Skyrocketing drug costs are a key issue facing physicians, patients, and policymakers, but an even thornier problem may be determining a drug’s value.

In this Q&A, Richard L. Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), weighs in on the value proposition for cancer drugs and the implications for physicians.
 

Q: What tools exist for determining a drug’s value?

A: A number of organizations have developed tools to try to determine the value of cancer drug treatments. ASCO, the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network have all developed tools for this purpose.

Our tool, the ASCO Value Framework, assesses the value of new cancer drug treatments based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost. While it’s hard to directly compare frameworks – given differences in methodology and the many nuances of evaluating clinical trial results – in 2018, ASCO and ESMO published a joint analysis of our value frameworks in the Journal of Clinical Oncology (2018; 37[4]:336-49).

The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined. It also identified a number of factors that may contribute to the discordant scores, revealing potential ways for both of our organizations to refine our frameworks in the future.

That said, ASCO’s Value Framework is just one part of our broader, multifaceted effort to achieve high-quality, high-value care for all patients with cancer. Other efforts include ASCO’s proposed Patient-Centered Oncology Payment model, the Choosing Wisely campaign to identify low-value clinical strategies, and CancerLinQ and the Quality Oncology Practice Initiative to implement quality measurement and improvement.
 

Q: How can the issues around drug price and value be addressed earlier in the context of clinical trials?

A: The definition of value ultimately comes down to the price that must be paid to achieve meaningfully improved health outcomes for individual patients or the broader population of affected individuals. Optimizing the value of a new cancer drug treatment begins with an innovation to address an unmet medical need, followed by defining and achieving clinically meaningful improvements in health outcomes through well-designed and efficiently conducted clinical trials. Effectiveness research is also essential to determining how well new treatments perform compared with available alternatives and how they perform in more diverse populations than those typically included in the clinical trials used to establish efficacy.

Patient goals, preferences, and choices shape the real-world experience of a new product, and the direct and indirect costs of a treatment to patients and their families significantly affect whether it is adopted widely. Until their value is clearly established, new and costly products should be deployed judiciously and after careful consideration of the goals of treatment, available options, and the unique needs, preferences, and goals of individual patients.

More research is needed to improve how we assess the value of new cancer drug treatments. New clinical efficacy endpoints – both provider- and patient-reported ones – that accurately describe how a patient feels and functions must be developed and should reflect outcomes of value to patients other than survival, particularly in noncurative settings.

Better predictive biomarkers can transform a drug of modest efficacy in an unselected population to one of high efficacy in a biomarker-defined subgroup and thereby contribute to improving the value of a treatment.

Regulatory and policy initiatives such as adaptive licensing, value-based insurance, and indication-specific pricing that affect marketing approval, reimbursement, or price, respectively, based on treatment effectiveness, also deserve careful consideration and further research to determine their effects on aligning cost with benefit while ensuring patient access to potentially life-extending therapies and continued innovation in drug development.
 

Q: Aside from the policy options, what’s the role of the oncologist in discussing the value of drugs with patients when determining a treatment plan?

A: Since oncologists don’t control drug prices, our role in improving the value of cancer care involves appropriately managing how resources are used and guiding patients during discussions around the right treatment plan for their particular diagnosis, prognosis, and treatment goals.

Adopting and adhering to high-quality oncology clinical pathways is an important way to improve the quality, efficiency, and value of cancer care. High-quality oncology pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways serve as an important tool in appropriately managing cancer care resources and improving the quality of care that patients with cancer receive, while also reducing costs.
 

Dr. Schilsky is the senior vice president and chief medical officer of ASCO. Formerly the chief of hematology/oncology in the department of medicine and deputy director of the University of Chicago Comprehensive Cancer Center, he is a leader in the field of clinical oncology, specializing in new drug development and the treatment of gastrointestinal cancers. Dr. Schilsky reported research funding from several pharmaceutical companies to ASCO for the Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial. He also reported travel/accommodation/expense support from Varian.

Skyrocketing drug costs are a key issue facing physicians, patients, and policymakers, but an even thornier problem may be determining a drug’s value.

In this Q&A, Richard L. Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), weighs in on the value proposition for cancer drugs and the implications for physicians.
 

Q: What tools exist for determining a drug’s value?

A: A number of organizations have developed tools to try to determine the value of cancer drug treatments. ASCO, the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network have all developed tools for this purpose.

Our tool, the ASCO Value Framework, assesses the value of new cancer drug treatments based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost. While it’s hard to directly compare frameworks – given differences in methodology and the many nuances of evaluating clinical trial results – in 2018, ASCO and ESMO published a joint analysis of our value frameworks in the Journal of Clinical Oncology (2018; 37[4]:336-49).

The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined. It also identified a number of factors that may contribute to the discordant scores, revealing potential ways for both of our organizations to refine our frameworks in the future.

That said, ASCO’s Value Framework is just one part of our broader, multifaceted effort to achieve high-quality, high-value care for all patients with cancer. Other efforts include ASCO’s proposed Patient-Centered Oncology Payment model, the Choosing Wisely campaign to identify low-value clinical strategies, and CancerLinQ and the Quality Oncology Practice Initiative to implement quality measurement and improvement.
 

Q: How can the issues around drug price and value be addressed earlier in the context of clinical trials?

A: The definition of value ultimately comes down to the price that must be paid to achieve meaningfully improved health outcomes for individual patients or the broader population of affected individuals. Optimizing the value of a new cancer drug treatment begins with an innovation to address an unmet medical need, followed by defining and achieving clinically meaningful improvements in health outcomes through well-designed and efficiently conducted clinical trials. Effectiveness research is also essential to determining how well new treatments perform compared with available alternatives and how they perform in more diverse populations than those typically included in the clinical trials used to establish efficacy.

Patient goals, preferences, and choices shape the real-world experience of a new product, and the direct and indirect costs of a treatment to patients and their families significantly affect whether it is adopted widely. Until their value is clearly established, new and costly products should be deployed judiciously and after careful consideration of the goals of treatment, available options, and the unique needs, preferences, and goals of individual patients.

More research is needed to improve how we assess the value of new cancer drug treatments. New clinical efficacy endpoints – both provider- and patient-reported ones – that accurately describe how a patient feels and functions must be developed and should reflect outcomes of value to patients other than survival, particularly in noncurative settings.

Better predictive biomarkers can transform a drug of modest efficacy in an unselected population to one of high efficacy in a biomarker-defined subgroup and thereby contribute to improving the value of a treatment.

Regulatory and policy initiatives such as adaptive licensing, value-based insurance, and indication-specific pricing that affect marketing approval, reimbursement, or price, respectively, based on treatment effectiveness, also deserve careful consideration and further research to determine their effects on aligning cost with benefit while ensuring patient access to potentially life-extending therapies and continued innovation in drug development.
 

Q: Aside from the policy options, what’s the role of the oncologist in discussing the value of drugs with patients when determining a treatment plan?

A: Since oncologists don’t control drug prices, our role in improving the value of cancer care involves appropriately managing how resources are used and guiding patients during discussions around the right treatment plan for their particular diagnosis, prognosis, and treatment goals.

Adopting and adhering to high-quality oncology clinical pathways is an important way to improve the quality, efficiency, and value of cancer care. High-quality oncology pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways serve as an important tool in appropriately managing cancer care resources and improving the quality of care that patients with cancer receive, while also reducing costs.
 

Dr. Schilsky is the senior vice president and chief medical officer of ASCO. Formerly the chief of hematology/oncology in the department of medicine and deputy director of the University of Chicago Comprehensive Cancer Center, he is a leader in the field of clinical oncology, specializing in new drug development and the treatment of gastrointestinal cancers. Dr. Schilsky reported research funding from several pharmaceutical companies to ASCO for the Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial. He also reported travel/accommodation/expense support from Varian.

Skyrocketing drug costs are a key issue facing physicians, patients, and policymakers, but an even thornier problem may be determining a drug’s value.

In this Q&A, Richard L. Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), weighs in on the value proposition for cancer drugs and the implications for physicians.
 

Q: What tools exist for determining a drug’s value?

A: A number of organizations have developed tools to try to determine the value of cancer drug treatments. ASCO, the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network have all developed tools for this purpose.

Our tool, the ASCO Value Framework, assesses the value of new cancer drug treatments based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost. While it’s hard to directly compare frameworks – given differences in methodology and the many nuances of evaluating clinical trial results – in 2018, ASCO and ESMO published a joint analysis of our value frameworks in the Journal of Clinical Oncology (2018; 37[4]:336-49).

The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined. It also identified a number of factors that may contribute to the discordant scores, revealing potential ways for both of our organizations to refine our frameworks in the future.

That said, ASCO’s Value Framework is just one part of our broader, multifaceted effort to achieve high-quality, high-value care for all patients with cancer. Other efforts include ASCO’s proposed Patient-Centered Oncology Payment model, the Choosing Wisely campaign to identify low-value clinical strategies, and CancerLinQ and the Quality Oncology Practice Initiative to implement quality measurement and improvement.
 

Q: How can the issues around drug price and value be addressed earlier in the context of clinical trials?

A: The definition of value ultimately comes down to the price that must be paid to achieve meaningfully improved health outcomes for individual patients or the broader population of affected individuals. Optimizing the value of a new cancer drug treatment begins with an innovation to address an unmet medical need, followed by defining and achieving clinically meaningful improvements in health outcomes through well-designed and efficiently conducted clinical trials. Effectiveness research is also essential to determining how well new treatments perform compared with available alternatives and how they perform in more diverse populations than those typically included in the clinical trials used to establish efficacy.

Patient goals, preferences, and choices shape the real-world experience of a new product, and the direct and indirect costs of a treatment to patients and their families significantly affect whether it is adopted widely. Until their value is clearly established, new and costly products should be deployed judiciously and after careful consideration of the goals of treatment, available options, and the unique needs, preferences, and goals of individual patients.

More research is needed to improve how we assess the value of new cancer drug treatments. New clinical efficacy endpoints – both provider- and patient-reported ones – that accurately describe how a patient feels and functions must be developed and should reflect outcomes of value to patients other than survival, particularly in noncurative settings.

Better predictive biomarkers can transform a drug of modest efficacy in an unselected population to one of high efficacy in a biomarker-defined subgroup and thereby contribute to improving the value of a treatment.

Regulatory and policy initiatives such as adaptive licensing, value-based insurance, and indication-specific pricing that affect marketing approval, reimbursement, or price, respectively, based on treatment effectiveness, also deserve careful consideration and further research to determine their effects on aligning cost with benefit while ensuring patient access to potentially life-extending therapies and continued innovation in drug development.
 

Q: Aside from the policy options, what’s the role of the oncologist in discussing the value of drugs with patients when determining a treatment plan?

A: Since oncologists don’t control drug prices, our role in improving the value of cancer care involves appropriately managing how resources are used and guiding patients during discussions around the right treatment plan for their particular diagnosis, prognosis, and treatment goals.

Adopting and adhering to high-quality oncology clinical pathways is an important way to improve the quality, efficiency, and value of cancer care. High-quality oncology pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways serve as an important tool in appropriately managing cancer care resources and improving the quality of care that patients with cancer receive, while also reducing costs.
 

Dr. Schilsky is the senior vice president and chief medical officer of ASCO. Formerly the chief of hematology/oncology in the department of medicine and deputy director of the University of Chicago Comprehensive Cancer Center, he is a leader in the field of clinical oncology, specializing in new drug development and the treatment of gastrointestinal cancers. Dr. Schilsky reported research funding from several pharmaceutical companies to ASCO for the Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial. He also reported travel/accommodation/expense support from Varian.

In an effort to improve healthcare for Americans by linking hospital payments to quality of care, Medicare’s Hospital Readmission Reduction Program (HRRP) began penalizing hospitals with “excess” readmission rates in 2012. The decision sparked widespread debate about the definition of a preventable readmission and whether a patient’s socioeconomic status should be considered for risk adjustment. Although coming back to the hospital after an admission is an undesirable outcome for any patient, the suitability of readmission as a quality measure remains a hot and debated topic. Research on the subject skyrocketed; over 12000 articles about hospital readmissions have been indexed in PubMed since 2000, and the number of publications has steadily increased since 2010 (Figure).

Although the HRRP is a Medicare initiative, there has been a substantial focus on readmissions in pediatrics as well. The National Quality Forum has endorsed three quality measures specific to readmission in children: (1) the rate of unplanned readmissions to the pediatric intensive care unit within 24 hours after discharge or transfer, (2) the pediatric lower respiratory infection readmission measure, defined as the percentage of admissions followed by one or more readmissions within 30 days of hospitalization for lower respiratory infection, and (3) the pediatric all-cause readmission measure, defined as the percentage of admissions followed by one or more readmissions within 30 days. These endorsements were preceded by studies showing that pediatric readmission rates varied substantially across hospitals and clinical conditions, and that children with chronic illnesses were at the highest risk.

Readmission is an attractive pediatric quality measure for a number of reasons. This measure is easy to apply to data at the hospital, health system, and payor levels at relatively low cost. Relatedly, the all-condition measure can be applied to all pediatric hospitalizations, overcoming the very real challenge in pediatric quality measurement of inadequate sample sizes to discern differences in healthcare quality at the hospital level for many disease-specific measures.¹ In addition, this measure moves beyond process measurement to quantify an outcome relevant to families as well as healthcare systems. Finally, the measure is founded on a compelling conceptual framework (albeit one that remains challenging to prove) that efforts to improve a patient’s hospital-to-home transition and discharge readiness will reduce their likelihood of readmission.

In this issue of the Journal of Hospital Medicine, Katherine Auger and colleagues present their analysis of pediatric readmission rates from 2010 to 2016 across 66 children’s hospitals.² They found that the median seven-day all-cause pediatric readmission rate was 5.1%, with no change in rates over the seven-year study period. Applying proprietary software to identify potentially preventable readmissions (PPR), they reported that approximately 40% of these readmissions may be preventable, a proportion that was also unchanged over time. Interestingly, 88% of the hospitals represented in their data were participating in the Solutions for Patient Safety national learning collaborative during the study period, making efforts to reduce seven-day readmission rates. Despite this, the figures presented in this paper of all-condition and potentially preventable readmission rates over time are very, very flat.

This work by Auger et al. contributes to our understanding about the preventability, or lack thereof, of pediatric all-condition readmissions. If 40% of these readmissions are indeed preventable, then why did Auger et al. not observe a declining proportion of PPR over time as a result of hospital participation in a national collaborative? Past quantitative and qualitative studies provide important context. First, the 40% rate of readmission preventability is twofold higher than that reported in past studies that relied on physician judgement to determine readmission preventability;^3,4 the authors’ use of proprietary software to categorize the preventability of a readmission limits our ability to explain the differences in these rates. However, in these past studies, the rates of initial agreement between physician reviewers about readmission preventability were poor, highlighting the challenges associated with determining readmission preventability. Moreover, qualitative studies suggest that physicians and families lack a shared understanding of the preventability of readmissions.⁵ Finally, a systematic review of pediatric hospital discharge interventions did not identify any one intervention that was consistently effective in reducing hospital readmission rates.⁶ The following important questions remain: Were hospitals’ efforts to reduce PPR targeting the wrong patients? Were the interventions insufficient or ineffective? Or are readmission measures insufficiently sensitive to improved processes of care?

Recognizing that the majority of research on readmission as well as HRRP penalties focuses on adult populations, perhaps we can apply some lessons learned from the HRRP to pediatrics. Recent analyses by Medicare Payment Advisory Commission (MedPAC) suggest that raw and risk-adjusted readmission rates have declined for conditions covered by the HRRP, with readmission rates for HRRP target conditions declining more quickly than that for nontarget conditions.⁷ Just as the HRRP has focused on target conditions with relatively high readmission rates, analogous efforts to focus pediatric readmission reduction on children at greatest risk may enable measurement of change over time. For example, although children with complex chronic medical conditions represent a small proportion of the pediatric population, they account for 60% of all pediatric readmissions in the United States. However, similar to the above-described meta-analysis of readmission reduction efforts in children, at least one meta-analysis has demonstrated that there is no one intervention or even bundle of interventions that has consistently reduced readmissions in adults.⁸ Although the readmission rates for HRRP target conditions have decreased, the results of clinical trials evaluating readmission reduction efforts are difficult to translate into practice given substantial heterogeneity in study designs, interventions, and patient populations.

Does this study by Auger et al. suggest that pediatric readmission reduction efforts are misguided or futile? No. But it does provide compelling data that efforts to reduce all-cause readmissions for all children may not yield measureable changes using the current measures. A narrowed focus on children with chronic illnesses, who account for approximately half of all pediatric admissions, may be warranted. A number of studies have summarized families’ preferences regarding their hospital-to-home transitions; the results indicate that families of children with chronic illness have unique desires and needs.^9,10 Perhaps it is time to take a step back from pediatric readmission reduction efforts, largely inspired by the HRRP, and redirect our resources to implement and evaluate processes and outcomes most valued by children and their families.

Disclosures

Drs. Lagu and Lindenauer have served as consultants for the Yale Center for Outcomes Research and Evaluation (under contract to the Centers for Medicare and Medicaid Services) providing clinical and methodological expertise and input on the development, reevaluation, and implementation of hospital outcome and efficiency measures.

Funding

Dr. Lagu is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award R01 HL139985-01A1 and 1R01HL146884-01. Dr. Lindenauer was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number K24HL132008.

Disclaimer

The views expressed in this manuscript do not necessarily reflect those of the Yale Center for Outcomes Research and Evaluation or the Centers for Medicare and Medicaid Services. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

In an effort to improve healthcare for Americans by linking hospital payments to quality of care, Medicare’s Hospital Readmission Reduction Program (HRRP) began penalizing hospitals with “excess” readmission rates in 2012. The decision sparked widespread debate about the definition of a preventable readmission and whether a patient’s socioeconomic status should be considered for risk adjustment. Although coming back to the hospital after an admission is an undesirable outcome for any patient, the suitability of readmission as a quality measure remains a hot and debated topic. Research on the subject skyrocketed; over 12000 articles about hospital readmissions have been indexed in PubMed since 2000, and the number of publications has steadily increased since 2010 (Figure).

Although the HRRP is a Medicare initiative, there has been a substantial focus on readmissions in pediatrics as well. The National Quality Forum has endorsed three quality measures specific to readmission in children: (1) the rate of unplanned readmissions to the pediatric intensive care unit within 24 hours after discharge or transfer, (2) the pediatric lower respiratory infection readmission measure, defined as the percentage of admissions followed by one or more readmissions within 30 days of hospitalization for lower respiratory infection, and (3) the pediatric all-cause readmission measure, defined as the percentage of admissions followed by one or more readmissions within 30 days. These endorsements were preceded by studies showing that pediatric readmission rates varied substantially across hospitals and clinical conditions, and that children with chronic illnesses were at the highest risk.

Readmission is an attractive pediatric quality measure for a number of reasons. This measure is easy to apply to data at the hospital, health system, and payor levels at relatively low cost. Relatedly, the all-condition measure can be applied to all pediatric hospitalizations, overcoming the very real challenge in pediatric quality measurement of inadequate sample sizes to discern differences in healthcare quality at the hospital level for many disease-specific measures.¹ In addition, this measure moves beyond process measurement to quantify an outcome relevant to families as well as healthcare systems. Finally, the measure is founded on a compelling conceptual framework (albeit one that remains challenging to prove) that efforts to improve a patient’s hospital-to-home transition and discharge readiness will reduce their likelihood of readmission.

In this issue of the Journal of Hospital Medicine, Katherine Auger and colleagues present their analysis of pediatric readmission rates from 2010 to 2016 across 66 children’s hospitals.² They found that the median seven-day all-cause pediatric readmission rate was 5.1%, with no change in rates over the seven-year study period. Applying proprietary software to identify potentially preventable readmissions (PPR), they reported that approximately 40% of these readmissions may be preventable, a proportion that was also unchanged over time. Interestingly, 88% of the hospitals represented in their data were participating in the Solutions for Patient Safety national learning collaborative during the study period, making efforts to reduce seven-day readmission rates. Despite this, the figures presented in this paper of all-condition and potentially preventable readmission rates over time are very, very flat.

This work by Auger et al. contributes to our understanding about the preventability, or lack thereof, of pediatric all-condition readmissions. If 40% of these readmissions are indeed preventable, then why did Auger et al. not observe a declining proportion of PPR over time as a result of hospital participation in a national collaborative? Past quantitative and qualitative studies provide important context. First, the 40% rate of readmission preventability is twofold higher than that reported in past studies that relied on physician judgement to determine readmission preventability;^3,4 the authors’ use of proprietary software to categorize the preventability of a readmission limits our ability to explain the differences in these rates. However, in these past studies, the rates of initial agreement between physician reviewers about readmission preventability were poor, highlighting the challenges associated with determining readmission preventability. Moreover, qualitative studies suggest that physicians and families lack a shared understanding of the preventability of readmissions.⁵ Finally, a systematic review of pediatric hospital discharge interventions did not identify any one intervention that was consistently effective in reducing hospital readmission rates.⁶ The following important questions remain: Were hospitals’ efforts to reduce PPR targeting the wrong patients? Were the interventions insufficient or ineffective? Or are readmission measures insufficiently sensitive to improved processes of care?

Recognizing that the majority of research on readmission as well as HRRP penalties focuses on adult populations, perhaps we can apply some lessons learned from the HRRP to pediatrics. Recent analyses by Medicare Payment Advisory Commission (MedPAC) suggest that raw and risk-adjusted readmission rates have declined for conditions covered by the HRRP, with readmission rates for HRRP target conditions declining more quickly than that for nontarget conditions.⁷ Just as the HRRP has focused on target conditions with relatively high readmission rates, analogous efforts to focus pediatric readmission reduction on children at greatest risk may enable measurement of change over time. For example, although children with complex chronic medical conditions represent a small proportion of the pediatric population, they account for 60% of all pediatric readmissions in the United States. However, similar to the above-described meta-analysis of readmission reduction efforts in children, at least one meta-analysis has demonstrated that there is no one intervention or even bundle of interventions that has consistently reduced readmissions in adults.⁸ Although the readmission rates for HRRP target conditions have decreased, the results of clinical trials evaluating readmission reduction efforts are difficult to translate into practice given substantial heterogeneity in study designs, interventions, and patient populations.

Does this study by Auger et al. suggest that pediatric readmission reduction efforts are misguided or futile? No. But it does provide compelling data that efforts to reduce all-cause readmissions for all children may not yield measureable changes using the current measures. A narrowed focus on children with chronic illnesses, who account for approximately half of all pediatric admissions, may be warranted. A number of studies have summarized families’ preferences regarding their hospital-to-home transitions; the results indicate that families of children with chronic illness have unique desires and needs.^9,10 Perhaps it is time to take a step back from pediatric readmission reduction efforts, largely inspired by the HRRP, and redirect our resources to implement and evaluate processes and outcomes most valued by children and their families.

Disclosures

Drs. Lagu and Lindenauer have served as consultants for the Yale Center for Outcomes Research and Evaluation (under contract to the Centers for Medicare and Medicaid Services) providing clinical and methodological expertise and input on the development, reevaluation, and implementation of hospital outcome and efficiency measures.

Funding

Dr. Lagu is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award R01 HL139985-01A1 and 1R01HL146884-01. Dr. Lindenauer was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number K24HL132008.

Disclaimer

The views expressed in this manuscript do not necessarily reflect those of the Yale Center for Outcomes Research and Evaluation or the Centers for Medicare and Medicaid Services. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

In an effort to improve healthcare for Americans by linking hospital payments to quality of care, Medicare’s Hospital Readmission Reduction Program (HRRP) began penalizing hospitals with “excess” readmission rates in 2012. The decision sparked widespread debate about the definition of a preventable readmission and whether a patient’s socioeconomic status should be considered for risk adjustment. Although coming back to the hospital after an admission is an undesirable outcome for any patient, the suitability of readmission as a quality measure remains a hot and debated topic. Research on the subject skyrocketed; over 12000 articles about hospital readmissions have been indexed in PubMed since 2000, and the number of publications has steadily increased since 2010 (Figure).

Although the HRRP is a Medicare initiative, there has been a substantial focus on readmissions in pediatrics as well. The National Quality Forum has endorsed three quality measures specific to readmission in children: (1) the rate of unplanned readmissions to the pediatric intensive care unit within 24 hours after discharge or transfer, (2) the pediatric lower respiratory infection readmission measure, defined as the percentage of admissions followed by one or more readmissions within 30 days of hospitalization for lower respiratory infection, and (3) the pediatric all-cause readmission measure, defined as the percentage of admissions followed by one or more readmissions within 30 days. These endorsements were preceded by studies showing that pediatric readmission rates varied substantially across hospitals and clinical conditions, and that children with chronic illnesses were at the highest risk.

Readmission is an attractive pediatric quality measure for a number of reasons. This measure is easy to apply to data at the hospital, health system, and payor levels at relatively low cost. Relatedly, the all-condition measure can be applied to all pediatric hospitalizations, overcoming the very real challenge in pediatric quality measurement of inadequate sample sizes to discern differences in healthcare quality at the hospital level for many disease-specific measures.¹ In addition, this measure moves beyond process measurement to quantify an outcome relevant to families as well as healthcare systems. Finally, the measure is founded on a compelling conceptual framework (albeit one that remains challenging to prove) that efforts to improve a patient’s hospital-to-home transition and discharge readiness will reduce their likelihood of readmission.

In this issue of the Journal of Hospital Medicine, Katherine Auger and colleagues present their analysis of pediatric readmission rates from 2010 to 2016 across 66 children’s hospitals.² They found that the median seven-day all-cause pediatric readmission rate was 5.1%, with no change in rates over the seven-year study period. Applying proprietary software to identify potentially preventable readmissions (PPR), they reported that approximately 40% of these readmissions may be preventable, a proportion that was also unchanged over time. Interestingly, 88% of the hospitals represented in their data were participating in the Solutions for Patient Safety national learning collaborative during the study period, making efforts to reduce seven-day readmission rates. Despite this, the figures presented in this paper of all-condition and potentially preventable readmission rates over time are very, very flat.

This work by Auger et al. contributes to our understanding about the preventability, or lack thereof, of pediatric all-condition readmissions. If 40% of these readmissions are indeed preventable, then why did Auger et al. not observe a declining proportion of PPR over time as a result of hospital participation in a national collaborative? Past quantitative and qualitative studies provide important context. First, the 40% rate of readmission preventability is twofold higher than that reported in past studies that relied on physician judgement to determine readmission preventability;^3,4 the authors’ use of proprietary software to categorize the preventability of a readmission limits our ability to explain the differences in these rates. However, in these past studies, the rates of initial agreement between physician reviewers about readmission preventability were poor, highlighting the challenges associated with determining readmission preventability. Moreover, qualitative studies suggest that physicians and families lack a shared understanding of the preventability of readmissions.⁵ Finally, a systematic review of pediatric hospital discharge interventions did not identify any one intervention that was consistently effective in reducing hospital readmission rates.⁶ The following important questions remain: Were hospitals’ efforts to reduce PPR targeting the wrong patients? Were the interventions insufficient or ineffective? Or are readmission measures insufficiently sensitive to improved processes of care?

Recognizing that the majority of research on readmission as well as HRRP penalties focuses on adult populations, perhaps we can apply some lessons learned from the HRRP to pediatrics. Recent analyses by Medicare Payment Advisory Commission (MedPAC) suggest that raw and risk-adjusted readmission rates have declined for conditions covered by the HRRP, with readmission rates for HRRP target conditions declining more quickly than that for nontarget conditions.⁷ Just as the HRRP has focused on target conditions with relatively high readmission rates, analogous efforts to focus pediatric readmission reduction on children at greatest risk may enable measurement of change over time. For example, although children with complex chronic medical conditions represent a small proportion of the pediatric population, they account for 60% of all pediatric readmissions in the United States. However, similar to the above-described meta-analysis of readmission reduction efforts in children, at least one meta-analysis has demonstrated that there is no one intervention or even bundle of interventions that has consistently reduced readmissions in adults.⁸ Although the readmission rates for HRRP target conditions have decreased, the results of clinical trials evaluating readmission reduction efforts are difficult to translate into practice given substantial heterogeneity in study designs, interventions, and patient populations.

Does this study by Auger et al. suggest that pediatric readmission reduction efforts are misguided or futile? No. But it does provide compelling data that efforts to reduce all-cause readmissions for all children may not yield measureable changes using the current measures. A narrowed focus on children with chronic illnesses, who account for approximately half of all pediatric admissions, may be warranted. A number of studies have summarized families’ preferences regarding their hospital-to-home transitions; the results indicate that families of children with chronic illness have unique desires and needs.^9,10 Perhaps it is time to take a step back from pediatric readmission reduction efforts, largely inspired by the HRRP, and redirect our resources to implement and evaluate processes and outcomes most valued by children and their families.

Disclosures

Drs. Lagu and Lindenauer have served as consultants for the Yale Center for Outcomes Research and Evaluation (under contract to the Centers for Medicare and Medicaid Services) providing clinical and methodological expertise and input on the development, reevaluation, and implementation of hospital outcome and efficiency measures.

Funding

Dr. Lagu is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award R01 HL139985-01A1 and 1R01HL146884-01. Dr. Lindenauer was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number K24HL132008.

Disclaimer

The views expressed in this manuscript do not necessarily reflect those of the Yale Center for Outcomes Research and Evaluation or the Centers for Medicare and Medicaid Services. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Of all the errors that occur in modern healthcare, medication errors are among the most ubiquitous and consequential. Adverse drug events (ADEs) account for approximately 700,000 emergency department visits, 100,000 hospitalizations, and 1.3 million people are injured by medication errors annually.¹ Among the most frequent causes of preventable ADEs are errors on the medication lists when patients are admitted to hospitals.² Therefore, preventing discrepancies between medications the patient is prescribed (and actually taking) inside and outside the hospital—the so-called “medication reconciliation”—is an intense, ongoing area of focus for health systems, pharmacies, and numerous quality and safety organizations seeking to reduce ADEs.

Past studies of medication reconciliation interventions have suggested benefit from restricting medication reconciliation to admission or discharge, pharmacist or pharmacy technician-led medication reconciliation, and pharmacy-led interventions (ie, telephone follow-up/home visit, patient counseling) for ensuring an accurate medication list.^3-5 Recent evidence suggests that pharmacist discharge medication reconciliation is associated with decreased readmission rates, decreased medication discrepancies, and adverse events associated with drug therapy issues.⁴ The successful interventions were promising, but disseminating such interventions can often be very complex.⁶

In this issue of the Journal of Hospital Medicine, Mixon et al. report the results of a subanalysis of the MARQUIS trial,⁷ wherein they individually examined the on-protocol effects of the interventions that MARQUIS recommended, comparing hospitals to their own running baseline data at the implementation of each intervention to data following the implementation. The authors found that only three of the nine interventions were associated with reducing potentially harmful discrepancies in the medication list—training existing staff to perform discharge medication reconciliation, hiring additional staff for this purpose, and defining roles and responsibilities and roles clearly—and that two were actually associated with harm—training existing staff to take best possible medication histories (BPMHs) and implementing a new Electronic Medical Record (EMR). MARQUIS is unique in not just attempting but in reporting “best case” real-world implementation using available literature to design mentored, practical approaches to those same interventions at sites not involved in their initial setup and validation.

EMR implementation should in theory improve accuracy (or at least legibility), but it can also contribute to new types of inaccuracy or, as the authors propose, deprioritize quality and safety as organizational goals during the rigors of digitization. Similarly, training staff to take a BPMH might create false confidence in the results or interact with medication reconciliation in other complex ways. Opting to add more work instead of hiring additional staff may have increased the burden of medication review and thus contributed to its inaccuracy.

On the contrary, certain interventions, such as having clear accountability for the medication list, hiring additional staff to construct that list, and clearly defining the roles of those involved in the reconciliation process, were associated with improved medication reconciliation. All these strategies require resource allocation, but at least the current study provides evidence that such resource allocation can be effective in new settings as they were in their original ones.

The study has important acknowledged limitations. The on-protocol analysis limited the authors to reporting associations rather than causality. Moreover, the original trial ran from 2011 to 2014, which was a time of rapid EMR implementation and new recognition of the problems posed by the same; several organizations are in a far more mature EMR context today. Conversely, newer technologies such as patient-facing medication reconciliation applications, cross-organization medication lists available from some EMR vendors, and health platforms that collect data from multiple EMRs were not evaluated because they did not exist at the time of the original trial. Another important trend in healthcare, the rise of Accountable Care Organizations and their focus on integration and defragmentation, may have an important part to play in medication list accuracy. All the above-mentioned aspects will be important avenues for ongoing research in real-world medication reconciliation.

Mixon’s findings come at a time when medication reconciliation is again a national health informatics priority, a key component of the Medicare Access and CHIP reauthorization Act of 2015 and Merit-based Incentive Payments System⁸ since 2019, with hospitals reporting medication reconciliation rates for financial in addition to quality and safety reasons. Hopefully, this study and others, in combination with the abovementioned incentives, will stimulate further research into impactful strategies for medication reconciliation and ideal ways to implement them. With luck, the end result will be more generalizable interventions, with a track record of success, that would help ensure that patients are prescribed, are reporting, are taking, and are noted to be taking the medications that they and their providers intended, both on presentation to the hospital and on discharge home.

Disclosures

Vicki Jue has no conflicts of interest to report. Raman Khanna reports developing CareWeb, a communication platform that has been licensed to Voalte, Inc. This work is unrelated to the current editorial. No other conflicts of interest to report.

Of all the errors that occur in modern healthcare, medication errors are among the most ubiquitous and consequential. Adverse drug events (ADEs) account for approximately 700,000 emergency department visits, 100,000 hospitalizations, and 1.3 million people are injured by medication errors annually.¹ Among the most frequent causes of preventable ADEs are errors on the medication lists when patients are admitted to hospitals.² Therefore, preventing discrepancies between medications the patient is prescribed (and actually taking) inside and outside the hospital—the so-called “medication reconciliation”—is an intense, ongoing area of focus for health systems, pharmacies, and numerous quality and safety organizations seeking to reduce ADEs.

Past studies of medication reconciliation interventions have suggested benefit from restricting medication reconciliation to admission or discharge, pharmacist or pharmacy technician-led medication reconciliation, and pharmacy-led interventions (ie, telephone follow-up/home visit, patient counseling) for ensuring an accurate medication list.^3-5 Recent evidence suggests that pharmacist discharge medication reconciliation is associated with decreased readmission rates, decreased medication discrepancies, and adverse events associated with drug therapy issues.⁴ The successful interventions were promising, but disseminating such interventions can often be very complex.⁶

In this issue of the Journal of Hospital Medicine, Mixon et al. report the results of a subanalysis of the MARQUIS trial,⁷ wherein they individually examined the on-protocol effects of the interventions that MARQUIS recommended, comparing hospitals to their own running baseline data at the implementation of each intervention to data following the implementation. The authors found that only three of the nine interventions were associated with reducing potentially harmful discrepancies in the medication list—training existing staff to perform discharge medication reconciliation, hiring additional staff for this purpose, and defining roles and responsibilities and roles clearly—and that two were actually associated with harm—training existing staff to take best possible medication histories (BPMHs) and implementing a new Electronic Medical Record (EMR). MARQUIS is unique in not just attempting but in reporting “best case” real-world implementation using available literature to design mentored, practical approaches to those same interventions at sites not involved in their initial setup and validation.

EMR implementation should in theory improve accuracy (or at least legibility), but it can also contribute to new types of inaccuracy or, as the authors propose, deprioritize quality and safety as organizational goals during the rigors of digitization. Similarly, training staff to take a BPMH might create false confidence in the results or interact with medication reconciliation in other complex ways. Opting to add more work instead of hiring additional staff may have increased the burden of medication review and thus contributed to its inaccuracy.

On the contrary, certain interventions, such as having clear accountability for the medication list, hiring additional staff to construct that list, and clearly defining the roles of those involved in the reconciliation process, were associated with improved medication reconciliation. All these strategies require resource allocation, but at least the current study provides evidence that such resource allocation can be effective in new settings as they were in their original ones.

The study has important acknowledged limitations. The on-protocol analysis limited the authors to reporting associations rather than causality. Moreover, the original trial ran from 2011 to 2014, which was a time of rapid EMR implementation and new recognition of the problems posed by the same; several organizations are in a far more mature EMR context today. Conversely, newer technologies such as patient-facing medication reconciliation applications, cross-organization medication lists available from some EMR vendors, and health platforms that collect data from multiple EMRs were not evaluated because they did not exist at the time of the original trial. Another important trend in healthcare, the rise of Accountable Care Organizations and their focus on integration and defragmentation, may have an important part to play in medication list accuracy. All the above-mentioned aspects will be important avenues for ongoing research in real-world medication reconciliation.

Mixon’s findings come at a time when medication reconciliation is again a national health informatics priority, a key component of the Medicare Access and CHIP reauthorization Act of 2015 and Merit-based Incentive Payments System⁸ since 2019, with hospitals reporting medication reconciliation rates for financial in addition to quality and safety reasons. Hopefully, this study and others, in combination with the abovementioned incentives, will stimulate further research into impactful strategies for medication reconciliation and ideal ways to implement them. With luck, the end result will be more generalizable interventions, with a track record of success, that would help ensure that patients are prescribed, are reporting, are taking, and are noted to be taking the medications that they and their providers intended, both on presentation to the hospital and on discharge home.

Disclosures

Vicki Jue has no conflicts of interest to report. Raman Khanna reports developing CareWeb, a communication platform that has been licensed to Voalte, Inc. This work is unrelated to the current editorial. No other conflicts of interest to report.

Of all the errors that occur in modern healthcare, medication errors are among the most ubiquitous and consequential. Adverse drug events (ADEs) account for approximately 700,000 emergency department visits, 100,000 hospitalizations, and 1.3 million people are injured by medication errors annually.¹ Among the most frequent causes of preventable ADEs are errors on the medication lists when patients are admitted to hospitals.² Therefore, preventing discrepancies between medications the patient is prescribed (and actually taking) inside and outside the hospital—the so-called “medication reconciliation”—is an intense, ongoing area of focus for health systems, pharmacies, and numerous quality and safety organizations seeking to reduce ADEs.

Past studies of medication reconciliation interventions have suggested benefit from restricting medication reconciliation to admission or discharge, pharmacist or pharmacy technician-led medication reconciliation, and pharmacy-led interventions (ie, telephone follow-up/home visit, patient counseling) for ensuring an accurate medication list.^3-5 Recent evidence suggests that pharmacist discharge medication reconciliation is associated with decreased readmission rates, decreased medication discrepancies, and adverse events associated with drug therapy issues.⁴ The successful interventions were promising, but disseminating such interventions can often be very complex.⁶

In this issue of the Journal of Hospital Medicine, Mixon et al. report the results of a subanalysis of the MARQUIS trial,⁷ wherein they individually examined the on-protocol effects of the interventions that MARQUIS recommended, comparing hospitals to their own running baseline data at the implementation of each intervention to data following the implementation. The authors found that only three of the nine interventions were associated with reducing potentially harmful discrepancies in the medication list—training existing staff to perform discharge medication reconciliation, hiring additional staff for this purpose, and defining roles and responsibilities and roles clearly—and that two were actually associated with harm—training existing staff to take best possible medication histories (BPMHs) and implementing a new Electronic Medical Record (EMR). MARQUIS is unique in not just attempting but in reporting “best case” real-world implementation using available literature to design mentored, practical approaches to those same interventions at sites not involved in their initial setup and validation.

EMR implementation should in theory improve accuracy (or at least legibility), but it can also contribute to new types of inaccuracy or, as the authors propose, deprioritize quality and safety as organizational goals during the rigors of digitization. Similarly, training staff to take a BPMH might create false confidence in the results or interact with medication reconciliation in other complex ways. Opting to add more work instead of hiring additional staff may have increased the burden of medication review and thus contributed to its inaccuracy.

On the contrary, certain interventions, such as having clear accountability for the medication list, hiring additional staff to construct that list, and clearly defining the roles of those involved in the reconciliation process, were associated with improved medication reconciliation. All these strategies require resource allocation, but at least the current study provides evidence that such resource allocation can be effective in new settings as they were in their original ones.

The study has important acknowledged limitations. The on-protocol analysis limited the authors to reporting associations rather than causality. Moreover, the original trial ran from 2011 to 2014, which was a time of rapid EMR implementation and new recognition of the problems posed by the same; several organizations are in a far more mature EMR context today. Conversely, newer technologies such as patient-facing medication reconciliation applications, cross-organization medication lists available from some EMR vendors, and health platforms that collect data from multiple EMRs were not evaluated because they did not exist at the time of the original trial. Another important trend in healthcare, the rise of Accountable Care Organizations and their focus on integration and defragmentation, may have an important part to play in medication list accuracy. All the above-mentioned aspects will be important avenues for ongoing research in real-world medication reconciliation.

Mixon’s findings come at a time when medication reconciliation is again a national health informatics priority, a key component of the Medicare Access and CHIP reauthorization Act of 2015 and Merit-based Incentive Payments System⁸ since 2019, with hospitals reporting medication reconciliation rates for financial in addition to quality and safety reasons. Hopefully, this study and others, in combination with the abovementioned incentives, will stimulate further research into impactful strategies for medication reconciliation and ideal ways to implement them. With luck, the end result will be more generalizable interventions, with a track record of success, that would help ensure that patients are prescribed, are reporting, are taking, and are noted to be taking the medications that they and their providers intended, both on presentation to the hospital and on discharge home.

Disclosures

Vicki Jue has no conflicts of interest to report. Raman Khanna reports developing CareWeb, a communication platform that has been licensed to Voalte, Inc. This work is unrelated to the current editorial. No other conflicts of interest to report.

The 25 million people in the United States with limited English proficiency (LEP), which is defined as speaking English less than “very well”, are at increased risk for healthcare disparities that result in preventable harm and poor patient experiences compared with English-proficient patients.^1,2 The use of trained professional interpreters is associated with improved communication, healthcare outcomes, safety, and experiences for LEP patients.³ However, underuse of professional interpreters remains common.⁴ Healthcare staff frequently use family members, friends, or minor children as interpreters or try to “get by” with the patient’s limited English skills or staff’s limited non-English skills.⁵ These practices regularly compromise patient safety and quality for LEP patients and their families.

In the article “Inpatient Communication Barriers and Drivers when Caring for Limited English Proficiency Children,” Dr. Choe and colleagues approach the problem of interpreter underuse by studying the barriers and facilitators that exist at their children’s hospital.⁶ The group conducted four sessions using Group Level Assessment, a structured, interactive approach to understanding a problem and identifying potential solutions. Sixty-four pediatric hospitalists and residents, bedside nurses, and staff interpreters participated. Participants identified four primary barriers to communicating effectively with LEP families: difficulty accessing interpreter services, uncertainty in communicating with LEP families, unclear roles and expectations of different team members, and unmet expectations related to family engagement. They also identified four drivers of effective communication: collaborative problem-solving between providers and interpreters, greater attention to cultural context, practicing empathy for patients and families, and using family centered communication strategies.

This study reinforces that myriad challenges remain in accessing and using an interpreter. The barriers identified fall into two major categories: systems for accessing interpretation and communication involving an interpreter. Both ultimately must be addressed to achieve equitable communication for LEP patients/families. As interpreter use is contingent upon access, optimizing delivery systems is an essential foundation. At this study site, key barriers were the opaque scheduling processes and inconsistent access to and unfamiliarity with interpreter-related technology (eg, for telephone or video interpretation). These barriers are likely generalizable to many other hospitals. Priority should be given to developing transparent, consistent, and reliable processes for interpreter access. Interventions to improve interpreter access, such as one-touch interpreter telephones at every hospital bedside, have been more successful in improving interpreter use than provider education or regulatory mandates.⁴

The challenges identified around communicating with LEP families via interpreter are also likely generalizable. In the current study, participants described a clear tension around the interpreters’ optimal role, in which the care team might want the interpreter to intervene or participate in the discussion more, while interpreter standards require that they remain a neutral conduit for information. This neutral-party approach, when taken to the extreme, can limit the bidirectional communication between clinical teams and interpreters necessary to address communication challenges. Fostering collaborative problem-solving between interpreters and clinicians, in both formal and informal settings, is critically needed to improve the quality of communication during encounters. In addition to the proposed presession meeting between the clinician and interpreter, incorporating a debriefing after an interpreter-mediated encounter could offer an opportunity for bidirectional feedback. Unfortunately, interpreter scheduling constraints, fueled by the lack of reimbursement for interpretation in most states, frequently limit the feasibility of such proposals.

Participating providers also reported decreased engagement with LEP families and that they spent less time with them. These observations also merit attention if we are to achieve equitable outcomes for LEP patients. A conversation via interpreter requires more time for the same content, given the time needed to interpret the message. The fact that participants reported spending less time with LEP families means that less communication occurs with those families, compared with others. There are well-established links between good communication and improved clinical outcomes, including everything from decreased glycosylated hemoglobin levels to lower inpatient narcotic use.⁷ Thus, it is not surprising that patients with fewer opportunities to communicate fully have worse clinical outcomes.⁸ Addressing this will require changing hospital culture and provider expectations. Healthcare systems could support this effort with interventions such as decreased nursing assignments, longer allocated rounding times, longer outpatient clinic visits, and additional “points” in resident patient caps, if they exist, for LEP patients. Such steps would be an important investment in improving outcomes and decreasing costs for these vulnerable patients.

For all the barriers identified by Choe and colleagues, solutions are needed. Some may be generalizable, some may be location-specific, and most will be somewhere in between, requiring context-specific tailoring. We recommend a quality improvement (QI) approach, as the evidence-based best practice for communicating with LEP patients and families is well-known, but the gap is in delivering care that meets that standard. Leveraging the growing QI expertise at many institutions to devise approaches that go beyond provider education to change the systems and culture around communicating with LEP patients holds our best promise for improving the safety and effectiveness of care for this population.

Disclosures

The authors have no financial relationships relevant to this article to disclose nor do they have any conflicts of interest relevant to this article to disclose.

Funding

Dr. Lion’s time was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, grant K23 HD078507 (PI Lion).

The 25 million people in the United States with limited English proficiency (LEP), which is defined as speaking English less than “very well”, are at increased risk for healthcare disparities that result in preventable harm and poor patient experiences compared with English-proficient patients.^1,2 The use of trained professional interpreters is associated with improved communication, healthcare outcomes, safety, and experiences for LEP patients.³ However, underuse of professional interpreters remains common.⁴ Healthcare staff frequently use family members, friends, or minor children as interpreters or try to “get by” with the patient’s limited English skills or staff’s limited non-English skills.⁵ These practices regularly compromise patient safety and quality for LEP patients and their families.

In the article “Inpatient Communication Barriers and Drivers when Caring for Limited English Proficiency Children,” Dr. Choe and colleagues approach the problem of interpreter underuse by studying the barriers and facilitators that exist at their children’s hospital.⁶ The group conducted four sessions using Group Level Assessment, a structured, interactive approach to understanding a problem and identifying potential solutions. Sixty-four pediatric hospitalists and residents, bedside nurses, and staff interpreters participated. Participants identified four primary barriers to communicating effectively with LEP families: difficulty accessing interpreter services, uncertainty in communicating with LEP families, unclear roles and expectations of different team members, and unmet expectations related to family engagement. They also identified four drivers of effective communication: collaborative problem-solving between providers and interpreters, greater attention to cultural context, practicing empathy for patients and families, and using family centered communication strategies.

This study reinforces that myriad challenges remain in accessing and using an interpreter. The barriers identified fall into two major categories: systems for accessing interpretation and communication involving an interpreter. Both ultimately must be addressed to achieve equitable communication for LEP patients/families. As interpreter use is contingent upon access, optimizing delivery systems is an essential foundation. At this study site, key barriers were the opaque scheduling processes and inconsistent access to and unfamiliarity with interpreter-related technology (eg, for telephone or video interpretation). These barriers are likely generalizable to many other hospitals. Priority should be given to developing transparent, consistent, and reliable processes for interpreter access. Interventions to improve interpreter access, such as one-touch interpreter telephones at every hospital bedside, have been more successful in improving interpreter use than provider education or regulatory mandates.⁴

The challenges identified around communicating with LEP families via interpreter are also likely generalizable. In the current study, participants described a clear tension around the interpreters’ optimal role, in which the care team might want the interpreter to intervene or participate in the discussion more, while interpreter standards require that they remain a neutral conduit for information. This neutral-party approach, when taken to the extreme, can limit the bidirectional communication between clinical teams and interpreters necessary to address communication challenges. Fostering collaborative problem-solving between interpreters and clinicians, in both formal and informal settings, is critically needed to improve the quality of communication during encounters. In addition to the proposed presession meeting between the clinician and interpreter, incorporating a debriefing after an interpreter-mediated encounter could offer an opportunity for bidirectional feedback. Unfortunately, interpreter scheduling constraints, fueled by the lack of reimbursement for interpretation in most states, frequently limit the feasibility of such proposals.

Participating providers also reported decreased engagement with LEP families and that they spent less time with them. These observations also merit attention if we are to achieve equitable outcomes for LEP patients. A conversation via interpreter requires more time for the same content, given the time needed to interpret the message. The fact that participants reported spending less time with LEP families means that less communication occurs with those families, compared with others. There are well-established links between good communication and improved clinical outcomes, including everything from decreased glycosylated hemoglobin levels to lower inpatient narcotic use.⁷ Thus, it is not surprising that patients with fewer opportunities to communicate fully have worse clinical outcomes.⁸ Addressing this will require changing hospital culture and provider expectations. Healthcare systems could support this effort with interventions such as decreased nursing assignments, longer allocated rounding times, longer outpatient clinic visits, and additional “points” in resident patient caps, if they exist, for LEP patients. Such steps would be an important investment in improving outcomes and decreasing costs for these vulnerable patients.

For all the barriers identified by Choe and colleagues, solutions are needed. Some may be generalizable, some may be location-specific, and most will be somewhere in between, requiring context-specific tailoring. We recommend a quality improvement (QI) approach, as the evidence-based best practice for communicating with LEP patients and families is well-known, but the gap is in delivering care that meets that standard. Leveraging the growing QI expertise at many institutions to devise approaches that go beyond provider education to change the systems and culture around communicating with LEP patients holds our best promise for improving the safety and effectiveness of care for this population.

Disclosures

The authors have no financial relationships relevant to this article to disclose nor do they have any conflicts of interest relevant to this article to disclose.

Funding

Dr. Lion’s time was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, grant K23 HD078507 (PI Lion).

The 25 million people in the United States with limited English proficiency (LEP), which is defined as speaking English less than “very well”, are at increased risk for healthcare disparities that result in preventable harm and poor patient experiences compared with English-proficient patients.^1,2 The use of trained professional interpreters is associated with improved communication, healthcare outcomes, safety, and experiences for LEP patients.³ However, underuse of professional interpreters remains common.⁴ Healthcare staff frequently use family members, friends, or minor children as interpreters or try to “get by” with the patient’s limited English skills or staff’s limited non-English skills.⁵ These practices regularly compromise patient safety and quality for LEP patients and their families.

In the article “Inpatient Communication Barriers and Drivers when Caring for Limited English Proficiency Children,” Dr. Choe and colleagues approach the problem of interpreter underuse by studying the barriers and facilitators that exist at their children’s hospital.⁶ The group conducted four sessions using Group Level Assessment, a structured, interactive approach to understanding a problem and identifying potential solutions. Sixty-four pediatric hospitalists and residents, bedside nurses, and staff interpreters participated. Participants identified four primary barriers to communicating effectively with LEP families: difficulty accessing interpreter services, uncertainty in communicating with LEP families, unclear roles and expectations of different team members, and unmet expectations related to family engagement. They also identified four drivers of effective communication: collaborative problem-solving between providers and interpreters, greater attention to cultural context, practicing empathy for patients and families, and using family centered communication strategies.

This study reinforces that myriad challenges remain in accessing and using an interpreter. The barriers identified fall into two major categories: systems for accessing interpretation and communication involving an interpreter. Both ultimately must be addressed to achieve equitable communication for LEP patients/families. As interpreter use is contingent upon access, optimizing delivery systems is an essential foundation. At this study site, key barriers were the opaque scheduling processes and inconsistent access to and unfamiliarity with interpreter-related technology (eg, for telephone or video interpretation). These barriers are likely generalizable to many other hospitals. Priority should be given to developing transparent, consistent, and reliable processes for interpreter access. Interventions to improve interpreter access, such as one-touch interpreter telephones at every hospital bedside, have been more successful in improving interpreter use than provider education or regulatory mandates.⁴

The challenges identified around communicating with LEP families via interpreter are also likely generalizable. In the current study, participants described a clear tension around the interpreters’ optimal role, in which the care team might want the interpreter to intervene or participate in the discussion more, while interpreter standards require that they remain a neutral conduit for information. This neutral-party approach, when taken to the extreme, can limit the bidirectional communication between clinical teams and interpreters necessary to address communication challenges. Fostering collaborative problem-solving between interpreters and clinicians, in both formal and informal settings, is critically needed to improve the quality of communication during encounters. In addition to the proposed presession meeting between the clinician and interpreter, incorporating a debriefing after an interpreter-mediated encounter could offer an opportunity for bidirectional feedback. Unfortunately, interpreter scheduling constraints, fueled by the lack of reimbursement for interpretation in most states, frequently limit the feasibility of such proposals.

Participating providers also reported decreased engagement with LEP families and that they spent less time with them. These observations also merit attention if we are to achieve equitable outcomes for LEP patients. A conversation via interpreter requires more time for the same content, given the time needed to interpret the message. The fact that participants reported spending less time with LEP families means that less communication occurs with those families, compared with others. There are well-established links between good communication and improved clinical outcomes, including everything from decreased glycosylated hemoglobin levels to lower inpatient narcotic use.⁷ Thus, it is not surprising that patients with fewer opportunities to communicate fully have worse clinical outcomes.⁸ Addressing this will require changing hospital culture and provider expectations. Healthcare systems could support this effort with interventions such as decreased nursing assignments, longer allocated rounding times, longer outpatient clinic visits, and additional “points” in resident patient caps, if they exist, for LEP patients. Such steps would be an important investment in improving outcomes and decreasing costs for these vulnerable patients.

For all the barriers identified by Choe and colleagues, solutions are needed. Some may be generalizable, some may be location-specific, and most will be somewhere in between, requiring context-specific tailoring. We recommend a quality improvement (QI) approach, as the evidence-based best practice for communicating with LEP patients and families is well-known, but the gap is in delivering care that meets that standard. Leveraging the growing QI expertise at many institutions to devise approaches that go beyond provider education to change the systems and culture around communicating with LEP patients holds our best promise for improving the safety and effectiveness of care for this population.

Disclosures

The authors have no financial relationships relevant to this article to disclose nor do they have any conflicts of interest relevant to this article to disclose.

Funding

Dr. Lion’s time was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, grant K23 HD078507 (PI Lion).

In the past five years, it has become increasingly apparent that hospital physiologic monitoring systems are not functioning optimally for children. On pediatric wards, 26%-48% of children are continuously monitored, and these children generate between 42 and 155 alarms per day.¹ Just 1% or fewer are considered actionable or informative, slowing nurses’ response times and placing patients at risk of delayed recognition of life-threatening events.^2,3 While some factors associated with alarm response times have been elucidated,³ in order to design safe and effective monitoring systems, further work is needed to understand the complex decision-making process that nurses face when encountering alarms outside a patient’s room. It is in this area that Schondelmeyer and colleagues strive to enhance our understanding in this issue of the Journal of Hospital Medicine.⁴

Schondelmeyer et al. conducted a single-center, observational study using mixed methods in a general pediatric unit. Trained observers shadowed nine nurses one to four times each, during which nurses were asked to “think aloud” as they managed physiologic monitor alarms, rationalizing their decisions about how and why they might respond for the observer to document. Observers accumulated 61 patient-hours of observation before investigators halted data collection because new insights about alarm responses were no longer emerging from the data (thematic saturation).

Nurses thought aloud about 207 alarms during the study, which the investigators estimated comprised about one third of the alarms that occurred during observation periods. Most of the 207 occurred while the nurse was already in the patient’s room, where a response decision is uncomplicated. More interesting were the 45 alarms heard while outside the patient’s room, where nurses face the complex decision of whether to interrupt their current tasks and respond or delay their response and assume the associated risk of nonresponse to a potentially deteriorating patient. Of the 45 alarms, nurses went into the room to evaluate the patient 15 times and, after doing so, reported that five of the 15 warranted in-person responses to address technical issues with the monitor, clinical issues, or patients’ comfort. Reassuring clinical contexts—such as presence of the medical team or family in the room and recent patient assessments—were the reasons most commonly provided to explain alarm nonresponse.

This study has two key limitations. First, the authors designed the study to observe nurses’ responses until thematic saturation was achieved. However, the small sample size (nine nurses, 45 out-of-room alarms) could raise questions about whether sufficient data were captured to make broadly generalizable conclusions, given the diverse range of patients, families, and clinical scenarios nurses encounter on an inpatient unit. Second, by instructing nurse participants to verbalize their rationale for response or nonresponse, investigators essentially asked nurses to override the “Type 1”, heuristic-based reasoning⁵ that research suggests regulates nursing responses to alarms when adapting to circumstances requiring high cognitive demand or a heavy workload.³ While innovative, it is possible that this approach prevented the investigators from fully achieving their stated objective of describing how bedside nurses think about and act upon alarms.

Nonetheless, the findings by Schondelmeyer and colleagues extend our emerging understanding of why alarm responses are disconcertingly slow. Nursing staff’s dismissal of monitor alarms that are discordant with a reassuring patient evaluation underscores the imperative to reduce nuisance alarms. Furthermore, the explicit statements justifying alarm nonresponse because of the presence of family members build upon prior findings of longer response times when family members are at the bedside³ and invite a provocative question: how would family members feel if they knew that they were being entrusted as a foundational component of safety monitoring in the hospital? In their recently published study conducted at the same hospital,⁶ Schondelmeyer’s team elicited perceptions that families are deeply concerned about staff nonresponse to alarms—as one nurse stated, parents “wonder what’s going on when no one comes in.” While there is a valuable role for integrating families into efforts to overcome threats to patient safety, as has been achieved with family error reporting⁷ and communication on family-centered rounds,⁸ this must occur in a structured, explicit, and deliberate manner, with families engaged as key stakeholders.

In summary, while Schondelmeyer and colleagues may not have exposed the depth of implicit thinking that governs nurses’ responses to alarms, they have highlighted the high-stakes decisions that nurses confront on a daily basis in an environment with exceedingly high alarm rates and low alarm actionability. The authors cite staff education among potential solutions to improve the safety of continuous monitoring, but such an intervention cannot be effective in a system that places impossible burdens on nurses. An openly family centered and multidisciplinary approach to reengineering the system for monitoring hospitalized children is needed to enable nurses to respond quickly and accurately to patients at risk of clinical deterioration.

Disclosures

The authors report no conflicts of interest.

In the past five years, it has become increasingly apparent that hospital physiologic monitoring systems are not functioning optimally for children. On pediatric wards, 26%-48% of children are continuously monitored, and these children generate between 42 and 155 alarms per day.¹ Just 1% or fewer are considered actionable or informative, slowing nurses’ response times and placing patients at risk of delayed recognition of life-threatening events.^2,3 While some factors associated with alarm response times have been elucidated,³ in order to design safe and effective monitoring systems, further work is needed to understand the complex decision-making process that nurses face when encountering alarms outside a patient’s room. It is in this area that Schondelmeyer and colleagues strive to enhance our understanding in this issue of the Journal of Hospital Medicine.⁴

Schondelmeyer et al. conducted a single-center, observational study using mixed methods in a general pediatric unit. Trained observers shadowed nine nurses one to four times each, during which nurses were asked to “think aloud” as they managed physiologic monitor alarms, rationalizing their decisions about how and why they might respond for the observer to document. Observers accumulated 61 patient-hours of observation before investigators halted data collection because new insights about alarm responses were no longer emerging from the data (thematic saturation).

Nurses thought aloud about 207 alarms during the study, which the investigators estimated comprised about one third of the alarms that occurred during observation periods. Most of the 207 occurred while the nurse was already in the patient’s room, where a response decision is uncomplicated. More interesting were the 45 alarms heard while outside the patient’s room, where nurses face the complex decision of whether to interrupt their current tasks and respond or delay their response and assume the associated risk of nonresponse to a potentially deteriorating patient. Of the 45 alarms, nurses went into the room to evaluate the patient 15 times and, after doing so, reported that five of the 15 warranted in-person responses to address technical issues with the monitor, clinical issues, or patients’ comfort. Reassuring clinical contexts—such as presence of the medical team or family in the room and recent patient assessments—were the reasons most commonly provided to explain alarm nonresponse.

This study has two key limitations. First, the authors designed the study to observe nurses’ responses until thematic saturation was achieved. However, the small sample size (nine nurses, 45 out-of-room alarms) could raise questions about whether sufficient data were captured to make broadly generalizable conclusions, given the diverse range of patients, families, and clinical scenarios nurses encounter on an inpatient unit. Second, by instructing nurse participants to verbalize their rationale for response or nonresponse, investigators essentially asked nurses to override the “Type 1”, heuristic-based reasoning⁵ that research suggests regulates nursing responses to alarms when adapting to circumstances requiring high cognitive demand or a heavy workload.³ While innovative, it is possible that this approach prevented the investigators from fully achieving their stated objective of describing how bedside nurses think about and act upon alarms.

Nonetheless, the findings by Schondelmeyer and colleagues extend our emerging understanding of why alarm responses are disconcertingly slow. Nursing staff’s dismissal of monitor alarms that are discordant with a reassuring patient evaluation underscores the imperative to reduce nuisance alarms. Furthermore, the explicit statements justifying alarm nonresponse because of the presence of family members build upon prior findings of longer response times when family members are at the bedside³ and invite a provocative question: how would family members feel if they knew that they were being entrusted as a foundational component of safety monitoring in the hospital? In their recently published study conducted at the same hospital,⁶ Schondelmeyer’s team elicited perceptions that families are deeply concerned about staff nonresponse to alarms—as one nurse stated, parents “wonder what’s going on when no one comes in.” While there is a valuable role for integrating families into efforts to overcome threats to patient safety, as has been achieved with family error reporting⁷ and communication on family-centered rounds,⁸ this must occur in a structured, explicit, and deliberate manner, with families engaged as key stakeholders.

In summary, while Schondelmeyer and colleagues may not have exposed the depth of implicit thinking that governs nurses’ responses to alarms, they have highlighted the high-stakes decisions that nurses confront on a daily basis in an environment with exceedingly high alarm rates and low alarm actionability. The authors cite staff education among potential solutions to improve the safety of continuous monitoring, but such an intervention cannot be effective in a system that places impossible burdens on nurses. An openly family centered and multidisciplinary approach to reengineering the system for monitoring hospitalized children is needed to enable nurses to respond quickly and accurately to patients at risk of clinical deterioration.

Disclosures

The authors report no conflicts of interest.

In the past five years, it has become increasingly apparent that hospital physiologic monitoring systems are not functioning optimally for children. On pediatric wards, 26%-48% of children are continuously monitored, and these children generate between 42 and 155 alarms per day.¹ Just 1% or fewer are considered actionable or informative, slowing nurses’ response times and placing patients at risk of delayed recognition of life-threatening events.^2,3 While some factors associated with alarm response times have been elucidated,³ in order to design safe and effective monitoring systems, further work is needed to understand the complex decision-making process that nurses face when encountering alarms outside a patient’s room. It is in this area that Schondelmeyer and colleagues strive to enhance our understanding in this issue of the Journal of Hospital Medicine.⁴

Schondelmeyer et al. conducted a single-center, observational study using mixed methods in a general pediatric unit. Trained observers shadowed nine nurses one to four times each, during which nurses were asked to “think aloud” as they managed physiologic monitor alarms, rationalizing their decisions about how and why they might respond for the observer to document. Observers accumulated 61 patient-hours of observation before investigators halted data collection because new insights about alarm responses were no longer emerging from the data (thematic saturation).

Nurses thought aloud about 207 alarms during the study, which the investigators estimated comprised about one third of the alarms that occurred during observation periods. Most of the 207 occurred while the nurse was already in the patient’s room, where a response decision is uncomplicated. More interesting were the 45 alarms heard while outside the patient’s room, where nurses face the complex decision of whether to interrupt their current tasks and respond or delay their response and assume the associated risk of nonresponse to a potentially deteriorating patient. Of the 45 alarms, nurses went into the room to evaluate the patient 15 times and, after doing so, reported that five of the 15 warranted in-person responses to address technical issues with the monitor, clinical issues, or patients’ comfort. Reassuring clinical contexts—such as presence of the medical team or family in the room and recent patient assessments—were the reasons most commonly provided to explain alarm nonresponse.

This study has two key limitations. First, the authors designed the study to observe nurses’ responses until thematic saturation was achieved. However, the small sample size (nine nurses, 45 out-of-room alarms) could raise questions about whether sufficient data were captured to make broadly generalizable conclusions, given the diverse range of patients, families, and clinical scenarios nurses encounter on an inpatient unit. Second, by instructing nurse participants to verbalize their rationale for response or nonresponse, investigators essentially asked nurses to override the “Type 1”, heuristic-based reasoning⁵ that research suggests regulates nursing responses to alarms when adapting to circumstances requiring high cognitive demand or a heavy workload.³ While innovative, it is possible that this approach prevented the investigators from fully achieving their stated objective of describing how bedside nurses think about and act upon alarms.

Nonetheless, the findings by Schondelmeyer and colleagues extend our emerging understanding of why alarm responses are disconcertingly slow. Nursing staff’s dismissal of monitor alarms that are discordant with a reassuring patient evaluation underscores the imperative to reduce nuisance alarms. Furthermore, the explicit statements justifying alarm nonresponse because of the presence of family members build upon prior findings of longer response times when family members are at the bedside³ and invite a provocative question: how would family members feel if they knew that they were being entrusted as a foundational component of safety monitoring in the hospital? In their recently published study conducted at the same hospital,⁶ Schondelmeyer’s team elicited perceptions that families are deeply concerned about staff nonresponse to alarms—as one nurse stated, parents “wonder what’s going on when no one comes in.” While there is a valuable role for integrating families into efforts to overcome threats to patient safety, as has been achieved with family error reporting⁷ and communication on family-centered rounds,⁸ this must occur in a structured, explicit, and deliberate manner, with families engaged as key stakeholders.

In summary, while Schondelmeyer and colleagues may not have exposed the depth of implicit thinking that governs nurses’ responses to alarms, they have highlighted the high-stakes decisions that nurses confront on a daily basis in an environment with exceedingly high alarm rates and low alarm actionability. The authors cite staff education among potential solutions to improve the safety of continuous monitoring, but such an intervention cannot be effective in a system that places impossible burdens on nurses. An openly family centered and multidisciplinary approach to reengineering the system for monitoring hospitalized children is needed to enable nurses to respond quickly and accurately to patients at risk of clinical deterioration.

Disclosures

The authors report no conflicts of interest.

In 2016, Pediatric Hospital Medicine (PHM) was recognized as a subspecialty under the American Board of Pediatrics (ABP), one of 24 certifying boards of the American Board of Medical Specialties. As with all new ABP subspecialty certification processes, a “practice pathway” with specific eligibility criteria allows individuals with expertise and sufficient practice experience within the discipline to take the certification examination. For PHM, certification via the practice pathway is permissible for the 2019, 2021, and 2023 certifying examinations.¹ In this perspective, we provide an illustration of ABP leadership and the PHM community partnering to mitigate unintentional gender bias that surfaced after the practice pathway eligibility criteria were implemented. We also provide recommendations to revise these criteria to eliminate future gender bias and promote equity in medicine.

In July 2019, individuals within the PHM community began to share stories of being denied eligibility to sit for the 2019 exam.² Some of the reported denials were due to an eligibility criterion related to “practice interruptions”, which stated that practice interruptions cannot exceed three months in the preceding four years or six months in the preceding five years. Notably, some women reported that their applications were denied because of practice interruptions due to maternity leave. These stories raised significant concerns of gender bias in the board certification process and sparked collective action to revise the board certification eligibility criteria. A petition was circulated within the PHM community and received 1,479 signatures in two weeks.

Given the magnitude of concern, leaders within the PHM community, with support from the American Academy of Pediatrics, collaboratively engaged with the ABP and members of the ABP PHM subboard to improve the transparency and equity of the eligibility process. As a result of this activism and effective dialogue, the ABP revised the PHM board certification eligibility criteria and removed the practice interruption criterion.¹ Through this unique experience of advocacy and partnership in medicine, the PHM community and ABP were able to work together to mitigate unintentional gender bias in the board certification process. However, this collaboration must continue as we believe the revised criteria remain unintentionally biased against women.

Gender bias is defined as the unfair difference in the way men and women are treated.³ Maternal bias is further characterized as bias experienced by mothers related to motherhood, often involving discrimination based on pregnancy, maternity leave, or breastfeeding. Both are common in medicine. Two-thirds of physician mothers report experiencing gender bias and more than a third experience maternal bias.⁴ This bias may be explicit, or intentional, but often the bias is unintentional. This bias can occur even with equal representation of women and men on committees determining eligibility, and even when the committee believes it is not biased.⁵ Furthermore, gender or maternal bias negatively affects individuals in medicine in regards to future employment, career advancement, and compensation.^6-11

Given these implications, we celebrate the removal of the practice interruptions criterion as it was unintentionally biased against women. Eligibility criteria that considered practice interruptions would have disproportionately affected women due to leaves related to pregnancy and due to discrepancies in the length of parental leave for mothers versus fathers. Though the ABP’s initial review of cases of denial did not demonstrate a significant difference in the proportion of men and women who were denied, these data may be misleading. Potential reasons why the ABP did not find significant differences in denial rates between women and men include: (1) some women who had recent maternity leaves chose not to apply because of concerns they may be denied; or (2) some women did not disclose maternity leaves on their application because they did not interpret maternity leave to be a practice interruption. This “self-censoring” may have resulted in incomplete data, making it difficult to fully understand the differential impact of this criterion on women versus men. Therefore, it is essential that we as a profession continue to identify any areas where gender bias exists in determining eligibility for certification, employment, or career advancement within medicine and eliminate it.

Despite the improvements made in the revised criteria, further revision is necessary to remove the criterion related to the “start date”, which will differentially affect women. This criterion states that an individual must have started their PHM practice on or before July of the first year of a four-year look-back period (eg, July 2015 for the 2019 cycle). We present three theoretical cases to illustrate gender bias with respect to this criterion (Table). Even though Applicants #2 and #3 accrue far more than the minimum number of hours in their first year—and more hours overall than Applicant #1—both of these women will remain ineligible under the revised criteria. While Applicant #2 could be eligible for the 2021 or 2023 cycle, Applicant #3, who is new to PHM practice in 2019 as a residency graduate, will not be eligible at all under the practice pathway due to delayed graduation from residency.

Disclosures

The authors have nothing to disclose.

In 2016, Pediatric Hospital Medicine (PHM) was recognized as a subspecialty under the American Board of Pediatrics (ABP), one of 24 certifying boards of the American Board of Medical Specialties. As with all new ABP subspecialty certification processes, a “practice pathway” with specific eligibility criteria allows individuals with expertise and sufficient practice experience within the discipline to take the certification examination. For PHM, certification via the practice pathway is permissible for the 2019, 2021, and 2023 certifying examinations.¹ In this perspective, we provide an illustration of ABP leadership and the PHM community partnering to mitigate unintentional gender bias that surfaced after the practice pathway eligibility criteria were implemented. We also provide recommendations to revise these criteria to eliminate future gender bias and promote equity in medicine.

In July 2019, individuals within the PHM community began to share stories of being denied eligibility to sit for the 2019 exam.² Some of the reported denials were due to an eligibility criterion related to “practice interruptions”, which stated that practice interruptions cannot exceed three months in the preceding four years or six months in the preceding five years. Notably, some women reported that their applications were denied because of practice interruptions due to maternity leave. These stories raised significant concerns of gender bias in the board certification process and sparked collective action to revise the board certification eligibility criteria. A petition was circulated within the PHM community and received 1,479 signatures in two weeks.

Given the magnitude of concern, leaders within the PHM community, with support from the American Academy of Pediatrics, collaboratively engaged with the ABP and members of the ABP PHM subboard to improve the transparency and equity of the eligibility process. As a result of this activism and effective dialogue, the ABP revised the PHM board certification eligibility criteria and removed the practice interruption criterion.¹ Through this unique experience of advocacy and partnership in medicine, the PHM community and ABP were able to work together to mitigate unintentional gender bias in the board certification process. However, this collaboration must continue as we believe the revised criteria remain unintentionally biased against women.

Gender bias is defined as the unfair difference in the way men and women are treated.³ Maternal bias is further characterized as bias experienced by mothers related to motherhood, often involving discrimination based on pregnancy, maternity leave, or breastfeeding. Both are common in medicine. Two-thirds of physician mothers report experiencing gender bias and more than a third experience maternal bias.⁴ This bias may be explicit, or intentional, but often the bias is unintentional. This bias can occur even with equal representation of women and men on committees determining eligibility, and even when the committee believes it is not biased.⁵ Furthermore, gender or maternal bias negatively affects individuals in medicine in regards to future employment, career advancement, and compensation.^6-11

Given these implications, we celebrate the removal of the practice interruptions criterion as it was unintentionally biased against women. Eligibility criteria that considered practice interruptions would have disproportionately affected women due to leaves related to pregnancy and due to discrepancies in the length of parental leave for mothers versus fathers. Though the ABP’s initial review of cases of denial did not demonstrate a significant difference in the proportion of men and women who were denied, these data may be misleading. Potential reasons why the ABP did not find significant differences in denial rates between women and men include: (1) some women who had recent maternity leaves chose not to apply because of concerns they may be denied; or (2) some women did not disclose maternity leaves on their application because they did not interpret maternity leave to be a practice interruption. This “self-censoring” may have resulted in incomplete data, making it difficult to fully understand the differential impact of this criterion on women versus men. Therefore, it is essential that we as a profession continue to identify any areas where gender bias exists in determining eligibility for certification, employment, or career advancement within medicine and eliminate it.

Despite the improvements made in the revised criteria, further revision is necessary to remove the criterion related to the “start date”, which will differentially affect women. This criterion states that an individual must have started their PHM practice on or before July of the first year of a four-year look-back period (eg, July 2015 for the 2019 cycle). We present three theoretical cases to illustrate gender bias with respect to this criterion (Table). Even though Applicants #2 and #3 accrue far more than the minimum number of hours in their first year—and more hours overall than Applicant #1—both of these women will remain ineligible under the revised criteria. While Applicant #2 could be eligible for the 2021 or 2023 cycle, Applicant #3, who is new to PHM practice in 2019 as a residency graduate, will not be eligible at all under the practice pathway due to delayed graduation from residency.

Disclosures

The authors have nothing to disclose.

In 2016, Pediatric Hospital Medicine (PHM) was recognized as a subspecialty under the American Board of Pediatrics (ABP), one of 24 certifying boards of the American Board of Medical Specialties. As with all new ABP subspecialty certification processes, a “practice pathway” with specific eligibility criteria allows individuals with expertise and sufficient practice experience within the discipline to take the certification examination. For PHM, certification via the practice pathway is permissible for the 2019, 2021, and 2023 certifying examinations.¹ In this perspective, we provide an illustration of ABP leadership and the PHM community partnering to mitigate unintentional gender bias that surfaced after the practice pathway eligibility criteria were implemented. We also provide recommendations to revise these criteria to eliminate future gender bias and promote equity in medicine.

In July 2019, individuals within the PHM community began to share stories of being denied eligibility to sit for the 2019 exam.² Some of the reported denials were due to an eligibility criterion related to “practice interruptions”, which stated that practice interruptions cannot exceed three months in the preceding four years or six months in the preceding five years. Notably, some women reported that their applications were denied because of practice interruptions due to maternity leave. These stories raised significant concerns of gender bias in the board certification process and sparked collective action to revise the board certification eligibility criteria. A petition was circulated within the PHM community and received 1,479 signatures in two weeks.

Given the magnitude of concern, leaders within the PHM community, with support from the American Academy of Pediatrics, collaboratively engaged with the ABP and members of the ABP PHM subboard to improve the transparency and equity of the eligibility process. As a result of this activism and effective dialogue, the ABP revised the PHM board certification eligibility criteria and removed the practice interruption criterion.¹ Through this unique experience of advocacy and partnership in medicine, the PHM community and ABP were able to work together to mitigate unintentional gender bias in the board certification process. However, this collaboration must continue as we believe the revised criteria remain unintentionally biased against women.

Gender bias is defined as the unfair difference in the way men and women are treated.³ Maternal bias is further characterized as bias experienced by mothers related to motherhood, often involving discrimination based on pregnancy, maternity leave, or breastfeeding. Both are common in medicine. Two-thirds of physician mothers report experiencing gender bias and more than a third experience maternal bias.⁴ This bias may be explicit, or intentional, but often the bias is unintentional. This bias can occur even with equal representation of women and men on committees determining eligibility, and even when the committee believes it is not biased.⁵ Furthermore, gender or maternal bias negatively affects individuals in medicine in regards to future employment, career advancement, and compensation.^6-11

Given these implications, we celebrate the removal of the practice interruptions criterion as it was unintentionally biased against women. Eligibility criteria that considered practice interruptions would have disproportionately affected women due to leaves related to pregnancy and due to discrepancies in the length of parental leave for mothers versus fathers. Though the ABP’s initial review of cases of denial did not demonstrate a significant difference in the proportion of men and women who were denied, these data may be misleading. Potential reasons why the ABP did not find significant differences in denial rates between women and men include: (1) some women who had recent maternity leaves chose not to apply because of concerns they may be denied; or (2) some women did not disclose maternity leaves on their application because they did not interpret maternity leave to be a practice interruption. This “self-censoring” may have resulted in incomplete data, making it difficult to fully understand the differential impact of this criterion on women versus men. Therefore, it is essential that we as a profession continue to identify any areas where gender bias exists in determining eligibility for certification, employment, or career advancement within medicine and eliminate it.

Despite the improvements made in the revised criteria, further revision is necessary to remove the criterion related to the “start date”, which will differentially affect women. This criterion states that an individual must have started their PHM practice on or before July of the first year of a four-year look-back period (eg, July 2015 for the 2019 cycle). We present three theoretical cases to illustrate gender bias with respect to this criterion (Table). Even though Applicants #2 and #3 accrue far more than the minimum number of hours in their first year—and more hours overall than Applicant #1—both of these women will remain ineligible under the revised criteria. While Applicant #2 could be eligible for the 2021 or 2023 cycle, Applicant #3, who is new to PHM practice in 2019 as a residency graduate, will not be eligible at all under the practice pathway due to delayed graduation from residency.

Disclosures

The authors have nothing to disclose.

“Better than a thousand days of diligent study is one day with a great teacher.”
—Japanese proverb

My chairman of medicine in medical school was a looming, intimidating, diagnostic genius—and one of the best teachers I have ever had. As a sub-intern it seemed I learned more in one month with him than in my prior six months of medical school.  After the rotation, I asked him how he became such an effective teacher. “Simple,” he said, “I invest significant time and effort.”

But time is limited and you have to be smart with how you invest it. Here are three pearls that are a wise investment—they will make you a better teacher.

Those who seem to teach effortlessly do so after substantial behind-the-scenes effort. Read on your patients before rounds. Identify key teaching points and useful literature. Get some questions ready to define knowledge gaps and create “Teaching Scripts.”

Teaching Scripts are preplanned summaries of specific topics that can be used on rounds or longer talks and are “triggered” by common scenarios (eg, hypoxia). Great teaching scripts use a “hook” to engage the learner (commonly a thought-provoking question or story), two to five teaching points, and purposeful questions, mnemonics, and visual representations.

You should aim to develop at least five teaching scripts on commonly encountered topics. Eventually, you should have twenty scripts you can easily reference.

Technology significantly enhances the efficiency and impact of your teaching. For example, on rounds use your cell phone to display and teach anatomy, radiographic images, and EKGs. Use an iPad as a mobile whiteboard. Use email to collate and disseminate teaching points or send links to valuable learning resources like procedural videos. At its best, you can develop new programs and recruit team members to create resources, like I did with an online series focused on teaching to teach using graphically-enhanced TED-style talks¹ and animated whiteboard videos.²

Do you easily remember the content from your medical school lectures?  Likely not. But you likely remember moments from your favorite comedian or TED talk. Unlike the many PowerPoint lectures you’ve sat through, I’ll bet you stay engaged in films and documentaries. Why the difference? In short—medical educators often don’t make content engaging, readily understood, or memorable. To be most effective in teaching, learn from experts in other fields. Think how storytelling, film, theater, and graphic design contribute to learning. Don’t be afraid to be different.

All of these disciplines recognize the power of storytelling to make their points more impactful and memorable. Leverage this by mixing lessons with stories to create teaching points that stick. Lessons of character and morals can be highlighted through stories of personal struggles, prior patients, or people you admire. Clinical tips can be reinforced through sharing a “clinical story”—concise retellings of high-yield patient cases with diagnosis or management tips.

These disciplines also recognize the importance of “setting the stage” to create an optimal experience. We too can learn from this by setting the stage for our learners. Build a learning environment that is positive, collaborative, and fun by being open, curious, and enthusiastic. Treat your team to coffee rounds or lunch and get to know each learner as you walk between patients. As Teddy Roosevelt said, “people don’t care how much you know, until they know how much you care.”

My chairman taught me that exceptional teaching is not a talent of the gifted, it is a skill of the diligent. If you invest in your teaching, you can make a tremendous impact in the lives of your learners. Are you ready to be empowered?

Acknowledgments

The author wishes to thank Rana Kabeer and Sally Salari for their assistance in storyboarding, graphic design, and video editing of the MENTOR Video Series.

Disclosures

Dr. Cronin has nothing to disclose.

 

“Better than a thousand days of diligent study is one day with a great teacher.”
—Japanese proverb

My chairman of medicine in medical school was a looming, intimidating, diagnostic genius—and one of the best teachers I have ever had. As a sub-intern it seemed I learned more in one month with him than in my prior six months of medical school.  After the rotation, I asked him how he became such an effective teacher. “Simple,” he said, “I invest significant time and effort.”

But time is limited and you have to be smart with how you invest it. Here are three pearls that are a wise investment—they will make you a better teacher.

Those who seem to teach effortlessly do so after substantial behind-the-scenes effort. Read on your patients before rounds. Identify key teaching points and useful literature. Get some questions ready to define knowledge gaps and create “Teaching Scripts.”

Teaching Scripts are preplanned summaries of specific topics that can be used on rounds or longer talks and are “triggered” by common scenarios (eg, hypoxia). Great teaching scripts use a “hook” to engage the learner (commonly a thought-provoking question or story), two to five teaching points, and purposeful questions, mnemonics, and visual representations.

You should aim to develop at least five teaching scripts on commonly encountered topics. Eventually, you should have twenty scripts you can easily reference.

Technology significantly enhances the efficiency and impact of your teaching. For example, on rounds use your cell phone to display and teach anatomy, radiographic images, and EKGs. Use an iPad as a mobile whiteboard. Use email to collate and disseminate teaching points or send links to valuable learning resources like procedural videos. At its best, you can develop new programs and recruit team members to create resources, like I did with an online series focused on teaching to teach using graphically-enhanced TED-style talks¹ and animated whiteboard videos.²

Do you easily remember the content from your medical school lectures?  Likely not. But you likely remember moments from your favorite comedian or TED talk. Unlike the many PowerPoint lectures you’ve sat through, I’ll bet you stay engaged in films and documentaries. Why the difference? In short—medical educators often don’t make content engaging, readily understood, or memorable. To be most effective in teaching, learn from experts in other fields. Think how storytelling, film, theater, and graphic design contribute to learning. Don’t be afraid to be different.

All of these disciplines recognize the power of storytelling to make their points more impactful and memorable. Leverage this by mixing lessons with stories to create teaching points that stick. Lessons of character and morals can be highlighted through stories of personal struggles, prior patients, or people you admire. Clinical tips can be reinforced through sharing a “clinical story”—concise retellings of high-yield patient cases with diagnosis or management tips.

These disciplines also recognize the importance of “setting the stage” to create an optimal experience. We too can learn from this by setting the stage for our learners. Build a learning environment that is positive, collaborative, and fun by being open, curious, and enthusiastic. Treat your team to coffee rounds or lunch and get to know each learner as you walk between patients. As Teddy Roosevelt said, “people don’t care how much you know, until they know how much you care.”

My chairman taught me that exceptional teaching is not a talent of the gifted, it is a skill of the diligent. If you invest in your teaching, you can make a tremendous impact in the lives of your learners. Are you ready to be empowered?

Acknowledgments

The author wishes to thank Rana Kabeer and Sally Salari for their assistance in storyboarding, graphic design, and video editing of the MENTOR Video Series.

Disclosures

Dr. Cronin has nothing to disclose.

 

“Better than a thousand days of diligent study is one day with a great teacher.”
—Japanese proverb

My chairman of medicine in medical school was a looming, intimidating, diagnostic genius—and one of the best teachers I have ever had. As a sub-intern it seemed I learned more in one month with him than in my prior six months of medical school.  After the rotation, I asked him how he became such an effective teacher. “Simple,” he said, “I invest significant time and effort.”

But time is limited and you have to be smart with how you invest it. Here are three pearls that are a wise investment—they will make you a better teacher.

Those who seem to teach effortlessly do so after substantial behind-the-scenes effort. Read on your patients before rounds. Identify key teaching points and useful literature. Get some questions ready to define knowledge gaps and create “Teaching Scripts.”

Teaching Scripts are preplanned summaries of specific topics that can be used on rounds or longer talks and are “triggered” by common scenarios (eg, hypoxia). Great teaching scripts use a “hook” to engage the learner (commonly a thought-provoking question or story), two to five teaching points, and purposeful questions, mnemonics, and visual representations.

You should aim to develop at least five teaching scripts on commonly encountered topics. Eventually, you should have twenty scripts you can easily reference.

Technology significantly enhances the efficiency and impact of your teaching. For example, on rounds use your cell phone to display and teach anatomy, radiographic images, and EKGs. Use an iPad as a mobile whiteboard. Use email to collate and disseminate teaching points or send links to valuable learning resources like procedural videos. At its best, you can develop new programs and recruit team members to create resources, like I did with an online series focused on teaching to teach using graphically-enhanced TED-style talks¹ and animated whiteboard videos.²

Do you easily remember the content from your medical school lectures?  Likely not. But you likely remember moments from your favorite comedian or TED talk. Unlike the many PowerPoint lectures you’ve sat through, I’ll bet you stay engaged in films and documentaries. Why the difference? In short—medical educators often don’t make content engaging, readily understood, or memorable. To be most effective in teaching, learn from experts in other fields. Think how storytelling, film, theater, and graphic design contribute to learning. Don’t be afraid to be different.

All of these disciplines recognize the power of storytelling to make their points more impactful and memorable. Leverage this by mixing lessons with stories to create teaching points that stick. Lessons of character and morals can be highlighted through stories of personal struggles, prior patients, or people you admire. Clinical tips can be reinforced through sharing a “clinical story”—concise retellings of high-yield patient cases with diagnosis or management tips.

These disciplines also recognize the importance of “setting the stage” to create an optimal experience. We too can learn from this by setting the stage for our learners. Build a learning environment that is positive, collaborative, and fun by being open, curious, and enthusiastic. Treat your team to coffee rounds or lunch and get to know each learner as you walk between patients. As Teddy Roosevelt said, “people don’t care how much you know, until they know how much you care.”

My chairman taught me that exceptional teaching is not a talent of the gifted, it is a skill of the diligent. If you invest in your teaching, you can make a tremendous impact in the lives of your learners. Are you ready to be empowered?

Acknowledgments

The author wishes to thank Rana Kabeer and Sally Salari for their assistance in storyboarding, graphic design, and video editing of the MENTOR Video Series.

Disclosures

Dr. Cronin has nothing to disclose.

 

Endoscopic submucosal dissection (ESD) is a viable treatment option for patients with submucosal (T1b) esophageal cancer who have a low risk of lymph node metastasis, according to an expert review.

Among patients with T1b esophageal cancer, ideal candidates for ESD have small (less than 2 cm), well-differentiated tumors that do not invade beyond the superficial submucosa (SM1) and lack lymphovascular invasion, reported lead author Mohamed O. Othman, MD, of Baylor College of Medicine in Houston, and colleagues. The literature review was recently commissioned by the American Gastroenterological Association (AGA), because of high clinical relevance.

“[ESD] has been gaining momentum as an alternative to surgery in treating early gastrointestinal neoplasms,” the investigators wrote in Clinical Gastroenterology and Hepatology.

Most patients who undergo surgical resection develop gastroesophageal reflux, the investigators noted, and many others develop serious complications or do not survive the procedure.

“Even a high-volume center such as Mayo Clinic reported a surgical mortality of 4% for T1a esophageal cancer,” the investigators wrote. “Moreover, 34% of patients developed postoperative complications such as anastomotic leaks, anastomotic strictures, cardiopulmonary complications, and feeding jejunostomy leaks. ... Therefore, a less-invasive alternative to esophagectomy would be extremely valuable in the management of early stage [esophageal cancer] if proven effective.”

The investigators reviewed studies evaluating safety and efficacy of surgical and endoscopic techniques, as well as available data for chemoradiation and radiofrequency ablation combinations, which could potentially optimize outcomes of endoscopic resection.

They concluded that most patients with esophageal cancer that does not extend beyond the mucosa (T1a) can be cured with endoscopic resection, based on 5-year survival rates from several Japanese trials. For patients with T1b disease, however, ESD is best suited for those with a low risk of lymph node metastasis. Unfortunately, identifying these candidates can be challenging, according to the investigators.

“The risk of lymph node metastasis depends on the depth of invasion, histologic type, and molecular characterization of the tumor,” the investigators explained, noting that depth of invasion is the trickiest to discern. Although endoscopic ultrasound (EUS) is still recommended for submucosal imaging, the review showed that EUS may overstage cancer in Barrett’s esophagus. The investigators suggested that volume laser endoscopy with infrared light could be a more accurate alternative, but it is not yet a clinical reality.

The review also showed potential for combining ESD with other modalities. For example, a study by Hamada and colleagues involving 66 patients with submucosal (T1b) esophageal squamous cell carcinoma found that a combination of ESD with chemoradiation led to similar 3- and 5-year survival rates as radical esophagectomy. The investigators highlighted the importance of lymph node metastasis in this study, as none of the 30 patients lacking lymph node involvement had metastatic recurrence, compared with 6 of the 36 patients who exhibited lymph node metastasis. According to the investigators, promising data are also anticipated for this combination among those with adenocarcinoma. And for patients with intestinal metaplasia and/or dysplasia, adding radiofrequency ablation after ESD appears to be an effective option; one recent study by Sharmila Subramaniam, BMBS, and colleagues found that this strategy led to clearance rates of 85% and 96% for metaplasia and dysplasia, respectively.

“Additional treatment should be determined by factors such as tumor grade, status of lymphovascular invasion, and depth of tumor, which have a direct influence on metastatic potential,” the investigators wrote.

The investigators suggested that, in the future, better diagnostics will be needed to characterize T1b disease, as this could streamline patient selection. “Future research should focus on novel biological and immunohistochemistry markers that can aid in the prediction of tumor behavior and [lymph node metastasis] in T1b esophageal cancer,” they concluded.

The study was commissioned by the American Gastroenterological Association. The investigators disclosed additional relationships with Boston Scientific, Olympus, Lumendi, and others.

SOURCE: Othman MO et al. CGH. 2019 Jun 4. doi: 10.1016/j.cgh.2019.05.045.

Endoscopic submucosal dissection (ESD) is a viable treatment option for patients with submucosal (T1b) esophageal cancer who have a low risk of lymph node metastasis, according to an expert review.

Among patients with T1b esophageal cancer, ideal candidates for ESD have small (less than 2 cm), well-differentiated tumors that do not invade beyond the superficial submucosa (SM1) and lack lymphovascular invasion, reported lead author Mohamed O. Othman, MD, of Baylor College of Medicine in Houston, and colleagues. The literature review was recently commissioned by the American Gastroenterological Association (AGA), because of high clinical relevance.

“[ESD] has been gaining momentum as an alternative to surgery in treating early gastrointestinal neoplasms,” the investigators wrote in Clinical Gastroenterology and Hepatology.

Most patients who undergo surgical resection develop gastroesophageal reflux, the investigators noted, and many others develop serious complications or do not survive the procedure.

“Even a high-volume center such as Mayo Clinic reported a surgical mortality of 4% for T1a esophageal cancer,” the investigators wrote. “Moreover, 34% of patients developed postoperative complications such as anastomotic leaks, anastomotic strictures, cardiopulmonary complications, and feeding jejunostomy leaks. ... Therefore, a less-invasive alternative to esophagectomy would be extremely valuable in the management of early stage [esophageal cancer] if proven effective.”

The investigators reviewed studies evaluating safety and efficacy of surgical and endoscopic techniques, as well as available data for chemoradiation and radiofrequency ablation combinations, which could potentially optimize outcomes of endoscopic resection.

They concluded that most patients with esophageal cancer that does not extend beyond the mucosa (T1a) can be cured with endoscopic resection, based on 5-year survival rates from several Japanese trials. For patients with T1b disease, however, ESD is best suited for those with a low risk of lymph node metastasis. Unfortunately, identifying these candidates can be challenging, according to the investigators.

“The risk of lymph node metastasis depends on the depth of invasion, histologic type, and molecular characterization of the tumor,” the investigators explained, noting that depth of invasion is the trickiest to discern. Although endoscopic ultrasound (EUS) is still recommended for submucosal imaging, the review showed that EUS may overstage cancer in Barrett’s esophagus. The investigators suggested that volume laser endoscopy with infrared light could be a more accurate alternative, but it is not yet a clinical reality.

The review also showed potential for combining ESD with other modalities. For example, a study by Hamada and colleagues involving 66 patients with submucosal (T1b) esophageal squamous cell carcinoma found that a combination of ESD with chemoradiation led to similar 3- and 5-year survival rates as radical esophagectomy. The investigators highlighted the importance of lymph node metastasis in this study, as none of the 30 patients lacking lymph node involvement had metastatic recurrence, compared with 6 of the 36 patients who exhibited lymph node metastasis. According to the investigators, promising data are also anticipated for this combination among those with adenocarcinoma. And for patients with intestinal metaplasia and/or dysplasia, adding radiofrequency ablation after ESD appears to be an effective option; one recent study by Sharmila Subramaniam, BMBS, and colleagues found that this strategy led to clearance rates of 85% and 96% for metaplasia and dysplasia, respectively.

“Additional treatment should be determined by factors such as tumor grade, status of lymphovascular invasion, and depth of tumor, which have a direct influence on metastatic potential,” the investigators wrote.

The investigators suggested that, in the future, better diagnostics will be needed to characterize T1b disease, as this could streamline patient selection. “Future research should focus on novel biological and immunohistochemistry markers that can aid in the prediction of tumor behavior and [lymph node metastasis] in T1b esophageal cancer,” they concluded.

The study was commissioned by the American Gastroenterological Association. The investigators disclosed additional relationships with Boston Scientific, Olympus, Lumendi, and others.

SOURCE: Othman MO et al. CGH. 2019 Jun 4. doi: 10.1016/j.cgh.2019.05.045.

Endoscopic submucosal dissection (ESD) is a viable treatment option for patients with submucosal (T1b) esophageal cancer who have a low risk of lymph node metastasis, according to an expert review.

Among patients with T1b esophageal cancer, ideal candidates for ESD have small (less than 2 cm), well-differentiated tumors that do not invade beyond the superficial submucosa (SM1) and lack lymphovascular invasion, reported lead author Mohamed O. Othman, MD, of Baylor College of Medicine in Houston, and colleagues. The literature review was recently commissioned by the American Gastroenterological Association (AGA), because of high clinical relevance.

“[ESD] has been gaining momentum as an alternative to surgery in treating early gastrointestinal neoplasms,” the investigators wrote in Clinical Gastroenterology and Hepatology.

Most patients who undergo surgical resection develop gastroesophageal reflux, the investigators noted, and many others develop serious complications or do not survive the procedure.

“Even a high-volume center such as Mayo Clinic reported a surgical mortality of 4% for T1a esophageal cancer,” the investigators wrote. “Moreover, 34% of patients developed postoperative complications such as anastomotic leaks, anastomotic strictures, cardiopulmonary complications, and feeding jejunostomy leaks. ... Therefore, a less-invasive alternative to esophagectomy would be extremely valuable in the management of early stage [esophageal cancer] if proven effective.”

The investigators reviewed studies evaluating safety and efficacy of surgical and endoscopic techniques, as well as available data for chemoradiation and radiofrequency ablation combinations, which could potentially optimize outcomes of endoscopic resection.

They concluded that most patients with esophageal cancer that does not extend beyond the mucosa (T1a) can be cured with endoscopic resection, based on 5-year survival rates from several Japanese trials. For patients with T1b disease, however, ESD is best suited for those with a low risk of lymph node metastasis. Unfortunately, identifying these candidates can be challenging, according to the investigators.

“The risk of lymph node metastasis depends on the depth of invasion, histologic type, and molecular characterization of the tumor,” the investigators explained, noting that depth of invasion is the trickiest to discern. Although endoscopic ultrasound (EUS) is still recommended for submucosal imaging, the review showed that EUS may overstage cancer in Barrett’s esophagus. The investigators suggested that volume laser endoscopy with infrared light could be a more accurate alternative, but it is not yet a clinical reality.

The review also showed potential for combining ESD with other modalities. For example, a study by Hamada and colleagues involving 66 patients with submucosal (T1b) esophageal squamous cell carcinoma found that a combination of ESD with chemoradiation led to similar 3- and 5-year survival rates as radical esophagectomy. The investigators highlighted the importance of lymph node metastasis in this study, as none of the 30 patients lacking lymph node involvement had metastatic recurrence, compared with 6 of the 36 patients who exhibited lymph node metastasis. According to the investigators, promising data are also anticipated for this combination among those with adenocarcinoma. And for patients with intestinal metaplasia and/or dysplasia, adding radiofrequency ablation after ESD appears to be an effective option; one recent study by Sharmila Subramaniam, BMBS, and colleagues found that this strategy led to clearance rates of 85% and 96% for metaplasia and dysplasia, respectively.

“Additional treatment should be determined by factors such as tumor grade, status of lymphovascular invasion, and depth of tumor, which have a direct influence on metastatic potential,” the investigators wrote.

The investigators suggested that, in the future, better diagnostics will be needed to characterize T1b disease, as this could streamline patient selection. “Future research should focus on novel biological and immunohistochemistry markers that can aid in the prediction of tumor behavior and [lymph node metastasis] in T1b esophageal cancer,” they concluded.

The study was commissioned by the American Gastroenterological Association. The investigators disclosed additional relationships with Boston Scientific, Olympus, Lumendi, and others.

SOURCE: Othman MO et al. CGH. 2019 Jun 4. doi: 10.1016/j.cgh.2019.05.045.