Response to Letter by Holloway and Benesch
Drs Holloway and Benesch express concern that the current American Heart Association (AHA) policy of disclosure of potential conflicts of interest may be insufficient. It is unfortunate that the disclosures were distracting, and although their comments on appearance of conflict cannot be directly addressed, for completeness we would like to clarify the process used in the case of this update to the recommendations for prevention of stroke in patients with stroke and transient ischemic attack1:
First, the need for an update was determined by the Scientific Statement Oversight Committee of the Stroke Council, not by the Secondary Prevention Writing Panel itself.
Second, in both the topic areas, antiplatelet agents and statins, 2 committee members without expressed conflicts were asked to formulate draft recommendations.
Third, the first author, Vice Chair of the 2006 statement,2 received the assignment to Chair the update, and his role was to ensure to the extent possible consistent applications of the Classification of the Evidence rules that are used by the AHA. To this end, and to remove himself further from the statement conclusions, direct involvement of the AHA’s Chief Science Officer via conference calls was arranged to help clarify any issues regarding the classification of the evidence, hierarchy of the recommendations and to provide for discussion of the issues between the primary writers and the AHA’s Chief Science Officer in order to ensure internal consistency as well as concordance with how other AHA statements are written.
Fourth, after the update was written and agreed on by the authors, it underwent peer review by members of the Stroke Council. After peer reviewer comments were resolved, the manuscript went forward to the association’s 39-member Science Advisory and Coordinating Committee (SACC). All AHA scientific statements, guidelines, advisories, recommendations, conference proceedings and other documents are sent to SACC, AHA’s highest science body, for final approval. The breadth of this group allows for a sufficient number of members without relevant relationships with industry to form an unconflicted review group. If SACC does not approve a document or if SACC has specific recommendations and suggestions, those concerns are brought to the writing group. The writing group is expected to address the comments and modify the document as warranted. The process for developing statements and guidelines is detailed in the online statement and guideline development manual, located at http://www.americanheart.org/presenter.jhtml?identifier=3023366.
Fifth, regarding the classification scheme used by AHA, any combination of Classification of Recommendation and Level of Evidence is possible. For example, a recommendation can be a Class I, even if it is based entirely on expert opinion and no research studies have ever been conducted on the recommendation (Level of Evidence C). Similarly, a Class IIa or IIb can be assigned a Level of Evidence A if there are multiple randomized controlled trials coming to divergent conclusions. Assigning a Level of Evidence B or C should not be construed as implying that the recommendation is weak. Many important clinical questions addressed in guidelines either do not lend themselves to experimentation or have not yet been addressed by high quality investigations. Even though randomized controlled trials may not be available, the clinical question may be so relevant that it would be delinquent to not include it in the guideline.
The AHA will continue to strive to produce statements free of commercial or other bias. It is noted that the letter does not argue against the interpretations of the current evidence that the committee arrived at after extensive deliberation but rather the process allowing individuals with potential conflicts to participate. Drs Hollowell’s and Benesh’s comments do signal the rapidly changing expectations in this area and continual evaluation of the process is warranted.
Adams RJ, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Sacco RL, Schwamm LH. Update to the AHA/ASA Recommendations for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack. Stroke. 2008; 39: 1647–1652.
Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006; 37: 577–617.