Eight standards are needed to create quality clinical guidelines, according to a report issued by the Institutes of Medicine.
Guidelines have become vital to clinicians trying to stay afloat in the flood of new medical discoveries. The number of randomized controlled trials published in MEDLINE grew from 5,000 per year from 1978 to 1985 to 25,000 per year from 1994 to 2001. They're of mixed or even suspect quality, authors wrote in their reports.
There were a handful of guidelines that synthesized best practices in the 1990s. But there's so much research that now there's now a glut of guidelines. The Agency for Healthcare Research and Quality’s National Guideline Clearinghouse contains nearly 2,700 of them, 722 added in 2008 alone.
With so many groups creating guidelines, the Institutes of Medicine wants to standardize them. First, the organization updated the definition to: "Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options."
The new definition is meant to distinguish clinical guidance derived from widely disparate development processes such as consensus statements, expert advice, and appropriate use criteria.
Next, the Institute of Medicine set eight standards:
--Establish transparent funding;
--Manage conflicts of interest;
--Balance guidelines writing committees among medical disciplines, between experts and clinicians, and including patient populations;
--Use systematic reviews that meet Institute of Medicine standards;
--Establish evidence foundations for and rating strength of recommendations, including a clear description of potential benefits and harms, evidence summaries and levels of confidence in the evidence;
--State recommendations in a standard form detailing precisely what the recommended action is, and under what circumstances it should be performed;
--Include all stakeholders in external reviews, including scientific and clinical experts, organizations, government agencies and patients and the public; and
--Update guidelines as needed.
An interactive graphic is here.
"These standards are necessary given that there is little documentation to judge the quality and reliability of many of the existing clinical practice guidelines," said Sheldon Greenfield, FACP, chair of the committee on guidelines, which also included Cynthia D. Mulrow, MACP, Senior Deputy Editor of the Annals of Internal Medicine.
Another report outlines 21 standards for systematic reviews, including starting them, finding and assessing individual studies, synthesizing evidence, reporting findings and improving quality.
"We recognize that it will take an investment of resources and time to achieve such high standards, but they should be adopted to minimize the chances that important health decisions are based on information that may be biased or erroneous," wrote the chair of that committee.