**Wright - Clinical Practice Guidelines Evolution at the American College of Cardiology

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**Wright - Clinical Practice Guidelines Evolution at the American College of Cardiology

  1. 1. CPGS: Evolution at ACCConsumers United for Evidence-based Healthcare 2011 Annual Membership Meeting August 12, 2011 Washington, DC Janet Wright MD FACC Sr VP for Science and Quality American College of Cardiology
  2. 2. Disclosures• Financial• Professional/Personal – ACC – Consumer influence on healthcare – Speaker underperformance • jwright@acc.org
  3. 3. 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
  4. 4. Potential Impact of IOM Standards on ACC/AHA Guideline Development• Standard 1: Establish Transparency  Neither ACC nor AHA accept funding for Clinical Practice Guidelines  All ACC and AHA funding sources are publicly accessible on our websites
  5. 5. Potential Impact of IOM Standards on ACC/AHA Guideline Development• Standard 2: Manage Conflict of Interest Relationship with Industry (RWI) Define Disclose Manage
  6. 6. 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.
  7. 7. 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
  8. 8. 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 or vote on a recommendation and/or corresponding text.
  9. 9. 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
  10. 10. 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 stakeholder organizations WCs are inclusive: methodologist, nurses, pharmacologist, internal medicine physicians Balance and diversity: gender, race, ethnicity, geographic location, practice vs. academic, low/high volume centers Patients and consumers not yet included on writing committees
  11. 11. Potential Impact of IOM Standards on ACC/AHA Guideline Development Standard 3: Create Multidisciplinary Guideline Development Group Composition Patients and consumers not yet included on writing committees WHY NOT?  Unknown pool of folks trained in EBM  Burden and expense of that training  Delay in development of Guideline  Potential for introduction of bias contradictory to the evidence adjudication process (esp with LOE: C recommendations)
  12. 12. Potential Impact of IOM Standards on ACC/AHA Guideline DevelopmentStandard 4: Perform Systematic Evidence Review √ Area of opportunity for ACC/AHA  Evidence review is implicit in our currently evolving process
  13. 13. ACCF/AHA Guideline Development Methodology Guideline Literature Evidence Tables Recommendation Topic Review Analysis Development Ad Hoc-Mostly set Summaryand Recommendations Tables-preselected supported by Future currently-Cover references and sub-section beingbroad summary tables searches piloted indisease PICO PCI, STEM In Processbased questions Evidence I, andtopics Grading Tool CABG Summary Tables
  14. 14. Potential Impact of IOM Standards on ACC/AHA Guideline DevelopmentStandard 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
  15. 15. Potential Impact of IOM Standards on ACC/AHA Guideline DevelopmentStandard 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 the recommended action 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
  16. 16. 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. Concerns expressed include - potential for industry influence - inability to detect, track, and manage RWI - time delays and resources to review and process - compromise of publication embargos
  17. 17. Potential Impact of IOM Standards on ACC/AHA Guideline DevelopmentStandard 8: Update CPG: New, Revised, Updated (Focused Update) Literature and major meetings are monitored Twice yearly Writing Committees evaluate the impact of new evidence on current recommendations. Guidelines are updated based on the evaluation of the Writing Committee and the Task Force. A major challenge is to create a “living guideline” where all updated recommendations are incorporated back into original guideline.

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