A core outcome set for future endometriosis research: an international consensus development study

Jmn Duffy; M Hirsch; M Vercoe; J Abbott; C Barker; B Collura; R Drake; Jlh Evers; M Hickey; A W Horne; M L Hull; S Kolekar; S Lensen; N P Johnson; V Mahajan; B W Mol; A-S Otter; L Puscasiu; M B Rodriguez; L Rombauts; A Vail; R Wang; C M Farquhar; endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research

doi:10.1111/1471-0528.16157

A core outcome set for future endometriosis research: an international consensus development study

BJOG. 2020 Jul;127(8):967-974. doi: 10.1111/1471-0528.16157. Epub 2020 Mar 30.

Authors

Jmn Duffy^{1

2}, M Hirsch^{1

3}, M Vercoe⁴, J Abbott⁵, C Barker⁶, B Collura⁷, R Drake⁸, Jlh Evers⁹, M Hickey¹⁰, A W Horne¹¹, M L Hull¹², S Kolekar⁸, S Lensen⁴, N P Johnson^{12

13}, V Mahajan⁸, B W Mol¹⁴, A-S Otter¹⁵, L Puscasiu¹⁶, M B Rodriguez⁴, L Rombauts¹⁴, A Vail¹⁷, R Wang¹², C M Farquhar⁴; endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research

Collaborators

endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research:
Jane P Daniels, Arianne C Lim, Katie Edmonds, Claire E MacLean, Amy C Appleton, Sarah Skelton, Dominic L Byrne, Rebecca K White, Margarida Sardo, Rebecca C Fowles, Baris Ata, Sarah A Richatd, Casandra C Puig Ybanez, Matthew C Peterson, Jasmin L Elms, Ann Parks, Bianca L F De Bie Rocks, Jodie C Roe, Ruby Doran, Marcello Ceccaroni, Ceu A Ferreira, Sofia Dias, Tracey Pinnington, Paula Laupa-Santiago, Marie C Turner, Anneke M F Schreurs, Eleanor Baggot, Razvan V Socolov, Menem Yossry, Tania M Hodges, Marina W P Barbossa, Târgu Mures, Tracy L Lytwyn, Sophia E L Egan-Reid, Susanna C L Devlin, Kira S Crees, Bethany C Baldwin, James R Scott, Amy K Gravolin, Errin F Chapman, Stephanie N Bartley, Alicia J Hamilton, Kirstie J Thorpe, Denise M Carmody, Joanna Eyeson, Madeleine D Davis, Jo Henry, Mike Armour, Presley Y F V Cummings, Lisa A Cook

Affiliations

¹ Institute for Women's Health, University College London, London, UK.
² King's Fertility, The Fetal Medicine Research Institute, London, UK.
³ University College London Hospitals NHS Foundation Trust, London, UK.
⁴ Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
⁵ School of Women's and Children's Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.
⁶ Radcliffe Women's Health Patient Participation Group, University of Oxford, Oxford, UK.
⁷ Resolve: The National Infertility Association, McLean, Virginia, USA.
⁸ endo:outcomes Patient and Public Participation Group, University of Auckland, Auckland, New Zealand.
⁹ Centre for Reproductive Medicine and Biology, University Medical Centre Maastricht, Maastricht, the Netherlands.
¹⁰ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.
¹¹ MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
¹² Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
¹³ World Endometriosis Society, Vancouver, British Columbia, Canada.
¹⁴ Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.
¹⁵ Osakidetza, OSI Bilbao, Basurto, Spain.
¹⁶ University of Medicine, Pharmacy, Science, and Technology, Targu Mures, Romania.
¹⁷ Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

PMID: 32227676
DOI: 10.1111/1471-0528.16157

Abstract

Objective: To develop a core outcome set for endometriosis.

Design: Consensus development study.

Setting: International.

Population: One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives.

Methods: Modified Delphi method and modified nominal group technique.

Results: The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment.

Conclusions: Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. TWEETABLE ABSTRACT: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.

Keywords: Consensus development study; core outcome set; endometriosis; modified Delphi method; modified nominal group technique.

Publication types

Systematic Review

MeSH terms

Biomedical Research*
Consensus
Delphi Technique
Endometriosis*
Endpoint Determination
Female
Health Personnel
Humans
Prospective Studies
Research Design
Research Personnel

Abstract

Publication types

MeSH terms

Grants and funding