用于评估预防早产干预措施的核心结局集。
A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.
作者信息
van 't Hooft Janneke, Duffy James M N, Daly Mandy, Williamson Paula R, Meher Shireen, Thom Elizabeth, Saade George R, Alfirevic Zarko, Mol Ben Willem J, Khan Khalid S
机构信息
Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, the Netherlands; the Irish Neonatal Health Alliance, Wicklow, Ireland; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, and Liverpool Women's Hospital, Liverpool, and Imperial College Health Care NHS Trust, Queen Charlotte's and Chelsea Hospital, and the Women's Health Research Unit, the Blizard Institute, Barts and the London School of Medicine and Dentistry, London, United Kingdom; the George Washington University Biostatistics Center, Rockville, Maryland; the Department of Obstetrics and Gynecology, University of Texas Medical Branch Hospitals, Galveston, Texas; and the Department of Obstetrics and Gynaecology, the Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
出版信息
Obstet Gynecol. 2016 Jan;127(1):49-58. doi: 10.1097/AOG.0000000000001195.
OBJECTIVE
To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women.
METHODS
A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect on total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as "critical" and less than 15% as "limited."
RESULTS
A total of 228 participants from five stakeholder groups from three lower middle-income countries, seven upper middle-income countries, and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine were related to offspring: gestational age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention.
CONCLUSION
This core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined.
DATABASE REGISTRATION
COMET Initiative, http://www.comet-initiative.org/studies/details/603, REGISTRATION NUMBER: 603.
目的
就一组关键临床结局达成共识，用于评估无症状孕妇早产预防干预措施。
方法
采用两阶段基于网络的德尔菲调查以及关键利益相关者面对面会议，就一组关键且重要的结局达成共识。我们联系了来自中高收入国家的五个利益相关者群体（父母、助产士、产科医生、新生儿科医生和研究人员）。通过系统文献综述和利益相关者的意见确定纳入德尔菲调查的结局。调查参与者根据1至9分的李克特量表对每个结局进行评分，1分表示“重要性有限”，9分表示“至关重要”。他们有机会在调查阶段之间思考总体反馈和利益相关者亚组反馈。为达成共识（事先定义），结局要求每个利益相关者群体至少70%的参与者将其评为“至关重要”，且少于15%的参与者评为“重要性有限”。
结果
来自三个中低收入国家、七个中高收入国家和17个高收入国家的五个利益相关者群体的228名参与者被要求对31个结局进行评分。其中，195名参与者完成了第一次调查，174名完成了第二次调查。就13个核心结局达成了共识：4个与孕妇相关：孕产妇死亡、孕产妇感染或炎症、胎膜早破以及干预对母亲的伤害。9个与后代相关：出生时的孕周、后代死亡、出生体重、早期神经发育疾病、晚期神经发育疾病、胃肠道疾病、感染、呼吸道疾病以及干预对后代的伤害。
结论
这个从国际多学科角度制定的用于评估早产预防研究的核心结局集，将确保评估早产预防的试验数据能够进行比较和整合。
数据库注册
COMET计划，http://www.comet-initiative.org/studies/details/603，注册号：603。
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