A Core Outcome Set for Evaluation of Interventions to Prevent XXXX .

@entity1 @entity32 @entity600 @entity281 @entity1576
OBJECTIVE: To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for @entity600 in asymptomatic pregnant @entity1 . 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 @entity1 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 @entity1 of each stakeholder group to score them as "critical" and less than 15% as "limited." RESULTS: A total of 228 @entity1 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 @entity1 , 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant @entity1 : maternal mortality, maternal @entity281 or @entity32 , 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, @entity281 , @entity1576 , and harm to offspring from intervention. CONCLUSION: This core outcome set for studies that evaluate prevention of @entity600 developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of @entity600 can be compared and combined. DATABASE REGISTRATION: COMET Initiative, http://www.comet-initiative.org/studies/details/603, Registration Number: 603.
