Citations

Objective 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). Design A consensus developmental study. Setting International. Population Two hundred and five stakeholders completed the first round. 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. Main outcome measures All outcomes were extracted from the literature. Results 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. Conclusions 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. Tweetable abstract 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.

Core Outcome Sets (COS) contain an agreed minimum set of outcomes to be measured and reported in all studies in a specific area, with the objective of standardizing outcome reporting. COS may minimize research waste by identifying outcomes important to key stakeholders, allowing for improved evidence synthesis, and facilitating translation of research findings to clinical practice. Over the past 5 years, there has been significant progress in developing COS relevant to studies of diabetes in pregnancy. This review summarizes work in this area, reviews the role of patient and public involvement in COS development, and suggests areas for future research.

Introduction Selective reporting bias, inconsistency in the chosen outcomes between trials and irrelevance of the chosen outcomes for women, limit the efficiency and value of research for prevention and treatment of gestational diabetes mellitus (GDM). One way to address these challenges is to develop core outcome sets (COSs). Methods and analysis The aim of this manuscript is to present a protocol for a study to develop COSs for GDM prevention and treatment. This is a three-phase project consisting of (1) a systematic review of the literature to create two lists of outcomes that have been reported in trials and systematic reviews of trials of interventions for the prevention and treatment of GDM, (2) a three-round, web-based e-Delphi survey with key stakeholders to prioritise these outcomes and (3) a consensus meeting to resolve any remaining disagreements and to agree on two COSs. Ethics and dissemination Ethical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 13 December 2018 (Reference: C.A.2078). We will disseminate our research findings through peer-reviewed, open access publications and present at international conferences to reach a wide range of knowledge users.

AbstractBackgroundGestational diabetes mellitus (GDM) is highly prevalent and has both short- and long-term implications for mother and infant.Sources of dataLiterature search using PubMed with keywords ‘Gestational diabetes’ and ‘diabetes in pregnancy’ together with published papers known to the authors.Areas of agreementThe cornerstone of management is medical nutrition therapy with regular self-monitoring of capillary blood glucose levels and intensification of therapy if glycaemic goals are not achieved. Post-partum, annual assessment for type 2 diabetes is recommended.Areas of controversyDiagnostic criteria and new biomarkers for GDM and the clinical and economic benefits of treating women with milder levels of glucose intolerance during pregnancy.Growing pointsWomen with GDM are a heterogeneous group with varying degrees of insulin resistance and beta cell dysfunction.Areas timely for developing researchDevelopment of alternative diagnostic markers and application of novel technologies for GDM management.