TY - JOUR
T1 - Developing a core outcome set for future infertility research
T2 - an international consensus development study
AU - Duffy, J. M. N.
AU - AlAhwany, H.
AU - Bhattacharya, S.
AU - Collura, B.
AU - Curtis, C.
AU - Evers, J. L. H.
AU - Farquharson, R. G.
AU - Franik, S.
AU - Giudice, L. C.
AU - Khalaf, Y.
AU - Knijnenburg, J. M. L.
AU - Leeners, B.
AU - Legro, R. S.
AU - Lensen, S.
AU - Vazquez-Niebla, J. C.
AU - Mavrelos, D.
AU - Mol, B. W. J.
AU - Niederberger, C.
AU - Ng, E. H. Y.
AU - Otter, A. S.
AU - Puscasiu, L.
AU - Rautakallio-Hokkanen, S.
AU - Repping, S.
AU - Sarris, Apostolos
AU - Simpson, J. L.
AU - Strandell, A.
AU - Strawbridge, C.
AU - Torrance, H. L.
AU - Vail, A.
AU - van Wely, M.
AU - Vercoe, M. A.
AU - Vuong, N. L.
AU - Wang, A. Y.
AU - Wang, R.
AU - Wilkinson, J.
AU - Youssef, M. A.
AU - Farquhar, C. M.
AU - Core Outcome Measure for Infertility Trials (COMMIT) initiative
N1 - Publisher Copyright:
© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.
PY - 2020/12
Y1 - 2020/12
N2 - 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.
AB - 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.
KW - Consensus development study
KW - core outcome sets
KW - modified Delphi method
KW - modified Nominal Group Technique
KW - outcome measures; outcomes
KW - CLINICAL-TRIALS
KW - PROTOCOL
U2 - 10.1093/humrep/deaa241
DO - 10.1093/humrep/deaa241
M3 - Article
C2 - 33252685
SN - 0268-1161
VL - 35
SP - 2725
EP - 2734
JO - Human Reproduction
JF - Human Reproduction
IS - 12
ER -