Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/130047
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Type: Journal article
Title: Developing a core outcome set for future infertility research: an international consensus development study
Author: Duffy, J.M.N.
AlAhwany, H.
Bhattacharya, S.
Collura, B.
Curtis, C.
Evers, J.L.H.
Farquharson, R.G.
Franik, S.
Giudice, L.C.
Khalaf, Y.
Knijnenburg, J.M.L.
Leeners, B.
Legro, R.S.
Lensen, S.
Vazquez-Niebla, J.C.
Mavrelos, D.
Mol, B.W.J.
Niederberger, C.
Ng, E.H.Y.
Otter, A.S.
et al.
Citation: Fertility and Sterility, 2020; 115(1):191-200
Publisher: Elsevier
Issue Date: 2020
ISSN: 0015-0282
1556-5653
Statement of
Responsibility: 
J.M.N.Duffy, H.AlAhwany, S.Bhattacharya, B.Collura ... Bernardus Mol ... Mary Hull ... et al.
Abstract: Study 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.
Keywords: Core Outcome Measure for Infertility Trials (COMMIT) initiative
Consensus development study; core outcome sets; modified Delphi method; modified Nominal Group Technique; outcomemeasures; outcome
Rights: The article has been co-published with permission inHuman ReproductionandFertility and Sterility. © The Authors, 2020. Published by ElsevierThis is anOpen 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. Forcommercial re use, please contact permissions@elsevier.com. The articles are identical except for minor stylistic and spelling differences in keeping witheach journal's style.
DOI: 10.1016/j.fertnstert.2020.11.012
Appears in Collections:Aurora harvest 8
Obstetrics and Gynaecology publications

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