Human Reproduction, Volume 35, Issue 12, December 2020, Pages 2725–2734 – 2020-11-30
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, and the Core Outcome Measure for Infertility Trials (COMMIT) initiative
Published: 30 November, 2020
1 King’s Fertility, Fetal Medicine Research Institute, London, UK
2 Institute for Women’s Health, University College London, London, UK
3 School of Medicine, University of Nottingham, Derby, UK
4 School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK
5 RESOLVE: The National Infertility Association, VA, USA
6 Fertility New Zealand, Auckland, New Zealand
7 School of Psychology, University of Waikato, Hamilton, New Zealand
8 Maastricht University Medical Centre, Maastricht, The Netherlands
9 Department of Obstetrics and Gynaecology, Liverpool Women’s NHS Foundation Trust, Liverpool, UK
10 Department of Obstetrics and Gynaecology, Mu¨nster University Hospital, Mu¨nster, Germany
11Center for Research, Innovation and Training in Reproduction and Infertility, Center for Reproductive Sciences, University of California, San Francisco, CA, USA
12 International Federation of Fertility Societies, Philadelphia, PA, USA
13 Department of Women and Children’s Health, King’s College London, Guy’s Hospital, London, UK
14 Freya Dutch Infertility Association, Gorinchem, The Netherlands
15 Department of Reproductive Endocrinology, University Hospital Zurich, Zurich, Switzerland
16 Department of Obstetrics and Gynaecology, Penn State College of Medicine, PA, USA
17 Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia
18 Cochrane Iberoamerica, Biomedical Research Institute Sant Pau, Barcelona, Spain
19 Reproductive Medicine Unit, University College Hospital, London, UK
20 Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia
21 Department of Urology, University of Illinois at Chicago College of Medicine, Chicago, IL, USA
22 Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong
23 Shenzhen Key Laboratory of Fertility Regulation, The University of Hong Kong-Shenzhen Hospital, China
24 Osakidetza OSI, Bilbao, Basurto, Spain
25 University of Medicine, Pharmacy, Sciences and Technology, Targu Mures, Romania
26 Fertility Europe, Evere, Belgium
27 Center for Reproductive Medicine, Amsterdam Reproduction and Development Institute, Amsterdam University Medical Centres, Amsterdam, The Netherlands
28 Department of Human and Molecular Genetics, Florida International University, FL, USA
29 Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Go¨ teborg, Sweden
30 Fertility Network UK, London, UK
31 Department of Reproductive Medicine, University Medical Centre Utrecht, Utrecht, the Netherlands
32 Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
33 Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand
34 Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy in Ho Chi Minh City, Ho Chi Minh City, Vietnam
35 Faculty of Health, University of Technology, Sydney, Broadway, Australia 36Department of Obstetrics and Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt
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.
Consensus development study / core outcome sets / modified Delphi method / modified Nominal Group Technique / outcome measures; outcomes