TY - JOUR
T1 - Study designs for comparative diagnostic test accuracy: A methodological review and classification scheme
AU - Yang, Bada
AU - Olsen, Maria
AU - Vali, Yasaman
AU - Langendam, Miranda W.
AU - Takwoingi, Yemisi
AU - Hyde, Christopher J.
AU - Bossuyt, Patrick M. M.
AU - Leeflang, Mariska M. G.
N1 - Funding Information: 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. Funding Information: We thank Pieter Zwanenburg, MSc (University of Amsterdam), for his comments and suggestions on improving a previous draft. Yemisi Takwoingi is funded by a UK National Institute for Health Research (NIHR) Postdoctoral Fellowship, and is supported by the NIHR Birmingham Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, NIHR, or the Department of Health and Social Care. Publisher Copyright: © 2021
PY - 2021/10/1
Y1 - 2021/10/1
N2 - 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.
AB - 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.
KW - Bias
KW - Comparative accuracy studies
KW - Diagnostic accuracy
KW - Study design
KW - Test comparison
UR - http://www.scopus.com/inward/record.url?scp=85110607671&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jclinepi.2021.04.013
DO - https://doi.org/10.1016/j.jclinepi.2021.04.013
M3 - Review article
C2 - 33915262
SN - 0895-4356
VL - 138
SP - 128
EP - 138
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -