Abstract
Introduction and hypothesisEvidence 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).MethodsRCTs 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.ResultsThirty-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.ConclusionsDevelopment 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.
Highlights
Introduction and hypothesisEvidence on Overactive bladder (OAB) management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability
Unless a patient-centred approach is established in clinical research, reduced patient satisfaction despite improvement in symptoms may complicate the development of clinical pathways
In order to support higher quality research evidence, the development of ‘core outcome sets’ (COS) and ‘core outcome measures sets (COMS) is essential. These efforts have been supported by the Core Outcome Measures in Effectiveness Trials (COMET) initiative and COS have been developed in many areas of research as well as clinical practice [5]
Summary
Introduction and hypothesisEvidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. 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. The lack of consistency in outcome reporting for OAB and other gynaecological conditions can produce data that are less comparable and robust and can slow the progression within this field by preventing the effective synthesis of data for high quality meta-analyses [4]. In order to support higher quality research evidence, the development of ‘core outcome sets’ (COS) and ‘core outcome measures sets (COMS) is essential. These efforts have been supported by the Core Outcome Measures in Effectiveness Trials (COMET) initiative and COS have been developed in many areas of research as well as clinical practice [5]
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