Journal of general internal medicine
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In this chapter of the Evidence-based Practice Centers Methods Guide for Medical Tests, we describe how the decision to use a medical test generates a broad range of outcomes and that each of these outcomes should be considered for inclusion in a systematic review. Awareness of these varied outcomes affects how a decision maker balances the benefits and risks of the test; therefore, a systematic review should present the evidence on these diverse outcomes. The key outcome categories include clinical management outcomes and direct health effects; emotional, social, cognitive, and behavioral responses to testing; legal and ethical outcomes, and costs. ⋯ Consider to which group the outcomes of testing are most relevant. Given resource limitations, prioritize which outcomes to include. This decision depends on the needs of the stakeholder(s), who should be assisted in prioritizing the outcomes for inclusion.
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In this paper, we discuss common challenges in and principles for conducting systematic reviews of genetic tests. The types of genetic tests discussed are those used to 1). determine risk or susceptibility in asymptomatic individuals; 2). reveal prognostic information to guide clinical management in those with a condition; or 3). predict response to treatments or environmental factors. This paper is not intended to provide comprehensive guidance on evaluating all genetic tests. ⋯ In situations where clinical factors associated with risk are well characterized, comparative effectiveness reviews should assess the added value of using genetic testing along with known factors compared with using the known factors alone. For genome-wide association studies, reviewers should determine whether the association has been validated in multiple studies to minimize both potential confounding and publication bias. In addition, reviewers should note whether appropriate adjustments for multiple comparisons were used.
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Recent research into the placebo effect has implications for the ethics of shared decision-making (SDM). The older biomedical model views SDM as affecting which therapy is chosen, but not the nature or likelihood of any health outcomes produced by the therapy. ⋯ An ethical tension is thereby created between SDM aimed strictly and solely at conveying accurate information, and "outcome engineering" in which SDM is adapted toward therapeutic goals. Several practical strategies mitigate this tension and promote respect for autonomous decision-making while still utilizing the therapeutic potential of SDM.
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This article discusses techniques that are appropriate when developing search strategies for systematic reviews of medical tests. This includes general advice for searching for systematic reviews and issues specific to systematic reviews of medical tests. ⋯ A comprehensive search should include multiple databases and sources of grey literature. A list of subject-specific databases is included in this article.