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Implicit bias in medicine and beyond
Recently, I reported to the Washtenaw County Circuit Courthouse in Ann Arbor, Mich., to fulfill my civic responsibility of jury duty. After check-in, a pool of 250 potential jurors were shown a video about implicit bias and shuttled off to different courtrooms for the jury selection process (voir dire, or “to speak the truth” in French). While not personally called up to the juror box on this day, I did have the opportunity to observe the attorneys and judge as they questioned potential jurors to uncover any indication that they might not be fair or impartial in judging the facts of this criminal case. After over 3 hours of questioning and several peremptory challenges, a jury was empaneled, and the rest of us were dismissed for the day.
In the legal system, implicit bias can adversely affect legal outcomes by impacting the beliefs and attitudes of multiple stakeholders, including attorneys and judges, litigants, witnesses, and of course jurors, threatening one of our society’s most fundamental principles of equal justice under the law. In the health care arena, implicit bias has been shown to impact patient-clinician communication and contribute to racial and ethnic disparities in patient outcomes. As a medical community, acknowledging and accepting the existence of implicit bias, its manifestations, and its impact is a critical first step to ensuring that every patient that walks into our exam rooms receives equitable care, and we can begin to move the needle in addressing persistent health disparities in patients with gastrointestinal diseases and beyond. While this is regrettably a politically charged topic in our current environment, I urge you to join me in reflecting on whether and how unconscious attitudes or stereotypes may unintentionally color the way in which you interact with patients in the clinic and serve to create or perpetuate inequities in treatment. (I also urge you to show up for jury duty!)
Turning to our April issue, we highlight two recent studies from AGA’s flagship journals, one showing an unexpected rise in pancreatic cancer incidence among women under the age of 55, and another evaluating survival outcomes by fibrosis stage in biopsy-proven nonalcoholic fatty liver disease. In this month’s Member Spotlight column, we introduce you to gastroenterologist Daniel Leffler, MD, who shares his experiences transitioning from a traditional academic career to a job in industry to further scientific advancements in celiac disease treatment. We hope you enjoy these articles and all the content included in our April issue!
Megan A. Adams, MD, JD, MSc
Recently, I reported to the Washtenaw County Circuit Courthouse in Ann Arbor, Mich., to fulfill my civic responsibility of jury duty. After check-in, a pool of 250 potential jurors were shown a video about implicit bias and shuttled off to different courtrooms for the jury selection process (voir dire, or “to speak the truth” in French). While not personally called up to the juror box on this day, I did have the opportunity to observe the attorneys and judge as they questioned potential jurors to uncover any indication that they might not be fair or impartial in judging the facts of this criminal case. After over 3 hours of questioning and several peremptory challenges, a jury was empaneled, and the rest of us were dismissed for the day.
In the legal system, implicit bias can adversely affect legal outcomes by impacting the beliefs and attitudes of multiple stakeholders, including attorneys and judges, litigants, witnesses, and of course jurors, threatening one of our society’s most fundamental principles of equal justice under the law. In the health care arena, implicit bias has been shown to impact patient-clinician communication and contribute to racial and ethnic disparities in patient outcomes. As a medical community, acknowledging and accepting the existence of implicit bias, its manifestations, and its impact is a critical first step to ensuring that every patient that walks into our exam rooms receives equitable care, and we can begin to move the needle in addressing persistent health disparities in patients with gastrointestinal diseases and beyond. While this is regrettably a politically charged topic in our current environment, I urge you to join me in reflecting on whether and how unconscious attitudes or stereotypes may unintentionally color the way in which you interact with patients in the clinic and serve to create or perpetuate inequities in treatment. (I also urge you to show up for jury duty!)
Turning to our April issue, we highlight two recent studies from AGA’s flagship journals, one showing an unexpected rise in pancreatic cancer incidence among women under the age of 55, and another evaluating survival outcomes by fibrosis stage in biopsy-proven nonalcoholic fatty liver disease. In this month’s Member Spotlight column, we introduce you to gastroenterologist Daniel Leffler, MD, who shares his experiences transitioning from a traditional academic career to a job in industry to further scientific advancements in celiac disease treatment. We hope you enjoy these articles and all the content included in our April issue!
Megan A. Adams, MD, JD, MSc
Recently, I reported to the Washtenaw County Circuit Courthouse in Ann Arbor, Mich., to fulfill my civic responsibility of jury duty. After check-in, a pool of 250 potential jurors were shown a video about implicit bias and shuttled off to different courtrooms for the jury selection process (voir dire, or “to speak the truth” in French). While not personally called up to the juror box on this day, I did have the opportunity to observe the attorneys and judge as they questioned potential jurors to uncover any indication that they might not be fair or impartial in judging the facts of this criminal case. After over 3 hours of questioning and several peremptory challenges, a jury was empaneled, and the rest of us were dismissed for the day.
In the legal system, implicit bias can adversely affect legal outcomes by impacting the beliefs and attitudes of multiple stakeholders, including attorneys and judges, litigants, witnesses, and of course jurors, threatening one of our society’s most fundamental principles of equal justice under the law. In the health care arena, implicit bias has been shown to impact patient-clinician communication and contribute to racial and ethnic disparities in patient outcomes. As a medical community, acknowledging and accepting the existence of implicit bias, its manifestations, and its impact is a critical first step to ensuring that every patient that walks into our exam rooms receives equitable care, and we can begin to move the needle in addressing persistent health disparities in patients with gastrointestinal diseases and beyond. While this is regrettably a politically charged topic in our current environment, I urge you to join me in reflecting on whether and how unconscious attitudes or stereotypes may unintentionally color the way in which you interact with patients in the clinic and serve to create or perpetuate inequities in treatment. (I also urge you to show up for jury duty!)
Turning to our April issue, we highlight two recent studies from AGA’s flagship journals, one showing an unexpected rise in pancreatic cancer incidence among women under the age of 55, and another evaluating survival outcomes by fibrosis stage in biopsy-proven nonalcoholic fatty liver disease. In this month’s Member Spotlight column, we introduce you to gastroenterologist Daniel Leffler, MD, who shares his experiences transitioning from a traditional academic career to a job in industry to further scientific advancements in celiac disease treatment. We hope you enjoy these articles and all the content included in our April issue!
Megan A. Adams, MD, JD, MSc
Colorectal cancer screening quality measures – beyond colonoscopy
Medicine in the United States is undergoing fundamental changes that will continue despite 2016 presidential election results. Changes include consolidation of provider networks, movement from volume- to value-based reimbursement, demands for price and quality transparency, and a shift from focusing solely on individual physician-patient interactions to a broader triple aim focus that incorporates individual patients, population, health, and cost. In this month’s column, Sameer Saini and colleagues suggest that we broaden our view of colorectal cancer screening quality metrics from a colonoscopy-centric focus to a focus on the bottom line: Do we reduce cancer in the population of patients that we serve? When we extend our view to a population level, we use current colonoscopy registries only as internal process controls. A successful health system will develop a mechanism to assess and demonstrate how well the collective team of providers accomplishes the only outcome that matters to patients: preventing colon cancer.
John I. Allen, MD, MBA, AGAF, Special Section Editor
Colorectal cancer (CRC) screening is one of the most valuable services provided by gastroenterologists. The evidence that screening “works” on a population level is undeniable. But not every screening program is equally effective. Data indicate ongoing underuse of screening, particularly in high-risk, vulnerable, and minority communities.1,2 Other data indicate that screening is overused, particularly in low-risk patients and in those with limited life expectancy.3-5 It is also known that endoscopist skill plays an important role in the effectiveness of screening. In short, there is ample room for improvement in the quality of CRC screening, and payers and the public have taken notice. Unsurprisingly, gastroenterologists are often focused on procedural quality indicators, such as adenoma detection and cecal intubation rates.6 These endoscopic quality measures are important indicators of high-quality colonoscopy, but colonoscopy is the common touch point of a much broader system of care that includes other screening tests and other providers (e.g., primary care providers [PCPs], pathologists, and anesthesiologists). Coordinating care across this system is essential for improving the health of patients. As the stewards of digestive health, we owe it to our patients to take a more comprehensive view of CRC screening quality and move beyond colonoscopy alone.
The complex web of care that comprises CRC screening is shown schematically in Figure 1. Appropriate screening begins with selection of suitable screening candidates. In the United States, where most screening is initiated during a clinician encounter, this important task falls primarily on the shoulders of PCPs. It is typically the role of the PCP to assess the two key patient factors that determine screening benefit: CRC risk (using personal and family history) and life expectancy (using age and overall health status). Once a patient has been deemed an appropriate candidate for screening, an acceptable screening test must be selected. Here, patient and practitioner are faced with a menu of options, including fecal occult blood testing (FOBT), colonoscopy, multitarget stool DNA, and computed tomography colonography. For average-risk screening, the ideal test depends primarily on patient preference and local availability.
If a screening test other than colonoscopy is selected, it becomes critical that a positive test is followed by timely and high-quality colonoscopy. High-quality colonoscopy begins with evidence-based preprocedure education and preparation, including appropriate selection of anesthesia services. Once a patient has been well prepared and adequately sedated, an endoscopist must carefully examine the colonic mucosa and completely resect any suspicious polyps. Unless discarded, resected polyps must be reviewed and categorized by a pathologist, including appropriate identification of serrated polyps. Finally, pathology results must be correctly interpreted by the clinician, with evidence-based follow-up recommendations made and effectively communicated to the patient and the referring provider. Additionally, in the short term, delayed gastrointestinal (GI) and non-GI complications of colonoscopy must be recognized and appropriately addressed. In the long term, the rate of interval cancers must be monitored.
Recognizing the importance of CRC screening, GI specialty societies have proposed a variety of quality measures to ensure that patients receive high-quality and high-value colonoscopy. Several of these measures have been adopted by CMS as part of the Physician Quality Reporting System. Non-GI groups, such as the National Center for Quality Assurance and the Ambulatory Surgery Center Association, have also proposed their own CRC screening–related measures.
Despite the proliferation of measures in the domain of CRC screening, current measures fall short in several ways. First, they are largely focused on colonoscopy technical performance, with less attention paid to the important steps that occur before and after colonoscopy. For example, the existing Healthcare Effectiveness Data and Information Set measure for underuse of CRC screening assesses the proportion of patients in a health plan between the ages 50 and 75 who are up to date for CRC screening. This measure is satisfied if a patient completes FOBT, regardless of the result. But FOBT alone is not sufficient to reduce mortality from CRC. Rather, it is imperative that a positive FOBT test be followed by colonoscopy. Numerous studies suggest a quality gap in this critical referral step.7
Yet, outside of selected clinical settings (e.g., the Veterans Affairs Healthcare System), no existing quality measure focuses on colonoscopy completion after positive FOBT. Other examples of important performance gaps beyond colonoscopy technical performance include appropriate use of monitored anesthesia care (data suggest overuse) and appropriate pathology interpretation (data suggest variation in the interpretation of serrated lesions, some of which are associated with increased risk of CRC).
Second, existing measures fail to consider individual patient factors that are known to be predictive of screening benefit, such as life expectancy and personal or familial cancer risk.8
Returning to the Healthcare Effectiveness Data and Information Set measure as an example, this measure relies on age alone to identify patients who are candidates for screening. Yet, it is widely recognized that life expectancy is a critically important factor when considering screening, particularly in older patients. However, existing measures fail to incorporate estimates of life expectancy. As a result, clinicians are encouraged to screen based on age alone. Data suggest that this leads to overuse in older, sicker patients younger than age 75 (the age cutoff suggested by guidelines and incorporated into the Healthcare Effectiveness Data and Information Set measure) and underuse in healthy and unscreened patients older than age 75.9
Furthermore, existing measures fail to systematically consider patient preferences and undervalue shared decision making. Data suggest, for instance, that patients who are offered a “menu” of options for screening rather than a single screening test are more likely to complete a screening test.10
But existing measures do not consider whether a physician assessed a patient’s preferences, or offered more than one screening option. Of course, measuring the quality of decision making is an evolving science that presents challenges and requires creative solutions.11
Finally, existing measures do not capture the collaborative nature of modern health care. For example, most existing measures focus on the performance of gastroenterologists and GI practices. Although such a focus is appropriate for specialty-specific quality improvement efforts, it neglects to capture the important interactions and hand-offs between providers needed for successful completion of screening (and downstream reduction in cancer mortality). As a result, this specialty-focused approach fails to meet the needs of patients, who are increasingly interested in whether the care they receive is improving their health regardless of who provides it. It also fails to meet the needs of payers, who are interested in whether a network of providers is delivering high-value care for its members. Developing measures that capture the collaborative nature of modern health care becomes increasingly important as payers embrace alternative payment models and other value-based reimbursement systems.
Given these challenges with existing measures, we propose the following concepts for consideration as noncolonoscopy quality measures of CRC screening:
1. Appropriateness of referral for CRC screening (PCP): Measures in this domain should incorporate assessment of family history, prior screening history, and/or life expectancy, all of which are predictive of screening benefit and can be extracted from structured electronic health record data.
2. Shared decision making in choosing a CRC screening test (PCP): Currently, measures in this domain are (by necessity) relatively simple, such as assessment of documentation of whether stool testing was offered alongside colonoscopy during a clinic visit.
3. Percentage of individuals with a positive noncolonoscopy CRC screening test who complete a colonoscopy within 6 months (PCP and GI): A measure in this domain can be developed and implemented using existing infrastructure. The Veterans Affairs Healthcare System currently uses such a measure to monitor appropriate follow-up of positive fecal immunochemical tests.
4. Predicted reduction in CRC mortality: This measure, which provides an estimate of the effectiveness and value of a screening program, represents the “bottom line” that is ultimately of interest to both patients and payers. However, composite measures that use projected results require sophisticated statistical approaches and case-mix adjustment. They must also contend with “churn” in the covered population.
Although a more comprehensive view of screening is desirable, operationalizing measure concepts, such as those proposed previously, is challenging for several reasons. First, as we have outlined, CRC screening is truly a “team sport.” The stakeholders in CRC screening include public health, primary care, gastroenterology, colorectal surgery, oncology, anesthesiology, and pathology practitioners. As a result, screening has no natural and obvious steward. Rather, various components of care are adopted by different specialty groups, and this approach leads to unmonitored gaps in care. We believe that gastroenterologists can and should take the lead in developing comprehensive quality measures for CRC screening. Such comprehensive measures will be of value to patients and to payers. Second, assessing quality of care more comprehensively has traditionally been infeasible. For example, incorporating life expectancy into quality measures requires electronic assessment of health status.
Traditionally, such efforts have been hampered by the lack of systematic clinical data collection. However, as meaningful use of electronic health records increases, measures that incorporate such information are likely to become increasingly feasible. Finally, we also need to consider how to make these improvements while avoiding measure proliferation. Proliferation leads to provider fatigue and discourages thoughtful clinical decision making, potentially worsening quality of care. Creative approaches, such as rotating measure sets over time, use of clinical decision support tools, and balancing underuse measures with overuse measures, may be warranted. Additionally, composite measures may prove to be more meaningful and more practical for patients, providers, and payers. Ultimately, a distinction must be made between quality assurance and quality improvement; both are important, but the types of measures and the level of measure sophistication used in each program undoubtedly vary.
In summary, gastroenterologists are uniquely positioned to advocate for high-quality CRC screening that extends beyond simply providing a high-quality colonoscopy. This broader view of quality benefits patients by ensuring that our expertise informs the metrics by which delivery of CRC screening is measured. It also ensures that we hold ourselves and our colleagues to the highest standards across the continuum of care. Additionally, as alternative payment models and value-based contracting are implemented, nonendoscopic screening methods will likely become more commonplace. Advocating for high-quality nonendoscopic screening will help maintain gastroenterologists’ role as the stewards of CRC screening and digestive health. Although operationalizing measure concepts such as those proposed here may be difficult, it is critical if we are to provide the best possible care for our patients.
References
1. Sabatino, S.A., White, M.C., Thompson, T.D., et al. Cancer screening test use – United States, 2013. MMWR Morb Mortal Wkly Rep. 2015;64:464-8.
2. Anderson, A.E., Henry, K.A., Samadder, N.J., et al. Rural vs urban residence affects risk-appropriate colorectal cancer screening. Clin Gastroenterol Hepatol. 2013;11:526-33.
3. Walter, L.C., Lindquist, K., Nugent, S., et al. Impact of age and comorbidity on colorectal cancer screening among older veterans. Ann Intern Med. 2009;150:465-73.
4. Murphy, C.C., Sandler, R.S., Grubber, J.M., et al. Underuse and overuse of colonoscopy for repeat screening and surveillance in the Veterans Health Administration. Clin Gastroenterol Hepatol. 2016;14:436-44.
5. Mittal, S., Lin, Y.-L., Tan, A., et al. Limited life expectancy among a subgroup of Medicare beneficiaries receiving screening colonoscopies. Clin Gastroenterol Hepatol. 2014;12:443-50.e1
6. Allen, J.I. Quality measures for colonoscopy: where should we be in 2015?. Curr Gastroenterol Rep. 2015;17:10.
7. Fisher, D.A., Jeffreys, A., Coffman, C.J., et al. Barriers to full colon evaluation for a positive fecal occult blood test. Cancer Epidemiol Biomark Prev. 2006;15:1232-5.
8. Saini, S.D., van Hees, F., Vijan, S. Smarter screening for cancer: possibilities and challenges of personalization. JAMA. 2014;312:2211-2.
9. Saini, S.D., Vijan, S., Schoenfeld, P., et al. Role of quality measurement in inappropriate use of screening for colorectal cancer: retrospective cohort study. BMJ. 2014;348:g1247.
10. Inadomi, J.M., Vijan, S., Janz, N.K., et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172:575-82.
11. Writing Committee Members, Drozda, J.P., Ferguson, T.B., et al. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2016;67:558-87.
Dr. Saini is a research scientist at the VA Center for Clinical Management Research and an assistant professor of internal medicine at the University of Michigan, Ann Arbor; Dr. Adams is a clinical lecturer in the division of gastroenterology, department of internal medicine, University of Michigan, and a research investigator, VA Center for Clinical Management Research; Dr. Brill is the chief medical officer of Predictive Health, Paradise Valley, Ariz., and a clinical assistant professor of medicine, University of Arizona School of Medicine, Phoenix; Dr. Gupta is codirector of Digestive Health Center, director of interventional endoscopy, and associate professor of medicine in the division of gastroenterology at Loyola University Medical Center; Dr. Naveed is a clinical assistant professor in the department of gastroenterology and hepatology, University of Iowa Hospitals and Clinics; Dr. Rosenberg is at Illinois Gastroenterology Group; and Dr. Gellad is associate professor of medicine at Duke University School of Medicine, Durham, N.C. Dr. Saini’s and Dr. Gellad’s research is funded by Veterans Affairs Health Services Research and Development Career Development Awards (CDA 09-213-2 and CDA 14-158). Dr. Gupta has received research support from Cook Medical, Cosmo Pharmaceuticals, and CDx Diagnostics.
Medicine in the United States is undergoing fundamental changes that will continue despite 2016 presidential election results. Changes include consolidation of provider networks, movement from volume- to value-based reimbursement, demands for price and quality transparency, and a shift from focusing solely on individual physician-patient interactions to a broader triple aim focus that incorporates individual patients, population, health, and cost. In this month’s column, Sameer Saini and colleagues suggest that we broaden our view of colorectal cancer screening quality metrics from a colonoscopy-centric focus to a focus on the bottom line: Do we reduce cancer in the population of patients that we serve? When we extend our view to a population level, we use current colonoscopy registries only as internal process controls. A successful health system will develop a mechanism to assess and demonstrate how well the collective team of providers accomplishes the only outcome that matters to patients: preventing colon cancer.
John I. Allen, MD, MBA, AGAF, Special Section Editor
Colorectal cancer (CRC) screening is one of the most valuable services provided by gastroenterologists. The evidence that screening “works” on a population level is undeniable. But not every screening program is equally effective. Data indicate ongoing underuse of screening, particularly in high-risk, vulnerable, and minority communities.1,2 Other data indicate that screening is overused, particularly in low-risk patients and in those with limited life expectancy.3-5 It is also known that endoscopist skill plays an important role in the effectiveness of screening. In short, there is ample room for improvement in the quality of CRC screening, and payers and the public have taken notice. Unsurprisingly, gastroenterologists are often focused on procedural quality indicators, such as adenoma detection and cecal intubation rates.6 These endoscopic quality measures are important indicators of high-quality colonoscopy, but colonoscopy is the common touch point of a much broader system of care that includes other screening tests and other providers (e.g., primary care providers [PCPs], pathologists, and anesthesiologists). Coordinating care across this system is essential for improving the health of patients. As the stewards of digestive health, we owe it to our patients to take a more comprehensive view of CRC screening quality and move beyond colonoscopy alone.
The complex web of care that comprises CRC screening is shown schematically in Figure 1. Appropriate screening begins with selection of suitable screening candidates. In the United States, where most screening is initiated during a clinician encounter, this important task falls primarily on the shoulders of PCPs. It is typically the role of the PCP to assess the two key patient factors that determine screening benefit: CRC risk (using personal and family history) and life expectancy (using age and overall health status). Once a patient has been deemed an appropriate candidate for screening, an acceptable screening test must be selected. Here, patient and practitioner are faced with a menu of options, including fecal occult blood testing (FOBT), colonoscopy, multitarget stool DNA, and computed tomography colonography. For average-risk screening, the ideal test depends primarily on patient preference and local availability.
If a screening test other than colonoscopy is selected, it becomes critical that a positive test is followed by timely and high-quality colonoscopy. High-quality colonoscopy begins with evidence-based preprocedure education and preparation, including appropriate selection of anesthesia services. Once a patient has been well prepared and adequately sedated, an endoscopist must carefully examine the colonic mucosa and completely resect any suspicious polyps. Unless discarded, resected polyps must be reviewed and categorized by a pathologist, including appropriate identification of serrated polyps. Finally, pathology results must be correctly interpreted by the clinician, with evidence-based follow-up recommendations made and effectively communicated to the patient and the referring provider. Additionally, in the short term, delayed gastrointestinal (GI) and non-GI complications of colonoscopy must be recognized and appropriately addressed. In the long term, the rate of interval cancers must be monitored.
Recognizing the importance of CRC screening, GI specialty societies have proposed a variety of quality measures to ensure that patients receive high-quality and high-value colonoscopy. Several of these measures have been adopted by CMS as part of the Physician Quality Reporting System. Non-GI groups, such as the National Center for Quality Assurance and the Ambulatory Surgery Center Association, have also proposed their own CRC screening–related measures.
Despite the proliferation of measures in the domain of CRC screening, current measures fall short in several ways. First, they are largely focused on colonoscopy technical performance, with less attention paid to the important steps that occur before and after colonoscopy. For example, the existing Healthcare Effectiveness Data and Information Set measure for underuse of CRC screening assesses the proportion of patients in a health plan between the ages 50 and 75 who are up to date for CRC screening. This measure is satisfied if a patient completes FOBT, regardless of the result. But FOBT alone is not sufficient to reduce mortality from CRC. Rather, it is imperative that a positive FOBT test be followed by colonoscopy. Numerous studies suggest a quality gap in this critical referral step.7
Yet, outside of selected clinical settings (e.g., the Veterans Affairs Healthcare System), no existing quality measure focuses on colonoscopy completion after positive FOBT. Other examples of important performance gaps beyond colonoscopy technical performance include appropriate use of monitored anesthesia care (data suggest overuse) and appropriate pathology interpretation (data suggest variation in the interpretation of serrated lesions, some of which are associated with increased risk of CRC).
Second, existing measures fail to consider individual patient factors that are known to be predictive of screening benefit, such as life expectancy and personal or familial cancer risk.8
Returning to the Healthcare Effectiveness Data and Information Set measure as an example, this measure relies on age alone to identify patients who are candidates for screening. Yet, it is widely recognized that life expectancy is a critically important factor when considering screening, particularly in older patients. However, existing measures fail to incorporate estimates of life expectancy. As a result, clinicians are encouraged to screen based on age alone. Data suggest that this leads to overuse in older, sicker patients younger than age 75 (the age cutoff suggested by guidelines and incorporated into the Healthcare Effectiveness Data and Information Set measure) and underuse in healthy and unscreened patients older than age 75.9
Furthermore, existing measures fail to systematically consider patient preferences and undervalue shared decision making. Data suggest, for instance, that patients who are offered a “menu” of options for screening rather than a single screening test are more likely to complete a screening test.10
But existing measures do not consider whether a physician assessed a patient’s preferences, or offered more than one screening option. Of course, measuring the quality of decision making is an evolving science that presents challenges and requires creative solutions.11
Finally, existing measures do not capture the collaborative nature of modern health care. For example, most existing measures focus on the performance of gastroenterologists and GI practices. Although such a focus is appropriate for specialty-specific quality improvement efforts, it neglects to capture the important interactions and hand-offs between providers needed for successful completion of screening (and downstream reduction in cancer mortality). As a result, this specialty-focused approach fails to meet the needs of patients, who are increasingly interested in whether the care they receive is improving their health regardless of who provides it. It also fails to meet the needs of payers, who are interested in whether a network of providers is delivering high-value care for its members. Developing measures that capture the collaborative nature of modern health care becomes increasingly important as payers embrace alternative payment models and other value-based reimbursement systems.
Given these challenges with existing measures, we propose the following concepts for consideration as noncolonoscopy quality measures of CRC screening:
1. Appropriateness of referral for CRC screening (PCP): Measures in this domain should incorporate assessment of family history, prior screening history, and/or life expectancy, all of which are predictive of screening benefit and can be extracted from structured electronic health record data.
2. Shared decision making in choosing a CRC screening test (PCP): Currently, measures in this domain are (by necessity) relatively simple, such as assessment of documentation of whether stool testing was offered alongside colonoscopy during a clinic visit.
3. Percentage of individuals with a positive noncolonoscopy CRC screening test who complete a colonoscopy within 6 months (PCP and GI): A measure in this domain can be developed and implemented using existing infrastructure. The Veterans Affairs Healthcare System currently uses such a measure to monitor appropriate follow-up of positive fecal immunochemical tests.
4. Predicted reduction in CRC mortality: This measure, which provides an estimate of the effectiveness and value of a screening program, represents the “bottom line” that is ultimately of interest to both patients and payers. However, composite measures that use projected results require sophisticated statistical approaches and case-mix adjustment. They must also contend with “churn” in the covered population.
Although a more comprehensive view of screening is desirable, operationalizing measure concepts, such as those proposed previously, is challenging for several reasons. First, as we have outlined, CRC screening is truly a “team sport.” The stakeholders in CRC screening include public health, primary care, gastroenterology, colorectal surgery, oncology, anesthesiology, and pathology practitioners. As a result, screening has no natural and obvious steward. Rather, various components of care are adopted by different specialty groups, and this approach leads to unmonitored gaps in care. We believe that gastroenterologists can and should take the lead in developing comprehensive quality measures for CRC screening. Such comprehensive measures will be of value to patients and to payers. Second, assessing quality of care more comprehensively has traditionally been infeasible. For example, incorporating life expectancy into quality measures requires electronic assessment of health status.
Traditionally, such efforts have been hampered by the lack of systematic clinical data collection. However, as meaningful use of electronic health records increases, measures that incorporate such information are likely to become increasingly feasible. Finally, we also need to consider how to make these improvements while avoiding measure proliferation. Proliferation leads to provider fatigue and discourages thoughtful clinical decision making, potentially worsening quality of care. Creative approaches, such as rotating measure sets over time, use of clinical decision support tools, and balancing underuse measures with overuse measures, may be warranted. Additionally, composite measures may prove to be more meaningful and more practical for patients, providers, and payers. Ultimately, a distinction must be made between quality assurance and quality improvement; both are important, but the types of measures and the level of measure sophistication used in each program undoubtedly vary.
In summary, gastroenterologists are uniquely positioned to advocate for high-quality CRC screening that extends beyond simply providing a high-quality colonoscopy. This broader view of quality benefits patients by ensuring that our expertise informs the metrics by which delivery of CRC screening is measured. It also ensures that we hold ourselves and our colleagues to the highest standards across the continuum of care. Additionally, as alternative payment models and value-based contracting are implemented, nonendoscopic screening methods will likely become more commonplace. Advocating for high-quality nonendoscopic screening will help maintain gastroenterologists’ role as the stewards of CRC screening and digestive health. Although operationalizing measure concepts such as those proposed here may be difficult, it is critical if we are to provide the best possible care for our patients.
References
1. Sabatino, S.A., White, M.C., Thompson, T.D., et al. Cancer screening test use – United States, 2013. MMWR Morb Mortal Wkly Rep. 2015;64:464-8.
2. Anderson, A.E., Henry, K.A., Samadder, N.J., et al. Rural vs urban residence affects risk-appropriate colorectal cancer screening. Clin Gastroenterol Hepatol. 2013;11:526-33.
3. Walter, L.C., Lindquist, K., Nugent, S., et al. Impact of age and comorbidity on colorectal cancer screening among older veterans. Ann Intern Med. 2009;150:465-73.
4. Murphy, C.C., Sandler, R.S., Grubber, J.M., et al. Underuse and overuse of colonoscopy for repeat screening and surveillance in the Veterans Health Administration. Clin Gastroenterol Hepatol. 2016;14:436-44.
5. Mittal, S., Lin, Y.-L., Tan, A., et al. Limited life expectancy among a subgroup of Medicare beneficiaries receiving screening colonoscopies. Clin Gastroenterol Hepatol. 2014;12:443-50.e1
6. Allen, J.I. Quality measures for colonoscopy: where should we be in 2015?. Curr Gastroenterol Rep. 2015;17:10.
7. Fisher, D.A., Jeffreys, A., Coffman, C.J., et al. Barriers to full colon evaluation for a positive fecal occult blood test. Cancer Epidemiol Biomark Prev. 2006;15:1232-5.
8. Saini, S.D., van Hees, F., Vijan, S. Smarter screening for cancer: possibilities and challenges of personalization. JAMA. 2014;312:2211-2.
9. Saini, S.D., Vijan, S., Schoenfeld, P., et al. Role of quality measurement in inappropriate use of screening for colorectal cancer: retrospective cohort study. BMJ. 2014;348:g1247.
10. Inadomi, J.M., Vijan, S., Janz, N.K., et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172:575-82.
11. Writing Committee Members, Drozda, J.P., Ferguson, T.B., et al. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2016;67:558-87.
Dr. Saini is a research scientist at the VA Center for Clinical Management Research and an assistant professor of internal medicine at the University of Michigan, Ann Arbor; Dr. Adams is a clinical lecturer in the division of gastroenterology, department of internal medicine, University of Michigan, and a research investigator, VA Center for Clinical Management Research; Dr. Brill is the chief medical officer of Predictive Health, Paradise Valley, Ariz., and a clinical assistant professor of medicine, University of Arizona School of Medicine, Phoenix; Dr. Gupta is codirector of Digestive Health Center, director of interventional endoscopy, and associate professor of medicine in the division of gastroenterology at Loyola University Medical Center; Dr. Naveed is a clinical assistant professor in the department of gastroenterology and hepatology, University of Iowa Hospitals and Clinics; Dr. Rosenberg is at Illinois Gastroenterology Group; and Dr. Gellad is associate professor of medicine at Duke University School of Medicine, Durham, N.C. Dr. Saini’s and Dr. Gellad’s research is funded by Veterans Affairs Health Services Research and Development Career Development Awards (CDA 09-213-2 and CDA 14-158). Dr. Gupta has received research support from Cook Medical, Cosmo Pharmaceuticals, and CDx Diagnostics.
Medicine in the United States is undergoing fundamental changes that will continue despite 2016 presidential election results. Changes include consolidation of provider networks, movement from volume- to value-based reimbursement, demands for price and quality transparency, and a shift from focusing solely on individual physician-patient interactions to a broader triple aim focus that incorporates individual patients, population, health, and cost. In this month’s column, Sameer Saini and colleagues suggest that we broaden our view of colorectal cancer screening quality metrics from a colonoscopy-centric focus to a focus on the bottom line: Do we reduce cancer in the population of patients that we serve? When we extend our view to a population level, we use current colonoscopy registries only as internal process controls. A successful health system will develop a mechanism to assess and demonstrate how well the collective team of providers accomplishes the only outcome that matters to patients: preventing colon cancer.
John I. Allen, MD, MBA, AGAF, Special Section Editor
Colorectal cancer (CRC) screening is one of the most valuable services provided by gastroenterologists. The evidence that screening “works” on a population level is undeniable. But not every screening program is equally effective. Data indicate ongoing underuse of screening, particularly in high-risk, vulnerable, and minority communities.1,2 Other data indicate that screening is overused, particularly in low-risk patients and in those with limited life expectancy.3-5 It is also known that endoscopist skill plays an important role in the effectiveness of screening. In short, there is ample room for improvement in the quality of CRC screening, and payers and the public have taken notice. Unsurprisingly, gastroenterologists are often focused on procedural quality indicators, such as adenoma detection and cecal intubation rates.6 These endoscopic quality measures are important indicators of high-quality colonoscopy, but colonoscopy is the common touch point of a much broader system of care that includes other screening tests and other providers (e.g., primary care providers [PCPs], pathologists, and anesthesiologists). Coordinating care across this system is essential for improving the health of patients. As the stewards of digestive health, we owe it to our patients to take a more comprehensive view of CRC screening quality and move beyond colonoscopy alone.
The complex web of care that comprises CRC screening is shown schematically in Figure 1. Appropriate screening begins with selection of suitable screening candidates. In the United States, where most screening is initiated during a clinician encounter, this important task falls primarily on the shoulders of PCPs. It is typically the role of the PCP to assess the two key patient factors that determine screening benefit: CRC risk (using personal and family history) and life expectancy (using age and overall health status). Once a patient has been deemed an appropriate candidate for screening, an acceptable screening test must be selected. Here, patient and practitioner are faced with a menu of options, including fecal occult blood testing (FOBT), colonoscopy, multitarget stool DNA, and computed tomography colonography. For average-risk screening, the ideal test depends primarily on patient preference and local availability.
If a screening test other than colonoscopy is selected, it becomes critical that a positive test is followed by timely and high-quality colonoscopy. High-quality colonoscopy begins with evidence-based preprocedure education and preparation, including appropriate selection of anesthesia services. Once a patient has been well prepared and adequately sedated, an endoscopist must carefully examine the colonic mucosa and completely resect any suspicious polyps. Unless discarded, resected polyps must be reviewed and categorized by a pathologist, including appropriate identification of serrated polyps. Finally, pathology results must be correctly interpreted by the clinician, with evidence-based follow-up recommendations made and effectively communicated to the patient and the referring provider. Additionally, in the short term, delayed gastrointestinal (GI) and non-GI complications of colonoscopy must be recognized and appropriately addressed. In the long term, the rate of interval cancers must be monitored.
Recognizing the importance of CRC screening, GI specialty societies have proposed a variety of quality measures to ensure that patients receive high-quality and high-value colonoscopy. Several of these measures have been adopted by CMS as part of the Physician Quality Reporting System. Non-GI groups, such as the National Center for Quality Assurance and the Ambulatory Surgery Center Association, have also proposed their own CRC screening–related measures.
Despite the proliferation of measures in the domain of CRC screening, current measures fall short in several ways. First, they are largely focused on colonoscopy technical performance, with less attention paid to the important steps that occur before and after colonoscopy. For example, the existing Healthcare Effectiveness Data and Information Set measure for underuse of CRC screening assesses the proportion of patients in a health plan between the ages 50 and 75 who are up to date for CRC screening. This measure is satisfied if a patient completes FOBT, regardless of the result. But FOBT alone is not sufficient to reduce mortality from CRC. Rather, it is imperative that a positive FOBT test be followed by colonoscopy. Numerous studies suggest a quality gap in this critical referral step.7
Yet, outside of selected clinical settings (e.g., the Veterans Affairs Healthcare System), no existing quality measure focuses on colonoscopy completion after positive FOBT. Other examples of important performance gaps beyond colonoscopy technical performance include appropriate use of monitored anesthesia care (data suggest overuse) and appropriate pathology interpretation (data suggest variation in the interpretation of serrated lesions, some of which are associated with increased risk of CRC).
Second, existing measures fail to consider individual patient factors that are known to be predictive of screening benefit, such as life expectancy and personal or familial cancer risk.8
Returning to the Healthcare Effectiveness Data and Information Set measure as an example, this measure relies on age alone to identify patients who are candidates for screening. Yet, it is widely recognized that life expectancy is a critically important factor when considering screening, particularly in older patients. However, existing measures fail to incorporate estimates of life expectancy. As a result, clinicians are encouraged to screen based on age alone. Data suggest that this leads to overuse in older, sicker patients younger than age 75 (the age cutoff suggested by guidelines and incorporated into the Healthcare Effectiveness Data and Information Set measure) and underuse in healthy and unscreened patients older than age 75.9
Furthermore, existing measures fail to systematically consider patient preferences and undervalue shared decision making. Data suggest, for instance, that patients who are offered a “menu” of options for screening rather than a single screening test are more likely to complete a screening test.10
But existing measures do not consider whether a physician assessed a patient’s preferences, or offered more than one screening option. Of course, measuring the quality of decision making is an evolving science that presents challenges and requires creative solutions.11
Finally, existing measures do not capture the collaborative nature of modern health care. For example, most existing measures focus on the performance of gastroenterologists and GI practices. Although such a focus is appropriate for specialty-specific quality improvement efforts, it neglects to capture the important interactions and hand-offs between providers needed for successful completion of screening (and downstream reduction in cancer mortality). As a result, this specialty-focused approach fails to meet the needs of patients, who are increasingly interested in whether the care they receive is improving their health regardless of who provides it. It also fails to meet the needs of payers, who are interested in whether a network of providers is delivering high-value care for its members. Developing measures that capture the collaborative nature of modern health care becomes increasingly important as payers embrace alternative payment models and other value-based reimbursement systems.
Given these challenges with existing measures, we propose the following concepts for consideration as noncolonoscopy quality measures of CRC screening:
1. Appropriateness of referral for CRC screening (PCP): Measures in this domain should incorporate assessment of family history, prior screening history, and/or life expectancy, all of which are predictive of screening benefit and can be extracted from structured electronic health record data.
2. Shared decision making in choosing a CRC screening test (PCP): Currently, measures in this domain are (by necessity) relatively simple, such as assessment of documentation of whether stool testing was offered alongside colonoscopy during a clinic visit.
3. Percentage of individuals with a positive noncolonoscopy CRC screening test who complete a colonoscopy within 6 months (PCP and GI): A measure in this domain can be developed and implemented using existing infrastructure. The Veterans Affairs Healthcare System currently uses such a measure to monitor appropriate follow-up of positive fecal immunochemical tests.
4. Predicted reduction in CRC mortality: This measure, which provides an estimate of the effectiveness and value of a screening program, represents the “bottom line” that is ultimately of interest to both patients and payers. However, composite measures that use projected results require sophisticated statistical approaches and case-mix adjustment. They must also contend with “churn” in the covered population.
Although a more comprehensive view of screening is desirable, operationalizing measure concepts, such as those proposed previously, is challenging for several reasons. First, as we have outlined, CRC screening is truly a “team sport.” The stakeholders in CRC screening include public health, primary care, gastroenterology, colorectal surgery, oncology, anesthesiology, and pathology practitioners. As a result, screening has no natural and obvious steward. Rather, various components of care are adopted by different specialty groups, and this approach leads to unmonitored gaps in care. We believe that gastroenterologists can and should take the lead in developing comprehensive quality measures for CRC screening. Such comprehensive measures will be of value to patients and to payers. Second, assessing quality of care more comprehensively has traditionally been infeasible. For example, incorporating life expectancy into quality measures requires electronic assessment of health status.
Traditionally, such efforts have been hampered by the lack of systematic clinical data collection. However, as meaningful use of electronic health records increases, measures that incorporate such information are likely to become increasingly feasible. Finally, we also need to consider how to make these improvements while avoiding measure proliferation. Proliferation leads to provider fatigue and discourages thoughtful clinical decision making, potentially worsening quality of care. Creative approaches, such as rotating measure sets over time, use of clinical decision support tools, and balancing underuse measures with overuse measures, may be warranted. Additionally, composite measures may prove to be more meaningful and more practical for patients, providers, and payers. Ultimately, a distinction must be made between quality assurance and quality improvement; both are important, but the types of measures and the level of measure sophistication used in each program undoubtedly vary.
In summary, gastroenterologists are uniquely positioned to advocate for high-quality CRC screening that extends beyond simply providing a high-quality colonoscopy. This broader view of quality benefits patients by ensuring that our expertise informs the metrics by which delivery of CRC screening is measured. It also ensures that we hold ourselves and our colleagues to the highest standards across the continuum of care. Additionally, as alternative payment models and value-based contracting are implemented, nonendoscopic screening methods will likely become more commonplace. Advocating for high-quality nonendoscopic screening will help maintain gastroenterologists’ role as the stewards of CRC screening and digestive health. Although operationalizing measure concepts such as those proposed here may be difficult, it is critical if we are to provide the best possible care for our patients.
References
1. Sabatino, S.A., White, M.C., Thompson, T.D., et al. Cancer screening test use – United States, 2013. MMWR Morb Mortal Wkly Rep. 2015;64:464-8.
2. Anderson, A.E., Henry, K.A., Samadder, N.J., et al. Rural vs urban residence affects risk-appropriate colorectal cancer screening. Clin Gastroenterol Hepatol. 2013;11:526-33.
3. Walter, L.C., Lindquist, K., Nugent, S., et al. Impact of age and comorbidity on colorectal cancer screening among older veterans. Ann Intern Med. 2009;150:465-73.
4. Murphy, C.C., Sandler, R.S., Grubber, J.M., et al. Underuse and overuse of colonoscopy for repeat screening and surveillance in the Veterans Health Administration. Clin Gastroenterol Hepatol. 2016;14:436-44.
5. Mittal, S., Lin, Y.-L., Tan, A., et al. Limited life expectancy among a subgroup of Medicare beneficiaries receiving screening colonoscopies. Clin Gastroenterol Hepatol. 2014;12:443-50.e1
6. Allen, J.I. Quality measures for colonoscopy: where should we be in 2015?. Curr Gastroenterol Rep. 2015;17:10.
7. Fisher, D.A., Jeffreys, A., Coffman, C.J., et al. Barriers to full colon evaluation for a positive fecal occult blood test. Cancer Epidemiol Biomark Prev. 2006;15:1232-5.
8. Saini, S.D., van Hees, F., Vijan, S. Smarter screening for cancer: possibilities and challenges of personalization. JAMA. 2014;312:2211-2.
9. Saini, S.D., Vijan, S., Schoenfeld, P., et al. Role of quality measurement in inappropriate use of screening for colorectal cancer: retrospective cohort study. BMJ. 2014;348:g1247.
10. Inadomi, J.M., Vijan, S., Janz, N.K., et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172:575-82.
11. Writing Committee Members, Drozda, J.P., Ferguson, T.B., et al. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2016;67:558-87.
Dr. Saini is a research scientist at the VA Center for Clinical Management Research and an assistant professor of internal medicine at the University of Michigan, Ann Arbor; Dr. Adams is a clinical lecturer in the division of gastroenterology, department of internal medicine, University of Michigan, and a research investigator, VA Center for Clinical Management Research; Dr. Brill is the chief medical officer of Predictive Health, Paradise Valley, Ariz., and a clinical assistant professor of medicine, University of Arizona School of Medicine, Phoenix; Dr. Gupta is codirector of Digestive Health Center, director of interventional endoscopy, and associate professor of medicine in the division of gastroenterology at Loyola University Medical Center; Dr. Naveed is a clinical assistant professor in the department of gastroenterology and hepatology, University of Iowa Hospitals and Clinics; Dr. Rosenberg is at Illinois Gastroenterology Group; and Dr. Gellad is associate professor of medicine at Duke University School of Medicine, Durham, N.C. Dr. Saini’s and Dr. Gellad’s research is funded by Veterans Affairs Health Services Research and Development Career Development Awards (CDA 09-213-2 and CDA 14-158). Dr. Gupta has received research support from Cook Medical, Cosmo Pharmaceuticals, and CDx Diagnostics.
Reaching safe harbor – legal implications of clinical practice guidelines
As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.
John I. Allen, M.D., MBA, AGAF, Special Section Editor
The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.
Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.2 However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.
Case
A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.
Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,3 the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?
Discussion
With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.
A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”4 To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.
In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”5 This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”5
There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”5 Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.6 However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,7 which runs counter to the standardized approach typically espoused by guidelines.
A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.8 This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.
So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.9 The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.
Conclusions
Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.
Disclaimer
The clinical scenario featured in this article is a hypothetical one, used to illustrate the type of clinical dilemmas gastroenterologists may face in daily practice with respect to clinical practice guidelines. Furthermore, the earlier discussion is intended as general commentary, and does not constitute legal advice in individual cases. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.
References
1. Institute of Medicine. Clinical practice guidelines we can trust. National Academies Press, Washington, D.C.; 2011.
2. Yapali, S., Talaat, N., Lok, A.S. Management of hepatitis B: our practice and how it relates to the guidelines. Clin Gastroenterol Hepatol. 2014;12:16-26.
3. ASGE Standards of Practice Committee. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73:1085-91.
4. Restatement (Second) of torts: liability for physical & emotional harm § 283 (1965). Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Pa. L. Rev. 645 2000-2001.
6. Ransohoff, D.F., Pignone, M., Sox, H.C. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139-40.
7. Ubel, P.A. Medical facts versus value judgments – toward preference-sensitive guidelines. N Engl J Med. 2015;26:2475-6.
8. Kachalia, A., Little, A., Isavoran, M., et al. Greatest impact of safe harbor rules may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff (Millwood). 2014;33:59-66.
9. Rex, D.K. Avoiding and defending malpractice suits for postcolonoscopy cancer: advice from an expert witness. Clin Gastroenterol Hepatol. 2013;11:768-73.
Dr. Oza is in the division of gastroenterology and liver diseases, Yale New Haven Medical Center, New Haven, Conn; Dr. El-Dika is in the division of gastroenterology, hepatology and nutrition, Ohio State University–Wexner Medical Center, Columbus; Dr. Adams is in the division of gastroenterology, department of medicine, University of Michigan Medical School, and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.
As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.
John I. Allen, M.D., MBA, AGAF, Special Section Editor
The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.
Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.2 However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.
Case
A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.
Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,3 the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?
Discussion
With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.
A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”4 To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.
In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”5 This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”5
There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”5 Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.6 However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,7 which runs counter to the standardized approach typically espoused by guidelines.
A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.8 This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.
So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.9 The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.
Conclusions
Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.
Disclaimer
The clinical scenario featured in this article is a hypothetical one, used to illustrate the type of clinical dilemmas gastroenterologists may face in daily practice with respect to clinical practice guidelines. Furthermore, the earlier discussion is intended as general commentary, and does not constitute legal advice in individual cases. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.
References
1. Institute of Medicine. Clinical practice guidelines we can trust. National Academies Press, Washington, D.C.; 2011.
2. Yapali, S., Talaat, N., Lok, A.S. Management of hepatitis B: our practice and how it relates to the guidelines. Clin Gastroenterol Hepatol. 2014;12:16-26.
3. ASGE Standards of Practice Committee. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73:1085-91.
4. Restatement (Second) of torts: liability for physical & emotional harm § 283 (1965). Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Pa. L. Rev. 645 2000-2001.
6. Ransohoff, D.F., Pignone, M., Sox, H.C. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139-40.
7. Ubel, P.A. Medical facts versus value judgments – toward preference-sensitive guidelines. N Engl J Med. 2015;26:2475-6.
8. Kachalia, A., Little, A., Isavoran, M., et al. Greatest impact of safe harbor rules may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff (Millwood). 2014;33:59-66.
9. Rex, D.K. Avoiding and defending malpractice suits for postcolonoscopy cancer: advice from an expert witness. Clin Gastroenterol Hepatol. 2013;11:768-73.
Dr. Oza is in the division of gastroenterology and liver diseases, Yale New Haven Medical Center, New Haven, Conn; Dr. El-Dika is in the division of gastroenterology, hepatology and nutrition, Ohio State University–Wexner Medical Center, Columbus; Dr. Adams is in the division of gastroenterology, department of medicine, University of Michigan Medical School, and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.
As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.
John I. Allen, M.D., MBA, AGAF, Special Section Editor
The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.
Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.2 However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.
Case
A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.
Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,3 the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?
Discussion
With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.
A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”4 To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.
In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”5 This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”5
There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”5 Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.6 However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,7 which runs counter to the standardized approach typically espoused by guidelines.
A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.8 This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.
So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.9 The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.
Conclusions
Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.
Disclaimer
The clinical scenario featured in this article is a hypothetical one, used to illustrate the type of clinical dilemmas gastroenterologists may face in daily practice with respect to clinical practice guidelines. Furthermore, the earlier discussion is intended as general commentary, and does not constitute legal advice in individual cases. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.
References
1. Institute of Medicine. Clinical practice guidelines we can trust. National Academies Press, Washington, D.C.; 2011.
2. Yapali, S., Talaat, N., Lok, A.S. Management of hepatitis B: our practice and how it relates to the guidelines. Clin Gastroenterol Hepatol. 2014;12:16-26.
3. ASGE Standards of Practice Committee. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73:1085-91.
4. Restatement (Second) of torts: liability for physical & emotional harm § 283 (1965). Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Pa. L. Rev. 645 2000-2001.
6. Ransohoff, D.F., Pignone, M., Sox, H.C. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139-40.
7. Ubel, P.A. Medical facts versus value judgments – toward preference-sensitive guidelines. N Engl J Med. 2015;26:2475-6.
8. Kachalia, A., Little, A., Isavoran, M., et al. Greatest impact of safe harbor rules may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff (Millwood). 2014;33:59-66.
9. Rex, D.K. Avoiding and defending malpractice suits for postcolonoscopy cancer: advice from an expert witness. Clin Gastroenterol Hepatol. 2013;11:768-73.
Dr. Oza is in the division of gastroenterology and liver diseases, Yale New Haven Medical Center, New Haven, Conn; Dr. El-Dika is in the division of gastroenterology, hepatology and nutrition, Ohio State University–Wexner Medical Center, Columbus; Dr. Adams is in the division of gastroenterology, department of medicine, University of Michigan Medical School, and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.
