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The ACC/AHA Perspective

Clinical Practice Guidelines: Opportunities and Barriers to Implementation. 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. IOM Workshop May 10-11, 2011.

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The ACC/AHA Perspective

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

  4. Overall Process / Flow of Work ACCF/AHA Task Force on Practice Guidelines (TFPG) Invitation criteria Partnership or collaboration Joint guideline topic/organizations identified Adhere to RWI Policy; overall balance Chair identified Writing Committee (WC) identified CPG scope, outline, assignments distributed Evidence review, recommendations and text 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

  5. 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

  6. 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

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

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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

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

  15. Potential Impact of IOM Standards on ACC/AHA Guideline Development • 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  Standard 5: Establish Evidence Foundations for Rating Strength of Recommendations

  16. Potential Impact of IOM Standards on ACC/AHA Guideline Development • 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.  Standard 6: Articulate Recommendations

  17. Potential Impact of IOM Standards on ACC/AHA Guideline Development • 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  Standard 7: Establish External Review

  18. Potential Impact of IOM Standards on ACC/AHA Guideline Development • 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.  Standard 8: Update

  19. Potential Impact of IOM Standards on ACC/AHA Guideline Development • 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  Challenges

  20. Potential Impact of IOM Standards on ACC/AHA Guideline Development • 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  Opportunities

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