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