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ISSUE 4: CUTCoME ASSESSMENT FEsEARCH7 Clinical investigation! as defined for this study, does not include certain kinds of research that in the Opinion of the Committee' will hP-~mP increasingly important in the years ahead. For example! ~ the area of drugs, where pr e-m arketing studies typically involve small numbers of patiently the actual use of medicines (and their impact on treatment cutoome)l are only partially predictable in advance of regulatory approval. The ultimate utility of a drug ~ medical practice will be affected by the skill with With it is And, the present of so overlaid states, and its relative performers Irk not anly with alternative Is, but also with Aver alternative treads Such as surgery or 'swat waiting) . Any Other intenrer Lions in con use/ including many major sulfa 1 cperations and invasive diagnostic procedures, have not received the careful pa e-m arketing assessments Directed at drugs (28-32). me reswit is the existence of large deficits in the information needed to provide a scientific halls for medical practice. Epidemiologic studies Ike required to answer important questions that may arise at any time in ~e history of dogs and pros available to ~ reat con cxx~itions. "acne assent" With ir~cludes the full sputum of meters and approach; useful in evaluating ~ results of diagrx:6is or treatment is seriously underacted, ci~ite ~ fact Cat it is a crucial area for rational clinical decision-- ki ~ , as well as health policy decisions (31). Thea- considerations point up the need for a broader definition of "clinical investigation" than is contained in the definition pro posed in the past. There is strong support within the committee for greater emphasis on the evaluative clinical sciences and for a national program to a==-C~ the ootocces of alternative treatments. The outcome values to patients of many common interventions are not well understood, in large part because systematic investigations of efficacy, effectiveness and ccsts have not been conducted to compare treatment options avail able for a given condition or illness. Examples of undere valuated treatment options include major surgery, invasive and risky diagnostic procedures, drugs `~=PO for indications other than Those evaluated in formal FD\-requlated efficacy studies, and the a.=- of intensive care units. Otner examples Include costly differences In professional opinions on the relative advantages of treating patients in the hospital or the outpatient sewing. the oorx~uct of this ~a~ chord follow the pattern of biblical and health service r~r~ wit grants awarded to academic cent; and 7See Appendix B: Wernberg, p. 82. 15

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investigators based on pear review. Although the results of outcome assessments are of vital interest to many parties, the program must be free f ~ regulatory or cost oontainment responsibility. The goal of this research is to improve the scientific basis for clinical and policy decision making. Rrcrm=endations 1. Need for Increased Scientific Evaluation of Outcomes The Commits== recommends acceleration in the growth in the nation's ~ tment to an organized agenda for treatment outcomes research. The agenda should (1) establish research programs to a~=-cc major treatment options for priority conditions such as angina p_ctoris, cataracts, arthritis of the hip, and prostatism; (2) promote the development of ~ _ ant methodologies through a program of grants and contracts; (3) fund investigator-initiated pro pceals; (4) support training grants and fellowship programs In the clinical evaluative sciences; and (5) establish feedback and education programs to practicing physicians and policy maters. 2. Increase In Funding of Outcome Assent The Committee applauds the commitment of The Medicare Trust Fund to allocate funds for ouboome research. We urge an increase in this level of funding over a period of years as megohms are developed. Additional dollars should be provided from private hearth insurance funds and corporations that are self-insured to provide stabs iffy and desirable growth. 3. Examination of Role of NIH in Outcome AE~SSmen~ The NIH has considerable Fax peptize in the area of outcome fluent. The Committee urges that the agency prepare studies on how it can be involved in the implementation of the above recommendations. 16