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.