Affiliation:
1. Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan
Abstract
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.
Subject
Clinical Neurology,Neurology,General Medicine
Reference17 articles.
1. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology: A Basic Science for Clinical Medicine. Philadelphia: Lippincott Williams and Wilkins; 1991: 51–68.
2. The STARD Initiative and the Reporting of Studies of Diagnostic Accuracy
Cited by
8 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献