Human Reproduction, Volume 35, Issue 12, December 2020, Pages 2735–2745 – 2020-11-30
J M N Duffy 1 2, S Bhattacharya 3, S Bhattacharya 3, M Bofill 4, B Collura 5, C Curtis 6 7, J L H Evers 8, L C Giudice 9 10, R G Farquharson 11, S Franik 12, M Hickey 13, M L Hull 14, V Jordan 4, Y Khalaf 15, R S Legro 16, S Lensen 13, D Mavrelos 17, B W Mol 18, C Niederberger 19, E H Y Ng 20 21, L Puscasiu 22, S Repping 23 24, I Sarris 1, M Showell 25, A Strandell 26, A Vail 27, M van Wely 23, M Vercoe 25, N L Vuong 28, A Y Wang 29, R Wang 18, J Wilkinson 27, M A Youssef 30, C M Farquhar 4 25, Core Outcome Measure for Infertility Trials (COMMIT) initiative
Published: 30 November, 2020
1King’s Fertility, Fetal Medicine Research Institute, London, UK.
2Institute for Women’s Health, University College London, London, UK.
3School of Medicine, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK.
4Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.
5RESOLVE, The National Infertility Association, VA, USA.
6Fertility New Zealand, Auckland, New Zealand.
7School of Psychology, University of Waikato, Hamilton, New Zealand.
8Maastricht University Medical Centre, Maastricht, The Netherlands.
9Center for Research, Innovation and Training in Reproduction and Infertility, Center for Reproductive Sciences, University of California, San Francisco, CA, USA.
10International Federation of Fertility Societies, Philadelphia, PA, USA.
11Department of Obstetrics and Gynaecology, Liverpool Women’s NHS Foundation Trust, Liverpool, UK.
12Department of Obstetrics and Gynaecology, Münster University Hospital, Münster, Germany.
13Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia.
14Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
15Department of Women and Children’s Health, King’s College London, Guy’s Hospital, London.
16Department of Obstetrics and Gynaecology, Penn State College of Medicine, PA, USA.
17Reproductive Medicine Unit, University College Hospital, London, UK.
18Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia.
19Department of Urology, University of Illinois at Chicago College of Medicine, Chicago, IL, USA.
20Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong.
21Shenzhen Key Laboratory of Fertility Regulation, The University of Hong Kong-Shenzhen Hospital, China.
22Pharmacy, Sciences and Technology, University of Medicine, Targu Mures, Romania.
23Amsterdam University Medical Centers, Amsterdam, The Netherlands.
24National Health Care Institute, Diemen, The Netherlands.
25Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
26Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.
27Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
28Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
29Faculty of Health, University of Technology, Sydney, Broadway, Australia.
30Department of Obstetrics & Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt.
Study question: Can consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting?
Summary answer: Consensus definitions for individual core outcomes, contextual statements and a standardized reporting table have been developed.
What is known already: Different definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development.
Study design, size, duration: Potential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process.
Participants/materials, setting, methods: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus development methods.
Main results and the role of chance: Forty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting.
Limitations, reasons for caution: We used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries.
Wider implications of the findings: A minimum data set should assist researchers in populating protocols, case report forms and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals 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. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. 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.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and a financial interest in NexHand. E.H.Y.N. reports research sponsorship from Merck. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their ‘traffic light’ system for infertility treatment ‘add-ons’. 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.
female infertility; infertility; male infertility / effectiveness / safety / outcomes