Elsevier

Preventive Medicine

Volume 36, Issue 5, May 2003, Pages 519-524
Preventive Medicine

Regular article
Status of practice guidelines in the United States: CDC guidelines as an example

https://doi.org/10.1016/S0091-7435(03)00014-8Get rights and content

Abstract

Background

Clinical practice guidelines have proliferated in the past several decades, starting with only a handful in the 1980s to over 1000 approved through The National Guideline Clearinghouse in 2002.

Methods

The purposes of this article to review research related to guideline adoption and impact and to make recommendations for assessing the outcomes of guidelines, using the CDC guideline process as an example.

Results

Despite the national movement toward standardization of evidence-based practice, few studies have been conducted to assess the costs of guideline development and implementation, and some practice guidelines have been implemented without concomitant assessment on patient outcomes and costs and benefits of changes in care.

Conclusions

An immediate mandate is to ensure that when guidelines are promulgated, they include an evaluation plan, developed by the implementer of the guideline, which takes advantage of existing qualitative and quantitative data and programs (e.g., patient-centered care, quality assurance, risk management) not limited to expensive and sophisticated clinical trials.

Introduction

Over the past few decades, two movements have had an important impact on how patient care is delivered. First, as early as the 1970s and increasingly in recent decades, variations and inequities in clinical care for a variety of health conditions such as acute myocardial infarction, cardiac surgery, use of diagnostic procedures, and tonsillectomy, have been noted. Such variations are concerning because they have been associated with factors unrelated to the need for care, factors such as geography, socioeconomic status, ethnicity, or gender [1], [2], [3], [4], [5]. Second, the mandate to mediate escalating costs of health care has resulted in increased motivation among clinicians and policy-makers to identify those practices which result in positive patient outcomes and those practices which cannot be justified because of insufficient evidence of either cost saving or patient benefit [6]. These two factors—recognition of inappropriate variations in patient care and of the need to base clinical practice on outcomes and evidence—have resulted in national efforts to set standards for care and to focus on quality and cost effectiveness.

Clinical practice guidelines offer one mechanism to improve equity and quality in patient care. In 1989, The Agency for Health Care Policy and Research (now Agency for Healthcare Quality and Research, AHRQ) was established to “enhance the quality, appropriateness and effectiveness of health care services and access to these services.” One of their initial activities was to produce a series of 19 clinical practice guidelines (http://www.ahrq.gov/clinic/cpgonline.htm). The Agency also commissioned The Institute of Medicine (IOM) to examine and make recommendations for development, dissemination and implementation of practice guidelines. The resulting two publications have served as the blueprint for rigorous and high quality practice guidelines [7], [8]. The IOM defined practice guidelines as “systematically developed statements to assist practitioners and patient decisions about appropriate health care for specific clinical circumstances” [8]. In 1996, AHRQ ceased developing guidelines but established The National Guideline Clearinghouse (http://www.guideline.gov/body home nf.asp?view=home), which now includes >1000 practice guidelines that meet specific quality criteria and are submitted by qualified groups such as other governmental and professional organizations. Currently, many professional organizations in health care are engaged in developing, adapting, and/or implementing evidence-based practice guidelines. In light of this emerging focus on practice guidelines as a mechanism to improve the quality, equity, and efficiency of patient care, the purposes of this article are to briefly review research related to their adoption and impact and to make recommendations for assessing the outcomes of guidelines, using the CDC guideline process as an example.

Section snippets

Studies assessing the adoption and impact of guidelines

Research to date on national practice guidelines has focused primarily on two areas: the extent to which guidelines are accepted and implemented by clinicians (i.e., diffusion and adoption), and their impact on processes and outcomes of patient care. While a number of studies have demonstrated that guideline adherence or attitudes regarding practice guidelines is poor, particularly among physicians [9], [10], [11], [12], other studies have demonstrated improvements in practice [13]. For

CDC guidelines as an example

In 1981, the Centers for Disease Control and prevention (CDC) published a manual, “Guidelines for the Prevention and Control of Nosocomial Infections,” containing nine clinical guidelines for infection prevention and control handwashing [40]. The publication and widespread dissemination of these guidelines revolutionized practice because it was the first time that a federal agency had gathered recommended, evidence-based standards of practice to prevent infections into a single document.

New CDC hand hygiene guideline for health care settings

The first national hand hygiene guideline was published by CDC in 1981 [40]. By the 1990s, the guideline had become outdated, but the CDC, citing fiscal constraints, halted their guideline writing and updating process in the mid-1980s. Therefore, APIC, the professional organization comprising about 12,000 professionals in infection prevention and control, took on the task of guideline development. Their first guideline, published in 1988 and revised in 1995, was on hand hygiene [44], [45]. In

Conceptual underpinnings

While the IOM, AHRQ, and other agencies have published criteria for guideline development and quality, there is less information or guidance for assessing the clinical impact of guidelines. For example, the IOM text on clinical practice guidelines [8] devotes only three pages to assessment of impact. Similarly, in 1996 CDC published a document on improving the quality of guidelines. Even though this document describes in detail the entire development process, including needs assessment,

Recommendations for assessing patient outcomes and costs of guidelines

Guideline development requires significant resources; the average time to prepare a HICPAC guideline, for example, is about 2 years and involves dozens of experts. Additional resources are required for disseminating and implementing guidelines, and because guidelines become outdated within a few years [48], there is additional cost for updating them on a regular basis.

Despite this national movement toward standardization of evidence-based practice, the clinical impact and patient outcomes

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