Poitiers University Hospital, Department of Obstetrics and Gynecology, Poitiers, France.
INSERM CIC-P 1402, Poitiers University Hospital, Poitiers, France.
BMC Pregnancy Childbirth. 2021 Mar 25;21(1):251. doi: 10.1186/s12884-021-03603-0.
We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA).
A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study.
Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women.
We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery.
The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).
我们旨在制定一套核心结局和关注变量，以在一项大型为期一年的法国观察性研究中，针对初产妇行会阴侧切术对产科肛门括约肌损伤（OASI）的影响进行研究，该研究纳入了 15000 名女性（INSTRUMODA）。
通过在线问卷，向参与 INSTRUMODA 研究的产科医生提出了一套结局和关注变量的清单，问卷分为 7 个类别：女性的妊娠史和病程、分娩过程、剖宫产方式、会阴侧切特征、产妇即时发病率、产妇一年期发病率、新生儿即时发病率。我们使用三轮 DELPHI 方法达成共识。在第一轮中，被 70%或更多的产科医生认为是必不可少的结局和变量被纳入核心内容，而被 70%的医生认为是“不重要”的结局和变量则被排除在外。在第二轮中，对未达成共识的结局和变量进行重新评估，如果被 50%或更多的产科医生认为是“不重要”或“必不可少”，则将其纳入或最终纳入核心内容。在第一轮中，还邀请了产科医生提出新的结局和/或变量，然后在第二轮和第三轮中对这些变量进行评估。我们使用相同的方法，为通过患者协会招募的社区妇女群体制定了一套核心结局和关注变量。在程序结束时，将社区妇女群体的核心结局和关注变量集与 INSTRUMODA 研究的核心结局集合并，为 INSTRUMODA 研究提供最终的核心结局集。
53 名产科医生和 16 名妇女填写了问卷。在每个群体的三轮 Delphi 程序之后，产科医生一致报告了 74 个结局和变量，社区妇女一致报告了 92 个结局和变量。通过混合这两个一致的内容，我们报告了一个最终的共识列表，其中包含 114 个产科医生和社区妇女关注的结局和变量。
我们在产科医生和社区妇女中建立了一套核心结局和关注变量，以研究会阴侧切术与剖宫产术中产科肛门括约肌损伤（OASI）的关联。
INSTRUMODA 研究于 2020 年 6 月 25 日在 https://clinicaltrials.gov 上注册（NCT04446780）。
