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James MN Duffy , Hisham Alahwany , Siladitya Bhattacharya , Barbara Collura , Cate Curtis , J.L.H. Evers , Roy G. Farquharson , Sebastian Franik , Linda C. Giudice , Yacoub Khalaf , J.M.L. Knijnenburg , Brigitte Leeners , Richard S. Legro , Sarah Lensen , Juan Carlos Vázquez-Niebla , D. Mavrelos , Ben W. Mol , Craig Niederberger , Ernest Hung Yu Ng , A.S. Otter , Lucian Pușcașiu , Satu Rautakallio-Hokkanen , Sjoerd Repping , Ippokratis Sarris , Joe Leigh Simpson , Annika Strandell , C. Strawbridge , Helen L. Torrance , Andy Vail , Madelon van Wely , M Vercoe , Lan N. Vuong , Alex Wang , Rui Wang , Jack Wilkinson , Mohamed Youssef , Cindy Farquhar , Ahmed M Abou-Setta , Juan J. Aguilera , Oluseyi O.A. Atanda , Eva Balkenende , Kurt T. Barnhart , Yusuf Beebeejaun , Siladitya Bhattacharya , Megan Black , Magdalena Bofill , Georgina M. Chambers , Abrar Ahmad Chughtai , Javier Crosby , Irene Cuevas , Arianna D'Angel , Danielle D. Dubois , Kirsten Duckitt , Carlos García Encinas , Anita Fincham , Marie-Odile Gerval , Nhu H. Giang , Ahmed Gibreel , Lynda J. Gingel , Elizabeth Glanville , Demián Glujovsky , Ingrid Granne , Georg Griesinger , Devashana Gupta , Zeinab Hamzehgardeshi , Martha Hickey , Martin Hirsch , Marcos Horton , M. Louise Hull , Shikha Jain , Marta J. Perez , Claire Jones , Vanessa Jordan , Mohan S. Kamath , Elena Kostova , Antonio La Marca , Tien Khac Le , Arthur Leader , Jian Li , Olabisi Loto , Karen L. Marks , Alison McTavish , David J. Mills , R. Nair , Dung Thi Phuong Nguyen , Allan Pacey , Lynn Sadler , Peggy Sagle , Juan-Enrique Schwarze , Heather Shapiro , Marian Showell , Charalampos Siristatidis , Akanksha Sood , C. Tu , Emma L. Votteler , Chi Chiu Wang , Andrew Watson , Menem Yossry ·

YOU? · · 2020 · Open Access · · DOI: https://doi.org/10.1093/humrep/deaa241

STUDY QUESTION Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, 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. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. 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. J.M.L.K. reports research sponsorship from Ferring and Theramex. 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.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. 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.

Related Topics

Medicine

Miscarriage

Pregnancy

Randomized Controlled Trial

Artificial Intelligence

Concepts

Medicine Fertility Miscarriage Pregnancy Live birth Delphi method Randomized controlled trial Gynecology Family medicine Obstetrics Population Computer science Surgery Environmental health Biology Artificial intelligence Genetics

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Type: article
Language: en
Landing Page: https://doi.org/10.1093/humrep/deaa241
PDF: https://academic.oup.com/humrep/article-pdf/35/12/2725/42359047/deaa241.pdf
OA Status: bronze
Cited By: 79
References: 44
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DOI: https://doi.org/10.1093/humrep/deaa241

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Title: Developing a core outcome set for future infertility research: an international consensus development study

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Language: en

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Publication year: 2020

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Authors: James MN Duffy, Hisham Alahwany, Siladitya Bhattacharya, Barbara Collura, Cate Curtis, J.L.H. Evers, Roy G. Farquharson, Sebastian Franik, Linda C. Giudice, Yacoub Khalaf, J.M.L. Knijnenburg, Brigitte Leeners, Richard S. Legro, Sarah Lensen, Juan Carlos Vázquez-Niebla, D. Mavrelos, Ben W. Mol, Craig Niederberger, Ernest Hung Yu Ng, A.S. Otter, Lucian Pușcașiu, Satu Rautakallio-Hokkanen, Sjoerd Repping, Ippokratis Sarris, Joe Leigh Simpson, Annika Strandell, C. Strawbridge, Helen L. Torrance, Andy Vail, Madelon van Wely, M Vercoe, Lan N. Vuong, Alex Wang, Rui Wang, Jack Wilkinson, Mohamed Youssef, Cindy Farquhar, Ahmed M Abou-Setta, Juan J. Aguilera, Oluseyi O.A. Atanda, Eva Balkenende, Kurt T. Barnhart, Yusuf Beebeejaun, Siladitya Bhattacharya, Megan Black, Magdalena Bofill, Georgina M. Chambers, Abrar Ahmad Chughtai, Javier Crosby, Irene Cuevas, Arianna D'Angel, Danielle D. Dubois, Kirsten Duckitt, Carlos García Encinas, Anita Fincham, Marie-Odile Gerval, Nhu H. Giang, Ahmed Gibreel, Lynda J. Gingel, Elizabeth Glanville, Demián Glujovsky, Ingrid Granne, Georg Griesinger, Devashana Gupta, Zeinab Hamzehgardeshi, Martha Hickey, Martin Hirsch, Marcos Horton, M. Louise Hull, Shikha Jain, Marta J. Perez, Claire Jones, Vanessa Jordan, Mohan S. Kamath, Elena Kostova, Antonio La Marca, Tien Khac Le, Arthur Leader, Jian Li, Olabisi Loto, Karen L. Marks, Alison McTavish, David J. Mills, R. Nair, Dung Thi Phuong Nguyen, Allan Pacey, Lynn Sadler, Peggy Sagle, Juan-Enrique Schwarze, Heather Shapiro, Marian Showell, Charalampos Siristatidis, Akanksha Sood, C. Tu, Emma L. Votteler, Chi Chiu Wang, Andrew Watson, Menem Yossry

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Landing page: https://doi.org/10.1093/humrep/deaa241

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Concepts: Medicine, Fertility, Miscarriage, Pregnancy, Live birth, Delphi method, Randomized controlled trial, Gynecology, Family medicine, Obstetrics, Population, Computer science, Surgery, Environmental health, Biology, Artificial intelligence, Genetics

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Cited by: 79

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