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

Autor:	Duffy JMN; King's Fertility, Fetal Medicine Research Institute, London, UK.; Institute for Women's Health, University College London, London, UK., Bhattacharya S; School of Medicine, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK., Bhattacharya S; School of Medicine, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK., Bofill M; Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand., Collura B; RESOLVE, The National Infertility Association, VA, USA., Curtis C; Fertility New Zealand, Auckland, New Zealand.; School of Psychology, University of Waikato, Hamilton, New Zealand., Evers JLH; Maastricht University Medical Centre, Maastricht, The Netherlands., Giudice LC; Center for Research, Innovation and Training in Reproduction and Infertility, Center for Reproductive Sciences, University of California, San Francisco, CA, USA.; International Federation of Fertility Societies, Philadelphia, PA, USA., Farquharson RG; Department of Obstetrics and Gynaecology, Liverpool Women's NHS Foundation Trust, Liverpool, UK., Franik S; Department of Obstetrics and Gynaecology, Münster University Hospital, Münster, Germany., Hickey M; Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia., Hull ML; Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia., Jordan V; Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand., Khalaf Y; Department of Women and Children's Health, King's College London, Guy's Hospital, London., Legro RS; Department of Obstetrics and Gynaecology, Penn State College of Medicine, PA, USA., Lensen S; Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia., Mavrelos D; Reproductive Medicine Unit, University College Hospital, London, UK., Mol BW; Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia., Niederberger C; Department of Urology, University of Illinois at Chicago College of Medicine, Chicago, IL, USA., Ng EHY; Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong.; Shenzhen Key Laboratory of Fertility Regulation, The University of Hong Kong-Shenzhen Hospital, China., Puscasiu L; Pharmacy, Sciences and Technology, University of Medicine, Targu Mures, Romania., Repping S; Amsterdam University Medical Centers, Amsterdam, The Netherlands.; National Health Care Institute, Diemen, The Netherlands., Sarris I; King's Fertility, Fetal Medicine Research Institute, London, UK., Showell M; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand., Strandell A; Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden., Vail A; Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK., van Wely M; Amsterdam University Medical Centers, Amsterdam, The Netherlands., Vercoe M; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand., Vuong NL; Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam., Wang AY; Faculty of Health, University of Technology, Sydney, Broadway, Australia., Wang R; Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia., Wilkinson J; Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK., Youssef MA; Department of Obstetrics & Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt., Farquhar CM; Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand., Abou-Setta AM, Aguilera JJ, AlAhwany H, Atanda OOA, Balkenende EME, Barnhart KT, Beebeejaun Y, Chambers GM, Chughtai AA, Cuevas-Sáiz I, Curtis C, D'Angelo A, Dubois DD, Duckitt K, Encinas C, Gerval MO, Giang NH, Gibreel A, Gingel LJ, Glanville EJ, Glujovsky D, Granne I, Griesinger G, Repromed DG, Hamzehgardeshi Z, Hirsch M, Horton M, Jain S, Perez MJ, Jones CA, Kamath MS, Knijnenburg J, Kostova E, La Marca A, Khac Le T, Leader A, Leeviers B, Chinese JL, Loto OM, Marks KL, Martinez-Vazquez RM, McTavish AR, Mills DJ, Nair RR, Nguyen DTP, Otter AS, Pacey AA, Rautakallio-Hokkanen S, Sadler LC, Sagle P, Schwarze JE, Shapiro HM, Simpson JL, Siristatidis CS, Sood A, Strawbridge C, Torrance HL, Tran CT, Votteler EL, Wang CC, Watson A, Yossry M
Jazyk:	angličtina
Zdroj:	Human reproduction (Oxford, England) [Hum Reprod] 2020 Dec 01; Vol. 35 (12), pp. 2735-2745.
DOI:	10.1093/humrep/deaa243
Abstrakt:	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. (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)
Databáze:	MEDLINE
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