PubMed · 1986 · 198 citations · 27 references
Public AffairsHealth PolicyDiagnostic AssessmentDiagnostic ImagingHealth Technology AssessmentClinical Effectiveness AssessmentComparative Effectiveness AssessmentDiagnostic EvaluationDiagnostic Test EvaluationMedical Technology AssessmentValue AssessmentClinical Evaluation StandardsCost-effectiveness Of Diagnostic TestingDiagnostic StrategyDiagnostic Testing AccuracyEfficient Resource UsePatient Outcome EvaluationPatient Outcome MeasurementPatient Outcome Monitoring
Most new diagnostic technologies lack adequate assessment of their impact on health, and comprehensive evaluation must establish technical capability, diagnostic accuracy, and effects on providers, therapy, and patient outcomes to ensure efficient use of resources. The paper presents guidelines to assess whether diagnostic technologies meet criteria for capability, accuracy, and impact. Patient benefit is best established through randomized controlled trials comparing the new test to alternative strategies, though less rigorous designs are logistically easier but may be less accurate. The authors conclude that technologies should be adopted only when they are cheaper, safer, at least as accurate as current methods, replace other tests without compromising accuracy, or enable effective therapy.
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.
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The Declining Specificity of Exercise Radionuclide Ventriculography
Alan Rozanski, George Diamond, Daniel S. Berman et al. · New England Journal of Medicine · 1983 · 319 citations