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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. - PowerPoint PPT Presentation
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The ACC/AHA Perspective
Alice K. Jacobs, MD, FAHA, FACCProfessor of Medicine
Boston University Medical CenterChair, ACC/AHA Task Force on
Practice Guidelines
Clinical Practice Guidelines:Opportunities and Barriers
to Implementation
IOM Workshop May 10-11, 2011
ACC/AHA Practice GuidelinesACC/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”
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 identifiedInvitation criteria
Partnership or collaborationAdhere to RWI policy; overall balance
COR, LOE
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 identifiedInvitation criteria
Partnership or collaborationAdhere to RWI Policy; overall balance
COR, LOEReconcile with existing GL
Recusal if relevant RWI
Official policy
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 2011http://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
CPGs 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)DefineDiscloseManage
Define: When it is RelevantFor 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 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.
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 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
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
ACCF/AHA Guideline Development Methodology
Guideline Topic
LiteratureReview
Evidence Analysis
Tables Recommendation Development
-Mostly set and preselected -Cover broad disease based topics
Ad HocSummary Tables-currently being piloted in PCI, STEMI, and CABG
Recommendations supported by references and summary tables
Futuresub-section searchesPICO questions
In ProcessEvidence Grading ToolSummary Tables
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
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.
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
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.
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
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