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DOI https://doi.org/10.1093/hropen/hoy007

A protocol developing, disseminating and implementing a core outcome set for infertility

J.M.N. Duffy1,2,*, S. Bhattacharya3, C. Curtis4,5, J.L.H. Evers6, R.G. Farquharson7, S. Franik8, Y. Khalaf9, R.S. Legro10, S.Lensen11, B.W. Mol12, C. Niederberger13, E.H.Y. Ng14, S. Repping15, A. Strandell16, H.L. Torrance17, A. Vail18, M. van Wely15, N.L. Vuong19, A.Y. Wang20, R. Wang21, J. Wilkinson18, M.A. Youssef22, and C.M. Farquhar11, on behalf of COMMIT: Core Outcomes Measures for Infertility Trials

  1. Balliol College, University of Oxford, Oxford, UK
  2. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  3. Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK
  4. Fertility New Zealand, Auckland, New Zealand 5
  5. School of Psychology, University of Waikato, Hamilton, New Zealand
  6. Centre for Reproductive Medicine and Biology, University Medical Centre Maastricht, Maastricht, The Netherlands
  7. Department of Obstetrics and Gynaecology, Liverpool Women’s NHS Foundation Trust, Liverpool, UK
  8.  Department of Obstetrics and Gynaecology, Münster University Hospital, Münster, Germany
  9. Assisted Conception Unit, Guy’s Hospital, London, UK
  10. Department of Obstetrics and Gynaecology, Penn State College of Medicine, PA, USA
  11. Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand
  12. Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Australia
  13. Department of Urology, University of Illinois at Chicago College of Medicine, Chicago, IL, USA
  14. Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong
  15. Center for Reproductive Medicine, Amsterdam Reproduction and Development Institute, Academic Medical Centre, Amsterdam, The Netherlands
  16. Sahlgrenska University Hospital, Göteborg, Sweden
  17. Department of Reproductive Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands
  18. Centre for Biostatistics, University of Manchester, Manchester, UK
  19. Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
  20. Faculty of Health, University of Technology Sydney, Broadway, Australia
  21. Robinson Research Institute and Adelaide Medical School, University of Adelaide, Adelaide, Australia
  22. Department of Obstetrics & Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt
Abstract

STUDY QUESTIONS
We aim to produce, disseminate and implement a core outcome set for future infertility research.
WHAT IS KNOWN ALREADY
Randomized controlled trials (RCTs) evaluating infertility treatments have reported many different outcomes, which are often defined and measured in different ways. Such variation contributes to an inability to compare, contrast and combine results of individual RCTs. The development of a core outcome set will ensure outcomes important to key stakeholders are consistently collected and reported across future infertility research.
STUDY DESIGN, SIZE, DURATION
This is a consensus study using the modified Delphi method. All stakeholders, including healthcare professionals, allied healthcare professionals, researchers and people with lived experience of infertility will be invited to participate.
PARTICIPANTS/MATERIALS, SETTING, METHODS
An international steering group, including people with lived experience of infertility, healthcare professionals, allied healthcare professionals and researchers, has been formed to guide the development of this core outcome set. Potential core outcomes have been identified through a comprehensive literature review of RCTs evaluating treatments for infertility and will be entered into a modified Delphi method. Participants will be asked to score potential core outcomes on a nine-point Likert scale anchored between one (not important) and nine (critical). Repeated reflection and rescoring should promote convergence towards consensus ‘core’ outcomes. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes.
STUDY FUNDING/COMPETING INTEREST(S)
This project is funded by the Royal Society of New Zealand Catalyst Fund (3712235). BWM reports consultancy fees from Guerbet, Merck, and ObsEva. R.S.L. reports consultancy fees from Abbvie, Bayer, Fractyl and Ogeda and research sponsorship from Ferring. S.B. is the Editor-in-Chief of Human Reproduction Open. The remaining authors declare no competing interests.

KEYWORDS:

infertility, consensus study, modified Delphi method, core outcome set, randomized controlled trials, systematic review, clinical practice guidelines

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