Protocol for developing a core outcome set for male infertility research: an international consensus development study.

Autor:	Rimmer MP; MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK., Howie RA; Edinburgh Fertility Centre, Simpsons Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK., Anderson RA; MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK.; Edinburgh Fertility Centre, Simpsons Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK., Barratt CLR; Reproductive Medicine Research Group, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK., Barnhart KT; Department of Obstetrics and Gynaecology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA., Beebeejaun Y; King's Fertility, The Fetal Medicine Research Unit, King's College London, London, UK., Bertolla RP; Division of Urology, Department of Surgery, Universidade Federal de Sao Paulo, Sao Paulo, Brazil., Bhattacharya S; University of Aberdeen, Aberdeen, UK., Björndahl L; ANOVA-Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden., Bortoletto P; The Ronald O. Perelman and Claudia Cohen Centre for Reproductive Medicine, Weill Cornell Medicine, New York, NY, USA., Brannigan RE; Northwestern University, Feinberg School of Medicine, Chicago, IL, USA., Cantineau AEP; University of Groningen, University Medical Centre, Groningen, Centre of Reproductive Medicine, Groningen, Netherlands., Caroppo E; Asl Bari, Reproductive Unit and Andrology Clinic, Conversano (Ba), Italy., Collura BL; RESOLVE: The National Infertility Association, McLean, VA, USA., Coward K; Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.; Women's Centre, John Radcliffe Hospital, Headington, Oxford, UK., Eisenberg ML; Stanford University, Stanford, CA, USA., De Geyter C; Reproductive Medicine and Gynaecological Endocrinology (RME), University Hospital, University of Basel, Basel, Switzerland., Goulis DG; Units of Human Reproduction and Reproductive Endocrinology, 1st Department of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece., Henkel RR; Department of Digestion, Metabolism and Reproduction, Imperial College London, London, UK., Ho VNA; IVFMD, My Duc Hospital, HOPE Research Centre, My Duc Hospital, Ho Chi Minh City, Vietnam., Hussein AF; Minia University, Minia, Egypt., Huyser C; Reproductive Biology Laboratory, Department of Obstetrics and Gynaecology, University of Pretoria, Steve Biko Academic Hospital, Pretoria, South Africa., Kadijk JH; Freya-Dutch Patient Association for Infertility, Gorinchem, The Netherlands., Kamath MS; Christian Medical College, Vellore, India., Khashaba S; University of New South Wales, Sydney, Australia.; IVF Australia, Sydney, Australia., Kobori Y; Dokkyo Medical University Saitama Medical Center, Mibu, Japan., Kopeika J; Guy's and St Thomas Hospital, London, UK., Kucuk T; Acibadem Maslak Hospital, Istanbul, Turkey., Luján S; Urology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain., Matsaseng TC; Stellenbosch University, Stellenbosch, Western Cape, South Africa.; Tygerberg Academic Hospital, Cape Town, South Africa., Mathur RS; Manchester University Foundation Trust, Manchester Academic Health Sciences Centre, Manchester, UK., McEleny K; Newcastle Fertility, The Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, UK., Mitchell RT; MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK., Mol BW; University of Aberdeen, Aberdeen, UK.; Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia., Murage AM; Harley Street Fertility Centre, Nairobi, Kenya., Ng EHY; Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, China., Pacey A; Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK., Perheentupa AH; Department of Obstetrics and Gynaecology, University of Turku and Turku University Hospital, Turku, Finland., Du Plessis S; College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, UAE.; Medical Physiology, Stellenbosch University, Tygerberg, South Africa., Rives N; Rouen University Hospital, Biology of Reproduction-CECOS Laboratory, Rouen, France., Sarris I; King's Fertility, The Fetal Medicine Research Unit, King's College London, London, UK.; Faculty of Life Sciences and Medicine, King's College London, London, UK., Schlegel PN; The Ronald O. Perelman and Claudia Cohen Centre for Reproductive Medicine, Weill Cornell Medicine, New York, NY, USA., Shabbir M; Guy's and St Thomas Hospital, London, UK., Śmiechowski M; Association for Infertility Treatment and Adoption Support 'Our Stork', Warsaw, Poland., Subramanian V; King's Fertility, The Fetal Medicine Research Unit, King's College London, London, UK., Sunkara SK; Faculty of Life Sciences and Medicine, King's College London, London, UK., Tarlarzis BC; Units of Human Reproduction and Reproductive Endocrinology, 1st Department of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece., Tüttelmann F; Institute of Reproductive Genetics, University of Münster, Münster, Germany., Vail A; Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK., van Wely M; Netherlands Satellite of the Cochrane Gynaecology and Fertility Group, Centre for Reproductive Medicine, Amsterdam, Netherlands.; Reproduction & Development Research Institute, Amsterdam University Medical Centre, Amsterdam, Netherlands., Vazquez-Levin MH; Laboratorio de Estudios de Interacción Celular en Reproducción y Cáncer, Instituto de Biología y Medicina Experimental (IBYME), Consejo Nacional de Investigaciones Científicas y Técnicas de Argentina (CONICET), Fundación IBYME (FIBYME), Buenos Aires, Argentina., Vuong LN; Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; HOPE Research Centre, My Duc Hospital, Ho Chi Minh City, Vietnam., Wang AY; Faculty of Health, University of Technology Sydney, Ultimo, Australia., Wang R; Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia., Zini A; Division of Urology, Department of Surgery, McGill University, Montreal, Quebec, Canada., Farquhar CM; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.; Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand., Niederberger C; Department of Urology, University of Illinois at Chicago, Chicago, IL, USA.; Department of Bioengineering, University of Illinois at Chicago College of Engineering, Chicago, IL, USA., Duffy JMN; King's Fertility, The Fetal Medicine Research Unit, King's College London, London, UK.
Jazyk:	angličtina
Zdroj:	Human reproduction open [Hum Reprod Open] 2022 Mar 16; Vol. 2022 (2), pp. hoac014. Date of Electronic Publication: 2022 Mar 16 (Print Publication: 2022).
DOI:	10.1093/hropen/hoac014
Abstrakt:	Study Question: We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research. What Is Known Already: Research into male infertility can be challenging to design, conduct and report. Evidence from randomized trials can be difficult to interpret and of limited ability to inform clinical practice for numerous reasons. These may include complex issues, such as variation in outcome measures and outcome reporting bias, as well as failure to consider the perspectives of men and their partners with lived experience of fertility problems. Previously, the Core Outcome Measure for Infertility Trials (COMMIT) initiative, an international consortium of researchers, healthcare professionals and people with fertility problems, has developed a core outcome set for general infertility research. Now, a bespoke core outcome set for male infertility is required to address the unique challenges pertinent to male infertility research. Study Design Size Duration: Stakeholders, including healthcare professionals, allied healthcare professionals, scientists, researchers and people with fertility problems, will be invited to participate. Formal consensus science methods will be used, including the modified Delphi method, modified Nominal Group Technique and the National Institutes of Health's consensus development conference. Participants/materials Setting Methods: An international steering group, including the relevant stakeholders outlined above, has been established to guide the development of this core outcome set. Possible core outcomes will be identified by undertaking a systematic review of randomized controlled trials evaluating potential treatments for male factor infertility. These outcomes will be entered into a modified Delphi method. Repeated reflection and re-scoring should promote convergence towards consensus outcomes, which will be prioritized during a consensus development meeting to identify a final core outcome set. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes. Study Funding/competing Interests: This work has been supported by the Urology Foundation small project award, 2021. C.L.R.B. is the recipient of a BMGF grant and received consultancy fees from Exscentia and Exceed sperm testing, paid to the University of Dundee and speaking fees or honoraria paid personally by Ferring, Copper Surgical and RBMO. S.B. received royalties from Cambridge University Press, Speaker honoraria for Obstetrical and Gynaecological Society of Singapore, Merk SMART Masterclass and Merk FERRING Forum, paid to the University of Aberdeen. Payment for leadership roles within NHS Grampian, previously paid to self, now paid to University of Aberdeen. An Honorarium is received as Editor in Chief of Human Reproduction Open. M.L.E. is an advisor to the companies Hannah and Ro. B.W.M. received an investigator grant from the NHMRC, No: GNT1176437 is a paid consultant for ObsEva and has received research funding from Ferring and Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. Aytu Bioscience also funded MiOXYS systems and sensors. Attendance at Fertility 2020 and Roadshow South Africa by Ralf Henkel was funded by LogixX Pharma Ltd. R.R.H. is also Editor in Chief of Andrologia and has been an employee of LogixX Pharma Ltd. since 2020. M.S.K. is an associate editor with Human Reproduction Open . K.Mc.E. received an honoraria for lectures from Bayer and Pharmasure in 2019 and payment for an ESHRE grant review in 2019. His attendance at ESHRE 2019 and AUA 2019 was sponsored by Pharmasure and Bayer, respectively. The remaining authors declare no competing interests. Trial Registration Number: Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586. Trial Registration Date: N/A. Date of First Patient’s Enrolment: N/A. (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)
Databáze:	MEDLINE
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