Durnea Constantin M, Pergialiotis Vasilios, Duffy James M N, Bergstrom Lina, Elfituri Abdullatif, Doumouchtsis Stergios K
Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Rowan House, Dorking Road, Epsom, London, KT18 7EG, UK.
Nortwick Park Hospital, London North West University Healthcare NHS Trust, London, UK.
Int Urogynecol J. 2018 Dec;29(12):1727-1745. doi: 10.1007/s00192-018-3781-5. Epub 2018 Oct 22.
We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality.
We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables.
Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = -0.013; P = 0.918).
Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.
我们评估了评估前盆腔阴道脱垂手术干预的随机对照试验中的结果及结果测量报告情况，并探讨了结果报告质量与期刊影响因子、发表年份及方法学质量之间的关系。
我们检索了从数据库建立至2017年10月的文献数据库。两名研究人员独立选择研究并评估研究特征、方法学质量（Jadad标准；范围为1 - 5）以及结果报告质量（腭裂伴中耳积液管理（MOMENT）标准；范围为1 - 6），并提取相关数据。我们使用多元线性回归来评估结果报告质量与其他变量之间的关联。
纳入了80篇报告来自10924名参与者数据的出版物。评估了17种不同的手术干预措施。报告了100种不同的结果和112种结果测量指标。各试验间结果报告不一致；例如，43项试验报告了解剖学治疗成功率（12种结果测量指标），25项试验报告了生活质量（15种结果测量指标），8项试验报告了术后疼痛（7种结果测量指标）。多元线性回归表明结果报告质量与方法学质量之间存在关系（β = 0.412；P = 0.018）。结果报告质量与影响因子（β = 0.078；P = 0.306）、发表年份（β = 0.149；P = 0.295）、研究规模（β = 0.008；P = 0.961）和商业资助（β = -0.013；P = 0.918）之间未显示出关系。
前盆腔阴道脱垂试验报告了许多不同的结果和结果测量指标，且常常忽略报告重要的安全性结果。制定、传播和实施核心结果集将有助于解决这些问题。
