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