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Key Patient Management Topics for Effectiveness Research in Breast Cancer
Pages 24-38

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From page 24...
... with existing HCFA administrative data of the sort on which the preliminary analyses presented at the workshop were based; (2) with existing HCFA data augmented by clinical data from medical records abstracted by PRO s or from specially conducted patient surveys and follow-up studies; and (3)
From page 25...
... Throughout the discussion were expressions of concern about the relative lack in the HCFA database of necessary clinical and therapeutic data and how those deficiencies might be overcome through effectiveness research. Eighteen specific study topics were advanced by committee members and recorded during the early part of the discussion; they are shown, in somewhat condensed form, in Table 4.
From page 26...
... Breast self-examination and clinical examination in relation to mammography Outcomes of screening mammography in terms of disease detection, prevention of advanced cancer, prevention of death, improvement in quality of life, and cost-effectiveness THERAPEUTIC ALTERNATIVES: RAD~AT~oNa THERAPEUTIC ALTERNATIVES: CHEMoTHERAPYa THERAPEUTIC ALTERNATIVES: SURGERY OPT~oNsa THERAPEUTIC ALTERNATIVES: HORMONAL TREATMENTa RECONSTRUCTIVE (COSMETIC) SURGERY Fo~ow-uP CARE Relationship of follow-up tests and age, stage of disease Role of bone scan Frequency of monitoring tests Psychological impact of follow-up PALLIATIVE CARE PATIENT EDUCATION Example: evaluate mailing educational materials in Social Security checks PATTERNS OF CARE Understanding patterns of use of the whole range of primary therapy alternatives (e.g., surgery options, radiation, chemotherapy)
From page 27...
... are discussed further in the subsection on "Methods Issues," below. Second, we recommend three clinical or patient management topics for initial attention in the effectiveness research program targeted on breast cancer: 1.
From page 28...
... Thus, we recommend that an effectiveness research program continue to support work on patterns of care, and that such projects be linked expressly to the three key clinical topics identified (screening and mammography, therapeutic alternatives, and posttreatment monitoring)
From page 29...
... Once these "existing" prevalent cancers are dealt with and routine screening only detects absolutely new cases, the treatment has its real test. Outcomes We recommend that effectiveness research deal with three related issues concerning outcomes.
From page 30...
... in this capacity, despite its application over the years in carefully designed cancer studies. Thus, we recommend that agencies involved in effectiveness research solicit outside expert opinion to define and select an adequate, appropriate set of outcome measures (other than mortality)
From page 31...
... PATIENT MANAGEMENT TOPICS Screening and Mammography We recommend that agencies involved with effectiveness research begin preliminary analyses on mammography and screening while undertaking a detailed planning effort to design a comprehensive, prospective, longitudinal research program focused on screening mammography. In the workshop discussion, committee members raised numerous questions about mammography itself, about widespread use of mammography as a screening technique, and about the downstream consequences and outcomes of screening mammography.
From page 32...
... For design of patient outcomes analysis, a full range of reliable and valid health status and quality-of-life measures must be considered; outside expert opinion should be sought about good candidate measures for this purpose. In addition, this plan should incorporate information and methods available from the SEER registries and the National Cancer Institute CCOPs.
From page 33...
... Third, the clinical circumstances of mammogram and biopsy are important. One distinction is whether the mammogram is part of a standard workup in a symptomatic woman or has been done in a routine screening program.
From page 34...
... We advise further that HCFA and other federal agencies use the HCFA databases and other resources to track the emergence of other therapies or combinations of therapies that might warrant closer attention in the future. As with screening mammography, some issues can be addressed immedi ately with a combination of existing HCFA databases and medical record
From page 35...
... These should incorporate a wide range of patient outcomes and examine practice behaviors of physicians and other providers more closely. We specifically mean to include health status and quality-of-life measures in this concept, even if they require that information be obtained directly from patients in addition to that obtained indirectly through information in medical records.
From page 36...
... Furthermore, in the case of tamoxifen administered in the ambulatory setting, HCFA claims data would not be available until 1991 (assuming an outpatient drug benefit mandated by the Medicare Catastrophic Coverage Act goes into effect) .~3 Thus, we believe that any outcome or effectiveness studies lacking accurate data of this sort will be flawed.
From page 37...
... This issue deserves emphasis because of the emerging evidence that older women receive different types of therapy than younger women with no apparent epidemiologic, clinical, or demographic justification. Women who are 65 or older may have relatively more advanced stages of breast cancer when they first appear for treatment, and
From page 38...
... We believe innovative ways to investigate this issue should be developed, perhaps by supporting research efforts that would use insurance claims files for non-Medicare populations in comparison with those for Medicare.


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