Update on ACG Guidelines Stephen B. Hanauer, MD President American College of Gastroenterology

Transcription

1 Update on ACG Guidelines Stephen B. Hanauer, MD President American College of Gastroenterology Clifford Joseph Barborka Professor of Medicine Northwestern University Feinberg School of Medicine Guideline Development Process 1

2 Guideline Development Guidelines derive from Practice Parameter Committee Authors solicited with Board approval Draft Guidelines Reviewed/Approved by Practice Parameter Committee Draft Guidelines Reviewed/Approved by Board Guidelines submitted/reviewed/published AJG Guideline Process Authors conference call with subgroup of ACG Practice Parameters Committee. Central issues in diagnosis & management identified (e.g. role of biologic agents in maintenance of remission for Crohn s) Pragmatic issues serve as headings of sections of the document. Because of heterogeneity in literature re: available data, for some questions cohort studies & case series may form foundation of the data available. For other questions, authors may limit data to randomized controlled trials and meta-analyses. 2

3 Guideline Process For each crucial clinical questions, the authors identify recent, relevant systematic reviews of evidence If recent systematic review available, authors cite and use review as evidence base for question. When recent systematic review is not available, authors perform review of literature In some circumstances authors perform formal systematic review of the literature Not feasible for every clinical question posed, but may be desirable for certain highly contentious, rapidly evolving, or extremely important issues. Guideline Process Authors generate recommendations regarding diagnosis and management of condition. Generally, between 1-4 recommendations generated from each section Recommendations generated by nominal group technique. Authorship group discusses the goal of the recommendation. Each member of group writes one or more statements that best expresses goal of recommendation. Statements are disseminated, without attribution of author, among the authors, who then rank the statements. Statement with lowest point total is endorsed. 3

4 Guideline Process Statements also graded for both strength of evidence, and strength of recommendation. Ratings are related, but distinct. E.g. recommendation with high quality evidence for very small benefit at some cost or risk to the patient may generate only a weak recommendation. Alternatively, a recommendation based on only weak evidence, but with little risk or cost may still generate a strong recommendation in its favor. Guideline Process Authors categorize recommendations using GRADE system High further research is very unlikely to change our confidence in estimate of effect; Moderate further research is likely to have an important impact on our confidence in the estimate of effect (may change the estimate) Low further research is very likely to have an important impact on our confidence in estimate of effect and is (likely to change the estimate) Very low any estimate of effect is very uncertain. 4

5 Guideline Process The recommendations are then categorized into strong or weak (it is permissible to use conditional or discretionary in place of weak ). The guidelines will allow for dissent from the majority opinion by one or more authors. This will simply be recorded by 0 dissent, 1 dissent, etc ACG Guidelines 5

6 Suggested algorithm for the evaluation and management of defecatory disorders 6

7 Suggested algorithm for evaluation and management of fecal incontinence 7

8 8

9 9

10 Evaluation of suspected DILI 10

11 11

12 Clinical Trials vs. Clinical Practice Clinical Trials Defined patient populationp Prescribed treatment regimen Regimented visit schedule Primary outcome at end- point visit (efficacy) Clinical Practice Heterogeneous patient population Modifiable treatment regimen Individualized visit schedule Variable outcomes and treatment duration (effectiveness) 12

13 Guidelines and Clinical Practice Every effort to regulate increasingly unwieldy health care systems seems to produce complex mechanisms that require even more rules and conventions in order to function. Accordingly we now have layer upon layer of guidelines and protocols.clinical guidelines remain closely linked to the many other forms of regulatory standardization that aim to bring order, predictability and commensurability to an increasingly vast and heterogeneous domain. Weisz G, et al. The emergence of clinical practice guidelines. Milbank Q. 2007; 85(4): The vast and heterogeneous domain Realm of clinical practice guidelines and Increasingly heterogeneous patient population to which these guideline apply. Upshur, RE Ann Fam Med May/June 2014 vol. 12 no

14 Proliferation of guidelines In 1990 there were 73 entries in PubMed In 2012 grew to 7,508 Thousands of clinical practice guidelines are produced annually It has been well established that practicing physicians have limited time to read Well documented that adhering to clinical practice guidelines for common chronic diseases is not feasible given the time permitted to practitioners. Upshur, RE Ann Fam Med May/June 2014 vol. 12 no Do Clinical Guidelines Still Make Sense? Multimorbidity is the rule, not the exception, and with age this becomes more true. In Canada, an estimated 40% of patients aged over 80 years have 4 or more chronic conditions. There are at least 20 common chronic conditions that afflict older adults. Consequently one finds there are 4, 845 possible combinations of 4 chronic conditions out of 20. It is quite unlikely that any clinical practice guideline will cover this range of possibility in sufficient detail to be directive. It is even less likely that there will be evidence from randomized trials that is directive to patients and clinicians and captures this heterogeneity. Upshur, RE Ann Fam Med May/June 2014 vol. 12 no

15 Do Clinical Guidelines Still Make Sense? The utility of any disease-specific clinical practice guideline also declines as this burden (multi-morbidity) increases. Meanwhile is call to increase focus on patient-centeredness. Seeking alignment of treatment goals among patients, care givers, and clinicians as an important priority. There is also great lack of clarity about the outcomes being pursued with the vast armamentarium of diagnostic and therapeutic power at physicians disposal. Clarity on desired outcomes in this context is urgently needed. Upshur, RE Ann Fam Med May/June 2014 vol. 12 no Do Clinical Guidelines Still Make Sense? An urgent priority is decision aids embedded in clinical practice guidelines to assist patients and clinicians in setting priorities for management choices. Some patients may wish less emphasis on risk reduction, particularly when putative benefits are difficult to discern among multiple competing risks. Upshur, RE Ann Fam Med May/June 2014 vol. 12 no

16 Barriers to Physician Adherence to Practice Guidelines in Relation to Behavior Change What is Quality?... the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Chassin MR, Galvin RW. Institute of Medicine, JAMA

17 The combined and unceasing efforts of healthcare professionals, patients and their families, researchers, payers, planners and educators to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development Batalden PB, Davidoff F. Qual Saf Health Care 2007 How to Achieve High Quality Care: Translation of Knowledge to Practice Dougherty D and Conway PH. JAMA

18 Analysis of an Administrative Claims Database Suggests Poor Quality of Care for Inflammatory Bowel Disease Melmed GY et al. ACG 2014 Program no. P1663 Methods Methods Assessed the AGA IBD measures using claims captured in the OptumInsight administrative claims database Patients 18 years of age with Crohn s disease or ulcerative colitis were identified using ICD-9 codes and were followed for 1 year after first IBD diagnosis Percentage of patients meeting AGA criteria for each measure was calculated 18

19 Results % 80.00% 00% 69.20% 60.00% 44.60% 40.00% 26.40% 20.00% 17.30% 21.70% 20.30% 20.60% 13.90% 0.00% 3.60% 2.70% Conclusions Quality of IBD care assessed by administrative claims is poor Future work needs to: Compare quality of care after 2012 to determine changes in adherence following publication of the measures Examine whether current AGA measures capture all aspects of quality care Explore alternative data sources that better capture provider recommendations to patients 19

20 Criticisms of Quality Measures Not consistent with personalized health care : Does not account for patient differences Does not consider patient tpreferences Does not allow for practitioner, clinic, hospital or system individuality Reliance on accountability with potential negative consequences as a means to change processes Pay for performance Public reporting Accreditation Maintenance of certification Increased reporting burden Accountability vs Quality Improvement Accountability Reactive Emphasis on reporting Focus on individual providers or metrics Punitive Benefit to patients indirect Extrinsic Motivation Quality Improvement Proactive and change oriented Emphasis on change Focus on system Avoids blame Direct benefit to patients Intrinsic Motivation Adapted from Kappelman M,

21 The PDSA Cycle of Quality Improvement How Do We Measure Quality? Types of quality indicators Structural measures Structure of health care delivery system (e.g. Location and type of facilities, personnel, electronic health record) Process measures How care is delivered (e.g. Frequency and nature of interactions, investigations, interventions) Outcome measures What results are experienced by patients (e.g. death, disability, hospitalization, surgery, QOL) 21

22 Process Indicators & Improvements are Important BUT Ultimately it is the Outcomes that Count ACG Practice Guidelines Emanate from Practice Parameters Committee Remain highest impact factor for AJG Continue to evolve as new information becomes available Offer guidance but not standard of care Still require personalization according to targeted outcomes, levels of risk, economics Provide opportunity to develop Quality Improvement 22