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Biomedical subjects

D H Feeny

Publications and source records attributed to D H Feeny.

21 records · Page 2Linked to original sources

Incorporating utility-based quality-of-life assessment measures in clinical trials. Two examples.

The utility approach to the measurement of health-related quality of life is discussed and its theoretical foundations and compatibility with economic evaluation are explained. The advantages of the approach include its generalizability, comprehensiveness, ability to integrate mortality and morbidity effects, ability to represent multiple viewpoints, and its incorporation of time and risk preferences in the scores. Disadvantages include interviewer administration, limitations on obtaining scores from all types of subjects, some lack of precision, and attenuated clinical sensibility. Use of the utility approach as an outcome measure in two recent clinical trials is also described. In a trial of an oral gold compound for arthritis, the utility measures were responsive and added information to that from standard clinical and other quality-of-life measures. The utility approach and clinical decision making are being used in an on-going trial of two procedures for prenatal diagnosis in which major potential differences include quality-of-life effects. The comprehensiveness of the utility approach overcomes difficulties in interpreting results from more narrowly focused psychosocial measures of outcome. In sum, the utility model provides a reliable, valid, and responsive approach to measuring quality of life as an outcome in clinical trials.

Adult↗

A framework for clinical evaluation of diagnostic technologies.

Most new diagnostic technologies have not been adequately assessed to determine whether their application improves health. Comprehensive evaluation of diagnostic technologies includes establishing technologic capability and determining the range of possible uses, diagnostic accuracy, impact on the health care provider, therapeutic impact and impact on patient outcome. Guidelines to determine whether each of these criteria have been met adequately are presented. Diagnostic technologies should be disseminated only if they are less expensive, produce fewer untoward effects and are at least as accurate as existing methods, if they eliminate the need for other investigations without loss of accuracy, or if they lead to institution of effective therapy. Establishing patient benefit often requires a randomized controlled trial in which patients receive the new test or an alternative diagnostic strategy. Other study designs are logistically less difficult but may not provide accurate assessment of benefit. Rigorous assessment of diagnostic technologies is needed for efficient use of health care resources.

Clinical Trials as Topic↗

The role of before-after studies of therapeutic impact in the evaluation of diagnostic technologies.

Studies in which clinicians' therapeutic plans are determined before and after application of a new test offer an attractive alternative to randomized trials as a strategy for establishing the usefulness of diagnostic technologies. To maximize scientific credibility such studies should include a number of design features: specific clinical questions should be addressed; consecutive patients presenting with a clinical problem should be entered; the test's accuracy should be assessed; and changes in therapy should be described in sufficient detail to allow an estimate of the impact on patient outcome. Even with attention to these issues, the validity of before-after studies of therapeutic impact is limited by possible discrepancies between clinicians' stated plans and actual behavior, and by the often tenuous link between change in therapy and patient benefit. Before-after designs will be most useful in primary investigations which, if positive, should be followed by more rigorous studies to establish patient benefit.

Diagnosis↗