Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials

Kelsi Batioja; Andriana Peña; Caleb Smith; Kirstien Minley; Audrey Wise; Samuel Shepard; Benjamin Heigle; Ryan Ottwell; Micah Hartwell; Matt Vassar

doi:10.1016/j.whi.2022.10.004

Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials

Kelsi Batioja, Andriana Peña, Caleb Smith, Kirstien Minley, Audrey Wise, Samuel Shepard, Benjamin Heigle, Ryan Ottwell, Micah Hartwell, Matt Vassar

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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.

Original language	English
Pages (from-to)	312-319
Number of pages	8
Journal	Women's Health Issues
Volume	33
Issue number	3
DOIs	https://doi.org/10.1016/j.whi.2022.10.004
State	Published - 1 May 2023

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10.1016/j.whi.2022.10.004

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Batioja, K., Peña, A., Smith, C., Minley, K., Wise, A., Shepard, S., Heigle, B., Ottwell, R., Hartwell, M., & Vassar, M. (2023). Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials. Women's Health Issues, 33(3), 312-319. https://doi.org/10.1016/j.whi.2022.10.004

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title = "Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials",

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.",

author = "Kelsi Batioja and Andriana Pe{\~n}a and Caleb Smith and Kirstien Minley and Audrey Wise and Samuel Shepard and Benjamin Heigle and Ryan Ottwell and Micah Hartwell and Matt Vassar",

note = "Funding Information: Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant. Funding Information: 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. Publisher Copyright: {\textcopyright} 2022 Jacobs Institute of Women's Health, George Washington University",

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Batioja, K , Peña, A , Smith, C , Minley, K , Wise, A , Shepard, S , Heigle, B , Ottwell, R , Hartwell, M & Vassar, M 2023, 'Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials', Women's Health Issues, vol. 33, no. 3, pp. 312-319. https://doi.org/10.1016/j.whi.2022.10.004

TY - JOUR

T1 - Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women

T2 - An Analysis of Randomized Controlled Trials

AU - Batioja, Kelsi

AU - Peña, Andriana

AU - Smith, Caleb

AU - Minley, Kirstien

AU - Wise, Audrey

AU - Shepard, Samuel

AU - Heigle, Benjamin

AU - Ottwell, Ryan

AU - Hartwell, Micah

AU - Vassar, Matt

N1 - Funding Information: Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant. Funding Information: 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. Publisher Copyright: © 2022 Jacobs Institute of Women's Health, George Washington University

PY - 2023/5/1

Y1 - 2023/5/1

N2 - 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.

AB - 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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U2 - 10.1016/j.whi.2022.10.004

DO - 10.1016/j.whi.2022.10.004

M3 - Article

C2 - 36443180

AN - SCOPUS:85143617469

SN - 1049-3867

VL - 33

SP - 312

EP - 319

JO - Women's Health Issues

JF - Women's Health Issues

IS - 3

ER -

Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials

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