title: Development of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study.
abstract: To develop a set of core outcomes for studies on pregnant women with epilepsy.
  
  
  
  Delphi consensus study.
  
  
  
  Healthcare professionals, and patient representatives with lived experience of epilepsy in the UK.
  
  
  
  We used a modified Delphi method and a consultation meeting to achieve consensus. Potential outcomes were identified by systematic review, and were scored using a Likert scale anchored between 1 (least important) and 5 (most important). We included outcomes that scored ≥4 by >70% of participants, and outcomes that scored ≤2 by <15% of participants.
  
  
  
  Outcomes in studies on epilepsy in pregnancy.
  
  
  
  Seventy-five healthcare professionals completed the first round, 48 (64%) completed the second round, and 37 (49%) completed the third round of the survey. Twenty-four patient representatives participated. The final core outcome set included 31 outcomes in three domains: neurological, offspring, and obstetric. Outcomes in the neurological domain were seizure control in pregnancy and postpartum, status epilepticus, maternal mortality, drowning, sudden unexpected death in epilepsy, postnatal depression, and quality of life. Offspring domain included congenital abnormalities (major and minor), fetal anticonvulsant syndrome, neurodevelopment, autism disorder, neonatal clinical complications, admission to a neonatal intensive care unit, and anthropometric measurements. The obstetric domain included live birth, stillbirth, miscarriage, ectopic, termination of pregnancy, admission to a high dependency or intensive care unit, breastfeeding, mode of delivery, preterm birth, pre-eclampsia, and eclampsia. Outcomes specific for studies on anti-epileptic drugs (AEDs) included maternal AED toxicity, AED compliance, neonatal withdrawal symptoms, and neonatal haemorrhagic disease.
  
  
  
  Embedding this core set in future clinical trials will promote the standardisation of reporting to inform clinical practice.
  
  
  
  A Delphi method identifying core outcomes for epilepsy in pregnancy. Final core set includes 31 outcomes.
authors.affiliation: Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors.forename: B H
authors.initials: BH
authors.lastname: Al Wattar
authors.affiliation: Barts Health NHS Trust, London, UK.
authors.forename: K
authors.initials: K
authors.lastname: Tamilselvan
authors.affiliation: Barts Health NHS Trust, London, UK.
authors.forename: R
authors.initials: R
authors.lastname: Khan
authors.affiliation: Barts Health NHS Trust, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Kelso
authors.affiliation: Barts Health NHS Trust, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Sinha
authors.affiliation: Birmingham Women's Hospital, Birmingham, UK.|University of Birmingham, Birmingham, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Pirie
authors.affiliation: University of Birmingham, Birmingham, UK.
authors.forename: D
authors.initials: D
authors.lastname: McCorry
authors.affiliation: Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.|Multidisciplinary Evidence Synthesis Hub (mEsh), Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.|The CROWN Initiative.
authors.forename: K S
authors.initials: KS
authors.lastname: Khan
authors.affiliation: Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.|Multidisciplinary Evidence Synthesis Hub (mEsh), Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Thangaratinam
mesh_terms: D032921:Consensus; D003697:Delphi Technique; D023381:Endpoint Determination; D004827:Epilepsy / Q000150:complications*; D005260:Female; D006801:Humans; D008428:Maternal Mortality; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology* / Q000209:etiology; D011256:Pregnancy Outcome / Q000453:epidemiology*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D006113:United Kingdom; D055815:Young Adult
keywords: 
  CROWN
  ; Core outcomes; Delphi; epilepsy; pregnancy