is to assess the patient’s safety and engage in safety planning. If the patient agrees to this next step, you may wish to provide a warm handoff to a trained social worker, nurse, or psychologist in the clinic who can spend more time covering this information with the patient. Some key components of a safety assessment include determining whether the violence or threat of violence is ongoing and identifying who lives in the home (eg, the partner, children, and any pets). You and the patient can also discuss red flags that would indicate elevated risk. You should discuss red flags that are unique to the patient’s relationship as well as common factors that have been found to heighten risk for IPV (eg, partner engaging in heavy alcohol use).¹

With the patient’s permission, collaboratively construct a safety plan that details how the patient can stay safe on a daily basis and how to safely leave should a dangerous situation arise (TABLE 2^9,24). The interactive safety planning tool available on the National Domestic Violence Hotline’s website can be a valuable resource (www.thehotline.org/plan-for-safety/).²⁴ Finally, if a patient is experiencing mental health concerns associated with IPV (eg, PTSD, depression, substance misuse, suicidal ideation), consider a referral to a domestic violence counseling center or mental health provider.

Move at the patient’s pace. Even if patients are willing to disclose IPV, they will differ in their readiness to discuss psychoeducation, safety planning, and referrals. Similarly, even if a patient is experiencing severe violence, they may not be ready to leave the relationship. Thus, it’s important to ask the patient for permission before initiating each successive step of the follow-up intervention. You and the patient may wish to schedule additional appointments to discuss this information at a pace the patient finds appropriate.

You may need to spend some time helping the patient recognize the severity of their situation and to feel empowered to take action. In addition, offer information and resources to all patients, even those who do not disclose IPV. Some patients may want to receive this information even if they do not feel comfortable sharing their experiences during the appointment.²⁰ You can also inform patients that they are welcome to bring up issues related to IPV at any future appointments in order to leave the door open to future disclosures.

THE CASE

The physician determined that Ms. T had been experiencing physical and psychological IPV in her current relationship. After responding empathically and obtaining the patient’s consent, the physician provided a warm handoff to the psychologist in the clinic. With Ms. T’s permission, the psychologist provided psychoeducation about IPV, and they discussed Ms. T’s current situation and risk level. They determined that Ms. T was at risk for subsequent episodes of IPV and they collaborated on a safety plan, making sure to discuss contact information for local and national crisis resources.

Continue to: Ms. T saved the phone number...

Ms. T saved the phone number for her local domestic violence shelter in her phone under a false name in case her husband looked through her phone. She said she planned to work on several safety plan items when her husband was away from the house and it was safe to do so. For example, she planned to identify additional ways to exit the house in an emergency and she was going to put together a bag with a change of clothes and some money and drop it off at a trusted friend’s house.

Ms. T and the psychologist agreed to follow up with an office visit in 1 week to discuss any additional safety concerns and to determine whether Ms. T could benefit from a referral to domestic violence counseling services or mental health treatment. The psychologist provided a summary of the topics she and Ms. T had discussed to the physician. The physician scheduled a follow-up appointment with Ms. T in 3 weeks to assess her current safety, troubleshoot any difficulties in implementing her safety plan, and offer additional resources, as needed.

CORRESPONDENCE
Andrea Massa, PhD, 125 Doughty Street, Suite 300, Charleston, SC 29403; massa@musc.edu

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Process improvement in any industry sector aims to increase the efficiency of resource utilization and delivery methods (cost) and the quality of the product (outcomes), with the goal of ultimately achieving continuous development.¹ In the health care industry, variation in processes and outcomes along with inefficiency in resource use that result in changes in value (the product of outcomes/costs) are the general targets of quality improvement (QI) efforts employing various implementation methodologies.² When the ultimate aim is to serve the patient (customer), best clinical practice includes both maintaining high quality (individual care delivery) and controlling costs (efficient care system delivery), leading to optimal delivery (value-based care). High-quality individual care and efficient care delivery are not competing concepts, but when working to improve both health care outcomes and cost, traditional and nontraditional barriers to system QI often arise.³

The possible scenarios after a QI intervention include backsliding (regression to the mean over time), steady-state (minimal fixed improvement that could sustain), and continuous improvement (tangible enhancement after completing the intervention with legacy effect).⁴ The scalability of results can be considered during the process measurement and the intervention design phases of all QI projects; however, the complex nature of barriers in the health care environment during each level of implementation should be accounted for to prevent failure in the scalability phase.⁵

The barriers to optimal QI outcomes leading to continuous improvement are multifactorial and are related to intrinsic and extrinsic factors.⁶ These factors include 3 fundamental levels: (1) individual level inertia/beliefs, prior personal knowledge, and team-related factors^7,8; (2) intervention-related and process-specific barriers and clinical practice obstacles; and (3) organizational level challenges and macro-level and population-level barriers (Figure). The obstacles faced during the implementation phase will likely include 2 of these levels simultaneously, which could add complexity and hinder or prevent the implementation of a tangible successful QI process and eventually lead to backsliding or minimal fixed improvement rather than continuous improvement. Furthermore, a patient-centered approach to QI would contribute to further complexity in design and execution, given the importance of reaching sustainable, meaningful improvement by adding elements of patient’s preferences, caregiver engagement, and the shared decision-making processes.⁹

Overcoming these multidomain barriers and reaching resilience and sustainability requires thoughtful planning and execution through a multifaceted approach.¹⁰ A meaningful start could include addressing the clinical inertia for the individual and the team by promoting open innovation and allowing outside institutional collaborations and ideas through networks.¹¹ On the individual level, encouraging participation and motivating health care workers in QI to reach a multidisciplinary operation approach will lead to harmony in collaboration. Concurrently, the organization should support the QI capability and scalability by removing competing priorities and establishing effective leadership that ensures resource allocation, communicates clear value-based principles, and engenders a psychological safety environment.

A continuous improvement state is the optimal QI target, a target that can be attained by removing obstacles and paving a clear pathway to implementation. Focusing on the 3 levels of barriers will position the organization for meaningful and successful QI phases to achieve continuous improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Process improvement in any industry sector aims to increase the efficiency of resource utilization and delivery methods (cost) and the quality of the product (outcomes), with the goal of ultimately achieving continuous development.¹ In the health care industry, variation in processes and outcomes along with inefficiency in resource use that result in changes in value (the product of outcomes/costs) are the general targets of quality improvement (QI) efforts employing various implementation methodologies.² When the ultimate aim is to serve the patient (customer), best clinical practice includes both maintaining high quality (individual care delivery) and controlling costs (efficient care system delivery), leading to optimal delivery (value-based care). High-quality individual care and efficient care delivery are not competing concepts, but when working to improve both health care outcomes and cost, traditional and nontraditional barriers to system QI often arise.³

The possible scenarios after a QI intervention include backsliding (regression to the mean over time), steady-state (minimal fixed improvement that could sustain), and continuous improvement (tangible enhancement after completing the intervention with legacy effect).⁴ The scalability of results can be considered during the process measurement and the intervention design phases of all QI projects; however, the complex nature of barriers in the health care environment during each level of implementation should be accounted for to prevent failure in the scalability phase.⁵

The barriers to optimal QI outcomes leading to continuous improvement are multifactorial and are related to intrinsic and extrinsic factors.⁶ These factors include 3 fundamental levels: (1) individual level inertia/beliefs, prior personal knowledge, and team-related factors^7,8; (2) intervention-related and process-specific barriers and clinical practice obstacles; and (3) organizational level challenges and macro-level and population-level barriers (Figure). The obstacles faced during the implementation phase will likely include 2 of these levels simultaneously, which could add complexity and hinder or prevent the implementation of a tangible successful QI process and eventually lead to backsliding or minimal fixed improvement rather than continuous improvement. Furthermore, a patient-centered approach to QI would contribute to further complexity in design and execution, given the importance of reaching sustainable, meaningful improvement by adding elements of patient’s preferences, caregiver engagement, and the shared decision-making processes.⁹

Overcoming these multidomain barriers and reaching resilience and sustainability requires thoughtful planning and execution through a multifaceted approach.¹⁰ A meaningful start could include addressing the clinical inertia for the individual and the team by promoting open innovation and allowing outside institutional collaborations and ideas through networks.¹¹ On the individual level, encouraging participation and motivating health care workers in QI to reach a multidisciplinary operation approach will lead to harmony in collaboration. Concurrently, the organization should support the QI capability and scalability by removing competing priorities and establishing effective leadership that ensures resource allocation, communicates clear value-based principles, and engenders a psychological safety environment.

A continuous improvement state is the optimal QI target, a target that can be attained by removing obstacles and paving a clear pathway to implementation. Focusing on the 3 levels of barriers will position the organization for meaningful and successful QI phases to achieve continuous improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Process improvement in any industry sector aims to increase the efficiency of resource utilization and delivery methods (cost) and the quality of the product (outcomes), with the goal of ultimately achieving continuous development.¹ In the health care industry, variation in processes and outcomes along with inefficiency in resource use that result in changes in value (the product of outcomes/costs) are the general targets of quality improvement (QI) efforts employing various implementation methodologies.² When the ultimate aim is to serve the patient (customer), best clinical practice includes both maintaining high quality (individual care delivery) and controlling costs (efficient care system delivery), leading to optimal delivery (value-based care). High-quality individual care and efficient care delivery are not competing concepts, but when working to improve both health care outcomes and cost, traditional and nontraditional barriers to system QI often arise.³

The possible scenarios after a QI intervention include backsliding (regression to the mean over time), steady-state (minimal fixed improvement that could sustain), and continuous improvement (tangible enhancement after completing the intervention with legacy effect).⁴ The scalability of results can be considered during the process measurement and the intervention design phases of all QI projects; however, the complex nature of barriers in the health care environment during each level of implementation should be accounted for to prevent failure in the scalability phase.⁵

The barriers to optimal QI outcomes leading to continuous improvement are multifactorial and are related to intrinsic and extrinsic factors.⁶ These factors include 3 fundamental levels: (1) individual level inertia/beliefs, prior personal knowledge, and team-related factors^7,8; (2) intervention-related and process-specific barriers and clinical practice obstacles; and (3) organizational level challenges and macro-level and population-level barriers (Figure). The obstacles faced during the implementation phase will likely include 2 of these levels simultaneously, which could add complexity and hinder or prevent the implementation of a tangible successful QI process and eventually lead to backsliding or minimal fixed improvement rather than continuous improvement. Furthermore, a patient-centered approach to QI would contribute to further complexity in design and execution, given the importance of reaching sustainable, meaningful improvement by adding elements of patient’s preferences, caregiver engagement, and the shared decision-making processes.⁹

Overcoming these multidomain barriers and reaching resilience and sustainability requires thoughtful planning and execution through a multifaceted approach.¹⁰ A meaningful start could include addressing the clinical inertia for the individual and the team by promoting open innovation and allowing outside institutional collaborations and ideas through networks.¹¹ On the individual level, encouraging participation and motivating health care workers in QI to reach a multidisciplinary operation approach will lead to harmony in collaboration. Concurrently, the organization should support the QI capability and scalability by removing competing priorities and establishing effective leadership that ensures resource allocation, communicates clear value-based principles, and engenders a psychological safety environment.

A continuous improvement state is the optimal QI target, a target that can be attained by removing obstacles and paving a clear pathway to implementation. Focusing on the 3 levels of barriers will position the organization for meaningful and successful QI phases to achieve continuous improvement.

Not long ago, the grandmother of my son’s friend died of COVID-19 infection. She was elderly and unvaccinated. Her grandson had no regrets over her unvaccinated status. “Why would she inject poison into her body?” he said, and then expressed a strong opinion that she had died because the hospital physicians refused to give her ivermectin and hydroxychloroquine. My son, wisely, did not push the issue.

Soon thereafter, my personal family physician emailed a newsletter to his patients (me included) with 3 important messages: (1) COVID vaccines were available in the office; (2) He was not going to prescribe hydroxychloroquine, no matter how adamantly it was requested; and (3) He warned against threatening him or his staff with lawsuits or violence over refusal to prescribe any unproven medication.

Mistakes will be made; corrections will be issued. This is the scientific process in action.

How, as a country, have we come to this? A sizeable portion of the public trusts the advice of quacks, hacks, and political opportunists over that of the nation’s most expert scientists and physicians. The National Institutes of Health maintains a website with up-to-date recommendations on the use of treatments for COVID-19. They assess the existing evidence and make recommendations for or against a wide array of interventions. (They recommend against the use of both ivermectin and hydroxychloroquine.) The Centers for Disease Control and Prevention publishes extensively about the current knowledge on the safety and efficacy of vaccines. Neither agency is part of a “deep state” or conspiracy. They are comprised of some of the nation’s leading scientists, including physicians, trying to protect the public from disease and foster good health.

Sadly, some physicians have been a source of inaccurate vaccine information; some even prescribe ineffective treatments despite the evidence. These physicians are either letting their politics override their good sense or are improperly assessing the scientific literature, or both. Medical licensing agencies, and specialty certification boards, need to find ways to prevent this—ways that can survive judicial scrutiny and allow for legitimate scientific debate.

I have been tempted to just accept the current situation as the inevitable outcome of social media–fueled tribalism. But when we know that the COVID death rate among the unvaccinated is 9 times that of people who have received a booster dose,¹ I can’t sit idly and watch the Internet pundits prevail. Instead, I continue to advise and teach my students to have confidence in trustworthy authorities and websites. Mistakes will be made; corrections will be issued. However, this is not evidence of malintent or incompetence, but rather, the scientific process in action.

I tell my students that one of the biggest challenges facing them and society is to figure out how to stop, or at least minimize the effects of, incorrect information, misleading statements, and outright lies in a society that values free speech. Physicians—young and old alike—must remain committed to communicating factual information to a not-always-receptive audience. And I wish my young colleagues luck; I hope that their passion for family medicine and their insights into social media may be just the combination that’s needed to redirect the public’s trust back to where it belongs during a health care crisis.

Not long ago, the grandmother of my son’s friend died of COVID-19 infection. She was elderly and unvaccinated. Her grandson had no regrets over her unvaccinated status. “Why would she inject poison into her body?” he said, and then expressed a strong opinion that she had died because the hospital physicians refused to give her ivermectin and hydroxychloroquine. My son, wisely, did not push the issue.

Soon thereafter, my personal family physician emailed a newsletter to his patients (me included) with 3 important messages: (1) COVID vaccines were available in the office; (2) He was not going to prescribe hydroxychloroquine, no matter how adamantly it was requested; and (3) He warned against threatening him or his staff with lawsuits or violence over refusal to prescribe any unproven medication.

Mistakes will be made; corrections will be issued. This is the scientific process in action.

How, as a country, have we come to this? A sizeable portion of the public trusts the advice of quacks, hacks, and political opportunists over that of the nation’s most expert scientists and physicians. The National Institutes of Health maintains a website with up-to-date recommendations on the use of treatments for COVID-19. They assess the existing evidence and make recommendations for or against a wide array of interventions. (They recommend against the use of both ivermectin and hydroxychloroquine.) The Centers for Disease Control and Prevention publishes extensively about the current knowledge on the safety and efficacy of vaccines. Neither agency is part of a “deep state” or conspiracy. They are comprised of some of the nation’s leading scientists, including physicians, trying to protect the public from disease and foster good health.

Sadly, some physicians have been a source of inaccurate vaccine information; some even prescribe ineffective treatments despite the evidence. These physicians are either letting their politics override their good sense or are improperly assessing the scientific literature, or both. Medical licensing agencies, and specialty certification boards, need to find ways to prevent this—ways that can survive judicial scrutiny and allow for legitimate scientific debate.

I have been tempted to just accept the current situation as the inevitable outcome of social media–fueled tribalism. But when we know that the COVID death rate among the unvaccinated is 9 times that of people who have received a booster dose,¹ I can’t sit idly and watch the Internet pundits prevail. Instead, I continue to advise and teach my students to have confidence in trustworthy authorities and websites. Mistakes will be made; corrections will be issued. However, this is not evidence of malintent or incompetence, but rather, the scientific process in action.

I tell my students that one of the biggest challenges facing them and society is to figure out how to stop, or at least minimize the effects of, incorrect information, misleading statements, and outright lies in a society that values free speech. Physicians—young and old alike—must remain committed to communicating factual information to a not-always-receptive audience. And I wish my young colleagues luck; I hope that their passion for family medicine and their insights into social media may be just the combination that’s needed to redirect the public’s trust back to where it belongs during a health care crisis.

Not long ago, the grandmother of my son’s friend died of COVID-19 infection. She was elderly and unvaccinated. Her grandson had no regrets over her unvaccinated status. “Why would she inject poison into her body?” he said, and then expressed a strong opinion that she had died because the hospital physicians refused to give her ivermectin and hydroxychloroquine. My son, wisely, did not push the issue.

Soon thereafter, my personal family physician emailed a newsletter to his patients (me included) with 3 important messages: (1) COVID vaccines were available in the office; (2) He was not going to prescribe hydroxychloroquine, no matter how adamantly it was requested; and (3) He warned against threatening him or his staff with lawsuits or violence over refusal to prescribe any unproven medication.

Mistakes will be made; corrections will be issued. This is the scientific process in action.

How, as a country, have we come to this? A sizeable portion of the public trusts the advice of quacks, hacks, and political opportunists over that of the nation’s most expert scientists and physicians. The National Institutes of Health maintains a website with up-to-date recommendations on the use of treatments for COVID-19. They assess the existing evidence and make recommendations for or against a wide array of interventions. (They recommend against the use of both ivermectin and hydroxychloroquine.) The Centers for Disease Control and Prevention publishes extensively about the current knowledge on the safety and efficacy of vaccines. Neither agency is part of a “deep state” or conspiracy. They are comprised of some of the nation’s leading scientists, including physicians, trying to protect the public from disease and foster good health.

Sadly, some physicians have been a source of inaccurate vaccine information; some even prescribe ineffective treatments despite the evidence. These physicians are either letting their politics override their good sense or are improperly assessing the scientific literature, or both. Medical licensing agencies, and specialty certification boards, need to find ways to prevent this—ways that can survive judicial scrutiny and allow for legitimate scientific debate.

I have been tempted to just accept the current situation as the inevitable outcome of social media–fueled tribalism. But when we know that the COVID death rate among the unvaccinated is 9 times that of people who have received a booster dose,¹ I can’t sit idly and watch the Internet pundits prevail. Instead, I continue to advise and teach my students to have confidence in trustworthy authorities and websites. Mistakes will be made; corrections will be issued. However, this is not evidence of malintent or incompetence, but rather, the scientific process in action.

I tell my students that one of the biggest challenges facing them and society is to figure out how to stop, or at least minimize the effects of, incorrect information, misleading statements, and outright lies in a society that values free speech. Physicians—young and old alike—must remain committed to communicating factual information to a not-always-receptive audience. And I wish my young colleagues luck; I hope that their passion for family medicine and their insights into social media may be just the combination that’s needed to redirect the public’s trust back to where it belongs during a health care crisis.

Samuel Mathis, MD, tries to cover a lot of ground during a wellness exam for his patients. Nutrition, immunizations, dental hygiene, and staying safe at school are a few of the topics on his list. And the Texas pediatrician asks one more question of children and their parents: “Are there any firearms in the house?”

If the answer is “yes,” Dr. Mathis discusses safety courses and other ideas with the families. “Rather than ask a bunch of questions, often I will say it’s recommended to keep them locked up and don’t forget toddlers can climb heights that you never would have envisioned,” said Dr. Mathis, an assistant professor at the University of Texas Medical Branch, Galveston.

Dr. Mathis said some of his physician colleagues are wary of bringing up the topic of guns in a state that leads the nation with more than 1 million registered firearms. “My discussion is more on firearm responsibility and just making sure they are taking extra steps to keep themselves and everyone around them safe. That works much better in these discussions.”
 

Gun safety: Public health concern, not politics

Conversations about gun safety are becoming more important than ever, not only with parents of pediatric patients but with youth and adults as well. The statistics tell why:

• Unintentional shooting deaths by children rose by nearly one third in a 3-month period in 2020, compared with the same period in 2019.
• Of every 10 gun deaths in the United States, 6 are by suicide.
• As of July 28, 372 mass shootings have occured.
• Firearms now represent the leading cause of death among the nation’s youth.

In 2018, the editors of Annals of Internal Medicine urged physicians in the United States to sign a pledge to talk with their patients about guns in the home. To date, at least 3,664 have done so.

In 2019, the American Academy of Family Medicine, with other leading physician and public health organizations, issued a “call to action,” recommending ways to reduce firearm-related injury and death in the United States. Physicians can and should address the issue, it said, by counseling patients about firearm safety.

“This is just another part of healthcare,” said Sarah C. Nosal, MD, a member of the board of directors of the AAFP, who practices at the Urban Horizons Family Health Center, New York.

Dr. Nosal said she asks about firearms during every well-child visit. She also focuses on patients with a history of depression or suicide attempts and those who have experienced domestic violence.
 

Are physicians counseling patients about gun safety?

A 2018 survey of physicians found that 73% of the 71 who responded agreed to discuss gun safety with at-risk patients. But just 5% said they always talk to those at-risk patients, according to Melanie G. Hagen, MD, professor of internal medicine at the University of Florida, Gainesville, who led the study. While the overwhelming majority agreed that gun safety is a public health issue, only 55% said they felt comfortable initiating conversations about firearms with their patients.

Have things changed since then? “Probably not,” Dr. Hagen said in an interview. She cited some reasons, at least in her state.

One obstacle is that many people, including physicians, believe that Florida’s physician gag law, which prohibited physicians from asking about a patient’s firearm ownership, was still in effect. The law, passed in 2011, was overturned in 2017. In her survey, 76% said they were aware it had been overturned. But that awareness appears not to be universal, she said.

In a 2020 report about physician involvement in promoting gun safety, researchers noted four main challenges: lingering fears about the overturned law and potential liability from violating it, feeling unprepared, worry that patients don’t want to discuss the topic, and lack of time to talk about it during a rushed office visit.

But recent research suggests that patients are often open to talking about gun safety, and another study found that if physicians are given educational materials on firearm safety, more will counsel patients about gun safety.
 

Are patients and parents receptive?

Parents welcome discussion from health care providers about gun safety, according to a study from the University of Pennsylvania, Philadelphia.

Researchers asked roughly 100 parents to watch a short video about a firearm safety program designed to prevent accidents and suicides from guns. The program, still under study, involves a discussion between a parent and a pediatrician, with information given on secure storage of guns and the offering of a free cable lock.

The parents, about equally divided between gun owners and non–gun owners, said they were open to discussion about firearm safety, especially when the conversation involves their child’s pediatrician. Among the gun owners, only one in three said all their firearms were locked, unloaded, and stored properly. But after getting the safety information, 64% said they would change the way they stored their firearms.

A different program that offered pediatricians educational materials on firearm safety, as well as free firearm locks for distribution, increased the likelihood that the physicians would counsel patients on gun safety, other researchers reported.
 

Getting the conversation started

Some patients “bristle” when they’re asked about guns, Dr. Hagen said. Focusing on the “why” of the question can soften their response. One of her patients, a man in his 80s, had worked as a prison guard. After he was diagnosed with clinical depression, she asked him if he ever thought about ending his life. He said yes.

“And in Florida, I know a lot of people have guns,” she said. The state ranks second in the nation, with more than a half million registered weapons.

When Dr. Hagen asked him if he had firearms at home, he balked. Why did she need to know? “People do get defensive,” she said. “Luckily, I had a good relationship with this man, and he was willing to listen to me. If it’s someone I have a good relationship with, and I have this initial bristling, if I say: ‘I’m worried about you, I’m worried about your safety,’ that changes the entire conversation.”

She talked through the best plan for this patient, and he agreed to give his weapons to his son to keep.

Likewise, she talks with family members of dementia patients, urging them to be sure the weapons are stored and locked to prevent tragic accidents.

Dr. Nosal said reading the room is key. “Often, we are having the conversation with a parent with a child present,” she said. “Perhaps that is not the conversation the parent or guardian wanted to have with the child present.” In such a situation, she suggests asking the parent if they would talk about it solo.

“It can be a challenge to know the appropriate way to start the conversation,” Dr. Mathis said. The topic is not taught in medical school, although many experts think it should be. Dr. Hagen recently delivered a lecture to medical students about how to broach the topic with patients. She said she hopes it will become a regular event.

“It really comes down to being willing to be open and just ask that first question in a nonjudgmental way,” Dr. Mathis said. It helps, too, he said, for physicians to remember what he always tries to keep in mind: “My job isn’t politics, my job is health.”

Among the points Dr. Hagen makes in her lecture about talking to patients about guns are the following:

• Every day, more than 110 Americans are killed with guns.
• Gun violence accounts for just 1%-2% of those deaths, but mass shootings serve to shine a light on the issue of gun safety.
• 110,000 firearm injuries a year require medical or legal attention. Each year, more than 1,200 children in this country die from gun-related injuries.
• More than 33,000 people, on average, die in the United States each year from gun violence, including more than 21,000 from suicide.
• About 31% of all U.S. households have firearms; 22% of U.S. adults own one or more.
• Guns are 70% less likely to be stored locked and unloaded in homes where suicides or unintentional gun injuries occur.
• Action points: Identify risk, counsel patients at risk, act when someone is in imminent danger (such as unsafe practices or suicide threats).
• Focus on identifying adults who have a risk of inflicting violence on self or others.
• Focus on health and well-being with all; be conversational and educational.
• Clinicians should ask five crucial questions, all with an “L,” if firearms are in the home: Is it Loaded? Locked? Are Little children present? Is the owner feeling Low? Are they Learned [educated] in gun safety?

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

Samuel Mathis, MD, tries to cover a lot of ground during a wellness exam for his patients. Nutrition, immunizations, dental hygiene, and staying safe at school are a few of the topics on his list. And the Texas pediatrician asks one more question of children and their parents: “Are there any firearms in the house?”

If the answer is “yes,” Dr. Mathis discusses safety courses and other ideas with the families. “Rather than ask a bunch of questions, often I will say it’s recommended to keep them locked up and don’t forget toddlers can climb heights that you never would have envisioned,” said Dr. Mathis, an assistant professor at the University of Texas Medical Branch, Galveston.

Dr. Mathis said some of his physician colleagues are wary of bringing up the topic of guns in a state that leads the nation with more than 1 million registered firearms. “My discussion is more on firearm responsibility and just making sure they are taking extra steps to keep themselves and everyone around them safe. That works much better in these discussions.”
 

Gun safety: Public health concern, not politics

Conversations about gun safety are becoming more important than ever, not only with parents of pediatric patients but with youth and adults as well. The statistics tell why:

• Unintentional shooting deaths by children rose by nearly one third in a 3-month period in 2020, compared with the same period in 2019.
• Of every 10 gun deaths in the United States, 6 are by suicide.
• As of July 28, 372 mass shootings have occured.
• Firearms now represent the leading cause of death among the nation’s youth.

In 2018, the editors of Annals of Internal Medicine urged physicians in the United States to sign a pledge to talk with their patients about guns in the home. To date, at least 3,664 have done so.

In 2019, the American Academy of Family Medicine, with other leading physician and public health organizations, issued a “call to action,” recommending ways to reduce firearm-related injury and death in the United States. Physicians can and should address the issue, it said, by counseling patients about firearm safety.

“This is just another part of healthcare,” said Sarah C. Nosal, MD, a member of the board of directors of the AAFP, who practices at the Urban Horizons Family Health Center, New York.

Dr. Nosal said she asks about firearms during every well-child visit. She also focuses on patients with a history of depression or suicide attempts and those who have experienced domestic violence.
 

Are physicians counseling patients about gun safety?

A 2018 survey of physicians found that 73% of the 71 who responded agreed to discuss gun safety with at-risk patients. But just 5% said they always talk to those at-risk patients, according to Melanie G. Hagen, MD, professor of internal medicine at the University of Florida, Gainesville, who led the study. While the overwhelming majority agreed that gun safety is a public health issue, only 55% said they felt comfortable initiating conversations about firearms with their patients.

Have things changed since then? “Probably not,” Dr. Hagen said in an interview. She cited some reasons, at least in her state.

One obstacle is that many people, including physicians, believe that Florida’s physician gag law, which prohibited physicians from asking about a patient’s firearm ownership, was still in effect. The law, passed in 2011, was overturned in 2017. In her survey, 76% said they were aware it had been overturned. But that awareness appears not to be universal, she said.

In a 2020 report about physician involvement in promoting gun safety, researchers noted four main challenges: lingering fears about the overturned law and potential liability from violating it, feeling unprepared, worry that patients don’t want to discuss the topic, and lack of time to talk about it during a rushed office visit.

But recent research suggests that patients are often open to talking about gun safety, and another study found that if physicians are given educational materials on firearm safety, more will counsel patients about gun safety.
 

Are patients and parents receptive?

Parents welcome discussion from health care providers about gun safety, according to a study from the University of Pennsylvania, Philadelphia.

Researchers asked roughly 100 parents to watch a short video about a firearm safety program designed to prevent accidents and suicides from guns. The program, still under study, involves a discussion between a parent and a pediatrician, with information given on secure storage of guns and the offering of a free cable lock.

The parents, about equally divided between gun owners and non–gun owners, said they were open to discussion about firearm safety, especially when the conversation involves their child’s pediatrician. Among the gun owners, only one in three said all their firearms were locked, unloaded, and stored properly. But after getting the safety information, 64% said they would change the way they stored their firearms.

A different program that offered pediatricians educational materials on firearm safety, as well as free firearm locks for distribution, increased the likelihood that the physicians would counsel patients on gun safety, other researchers reported.
 

Getting the conversation started

Some patients “bristle” when they’re asked about guns, Dr. Hagen said. Focusing on the “why” of the question can soften their response. One of her patients, a man in his 80s, had worked as a prison guard. After he was diagnosed with clinical depression, she asked him if he ever thought about ending his life. He said yes.

“And in Florida, I know a lot of people have guns,” she said. The state ranks second in the nation, with more than a half million registered weapons.

When Dr. Hagen asked him if he had firearms at home, he balked. Why did she need to know? “People do get defensive,” she said. “Luckily, I had a good relationship with this man, and he was willing to listen to me. If it’s someone I have a good relationship with, and I have this initial bristling, if I say: ‘I’m worried about you, I’m worried about your safety,’ that changes the entire conversation.”

She talked through the best plan for this patient, and he agreed to give his weapons to his son to keep.

Likewise, she talks with family members of dementia patients, urging them to be sure the weapons are stored and locked to prevent tragic accidents.

Dr. Nosal said reading the room is key. “Often, we are having the conversation with a parent with a child present,” she said. “Perhaps that is not the conversation the parent or guardian wanted to have with the child present.” In such a situation, she suggests asking the parent if they would talk about it solo.

“It can be a challenge to know the appropriate way to start the conversation,” Dr. Mathis said. The topic is not taught in medical school, although many experts think it should be. Dr. Hagen recently delivered a lecture to medical students about how to broach the topic with patients. She said she hopes it will become a regular event.

“It really comes down to being willing to be open and just ask that first question in a nonjudgmental way,” Dr. Mathis said. It helps, too, he said, for physicians to remember what he always tries to keep in mind: “My job isn’t politics, my job is health.”

Among the points Dr. Hagen makes in her lecture about talking to patients about guns are the following:

• Every day, more than 110 Americans are killed with guns.
• Gun violence accounts for just 1%-2% of those deaths, but mass shootings serve to shine a light on the issue of gun safety.
• 110,000 firearm injuries a year require medical or legal attention. Each year, more than 1,200 children in this country die from gun-related injuries.
• More than 33,000 people, on average, die in the United States each year from gun violence, including more than 21,000 from suicide.
• About 31% of all U.S. households have firearms; 22% of U.S. adults own one or more.
• Guns are 70% less likely to be stored locked and unloaded in homes where suicides or unintentional gun injuries occur.
• Action points: Identify risk, counsel patients at risk, act when someone is in imminent danger (such as unsafe practices or suicide threats).
• Focus on identifying adults who have a risk of inflicting violence on self or others.
• Focus on health and well-being with all; be conversational and educational.
• Clinicians should ask five crucial questions, all with an “L,” if firearms are in the home: Is it Loaded? Locked? Are Little children present? Is the owner feeling Low? Are they Learned [educated] in gun safety?

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

Samuel Mathis, MD, tries to cover a lot of ground during a wellness exam for his patients. Nutrition, immunizations, dental hygiene, and staying safe at school are a few of the topics on his list. And the Texas pediatrician asks one more question of children and their parents: “Are there any firearms in the house?”

If the answer is “yes,” Dr. Mathis discusses safety courses and other ideas with the families. “Rather than ask a bunch of questions, often I will say it’s recommended to keep them locked up and don’t forget toddlers can climb heights that you never would have envisioned,” said Dr. Mathis, an assistant professor at the University of Texas Medical Branch, Galveston.

Dr. Mathis said some of his physician colleagues are wary of bringing up the topic of guns in a state that leads the nation with more than 1 million registered firearms. “My discussion is more on firearm responsibility and just making sure they are taking extra steps to keep themselves and everyone around them safe. That works much better in these discussions.”
 

Gun safety: Public health concern, not politics

Conversations about gun safety are becoming more important than ever, not only with parents of pediatric patients but with youth and adults as well. The statistics tell why:

• Unintentional shooting deaths by children rose by nearly one third in a 3-month period in 2020, compared with the same period in 2019.
• Of every 10 gun deaths in the United States, 6 are by suicide.
• As of July 28, 372 mass shootings have occured.
• Firearms now represent the leading cause of death among the nation’s youth.

In 2018, the editors of Annals of Internal Medicine urged physicians in the United States to sign a pledge to talk with their patients about guns in the home. To date, at least 3,664 have done so.

In 2019, the American Academy of Family Medicine, with other leading physician and public health organizations, issued a “call to action,” recommending ways to reduce firearm-related injury and death in the United States. Physicians can and should address the issue, it said, by counseling patients about firearm safety.

“This is just another part of healthcare,” said Sarah C. Nosal, MD, a member of the board of directors of the AAFP, who practices at the Urban Horizons Family Health Center, New York.

Dr. Nosal said she asks about firearms during every well-child visit. She also focuses on patients with a history of depression or suicide attempts and those who have experienced domestic violence.
 

Are physicians counseling patients about gun safety?

A 2018 survey of physicians found that 73% of the 71 who responded agreed to discuss gun safety with at-risk patients. But just 5% said they always talk to those at-risk patients, according to Melanie G. Hagen, MD, professor of internal medicine at the University of Florida, Gainesville, who led the study. While the overwhelming majority agreed that gun safety is a public health issue, only 55% said they felt comfortable initiating conversations about firearms with their patients.

Have things changed since then? “Probably not,” Dr. Hagen said in an interview. She cited some reasons, at least in her state.

One obstacle is that many people, including physicians, believe that Florida’s physician gag law, which prohibited physicians from asking about a patient’s firearm ownership, was still in effect. The law, passed in 2011, was overturned in 2017. In her survey, 76% said they were aware it had been overturned. But that awareness appears not to be universal, she said.

In a 2020 report about physician involvement in promoting gun safety, researchers noted four main challenges: lingering fears about the overturned law and potential liability from violating it, feeling unprepared, worry that patients don’t want to discuss the topic, and lack of time to talk about it during a rushed office visit.

But recent research suggests that patients are often open to talking about gun safety, and another study found that if physicians are given educational materials on firearm safety, more will counsel patients about gun safety.
 

Are patients and parents receptive?

Parents welcome discussion from health care providers about gun safety, according to a study from the University of Pennsylvania, Philadelphia.

Researchers asked roughly 100 parents to watch a short video about a firearm safety program designed to prevent accidents and suicides from guns. The program, still under study, involves a discussion between a parent and a pediatrician, with information given on secure storage of guns and the offering of a free cable lock.

The parents, about equally divided between gun owners and non–gun owners, said they were open to discussion about firearm safety, especially when the conversation involves their child’s pediatrician. Among the gun owners, only one in three said all their firearms were locked, unloaded, and stored properly. But after getting the safety information, 64% said they would change the way they stored their firearms.

A different program that offered pediatricians educational materials on firearm safety, as well as free firearm locks for distribution, increased the likelihood that the physicians would counsel patients on gun safety, other researchers reported.
 

Getting the conversation started

Some patients “bristle” when they’re asked about guns, Dr. Hagen said. Focusing on the “why” of the question can soften their response. One of her patients, a man in his 80s, had worked as a prison guard. After he was diagnosed with clinical depression, she asked him if he ever thought about ending his life. He said yes.

“And in Florida, I know a lot of people have guns,” she said. The state ranks second in the nation, with more than a half million registered weapons.

When Dr. Hagen asked him if he had firearms at home, he balked. Why did she need to know? “People do get defensive,” she said. “Luckily, I had a good relationship with this man, and he was willing to listen to me. If it’s someone I have a good relationship with, and I have this initial bristling, if I say: ‘I’m worried about you, I’m worried about your safety,’ that changes the entire conversation.”

She talked through the best plan for this patient, and he agreed to give his weapons to his son to keep.

Likewise, she talks with family members of dementia patients, urging them to be sure the weapons are stored and locked to prevent tragic accidents.

Dr. Nosal said reading the room is key. “Often, we are having the conversation with a parent with a child present,” she said. “Perhaps that is not the conversation the parent or guardian wanted to have with the child present.” In such a situation, she suggests asking the parent if they would talk about it solo.

“It can be a challenge to know the appropriate way to start the conversation,” Dr. Mathis said. The topic is not taught in medical school, although many experts think it should be. Dr. Hagen recently delivered a lecture to medical students about how to broach the topic with patients. She said she hopes it will become a regular event.

“It really comes down to being willing to be open and just ask that first question in a nonjudgmental way,” Dr. Mathis said. It helps, too, he said, for physicians to remember what he always tries to keep in mind: “My job isn’t politics, my job is health.”

Among the points Dr. Hagen makes in her lecture about talking to patients about guns are the following:

• Every day, more than 110 Americans are killed with guns.
• Gun violence accounts for just 1%-2% of those deaths, but mass shootings serve to shine a light on the issue of gun safety.
• 110,000 firearm injuries a year require medical or legal attention. Each year, more than 1,200 children in this country die from gun-related injuries.
• More than 33,000 people, on average, die in the United States each year from gun violence, including more than 21,000 from suicide.
• About 31% of all U.S. households have firearms; 22% of U.S. adults own one or more.
• Guns are 70% less likely to be stored locked and unloaded in homes where suicides or unintentional gun injuries occur.
• Action points: Identify risk, counsel patients at risk, act when someone is in imminent danger (such as unsafe practices or suicide threats).
• Focus on identifying adults who have a risk of inflicting violence on self or others.
• Focus on health and well-being with all; be conversational and educational.
• Clinicians should ask five crucial questions, all with an “L,” if firearms are in the home: Is it Loaded? Locked? Are Little children present? Is the owner feeling Low? Are they Learned [educated] in gun safety?

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

The Environmental Protection Agency (EPA) should conduct an ecologic risk assessment of the UV filters found in sunscreens to understand their effects on aquatic environments and human health, an expert panel of the National Academies of Sciences, Engineering, and Medicine (NAS) said on Aug. 9.

The assessment is urgently needed, the experts said, and the results should be shared with the Food and Drug Administration, which oversees sunscreens.

mark wragg/iStockphoto.com

In its 400-page report, titled the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, the panel does not make recommendations but suggests that such an EPA risk assessment should highlight gaps in knowledge.

“We are teeing up the critical information that will be used to take on the challenge of risk assessment,” Charles A. Menzie, PhD, chair of the committee that wrote the report, said at a media briefing Aug. 9 when the report was released. Dr. Menzie is a principal at Exponent, Inc., an engineering and scientific consulting firm. He is former executive director of the Society of Environmental Toxicology and Chemistry.

The EPA sponsored the study, which was conducted by a committee of the National Academy of Sciences, a nonprofit, nongovernmental organization authorized by Congress that studies issues related to science, technology, and medicine.
 

Balancing aquatic, human health concerns

Such an EPA assessment, Dr. Menzie said in a statement, will help inform efforts to understand the environmental effects of UV filters as well as clarify a path forward for managing sunscreens. For years, concerns have been raised about the potential toxicity of sunscreens regarding many marine and freshwater aquatic organisms, especially coral. That concern, however, must be balanced against the benefits of sunscreens, which are known to protect against skin cancer. A low percentage of people use sunscreen regularly, Dr. Menzie and other panel members said.

“Only about a third of the U.S. population regularly uses sunscreen,” Mark Cullen, MD, vice chair of the NAS committee and former director of the Center for Population Health Sciences, Stanford (Calif.) University, said at the briefing. About 70% or 80% of people use it at the beach or outdoors, he said.
 

Report background, details

UV filters are the active ingredients in physical as well as chemical sunscreen products. They decrease the amount of UV radiation that reaches the skin. They have been found in water, sediments, and marine organisms, both saltwater and freshwater.

Currently, 17 UV filters are used in U.S. sunscreens; 15 of those are organic, such as oxybenzone and avobenzone, and are used in chemical sunscreens. They work by absorbing the rays before they damage the skin. In addition, two inorganic filters, which are used in physical sunscreens, sit on the skin and as a shield to block the rays.

The recommendations

The panel is urging the EPA to complete a formal risk assessment of the UV filters “with some urgency,” Dr. Cullen said. That will enable decisions to be made about the use of the products. The risks to aquatic life must be balanced against the need for sun protection to reduce skin cancer risk.

The experts made two recommendations:

• The EPA should conduct ecologic risk assessments for all the UV filters now marketed and for all new ones. The assessment should evaluate the filters individually as well as the risk from co-occurring filters. The assessments should take into account the different exposure scenarios.
• The EPA, along with partner agencies, and sunscreen and UV filter manufacturers should fund, support, and conduct research and share data. Research should include study of human health outcomes if usage and availability of sunscreens change.

Dermatologists should “continue to emphasize the importance of protection from UV radiation in every way that can be done,” Dr. Cullen said, including the use of sunscreen as well as other protective practices, such as wearing long sleeves and hats, seeking shade, and avoiding the sun during peak hours.
 

A dermatologist’s perspective

“I applaud their scientific curiosity to know one way or the other whether this is an issue,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC. “I welcome this investigation.”

The multitude of studies, Dr. Friedman said, don’t always agree about whether the filters pose dangers. He noted that the concentration of UV filters detected in water is often lower than the concentrations found to be harmful in a lab setting to marine life, specifically coral.

However, he said, “these studies are snapshots.” For that reason, calling for more assessment of risk is desirable, Dr. Friedman said, but “I want to be sure the call to do more research is not an admission of guilt. It’s very easy to vilify sunscreens – but the facts we know are that UV light causes skin cancer and aging, and sunscreen protects us against this.”

Dr. Friedman has disclosed no relevant financial relationships.

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

The Environmental Protection Agency (EPA) should conduct an ecologic risk assessment of the UV filters found in sunscreens to understand their effects on aquatic environments and human health, an expert panel of the National Academies of Sciences, Engineering, and Medicine (NAS) said on Aug. 9.

The assessment is urgently needed, the experts said, and the results should be shared with the Food and Drug Administration, which oversees sunscreens.

mark wragg/iStockphoto.com

In its 400-page report, titled the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, the panel does not make recommendations but suggests that such an EPA risk assessment should highlight gaps in knowledge.

“We are teeing up the critical information that will be used to take on the challenge of risk assessment,” Charles A. Menzie, PhD, chair of the committee that wrote the report, said at a media briefing Aug. 9 when the report was released. Dr. Menzie is a principal at Exponent, Inc., an engineering and scientific consulting firm. He is former executive director of the Society of Environmental Toxicology and Chemistry.

The EPA sponsored the study, which was conducted by a committee of the National Academy of Sciences, a nonprofit, nongovernmental organization authorized by Congress that studies issues related to science, technology, and medicine.
 

Balancing aquatic, human health concerns

Such an EPA assessment, Dr. Menzie said in a statement, will help inform efforts to understand the environmental effects of UV filters as well as clarify a path forward for managing sunscreens. For years, concerns have been raised about the potential toxicity of sunscreens regarding many marine and freshwater aquatic organisms, especially coral. That concern, however, must be balanced against the benefits of sunscreens, which are known to protect against skin cancer. A low percentage of people use sunscreen regularly, Dr. Menzie and other panel members said.

“Only about a third of the U.S. population regularly uses sunscreen,” Mark Cullen, MD, vice chair of the NAS committee and former director of the Center for Population Health Sciences, Stanford (Calif.) University, said at the briefing. About 70% or 80% of people use it at the beach or outdoors, he said.
 

Report background, details

UV filters are the active ingredients in physical as well as chemical sunscreen products. They decrease the amount of UV radiation that reaches the skin. They have been found in water, sediments, and marine organisms, both saltwater and freshwater.

Currently, 17 UV filters are used in U.S. sunscreens; 15 of those are organic, such as oxybenzone and avobenzone, and are used in chemical sunscreens. They work by absorbing the rays before they damage the skin. In addition, two inorganic filters, which are used in physical sunscreens, sit on the skin and as a shield to block the rays.

The recommendations

The panel is urging the EPA to complete a formal risk assessment of the UV filters “with some urgency,” Dr. Cullen said. That will enable decisions to be made about the use of the products. The risks to aquatic life must be balanced against the need for sun protection to reduce skin cancer risk.

The experts made two recommendations:

• The EPA should conduct ecologic risk assessments for all the UV filters now marketed and for all new ones. The assessment should evaluate the filters individually as well as the risk from co-occurring filters. The assessments should take into account the different exposure scenarios.
• The EPA, along with partner agencies, and sunscreen and UV filter manufacturers should fund, support, and conduct research and share data. Research should include study of human health outcomes if usage and availability of sunscreens change.

Dermatologists should “continue to emphasize the importance of protection from UV radiation in every way that can be done,” Dr. Cullen said, including the use of sunscreen as well as other protective practices, such as wearing long sleeves and hats, seeking shade, and avoiding the sun during peak hours.
 

A dermatologist’s perspective

“I applaud their scientific curiosity to know one way or the other whether this is an issue,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC. “I welcome this investigation.”

The multitude of studies, Dr. Friedman said, don’t always agree about whether the filters pose dangers. He noted that the concentration of UV filters detected in water is often lower than the concentrations found to be harmful in a lab setting to marine life, specifically coral.

However, he said, “these studies are snapshots.” For that reason, calling for more assessment of risk is desirable, Dr. Friedman said, but “I want to be sure the call to do more research is not an admission of guilt. It’s very easy to vilify sunscreens – but the facts we know are that UV light causes skin cancer and aging, and sunscreen protects us against this.”

Dr. Friedman has disclosed no relevant financial relationships.

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

The Environmental Protection Agency (EPA) should conduct an ecologic risk assessment of the UV filters found in sunscreens to understand their effects on aquatic environments and human health, an expert panel of the National Academies of Sciences, Engineering, and Medicine (NAS) said on Aug. 9.

The assessment is urgently needed, the experts said, and the results should be shared with the Food and Drug Administration, which oversees sunscreens.

mark wragg/iStockphoto.com

In its 400-page report, titled the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, the panel does not make recommendations but suggests that such an EPA risk assessment should highlight gaps in knowledge.

“We are teeing up the critical information that will be used to take on the challenge of risk assessment,” Charles A. Menzie, PhD, chair of the committee that wrote the report, said at a media briefing Aug. 9 when the report was released. Dr. Menzie is a principal at Exponent, Inc., an engineering and scientific consulting firm. He is former executive director of the Society of Environmental Toxicology and Chemistry.

The EPA sponsored the study, which was conducted by a committee of the National Academy of Sciences, a nonprofit, nongovernmental organization authorized by Congress that studies issues related to science, technology, and medicine.
 

Balancing aquatic, human health concerns

Such an EPA assessment, Dr. Menzie said in a statement, will help inform efforts to understand the environmental effects of UV filters as well as clarify a path forward for managing sunscreens. For years, concerns have been raised about the potential toxicity of sunscreens regarding many marine and freshwater aquatic organisms, especially coral. That concern, however, must be balanced against the benefits of sunscreens, which are known to protect against skin cancer. A low percentage of people use sunscreen regularly, Dr. Menzie and other panel members said.

“Only about a third of the U.S. population regularly uses sunscreen,” Mark Cullen, MD, vice chair of the NAS committee and former director of the Center for Population Health Sciences, Stanford (Calif.) University, said at the briefing. About 70% or 80% of people use it at the beach or outdoors, he said.
 

Report background, details

UV filters are the active ingredients in physical as well as chemical sunscreen products. They decrease the amount of UV radiation that reaches the skin. They have been found in water, sediments, and marine organisms, both saltwater and freshwater.

Currently, 17 UV filters are used in U.S. sunscreens; 15 of those are organic, such as oxybenzone and avobenzone, and are used in chemical sunscreens. They work by absorbing the rays before they damage the skin. In addition, two inorganic filters, which are used in physical sunscreens, sit on the skin and as a shield to block the rays.

The recommendations

The panel is urging the EPA to complete a formal risk assessment of the UV filters “with some urgency,” Dr. Cullen said. That will enable decisions to be made about the use of the products. The risks to aquatic life must be balanced against the need for sun protection to reduce skin cancer risk.

The experts made two recommendations:

• The EPA should conduct ecologic risk assessments for all the UV filters now marketed and for all new ones. The assessment should evaluate the filters individually as well as the risk from co-occurring filters. The assessments should take into account the different exposure scenarios.
• The EPA, along with partner agencies, and sunscreen and UV filter manufacturers should fund, support, and conduct research and share data. Research should include study of human health outcomes if usage and availability of sunscreens change.

Dermatologists should “continue to emphasize the importance of protection from UV radiation in every way that can be done,” Dr. Cullen said, including the use of sunscreen as well as other protective practices, such as wearing long sleeves and hats, seeking shade, and avoiding the sun during peak hours.
 

A dermatologist’s perspective

“I applaud their scientific curiosity to know one way or the other whether this is an issue,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC. “I welcome this investigation.”

The multitude of studies, Dr. Friedman said, don’t always agree about whether the filters pose dangers. He noted that the concentration of UV filters detected in water is often lower than the concentrations found to be harmful in a lab setting to marine life, specifically coral.

However, he said, “these studies are snapshots.” For that reason, calling for more assessment of risk is desirable, Dr. Friedman said, but “I want to be sure the call to do more research is not an admission of guilt. It’s very easy to vilify sunscreens – but the facts we know are that UV light causes skin cancer and aging, and sunscreen protects us against this.”

Dr. Friedman has disclosed no relevant financial relationships.

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

The Food and Drug Administration has sent warning letters to three companies, including Amazon, for selling mole and skin tag removal products that have not been approved by the agency, according to a press release issued on Aug. 9.

In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.

The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.

The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.

Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.

Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.

The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.

The Food and Drug Administration has sent warning letters to three companies, including Amazon, for selling mole and skin tag removal products that have not been approved by the agency, according to a press release issued on Aug. 9.

In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.

The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.

The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.

Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.

Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.

The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.

The Food and Drug Administration has sent warning letters to three companies, including Amazon, for selling mole and skin tag removal products that have not been approved by the agency, according to a press release issued on Aug. 9.

In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.

The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.

The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.

Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.

Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.

The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.

In October 2020, Medicare released an updated guidance to reduce Mohs micrographic surgery (MMS) reimbursement issues,¹ which initially was released in 2013. This guidance defines the latest performance and documentation requirements that Medicare requires for MMS. Understanding these requirements and making sure that your Mohs surgical reports have all the needed documentation details are critical because auditors from not only Medicare Administrative Contractors (MACs) but also private insurers and Medicare Advantage plans have adopted these standards and will deny payment for Mohs surgical codes if they are not met. This article provides a review of the updated Medicare requirements to make sure your MMS procedure notes are audit proof.

Notes Must Indicate Mohs Is the Most Appropriate Treatment

I review many of my colleagues’ Mohs notes and can tell you that some of the requirements laid out in the updated guidance typically are already reported by Mohs surgeons in their notes, including the location, number, and size of the lesion or lesions treated and the number of stages performed. However, there are some new requirements that often are not reported by Mohs surgeons that now need to be included. The guidance indicates the following:

The majority of skin cancers can be managed by simple excision or destruction techniques. The medical record of a patient undergoing MMS should clearly show that this procedure was chosen because of the complexity (eg, poorly defined clinical borders, possible deep invasion, prior irradiation), size or location (eg, maximum conservation of tumor-free tissue is important). Medicare will consider reimbursement for MMS for accepted diagnoses and indications, which you must document in the patient’s medical record as being appropriate for MMS and that MMS is the most appropriate choice for the treatment of a particular lesion.¹

In my experience, most Mohs notes include some statement that the skin cancer treated is appropriate based on the Mohs appropriate use criteria (AUC) or the AUC score. However, notes should make clear not just that the lesion treated is “appropriate” for MMS but also that it is the most appropriate treatment (eg, why the lesion was not managed by standard excision or destruction technique).

Mohs Surgeon Must Perform the Surgery and Interpret Slides

The updated guidance clearly indicates that MMS may only be performed by a physician who is specifically trained and highly skilled in Mohs techniques and pathologic identification: “Medicare will only reimburse for MMS services when the Mohs surgeon acts as both surgeon and pathologist.”¹ Mohs micrographic surgery codes may not be billed if preparation or interpretation of the pathology slides is performed by a physician other than the Mohs surgeon. Operative notes and pathology documentation in the patient’s medical record should clearly show that MMS was performed using an accepted MMS technique in which the physician acts in 2 integrated and distinct capacities—surgeon and pathologist—thereby confirming that the procedure meets the definition of the Current Procedural Terminology code(s).

Furthermore, the Mohs operative report should detail “the number of specimens per stage.”¹ I interpret this statement to indicate that the Mohs surgeon should document the number of tissue blocks examined in each stage of Mohs surgery. For example, a statement in the notes such as “the specimen from the first Mohs stage was oriented, mapped, and divided into 4 blocks” should suffice to meet this requirement.

Histologic Description Must Be Included in Mohs Notes

Medicare will require the Mohs surgeon to document “the histology of the specimens taken. That description should include depth of invasion, pathological pattern, cell morphology, and, if present, perineural invasion or presence of scar tissue.”¹ Although this histologic description requirement appears daunting, it is common for Mohs surgeons to indicate their pathologic findings on their Mohs map such as “NBCC” next to a red area to indicate “nodular basal cell carcinoma visualized.” A template-based system to translate typical pathologic findings can be employed to rapidly and accurately populate a Mohs note with histologic description such as “NBBC=nodular aggregates of palisaded basaloid epithelial tumor arising from the epidermis forming a palisade with a cleft forming from the adjacent mucinous stroma extending to the mid dermis. Centrally the nuclei become crowded with scattered mitotic figures and necrotic bodies evident.”

Recent Improvement for 1-Stage Mohs Surgeries

The most notable improvement in the 2020 MMS reimbursement requirements vs the prior version is that, “If tumor is visualized on stage one, you must describe the histology of the specimens taken.”¹ This indicates that if no tumor is visualized in the first stage, then no description of the tumor is possible or necessary. This is a much-needed improvement, as I have observed that some auditors have denied 1-stage Mohs surgeries due to lack of tumor histology description.

Final Thoughts

Overall, the updated Medicare guidance provides important details in the requirements for performance and documentation of Mohs surgery cases. However, additional critical information will be found in Mohs coverage policies and local coverage determinations (LCDs) from MACs and private insurers.^2-4 Each LCD and insurer Mohs payment policy has unique wording and requirements. Coverage of MMS for specific malignant diagnoses, histologic subtypes, locations, and clinical scenarios varies between LCDs; most are based directly on the Mohs AUC, while others have a less specific coverage criteria. To understand the specific documentation and coverage requirements of the MAC for a particular region or private insurer, Mohs surgeons are encouraged to familiarize themselves with the Mohs surgery LCD of their local MAC and coverage policies of their insurers and to ensure their documentation substantiates these requirements. Making sure that your MMS documentation is accurate and complies with Medicare and insurer requirements will keep you out of hot water with auditors and allow reimbursement for this critical skin cancer procedure.

In October 2020, Medicare released an updated guidance to reduce Mohs micrographic surgery (MMS) reimbursement issues,¹ which initially was released in 2013. This guidance defines the latest performance and documentation requirements that Medicare requires for MMS. Understanding these requirements and making sure that your Mohs surgical reports have all the needed documentation details are critical because auditors from not only Medicare Administrative Contractors (MACs) but also private insurers and Medicare Advantage plans have adopted these standards and will deny payment for Mohs surgical codes if they are not met. This article provides a review of the updated Medicare requirements to make sure your MMS procedure notes are audit proof.

Notes Must Indicate Mohs Is the Most Appropriate Treatment

I review many of my colleagues’ Mohs notes and can tell you that some of the requirements laid out in the updated guidance typically are already reported by Mohs surgeons in their notes, including the location, number, and size of the lesion or lesions treated and the number of stages performed. However, there are some new requirements that often are not reported by Mohs surgeons that now need to be included. The guidance indicates the following:

The majority of skin cancers can be managed by simple excision or destruction techniques. The medical record of a patient undergoing MMS should clearly show that this procedure was chosen because of the complexity (eg, poorly defined clinical borders, possible deep invasion, prior irradiation), size or location (eg, maximum conservation of tumor-free tissue is important). Medicare will consider reimbursement for MMS for accepted diagnoses and indications, which you must document in the patient’s medical record as being appropriate for MMS and that MMS is the most appropriate choice for the treatment of a particular lesion.¹

In my experience, most Mohs notes include some statement that the skin cancer treated is appropriate based on the Mohs appropriate use criteria (AUC) or the AUC score. However, notes should make clear not just that the lesion treated is “appropriate” for MMS but also that it is the most appropriate treatment (eg, why the lesion was not managed by standard excision or destruction technique).

Mohs Surgeon Must Perform the Surgery and Interpret Slides

The updated guidance clearly indicates that MMS may only be performed by a physician who is specifically trained and highly skilled in Mohs techniques and pathologic identification: “Medicare will only reimburse for MMS services when the Mohs surgeon acts as both surgeon and pathologist.”¹ Mohs micrographic surgery codes may not be billed if preparation or interpretation of the pathology slides is performed by a physician other than the Mohs surgeon. Operative notes and pathology documentation in the patient’s medical record should clearly show that MMS was performed using an accepted MMS technique in which the physician acts in 2 integrated and distinct capacities—surgeon and pathologist—thereby confirming that the procedure meets the definition of the Current Procedural Terminology code(s).

Furthermore, the Mohs operative report should detail “the number of specimens per stage.”¹ I interpret this statement to indicate that the Mohs surgeon should document the number of tissue blocks examined in each stage of Mohs surgery. For example, a statement in the notes such as “the specimen from the first Mohs stage was oriented, mapped, and divided into 4 blocks” should suffice to meet this requirement.

Histologic Description Must Be Included in Mohs Notes

Medicare will require the Mohs surgeon to document “the histology of the specimens taken. That description should include depth of invasion, pathological pattern, cell morphology, and, if present, perineural invasion or presence of scar tissue.”¹ Although this histologic description requirement appears daunting, it is common for Mohs surgeons to indicate their pathologic findings on their Mohs map such as “NBCC” next to a red area to indicate “nodular basal cell carcinoma visualized.” A template-based system to translate typical pathologic findings can be employed to rapidly and accurately populate a Mohs note with histologic description such as “NBBC=nodular aggregates of palisaded basaloid epithelial tumor arising from the epidermis forming a palisade with a cleft forming from the adjacent mucinous stroma extending to the mid dermis. Centrally the nuclei become crowded with scattered mitotic figures and necrotic bodies evident.”

Recent Improvement for 1-Stage Mohs Surgeries

The most notable improvement in the 2020 MMS reimbursement requirements vs the prior version is that, “If tumor is visualized on stage one, you must describe the histology of the specimens taken.”¹ This indicates that if no tumor is visualized in the first stage, then no description of the tumor is possible or necessary. This is a much-needed improvement, as I have observed that some auditors have denied 1-stage Mohs surgeries due to lack of tumor histology description.

Final Thoughts

Overall, the updated Medicare guidance provides important details in the requirements for performance and documentation of Mohs surgery cases. However, additional critical information will be found in Mohs coverage policies and local coverage determinations (LCDs) from MACs and private insurers.^2-4 Each LCD and insurer Mohs payment policy has unique wording and requirements. Coverage of MMS for specific malignant diagnoses, histologic subtypes, locations, and clinical scenarios varies between LCDs; most are based directly on the Mohs AUC, while others have a less specific coverage criteria. To understand the specific documentation and coverage requirements of the MAC for a particular region or private insurer, Mohs surgeons are encouraged to familiarize themselves with the Mohs surgery LCD of their local MAC and coverage policies of their insurers and to ensure their documentation substantiates these requirements. Making sure that your MMS documentation is accurate and complies with Medicare and insurer requirements will keep you out of hot water with auditors and allow reimbursement for this critical skin cancer procedure.

In October 2020, Medicare released an updated guidance to reduce Mohs micrographic surgery (MMS) reimbursement issues,¹ which initially was released in 2013. This guidance defines the latest performance and documentation requirements that Medicare requires for MMS. Understanding these requirements and making sure that your Mohs surgical reports have all the needed documentation details are critical because auditors from not only Medicare Administrative Contractors (MACs) but also private insurers and Medicare Advantage plans have adopted these standards and will deny payment for Mohs surgical codes if they are not met. This article provides a review of the updated Medicare requirements to make sure your MMS procedure notes are audit proof.

Notes Must Indicate Mohs Is the Most Appropriate Treatment

I review many of my colleagues’ Mohs notes and can tell you that some of the requirements laid out in the updated guidance typically are already reported by Mohs surgeons in their notes, including the location, number, and size of the lesion or lesions treated and the number of stages performed. However, there are some new requirements that often are not reported by Mohs surgeons that now need to be included. The guidance indicates the following:

The majority of skin cancers can be managed by simple excision or destruction techniques. The medical record of a patient undergoing MMS should clearly show that this procedure was chosen because of the complexity (eg, poorly defined clinical borders, possible deep invasion, prior irradiation), size or location (eg, maximum conservation of tumor-free tissue is important). Medicare will consider reimbursement for MMS for accepted diagnoses and indications, which you must document in the patient’s medical record as being appropriate for MMS and that MMS is the most appropriate choice for the treatment of a particular lesion.¹

In my experience, most Mohs notes include some statement that the skin cancer treated is appropriate based on the Mohs appropriate use criteria (AUC) or the AUC score. However, notes should make clear not just that the lesion treated is “appropriate” for MMS but also that it is the most appropriate treatment (eg, why the lesion was not managed by standard excision or destruction technique).

Mohs Surgeon Must Perform the Surgery and Interpret Slides

The updated guidance clearly indicates that MMS may only be performed by a physician who is specifically trained and highly skilled in Mohs techniques and pathologic identification: “Medicare will only reimburse for MMS services when the Mohs surgeon acts as both surgeon and pathologist.”¹ Mohs micrographic surgery codes may not be billed if preparation or interpretation of the pathology slides is performed by a physician other than the Mohs surgeon. Operative notes and pathology documentation in the patient’s medical record should clearly show that MMS was performed using an accepted MMS technique in which the physician acts in 2 integrated and distinct capacities—surgeon and pathologist—thereby confirming that the procedure meets the definition of the Current Procedural Terminology code(s).

Furthermore, the Mohs operative report should detail “the number of specimens per stage.”¹ I interpret this statement to indicate that the Mohs surgeon should document the number of tissue blocks examined in each stage of Mohs surgery. For example, a statement in the notes such as “the specimen from the first Mohs stage was oriented, mapped, and divided into 4 blocks” should suffice to meet this requirement.

Histologic Description Must Be Included in Mohs Notes

Medicare will require the Mohs surgeon to document “the histology of the specimens taken. That description should include depth of invasion, pathological pattern, cell morphology, and, if present, perineural invasion or presence of scar tissue.”¹ Although this histologic description requirement appears daunting, it is common for Mohs surgeons to indicate their pathologic findings on their Mohs map such as “NBCC” next to a red area to indicate “nodular basal cell carcinoma visualized.” A template-based system to translate typical pathologic findings can be employed to rapidly and accurately populate a Mohs note with histologic description such as “NBBC=nodular aggregates of palisaded basaloid epithelial tumor arising from the epidermis forming a palisade with a cleft forming from the adjacent mucinous stroma extending to the mid dermis. Centrally the nuclei become crowded with scattered mitotic figures and necrotic bodies evident.”

Recent Improvement for 1-Stage Mohs Surgeries

The most notable improvement in the 2020 MMS reimbursement requirements vs the prior version is that, “If tumor is visualized on stage one, you must describe the histology of the specimens taken.”¹ This indicates that if no tumor is visualized in the first stage, then no description of the tumor is possible or necessary. This is a much-needed improvement, as I have observed that some auditors have denied 1-stage Mohs surgeries due to lack of tumor histology description.

Final Thoughts

Overall, the updated Medicare guidance provides important details in the requirements for performance and documentation of Mohs surgery cases. However, additional critical information will be found in Mohs coverage policies and local coverage determinations (LCDs) from MACs and private insurers.^2-4 Each LCD and insurer Mohs payment policy has unique wording and requirements. Coverage of MMS for specific malignant diagnoses, histologic subtypes, locations, and clinical scenarios varies between LCDs; most are based directly on the Mohs AUC, while others have a less specific coverage criteria. To understand the specific documentation and coverage requirements of the MAC for a particular region or private insurer, Mohs surgeons are encouraged to familiarize themselves with the Mohs surgery LCD of their local MAC and coverage policies of their insurers and to ensure their documentation substantiates these requirements. Making sure that your MMS documentation is accurate and complies with Medicare and insurer requirements will keep you out of hot water with auditors and allow reimbursement for this critical skin cancer procedure.