Boutros N N, Arfken C L
Department of Psychiatry and Behavioral Neurosciences, Wayne State University, School of Medicine, 2751 E. Jefferson, Detroit, MI 48207, USA.
Clin EEG Neurosci. 2007 Apr;38(2):62-5. doi: 10.1177/155005940703800206.
A four-step approach for developing diagnostic tests in psychiatry is proposed. Step 1, a biological variable is observed to be deviant from healthy controls in a particular patient population. The demonstration of test retest reliability of the finding using blinding procedures is an essential component of this early step. Step 2, is the demonstration of potential clinical usefulness of the specific finding. The two most important objectives at this step are demonstration of difference between the target patient population and appropriate control groups (these should be groups of patients with diagnoses that commonly appear on the differential diagnostic lists of the target disorder). Estimation of the effect size of the finding could be a reasonable guide to which findings should be considered good candidates for Step 3 studies. During Step 3 the performance characteristics of the test should be established. Specifically, the sensitivity, specificity, positive and negative predictive values of the biological marker should be examined. Step 4 defines the clinical application of the test and helps standardize the technique used in large and multicenter clinical trials. Multicenter trials should pave the road towards standardization of laboratory procedures used to conduct the test, as well as providing data regarding cost effectiveness and impact on both short-term and long-term clinical outcomes.
本文提出了一种用于开发精神病学诊断测试的四步法。第一步，在特定患者群体中观察到一个生物学变量与健康对照存在差异。使用盲法程序证明该发现的重测信度是这一早期步骤的重要组成部分。第二步，证明该特定发现的潜在临床实用性。此步骤的两个最重要目标是证明目标患者群体与适当对照组之间的差异（这些对照组应为诊断出现在目标疾病鉴别诊断列表中的患者群体）。对该发现效应大小的估计可能是判断哪些发现应被视为第三步研究的良好候选对象的合理指南。在第三步中，应确定测试的性能特征。具体而言，应检查生物标志物的敏感性、特异性、阳性和阴性预测值。第四步定义测试的临床应用，并有助于规范大型多中心临床试验中使用的技术。多中心试验应为用于进行测试的实验室程序的标准化铺平道路，并提供有关成本效益以及对短期和长期临床结果影响的数据。
