College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.
Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.
BJOG. 2021 Oct;128(11):1855-1868. doi: 10.1111/1471-0528.16825. Epub 2021 Aug 3.
To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM).
A consensus developmental study.
International.
Two hundred and five stakeholders completed the first round.
The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS.
All outcomes were extracted from the literature.
We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death.
This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM.
165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.
为评估治疗孕前糖尿病（PGDM）孕妇干预措施有效性的随机对照试验（RCT）制定核心结局集（COS）。
共识发展研究。
国际。
205 名利益相关者完成了第一轮。
研究包括三个部分。（1）系统综述文献，列出评估治疗 PGDM 孕妇干预措施有效性的 RCT 报告的结局。（2）三轮在线德尔菲调查，由国际利益相关者（包括医疗保健专业人员、研究人员和 PGDM 妇女）对这些结局进行优先排序。（3）共识会议，来自每个组的利益相关者决定最终的 COS。
所有结局均从文献中提取。
我们从符合全部纳入标准的 67 份记录中提取了 131 个独特的结局。在完成第一轮的 205 名利益相关者中，174/205（85%）和 165/174（95%）分别完成了第二轮和第三轮。随后的共识会议上的与会者选择了 19 个结局纳入 COS：特定孕期的血红蛋白 A1c、孕期体重增加、严重的母体低血糖、糖尿病酮症酸中毒、流产、妊娠高血压、子痫前期、母体死亡、出生体重、大于胎龄儿、小于胎龄儿、出生时的胎龄、早产、分娩方式、肩难产、新生儿低血糖、先天性畸形、死产和新生儿死亡。
该 COS 将使比较 RCT 以便进行稳健的证据综合、改善试验报告和优化研究效率，从而更好地评估治疗 PGDM 孕妇的干预措施。
165 名关键利益相关者已制定出#治疗#孕前糖尿病患者的#核心结局#，以评估干预措施的有效性。
