1. The ACC/AHA Perspective Alice K. Jacobs, MD, FAHA, FACC Professor of Medicine Boston University Medical Center Chair, ACC/AHA Task Force on Practice Guidelines Clinical Practice Guidelines: Opportunities and Barriers to Implementation IOM Workshop May 10-11, 2011

2. ACC/AHA Practice Guidelines Joint relationship between ACC and AHA initiated in 1981 1984- first ACC/AHA Guideline on Pacemaker Insertion published 17 Guidelines currently available with a total of >3,000 recommendations 3 new guidelines, 2 published 4 guidelines being revised 3 guidelines being “updated”

3. ACCF/AHA Task Force on Practice Guidelines (TFPG) Chair identified Writing Committee (WC) identified Peer Review/Governing bodies review and approval Joint publication CPG scope, outline, assignments distributed Evidence review, recommendations and text written WC consensus achieved; balloting Overall Process / Flow of Work Joint guideline topic/organizations identified Invitation criteria Partnership or collaboration Adhere to RWI policy; overall balance COR, LOE

5. ACCF/AHA Task Force on Practice Guidelines (TFPG) Chair identified Writing Committee (WC) identified Peer Review/Governing bodies review and approval Joint publication CPG scope, outline, assignments distributed Evidence review, recommendations and text written WC consensus achieved; balloting Overall Process / Flow of Work Joint guideline topic/organizations identified Invitation criteria Partnership or collaboration Adhere to RWI Policy; overall balance COR, LOE Reconcile with existing GL Recusal if relevant RWI Official policy

6. Standards for Developing Trustworthy Clinical Practice Guidelines  Establish Transparency  Manage Conflict of Interest  Create Multidisciplinary Guideline Development Group Composition  Perform Systematic Evidence Review  Establish Evidence Foundations for Rating Strength of Recommendations  Articulate Recommendations  Establish External Review  Update IOM Report, March 2011 http://www.nap.edu/catalog/13058.html

7. Potential Impact of IOM Standards on ACC/AHA Guideline Development Standard 1: Establish Transparency Neither ACC nor AHA accept funding for CPGs All ACC and AHA funding sources are publicly accessible on our websites

8. Potential Impact of IOM Standards on ACC/AHA Guideline Development Standard 2: Manage Conflict of Interest Relationship with Industry (RWI)  Define  Disclose  Manage

9. Define: When it is Relevant For the purpose of identifying who can be appointed as a chair and/or member of a writing committee, a person has a relevant relationship with a company or other entity IF: The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or The person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.

10. Disclose In Advance – RWI reviewed and vetted to ensure balanced committee Ongoing – verbal and in writing at every meeting and conference call Published – in print and online using a tabular format to highlight type and level of relationship; publication of all relevant relationships for authors and peer reviewers with each guideline, including documentation of sections from which authors recuse themselves from writing/voting, as well as online posting of author and oversight Task Force member comprehensive RWI

11. Manage: The Writing and Voting Process  If a member of a writing committee has a relevant RWI regarding a product or competing product in the section of the document then the member is permitted to participate in the discussions but is not permitted to draft and vote on a recommendation and/or corresponding text.

12. Manage: The Writing and Voting Process  Chair plus 50% of writing committee may have no relevant RWI  Potential WC members do not “self-filter” for relevant RWI  Policy extends to 12 month period prior to invitation and includes products in development

13. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Standard 3: Create Multidisciplinary Guideline Development Group Composition Harmonization is key - full partnership to all key stakeholder organizations Writing Committees include the expertise of a methodologist, a pharmacologist, and other key stakeholders such as internal medicine physicians, and nurses, depending on the guideline topic Other issues related to balance and bias considered including gender, race, ethnicity, geographic location, practice vs. academic, low/high volume centers  Patients or consumers not yet included on writing committees

14. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Standard 4: Perform Systematic Evidence Review √ Area of opportunity for ACC/AHA  Evidence review is implicit to our process which is currently evolving

15. ACCF/AHA Guideline Development Methodology Guideline Topic Literature Review Evidence Analysis TablesRecommendation Development - Mostly set and preselected -Cover broad disease based topics Ad Hoc Summary Tables- currently being piloted in PCI, STEMI, and CABG Recommendations supported by references and summary tables Future  sub-section searches  PICO questions In Process  Evidence Grading Tool  Summary Tables

16. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Standard 5: Establish Evidence Foundations for Rating Strength of Recommendations Area of opportunity for ACC/AHA Strength of recommendation is ranked using a standardized classification (COR) based on the size of the treatment effect (benefit vs risk) Level of evidence is ranked using a standardized classification (certainty of precision of treatment effect) Validity and reliability of new tool to rate quality of evidence currently being tested

17. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Standard 6: Articulate Recommendations Our standard COR/LOE Table includes required verbs (standard phrases) linked to each COR. All recommendations are articulated in a standardized form detailing precisely what the recommended action is and under what circumstances it should be performed. “Comparator verbs” added to the Table to allow for direct comparison of therapies. Language added denoting no benefit vs. harm of treatment for Class III recommendations.

18. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Standard 7: Establish External Review Rigorous review process that includes all relevant stakeholders and oversight bodies of ACC and AHA  We do NOT open our review process for public comment. Releasing draft recommendations could: - jeopardize integrity of the WC by inflicting bias - compromise transparency because inability to track and manage the integrity of the information - provide vehicle for industry influence on process - challenge confidentiality and publication embargoes

19. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Standard 8: Update CPG: New, Revised, Updated (Focused Update) Literature and major meetings monitored Twice yearly pertinent Writing Committees are surveyed and asked to evaluate the potential impact of new evidence on current recommendations. Guidelines are then updated based on the evaluation of the Writing Committee and TFPG. A major challenge has been how to create a “living guideline” where all updated recommendations (changed, new, deleted) are incorporated back into original guideline.

20. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Challenges Systematic Evidence Review: funding and staff Reconcile time to organize, perform, and analyze evidence with need for guidelines to remain current and responsive to new evidence External review and public comment Include patients and consumer advocate groups in process

21. Potential Impact of IOM Standards on ACC/AHA Guideline Development  Opportunities Include patients and consumer advocate groups in process Collaborate on Systematic Evidence Review Enhance the process for adjudication of evidence Consider centralized RWI database using consistent definitions across all guideline developers Plan an ACC/AHA Guidelines Methodology Summit December 2011