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T3 Translational Science in Gastroenterology: Getting to Best Outcomes
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2013;11:1559–1561
ADVANCES IN TRANSLATIONAL SCIENCE Joseph H. Sellin, Section Editor
T3 Translational Science in Gastroenterology: Getting to Best Outcomes WALLACE CRANDALL Nationwide Children’s Hospital and The Ohio State University College of Medicine, Columbus, Ohio
Achieving the best possible outcomes requires the reliable implementation of best practices for every patient. Specifically, optimizing outcomes requires a spectrum of research spanning basic science, drug development, clinical efficacy and effectiveness, health services, quality improvement, and implementation research. However, our rapid increase in understanding the mechanisms of health and disease and their treatment has far outpaced our ability to reliably provide that care, resulting in poor reliability and enormous variation in care. T3 translational research studies attempt to answer questions surrounding reliable implementation of interventions, decreasing variations in care, and spreading effective therapies. To answer these questions, T3 research may use traditional research methodology such as randomized controlled trials (RCTs); however, various other approaches such as quasiexperimental designs (eg, time-series analysis) are often used. Although uncommon, T3 research has shown promise in not only improving process measures such as correct dosing of medications, but also outcome measures such as improved remission rates in patients with IBD. A more complete integration of T3 translational research into the more traditional research continuum is necessary if we are to achieve the best possible outcomes for our patients. Keywords: Translational Science; Quality Improvement; Inflammatory Bowel Disease; Reliability; Variation.
P
roviding the best possible care and achieving the best possible outcomes for every patient is the goal of all responsible clinicians. Achieving this goal requires the reliable implementation of best practices for every patient. However, best practices are often uncertain, and the reliability of medical care in our current system is lacking. Achieving best outcomes, therefore, requires advances in both our knowledge of what works, and our understanding of how to deliver that care reliably. Currently, the large majority of governmental, foundational, and pharmaceutical research dollars are directed to basic science discovery, therapeutics development, and clinical efficacy studies (ie, to studying what works). This has resulted in dramatic advances in our understanding of the mechanisms of health and disease and a better understanding of effective therapy. In contrast, relatively little time or money is spent in examining how to best achieve high reliability in delivering these therapeutics to patients. This rapid increase in knowledge, without a concomitant increase in our ability to reliably deliver care, has resulted in what the Institute of Medicine has termed the “Quality Chasm.”1
Achieving Optimal Outcomes Optimizing outcomes requires a spectrum of research spanning basic science, drug development, clinical efficacy and effectiveness, health services, quality improvement (QI), and implementation research. Various versions of this model exist, each describing a number of translational research steps. Dougherty and Conway2 proposed one such model aimed at organizing research efforts, transforming health care delivery, and improving outcomes. It requires 3 major translational (T) steps, each progressively building on the findings of prior steps. Specifically, traditional basic biomedical science would result in discoveries with therapeutic implications. These therapeutics then would undergo evaluation to determine clinical efficacy (T1). If efficacy was shown in well-defined populations, additional outcomes, comparative effectiveness, and health services research studies to determine effectiveness in broader populations would be performed (T2). Clinically effective therapies then would be studied to determine how to reliably implement, scale, and spread the findings in routine clinical practice (T3). Achieving the best possible outcomes would be achieved only by maximizing efforts at each translational step. This article focuses on the role of T3 translational research in improving reliability and outcomes, using inflammatory bowel disease (IBD) as an example.
Is Translational Step 3 Research Needed: Reliability and Variation in Medicine The reliability of medical care can be thought of as the ability of the medical system to consistently produce the correct results (avoid errors). In general, the reliability of the health care system is limited. Studies in adults and children suggest that only 60% of recommended care is actually delivered to patients.3,4 Similar concerns exist for the reliability of subspecialty care. For example, a study of 67 consecutive adult IBD patients presenting to Brigham and Women’s Hospital for a second opinion showed that 64% to 82% had suboptimal dosing medications, 59% were not using steroid-sparing agents, and 33% had not received colorectal cancer screening per recommendations.5 Abbreviations used in this paper: CD, Crohn’s disease; IBD, inflammatory bowel disease; ICN, ImproveCareNow; QI, quality improvement; RCT, randomized controlled trial; T, translational; TNF, tumor necrosis factor; TMPT, thiopurine methyltransferase; UC, ulcerative colitis. © 2013 by the AGA Institute 1542-3565/$36.00 http://dx.doi.org/10.1016/j.cgh.2013.10.001
1560 WALLACE CRANDALL
Similarly, when examining 246 children with Crohn’s disease (CD) followed up at 48 separate practice sites, it was found that only 70% had a purified protein derivative or chest radiograph before initiating anti–tumor necrosis factor (TNF) therapy, thiopurine methyltransferase (TPMT) was measured in 61% of patients before initiating thiopurines, and 69% of patients with normal TPMT status were started on the recommended dose of thiopurine.6 A related concern is that of variability in medical care. Profound variation in care was highlighted in a study by Kappelman et al7 in which they examined the use of immunomodulator therapy at 10 centers in the United States and Canada within 3 months of diagnosis in children with CD. Use of immunomodulators ranged from roughly 30% at one center to almost 100% at another, with the remaining centers showing an incremental increase in use from the center with the least frequent use to the center with the most frequent use. Poor reliability and excessive variation in care can lead to overuse, underuse, and misuse of medical therapy. Early use of anti-TNF therapy in selected populations is thought to improve outcomes, including reductions in hospitalizations and surgery. Failure to use these agents in select patients may be considered underuse of medication. In contrast, irritable bowel syndrome may co-exist with IBD in almost half of patients and may not be distinguishable from IBD using routine disease activity indices.8,9 Initiation of an anti-TNF for symptoms secondary to irritable bowel syndrome rather than symptoms from IBD would be an example of overuse of medication. Finally, starting anti-TNF therapy in a patient with tuberculosis or hepatitis B would be examples of misuse of medication. T3 translation research can focus on ways to deliver care reliably while minimizing unintended variation, and thereby avoiding underuse, overuse, and misuse of medications. If performed effectively, this can result not only in improved outcomes, but often at reduced cost, resulting in better value of care.
Translational Step 3 Methodology T3 translational research studies attempt to answer questions surrounding reliable implementation of interventions, decreasing variation in care, and spreading effective therapies. To answer these questions, T3 research may use traditional research methodology such as randomized controlled trials (RCTs); however, various other approaches such as quasiexperimental designs often are used.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 11, No. 12
Experimental designs such as RCTs maximize internal validity and avoid multiple sources of potential confounding. However, given the requisite strict inclusion and exclusion criteria of these studies, external validity may be compromised (ie, one may not be able to extrapolate the results to the broader population). In fact, a recent study by Ha et al10 investigated the percentage of IBD patients in routine clinical practice who would qualify for enrollment into one of a number of pivotal studies of biologic use, and found that only 31% of patients would have qualified. Further, they noted that response to biologics was lower in the group that would not have qualified for the RCTs. Because randomization often is not feasible or ethical in T3 research, and because generalizability to the broader population is required, quasiexperimental designs may be used to maximize internal validity without the requirement of random allocation, and with greater inclusiveness of the potential study population. Further, these study designs allow for more rigorous testing (and therefore confidence in the results) than simple pretestposttest (before-after studies) or static-group designs.11 One common example of the quasiexperimental design is the time-series study. Time-series designs establish a baseline level of performance for some desired process or outcome (eg, the percentage of patients treated with corticosteroids, the percentage of patients in remission), document periods of intervention, and record repeated observations of the process or outcome over time. These data are plotted on a graph, with a centerline representing the mean performance, and upper and lower control limits typically representing 3 standard deviations from the mean (Figure 1). By using a set of statistical rules, statistically significant changes in baseline performance can be identified, and the baseline level of performance then is adjusted with a new center line and control limits. As with any study design, demonstration of a change does not ensure that the result can be attributed directly to the intervention, therefore, it is important to carefully consider, and exclude where possible, alternative explanations.
Translational Step 3 Research in Inflammatory Bowel Disease As in most areas of medicine, T3 translational science is uncommon in IBD; however, examples of its use do exist. By using both time-series analysis and traditional statistical techniques, investigators from the ImproveCareNow (ICN) network,
Figure 1. Remission rate for IBD patients at Nationwide Children’s Hospital from 2007 to 2013. Remission rate has improved from a baseline of 58% to 86% currently. Three baseline adjustments have occurred to reflect statistically significant improvements in remission rate.
December 2013
a group of more than 50 pediatric gastroenterology practices, reported on their use of QI methodology to improve process and outcome measures in the initial participating sites.12 Interventions were based on established QI principles, including use of the Model for Improvement, the Chronic Care Model, and high reliability principles, and included the implementation of simple care guidelines around testing and medication dosing, previsit planning, population management, basic selfmanagement support, and auditing.13 Performance reports were provided to the care teams regularly. ICN showed improvements in process measures such as the measurement of TPMT before initiation of thiopurines (CD: 60%–80%, P ¼ .12; ulcerative colitis [UC]: 50%–73%, P < .01) and the percentage of patients receiving a starting dose of thiopurines appropriate to their TPMT status (CD: 48%–56%, P < .01; UC: 23%–64%, P < .01). Similarly, there was improvement in outcome measures, with an increase in remission rate from 55% to 68% for CD, and from 61% to 72% in UC. They also noted an increase from 86% to 90% in the percentage of CD patients not receiving corticosteroids. ICN sites have continued to work to provide highly reliable model care, with some sites achieving remission rates exceeding 85% (unpublished data).
Barriers to Implementation Even in the cases of T3 research showing positive results, such as with the ICN study, it is challenging to universally implement the interventions that were shown to be successful. In the ICN study, for example, not all centers showed significant improvement, likely in part owing to differences in the degree of implementation of the interventions. A number of factors may influence how completely the interventions are implemented in any given practice/center. The support of senior leadership, site QI expertise and experience, QI culture, financial support, how the implementation responsibilities are distributed between team members, and other contextual factors all likely influence the success of any set of interventions. Concerns of cost may be addressed as we move from a fee-based to a value-based reimbursement model. However, both cost/value and contextual factors must be examined in future studies to understand how to widely implement positive results.
The Future of Translational Step 3 Research in Inflammatory Bowel Disease In 2012, pediatric gastroenterologists met for a one-day single-topic symposium (organized according to the Translational Model as proposed by Dougherty and Conway2) entitled “Discovering the Future of Pediatric IBD Care” to review state-of-the-art research in pediatric IBD in basic science, clinical research, and QI. The conference resulted in a proposal for a 5-year quality and research agenda in pediatric IBD, much of which also would be relevant for adult IBD. It was recommended that future research include T3 studies that would maximize the effectiveness of QI techniques for discovering and implementing methods to improve outcomes in pediatric IBD (Journal of Pediatric Gastroenterology & Nutrition, in press). Examples of such studies would include determining which QI interventions (eg, previsit planning, self-management support) are most impactful, understanding the role of contextual factors
T3 TRANSLATIONAL SCIENCE IN GASTROENTEROLOGY 1561
(eg, institutional support, senior leader engagement) in determining success, and learning how to rapidly and reliably identify and implement assessment and treatment recommendations as they are developed. An increased focus on T3 translational research is required to develop the tools and processes needed to achieve reliable delivery of current (and future) best practices, and thereby achieve the best outcome for each patient. References 1. Institute of Medicine, US Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001:337. 2. Dougherty D, Conway PH. The “3T’s” road map to transform US health care: the “how” of high-quality care. JAMA 2008;299: 2319–2321. 3. Mangione-Smith R, DeCristofaro AH, Setodji CM, et al. The quality of ambulatory care delivered to children in the United States. N Engl J Med 2007;357:1515–1523. 4. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med 2003; 348:2635–2645. 5. Reddy SI, Friedman S, Telford JJ, et al. Are patients with inflammatory bowel disease receiving optimal care? Am J Gastroenterol 2005;100:1357–1361. 6. Colletti RB, Baldassano RN, Milov DE, et al. Variation in care in pediatric Crohn disease. J Pediatr Gastroenterol Nutr 2009; 49:297–303. 7. Kappelman MD, Bousvaros A, Hyams J, et al. Intercenter variation in initial management of children with Crohn’s disease. Inflamm Bowel Dis 2007;13:890–895. 8. Halpin SJ, Ford AC. Prevalence of symptoms meeting criteria for irritable bowel syndrome in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2012;107: 1474–1482. 9. Lahiff C, Safaie P, Awais A, et al. The Crohn’s disease activity index (CDAI) is similarly elevated in patients with Crohn’s disease and in patients with irritable bowel syndrome. Aliment Pharmacol Ther 2013;37:786–794. 10. Ha C, Ullman TA, Siegel CA, et al. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol 2012; 10:1002–1007, quiz e78. 11. Speroff T, O’Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care 2004;13:17–32. 12. Crandall WV, Margolis PA, Kappelman MD, et al. Improved outcomes in a quality improvement collaborative for pediatric inflammatory bowel disease. Pediatrics 2012;129:e1030–e1041. 13. Crandall W, Kappelman MD, Colletti RB, et al. ImproveCareNow: the development of a pediatric inflammatory bowel disease improvement network. Inflamm Bowel Dis 2011;17:450–457.
Reprint requests Address requests for reprints to: Wallace Crandall, MD, 700 Children’s Drive, Columbus, Ohio 43205. e-mail: Wallace.Crandall@ NationwideChildrens.org; fax: (614) 722-3454. Acknowledgements The author would like to thank Dr Carlo DiLorenzo and Dr Richard Colletti for their careful review and thoughtful edits of this manuscript. Conflicts of interest The author discloses the following: Dr Crandall has received research support from AbbVie and has served as a consultant for Abbott and Boehringer Ingelheim Pharma GmbH and Co.
ADVANCES IN TRANSLATIONAL SCIENCE Joseph H. Sellin, Section Editor
T3 Translational Science in Gastroenterology: Getting to Best Outcomes WALLACE CRANDALL Nationwide Children’s Hospital and The Ohio State University College of Medicine, Columbus, Ohio
Achieving the best possible outcomes requires the reliable implementation of best practices for every patient. Specifically, optimizing outcomes requires a spectrum of research spanning basic science, drug development, clinical efficacy and effectiveness, health services, quality improvement, and implementation research. However, our rapid increase in understanding the mechanisms of health and disease and their treatment has far outpaced our ability to reliably provide that care, resulting in poor reliability and enormous variation in care. T3 translational research studies attempt to answer questions surrounding reliable implementation of interventions, decreasing variations in care, and spreading effective therapies. To answer these questions, T3 research may use traditional research methodology such as randomized controlled trials (RCTs); however, various other approaches such as quasiexperimental designs (eg, time-series analysis) are often used. Although uncommon, T3 research has shown promise in not only improving process measures such as correct dosing of medications, but also outcome measures such as improved remission rates in patients with IBD. A more complete integration of T3 translational research into the more traditional research continuum is necessary if we are to achieve the best possible outcomes for our patients. Keywords: Translational Science; Quality Improvement; Inflammatory Bowel Disease; Reliability; Variation.
P
roviding the best possible care and achieving the best possible outcomes for every patient is the goal of all responsible clinicians. Achieving this goal requires the reliable implementation of best practices for every patient. However, best practices are often uncertain, and the reliability of medical care in our current system is lacking. Achieving best outcomes, therefore, requires advances in both our knowledge of what works, and our understanding of how to deliver that care reliably. Currently, the large majority of governmental, foundational, and pharmaceutical research dollars are directed to basic science discovery, therapeutics development, and clinical efficacy studies (ie, to studying what works). This has resulted in dramatic advances in our understanding of the mechanisms of health and disease and a better understanding of effective therapy. In contrast, relatively little time or money is spent in examining how to best achieve high reliability in delivering these therapeutics to patients. This rapid increase in knowledge, without a concomitant increase in our ability to reliably deliver care, has resulted in what the Institute of Medicine has termed the “Quality Chasm.”1
Achieving Optimal Outcomes Optimizing outcomes requires a spectrum of research spanning basic science, drug development, clinical efficacy and effectiveness, health services, quality improvement (QI), and implementation research. Various versions of this model exist, each describing a number of translational research steps. Dougherty and Conway2 proposed one such model aimed at organizing research efforts, transforming health care delivery, and improving outcomes. It requires 3 major translational (T) steps, each progressively building on the findings of prior steps. Specifically, traditional basic biomedical science would result in discoveries with therapeutic implications. These therapeutics then would undergo evaluation to determine clinical efficacy (T1). If efficacy was shown in well-defined populations, additional outcomes, comparative effectiveness, and health services research studies to determine effectiveness in broader populations would be performed (T2). Clinically effective therapies then would be studied to determine how to reliably implement, scale, and spread the findings in routine clinical practice (T3). Achieving the best possible outcomes would be achieved only by maximizing efforts at each translational step. This article focuses on the role of T3 translational research in improving reliability and outcomes, using inflammatory bowel disease (IBD) as an example.
Is Translational Step 3 Research Needed: Reliability and Variation in Medicine The reliability of medical care can be thought of as the ability of the medical system to consistently produce the correct results (avoid errors). In general, the reliability of the health care system is limited. Studies in adults and children suggest that only 60% of recommended care is actually delivered to patients.3,4 Similar concerns exist for the reliability of subspecialty care. For example, a study of 67 consecutive adult IBD patients presenting to Brigham and Women’s Hospital for a second opinion showed that 64% to 82% had suboptimal dosing medications, 59% were not using steroid-sparing agents, and 33% had not received colorectal cancer screening per recommendations.5 Abbreviations used in this paper: CD, Crohn’s disease; IBD, inflammatory bowel disease; ICN, ImproveCareNow; QI, quality improvement; RCT, randomized controlled trial; T, translational; TNF, tumor necrosis factor; TMPT, thiopurine methyltransferase; UC, ulcerative colitis. © 2013 by the AGA Institute 1542-3565/$36.00 http://dx.doi.org/10.1016/j.cgh.2013.10.001
1560 WALLACE CRANDALL
Similarly, when examining 246 children with Crohn’s disease (CD) followed up at 48 separate practice sites, it was found that only 70% had a purified protein derivative or chest radiograph before initiating anti–tumor necrosis factor (TNF) therapy, thiopurine methyltransferase (TPMT) was measured in 61% of patients before initiating thiopurines, and 69% of patients with normal TPMT status were started on the recommended dose of thiopurine.6 A related concern is that of variability in medical care. Profound variation in care was highlighted in a study by Kappelman et al7 in which they examined the use of immunomodulator therapy at 10 centers in the United States and Canada within 3 months of diagnosis in children with CD. Use of immunomodulators ranged from roughly 30% at one center to almost 100% at another, with the remaining centers showing an incremental increase in use from the center with the least frequent use to the center with the most frequent use. Poor reliability and excessive variation in care can lead to overuse, underuse, and misuse of medical therapy. Early use of anti-TNF therapy in selected populations is thought to improve outcomes, including reductions in hospitalizations and surgery. Failure to use these agents in select patients may be considered underuse of medication. In contrast, irritable bowel syndrome may co-exist with IBD in almost half of patients and may not be distinguishable from IBD using routine disease activity indices.8,9 Initiation of an anti-TNF for symptoms secondary to irritable bowel syndrome rather than symptoms from IBD would be an example of overuse of medication. Finally, starting anti-TNF therapy in a patient with tuberculosis or hepatitis B would be examples of misuse of medication. T3 translation research can focus on ways to deliver care reliably while minimizing unintended variation, and thereby avoiding underuse, overuse, and misuse of medications. If performed effectively, this can result not only in improved outcomes, but often at reduced cost, resulting in better value of care.
Translational Step 3 Methodology T3 translational research studies attempt to answer questions surrounding reliable implementation of interventions, decreasing variation in care, and spreading effective therapies. To answer these questions, T3 research may use traditional research methodology such as randomized controlled trials (RCTs); however, various other approaches such as quasiexperimental designs often are used.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 11, No. 12
Experimental designs such as RCTs maximize internal validity and avoid multiple sources of potential confounding. However, given the requisite strict inclusion and exclusion criteria of these studies, external validity may be compromised (ie, one may not be able to extrapolate the results to the broader population). In fact, a recent study by Ha et al10 investigated the percentage of IBD patients in routine clinical practice who would qualify for enrollment into one of a number of pivotal studies of biologic use, and found that only 31% of patients would have qualified. Further, they noted that response to biologics was lower in the group that would not have qualified for the RCTs. Because randomization often is not feasible or ethical in T3 research, and because generalizability to the broader population is required, quasiexperimental designs may be used to maximize internal validity without the requirement of random allocation, and with greater inclusiveness of the potential study population. Further, these study designs allow for more rigorous testing (and therefore confidence in the results) than simple pretestposttest (before-after studies) or static-group designs.11 One common example of the quasiexperimental design is the time-series study. Time-series designs establish a baseline level of performance for some desired process or outcome (eg, the percentage of patients treated with corticosteroids, the percentage of patients in remission), document periods of intervention, and record repeated observations of the process or outcome over time. These data are plotted on a graph, with a centerline representing the mean performance, and upper and lower control limits typically representing 3 standard deviations from the mean (Figure 1). By using a set of statistical rules, statistically significant changes in baseline performance can be identified, and the baseline level of performance then is adjusted with a new center line and control limits. As with any study design, demonstration of a change does not ensure that the result can be attributed directly to the intervention, therefore, it is important to carefully consider, and exclude where possible, alternative explanations.
Translational Step 3 Research in Inflammatory Bowel Disease As in most areas of medicine, T3 translational science is uncommon in IBD; however, examples of its use do exist. By using both time-series analysis and traditional statistical techniques, investigators from the ImproveCareNow (ICN) network,
Figure 1. Remission rate for IBD patients at Nationwide Children’s Hospital from 2007 to 2013. Remission rate has improved from a baseline of 58% to 86% currently. Three baseline adjustments have occurred to reflect statistically significant improvements in remission rate.
December 2013
a group of more than 50 pediatric gastroenterology practices, reported on their use of QI methodology to improve process and outcome measures in the initial participating sites.12 Interventions were based on established QI principles, including use of the Model for Improvement, the Chronic Care Model, and high reliability principles, and included the implementation of simple care guidelines around testing and medication dosing, previsit planning, population management, basic selfmanagement support, and auditing.13 Performance reports were provided to the care teams regularly. ICN showed improvements in process measures such as the measurement of TPMT before initiation of thiopurines (CD: 60%–80%, P ¼ .12; ulcerative colitis [UC]: 50%–73%, P < .01) and the percentage of patients receiving a starting dose of thiopurines appropriate to their TPMT status (CD: 48%–56%, P < .01; UC: 23%–64%, P < .01). Similarly, there was improvement in outcome measures, with an increase in remission rate from 55% to 68% for CD, and from 61% to 72% in UC. They also noted an increase from 86% to 90% in the percentage of CD patients not receiving corticosteroids. ICN sites have continued to work to provide highly reliable model care, with some sites achieving remission rates exceeding 85% (unpublished data).
Barriers to Implementation Even in the cases of T3 research showing positive results, such as with the ICN study, it is challenging to universally implement the interventions that were shown to be successful. In the ICN study, for example, not all centers showed significant improvement, likely in part owing to differences in the degree of implementation of the interventions. A number of factors may influence how completely the interventions are implemented in any given practice/center. The support of senior leadership, site QI expertise and experience, QI culture, financial support, how the implementation responsibilities are distributed between team members, and other contextual factors all likely influence the success of any set of interventions. Concerns of cost may be addressed as we move from a fee-based to a value-based reimbursement model. However, both cost/value and contextual factors must be examined in future studies to understand how to widely implement positive results.
The Future of Translational Step 3 Research in Inflammatory Bowel Disease In 2012, pediatric gastroenterologists met for a one-day single-topic symposium (organized according to the Translational Model as proposed by Dougherty and Conway2) entitled “Discovering the Future of Pediatric IBD Care” to review state-of-the-art research in pediatric IBD in basic science, clinical research, and QI. The conference resulted in a proposal for a 5-year quality and research agenda in pediatric IBD, much of which also would be relevant for adult IBD. It was recommended that future research include T3 studies that would maximize the effectiveness of QI techniques for discovering and implementing methods to improve outcomes in pediatric IBD (Journal of Pediatric Gastroenterology & Nutrition, in press). Examples of such studies would include determining which QI interventions (eg, previsit planning, self-management support) are most impactful, understanding the role of contextual factors
T3 TRANSLATIONAL SCIENCE IN GASTROENTEROLOGY 1561
(eg, institutional support, senior leader engagement) in determining success, and learning how to rapidly and reliably identify and implement assessment and treatment recommendations as they are developed. An increased focus on T3 translational research is required to develop the tools and processes needed to achieve reliable delivery of current (and future) best practices, and thereby achieve the best outcome for each patient. References 1. Institute of Medicine, US Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001:337. 2. Dougherty D, Conway PH. The “3T’s” road map to transform US health care: the “how” of high-quality care. JAMA 2008;299: 2319–2321. 3. Mangione-Smith R, DeCristofaro AH, Setodji CM, et al. The quality of ambulatory care delivered to children in the United States. N Engl J Med 2007;357:1515–1523. 4. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med 2003; 348:2635–2645. 5. Reddy SI, Friedman S, Telford JJ, et al. Are patients with inflammatory bowel disease receiving optimal care? Am J Gastroenterol 2005;100:1357–1361. 6. Colletti RB, Baldassano RN, Milov DE, et al. Variation in care in pediatric Crohn disease. J Pediatr Gastroenterol Nutr 2009; 49:297–303. 7. Kappelman MD, Bousvaros A, Hyams J, et al. Intercenter variation in initial management of children with Crohn’s disease. Inflamm Bowel Dis 2007;13:890–895. 8. Halpin SJ, Ford AC. Prevalence of symptoms meeting criteria for irritable bowel syndrome in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2012;107: 1474–1482. 9. Lahiff C, Safaie P, Awais A, et al. The Crohn’s disease activity index (CDAI) is similarly elevated in patients with Crohn’s disease and in patients with irritable bowel syndrome. Aliment Pharmacol Ther 2013;37:786–794. 10. Ha C, Ullman TA, Siegel CA, et al. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol 2012; 10:1002–1007, quiz e78. 11. Speroff T, O’Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care 2004;13:17–32. 12. Crandall WV, Margolis PA, Kappelman MD, et al. Improved outcomes in a quality improvement collaborative for pediatric inflammatory bowel disease. Pediatrics 2012;129:e1030–e1041. 13. Crandall W, Kappelman MD, Colletti RB, et al. ImproveCareNow: the development of a pediatric inflammatory bowel disease improvement network. Inflamm Bowel Dis 2011;17:450–457.
Reprint requests Address requests for reprints to: Wallace Crandall, MD, 700 Children’s Drive, Columbus, Ohio 43205. e-mail: Wallace.Crandall@ NationwideChildrens.org; fax: (614) 722-3454. Acknowledgements The author would like to thank Dr Carlo DiLorenzo and Dr Richard Colletti for their careful review and thoughtful edits of this manuscript. Conflicts of interest The author discloses the following: Dr Crandall has received research support from AbbVie and has served as a consultant for Abbott and Boehringer Ingelheim Pharma GmbH and Co.