Developing a core outcome set for future infertility research: an international consensus development study.

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dc.contributor.authorDuffy, J.M.N.en_NZ
dc.contributor.authorAlAhwany, H.en_NZ
dc.contributor.authorBhattacharya, S.en_NZ
dc.contributor.authorCollura, B.en_NZ
dc.contributor.authorCurtis, Cateen_NZ
dc.contributor.authorEvers, J.L.H.en_NZ
dc.contributor.authorFarquharson, R.G.en_NZ
dc.contributor.authorFranik, S.en_NZ
dc.contributor.authorGiudice, L.C.en_NZ
dc.contributor.authorKhalaf, Y.en_NZ
dc.contributor.authorKnijnenburg, J.M.L.en_NZ
dc.contributor.authorLeeners, B.en_NZ
dc.contributor.authorLegro, R.S.en_NZ
dc.contributor.authorLensen, S.en_NZ
dc.contributor.authorVazquez-Niebla, J.C.en_NZ
dc.contributor.authorMavrelos, D.en_NZ
dc.contributor.authorMol, B.W.J.en_NZ
dc.contributor.authorNiederberger, C.en_NZ
dc.contributor.authorNg, E.H.Y.en_NZ
dc.contributor.authorOtter, A.S.en_NZ
dc.contributor.authorPuscasiu, L.en_NZ
dc.contributor.authorRautakallio-Hokkanen, S.en_NZ
dc.contributor.authorRepping, S.en_NZ
dc.contributor.authorSarris, I.en_NZ
dc.contributor.authorSimpson, J.L.en_NZ
dc.contributor.authorStrandell, A.en_NZ
dc.contributor.authorStrawbridge, C.en_NZ
dc.contributor.authorTorrance, H.L.en_NZ
dc.contributor.authorVail, A.en_NZ
dc.contributor.authorvan Wely, M.en_NZ
dc.contributor.authorVercoe, M.A.en_NZ
dc.contributor.authorVuong, N.L.en_NZ
dc.contributor.authorWang, A.Y.en_NZ
dc.contributor.authorWang, R.en_NZ
dc.contributor.authorWilkinson, J.en_NZ
dc.contributor.authorYoussef, M.A.en_NZ
dc.contributor.authorFarquhar, C.M.en_NZ
dc.contributor.authorCore Outcome Measure for Infertility Trials (COMMIT) initiativeen_NZ
dc.coverage.spatialUnited Statesen_NZ
dc.date.accessioned2021-06-16T03:07:55Z
dc.date.available2021-06-16T03:07:55Z
dc.date.issued2021en_NZ
dc.description.abstractSTUDY QUESTION: Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials Initiative: 1023.en_NZ
dc.format.mimetypeapplication/pdf
dc.identifier.citationDuffy, J. M. ., AlAhwany, H., Bhattacharya, S., Collura, B., Curtis, C., Evers, J. L. H., … Core Outcome Measure for Infertility Trials (COMMIT) initiative. (2021). Developing a core outcome set for future infertility research: an international consensus development study. Fertil Steril, 115(1), 191–200. https://doi.org/10.1016/j.fertnstert.2020.11.012en
dc.identifier.doi10.1016/j.fertnstert.2020.11.012en_NZ
dc.identifier.eissn1556-5653en_NZ
dc.identifier.urihttps://hdl.handle.net/10289/14375
dc.language.isoenen_NZ
dc.relation.isPartOfFertil Sterilen_NZ
dc.rightsThe article has been co-published with permission in Human Reproduction and Fertility and Sterility. © The Authors, 2020. Published by Elsevier This is an Open Access article distributed under the terms of the Creative Commons Attributian-NonCommerciallicence (https://creativecom mons.orq/licenses/bv-nc/4.0/) which permits noncommercial reproduction and distribution of the work, in any medium, provided the original work is properly cited. For commercial re use, please contact permissions@elsevier.com. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style.
dc.subjectConsensus development studyen_NZ
dc.subjectcore outcome setsen_NZ
dc.subjectmodified Delphi methoden_NZ
dc.subjectmodified Nominal Group Techniqueen_NZ
dc.subjectoutcome measuresen_NZ
dc.subjectoutcomesen_NZ
dc.titleDeveloping a core outcome set for future infertility research: an international consensus development study.en_NZ
dc.typeJournal Article
pubs.begin-page191
pubs.elements-id258766
pubs.end-page200
pubs.issue1en_NZ
pubs.organisational-group/Waikato
pubs.organisational-group/Waikato/2025 PBRF
pubs.organisational-group/Waikato/DASL
pubs.organisational-group/Waikato/DASL/2025 PBRF - DASL
pubs.organisational-group/Waikato/DASL/DALPS Academics
pubs.organisational-group/Waikato/DASL/SPSY
pubs.organisational-group/Waikato/DASL/SPSY/2025 PBRF - SPSY
pubs.organisational-group/Waikato/DASL/SPSY/SPSY Academics
pubs.publication-statusPublisheden_NZ
pubs.user.infoCurtis, Teresa (ccurtis@waikato.ac.nz)
pubs.volume115en_NZ
uow.verification.statusverified
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