A protocol for developing a core outcome set for ectopic pregnancy
Krystle Y. Chong,
Sarah Solangon,
James Kemper,
Kurt Barnhart,
Pamela Causa Andrieu,
Perrine Capmas,
Carolina Chacon,
George Condous,
Liesl de Waard,
James M. N. Duffy,
Andrew Horne,
Maria Memtsa,
Femke Mol,
Munira Oza,
Annika Strandell,
Madelon van Wely,
Janneke van’t Hooft,
Lan N. Vuong,
Jian Zhang,
Davor Jurkovic,
Ben W. Mol,
International Collaboration on Core Outcomes in Ectopic Pregnancy
Affiliations
Krystle Y. Chong
Monash Women’s, Monash Health
Sarah Solangon
Institute for Women’s Health, University College London
James Kemper
Monash Women’s, Monash Health
Kurt Barnhart
Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Penn Medicine/University of Pennsylvania School of Medicine
Pamela Causa Andrieu
Department of Radiology, Memorial Sloan Kettering Cancer Center
Perrine Capmas
Department of obstetrics and Gynecology, Bicetre University Hospital, Paris Saclay University
Carolina Chacon
Radiology Service, Hospital Italiano de Buenos Aires
George Condous
Acute Gynaecology, Early Pregnancy and Advanced Endosurgery Unit, Sydney Medical School Nepean, University of Sydney, Nepean Hospital
Liesl de Waard
Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University
James M. N. Duffy
Institute for Women’s Health, University College London
Andrew Horne
MRC Centre for Reproductive Health, University of Edinburgh
Maria Memtsa
Institute for Women’s Health, University College London
Femke Mol
Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute
Munira Oza
The Ectopic Pregnancy Trust
Annika Strandell
Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg
Madelon van Wely
Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute
Janneke van’t Hooft
Department of Obstetrics and Gynaecology, Amsterdam UMC
Lan N. Vuong
Department of Obstetrics and Gynecology, University of Medicine and Pharmacy
Jian Zhang
Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University
Davor Jurkovic
Institute for Women’s Health, University College London
Ben W. Mol
Monash Women’s, Monash Health
International Collaboration on Core Outcomes in Ectopic Pregnancy
Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492 . Registered in November 2019.
