A protocol for developing a core outcome set for ectopic pregnancy

Trials

George Condous¹  Madelon van Wely²  Femke Mol²  Janneke van’t Hooft³  Liesl de Waard⁴  Kurt Barnhart⁵  Annika Strandell⁶  Jian Zhang⁷  Lan N. Vuong⁸  Pamela Causa Andrieu⁹  Perrine Capmas^1,10  Maria Memtsa^1,11  Davor Jurkovic^1,11  Sarah Solangon^1,11  James M. N. Duffy^1,12  Andrew Horne^1,13  James Kemper^1,14  Ben W. Mol^1,15  Krystle Y. Chong^1,15  Carolina Chacon^1,16  Munira Oza^1,17 

[1] Acute Gynaecology, Early Pregnancy and Advanced Endosurgery Unit, Sydney Medical School Nepean, University of Sydney, Nepean Hospital, Camperdown, NSW, Australia;Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam, UMC, Netherlands;Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Penn Medicine/University of Pennsylvania School of Medicine, Philadelphia, PA, USA;Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China;Department of Obstetrics and Gynecology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam;Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA;Radiology Service, Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, Argentina;Department of obstetrics and Gynecology, Bicetre University Hospital, Paris Saclay University, Le Kremlin Bicêtre, France;Institute for Women’s Health, University College London, London, UK;Institute for Women’s Health, University College London, London, UK;King’s Fertility, Fetal Medicine Research Institute, London, UK;MRC Centre for Reproductive Health, University of Edinburgh, EH16 4TJ, Edinburgh, UK;Monash Women’s, Monash Health, Clayton, Australia;Monash Women’s, Monash Health, Clayton, Australia;Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia;Radiology Service, Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, Argentina;The Ectopic Pregnancy Trust, London, UK;

关键词: Ectopic pregnancy;    Consensus study;    Modified Delphi method;    Core outcome set;    Randomised controlled trials;   

DOI  :  10.1186/s13063-021-05772-x

来源: Springer

【 摘 要 】

BackgroundRandomised 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 aimTo develop and implement a core outcome set to guide future research in ectopic pregnancy.Methods and analysisWe 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 registrationCOMET 1492. Registered in November 2019.

【 授权许可】

CC BY