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

Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Rimmer, Michael P.
- Howie, Ruth A.
- Anderson, Richard A.
- Barratt, Christopher L. R.
- Barnhart, Kurt T.
- Beebeejaun, Yusuf
- Bertolla, Ricardo Pimenta
- Bhattacharya, Siladitya
- Bjorndahl, Lars
- Bortoletto, Pietro
- Brannigan, Robert E.
- Cantineau, Astrid E. P.
- Caroppo, Ettore
- Collura, Barbara L.
- Coward, Kevin
- Eisenberg, Michael L.
- De Geyter, Christian
- Goulis, Dimitrios G.
- Henkel, Ralf R.
- Ho, Vu N. A.
- Hussein, Alayman F.
- Huyser, Carin
- Kadijk, Jozef H.
- Kamath, Mohan S.
- Khashaba, Shadi
- Kobori, Yoshitomo
- Kopeika, Julia
- Kucuk, Tansu
- Matsaseng, Thabo Christopher
- Mathur, Raj S.
- McEleny, Kevin
- Mitchell, Rod T.
- Mol, Ben W.
- Murage, Alfred M.
- Ng, Ernest H. Y.
- Pacey, Allan
- Perheentupa, Antti H.
- Du Plessis, Stefan
- Rives, Nathalie
- Sarris, Ippokratis
- Schlegel, Peter N.
- Shabbir, Majid
- Smiechowski, Maciej
- Subramanian, Venkatesh
- Sunkara, Sesh K.
- Tarlarzis, Basil C.
- Tuttelmann, Frank
- Vail, Andy
- van Wely, Madelon
- Vazquez-Levin, Monica H.
- Vuong, Lan N.
- Wang, Alex Y.
- Wang, Rui
- Zini, Armand
- Farquhar, Cindy M.
- Niederberger, Craig
- Duffy, James M. N.
Grupos
Abstract
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.
© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.
Datos de la publicación
- ISSN/ISSNe:
- 2399-3529, 2399-3529
- Tipo:
- Review
- Páginas:
- -
- PubMed:
- 35402735
Human Reproduction Open OXFORD UNIV PRESS
Documentos
- No hay documentos
Filiaciones
Keywords
- clinical practice guidelines; consensus study; core outcome set; fertility; male fertility; modified Delphi method; randomized controlled trials; reproduction; reproductive healthcare; systematic review
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Cita
Rimmer MP,Howie RA,Anderson RA,Barratt CLR,Barnhart KT,Beebeejaun Y,Bertolla RP,Bhattacharya S,Bjorndahl L,Bortoletto P,Brannigan RE,Cantineau AEP,Caroppo E,Collura BL,Coward K,Eisenberg ML,De Geyter C,Goulis DG,Henkel RR,Ho V,Hussein AF,Huyser C,Kadijk JH,Kamath MS,Khashaba S,Kobori Y,Kopeika J,Kucuk T,Lujan S,Matsaseng TC,Mathur RS,McEleny K,Mitchell RT,Mol BW,Murage AM,Ng EHY,Pacey A,Perheentupa AH,Du S,Rives N,Sarris I,Schlegel PN,Shabbir M,Smiechowski M,Subramanian V,Sunkara SK,Tarlarzis BC,Tuttelmann F,Vail A,van M,Vazquez MH,Vuong LN,Wang AY,Wang R,Zini A,Farquhar CM,Niederberger C,Duffy JMN. Protocol for developing a core outcome set for male infertility research: an international consensus development study. Hum Reprod Open. 2022. 2022(2):hoac014. IF:8,300. (1).