Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
BJOG. 2019 Jan;126(1):83-93. doi: 10.1111/1471-0528.15335. Epub 2018 Jul 29.
To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS.
A two-round Delphi survey and face-to-face meeting.
Healthcare professionals and women's representatives.
Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes.
Outcomes from systematic reviews and consultations.
Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible.
These COS will help standardise outcome reporting in PPH trials.
Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.
制定用于（1）预防和（2）治疗产后出血（PPH）的干预措施的核心结局集（COS），并就如何报告 COS 提出建议。
两轮德尔菲调查和面对面会议。
医疗保健专业人员和妇女代表。
通过对 PPH 研究的系统评价和利益相关者咨询确定了结局。参与者在德尔菲调查中对每个结局进行了 1（不重要）到 9（非常重要）的李克特量表评分。在面对面会议上讨论了结果，以达成最终的 COS。会议上的共识定义为≥70%的参与者将该结局评为非常重要（7-9）。讲座、讨论和投票用于达成如何报告 COS 结局的一致意见。
系统评价和咨询的结局。
预防组的两轮德尔菲调查均有 152/205（74%）参与者完成，治疗组的两轮德尔菲调查均有 143/197（73%）参与者完成。对于预防 PPH，选择了九个核心结局：出血量、休克、产妇死亡、使用额外的宫缩剂、输血、转移到更高水平的护理、女性的幸福感、对干预措施的可接受性和满意度、母乳喂养和不良反应。对于治疗 PPH，选择了 12 个核心结局：出血量、休克、凝血功能障碍、子宫切除术、器官功能障碍、产妇死亡、输血、使用额外的止血干预、转移到更高水平的护理、女性的幸福感、对干预措施的可接受性和满意度、母乳喂养和不良反应。制定了如何尽可能报告这些结局的建议。
这些 COS 将有助于标准化 PPH 试验的结局报告。
PPH 的核心结局集：预防 PPH 的九个核心结局和治疗 PPH 的 12 个核心结局。
