A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.
A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.
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DOI:
10.1097/aog.0000000000001195
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发表时间:
2016-01
影响因子:
7.2
通讯作者:
Global Obstetrics Network (GONet)
中科院分区:
文献类型:
--
作者:
van 't Hooft J;Duffy JMN;Daly M;Williamson PR;Meher S;Thom E;Saade GR;Alfirevic Z;Mol BWJ;Khan KS;Global Obstetrics Network (GONet)
To develop consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were employed to develop 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 upon total and stakeholder sub-group feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group scoring them as ‘critical’ and less than 15% as ‘limited’. 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 outcome: four related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine related to offspring: gestation age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention. 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.