For more than two decades, the National Heart, Lung, and Blood Institute (NHLBI) has been a leader in conducting national education programs to promote timely transfer of research findings to health professionals, patients, and the general public. An important and visible aspect of this effort has been the development and issuance of clinical guidelines with respect to high blood pressure, high blood cholesterol, and asthma. Historically, the primary purpose of such guidelines was to serve as a foundation for the many Institute-coordinated educational activities that addressed these topics. Today, clinical practice guidelines have taken on multiple dimensions as a result of increased attention from methodologists, professional associations, third-party payers, and policy makers. It appears likely that future health care strategies, managed or otherwise, will in some fashion have provisions for clinical practice guidelines.
To place the NHLBI in the context of these efforts, it is important to understand what our guidelines are and—perhaps more important—what they are not. In developing its guidelines, the NHLBI analyzes research results with the goal of providing information that may enable health care providers to enhance their ability to detect, treat, and prevent disease. Thus, NHLBI guidelines represent opportunities to improve individual and public health, not mandates to the medical community or prescriptions for a given patient or population group. This analysis of research outcomes is an integral part of the NHLBI mission that may prove useful in development of general practice guidelines by other agencies specifically charged with that task.
The NHLBI approach to developing clinical guidelines has been useful and effective in achieving the desired objectives. Given the current climate, however, we thought it timely and important to reexamine this approach to ensure that the Institute continues to meet the needs of the community today and in the future. To that end, the Institute conducted a series of meetings involving staff, panel members and chairs from previous NHLBI-sponsored guideline panels, and outside experts who had participated in alternative methods of guideline development. Major conclusions that emerged from these meetings are summarized below.
The NHLBI will continue its development and coordination of clinical guidelines. The NHLBI is unique in that such guidelines are a fundamental part of the life cycle of its national programs. They reflect and highlight the findings of scientific research and provide the basis for educational programs to translate and disseminate research results to the community. Feedback from this translation and dissemination process, in turn, leads to new directions for basic and clinical research.
The Institute will continue to explore various methodologies that may be used to develop credible, valid guidelines. Flexibility is needed not only to tailor specific methodologies to the objectives and needs of a particular program but also to encourage improvements and innovations in guideline development. A range of methods, from highly quantitative analysis to group consensus, are available, and each has its place in guideline development. Although sometimes open to controversy, consensus methods are important and valuable to further scientific and clinical understanding of a condition, particularly when data are contradictory or inconclusive.
Careful attention will be given to selecting a type of scientific literature review that is appropriate to the objectives of a particular set of guidelines. Guideline reports need to include information to inform readers about whether recommendations are based on specific data (published or unpublished), expert opinion, or both. A number of possible editorial procedures can be used to provide the relevant information, yet maintain a readable narrative format.
NHLBI guidelines also will include a “Methods” section that explicitly describes the approach used. This will help readers appreciate the context of guidelines and their development and judge the credibility of the report.
As in the past, guideline development panels will be asked to consider a scope for guidelines that is appropriate to the panel’s objectives. Early in the process of guideline development, a determination should be made about how comprehensive the considerations will be (eg, intended for a broad audience or highly focused on selected areas of expected impact).
The Institute will investigate methods for identifying patient preferences for treatment. Needs and preferences can be assessed by a variety of approaches, such as conducting focus groups, inviting patient testimony, or having patient representation on the panel. In addition, economic aspects of recommendations will continue to be addressed as appropriate.
The NHLBI will explore the possibility of expanding the range of publication and dissemination formats to make the guidelines available to different audiences. Current NHLBI programs develop full reports, executive summaries, and various publications targeted to specific groups of clinicians and patients, including minorities. Production of technical reports detailing the methodology used and the literature reviewed, as well as abbreviated reference guides for clinicians, may also be considered. Conducting focus groups among target audiences may help to identify appropriate and attractive formats for various audiences.
Finally, the Institute recognizes the importance of identifying opportunities to evaluate the impact of guidelines. Several approaches (eg, measurement of awareness of guidelines, physician practices, drug sales, risk factor levels, and morbidity and mortality statistics; demonstration and evaluation research focused on implementation of specific guidelines) are currently used to monitor and assess dissemination and utilization. In the future, the Institute will expand its efforts to identify other evaluation strategies and to ensure that they are considered in early phases of guideline development.
We at the NHLBI are dedicated to putting research results to work so that our ultimate goal of improving the public health may be realized. We are confident that these new and enhanced approaches to clinical guideline development will bring us more swiftly to that goal.
- Copyright © 1995 by American Heart Association