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A core outcome set for the treatment of pregnant women with pregestational diabetes: An international consensus study

Kgosidialwa, Oratile
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Identifiers
http://hdl.handle.net/10379/16942
https://doi.org/10.13025/17003
Repository DOI
Publication Date
2021-09-10
Keywords
Pregestational diabetes, Core Outcome Set, Treatment, Interventions, Pregnant women, Medicine, Nursing, and Health Sciences, Medicine, Diabetes, Endocrinology, Endocrinology, Diabetes and Metabolism
Type
Thesis
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Abstract
Background Meaningful comparisons between studies evaluating interventions of pregnant women with pre-gestational diabetes mellitus (PGDM) are limited due to the heterogeneity in outcome selection and reporting. The aim of this study was to develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM. Research Design and Methods 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. Results We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Two hundred and five stakeholders completed round 1 of the eDelphi survey, of whom 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants of the consensus meeting chose 19 outcomes for inclusion in the final COS: trimester specific HbA1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy induced hypertension, pre-eclampsia, maternal death, birth weight, 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. Conclusions This COS will enable better comparisons between RCTs, allowing robust evidence synthesis. The COS will improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM.
Funder
Royal College of Physicians of Ireland
Publisher
NUI Galway
Publisher DOI
Rights
Attribution-NonCommercial-NoDerivs 3.0 Ireland
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University of Galway Theses (PhD Theses)