Decision making about healthcare-related tests and diagnostic test strategies. Paper 2: a review of methodological and practical challenges.

OBJECTIVES: In this first of a series of five articles, we provide an overview of how and why healthcare-related tests and diagnostic strategies are currently applied. We also describe how our findings can be integrated with existing frameworks for making decisions that guide the use of healthcare-related tests and diagnostic strategies.

STUDY DESIGN AND SETTING: We searched MEDLINE, references of identified articles, chapters in relevant textbooks, and identified articles citing classic literature on this topic.

RESULTS: We provide updated frameworks for the potential roles and applications of tests with suggested definitions and practical examples. We also discuss study designs that are commonly used to assess tests' performance and the effects of tests on people's health. These designs include diagnostic randomized controlled trials and retrospective validation. We describe the utility of these and other currently suggested designs, which questions they can answer and which ones they cannot. In addition, we summarize the challenges unique to decision-making resulting from the use of tests.

CONCLUSION: This overview highlights current challenges in the application of tests in decision-making in healthcare, provides clarifications, and informs the proposed solutions.