American Association for Clinical Chemistry
Better health through laboratory medicine
October 2008 Clinical Laboratory News: Guidelines Have an Impact But Face Tough Challenges


October 2008: Volume 34, Number 10 

2008 Annual Meeting Highlights

Guidelines Have an Impact But Face Tough Challenges
Session Looks at Boosting Use of Laboratory Practice Guidelines

By Phil Kibak

As a scientific organization that promotes quality in laboratory medicine, NACB has developed 19 laboratory practice guidelines since 1994. However, clinical guidelines are not always followed, even if their implementation can result in a positive effect on clinical care, noted J. Rex Astles, PhD, at the symposium Laboratory Practice Guidelines: Improving the Process-Maximizing the Impact. “Physicians may be unaware of them or unfamiliar with them, they may disagree with them, or they may think the guidelines are confusing, inconvenient, or cannot be implemented easily.”

Mismanaged healthcare is a big problem in the U.S., Astles said. “Up to 30% of Americans receive contraindicated care, only 50% receive recommended preventive services, and only about 55% receive recommended services for acute or chronic conditions.” Astles, who is senior health scientist at the CDC’s Laboratory System Development Branch, also described what goes into developing a guideline. “It can take as much as several years—and many meetings—to create clinical guidelines, and the cost involved can be as high as $2 million.”

Barriers to Guideline Adherence

If so much can be gained by using a clinical practice guideline, then why isn’t the adoption rate higher? “Regardless of what they are called—guidance, recommendations, best practices, or consensus statements—guidelines are voluntary, at least at some level, and there are typically many disincentives for adopting them,” Astles explained. Stumbling blocks to implementation include lack of self-efficacy, lack of outcome expectancy, and inertia of previous practice. In addition, guidelines may be perceived as difficult to use, inconvenient, or confusing. “Clinicians may interpret the evidence differently, or decide that the risks of the treatments suggested by the guidelines outweigh the benefits. Or, the therapy may cost too much or cause discomfort. From a practice perspective, there may be poor reimbursement or increased liability from following the guidelines.”

Astles referred to data from a study in which he and his CDC colleagues evaluated laboratory practice in the preanalytical phase of antimicrobial susceptibility testing among facilities in Washington state (J Clin Microbiol 2007;45(7):2230–34). Data from surveys sent to 102 hospital, reference, physician office-clinic, and public health laboratories were used to assess use of CLSI performance standards. Only 40% of respondents indicated that they were using the most current CLSI guidelines. But interventions such as technical workshops, a national teleconference, and reviewing educational materials led to changes in outcomes. Between 2001 and 2005 small hospital usage of the standards increased from 28% to 62%. “The thing to remember is that current impediments are future opportunities,” Astles said.

Clinical guideline development is a dynamic process that doesn’t stop after the guideline is published. Ninety percent of clinical practice guidelines are still valid after 3.6 years, but half are outdated by 5.8 years. The bottom line, Astles explained, is that organizations that produce these guidelines should reassess them every three years.

Tools in Guideline Development

At the same session, Mary Nix, project officer, Center for Outcomes and Evidence at AHRQ, presented information about the National Guideline Clearinghouse (NGC), a comprehensive database of evidence-based clinical practice guidelines and related documents. An initiative of AHRQ, the NGC was created to provide healthcare providers and health plans an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their implementation, and use.

“In our database we now have more than 2,200 guidelines from about 300 organizations,” Nix said. She gave an overview of the tools used in clinical guideline development, including three methods focused on helping guideline developers design useful guidelines that are more likely to be implemented. The AGREE tool (Appraisal of Guidelines, Research and Evaluation in Europe) was developed by an international collaboration of researchers and policy makers in order to improve the quality and effectiveness of clinical practice guidelines. It establishes a shared framework for developing, reporting, and assessment based on 23 key items organized into six domains: scope and purpose; stakeholder involvement; rigor of development; clarity and presentation; applicability; and editorial independence.

Another tool, GLIA (Guideline Implementability Appraisal) identifies obstacles to guideline implementation. GLIA uses a series of question that examine global elements of a guideline’s implementability, and pushes guideline developers to look at decidability, executability, measurable outcomes, flexibility, and other metrics for each individual recommendation. Similarly, the Grading of Recommendations Assessment, Development, and Evaluation (short GRADE) Working Group began in the year 2000 as an informal collaboration of people interested in tackling the shortcomings of present grading systems in healthcare. The working group developed a common, sensible, and transparent approach to grading quality of evidence and strength of recommendations. Many international organizations helped develop the approach and have started using it.

NACB Survey Results Coming

In the Spring of 2008, NACB leaders developed a survey on the use and impact of laboratory medicine practice guidelines. When drafting the survey, the group focused on questions about the implementation and use of both NACB guidelines and guidelines in general. The survey was sent to about 10,000 laboratorians and about 500 completed it, noted Stephen Kahn, PhD, director of laboratories at Loyola University Medical Center in Maywood, Ill. He presented some preliminary findings during the session.

About 85% of respondents replied that guidelines do have an impact on laboratory practices, and 73% said they drive changes in operations. “Which organizations develop guidelines that impact the laboratory work setting? From the survey, the top five organizations are the ADA, CLSI, CDC, ACC, and NACB. Guidelines that have been most influential include the NACB’s POCT (2007) and Biomarkers of ACS (2007),” Kahn said.

From the survey results, Kahn cited lack of cooperation or awareness on the part of physicians as barriers to implementing clinical practice guidelines. The respondents also mentioned the lack of a champion and the lack of resources, staff, or time as obstacles to applying guidelines. “Having a champion, such as a pathology or lab director or another institutional leader, can go a long way toward facilitating guideline use and implementation,” Kahn said.