1. ACC/AHA GUIDELINES 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. ACC/AHA GUIDELINES ACC/AHA Practice Guidelines 1984-2010 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”

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

4. ACC/AHA GUIDELINES Class I Benefit >>> Risk Procedure/ Treatment SHOULD be performed/ administered Class IIa Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment Class IIb Benefit ≥ Risk Additional studies with broad objectives needed; additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED Class III Risk ≥ Benefit Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL should is recommended is indicated is useful/effective/ beneficial is reasonable can be useful/effective/ beneficial is probably recommended or indicated may/might be considered may/might be reasonable usefulness/effectiveness is unknown /unclear/uncertain or not well established is not recommended is not indicated should not is not useful/effective/beneficial may be harmful Classification of Recommendations Size of Treatment Effect

5. ACC/AHA GUIDELINES Class I Benefit >>> Risk Procedure/ Treatment SHOULD be performed/ administered Class IIa Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment Class IIb Benefit ≥ Risk Additional studies with broad objectives needed; additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED Class III Risk ≥ Benefit Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL Level BLimited (2-3) population risk strata evaluated; single randomized trial or non- randomized studies Level of Evidence Level A Multiple (3-5) population risk strata evaluated; General consistency of direction and magnitude of effect; multiple randomized trials or meta-analyses Level CVery limited (1-2) population risk strata evaluated; consensus opinion, case studies, standard of care Estimate of Certainty (Precision) of Treatment Effect

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

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

8. ACC/AHA GUIDELINES ACC/AHA Guideline Review Process Writing Committee (12-15 members) Consensus Revision/response by writing committee Task Force lead reviewer Additional reviewers ACC Board of Trustees PublicationPublication AHA Science Advisory Coordinating Committee Other organizations Official ACC reviewers Official AHA reviewers Content reviewers Task Force Chair Approval of Task Force Partner/CollabreviewersPartner/Collabreviewers Pharmacy reviewer ACC/AHA Task Force Adapted from Gibbons. Circulation. 2003;107:2979-2986. Re-Ballot of WC

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

10. ACC/AHA GUIDELINES ACC/AHA 2004 STEMI Guidelines

11. ACC/AHA GUIDELINES 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. ACC/AHA GUIDELINES The Problem 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

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

15. ACC/AHA GUIDELINES Streamlining the Guidelines: A Look Into the Future Fast Fluid Relevant at the point of care

16. ACC/AHA GUIDELINES 1. What do you believe are the biggest challenges clinical practice guidelines’ developers face today? 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

17. ACC/AHA GUIDELINES 1. What do you believe are the biggest challenges clinical practice guidelines’ developers face today? 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

18. ACC/AHA GUIDELINES 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines? 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.

19. ACC/AHA GUIDELINES 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines? 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

20. ACC/AHA GUIDELINES 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines? 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

21. ACC/AHA GUIDELINES 2. What topics and/or processes do you think the committee should consider in deriving quality standards for Clinical Practice Guidelines? 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