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

Duffy, JMN; AlAhwany, H; Bhattacharya, S; Collura, B; Curtis, C; Evers, JLH; Farquharson, RG; Franik, S; Giudice, LC; Khalaf, Y; Knijnenburg, JML; Leeners, B; Legro, RS; Lensen, S; Vazquez-Niebla, JC; Mavrelos, D; Mol, BWJ; Niederberger, C; Ng, EHY; Otter, AS; Puscasiu, L; Rautakallio-Hokkanen, S; Repping, S; Sarris, I; Simpson, JL; Strandell, A; Strawbridge, C; Torrance, HL; Vail, A; van Wely, M; Vercoe, MA; Vuong, NL; Wang, AY; Wang, R; Wilkinson, J; Youssef, MA; Farquhar, CM; Core Outcome Measure for Infertility Trials (COMMIT) initiative,

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

Duffy, JMN AlAhwany, H Bhattacharya, S Collura, B Curtis, C Evers, JLH Farquharson, RG Franik, S Giudice, LC Khalaf, Y Knijnenburg, JML Leeners, B Legro, RS Lensen, S Vazquez-Niebla, JC Mavrelos, D Mol, BWJ Niederberger, C Ng, EHY Otter, AS Puscasiu, L Rautakallio-Hokkanen, S Repping, S Sarris, I Simpson, JL Strandell, A Strawbridge, C Torrance, HL Vail, A van Wely, M Vercoe, MA Vuong, NL Wang, AY Wang, R Wilkinson, J Youssef, MA Farquhar, CM Core Outcome Measure for Infertility Trials (COMMIT) initiative,

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Publisher:: Elsevier
Publication Type:: Journal Article
Citation:: Fertility and Sterility, 2021, 115, (1), pp. 191-200
Issue Date:: 2021-01

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Field	Value	Language
dc.contributor.author	Duffy, JMN
dc.contributor.author	AlAhwany, H
dc.contributor.author	Bhattacharya, S
dc.contributor.author	Collura, B
dc.contributor.author	Curtis, C
dc.contributor.author	Evers, JLH
dc.contributor.author	Farquharson, RG
dc.contributor.author	Franik, S
dc.contributor.author	Giudice, LC
dc.contributor.author	Khalaf, Y
dc.contributor.author	Knijnenburg, JML
dc.contributor.author	Leeners, B
dc.contributor.author	Legro, RS
dc.contributor.author	Lensen, S
dc.contributor.author	Vazquez-Niebla, JC
dc.contributor.author	Mavrelos, D
dc.contributor.author	Mol, BWJ
dc.contributor.author	Niederberger, C
dc.contributor.author	Ng, EHY
dc.contributor.author	Otter, AS
dc.contributor.author	Puscasiu, L
dc.contributor.author	Rautakallio-Hokkanen, S
dc.contributor.author	Repping, S
dc.contributor.author	Sarris, I
dc.contributor.author	Simpson, JL
dc.contributor.author	Strandell, A
dc.contributor.author	Strawbridge, C
dc.contributor.author	Torrance, HL
dc.contributor.author	Vail, A
dc.contributor.author	van Wely, M
dc.contributor.author	Vercoe, MA
dc.contributor.author	Vuong, NL
dc.contributor.author	Wang, AY
dc.contributor.author	Wang, R
dc.contributor.author	Wilkinson, J
dc.contributor.author	Youssef, MA
dc.contributor.author	Farquhar, CM
dc.contributor.author	Core Outcome Measure for Infertility Trials (COMMIT) initiative,
dc.date.accessioned	2021-09-16T01:59:29Z
dc.date.available	2020-07-22
dc.date.available	2021-09-16T01:59:29Z
dc.date.issued	2021-01
dc.identifier.citation	Fertility and Sterility, 2021, 115, (1), pp. 191-200
dc.identifier.issn	0015-0282
dc.identifier.issn	1556-5653
dc.identifier.uri	http://hdl.handle.net/10453/150580
dc.description.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.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	Elsevier
dc.relation.ispartof	Fertility and Sterility
dc.relation.isbasedon	10.1016/j.fertnstert.2020.11.012
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1114 Paediatrics and Reproductive Medicine, 1117 Public Health and Health Services
dc.subject.classification	Obstetrics & Reproductive Medicine
dc.subject.mesh	Biomedical Research
dc.subject.mesh	Consensus
dc.subject.mesh	Datasets as Topic
dc.subject.mesh	Delphi Technique
dc.subject.mesh	Evidence-Based Practice
dc.subject.mesh	Female
dc.subject.mesh	Humans
dc.subject.mesh	Infertility
dc.subject.mesh	International Cooperation
dc.subject.mesh	Male
dc.subject.mesh	Outcome and Process Assessment, Health Care
dc.subject.mesh	Practice Guidelines as Topic
dc.subject.mesh	Pregnancy
dc.subject.mesh	Reproductive Medicine
dc.subject.mesh	Research
dc.subject.mesh	Humans
dc.subject.mesh	Infertility
dc.subject.mesh	Consensus
dc.subject.mesh	Reproductive Medicine
dc.subject.mesh	Pregnancy
dc.subject.mesh	Research
dc.subject.mesh	Biomedical Research
dc.subject.mesh	International Cooperation
dc.subject.mesh	Delphi Technique
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Practice Guidelines as Topic
dc.subject.mesh	Evidence-Based Practice
dc.subject.mesh	Datasets as Topic
dc.subject.mesh	Outcome and Process Assessment, Health Care
dc.subject.mesh	Biomedical Research
dc.subject.mesh	Consensus
dc.subject.mesh	Datasets as Topic
dc.subject.mesh	Delphi Technique
dc.subject.mesh	Evidence-Based Practice
dc.subject.mesh	Female
dc.subject.mesh	Humans
dc.subject.mesh	Infertility
dc.subject.mesh	International Cooperation
dc.subject.mesh	Male
dc.subject.mesh	Outcome and Process Assessment, Health Care
dc.subject.mesh	Practice Guidelines as Topic
dc.subject.mesh	Pregnancy
dc.subject.mesh	Reproductive Medicine
dc.subject.mesh	Research
dc.title	Developing a core outcome set for future infertility research: an international consensus development study.
dc.type	Journal Article
utslib.citation.volume	115
utslib.location.activity	United States
utslib.for	1103 Clinical Sciences
utslib.for	1114 Paediatrics and Reproductive Medicine
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Public Health
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
dc.date.updated	2021-09-16T01:59:28Z
pubs.issue	1
pubs.publication-status	Published
pubs.volume	115
utslib.citation.issue	1

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.

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http://hdl.handle.net/10453/150580