Institute of Medicine Report

Abstract

WASHINGTON, DC—At a time when health care's escalating costs are dominating the national stage, the economy is faltering and US Presidential candidates are introducing plans to bring medical care to the uninsured, the Institute of Medicine (IOM) has released a report calling for a new national program to assess the efficacy of the clinical services patients receive from a broad perspective, with an eye to determining what really works. The committee that wrote the report, which was funded by the Robert Wood Johnson Foundation, wants Congress to direct the US Department of Health and Human Services to establish this new program, which would conduct systematic, evidence-based reviews and develop and promote stringent standards for clinical practice guidelines. No cost-related recommendations were made, though. As envisioned by the IOM, the new clinical assessment program would appoint an independent, standing Priority Setting Advisory Committee (PSAC) to establish a workable process for selecting high-priority topics for systematic reviews of clinical effectiveness. PSAC members would be chosen according to expertise, with “minimal bias due to conflicts of interest.” While IOM recommendations don't have the force of law or regulation, the prestigious weight of IOM reports can have a major influence on medicine, as has happened with the IOM's identification of patient harm due to medical errors. The report, titled Knowing What Works in Health Care: A Roadmap for the Nation, cites “the imperative for immediate action” to change how the United States gathers and applies scientific evidence to evaluate the effectiveness of clinical interventions.FigureThe committee noted a particular concern about the rapid marketplace entry of new and often very costly health care technologies and treatments that have not been evaluated completely for clinical effectiveness and are not grounded in evidence-based science. From 1992 to 2001, the total number of biotechnology patents granted per year tripled, according to the report, from fewer than 2,600 to nearly 7,800. In addition, not only have medical treatments exploded, but the number of articles in the professional literature investigating the effectiveness of these treatments has also mushroomed, leading to serious information overload. Added Urgency The need for action cited by the IOM takes on added urgency, the report states, because of the aging of the 77 million US baby boomers, who are likely to develop multiple illnesses as they age and thus will “place increased demands on the health system and will add to cost pressures.” The report notes that “In the context of rapidly rising costs, society's ability to distinguish between health interventions that work and those that do not work, and for whom they work, is becoming more and more important.” Lack of Coordination While a number of organizations—including the American Society of Clinical Oncology and the National Comprehensive Cancer Network—currently develop evidence-based clinical practice guidelines, the IOM committee cites an overall lack of coordination and confusion in US medicine resulting from the lack of one national assessment agency, which has in turn resulted in duplication of effort and in some cases competing practice guidelines. This lack of coordination and confusion has led to a general uncertainty about which guidelines are the most reliable, the committee concluded. Thus, “a system coordinated by a single, national entity that can prioritize and coordinate these evaluations would enable us to sort the wheat from the chaff and make sense of it all,” said IOM Committee Chair Barbara J. McNeil, MD, PhD, the Ridley Watts Professor and Head of the Department of Health Care Policy at Harvard Medical School, in releasing the new report. Dr. McNeil is also Professor of Radiology at Harvard Medical School and Brigham and Women's Hospital. “To a great extent, the resolution of some of the nation's most pressing health policy concerns hinges on the capacity to identify highly effective clinical services,” the report notes. It pays tribute to US groups that have evaluated or promoted the evaluation of clinical interventions over the years, including the US Food and Drug Administration; the ECRI Institute; the RAND Corporation; the Agency for Healthcare Research and Quality; the Council of Medical Specialty Societies; the US Preventive Services Task Force; the Centers for Medicare and Medicaid Services; and the Blue Cross and Blue Shield Association. But, even though many public and private organizations evaluate clinical effectiveness and are improving in their capacity to do so, “significant gaps in the ability to develop, synthesize, and apply the evidence on clinical evidence remain,” gaps that can result in unevenness and variations in treatment from patient to patient. While all medical treatments should be systematically evaluated, part of the problem in evaluating clinical treatments is that the quality of systematic reviews varies, the IOM committee found. “Under the status quo, the quality of the reviews is variable, methods are poorly documented, and findings are often unreliable,” the report states. Thus the committee recommends that the new national clinical assessment program “establish evidence-based, methodological standards for systematic reviews, including standard terminology for characterizing the strength of evidence and a standard reporting format for systematic reviews.” One problem identified by the IOM committee: “It is not clear whether there are sufficient numbers of qualified researchers to conduct high-quality reviews,” a situation that might necessitate the expansion of this specialized workforce. Underlying the report is the assumption that the US clinical research establishment will remain strong and will continue to develop new treatments and clinical interventions—the very ones that will need thorough evaluation by the new assessment program the IOM calls for. But in the cancer field, for example, advances in clinical care are threatened by budgetary restrictions on the very research that produces the new clinical treatments to be assessed. The weak economic climate and uncertainty about what a new US President might do also make the reality of the IOM committee's roadmap for assessment of treatment efficacy problematic. But according to Dr. McNeil and committee members, the nation cannot afford not to do a better job of assessing medical treatments. Regardless of who becomes President, “the expense of emerging technologies and the projected increases in consumer demand virtually ensure that cost control will be a central focus for policy makers, health plans, and others in the coming years,” the committee concludes.