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https://doi.org/10.1016/j.fertnstert.2020.11.013

Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study

J. M. N. Duffy,a,b S. Bhattacharya,c S. Bhattacharya,c M. Bofill,d B. Collura,e C. Curtis,f,g J. L. H. Evers,h L. C. Giudice,i,j R. G. Farquharson,k S. Franik,l M. Hickey,m M. L. Hull,n V. Jordan,d Y. Khalaf,o R. S. Legro,p S. Lensen,m D. Mavrelos,q B. W. Mol,r C. Niederberger,s E. H. Y. Ng,t,u L. Puscasiu,v S. Repping,w,x I. Sarris,a M. Showell,y A. Strandell,z A. Vail,aa M. van Wely,w M. Vercoe,y N. L. Vuong,bb A. Y. Wang,cc R. Wang,r J. Wilkinson,aa M. A. Youssef,dd C. M.  arquhard,y and the Core Outcome Measure for Infertility Trials (COMMIT) initiativez

a King’s Fertility, Fetal Medicine Research Institute, London, UK;

b Institute for Women’s Health, University College London, London, UK;

c School of Medicine, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK;

d Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand;

e RESOLVE: The National Infertility Association, Virginia, United States;

f Fertility New Zealand, Auckland, New Zealand;

g School of Psychology, University of Waikato, Hamilton, New Zealand;

h Maastricht University Medical Centre, Maastricht, The Netherlands;

i Center for Research, Innovation and Training in Reproduction and Infertility, Center for Reproductive Sciences, University of California, San Francisco, California, United States;

j International Federation of Fertility Societies, Philadelphia, Pennsylvania, United States;

k Department of Obstetrics and Gynaecology, Liverpool Women's NHS Foundation Trust, Liverpool, UK;

l Department of Obstetrics and Gynaecology, Munster University Hospital, M € unster, €
Germany;

m Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia;

n Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia;

o Department of Women and Children’s Health, King’s College London, Guy’s Hospital, London;

p Department of Obstetrics and Gynaecology, Penn State College of Medicine, Pennsylvania; q Reproductive Medicine Unit, University College Hospital, London, UK;

r Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia;

s Department of Urology, University of Illinois at Chicago College of Medicine, Chicago, Illinois;

t Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong;

u Shenzhen Key Laboratory of Fertility Regulation, The University of Hong Kong-Shenzhen Hospital, China;

v University of Medicine, Pharmacy, Sciences and Technology, Targu Mures, Romania;

w Amsterdam University Medical Centers, Amsterdam, The Netherlands;

x National Health Care Institute, Diemen, The Netherlands;

y Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand;

z Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden;

aa Centre for Biostatistics, Universityof Manchester, Manchester Academic Health Science Centre, Manchester, UK;

bb Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; cc Faculty of Health, University of Technology, Sydney, Broadway, Australia; and dd Department of Obstetrics & Gynaecology, Faculty of
Medicine, Cairo University, Cairo, Egypt

Abstract

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. Hans Evers reports being the Editor Emeritus of Human Reproduction. 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 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. Ernest Ng reports research sponsorship from Merck. Annika Strandell reports consultancy fees from Guerbet. Jack Wilkinson reports being a statistical editor for the
Cochrane Gynaecology and Fertility group. Andy Vail 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 HFEA for his advice on review of research evidence to inform their ‘traffic light’ system for infertility treatment ‘add-ons'. 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.

KEYWORDS:

Female infertility, infertility, male infertility, effectiveness, safety, outcomes

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