Developing a core outcome set for future infertility research: an international consensus development study
Por:
Duffy, JMN, AlAhwany, H, Bhattacharya, S, Collura, B, Curtis, C, Evers, JLH, Farquharson, RG, Franik, S, Giudice, LC, Khalaf, Y, Knijnenburg, JML, Leeners, B, Legro, RS, Lensen, S, Vazquez-Niebla, JC, Mavrelos, D, Mol, BWJ, Niederberger, C, Ng, EHY, Otter, AS, Puscasiu, L, Rautakallio-Hokkanen, S, Repping, S, Sarris, I, Simpson, JL, Strandell, A, Strawbridge, C, Torrance, HL, Vail, A, van Wely, M, Vercoe, MA, Vuong, NL, Wang, AY, Wang, R, Wilkinson, J, Youssef, MA, Farquhar, CM, Core Outcome Measure Infertility T
Publicada:
1 dic 2020
Resumen:
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.
Filiaciones:
Duffy, JMN:
Kings Fertil, Fetal Med Res Inst, London, England
UCL, Inst Womens Hlth, London, England
AlAhwany, H:
Univ Nottingham, Sch Med, Derby, England
Bhattacharya, S:
Univ Aberdeen, Sch Med Med Sci & Nutr, Aberdeen, Scotland
Collura, B:
RESOLVE Natl Infertil Assoc, McLean, VA USA
Curtis, C:
Fertil New Zealand, Auckland, New Zealand
Univ Waikato, Sch Psychol, Hamilton, New Zealand
Evers, JLH:
Maastricht Univ, Med Ctr, Maastricht, Netherlands
Farquharson, RG:
Liverpool Womens NHS Fdn Trust, Dept Obstet & Gynaecol, Liverpool, Merseyside, England
Franik, S:
Munster Univ Hosp, Dept Obstet & Gynaecol, Munster, Germany
Giudice, LC:
Univ Calif San Francisco, Ctr Res Innovat & Training Reprod & Infertil, Ctr Reprod Sci, San Francisco, CA 94143 USA
Int Federat Fertil Soc, Philadelphia, PA USA
Khalaf, Y:
Kings Coll London, Guys Hosp, Dept Women & Childrens Hlth, London, England
Knijnenburg, JML:
Freya Dutch Infertil Assoc, Gorinchem, Netherlands
Leeners, B:
Univ Hosp Zurich, Dept Reprod Endocrinol, Zurich, Switzerland
Legro, RS:
Penn State Coll Med, Dept Obstet & Gynaecol, Hershey, PA USA
Lensen, S:
Univ Melbourne, Dept Obstet & Gynaecol, Melbourne, Vic, Australia
Vazquez-Niebla, JC:
Biomed Res Inst St Pau, Cochrane Iberoamer, Barcelona, Spain
Mavrelos, D:
Univ Coll Hosp, Reprod Med Unit, London, England
Mol, BWJ:
Monash Univ, Dept Obstet & Gynaecol, Melbourne, Vic, Australia
Niederberger, C:
Univ Illinois, Coll Med, Dept Urol, Chicago, IL USA
Ng, EHY:
Univ Hong Kong, Dept Obstet & Gynaecol, Hong Kong, Peoples R China
Univ Hong Kong, Shenzhen Key Lab Fertil Regulat, Shenzhen Hosp, Hong Kong, Peoples R China
Otter, AS:
Osakidetza OSI, Bilbao, Basurto, Spain
Puscasiu, L:
Univ Med Pharm Sci & Technol, Targu Mures, Romania
Rautakallio-Hokkanen, S:
Fertil Europe, Evere, Belgium
Repping, S:
Univ Amsterdam, Ctr Reprod Med, Amsterdam Reprod & Dev Inst, Med Ctr, Amsterdam, Netherlands
Sarris, I:
Kings Fertil, Fetal Med Res Inst, London, England
Simpson, JL:
Florida Int Univ, Dept Human & Mol Genet, Miami, FL 33199 USA
Strandell, A:
Univ Gothenburg, Sahlgrenska Acad, Dept Obstet & Gynecol, Gothenburg, Sweden
Strawbridge, C:
Fertil Network UK, London, England
Torrance, HL:
Univ Med Ctr Utrecht, Dept Reprod Med, Utrecht, Netherlands
Vail, A:
Univ Manchester, Manchester Acad Hlth Sci Ctr, Ctr Biostat, Manchester, Lancs, England
van Wely, M:
Univ Amsterdam, Ctr Reprod Med, Amsterdam Reprod & Dev Inst, Med Ctr, Amsterdam, Netherlands
Vercoe, MA:
Univ Auckland, Cochrane Gynaecol & Fertil Grp, Auckland, New Zealand
Vuong, NL:
Univ Med & Pharm Ho Chi Minh City, Dept Obstet & Gynaecol, Ho Chi Minh City, Vietnam
Wang, AY:
Univ Technol, Fac Hlth, Sydney, NSW, Australia
Wang, R:
Monash Univ, Dept Obstet & Gynaecol, Melbourne, Vic, Australia
Wilkinson, J:
Univ Manchester, Manchester Acad Hlth Sci Ctr, Ctr Biostat, Manchester, Lancs, England
Youssef, MA:
Cairo Univ, Fac Med, Dept Obstet & Gynaecol, Cairo, Egypt
Farquhar, CM:
Univ Auckland, Cochrane Gynaecol & Fertil Grp, Auckland, New Zealand
Hybrid Gold, Green Published
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