Manual for ACC/AHA Guideline Writing Committees

Methodologies and Policies from the ACC/AHA Task Force on Practice Guidelines

Section II: Tools and Methods for Creating Guidelines

• Step One: Determine the Guideline Scope and Clinical Objectives

Topic Selection
ACC/AHA clinical practice guidelines are written on three general categories: health conditions, procedures, and diagnostics. The Task Force determines the topics for guidelines and selects the writing committee members, while the writing committee is responsible for developing the guideline's content.

Determining the Guideline's Scope
Before and during the first meeting, the writing committee primarily focuses on coming to consensus about the guideline's scope (see Checklist 1). Literature searching is conducted to determine the scope of the guideline, as appropriate (see Step Two).

Ideally, a set of guidelines should give practitioners, patients, and policymakers an explicit description of the projected health benefits and the projected harms or risks. In addition, projected outcomes should be compared with those for alternative courses of care for the clinical condition in question. -Institute of Medicine, 1990

ACC/AHA guidelines are usually intended to provide recommendations applicable in the United States; however some guidelines written in collaboration with the European Society of Cardiology or other partners have a broader target audience. The methodology for international guidelines is the same as national guidelines, with conclusions and recommendations based on expert judgement applied to clinical evidence. International differences in disease management and health care resource availability may be noted when such differences might have significant impact on the implementation of recommendations.

Although some guidelines also address issues of cost-effectiveness and related economic analyses, ACC/AHA guidelines are generally meant to provide clinically relevant information outside of the context of costs and reimbursement. If cost issues must be included, guideline writers should limit the scope to previously published analyses and not attempt to create any new economic analysis within the document.

Guideline Updates and Revisions
Maintaining guideline content that is up-to-date with the clinical evidence and best practices in the field of cardiology is an ongoing challenge. The Task Force is exploring new systems to update guideline content more regularly. In the meantime, all guidelines are reviewed for possible update within one year after publication. The research analyst and the chair monitor literature on the topic, and compare the current guideline recommendations against the latest data. The entire writing committee is periodically surveyed to determine if the guideline (or sections within the guideline) needs updating. Guideline updates should focus on substantive changes to recommendations rather than editorial changes to the document. Otherwise, all methodology in this manual applies to updates and revisions.

Guideline Structure
Guideline writers are encouraged to define as precisely as possible the overall guideline structure at the early stages of guideline creation. The Task Force has provided standard guideline outlines for each guideline type (see Table 2). These outlines improve consistency across guidelines and facilitate the effectiveness of on-line searching of our guidelines. They provide a common structure while allowing for flexibility as the topic demands. Guideline writers should determine at the outsets which "standard concepts" apply to their guideline, then proceed with creating detailed clinical objectives under each concept. The standard outlines are not prescriptive, nor are they meant to encourage the creation of textbook-style guidelines.

Identifying the Clinical Objectives
The main goal of guideline creation is to develop recommendations that allow providers to understand the evidence on the topic and apply it to clinical practice. As such, guideline writers should progress with specific clinical objectives in mind. It may be very helpful at the outset to consider what kind of guidance the readers will expect in the completed document, such as:

• The role of exercise testing in asymptomatic patients
• The use of inotropic agents in patients with end-stage heart failure
• Managing mitral regurgitation medically versus surgically

A comprehensive collection of clinical objectives should be created within each main concept addressed by the guideline outline. These clinical objectives serve as the basis for literature searching and sorting, and later for the compilation of guideline recommendations.

 

Checklist 1. Determining the Guideline Scope and Clinical Objectives Questions related to the guideline overall What is the guideline's targeted health condition, procedure, or diagnostic? What is the purpose of the guideline? What is within the scope of the guideline? What is outside the scope of the guideline? What is the epidemiology of the topic? Who are the guideline's intended users? What is the target patient population to be addressed in the guideline? How does the guideline relate to other existing ACC/AHA guidelines? Can a few flow diagrams summarize the guideline, or at least key sub-sections? Questions related to the guideline's clinical objectives What are the important clinical objectives related to the guideline topic? What sub-topics and related topics must be included in the guideline? Are flow diagrams appropriate to these sub-topics and related topics? What are the potential benefits and risks for individual patients associated with an intervention or procedure? What amount of clinical flexibility is appropriate for the topic area? What clinical options are available? What topics have already been covered in existing ACC/AHA guidelines?