A systematic review on outcome reporting in randomised controlled trials on surgical interventions for female stress urinary incontinence: a call to develop a core outcome set.
Core outcome sets
meta-analysis
outcome variation
research waste
stress urinary incontinence
systematic review
trials
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
accepted:
22
05
2019
pubmed:
30
7
2019
medline:
17
10
2019
entrez:
30
7
2019
Statut:
ppublish
Résumé
Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence. Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI. Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE. Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI. Two researchers independently assessed the included studies and documented outcomes. Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (β = 0.538, P < 0.001; β = 0.218, P = 0.011, respectively). Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success rate - complete cure, partial improvement, or failure of response; urodynamic evaluation outcomes - overactive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomes - quality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures. There is significant variation in outcome reporting in SUI trials. Our systematic review findings aim to form the basis for the development of a core outcome set.
Sections du résumé
BACKGROUND
BACKGROUND
Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence.
OBJECTIVES
OBJECTIVE
Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI.
SEARCH STRATEGY
METHODS
Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE.
SELECTION CRITERIA
METHODS
Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI.
DATA COLLECTION AND ANALYSIS
METHODS
Two researchers independently assessed the included studies and documented outcomes.
MAIN RESULTS
RESULTS
Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (β = 0.538, P < 0.001; β = 0.218, P = 0.011, respectively).
CONCLUSIONS
CONCLUSIONS
Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success rate - complete cure, partial improvement, or failure of response; urodynamic evaluation outcomes - overactive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomes - quality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures.
TWEETABLE ABSTRACT
CONCLUSIONS
There is significant variation in outcome reporting in SUI trials. Our systematic review findings aim to form the basis for the development of a core outcome set.
Identifiants
pubmed: 31357257
doi: 10.1111/1471-0528.15891
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1417-1422Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 Royal College of Obstetricians and Gynaecologists.
Références
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