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

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.

Automated summary

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.