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

O Kgosidialwa; D Bogdanet; A M Egan; P M O'Shea; C Newman; T P Griffin; C McDonagh; C O'Shea; L Carmody; S D Cooray; E Anastasiou; E Wender-Ozegowska; C Clarson; A Spadola; F Alvarado; E Noctor; E Dempsey; A Napoli; C Crowther; S Galjaard; M R Loeken; Mja Maresh; P Gillespie; H de Valk; A Agostini; L Biesty; D Devane; F Dunne; INSPIRED Research Group

doi:10.1111/1471-0528.16825

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

BJOG. 2021 Oct;128(11):1855-1868. doi: 10.1111/1471-0528.16825. Epub 2021 Aug 3.

Authors

O Kgosidialwa¹, D Bogdanet¹, A M Egan², P M O'Shea¹, C Newman¹, T P Griffin¹, C McDonagh¹, C O'Shea¹, L Carmody¹, S D Cooray^{3

4}, E Anastasiou⁵, E Wender-Ozegowska⁶, C Clarson^{7

8}, A Spadola⁹, F Alvarado⁹, E Noctor¹⁰, E Dempsey¹¹, A Napoli¹², C Crowther¹³, S Galjaard¹⁴, M R Loeken^{15

16}, Mja Maresh¹⁷, P Gillespie¹⁸, H de Valk¹⁹, A Agostini²⁰, L Biesty²¹, D Devane^{21

22}, F Dunne¹; INSPIRED Research Group

Affiliations

¹ College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.
² Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.
³ Diabetes and Endocrinology Units, Monash Health, Clayton, Vic., Australia.
⁴ Monash Centre for Health Research and Implementation, Monash University, Clayton, Vic., Australia.
⁵ Department Diabetes & Pregnancy Outpatients, Mitera Hospital, Athens, Greece.
⁶ Department of Reproduction, Poznan University of Medical Sciences, Poznan, Poland.
⁷ Department of Paediatrics, University of Western Ontario, London, ON, Canada.
⁸ Lawson Health Research Institute, London, ON, Canada.
⁹ Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.
¹⁰ Division of Endocrinology, University Hospital Limerick, Limerick, Ireland.
¹¹ INFANT Centre and Department of Paediatrics & Child Health, University College Cork, Cork, Ireland.
¹² Department of Clinical and Molecular Medicine, Sant'Andrea University Hospital, Sapienza, University of Rome, Rome, Italy.
¹³ Liggins Institute, The University of Auckland, Auckland, New Zealand.
¹⁴ Department of Obstetrics and Gynaecology, Division of Obstetrics and Prenatal Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.
¹⁵ Section of Islet Cell and Regenerative Biology, Joslin Diabetes Center, Boston, MA, USA.
¹⁶ Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹⁷ Department of Obstetrics, St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
¹⁸ Health Economics and Policy Analysis Centre (HEPAC), National University of Ireland, Galway, Ireland.
¹⁹ Department of Internal Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands.
²⁰ A.S.LViterbo Distretto A, Consultorio Montefiascone, Rome, Italy.
²¹ School of Nursing & Midwifery, National University of Ireland Galway, Galway, Ireland.
²² HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.

Abstract

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.

Keywords: Core outcome set; interventions; pregestational diabetes; randomised controlled trials; treatment.

Publication types

Systematic Review

MeSH terms

Consensus
Delphi Technique
Diabetes, Gestational / therapy*
Female
Humans
International Cooperation
Outcome Assessment, Health Care / standards*
Pregnancy
Prenatal Care / standards*
Randomized Controlled Trials as Topic
Stakeholder Participation
Treatment Outcome

Abstract

Publication types

MeSH terms

Grants and funding