When treating patients, doctors and other healthcare providers often are faced with difficult decisions and considerable uncertainty. They rely on the scientific literature, in addition to their knowledge, experience, and patient preferences, to inform their decisions. Clinical practice guidelines are statements that include recommendations intended to optimize patient care. They are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. Because of the large number of clinical practice guidelines available, practitioners and other guideline users find it challenging to determine which guidelines are of high quality. If guideline users had a mechanism to immediately identify high quality, trustworthy clinical practice guidelines, their health-related decision making would be improved—potentially improving both health care quality and health outcomes.
The U.S. Congress, through the Medicare Improvements for Patients and Providers Act of 2008, asked the IOM to undertake a study on the best methods used in developing clinical practice guidelines. The IOM developed eight standards for developing rigorous, trustworthy clinical practice guidelines (see the complete list of standards). To properly evaluate the effects of the standards on clinical practice guidelines development and health care quality and outcomes, the IOM encourages the Agency for Health Care Research and Quality to pilot-test the standards and assess their reliability and validity. While there always will be uncertainty in clinical practice, ensuring that clinicians have trustworthy guidelines will bring more evidence to bear on clinician and patient decision making.
Healthcare decision makers—including clinicians and other healthcare providers—increasingly turn to systematic reviews for reliable, evidence-based comparisons of health interventions. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies. They can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. But the quality of systematic reviews varies; often the scientific rigor of the collected literature is not scrutinized or there are errors in data extraction and meta-analysis.
In the Medicare Improvement for Patients and Providers Act of 2008, Congress directed the IOM to develop standards for conducting systematic reviews. In this report, the IOM recommends standards for systematic reviews of the comparative effectiveness of medical or surgical interventions (see the list of the standards). The standards are meant to assure objective, transparent, and scientifically valid systematic reviews. The evidence base for how best to conduct systematic reviews is limited, and no set of standards is generally accepted or consistently applied. For example, there is little research on how to manage bias for individuals providing input into the systematic review, or on who should screen and select studies for the review. In developing its standards, the IOM relied on the current methodological evidence and guidance from respected organizations that produce systematic reviews. The IOM's standards address the entire systematic review process, from locating, screening, and selecting studies for the review, to synthesizing the findings (including meta-analysis) and assessing the overall quality of the body of evidence, to producing the final review report.
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