Chapter 1: Introduction to the Methods Guide for Medical Test Reviews

Abstract

Evaluation of medical tests presents challenges distinct from those involved in the evaluation of therapies; in particular, the very great importance of context and the dearth of comprehensive RCTs aimed at comparing the clinical outcomes of different tests and test strategies. Available guidance provides some suggestions: 1) Use of the PICOTS typology for clarifying the context relevant to the review, and 2) use of an organizing framework for classifying the types of medical test evaluation studies and their relationship to potential key questions. However, there is a diversity of recommendations for reviewers of medical tests and a proliferation of concepts, terms, and methods. As a contribution to the field, this Methods Guide for Medical Test Reviews seeks to provide practical guidance for achieving the goals of clarity, consistency, tractability, and usefulness.

Figure 1

Causal chain diagram.

Figure 2

A mapping across three major organizing frameworks for evaluating clinical tests. Notes: ECRI Institute created this figure based on the specified evaluation frameworks. For a detailed description of each included framework, the reader is referred to the original references.– Domain 1—analytical validity; Domain 2—clinical validity; Domain 3—clinical utility; Domain 4—ethical, legal and societal implications.