The speaker from the American College of Cardiology discussed how ACC/AHA clinical practice guidelines are evolving to meet new IOM standards, including more transparent management of conflicts of interest, multidisciplinary writing groups, systematic evidence reviews, standardized recommendation grading, and consideration of public comments in external review. However, patients and consumers are not yet included directly in writing groups due to training needs and potential for bias. Guidelines are monitored and updated regularly based on new evidence evaluations.

1. CPGS: Evolution at ACC
Consumers 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. Disclosures
• Financial
• Professional/Personal
– ACC
– Consumer influence on healthcare
– Speaker underperformance
• jwright@acc.org

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

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. 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. 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. 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. 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. 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. 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 in our currently
evolving process

13. ACCF/AHA Guideline Development Methodology
Guideline Literature Evidence Tables Recommendation
Topic Review Analysis Development
Ad Hoc
-Mostly set Summary
and Recommendations
Tables-
preselected supported by
Future currently
-Cover references and
sub-section being
broad summary tables
searches piloted in
disease PICO PCI, STEM
In Process
based questions
Evidence I, and
topics Grading Tool CABG
Summary
Tables

14. 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

15. 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 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. 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. Potential Impact of IOM Standards on
ACC/AHA Guideline Development
Standard 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.