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. 2020 Dec 1;35(12):2725-2734.
doi: 10.1093/humrep/deaa241.

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

J M N Duffy  1   2 , H AlAhwany  3 , S Bhattacharya  4 , B Collura  5 , C Curtis  6   7 , J L H Evers  8 , R G Farquharson  9 , S Franik  10 , L C Giudice  11   12 , Y Khalaf  13 , J M L Knijnenburg  14 , B Leeners  15 , R S Legro  16 , S Lensen  17 , J C Vazquez-Niebla  18 , D Mavrelos  19 , B W J Mol  20 , C Niederberger  21 , E H Y Ng  22   23 , A S Otter  24 , L Puscasiu  25 , S Rautakallio-Hokkanen  26 , S Repping  27 , I Sarris  1 , J L Simpson  28 , A Strandell  29 , C Strawbridge  30 , H L Torrance  31 , A Vail  32 , M van Wely  27 , M A Vercoe  33 , N L Vuong  34 , A Y Wang  35 , R Wang  20 , J Wilkinson  32 , M A Youssef  36 , C M Farquhar  33 ; Core Outcome Measure for Infertility Trials (COMMIT) initiative
Collaborators, Affiliations

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

J M N Duffy et al. Hum Reprod. .

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 (RCTs) 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, Fertility 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. 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.

Trial registration number: Core Outcome Measures in Effectiveness Trials Initiative: 1023.

Keywords: Consensus development study; core outcome sets; modified Delphi method; modified Nominal Group Technique; outcome measures; outcomes.

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Figures

Figure 1.
Figure 1.
Flow of participants and outcomes.
Figure 2.
Figure 2.
A core outcome set for future infertility research.
See this image and copyright information in PMC

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References

    1. Barnhart KT. Live birth is the correct outcome for clinical trials evaluating therapy for the infertile couple. Fertil Steril 2014;101:1205–1208. - PMC - PubMed
    1. Braakhekke M, Kamphuis EI, van Rumste MM, Mol F, van der Veen F, Mol BW. How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine? Hum Reprod 2014;29:1211–1217. - PubMed
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–207. - PMC - PubMed
    1. Core Outcomes in Women's and Newborn Health Initiative. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health. Hum Reprod 2014;29:1349–1350. - PubMed
    1. Dapuzzo L, Seitz FE, Dodson WC, Stetter C, Kunselman AR, Legro RS. Incomplete and inconsistent reporting of maternal and fetal outcomes in infertility treatment trials. Fertil Steril 2011;95:2527–2530. - PMC - PubMed

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