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).
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.
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.
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.
Women's health issues : official publication of the Jacobs Institute of Women's Health. 2022 Nov 25 [Epub ahead of print]
Kelsi Batioja, Andriana Peña, Caleb Smith, Kirstien Minley, Audrey Wise, Samuel Shepard, Benjamin Heigle, Ryan Ottwell, Micah Hartwell, Matt Vassar
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma. Electronic address: ., Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma., Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma; Department of Internal Medicine, University of Oklahoma, School of Community Medicine, Tulsa, Oklahoma., Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma.