Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study
| Autor: | J.M.N. Duffy, S. Bhattacharya, M. Bofill, B. Collura, C. Curtis, J.L.H. Evers, L.C. Giudice, R.G. Farquharson, S. Franik, M. Hickey, M.L. Hull, V. Jordan, Y. Khalaf, R.S. Legro, S. Lensen, D. Mavrelos, B.W. Mol, C. Niederberger, E.H.Y. Ng, L. Puscasiu, S. Repping, I. Sarris, M. Showell, A. Strandell, A. Vail, M. van Wely, M. Vercoe, N.L. Vuong, A.Y. Wang, R. Wang, J. Wilkinson, M.A. Youssef, C.M. Farquhar, Ahmed M. Abou-Setta, Juan J. Aguilera, Hisham AlAhwany, Oluseyi O.A. Atanda, Eva M.E. Balkenende, Kurt T. Barnhart, Yusuf Beebeejaun, Megan Black, Georgina M. Chambers, Abrar A. Chughtai, Javier A. Crosby, Irene Cuevas-Sáiz, Cate Curtis, Arianna D'Angelo, Danielle D. Dubois, Kirsten Duckitt, Carlos Encinas, Marie-Odile Gerval, Nhu H. Giang, Ahmed Gibreel, Lynda J. Gingel, Elizabeth J. Glanville, Demian Glujovsky, Ingrid Granne, Georg Griesinger, Devashana Gupta Repromed, Zeinab Hamzehgardeshi, Martin Hirsch, Marcos Horton, Shikha Jain, Marta Jansa Perez, Claire A. Jones, Mohan S. Kamath, José Knijnenburg, Elena Kostova, Antonio La Marca, Tien Khac Le, Arthur Leader, Brigitte Leeviers, Jian Li Chinese, Olabisi M. Loto, Karen L. Marks, Rodrigo M. Martinez-Vazquez, Alison R. McTavish, David J. Mills, Raju R. Nair, Dung Thi Phuong Nguyen, Anne-Sophie Otter, Allan A. Pacey, Satu Rautakallio-Hokkanen, Lynn C. Sadler, Peggy Sagle, Juan-Enrique Schwarze, Heather M. Shapiro, Joe L. Simpson, Charalampos S. Siristatidis, Akanksha Sood, Catherine Strawbridge, Helen L. Torrance, Cam Tu Tran, Emma L. Votteler, Chi Chiu Wang, Andrew Watson, Menem Yossry |
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| Přispěvatelé: | Center for Reproductive Medicine, APH - Personalized Medicine, APH - Methodology, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, Graduate School, RS: GROW - R4 - Reproductive and Perinatal Medicine |
| Rok vydání: | 2021 |
| Předmět: |
Research design
effectiveness Female infertility infertility male infertility outcomes safety Consensus Datasets as Topic Evidence-Based Practice Female Humans Infertility International Cooperation Male Outcome Assessment Health Care Practice Guidelines as Topic Pregnancy Reference Standards Reproductive Medicine Research Design Treatment Outcome 0301 basic medicine Outcome Assessment fibroids Reproductive technology Effectiveness Male infertility Outcomes Safety Fertility New Zealand 0302 clinical medicine Health care 030212 general & internal medicine media_common 030219 obstetrics & reproductive medicine STATEMENT Rehabilitation Obstetrics and Gynecology TRIALS Psychology Evidence-based practice media_common.quotation_subject female infertility Specialty 1103 Clinical Sciences 1114 Paediatrics and Reproductive Medicine 1117 Public Health and Health Services DATA-COLLECTION 03 medical and health sciences MANAGEMENT Obstetrics & Reproductive Medicine Medical education business.industry Standardized approach 11 Medical and Health Sciences 16 Studies in Human Society Secondary research Original Articles CARE AcademicSubjects/MED00905 Health Care 030104 developmental biology EXPERT PANEL business male infertility / effectiveness / safety / outcomes |
| Zdroj: | Wilkinson, J & Vail, A 2020, ' Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study ', Human reproduction (Oxford, England) . https://doi.org/10.1093/humrep/deaa243 Human reproduction (Oxford, England), 35(12), 2735-2745. Oxford University Press Fertility and sterility, 115(1), 201-212. Elsevier Inc. Fertility and Sterility, 115(1), 201-212. Elsevier Science Human Reproduction, 35(12), 2735-2745. Oxford University Press Human Reproduction (Oxford, England) |
| ISSN: | 0015-0282 0268-1161 |
| DOI: | 10.1016/j.fertnstert.2020.11.013 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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