TY - JOUR
T1 - A core outcome set for future endometriosis research: an international consensus development study
AU - Duffy, J.M.N.
AU - Hirsch, M.
AU - Vercoe, M.
AU - Abbott, J.
AU - Barker, C.
AU - Collura, B.
AU - Drake, R.
AU - Evers, J.L.H.
AU - Hickey, M.
AU - Horne, A.W.
AU - Hull, M.L.
AU - Kolekar, S.
AU - Lensen, S.
AU - Johnson, N.P.
AU - Mahajan, V.
AU - Mol, B.W.
AU - Otter, A.S.
AU - Puscasiu, L.
AU - Rodriguez, M.B.
AU - Rombauts, L.
AU - Vail, A.
AU - Wang, R.
AU - Farquhar, C.M.
AU - endo:outcomes – an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research
N1 - Funding Information:
This study was funded by the Catalyst Fund, the Royal Society of New Zealand, and Endometriosis Millennium Fund, Royal College of Obstetricians and Gynaecologists. The funders had no role in the design and conduct of the study, the collection, management, analysis, or interpretation of the data, or preparation of the article.
Funding Information:
MLH has received travel grants from Merck‐Serono and Geurbet, research funding from AbbVie, Merck, Origio, and Myovant, and has been a consultant to Vifor Pharma. AWH has received consultancy fees from AbbVie, Ferring, Nordic Pharma, and Roche Diagnostics. NPJ has received conference expenses from Bayer Pharma, Merck‐Serono, and Merck and Co., research funding from AbbVie, and has been a consultant to Guerbet, Mvovant Sciences, and Vifor Pharma. LR has received research funding from Ferring Australia, Merck‐Serono, and MSD, and chairs the Ferring Australia advisory board. The remaining authors report no competing interests. Completed disclosure of interests form available to view online as supporting information.
Funding Information:
This study was funded by the Catalyst Fund, the Royal Society of New Zealand and Endometriosis Millennium Fund, Royal College of Obstetricians and Gynaecologists. The funders had no role in the design and conduct of the study, the collection, management, analysis or interpretation of the data, or preparation of the article. We would like to thank the healthcare professionals, researchers and patient representatives who participated in the Delphi survey and consensus development meetings.
Publisher Copyright:
© 2020 Royal College of Obstetricians and Gynaecologists
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
KW - consensus development study
KW - core outcome set
KW - endometriosis
KW - modified delphi method
KW - modified nominal group technique
KW - Consensus development study
KW - modified Delphi method
U2 - 10.1111/1471-0528.16157
DO - 10.1111/1471-0528.16157
M3 - Article
C2 - 32227676
SN - 1470-0328
VL - 127
SP - 967
EP - 974
JO - Bjog-an International Journal of Obstetrics and Gynaecology
JF - Bjog-an International Journal of Obstetrics and Gynaecology
IS - 8
ER -