Guidelines for the clinical and economic evaluation of health care technologies.
The health care system is routinely confronted with promising new technologies. In the past, most new technologies have been integrated into clinical practice without a rigorous demonstration of their effectiveness or efficiency. In order to provide a more rational approach to the adoption and utilization of health technology a comprehensive set of guidelines for both clinical and economic evaluation is proposed. While conceived of as an ideal that is unlikely to be universally met in practice, it is argued that decision making can be improved by striving towards this goal. The clinical guidelines stress the advantages of subjecting major new technologies to randomized controlled trials and insisting upon a demonstration of patient benefit in the application of diagnostic technologies. The economic guidelines stress comparisons with relevant alternative uses of the resources and the assessment of the impact on the quality of life. While application of the guidelines will produce rigorous and useful evidence, the final decisions concerning the allocation of health care resources must rest fundamentally on social value judgements and not solely, or even primarily, on informed expert opinion.
D002986:Clinical Trials as Topic; D035061:Control Groups; D003362:Cost-Benefit Analysis; D003625:Data Collection; D003933:Diagnosis; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D011786:Quality Control; D011897:Random Allocation; D012107:Research Design; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000592:standards; D013812:Therapeutics