Country update - USA
Guidelines Development and Implementation in the United States
The United States has a history in clinical practice guideline development that goes back to the early 1980s. Although the methodology originally employed has undergone considerable changes, concurrently, some inaugural editions of those guidelines have been updated every few years with ever-increasing standards.
Today, in the United States, the majority of guidelines are developed by medical specialty societies (e.g., American College of Physicians, American Academy of Pediatrics, American College of Chest Physicians), other professional associations (e.g., American Optometric Association, American Heart Association), and disease-specific societies (eg, American Epilepsy Society, Multiple Sclerosis Council). Other guideline developers primarily include private nonprofit organizations (e.g., Consortium for Spinal Cord Medicine, Health Care Association of New Jersey) and academic institutions.
Medical specialty societies, professional associations and disease-specific societies are responsible for roughly 80% of the 142 US organizations whose guidelines are posted on the National Guideline Clearinghouse (NGC), a database hosted by the Agency for Healthcare Research and Quality (AHRQ) of the US Department of Health and Human Services, a federal government entity. Most US guidelines are posted on the NGC, and many are also posted in the G-I-N library. The NGC includes guidelines from countries all over the world.
In the past year, and especially with the recent healthcare reform legislation, the US government has infused billions of dollars into comparative effectiveness research and placed a priority on evidence-based medical decisions. The US government currently funds some guidelines (129 were posted on the NGC as of May 12, 20103), mainly through the Centers for Disease Control and some branches of the National Institutes of Health (eg, the National Heart, Lung, and Blood Institute). The US Preventive Services Task Force (USPSTF) is supported and convened by AHRQ to make “recommendations about which preventive services should be incorporated routinely into primary medical care and for which populations.” Other than the USPSTF, AHRQ does not develop clinical practice guidelines directly but does promote comparative effectiveness reviews and other systematic reviews that serve as a foundation for guidelines produced by others.
The multiple sources of guidelines have produced many individuals with experience and expertise in guideline development, as well as knowledge of the tools and techniques of evidence-based medicine. Furthermore, guidelines produced by medical specialty societies and other membership organizations generally are accepted by their membership and can be readily marketed to the appropriate user populations. However, the multiplicity of developers has created a system that can be fragmented and result in variable levels of methodological rigor and conflicting guidance for physicians and other health-care professionals. Due to the disjointed efforts and lack of a centralized funding source, incentives do not always properly align to promote harmonization of competing guidelines, yet there is a movement rapidly gaining acceptance to harmonize guidelines as much as possible. Efforts to collaborate across organizations and disciplines (both by specialty and by type of practitioner) have been increasing and include international collaborations.
The Institute of Medicine (IOM), an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public, currently has a committee working on the development of “trustworthy standards” for clinical practice guidelines.
A sister committee is charged with developing standards for evidence reviews. The resulting reports are not expected until 2011, but the anticipation is high for the IOM to raise the bar for the methodological rigor of the processes. Funding is a concern that guideline developers would also like to see addressed in these reports, especially since previous reports from the IOM appealed to developers to refrain from accepting financial support from pharmaceutical companies and medical device manufacturers, resulting in few remaining sources.
US guideline developers are also challenged by the intense scrutiny of the media, the US Congress, and others to rigorously address and manage conflicts of interest. Conflicts are very important to avoid or manage so that there are no real or perceived biases in the recommendations, but they are not just related to the funding sources. Individual content experts sometimes consult or speak for pharmaceutical or medical device manufacturers.
Much of the clinical research studies are funded by industry, and the investigators become the most knowledgeable experts in their particular content area. Conflicts of interest have been the topic of many articles, but there are no mutually agreed-upon constructive definitions or processes. Guideline producers, and education providers and others, have been struggling to develop their own policies for review and enforcement, resulting in widespread variability. Although this is not just a US problem, it is in the United States that the guideline developers must proactively protect their guidelines, panels, and organizations from the potential threat of intense scrutiny and possible public relation ordeals.
Today, in the United States, evidence-based guideline recommendations are being used as a foundation for performance measures and other quality improvement tools, medical education curricula, and even health-care policies. Guideline developers and others are developing performance measures by which health-care providers will be held accountable and reimbursed accordingly. One of the most prolific of these measure developers, the Physician Consortium for Performance Improvement, has recently passed a policy setting criteria for the standardized evaluation of the evidence base, primarily to promote the rigor and consistency of the scientific and oversight procedures for guideline development. Evidence-based guideline recommendations are increasingly being incorporated into electronic medical record systems and both electronic and nonelectronic point-of-care decision support tools.
US physicians have postgraduate credentialing requirements set by their own medical specialty boards, as well as maintenanceof licensure, required under the states in which they practice. Recent advancements in understanding the effectiveness of continuing medical education and lifelong learning theory have encouraged the incorporation of performance improvement elements into the requirements. The development of educational curricula begins with a gap analysis, understanding what is currently happening in practice compared with what should be happening. Therefore, quality medical education in the United States should be designed around the known evidence and guideline recommendations.
The Centers for Medicare and Medicaid Services (CMS) sets the reimbursement rates for care provided to the elderly and lowerincome populations. Private health insurers often follow similar policies. Evidence-based guideline recommendations have sometimes been cited as a basis for CMS rules.
US guideline developers and others working in evidence-based medicine are looking forward to learning from each other and our international colleagues at the G-I-N 2010 Conference, held August 25-28, 2010, in Chicago, IL. Nine US organizations are currently members of G-I-N. However, with the meeting in Chicago this year, it is expected that this number will grow. We look forward to seeing you there!
- Some non-US guideline developers may be included in this data.
- Current as of May 12, 2010.
- The ECRI Institute, which provided these data, has been the contractor to the AHRQ since 1997 to create and maintain the National Guideline Clearinghouse.
- Agency for Healthcare Research and Quality (AHRQ). About USPSTF. www.ahrq.gov/clini/uspstfab.htm. Accessed June 1, 2010
- The Institute of Medicine. About the IOM. www.iom.edu/About-IOM.aspx. Accessed June 3, 2010.
- Effectiveness of Continuing Medical Education: American College of
Thanks to Sandra Zelman-Lewis for her contribution with this piece.
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