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How Good Is Your Dentist? How Good Is Your Endoscopist? The Quality Imperative
Comment From the Editor How Good Is Your Dentist? How Good Is Your Endoscopist? The Quality Imperative
R
ecently, I polled my GI friends to determine how they selected their dentist, and whether their dentist practiced “high-quality” dentistry. Most had received recommendations from friends, and selected a dentist based on convenience of location. I asked if they were happy with their dentist, and if the dentist was “above average,” “average,” or “below average” in terms of dental skills and expertise. Every dentist who takes care of my friends and colleagues is “above average.” Apparently, dentistry is like Lake Wobegon, where “all of the children are above average.” Then, I asked, “How do you know if your dentist is above average?” Did the dentist use low-dose digital imaging to reduce radiation; monitor and report rates of infection; report the frequency of repeat fillings or crowns, root-canal experience, overall rates of complications, instrument sterilization, and more? Not one of my quality-conscious friends had considered these elements when selecting their dentist. If they had asked about these quality metrics, I suspect that most dentists would not be prepared with the answers. In gastroenterology, we have a similar problem: How do we know if we or our colleagues are delivering high-quality care? Several years ago, I realized that I could find out more about the contractor who works on my house than I could about the doctor who performs my colonoscopy. As we approach a healthcare world where “accountability” and “quality” are buzz words, this will no longer be acceptable. GASTROENTEROLOGY 2012;142:194 –196
Payers and patients will expect us to have data about the quality of our practice. In this commentary, I will use the example of colonoscopy to discuss issues surrounding key quality end points and the use of surrogate quality indicators. These issues apply to all aspects of our specialty. Colonoscopy is the most common endoscopic procedure performed in the United States,1,2 and provides an instructive model for considering quality. The procedure is now used for primary screening, surveillance and evaluation of symptoms. Screening and surveillance account for ⬎60% of colonoscopy procedures. Table 1 highlights quality indicators which have been identified by expert panels3,4; efforts to measure some of these indicators in clinical practice are underway.5–7 Ideally, quality indicators should be linked to key outcomes of importance. There is evidence that rates of cecal intubation8 and adenoma or polyp detection rates8,9 are associated with specific rates of interval colorectal cancer (CRC), and many experts have advocated incorporating these measures into routine practice. Measuring quality should be aimed toward improving important outcomes and avoiding unintended consequences, which could include “gaming the system” or causing harms.10 For example, if cecal intubation is a requirement for reimbursement, endoscopists may be overly vigorous in attempts to reach the cecum, which could harm patients. If polyp or adenoma detection rates are used, removal of every possible small polyp could be associated with some increase in procedural risk. Therefore, the adoption of any “standard” measure should be followed by rigorous efforts to determine whether there are unintended harms.
Surrogate end points of quality should not replace the need to measure important end points. When it comes to screening and surveillance with colonoscopy, 2 outcomes are particularly important: rates of interval CRC and adverse events. Any calculation of risk and benefit must account for these outcomes, and any measurement of quality should be linked directly or indirectly with these events.
Interval CRC Interval CRC risk has been measured in two different ways based on available literature.11 Patients who had colonoscopy with detection and removal of adenomas are usually enrolled in surveillance programs, stratified by risk. In large chemoprevention studies, patients were randomly assigned to an intervention (diet, calcium, aspirin) or placebo, and had follow-up colonoscopy within 3 years of baseline. The risk of developing CRC within 3 years after baseline colonoscopy is 0.3%– 0.9% or 1.7–2.8 per 1000 person-years of follow-up. A second method of analysis is to determine how many patients with CRC had a prior colonoscopy within 3 years of diagnosis. This methodology does not provide a rate of interval cancer per colonoscopy, but does provide insight into how many patients who develop cancer had a recent examination. Using cancer registries, and looking back at claims data, investigators find that 2%–9% of patients in cancer registries had colonoscopy within 3 years. Causes of interval cancer include missed lesions and incompletely removed lesions, which may be related to quality. New, fast-growing lesions (related to biology) may account for a small proportion of interval lesions. There is no question that interval CRC is an undesirable outcome after colonoscopy. We currently have
Comment From the Editor, continued Table 1. Quality Indicators for Colonoscopy Screening and Surveillance3,4 Colonoscopy quality indicator by type Documentation
Performance
Follow-up/communication
Key outcomes
Examples Patient demographics; preprocedure assessment of risk; documentation of prior exam and interval; technical description of the procedure; description of colonoscopic findings and management; recording of unplanned events and interventions; follow-up plan Cecal intubation with documentation Adenoma or polyp detection rate Immediate unplanned events or interventions Appropriate documentation of pathology Recommended follow-up interval consistent with evidence-based guidelines or rationale for deviation from guideline Communication to primary provider and patient Interval colorectal cancer Adverse events
no system in the United States for measuring this important outcome. Canadian studies have demonstrated the feasibility of using a province-wide cancer registry, to look back to determine if patients had a prior colonoscopy.12 If we are serious about measuring quality, then our specialty needs to develop methodology to capture this vital measure.
Adverse Events Adverse events that occur during endoscopic procedures are regularly captured at the time of colonoscopy. However, we now have studies showing that the rate of immediate events underestimates the true rate of adverse events which occur within 30 days of the procedure.13,14 In 1 study of patients receiving screening or surveillance colonoscopy, bleeding was reported at the time of procedure in 0.6 per 1000 examinations, whereas the 30-day rate of bleeding which required hospitalization was 1.53/ 1000 examinations.15 It is likely that many delayed events are not necessarily linked to the endoscopic report, and thus not attributed to the procedure. If patients go to other healthcare facilities to deal with a complication, the endoscopist may not be aware of the event. Developing systems which enable
follow-up of patients after procedures to capture delayed events will provide a more accurate reflection of risk.
Other Surrogate Indicators of Colonoscopy Quality One of the most obvious deficiencies in colonoscopy quality surrounds the use of surveillance. We have evidence from physician surveys and from a large study of practice behavior in the PLCO (Prostate, Lung, Colorectal and Ovarian cancer) study15 demonstrating both under- and overutilization of colonoscopy during surveillance. This study found that 25%–50% of patients with no polyps or low-risk polyps were receiving surveillance at shorter than recommended intervals. Although some early colonoscopy might be justified owing to inadequate baseline examinations, this pattern of overutilization in low-risk individuals exposes patients to unnecessary risks and costs. Overutilization of procedures and tests in medicine has been recognized as an important driver of health cost by President Obama and others,16 and there will undoubtedly be efforts to reduce cost by narrowing utilization to comply with evidence-based guidelines.
What About Quality in the Nonendoscopic Practice of Gastroenterology and Hepatology? The principles we apply to assessing quality of endoscopic practice should apply to our nonendoscopic practice. We should examine our processes of care and first ask: What are the most important outcomes? If I am managing a patient with cirrhosis, the important end points might be prevention of variceal bleeding, identification of early, treatable hepatocellular carcinoma, and timely transplantation if appropriate. If I am managing a patient with Crohn’s disease, key indicators might be achieving clinical and endoscopic remission, avoiding treatment-related complications, rates of surgery, and disease complications. If I am managing reflux disease, the end points might be development of stricture or Barrett’s esophagus, as well as quality of life. To be meaningful, indicators must be linked with important outcomes.
Conclusion Measuring quality is a process that should begin by considering the most important outcomes. At the provider level, we need to adopt surrogate end points that are closely linked with these outcomes. To do otherwise diverts energy and resources to processes that may not improve patient care. Ultimately, we need to develop national registries to track key outcomes such as interval CRC and 30-day adverse events. This is a challenge for every specialty in medicine; we can no longer assume we are practicing high-quality medicine without measuring it. What will you say when your patient asks: “Doctor, are you measuring quality in your practice, and if so, are you meeting acceptable benchmarks?” DAVID LIEBERMAN Associate Editor Division of Gastroenterology and Hepatology 195
Comment From the Editor, continued Oregon Health and Science University Portland, Oregon 6.
References 1. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part II: lower gastrointestinal diseases. Gastroenterology 2009;136:741–754. 2. Seeff LC, Richards TB, Shapiro JA, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC’s survey of endoscopic capacity. Gastroenterology 2005;127:1670 – 1677. 3. Rex DK, Petrini JL, Baron TH, et al. Quality indicators for colonoscopy. Am J Gastroenterol 2006;101:873– 885. 4. Lieberman D, Nadel M, Smith R, et al. Standardized colonoscopy reporting and data system (CO-RADS): report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Gastrointest Endosc 2007;65:757–766. 5. Lieberman DA, Faigel DO, Logan J, et al. Assessment of colonoscopy quality: re-
196
7.
8.
9.
10.
sults from a multi-center consortium. Gastrointest Endosc 2009;69:645– 653. Barclay RL, Vicari JJ, Doughty AS, et al. Adenoma detection rates and colonoscopic withdrawal times during screening colonoscopy. N Engl J Med 2006; 355:2533–2541. Shaukat A, Oancea C, Bond JH, et al. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol 2009;7:1335–1340. Baxter NN, Sutrahar R, Forbes SS, et al. Analysis of administrative data finds endoscopist quality measures associated with post-colonoscopy colorectal cancer. Gastroenterology 2011;140:65–72. Kaminski MF, Regula J, Kraszewska E, et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010;362:1795–1803. Chassin MR, Loeb JM, Schmaltz SP, et al. Accountability measure: using measurement to promote quality improvement. N Engl J Med 2010;363:683– 688.
11. Lieberman D. Progress and challenges in colorectal cancer screening and surveillance. Gastroenterology 2010;138: 2115–2126. 12. Singh H, Nugent Z, Demers AA, et al. Rate and predictors of early/missed colorectal cancers after colonoscopy in Manitoba: a population-based study. Am J Gastroenterol 105;2588 –2596. 13. Ko CW, Riffle S, Michaels L, et al. Serious complications within 30 days of screening and surveillance colonoscopy: a multicenter study. Clin Gastroenterol Hepatol 2010;8:166 –173. 14. Warren JL, Klabunde CN, Mariotto AB, et al. Adverse events after outpatient colonoscopy in the Medicare population. Ann Intern Med 2009;150:849 – 857. 15. Schoen RE, Pinsky PF, Weissfeld JL, et al. Utilization of surveillance colonoscopy in community practice. Gastroenterology 2010;138:73–78. 16. Gawande A. The cost conundrum. New Yorker, June 1, 2009; 36 – 44.
doi:10.1053/j.gastro.2011.12.016
R
ecently, I polled my GI friends to determine how they selected their dentist, and whether their dentist practiced “high-quality” dentistry. Most had received recommendations from friends, and selected a dentist based on convenience of location. I asked if they were happy with their dentist, and if the dentist was “above average,” “average,” or “below average” in terms of dental skills and expertise. Every dentist who takes care of my friends and colleagues is “above average.” Apparently, dentistry is like Lake Wobegon, where “all of the children are above average.” Then, I asked, “How do you know if your dentist is above average?” Did the dentist use low-dose digital imaging to reduce radiation; monitor and report rates of infection; report the frequency of repeat fillings or crowns, root-canal experience, overall rates of complications, instrument sterilization, and more? Not one of my quality-conscious friends had considered these elements when selecting their dentist. If they had asked about these quality metrics, I suspect that most dentists would not be prepared with the answers. In gastroenterology, we have a similar problem: How do we know if we or our colleagues are delivering high-quality care? Several years ago, I realized that I could find out more about the contractor who works on my house than I could about the doctor who performs my colonoscopy. As we approach a healthcare world where “accountability” and “quality” are buzz words, this will no longer be acceptable. GASTROENTEROLOGY 2012;142:194 –196
Payers and patients will expect us to have data about the quality of our practice. In this commentary, I will use the example of colonoscopy to discuss issues surrounding key quality end points and the use of surrogate quality indicators. These issues apply to all aspects of our specialty. Colonoscopy is the most common endoscopic procedure performed in the United States,1,2 and provides an instructive model for considering quality. The procedure is now used for primary screening, surveillance and evaluation of symptoms. Screening and surveillance account for ⬎60% of colonoscopy procedures. Table 1 highlights quality indicators which have been identified by expert panels3,4; efforts to measure some of these indicators in clinical practice are underway.5–7 Ideally, quality indicators should be linked to key outcomes of importance. There is evidence that rates of cecal intubation8 and adenoma or polyp detection rates8,9 are associated with specific rates of interval colorectal cancer (CRC), and many experts have advocated incorporating these measures into routine practice. Measuring quality should be aimed toward improving important outcomes and avoiding unintended consequences, which could include “gaming the system” or causing harms.10 For example, if cecal intubation is a requirement for reimbursement, endoscopists may be overly vigorous in attempts to reach the cecum, which could harm patients. If polyp or adenoma detection rates are used, removal of every possible small polyp could be associated with some increase in procedural risk. Therefore, the adoption of any “standard” measure should be followed by rigorous efforts to determine whether there are unintended harms.
Surrogate end points of quality should not replace the need to measure important end points. When it comes to screening and surveillance with colonoscopy, 2 outcomes are particularly important: rates of interval CRC and adverse events. Any calculation of risk and benefit must account for these outcomes, and any measurement of quality should be linked directly or indirectly with these events.
Interval CRC Interval CRC risk has been measured in two different ways based on available literature.11 Patients who had colonoscopy with detection and removal of adenomas are usually enrolled in surveillance programs, stratified by risk. In large chemoprevention studies, patients were randomly assigned to an intervention (diet, calcium, aspirin) or placebo, and had follow-up colonoscopy within 3 years of baseline. The risk of developing CRC within 3 years after baseline colonoscopy is 0.3%– 0.9% or 1.7–2.8 per 1000 person-years of follow-up. A second method of analysis is to determine how many patients with CRC had a prior colonoscopy within 3 years of diagnosis. This methodology does not provide a rate of interval cancer per colonoscopy, but does provide insight into how many patients who develop cancer had a recent examination. Using cancer registries, and looking back at claims data, investigators find that 2%–9% of patients in cancer registries had colonoscopy within 3 years. Causes of interval cancer include missed lesions and incompletely removed lesions, which may be related to quality. New, fast-growing lesions (related to biology) may account for a small proportion of interval lesions. There is no question that interval CRC is an undesirable outcome after colonoscopy. We currently have
Comment From the Editor, continued Table 1. Quality Indicators for Colonoscopy Screening and Surveillance3,4 Colonoscopy quality indicator by type Documentation
Performance
Follow-up/communication
Key outcomes
Examples Patient demographics; preprocedure assessment of risk; documentation of prior exam and interval; technical description of the procedure; description of colonoscopic findings and management; recording of unplanned events and interventions; follow-up plan Cecal intubation with documentation Adenoma or polyp detection rate Immediate unplanned events or interventions Appropriate documentation of pathology Recommended follow-up interval consistent with evidence-based guidelines or rationale for deviation from guideline Communication to primary provider and patient Interval colorectal cancer Adverse events
no system in the United States for measuring this important outcome. Canadian studies have demonstrated the feasibility of using a province-wide cancer registry, to look back to determine if patients had a prior colonoscopy.12 If we are serious about measuring quality, then our specialty needs to develop methodology to capture this vital measure.
Adverse Events Adverse events that occur during endoscopic procedures are regularly captured at the time of colonoscopy. However, we now have studies showing that the rate of immediate events underestimates the true rate of adverse events which occur within 30 days of the procedure.13,14 In 1 study of patients receiving screening or surveillance colonoscopy, bleeding was reported at the time of procedure in 0.6 per 1000 examinations, whereas the 30-day rate of bleeding which required hospitalization was 1.53/ 1000 examinations.15 It is likely that many delayed events are not necessarily linked to the endoscopic report, and thus not attributed to the procedure. If patients go to other healthcare facilities to deal with a complication, the endoscopist may not be aware of the event. Developing systems which enable
follow-up of patients after procedures to capture delayed events will provide a more accurate reflection of risk.
Other Surrogate Indicators of Colonoscopy Quality One of the most obvious deficiencies in colonoscopy quality surrounds the use of surveillance. We have evidence from physician surveys and from a large study of practice behavior in the PLCO (Prostate, Lung, Colorectal and Ovarian cancer) study15 demonstrating both under- and overutilization of colonoscopy during surveillance. This study found that 25%–50% of patients with no polyps or low-risk polyps were receiving surveillance at shorter than recommended intervals. Although some early colonoscopy might be justified owing to inadequate baseline examinations, this pattern of overutilization in low-risk individuals exposes patients to unnecessary risks and costs. Overutilization of procedures and tests in medicine has been recognized as an important driver of health cost by President Obama and others,16 and there will undoubtedly be efforts to reduce cost by narrowing utilization to comply with evidence-based guidelines.
What About Quality in the Nonendoscopic Practice of Gastroenterology and Hepatology? The principles we apply to assessing quality of endoscopic practice should apply to our nonendoscopic practice. We should examine our processes of care and first ask: What are the most important outcomes? If I am managing a patient with cirrhosis, the important end points might be prevention of variceal bleeding, identification of early, treatable hepatocellular carcinoma, and timely transplantation if appropriate. If I am managing a patient with Crohn’s disease, key indicators might be achieving clinical and endoscopic remission, avoiding treatment-related complications, rates of surgery, and disease complications. If I am managing reflux disease, the end points might be development of stricture or Barrett’s esophagus, as well as quality of life. To be meaningful, indicators must be linked with important outcomes.
Conclusion Measuring quality is a process that should begin by considering the most important outcomes. At the provider level, we need to adopt surrogate end points that are closely linked with these outcomes. To do otherwise diverts energy and resources to processes that may not improve patient care. Ultimately, we need to develop national registries to track key outcomes such as interval CRC and 30-day adverse events. This is a challenge for every specialty in medicine; we can no longer assume we are practicing high-quality medicine without measuring it. What will you say when your patient asks: “Doctor, are you measuring quality in your practice, and if so, are you meeting acceptable benchmarks?” DAVID LIEBERMAN Associate Editor Division of Gastroenterology and Hepatology 195
Comment From the Editor, continued Oregon Health and Science University Portland, Oregon 6.
References 1. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part II: lower gastrointestinal diseases. Gastroenterology 2009;136:741–754. 2. Seeff LC, Richards TB, Shapiro JA, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC’s survey of endoscopic capacity. Gastroenterology 2005;127:1670 – 1677. 3. Rex DK, Petrini JL, Baron TH, et al. Quality indicators for colonoscopy. Am J Gastroenterol 2006;101:873– 885. 4. Lieberman D, Nadel M, Smith R, et al. Standardized colonoscopy reporting and data system (CO-RADS): report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Gastrointest Endosc 2007;65:757–766. 5. Lieberman DA, Faigel DO, Logan J, et al. Assessment of colonoscopy quality: re-
196
7.
8.
9.
10.
sults from a multi-center consortium. Gastrointest Endosc 2009;69:645– 653. Barclay RL, Vicari JJ, Doughty AS, et al. Adenoma detection rates and colonoscopic withdrawal times during screening colonoscopy. N Engl J Med 2006; 355:2533–2541. Shaukat A, Oancea C, Bond JH, et al. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol 2009;7:1335–1340. Baxter NN, Sutrahar R, Forbes SS, et al. Analysis of administrative data finds endoscopist quality measures associated with post-colonoscopy colorectal cancer. Gastroenterology 2011;140:65–72. Kaminski MF, Regula J, Kraszewska E, et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010;362:1795–1803. Chassin MR, Loeb JM, Schmaltz SP, et al. Accountability measure: using measurement to promote quality improvement. N Engl J Med 2010;363:683– 688.
11. Lieberman D. Progress and challenges in colorectal cancer screening and surveillance. Gastroenterology 2010;138: 2115–2126. 12. Singh H, Nugent Z, Demers AA, et al. Rate and predictors of early/missed colorectal cancers after colonoscopy in Manitoba: a population-based study. Am J Gastroenterol 105;2588 –2596. 13. Ko CW, Riffle S, Michaels L, et al. Serious complications within 30 days of screening and surveillance colonoscopy: a multicenter study. Clin Gastroenterol Hepatol 2010;8:166 –173. 14. Warren JL, Klabunde CN, Mariotto AB, et al. Adverse events after outpatient colonoscopy in the Medicare population. Ann Intern Med 2009;150:849 – 857. 15. Schoen RE, Pinsky PF, Weissfeld JL, et al. Utilization of surveillance colonoscopy in community practice. Gastroenterology 2010;138:73–78. 16. Gawande A. The cost conundrum. New Yorker, June 1, 2009; 36 – 44.
doi:10.1053/j.gastro.2011.12.016