随机对照试验（RCTs）中关于女性特发性过度活动膀胱（OAB）药物治疗结局的报告；制定核心结局集（COS）的系统评价。
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).
机构信息
Institute of Medical and Biomedical Education, St George's University of London, London, UK.
2nd Department of Obstetrics-Gynaecology, "luliu Hatieganu", University of Medicine and Pharmacy, Cluj-Napoca, Romania.
出版信息
Int Urogynecol J. 2022 May;33(5):1243-1250. doi: 10.1007/s00192-021-05040-1. Epub 2022 Jan 10.
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.
简介和假设
OAB 管理的证据仍然不理想，随机对照试验（RCT）中的方法学限制影响了它们的可比性。高质量的荟萃分析仍然缺乏。本研究旨在比较 RCT 中结局和结局测量的选择和报告，并评估方法学质量和结局报告质量，作为制定核心结局集（COS）过程的第一阶段。
方法
使用 Pubmed、EMBASE、Medline、Cochrane、ICTRP 和 Clinicaltrials.gov 从成立到 2020 年 1 月，以英文搜索成年女性的 RCT。记录药物治疗管理、干预、样本量、期刊类型和商业资助。使用 JADAD 和 MOMENT 评分评估方法学和结局报告质量。
结果
纳入 38 项试验（18316 名女性）。使用 62 种结局测量报告了 69 种结局。报告最多的结局领域是疗效（86.8%）、安全性（73.7%）和生活质量（60.5%）。每个领域报告最多的结局是急迫性尿失禁发作（UUI）（52.6%）、抗毒蕈碱副作用（76.3%）和经验证问卷评分变化（36.8%）。JADAD 和 MOMENT 评分之间存在显著的相关性（Spearman's rho=0.548，p<0.05）。这表明方法学质量越高，结局报告质量越高。
结论
COS 和核心结局测量集的制定将解决变化，提高证据质量。我们建议每个领域报告最多的结局作为临时 COS。对于疗效，我们建议：UUI 发作、尿急和夜尿发作；对于安全性：抗毒蕈碱不良反应、其他不良反应和停药率；对于生活质量：OAB-q、PPBC 和 IIQ 评分。
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