Developing a core outcome set for future infertility research

Duffy, James M. N.|||0000-0001-6127-9859; AlAhwany, Hisham; Bhattacharya, Sohinee|||0000-0002-2358-5860; Collura, Barbara; Curtis, Cate|||0000-0001-9832-4975; Evers, Johannes L.H.; Farquharson, Roy Gibb; Franik, Sebastian; Giudice, Linda C.; Khalaf, Yacoub; Knijnenburg, José M. L.; Leeners, Brigitte|||0000-0003-4027-6151; Legro, Richard S.|||0000-0001-9927-7584; Lensen, Sarah; Vázquez-Niebla, Juan Carlos|||0000-0002-7780-4387; Mavrelos, Dimitrios; Mol, Ben Willem J.|||0000-0001-8337-550X; Niederberger, Craig|||0000-0003-1691-7289; Ng, Ernest Hung Yu|||0000-0002-7688-4557; Otter, Anne Sophie Denise; Puscasiu, Lucian; Rautakallio-Hokkanen, Satu|||0000-0001-6509-6320; Repping, Sjoerd|||0000-0002-6959-149X; Sarris, Ippokratis|||0000-0002-8912-5920; Simpson, Joe Leigh|||0000-0002-5309-6881; Strandell, Annika Margareta; Strawbridge, Cat; Torrance, Helen L.; Vail, Andy|||0000-0001-8274-2726; van Wely, Madelon|||0000-0001-8263-213X; Vercoe, Melissa A.; Vuong, Ngoc Lan; Wang, A.Y.; Wang, Rui|||0000-0002-6622-8134; Wilkinson, Jack; Youssef, Mohamed A.|||0000-0002-0320-0492; Farquhar, Cindy M.|||0000-0002-3685-3553; Abou-Setta, Ahmed M.; Aguilera, Juan J.; Atanda, Oluseyi O. A.; Balkenende, Eva M. E.; Barnhart, Kurt T.; Beebeejaun, Yusuf; McTavish, A.R.; Black, Megan; Bofill, Magdalena; Jordan, Vanessa; Showell, M.; Chambers, Georgina M.|||0000-0003-0215-3249; Chughtai, Abrar A.; Crosby, Javier A.; Schwarze, Juan Enrique; Cuevas, Irene|||0000-0002-9587-0492; D'Angelo, Arianna; Dubois, Danielle D.; Duckitt, Kristen; Encinas, Carlos; Fincham, Anita; Gerval, Marie-Odile; Giang, Nhu H.; Le, Tien Khac; Thi Phuong Nguyen, Dung; Tu Tran, Cam; Gibreel, Ahmed; Gingel, Linda J.; Jansa Perez, Marta; Mills, David J.; Marks, Karen L.; Glanville, Elisabeth J.; Glujovsky, Demian|||0000-0002-0586-9341; Granne, Ingrid; Griesinger, Georg|||0000-0002-0606-5804; Gupta, Devashana; Hamzehgardeshi, Zeinab; Hickey, Martha|||0000-0002-3941-082X; Hirsch, Martin; Horton, Marcos; Hull, M. Louise; Jain, Shikha|||0000-0002-2932-1022; Jones, Claire A.; Shapiro, H.M.; Kamath, Mohan S.; Kostova, Elena; La Marca, Antonio|||0000-0001-7921-9547; Leader, Arthur; Li, Jian|||0000-0003-3060-0501; Loto, Olabisi M.; Nair, Raju R.; Pacey, Allan A.|||0000-0002-4387-8871; Sadler, Lynn C.; Sagle, Peggy; Siristatidis, Charalampos S.; Sood, Akanksha; Votteler, Emma L.; Wang, Chi Chiu|||0000-0002-3928-7278; Watson, Andrew; Yossry, Menem

Developing a core outcome set for future infertility research

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 evalua...

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Autores:	Duffy, James M. N.\|\|\|0000-0001-6127-9859, AlAhwany, Hisham, Bhattacharya, Sohinee\|\|\|0000-0002-2358-5860, Collura, Barbara, Curtis, Cate\|\|\|0000-0001-9832-4975, Evers, Johannes L.H., Farquharson, Roy Gibb, Franik, Sebastian, Giudice, Linda C., Khalaf, Yacoub, Knijnenburg, José M. L., Leeners, Brigitte\|\|\|0000-0003-4027-6151, Legro, Richard S.\|\|\|0000-0001-9927-7584, Lensen, Sarah, Vázquez-Niebla, Juan Carlos\|\|\|0000-0002-7780-4387, Mavrelos, Dimitrios, Mol, Ben Willem J.\|\|\|0000-0001-8337-550X, Niederberger, Craig\|\|\|0000-0003-1691-7289, Ng, Ernest Hung Yu\|\|\|0000-0002-7688-4557, Otter, Anne Sophie Denise, Puscasiu, Lucian, Rautakallio-Hokkanen, Satu\|\|\|0000-0001-6509-6320, Repping, Sjoerd\|\|\|0000-0002-6959-149X, Sarris, Ippokratis\|\|\|0000-0002-8912-5920, Simpson, Joe Leigh\|\|\|0000-0002-5309-6881, Strandell, Annika Margareta, Strawbridge, Cat, Torrance, Helen L., Vail, Andy\|\|\|0000-0001-8274-2726, van Wely, Madelon\|\|\|0000-0001-8263-213X, Vercoe, Melissa A., Vuong, Ngoc Lan, Wang, A.Y., Wang, Rui\|\|\|0000-0002-6622-8134, Wilkinson, Jack, Youssef, Mohamed A.\|\|\|0000-0002-0320-0492, Farquhar, Cindy M.\|\|\|0000-0002-3685-3553, Abou-Setta, Ahmed M., Aguilera, Juan J., Atanda, Oluseyi O. A., Balkenende, Eva M. E., Barnhart, Kurt T., Beebeejaun, Yusuf, McTavish, A.R., Black, Megan, Bofill, Magdalena, Jordan, Vanessa, Showell, M., Chambers, Georgina M.\|\|\|0000-0003-0215-3249, Chughtai, Abrar A., Crosby, Javier A., Schwarze, Juan Enrique, Cuevas, Irene\|\|\|0000-0002-9587-0492, D'Angelo, Arianna, Dubois, Danielle D., Duckitt, Kristen, Encinas, Carlos, Fincham, Anita, Gerval, Marie-Odile, Giang, Nhu H., Le, Tien Khac, Thi Phuong Nguyen, Dung, Tu Tran, Cam, Gibreel, Ahmed, Gingel, Linda J., Jansa Perez, Marta, Mills, David J., Marks, Karen L., Glanville, Elisabeth J., Glujovsky, Demian\|\|\|0000-0002-0586-9341, Granne, Ingrid, Griesinger, Georg\|\|\|0000-0002-0606-5804, Gupta, Devashana, Hamzehgardeshi, Zeinab, Hickey, Martha\|\|\|0000-0002-3941-082X, Hirsch, Martin, Horton, Marcos, Hull, M. Louise, Jain, Shikha\|\|\|0000-0002-2932-1022, Jones, Claire A., Shapiro, H.M., Kamath, Mohan S., Kostova, Elena, La Marca, Antonio\|\|\|0000-0001-7921-9547, Leader, Arthur, Li, Jian\|\|\|0000-0003-3060-0501, Loto, Olabisi M., Nair, Raju R., Pacey, Allan A.\|\|\|0000-0002-4387-8871, Sadler, Lynn C., Sagle, Peggy, Siristatidis, Charalampos S., Sood, Akanksha, Votteler, Emma L., Wang, Chi Chiu\|\|\|0000-0002-3928-7278, Watson, Andrew, Yossry, Menem
Tipo de recurso:	artículo
Fecha de publicación:	2020
País:	España
Institución:	Universitat Autònoma de Barcelona
Repositorio:	Dipòsit Digital de Documents de la UAB
Idioma:	inglés
OAI Identifier:	oai:ddd.uab.cat:283569
Acceso en línea:	https://ddd.uab.cat/record/283569 https://dx.doi.org/urn:doi:10.1093/humrep/deaa241
Access Level:	acceso abierto
Palabra clave:	Consensus development study Core outcome sets Modified Delphi method Modified Nominal Group Technique Outcome measures Outcomes

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oai_identifier_str	oai:ddd.uab.cat:283569
network_acronym_str	ES
network_name_str	España
repository_id_str
dc.title.none.fl_str_mv	Developing a core outcome set for future infertility research An international consensus development study
title	Developing a core outcome set for future infertility research
spellingShingle	Developing a core outcome set for future infertility research Duffy, James M. N.\|\|\|0000-0001-6127-9859 Consensus development study Core outcome sets Modified Delphi method Modified Nominal Group Technique Outcome measures Outcomes
title_short	Developing a core outcome set for future infertility research
title_full	Developing a core outcome set for future infertility research
title_fullStr	Developing a core outcome set for future infertility research
title_full_unstemmed	Developing a core outcome set for future infertility research
title_sort	Developing a core outcome set for future infertility research
dc.creator.none.fl_str_mv	Duffy, James M. N.\|\|\|0000-0001-6127-9859 AlAhwany, Hisham Bhattacharya, Sohinee\|\|\|0000-0002-2358-5860 Collura, Barbara Curtis, Cate\|\|\|0000-0001-9832-4975 Evers, Johannes L.H. Farquharson, Roy Gibb Franik, Sebastian Giudice, Linda C. Khalaf, Yacoub Knijnenburg, José M. L. Leeners, Brigitte\|\|\|0000-0003-4027-6151 Legro, Richard S.\|\|\|0000-0001-9927-7584 Lensen, Sarah Vázquez-Niebla, Juan Carlos\|\|\|0000-0002-7780-4387 Mavrelos, Dimitrios Mol, Ben Willem J.\|\|\|0000-0001-8337-550X Niederberger, Craig\|\|\|0000-0003-1691-7289 Ng, Ernest Hung Yu\|\|\|0000-0002-7688-4557 Otter, Anne Sophie Denise Puscasiu, Lucian Rautakallio-Hokkanen, Satu\|\|\|0000-0001-6509-6320 Repping, Sjoerd\|\|\|0000-0002-6959-149X Sarris, Ippokratis\|\|\|0000-0002-8912-5920 Simpson, Joe Leigh\|\|\|0000-0002-5309-6881 Strandell, Annika Margareta Strawbridge, Cat Torrance, Helen L. Vail, Andy\|\|\|0000-0001-8274-2726 van Wely, Madelon\|\|\|0000-0001-8263-213X Vercoe, Melissa A. Vuong, Ngoc Lan Wang, A.Y. Wang, Rui\|\|\|0000-0002-6622-8134 Wilkinson, Jack Youssef, Mohamed A.\|\|\|0000-0002-0320-0492 Farquhar, Cindy M.\|\|\|0000-0002-3685-3553 Abou-Setta, Ahmed M. Aguilera, Juan J. Atanda, Oluseyi O. A. Balkenende, Eva M. E. Barnhart, Kurt T. Beebeejaun, Yusuf McTavish, A.R. Black, Megan Bofill, Magdalena Jordan, Vanessa Showell, M. Chambers, Georgina M.\|\|\|0000-0003-0215-3249 Chughtai, Abrar A. Crosby, Javier A. Schwarze, Juan Enrique Cuevas, Irene\|\|\|0000-0002-9587-0492 D'Angelo, Arianna Dubois, Danielle D. Duckitt, Kristen Encinas, Carlos Fincham, Anita Gerval, Marie-Odile Giang, Nhu H. Le, Tien Khac Thi Phuong Nguyen, Dung Tu Tran, Cam Gibreel, Ahmed Gingel, Linda J. Jansa Perez, Marta Mills, David J. Marks, Karen L. Glanville, Elisabeth J. Glujovsky, Demian\|\|\|0000-0002-0586-9341 Granne, Ingrid Griesinger, Georg\|\|\|0000-0002-0606-5804 Gupta, Devashana Hamzehgardeshi, Zeinab Hickey, Martha\|\|\|0000-0002-3941-082X Hirsch, Martin Horton, Marcos Hull, M. Louise Jain, Shikha\|\|\|0000-0002-2932-1022 Jones, Claire A. Shapiro, H.M. Kamath, Mohan S. Kostova, Elena La Marca, Antonio\|\|\|0000-0001-7921-9547 Leader, Arthur Li, Jian\|\|\|0000-0003-3060-0501 Loto, Olabisi M. Nair, Raju R. Pacey, Allan A.\|\|\|0000-0002-4387-8871 Sadler, Lynn C. Sagle, Peggy Siristatidis, Charalampos S. Sood, Akanksha Votteler, Emma L. Wang, Chi Chiu\|\|\|0000-0002-3928-7278 Watson, Andrew Yossry, Menem
author	Duffy, James M. N.\|\|\|0000-0001-6127-9859
author_facet	Duffy, James M. N.\|\|\|0000-0001-6127-9859 AlAhwany, Hisham Bhattacharya, Sohinee\|\|\|0000-0002-2358-5860 Collura, Barbara Curtis, Cate\|\|\|0000-0001-9832-4975 Evers, Johannes L.H. Farquharson, Roy Gibb Franik, Sebastian Giudice, Linda C. Khalaf, Yacoub Knijnenburg, José M. L. Leeners, Brigitte\|\|\|0000-0003-4027-6151 Legro, Richard S.\|\|\|0000-0001-9927-7584 Lensen, Sarah Vázquez-Niebla, Juan Carlos\|\|\|0000-0002-7780-4387 Mavrelos, Dimitrios Mol, Ben Willem J.\|\|\|0000-0001-8337-550X Niederberger, Craig\|\|\|0000-0003-1691-7289 Ng, Ernest Hung Yu\|\|\|0000-0002-7688-4557 Otter, Anne Sophie Denise Puscasiu, Lucian Rautakallio-Hokkanen, Satu\|\|\|0000-0001-6509-6320 Repping, Sjoerd\|\|\|0000-0002-6959-149X Sarris, Ippokratis\|\|\|0000-0002-8912-5920 Simpson, Joe Leigh\|\|\|0000-0002-5309-6881 Strandell, Annika Margareta Strawbridge, Cat Torrance, Helen L. Vail, Andy\|\|\|0000-0001-8274-2726 van Wely, Madelon\|\|\|0000-0001-8263-213X Vercoe, Melissa A. Vuong, Ngoc Lan Wang, A.Y. Wang, Rui\|\|\|0000-0002-6622-8134 Wilkinson, Jack Youssef, Mohamed A.\|\|\|0000-0002-0320-0492 Farquhar, Cindy M.\|\|\|0000-0002-3685-3553 Abou-Setta, Ahmed M. Aguilera, Juan J. Atanda, Oluseyi O. A. Balkenende, Eva M. E. Barnhart, Kurt T. Beebeejaun, Yusuf McTavish, A.R. Black, Megan Bofill, Magdalena Jordan, Vanessa Showell, M. Chambers, Georgina M.\|\|\|0000-0003-0215-3249 Chughtai, Abrar A. Crosby, Javier A. Schwarze, Juan Enrique Cuevas, Irene\|\|\|0000-0002-9587-0492 D'Angelo, Arianna Dubois, Danielle D. Duckitt, Kristen Encinas, Carlos Fincham, Anita Gerval, Marie-Odile Giang, Nhu H. Le, Tien Khac Thi Phuong Nguyen, Dung Tu Tran, Cam Gibreel, Ahmed Gingel, Linda J. Jansa Perez, Marta Mills, David J. Marks, Karen L. Glanville, Elisabeth J. Glujovsky, Demian\|\|\|0000-0002-0586-9341 Granne, Ingrid Griesinger, Georg\|\|\|0000-0002-0606-5804 Gupta, Devashana Hamzehgardeshi, Zeinab Hickey, Martha\|\|\|0000-0002-3941-082X Hirsch, Martin Horton, Marcos Hull, M. Louise Jain, Shikha\|\|\|0000-0002-2932-1022 Jones, Claire A. Shapiro, H.M. Kamath, Mohan S. Kostova, Elena La Marca, Antonio\|\|\|0000-0001-7921-9547 Leader, Arthur Li, Jian\|\|\|0000-0003-3060-0501 Loto, Olabisi M. Nair, Raju R. Pacey, Allan A.\|\|\|0000-0002-4387-8871 Sadler, Lynn C. Sagle, Peggy Siristatidis, Charalampos S. Sood, Akanksha Votteler, Emma L. Wang, Chi Chiu\|\|\|0000-0002-3928-7278 Watson, Andrew Yossry, Menem
author_role	author
author2	AlAhwany, Hisham Bhattacharya, Sohinee\|\|\|0000-0002-2358-5860 Collura, Barbara Curtis, Cate\|\|\|0000-0001-9832-4975 Evers, Johannes L.H. Farquharson, Roy Gibb Franik, Sebastian Giudice, Linda C. Khalaf, Yacoub Knijnenburg, José M. L. Leeners, Brigitte\|\|\|0000-0003-4027-6151 Legro, Richard S.\|\|\|0000-0001-9927-7584 Lensen, Sarah Vázquez-Niebla, Juan Carlos\|\|\|0000-0002-7780-4387 Mavrelos, Dimitrios Mol, Ben Willem J.\|\|\|0000-0001-8337-550X Niederberger, Craig\|\|\|0000-0003-1691-7289 Ng, Ernest Hung Yu\|\|\|0000-0002-7688-4557 Otter, Anne Sophie Denise Puscasiu, Lucian Rautakallio-Hokkanen, Satu\|\|\|0000-0001-6509-6320 Repping, Sjoerd\|\|\|0000-0002-6959-149X Sarris, Ippokratis\|\|\|0000-0002-8912-5920 Simpson, Joe Leigh\|\|\|0000-0002-5309-6881 Strandell, Annika Margareta Strawbridge, Cat Torrance, Helen L. Vail, Andy\|\|\|0000-0001-8274-2726 van Wely, Madelon\|\|\|0000-0001-8263-213X Vercoe, Melissa A. Vuong, Ngoc Lan Wang, A.Y. Wang, Rui\|\|\|0000-0002-6622-8134 Wilkinson, Jack Youssef, Mohamed A.\|\|\|0000-0002-0320-0492 Farquhar, Cindy M.\|\|\|0000-0002-3685-3553 Abou-Setta, Ahmed M. Aguilera, Juan J. Atanda, Oluseyi O. A. Balkenende, Eva M. E. Barnhart, Kurt T. Beebeejaun, Yusuf McTavish, A.R. Black, Megan Bofill, Magdalena Jordan, Vanessa Showell, M. Chambers, Georgina M.\|\|\|0000-0003-0215-3249 Chughtai, Abrar A. Crosby, Javier A. Schwarze, Juan Enrique Cuevas, Irene\|\|\|0000-0002-9587-0492 D'Angelo, Arianna Dubois, Danielle D. Duckitt, Kristen Encinas, Carlos Fincham, Anita Gerval, Marie-Odile Giang, Nhu H. Le, Tien Khac Thi Phuong Nguyen, Dung Tu Tran, Cam Gibreel, Ahmed Gingel, Linda J. Jansa Perez, Marta Mills, David J. Marks, Karen L. Glanville, Elisabeth J. Glujovsky, Demian\|\|\|0000-0002-0586-9341 Granne, Ingrid Griesinger, Georg\|\|\|0000-0002-0606-5804 Gupta, Devashana Hamzehgardeshi, Zeinab Hickey, Martha\|\|\|0000-0002-3941-082X Hirsch, Martin Horton, Marcos Hull, M. Louise Jain, Shikha\|\|\|0000-0002-2932-1022 Jones, Claire A. Shapiro, H.M. Kamath, Mohan S. Kostova, Elena La Marca, Antonio\|\|\|0000-0001-7921-9547 Leader, Arthur Li, Jian\|\|\|0000-0003-3060-0501 Loto, Olabisi M. Nair, Raju R. Pacey, Allan A.\|\|\|0000-0002-4387-8871 Sadler, Lynn C. Sagle, Peggy Siristatidis, Charalampos S. Sood, Akanksha Votteler, Emma L. Wang, Chi Chiu\|\|\|0000-0002-3928-7278 Watson, Andrew Yossry, Menem
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv	Consensus development study Core outcome sets Modified Delphi method Modified Nominal Group Technique Outcome measures Outcomes
topic	Consensus development study Core outcome sets Modified Delphi method Modified Nominal Group Technique Outcome measures Outcomes
description	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.
publishDate	2020
dc.date.none.fl_str_mv	2 2020-01-01 2020 2020-01-01
dc.type.none.fl_str_mv	Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://ddd.uab.cat/record/283569 https://dx.doi.org/urn:doi:10.1093/humrep/deaa241
url	https://ddd.uab.cat/record/283569 https://dx.doi.org/urn:doi:10.1093/humrep/deaa241
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.source.none.fl_str_mv	reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona
instname_str	Universitat Autònoma de Barcelona
reponame_str	Dipòsit Digital de Documents de la UAB
collection	Dipòsit Digital de Documents de la UAB
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spelling	Developing a core outcome set for future infertility researchAn international consensus development studyDuffy, James M. N.\|\|\|0000-0001-6127-9859AlAhwany, HishamBhattacharya, Sohinee\|\|\|0000-0002-2358-5860Collura, BarbaraCurtis, Cate\|\|\|0000-0001-9832-4975Evers, Johannes L.H.Farquharson, Roy GibbFranik, SebastianGiudice, Linda C.Khalaf, YacoubKnijnenburg, José M. L.Leeners, Brigitte\|\|\|0000-0003-4027-6151Legro, Richard S.\|\|\|0000-0001-9927-7584Lensen, SarahVázquez-Niebla, Juan Carlos\|\|\|0000-0002-7780-4387Mavrelos, DimitriosMol, Ben Willem J.\|\|\|0000-0001-8337-550XNiederberger, Craig\|\|\|0000-0003-1691-7289Ng, Ernest Hung Yu\|\|\|0000-0002-7688-4557Otter, Anne Sophie DenisePuscasiu, LucianRautakallio-Hokkanen, Satu\|\|\|0000-0001-6509-6320Repping, Sjoerd\|\|\|0000-0002-6959-149XSarris, Ippokratis\|\|\|0000-0002-8912-5920Simpson, Joe Leigh\|\|\|0000-0002-5309-6881Strandell, Annika MargaretaStrawbridge, CatTorrance, Helen L.Vail, Andy\|\|\|0000-0001-8274-2726van Wely, Madelon\|\|\|0000-0001-8263-213XVercoe, Melissa A.Vuong, Ngoc LanWang, A.Y.Wang, Rui\|\|\|0000-0002-6622-8134Wilkinson, JackYoussef, Mohamed A.\|\|\|0000-0002-0320-0492Farquhar, Cindy M.\|\|\|0000-0002-3685-3553Abou-Setta, Ahmed M.Aguilera, Juan J.Atanda, Oluseyi O. A.Balkenende, Eva M. E.Barnhart, Kurt T.Beebeejaun, YusufMcTavish, A.R.Black, MeganBofill, MagdalenaJordan, VanessaShowell, M.Chambers, Georgina M.\|\|\|0000-0003-0215-3249Chughtai, Abrar A.Crosby, Javier A.Schwarze, Juan EnriqueCuevas, Irene\|\|\|0000-0002-9587-0492D'Angelo, AriannaDubois, Danielle D.Duckitt, KristenEncinas, CarlosFincham, AnitaGerval, Marie-OdileGiang, Nhu H.Le, Tien KhacThi Phuong Nguyen, DungTu Tran, CamGibreel, AhmedGingel, Linda J.Jansa Perez, MartaMills, David J.Marks, Karen L.Glanville, Elisabeth J.Glujovsky, Demian\|\|\|0000-0002-0586-9341Granne, IngridGriesinger, Georg\|\|\|0000-0002-0606-5804Gupta, DevashanaHamzehgardeshi, ZeinabHickey, Martha\|\|\|0000-0002-3941-082XHirsch, MartinHorton, MarcosHull, M. LouiseJain, Shikha\|\|\|0000-0002-2932-1022Jones, Claire A.Shapiro, H.M.Kamath, Mohan S.Kostova, ElenaLa Marca, Antonio\|\|\|0000-0001-7921-9547Leader, ArthurLi, Jian\|\|\|0000-0003-3060-0501Loto, Olabisi M.Nair, Raju R.Pacey, Allan A.\|\|\|0000-0002-4387-8871Sadler, Lynn C.Sagle, PeggySiristatidis, Charalampos S.Sood, AkankshaVotteler, Emma L.Wang, Chi Chiu\|\|\|0000-0002-3928-7278Watson, AndrewYossry, MenemConsensus development studyCore outcome setsModified Delphi methodModified Nominal Group TechniqueOutcome measuresOutcomesSTUDY 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.Universitat Autònoma de Barcelona 22020-01-0120202020-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/283569https://dx.doi.org/urn:doi:10.1093/humrep/deaa241reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2835692026-06-06T12:50:31Z
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Developing a core outcome set for future infertility research

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