Zweig M H, Robertson E A
Clin Chem. 1982 Jun;28(6):1272-6.
A laboratory test is clinically useful only if it successfully answers a question of consequence to patient management. Unfortunately, the results and conclusions of many published test evaluations are misleading or of uncertain validity because common-sense principles of study design are overlooked. This is illustrated by examples from recent literature. We suggest that tests should be evaluated with prospective studies of patients representative of the population for which the test will ultimately be used. The clinical question to be addressed by the test should be clearly stated, and then answered for each patient by means independent of the test being evaluated. When comparing tests with each other, decision levels should be chosen to give either the same sensitivity or specificity for each. The use of soundly designed protocols for the clinical evaluation of tests provides the information needed to select the most effective tests.
一项实验室检查只有在成功回答了对患者管理具有重要意义的问题时，才具有临床实用性。不幸的是，许多已发表的检查评估的结果和结论具有误导性或有效性不确定，因为研究设计的常识性原则被忽视了。近期文献中的例子说明了这一点。我们建议，应该对代表最终将使用该检查的人群的患者进行前瞻性研究，以评估检查。应该明确说明该检查要解决的临床问题，然后通过独立于所评估检查的方法对每位患者进行解答。在相互比较检查时，应选择决策水平，以使每种检查具有相同的敏感性或特异性。使用设计合理的方案对检查进行临床评估可提供选择最有效检查所需的信息。
