Cargando…
Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS)
INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures acros...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120103/ https://www.ncbi.nlm.nih.gov/pubmed/35006311 http://dx.doi.org/10.1007/s00192-021-05040-1 |
_version_ | 1784710859508940800 |
---|---|
author | Moussa, Reem Rada, Maria Patricia Durnea, Constantin Falconi, Gabriele Betschart, Cornelia Haddad, Jorge Milhem Sedgwick, Philip Doumouchtsis, Stergios K. |
author_facet | Moussa, Reem Rada, Maria Patricia Durnea, Constantin Falconi, Gabriele Betschart, Cornelia Haddad, Jorge Milhem Sedgwick, Philip Doumouchtsis, Stergios K. |
author_sort | Moussa, Reem |
collection | PubMed |
description | INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman’s rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00192-021-05040-1. |
format | Online Article Text |
id | pubmed-9120103 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-91201032022-05-21 Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) Moussa, Reem Rada, Maria Patricia Durnea, Constantin Falconi, Gabriele Betschart, Cornelia Haddad, Jorge Milhem Sedgwick, Philip Doumouchtsis, Stergios K. Int Urogynecol J Original Article INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman’s rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00192-021-05040-1. Springer International Publishing 2022-01-10 2022 /pmc/articles/PMC9120103/ /pubmed/35006311 http://dx.doi.org/10.1007/s00192-021-05040-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Article Moussa, Reem Rada, Maria Patricia Durnea, Constantin Falconi, Gabriele Betschart, Cornelia Haddad, Jorge Milhem Sedgwick, Philip Doumouchtsis, Stergios K. Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) |
title | Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) |
title_full | Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) |
title_fullStr | Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) |
title_full_unstemmed | Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) |
title_short | Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS) |
title_sort | outcome reporting in randomized controlled trials (rcts) on the pharmacological management of idiopathic overactive bladder (oab) in women; a systematic review for the development of core outcome sets (cos) |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120103/ https://www.ncbi.nlm.nih.gov/pubmed/35006311 http://dx.doi.org/10.1007/s00192-021-05040-1 |
work_keys_str_mv | AT moussareem outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT radamariapatricia outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT durneaconstantin outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT falconigabriele outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT betschartcornelia outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT haddadjorgemilhem outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT sedgwickphilip outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT doumouchtsisstergiosk outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos AT outcomereportinginrandomizedcontrolledtrialsrctsonthepharmacologicalmanagementofidiopathicoveractivebladderoabinwomenasystematicreviewforthedevelopmentofcoreoutcomesetscos |