Process of Guideline Development

Key steps in the development of this guideline are listed in Table 1.4. Having determined the broad scope of the current guideline, subcommittees of the guideline committee were formed for each section of the guideline. Literature searches with relevant key words and phrases for each guideline section were provided to members of the subcommittees and the full Guideline Committee. Members of each subcommittee were asked to review the search and identify any additional relevant medical evidence for each assigned section. Changes in recommendation and background were carried out by each subcommittee with conference calls directed by the Guideline Committee chair. Each section was presented for comments and consensus approval to the Guideline Committee. Once subsections were complete, the Executive Council reviewed and commented on each section and these comments were returned to the Guideline Committee for changes and once complete, for final approval by the Executive Council. Appendix A provides a grid showing changes to the 2006 guideline.

Consensus. The development of a guideline involves the selection of individuals with expertise and experience to drive the process of formulating specific recommendations and producing a written document. The role of these experts goes well beyond the formulation of recommendations supported by expert opinion.

Experts involved in the guideline process must function as a collective, not as isolated individuals. Expert opinion is not always unanimous. Interpretations of data vary. Disagreements arise over the generalizability and applicability of trial results to various patient subgroups. Experts are influenced by their own experiences with particular therapies, but still generally agree on the clinical value of trial data. Discomfort with the results of trials reported as positive or negative generally focus on factors that potentially compromise the evidence. Unfortunately, there are no absolute rules for downgrading or upgrading trial results or for deciding whether the limitations of the trial are sufficient to negate what has been regarded as a traditionally positive or negative statistical result.

The HFSA guideline committee sought resolution of difficult cases through consensus building. An open, dynamic discussion meant that no single voice was allowed to dominate. Written documents were essential to this process, because they provided the opportunity for feedback from all members of the group. On occasion, consensus of opinion was sufficient to override positive or negative results of almost any form of evidence. The HFSA process had a strong commitment to recommendations based on objective evidence rigorously reviewed by a panel of experts.

Issues that caused particular difficulty for the HFSA guideline process usually were some of the more important ones faced by the committee, because they mirrored those that are often most challenging to clinicians in day-to-day practice. The foundation of the HFSA guideline process was the belief that the careful judgment of recognized opinion leaders in these controversial areas is more likely to be correct than ad hoc decisions made "on the spot" by physicians in practice.

The involvement of many groups in the development of this guideline helped avoid the introduction of real or perceived bias, which can be personal, practice-based, or based on financial interest. Committee members and reviewers from the Executive Council received no direct financial support from the HFSA or any other source for the development of the guideline. Support was provided by the HFSA administrative staff, but the writing of the document was performed on a volunteer basis primarily by the Committee. Information concerning financial relationships that might represent conflicts of interest was collected annually from all members of the Guideline Committee and the Executive Council. Current relationships are shown in Appendix C.

Dissemination and Continuity. The value of a practice guideline is significantly influenced by the scope of its dissemination. The first and second HFSA guidelines were available on the Internet, and thousands of copies were downloaded. The current document will be accessible on the Internet both for file transfer and as a hypertext source of detailed knowledge concerning HF.

An important final consideration is the continuity of the guideline development process. The intent is to create a "living document" that will be updated and amended as necessary to ensure continuing relevance. The rapid development of new knowledge in HF from basic and clinical research and the continuing evolution of pharmacologic and device therapy for this condition provides a strong mandate for timely updates. The HFSA intends to undertake targeted reviews and updates in areas where new research has implications for practice. Section 17: The Genetic Evaluation of Cardiomyopathy is an example of this policy.