Van den Bruel A, Cleemput I, Aertgeerts B, Ramaekers D, Buntinx F
Department of General Practice, Katholieke Universiteit Leuven, Belgium; Belgian Health Care Knowledge Centre, Brussels, Belgium.
J Clin Epidemiol. 2007 Nov;60(11):1116-22. doi: 10.1016/j.jclinepi.2007.03.015. Epub 2007 Aug 29.
Before introducing a test in clinical practice, its characteristics and added value should be assessed. Diagnostic accuracy studies only are not sufficient; the test's impact on patient outcome ought to be assessed as well. To do this, we propose a stepwise evaluation of diagnostic tests.
Theoretical-conceptual approach.
First, the test's technical accuracy refers to the ability to produce usable information under standardized conditions. In a second step, the place of the new test in the clinical pathway is determined. Thirdly, the test's diagnostic accuracy is assessed, depending on its intended goal. The fourth step assesses the test's impact on the patient outcome. Depending on the place of the test in the clinical pathway, existing evidence can be used, or new evidence will be needed. At the final step, a cost-effectiveness analysis assesses the test's financial and societal consequences.
Diagnostic tests evaluation should consider the technical accuracy, the test's place in the clinical pathway, its diagnostic accuracy, and its impact on patient outcome.
在临床实践中引入一项检测之前，应评估其特性和附加价值。仅进行诊断准确性研究是不够的；还应评估该检测对患者结局的影响。为此，我们提出了一种对诊断检测进行逐步评估的方法。
理论概念方法。
首先，检测的技术准确性是指在标准化条件下产生可用信息的能力。第二步，确定新检测在临床路径中的位置。第三步，根据其预期目标评估检测的诊断准确性。第四步评估检测对患者结局的影响。根据检测在临床路径中的位置，可以使用现有证据，或者需要新的证据。在最后一步，成本效益分析评估检测的财务和社会后果。
诊断检测评估应考虑技术准确性、检测在临床路径中的位置、其诊断准确性以及对患者结局的影响。
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