Study designs for comparative diagnostic test accuracy: A methodological review and classification scheme

doi:10.1016/j.jclinepi.2021.04.013

Journal of Clinical Epidemiology

Volume 138, October 2021, Pages 128-138

https://doi.org/10.1016/j.jclinepi.2021.04.013 Get rights and content

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Abstract

Objectives

(1) To identify and classify comparative diagnostic test accuracy (DTA) study designs; (2) to describe study design labels used by authors of comparative DTA studies.

Methods

We performed a methodological review of 100 comparative DTA studies published between 2015 and 2017, randomly sampled from studies included in 238 comparative DTA systematic reviews indexed in MEDLINE in 2017. From each study report, we extracted six design elements characterizing participant flow and the labels used by authors.

Results

We identified a total of 46 unique combinations of study design features in our sample, based on six design elements characterizing participant flow. We classified the studies into five study design categories based on how participants were allocated to receive each index test: ‘fully paired’ (n=79), ‘partially paired, random subset’ (n=0), ‘partially paired, nonrandom subset’ (n=2), ‘unpaired randomized’ (n=1) and ‘unpaired nonrandomized’ (n=3). The allocation method used in 15 studies was unclear. Sixty-one studies reported, in total, 29 unique study design labels but only four labels referred to specific design features of comparative studies.

Conclusion

Our classification scheme can help systematic review authors define study eligibility criteria, assess risk of bias, and communicate the strength of the evidence. A standardized labelling scheme could be developed to facilitate communication of specific design features.

Keywords

Diagnostic accuracy

Test comparison

Study design

Comparative accuracy studies

Bias

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: Conflicts of interest: The authors have no conflict of interests to declare.

: Funding: Amsterdam UMC (The Netherlands) provided funding for this study. The funding organization had no role in the design, collection, analysis, and interpretation of the data or the decision to approve publication of the finished manuscript.

: CRediT author statement: B.Y.: Conceptualization, Project administration, Methodology, Investigation, Formal analysis, Writing – Original Draft, Writing – Review & Editing. M.O.: Conceptualization, Methodology, Investigation, Formal analysis, Writing – Review & Editing. Y.V.: Investigation, Formal analysis, Writing – Review & Editing. M.W.L.: Conceptualization, Methodology, Writing – Review & Editing, Supervision. Y.T.: Methodology, Writing – Review & Editing. C.H.: Methodology, Writing – Review & Editing. P.M.M.B.: Methodology, Formal analysis, Writing – Review & Editing, Supervision. M.M.G.L.: Conceptualization, Methodology, Formal analysis, Writing – Review & Editing, Supervision.