ACC/AHA Practice Guidelines Institute of Medicine Workshop on Standards for Clinical Practice Guidelines

1. ACC/AHA Practice Guidelines Institute of Medicine Workshop on Standards for Clinical Practice Guidelines Alice K. Jacobs, M.D. Chair, Task Force on Practice Guidelines Boston University Medical Center Boston, MA

2. Joint relationship between ACC and AHA initiated in 1981 1984- first ACC/AHA Guideline on Pacemaker Insertion published 22 Guidelines currently available with a total of >3,000 recommendations 5 new guidelines in process 2 guidelines being revised 3 guidelines being “updated” ACC/AHA Practice Guidelines 1984-2010

3. Overall Process / Flow of Work ACCF/AHA Task Force on Practice Guidelines (TFPG) Invitation criteria Partnership or collaboration Joint guideline topic/organizations identified 50% without RWI; Chair no RWI; previous 12 months; overall balance Chair identified Writing Committee (WC) identified WC assignments distributed Text and recommendations written COR, LOE WC consensus achieved; balloting Peer Review/Governing bodies review and approval Joint publication

4. Classification of Recommendations Size of Treatment Effect

5. Level of Evidence Estimate of Certainty (Precision) of Treatment Effect

6. Overall Process / Flow of Work ACCF/AHA Task Force on Practice Guidelines (TFPG) Invitation criteria Partnership or collaboration Joint guideline topic/organizations identified 50% without RWI; Chair no RWI; previous 12 months; overall balance Chair identified Writing Committee (WC) identified WC assignments distributed Text and recommendations written COR, LOE Reconcile with existing GL WC consensus achieved; balloting Peer Review/Governing bodies review and approval Joint publication

7. Overall Process / Flow of Work ACCF/AHA Task Force on Practice Guidelines (TFPG) Invitation criteria Partnership or collaboration Joint guideline topic/organizations identified 50% without RWI; Chair no RWI; previous 12 months; overall balance Chair identified Writing Committee (WC) identified WC assignments distributed Text and recommendations written COR, LOE Reconcile with existing GL WC consensus achieved; balloting Recusal if relevant RWI Peer Review/Governing bodies review and approval Joint publication

8. ACC/AHA Guideline Review Process Writing Committee(12-15 members) Consensus Official ACCreviewers Official AHAreviewers Contentreviewers Partner/Collab reviewers Pharmacyreviewer ACC/AHATask Force Re-Ballot ofWC Revision/response by writing committee Task Force lead reviewer Approval ofTask Force Additionalreviewers Task Force Chair ACC Boardof Trustees AHA Science AdvisoryCoordinating Committee Otherorganizations Publication Adapted from Gibbons. Circulation. 2003;107:2979-2986.

9. Overall Process / Flow of Work ACCF/AHA Task Force on Practice Guidelines (TFPG) Invitation criteria Partnership or collaboration Joint guideline topic/organizations identified 50% without RWI; Chair no RWI; previous 12 months; overall balance Chair identified Writing Committee (WC) identified WC assignments distributed Text and recommendations written COR, LOE Reconcile with existing GL WC consensus achieved; balloting Recusal if relevant RWI Peer Review/Governing bodies review and approval Official policy Joint publication

10. ACC/AHA 2004 STEMI Guidelines

11. ACC/AHA 2004 STEMI Guidelines • 368 pages • 1398 references • 419 recommendations • 34 Tables • 37 Figures • 93 reviewers • 2141 peer review comments • 3.5 pounds!

12. Goal Synthesize rapidly evolving evidence Disseminate to practitioners quickly (but not too quickly) Reality Current process ≥ two years from first meeting to publication (median = 821 days/2.3 years) New RWI process adds time The Problem

13. Pilot Processes Process Improvement • Focused Updates • Consensus Conference Format • Focus on Recommendation Tables with minimal text and links to Evidence Tables and references • Evaluate Bayesian analysis methodology • Incorporate comparative-effectiveness studies • Seek grant support to initiate quality systematic reviews

14. Link Between Overall ACC/AHA ACS Guidelines Adherence and Mortality in CRUSADE (n=64,775) Every 10%  in guidelines adherence  10%  in mortality (OR=0.90, 95% CI: 0.84-0.97) Peterson. JAMA 2006;295:1863-1912.

15. Streamlining the Guidelines: A Look Into the Future • Fast • Fluid • Relevant at the point of care

16. What do you do when the scientific evidence is absent or poor? Work with available information such as consensus documents, reviews, case reports Use consensus of expert opinion Develop “Future Research Needs” section How do you reconcile disagreements in evidence interpretation among guidelines? All recommendations are required to be concordant in the absence of new evidence Task Force liaison and Task Force lead reviewer on every writing committee 1. What do you believe are the biggest challenges clinical practice guidelines’ developers face today?

17. How do guidelines accommodate subgroups whose treatment outcomes may differ from the average patient? Topic areas are sub-divided into topics that address special populations and treatment nuances but only when data available Are there other challenges you believe are important? Management of RWI and potential COI Volunteer time, capacity Time and cost to complete systematic evidence review Keeping guidelines current and ahead of clinical practice 1. What do you believe are the biggest challenges clinical practice guidelines’ developers face today?

18. What should the composition of CPG development panels look like? Content experts, epidemiologists, methodologists What methods might be developed for determining which recommendations should be applied to quality measures or EMR decision prompts?? ACC/AHA Performance Measures use Class I and III recommendations which are most readily converted into point-of-care decision support tools. 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines?

19. Is there an available assessment tool that adequately rates both the level of evidence and the strength of clinical recommendations that should be used as standard practice in guideline development? Every tool has strengths and weaknesses; most do not address areas where evidence lacking or contradictory What administrative or legal approaches might improve the quality of CPG?? Membership in group/association for guideline developers Use of standard methodology, checks and balances 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines?

20. What explicit approaches might harmonize guideline developers and increase guidelines convergence? Collaboration, synergizing processes, combined development pilots What types of strategies might promote greater utilization of guidelines?? User-friendly formats, clear and concise recommendations, concordant recommendations across documents and organizations, point-of-care tools, standards for EMR incorporation AHA Get With the Guidelines, ACC D2B 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines?

21. Are there any other characteristics of guideline standards you think are important for the committee to consider? Resource requirements Time required to develop guidelines Incorporating new evidence in a timely fashion 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines?