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

J. M.N. Duffy; M. Hirsch; M. Vercoe; J. Abbott; C. Barker; B. Collura; R. Drake; J. L.H. 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; 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

doi:10.1111/1471-0528.16157

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

J. M.N. Duffy^*, M. Hirsch, M. Vercoe, J. Abbott, C. Barker, B. Collura, R. Drake, J. L.H. 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. RombautsA. Vail, R. Wang, C. M. Farquhar, 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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Pages (from-to)	967-974
Number of pages	8
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Volume	127
Issue number	8
Early online date	30 Mar 2020
DOIs	https://doi.org/10.1111/1471-0528.16157
Publication status	Published - Jul 2020

Bibliographical note

Funding Information
Catalyst Fund
Endometriosis Millennium Fund

Funding

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. 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.

Keywords

Consensus development study
core outcome set
endometriosis
modified Delphi method
modified nominal group technique
Prospective Studies
Humans
Endometriosis
Consensus
Delphi Technique
Research Personnel
Health Personnel
Endpoint Determination
Biomedical Research
Female
Research Design

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Duffy, J. M. N., Hirsch, M., Vercoe, M., Abbott, J., Barker, C., Collura, B., Drake, R., Evers, J. L. H., Hickey, M., Horne, A. W., Hull, M. L., Kolekar, S., Lensen, S., Johnson, N. P., Mahajan, V., Mol, B. W., Otter, A. S., Puscasiu, L., Rodriguez, M. B., ... Cook, L. A. (2020). A core outcome set for future endometriosis research: an international consensus development study. BJOG: An International Journal of Obstetrics and Gynaecology, 127(8), 967-974. https://doi.org/10.1111/1471-0528.16157

Duffy, JMN, Hirsch, M, Vercoe, M, Abbott, J, Barker, C, Collura, B, Drake, R, Evers, JLH, Hickey, M, Horne, AW, Hull, ML, Kolekar, S, Lensen, S, Johnson, NP, Mahajan, V, Mol, BW, Otter, AS, Puscasiu, L, Rodriguez, MB, Rombauts, L, Vail, A, Wang, R, Farquhar, CM, Daniels, JP, Lim, AC, Edmonds, K, MacLean, CE, Appleton, AC, Skelton, S, Byrne, DL, White, RK, Sardo, M, Fowles, RC, Ata, B, Richatd, SA, Puig Ybanez, CC, Peterson, MC, Elms, JL, Parks, A, De Bie Rocks, BLF, Roe, JC, Doran, R, Ceccaroni, M, Ferreira, CA, Dias, S, Pinnington, T, Laupa-Santiago, P, Turner, MC, Schreurs, AMF, Baggot, E, Socolov, RV, Yossry, M, Hodges, TM, Barbossa, MWP, Mures, T, Lytwyn, TL, Egan-Reid, SEL, Devlin, SCL, Crees, KS, Baldwin, BC, Scott, JR, Gravolin, AK, Chapman, EF, Bartley, SN, Hamilton, AJ, Thorpe, KJ, Carmody, DM, Eyeson, J, Davis, MD, Henry, J, Armour, M, Cummings, PYFV & Cook, LA 2020, 'A core outcome set for future endometriosis research: an international consensus development study', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 127, no. 8, pp. 967-974. https://doi.org/10.1111/1471-0528.16157

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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.",

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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.

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AU - Sardo, Margarida

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AU - Ata, Baris

AU - Richatd, Sarah A.

AU - Puig Ybanez, Casandra C.

AU - Peterson, Matthew C.

AU - Elms, Jasmin L.

AU - Parks, Ann

AU - De Bie Rocks, Bianca L.F.

AU - Roe, Jodie C.

AU - Doran, Ruby

AU - Ceccaroni, Marcello

AU - Ferreira, Ceu A.

AU - Dias, Sofia

AU - Pinnington, Tracey

AU - Laupa-Santiago, Paula

AU - Turner, Marie C.

AU - Schreurs, Anneke M.F.

AU - Baggot, Eleanor

AU - Socolov, Razvan V.

AU - Yossry, Menem

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AU - Egan-Reid, Sophia E.L.

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AU - Crees, Kira S.

AU - Baldwin, Bethany C.

AU - Scott, James R.

AU - Gravolin, Amy K.

AU - Chapman, Errin F.

AU - Bartley, Stephanie N.

AU - Hamilton, Alicia J.

AU - Thorpe, Kirstie J.

AU - Carmody, Denise M.

AU - Eyeson, Joanna

AU - Davis, Madeleine D.

AU - Henry, Jo

AU - Armour, Mike

AU - Cummings, Presley Y.F.V.

AU - Cook, Lisa A.

N1 - Funding Information Catalyst Fund Endometriosis Millennium Fund

PY - 2020/7

Y1 - 2020/7

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.

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

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

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