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 |
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dc.contributor.author |
Vazquez-Niebla, JC |
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dc.contributor.author |
Mavrelos, D |
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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.coverage.spatial |
England |
|
dc.date.accessioned |
2022-07-25T23:18:32Z |
|
dc.date.available |
2022-07-25T23:18:32Z |
|
dc.date.issued |
2020-12 |
|
dc.identifier.citation |
(2020). Human Reproduction, 35(12), 2725-2734. |
|
dc.identifier.issn |
0268-1161 |
|
dc.identifier.uri |
https://hdl.handle.net/2292/60513 |
|
dc.description.abstract |
<h4>Study question</h4>Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed?<h4>Summary answer</h4>A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility.<h4>What is known already</h4>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.<h4>Study design, size, duration</h4>A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).<h4>Participants/materials, setting, methods</h4>Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.<h4>Main results and the role of chance</h4>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.<h4>Limitations, reasons for caution</h4>We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold.<h4>Wider implications of the findings</h4>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, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set.<h4>Study funding/competing interest(s)</h4>This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. 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. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. 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.<h4>Trial registration number</h4>Core Outcome Measures in Effectiveness Trials Initiative: 1023. |
|
dc.format.medium |
Print |
|
dc.language |
eng |
|
dc.publisher |
Oxford University Press (OUP) |
|
dc.relation.ispartofseries |
Human reproduction (Oxford, England) |
|
dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
|
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
|
dc.rights.uri |
https://creativecommons.org/licenses/by-nc/4.0/ |
|
dc.subject |
Core Outcome Measure for Infertility Trials (COMMIT) initiative |
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dc.subject |
Humans |
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dc.subject |
Infertility |
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dc.subject |
Consensus |
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dc.subject |
Pregnancy |
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dc.subject |
New Zealand |
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dc.subject |
Female |
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dc.subject |
Live Birth |
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dc.subject |
Randomized Controlled Trials as Topic |
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dc.subject |
Systematic Reviews as Topic |
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dc.subject |
Outcome Assessment, Health Care |
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dc.subject |
Consensus development study |
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dc.subject |
core outcome sets |
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dc.subject |
modified Delphi method |
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dc.subject |
modified Nominal Group Technique |
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dc.subject |
outcome measures |
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dc.subject |
outcomes |
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dc.subject |
Clinical Research |
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dc.subject |
Clinical Trials and Supportive Activities |
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dc.subject |
Contraception/Reproduction |
|
dc.subject |
Reproductive health and childbirth |
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dc.subject |
Generic health relevance |
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dc.subject |
3 Good Health and Well Being |
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dc.subject |
Science & Technology |
|
dc.subject |
Life Sciences & Biomedicine |
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dc.subject |
Obstetrics & Gynecology |
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dc.subject |
Reproductive Biology |
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dc.subject |
outcome measures; outcomes |
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dc.subject |
CLINICAL-TRIALS |
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dc.subject |
PROTOCOL |
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dc.subject |
11 Medical and Health Sciences |
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dc.subject |
16 Studies in Human Society |
|
dc.title |
Developing a core outcome set for future infertility research: an international consensus development study† ‡. |
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dc.type |
Journal Article |
|
dc.identifier.doi |
10.1093/humrep/deaa241 |
|
pubs.issue |
12 |
|
pubs.begin-page |
2725 |
|
pubs.volume |
35 |
|
dc.date.updated |
2022-06-07T20:20:42Z |
|
dc.rights.holder |
Copyright: The author |
en |
dc.identifier.pmid |
33252685 (pubmed) |
|
pubs.author-url |
https://www.ncbi.nlm.nih.gov/pubmed/33252685 |
|
pubs.end-page |
2734 |
|
pubs.publication-status |
Published |
|
dc.rights.accessrights |
http://purl.org/eprint/accessRights/OpenAccess |
en |
pubs.subtype |
Research Support, Non-U.S. Gov't |
|
pubs.subtype |
research-article |
|
pubs.subtype |
Journal Article |
|
pubs.elements-id |
831404 |
|
pubs.org-id |
Medical and Health Sciences |
|
pubs.org-id |
School of Medicine |
|
pubs.org-id |
Obstetrics and Gynaecology |
|
dc.identifier.eissn |
1460-2350 |
|
dc.identifier.pii |
6010638 |
|
pubs.record-created-at-source-date |
2022-06-08 |
|
pubs.online-publication-date |
2020-12-01 |
|