IOM issues clinical practice guidelines

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The Institute of Medicine (IOM) has released two reports that recommend standards for developing systematic reviews and promoting clinical practice guidelines.

A lack of universal standards for developing systematic reviews and a dearth of clinical practice guidelines has lead to variability in the handling of conflicts of interest, appraisals of evidence and the rigor of evaluations, the Washington, D.C.-based organization stated.

The IOM recommended eight standards for clinical practice guidelines, which are statements that include recommendations for optimizing patient care informed by systematic review of evidence and assessment of the benefits and harms of alternative care options.

In the second report, the organization listed 21 standards to ensure objective, transparent and scientifically valid reviews. These reviews identify, select, assess and synthesize the findings of similar but separate studies and can help clarify the potential benefits and harms of drugs, devices and services, the IOM stated.

To prevent actual or perceived conflicts of interest from eroding trust in clinical practice guidelines, guideline development groups should not have intellectual, institutional, financial or other forms of conflicts, the guidelines report stated. However, if a group cannot perform its work without conflicted members, these individuals should make up only a minority of the members.

Furthermore, those who fund guideline development work should have no role in the development process. Similarly, individuals with financial conflicts of interest and those with professional or intellectual biases that would lessen an evaluation's credibility should be excluded from the teams that conduct systematic reviews, the IOM report on reviews said.

"Getting input from consumers, health professionals, insurers and other intended users can boost the quality of reviews and guidelines and make them more relevant," the Institute stated. “Guideline development groups should include a current or former patient and a patient advocate or representative of a consumer organization.”

Systematic reviews should include a method to collect information from individuals with relevant perspectives and expertise. Individuals providing input should publicly acknowledge their potential biases and conflicts and be excluded from the process if their participation would diminish the evaluation’s credibility, the organization continued.

Because guideline developers often have to make subjective judgments about evidence, they should explicitly describe the part that value judgments, theory or clinical experience played in their recommendations, the guidelines report noted. "They should explain the reasoning underlying each recommendation they make, including their assessment of the quality, completeness and consistency of the available evidence."

The reports were requested by Congress and sponsored by the U.S. Department of Health and Human Services. They can be accessed here.