4.6 Review

Quality of surgical patient-reported outcome measure validation studies is often deficient: a systematic review

Journal

JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 158, Issue -, Pages 27-33

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2023.03.023

Keywords

Patient -reported outcome measure; PROM; Validity; Validation study; Methodology; COSMIN

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This study examined the methodological basis behind the conclusions of PROM validation studies. The results revealed that PROM studies often had insufficient sample sizes and focused on a limited number of validity subfields, raising concerns about the deterministic conclusions regarding the validity of PROMs.
Objectives: To examine the methodological basis behind the conclusions of patient-reported outcome measure (PROM) validation studies.Study Design and Setting: A systematic review was performed on surgical studies evaluating the measurement properties of a PROM between June 1 and December 31, 2021. The quality of the validity subfield evaluation in the studies was assessed according to the consensus-based standards for the selection of health measurement instruments checklist. Nine validity subfields were assessed.Results: The median sample size of the 87 included studies was 125 (interquartile range: 99-226), and 22 of the studies (25%) had an insufficient sample size according to the consensus-based standards for the selection of health measurement instruments checklist. For the nine validity subfields, the mean number of correctly assessed subfields was 3.6 (standard deviation: 1.5). In 68 of the studies (78%), the conclusion determined the PROM to be valid. In these studies, the mean number of evaluated validity subfields was 3.8 (standard deviation: 1.4). None of the studies reported that the PROM was not valid.Conclusion: The empirical basis of the conclusions drawn in studies investigating the measurement properties of a PROM is often defi-cient. PROM studies were often performed with insufficient sample sizes and focused on only a few validity subfields, calling into question the deterministic conclusions that a PROM is valid.(c) 2023 Elsevier Inc. All rights reserved.

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