sional characteristics of physicians (explicitly including physician specialty, such as “specialist” versus “generalist” and type of specialist).

Third, definitions and patterns of outcomes were judged to need considerable attention. Outcomes should be more comprehensively defined in line with recent developments in the field of health status and quality-of-life measurement. Use of reliable and valid “generic” measures of health status coupled with selected “disease-specific” measures is an appropriate, desirable, and practical research strategy. For all patients, measures of morbidity (including pain and other symptoms), functional status (including physical capacity and ability to function in daily life), psychological and emotional well-being, social functioning and support networks, and general outlook on health are important. Patient values and preferences need to be explicitly taken into account, so it is important to differentiate between outcomes and patient preferences for outcomes and to encourage the acquisition and use of information on patient preferences, given different outcomes. The committee also recommended that agencies involved in effectiveness research solicit outside expert opinion to define and select an adequate, appropriate set of outcome measures (other than mortality) and instruments to be considered for use in this research effort generally and for use explicitly for breast cancer.

The committee identified three other topics relating to outcomes. One was complications of surgery, especially in the Medicare population, and whether those complications vary by geographic region, by provider, or by type of surgery and whether the use of chemotherapy or tamoxifen is related to complications in any way. Another was toxicity of standard therapies (radiation and chemotherapy) in elderly women. The last was quality-of-life outcomes for women with recurrent breast disease.

Fourth among the nonclinical or methods topics was that other general issues of methodology, including indices of severity, case mix, and staging, were felt to warrant separate attention. This included methods for gathering a minimum set of appropriate clinical data and for developing a standard severity-of-illness or staging index. Among the elements in such an index might be comorbidity (e.g., coexisting diagnoses of the sort that can be derived from Medicare Part A files), pathological stage and type of disease, and hormone receptor status.

The committee also recommended three clinical or patient management topics for initial attention in the effectiveness research program targeted on breast cancer: screening and mammography; therapeutic alternatives for primary cancer, particularly as a function of age and stage of disease and of provider characteristics; and approaches to follow-up monitoring and care (including therapy for recurrent disease).

With respect to screening and mammography, the committee recommended that agencies responsible for effectiveness research begin preliminary analy-



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