Laboratory of Experimental Surgery and Surgical Research NS Christeas, Athens University Medical School, Athens, Greece.
Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, London, UK.
BJOG. 2018 Nov;125(12):1522-1531. doi: 10.1111/1471-0528.15408. Epub 2018 Sep 25.
Selecting appropriate outcomes to reflect both beneficial and harmful effects is a critical step in designing childbirth trauma trials.
To evaluate the outcomes and outcome measures reported in randomised controlled trials evaluating interventions for childbirth trauma.
Randomised trials were identified by searching bibliographical databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE.
Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations.
Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted the relevant data. Spearman's ρ correlation and multivariate linear regression analysis using the backward stepwise model were used for analysis.
Forty-eight randomised trials, reporting data from 20 308 women, were included. Seventeen different interventions were evaluated. Included trials reported 77 different outcomes and 50 different outcome measures. Commonly reported outcomes included pain (34 trials; 70%), wound healing (20 trials; 42%), and anorectal dysfunction (16 trials, 33%). In the multivariate analysis, no relationship was demonstrated between the quality of outcome reporting and year of publication (P = 0.31), journal impact factor (P = 0.49), and methodological quality (P = 0.13).
Outcome reporting in childbirth trauma research is heterogeneous. Developing, disseminating, and implementing a core outcome set in future childbirth trauma research could help address these issues.
Developing @coreoutcomes for childbirth trauma research could help to reduce #research waste.
选择既能反映有益效果又能反映有害效果的恰当结局是设计分娩创伤试验的关键步骤。
评估评价分娩创伤干预措施的随机对照试验报告的结局和结局测量指标。
通过检索书目数据库，包括 Cochrane 对照试验中心注册库（CENTRAL）、MEDLINE 和 EMBASE，确定随机试验。
评估不同技术在会阴裂伤管理中的疗效和安全性的随机试验。
两位研究人员独立评估纳入研究、评估方法学质量并提取相关数据。采用向后逐步模型的斯皮尔曼 ρ 相关和多变量线性回归分析进行分析。
纳入了 48 项随机试验，报告了来自 20308 名女性的数据。评估了 17 种不同的干预措施。纳入的试验报告了 77 种不同的结局和 50 种不同的结局测量指标。常见的报告结局包括疼痛（34 项试验；70%）、伤口愈合（20 项试验；42%）和肛肠功能障碍（16 项试验，33%）。在多变量分析中，结局报告的质量与发表年份（P = 0.31）、期刊影响因子（P = 0.49）和方法学质量（P = 0.13）之间没有关系。
分娩创伤研究中的结局报告存在异质性。在未来的分娩创伤研究中制定、传播和实施核心结局集可能有助于解决这些问题。
为分娩创伤研究制定@coreoutcomes 可以帮助减少#研究浪费。
