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:
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:
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.
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and rigorous, includes a combination of database, grey literature, and hand searching to locate published and unpublished literature.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’."
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.