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Enhancing Clinical Practice Guidelines: Implementing IOM Standards

Explore the comprehensive approach of ACC/AHA guidelines' development process and the potential impact of IOM standards on guideline development, focusing on transparency, conflict of interest management, and guideline composition. Learn how these standards aim to ensure trustworthy and balanced guidelines.

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Enhancing Clinical Practice Guidelines: Implementing IOM Standards

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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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