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Literature Reviews in the Health Sciences

Connect with useful information and resources to learn about different types of literature reviews and the process of conducting them.

Diagnostic Test Accuracy Review

Definition

Systematic reviews of diagnostic test accuracy provide a summary of test performance based on all available evidence, evaluate the quality of published studies, and account for variation in findings between studies (Deeks, 2001; Leeflang, 2014).

Primary studies that investigate the accuracy of diagnostic tests are termed diagnostic test accuracy (DTA) studies.

Diagnostic Test Accuracy (DTA) Studies

Diagnostic test accuracy studies compare a diagnostic test of interest (the ‘index test’) to an existing diagnostic test (the ‘reference test’), which is known to be the best test currently available for accurately identifying the presence or absence of the condition of interest.. The outcomes of the two tests are then compared with one another in order to evaluate the accuracy of the index test (Campbell et al., 2020).

According to Leeflang (2014) there are two main types of studies of DTA:

  • Diagnostic case-control design (two gate design): In this study design people with the condition (cases) come from one population (i.e. a health care center for people known to have the condition), while people without the condition come from another (controls). Although this design gives an indication of the maximum accuracy of the test, the results will generally give an exaggerated indication of the test’s accuracy in practice.
  • Cross-sectional design: A more cohort-like approach, this study design involves all patients suspected of having the condition of interest undergoing both the index test(s) and the reference test. Those who test positive for the condition by the reference test can be considered to be the cases, whereas those who test negative are the controls. This study design is held to reflect actual practice better and is more likely to provide a valid estimate of diagnostic accuracy.

When is a Diagnostic Test Accuracy methodology appropriate?

When to Use It: New diagnostic tests are continuously developed, driven by demands for improvements in speed, cost, ease of performance, patient safety and accuracy. According to the JBI Manual, "Consequently there are often several tests available for the diagnosis of a particular condition. This highlights the importance of clinicians and other healthcare practitioners having access to high level evidence on the accuracy of the diagnostic tests they use or are considering using. The end goal of diagnostic tests is that they result in improved outcomes in areas that are important to the patient" (section 9.1). 

Diagnostic Test Accuracy Reviews are best designed for:

  • Assessing the true evidence from diagnostic test accuracy (DTA) studies

Note: Systematic reviews that investigate whether diagnostic tests improve outcomes are reviews of effectiveness, and should be carried out using methods associated with conducting systematic reviews of effectiveness.

Outline of Stages

Timeframe: 12+ months.

Question: Participants, index test(s) to evaluate (may be old or new), target condition(s) (what you are trying to diagnose), reference standard(s) or reference test (the existing diagnostic test) for verification of index test results (there may be more than one reference standard.

Most diagnostic test accuracy (DTA) review questions are comparative-to replace an existing test, to be used in addition to another test or to decide whether another test should be undertaken (triage).

Sources and searches: Comprehensive and rigorous, includes a combination of database, grey literature, and hand searching to locate published and unpublished literature.

Selection: Based upon clear inclusion/exclusion criteria.

Appraisal: Critical and rigorous assessment of bias and appraisal using STARD and/or QUADAS-2 or JBI critical appraisal checklist.

Synthesis: Qualitative with Summary of Findings table (SOF) and quantitative (Meta-Analysis)-varies slightly from a traditional systematic review.

*The Cochrane DTA review structure has three fixed subheadings under the discussion section to guide the interpretation of the results: ‘Summary of main results’, ‘Qualifying DTA evidence’, and ‘Applicability of findings to the review question’. The authors’ conclusions section is divided into ‘Implications for practice’ and ‘Implications for research’."

Methods and Guidance

The following resources provide an overview and guidance on conducting and reporting a diagnostic test accuracy review.

Methods & Guidance

The official step-by-step guide that describes in detail the process of preparing and maintaining systematic reviews of test accuracy. 

An extensive and detailed outline within the JBI Manual for Evidence Synthesis on how to properly conduct a diagnostic test accuracy review. 

Reporting Guideline

Published in 2018, the 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews of diagnostic test accuracy studies.

STARD 2015 is an updated 30-item checklist that replaces the original STARD (2003) guideline, which seeks to improve completeness and transparency in reporting of diagnostic accuracy studies.

Examples of Diagnostic Test Accuracy Reviews

Supplementary Resources