Abstract
Background
Stress urinary incontinence (SUI) significantly reduces women's quality of life (QoL).
Use of patient-reported outcomes (PROs) is increasing in randomized control trials
(RCTs), thus standardization is important to ensure reporting completeness. We aim
to evaluate completeness of reporting of RCTs for surgical management of SUI in women
based on an adaptation of the Consolidated Standards of Reporting Trials statement
with PRO extension (CONSORT-PRO).
Study Design
A literature search was conducted and all RCTs meeting inclusion criteria were evaluated
using the CONSORT-PRO adapted checklist and the Cochrane Collaboration risk of bias
assessment tool (RoB). We calculated a completion percentage score for each trial's
adherence to the CONSORT-PRO adapted checklist and used bivariate regression analysis
to examine associations between trial characteristics and completion percentage scores.
Results
Forty-three RCTs underwent data extraction and analysis. Mean completion percentage
of the CONSORT-PRO was 50.53% (SD = 15.63). A total of 38 (of 43; 88.37%) RCTs received
an RoB 2.0 rating of “some concern.” RCTs with follow-up longer than 3 months had
statistically significantly higher CONSORT-PRO completion: 3–6 months (p = .049), 6–12 months (p = .009), more than 12 months (p = .021). Compared with studies without a conflict of interest statement, studies
reporting a conflict of interest (p < .001) or reporting no conflict of interest (p = .048) had higher reporting completeness.
Conclusions
Our results suggest many RCTs addressing surgical management of SUI in women have
poor adherence to CONSORT-PRO reporting guidelines. Improving reporting completeness
through adherence to the CONSORT-PRO checklist can better inform clinical decision
making and improve QoL.
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Article info
Publication history
Published online: November 25, 2022
Accepted:
October 21,
2022
Received in revised form:
October 15,
2022
Received:
March 21,
2022
Publication stage
In Press Corrected ProofFootnotes
Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant.
No financial or other sources of support were provided during the development of this manuscript. Dr. Hartwell reports receiving funding from the National Institute of Justice for work unrelated to the current subject. Dr. Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences — all outside of the present work. All other authors have nothing to report.
Identification
Copyright
© 2022 Jacobs Institute of Women's Health, George Washington University. Published by Elsevier Inc. All rights reserved.
