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AHCPR-SPONSORED CLINICAL EFFECTIVENESS TRIALS WILL GET UNDER WAY IN FY 1994

Executive Summary

AHCPR-SPONSORED CLINICAL EFFECTIVENESS TRIALS WILL GET UNDER WAY IN FY 1994, the FY 1994-98 strategic plan of the HHS Agency for Health Care Policy and Research states. Discussed at a Sept. 14 meeting of the agency's National Advisory Council for Health Care Policy, Research and Evaluation, the plan stresses that the clinical effectiveness trials will be "substantially different" from traditional efficacy studies in that the effectiveness trials will be "designed to focus on clinical outcomes that occur under ordinary conditions, achieved by representative community providers caring for representative patients. Effectiveness trials will provide definitive information to assist providers and patients faced with clinical choices." The effectiveness trials will be conducted as part of the work of AHCPR's Patient Outcomes Research Teams (PORTs). Unlike the AHCPR-funded panels that develop clinical practice guidelines, the PORT grantees conduct original research, although they so far have focused on meta-analyses of existing data. In general, PORTs examine medical conditions for which there is too little published data to construct a practice guideline. AHCPR Center for Medical Effectiveness Research Director Richard Greene, MD, explained that the agency has avoided clinical trials in the past because they are expensive and time-consuming. Nonetheless, he maintained that the agency will be able to undertake clinical trials without a substantial increase in the $15 mil. annual budget now dedicated to the PORTs because the agency will find "creative ways of doing them cheaply." Greene estimated that as many as six of the 12 PORTs may eventually participate in clinical trials to answer questions that cannot be addressed using existing literature or data. AHCPR has not yet targeted any specific medical conditions for the trials. As of January 1992, there were 12 PORTs in operation analyzing treatment alternatives for prostate disease; low back pain; acute myocardial infarction; cataract treatment; total knee replacement; ischemic heart disease; biliary tract disease; pneumonia; type II diabetes; hip fracture and hip replacement; Cesarean section and other obstetrical procedures; and prevention of stroke. The agency plans to award PORT contracts for research on unstable angina and cardiac rehabilitation by the end of fiscal year 1992 (Sept. 30). Future PORTs, according to the strategic plan, will study low birth weight, breast cancer, schizophrenia, substance abuse and chronic pulmonary disease. PORT grants extend for five years. AHCPR Administrator Jarrett Clinton, MD, reported at the Sept. 14 meeting that the agency is also considering whether to develop a clinical practice guideline on smoking cessation. Guidelines already have been issued addressing the management of bed sores, urinary incontinence ("The Pink Sheet" March 30, p. 11) and acute pain ("The Pink Sheet" March 9, p. 3). AHCPR has pushed back the release of a medical practice guideline on benign prostatic hyperplasia from this autumn to early 1993 ("The Pink Sheet" June 29, p. 6). The AHCPR plan indicates that the agency is giving increased attention to public-private coordination of technology assessment and health services research. In this area, AHCPR noted that it has been "contacted by public and private organizations concerned with the redundancy of multiple independent health technology assessments." AHCPR said it is beginning to "conceptualize the issues and options related to public-private partnerships in assessing health care technology" under the leadership of the agency's advisory council. "These activities are expected to result in an expansion of AHCPR's health technology assessment program by FY 1994, perhaps doubling the number of annual assessments and brief technology reviews beyond the current 10-12 per year." While AHCPR's technology assessment program is often viewed as geared to Medicare coverage policy, the agency reported that it is receiving inquiries for reports and recommendations for studies by Medicaid agencies, private insurers and corporate health benefits managers. The state of Illinois has enacted legislation directing that any AHCPR analyses of organ transplant procedures shall be considered "determinative" of their clinical effectiveness for insurance purposes, AHCPR said. Legislation to reauthorize AHCPR for three years beginning with FY 1993 cleared the Senate Labor & Human Resources Committee on Sept. 16. S 3179 includes a provision directing AHCPR to create an interagency technology assessment task force, with members drawn from the Public Health Service, Health Care Financing Administration, Veterans Affairs Department and Defense Department. The task force would foster coordination on technology assessments and identify high-priority topics for technology assessment or practice guidelines. The bill also would authorize AHCPR funding of up to $115 mil. in FY 1993, $145 mil. in 1994, and $175 mil. in 1995. A House AHCPR reauthorization bill, HR 5673, cleared the full House on Sept. 22. It directs that "such sums as may be necessary" be provided through FY 1996 rather than authorizing specific funding levels.
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