Abstract
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 (RCT) 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, Ferility 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. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger 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. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong 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.
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 (RCT) 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, Ferility 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. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger 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. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong 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.
| Original language | English |
|---|---|
| Pages (from-to) | 191-200 |
| Number of pages | 10 |
| Journal | Fertility and Sterility |
| Volume | 115 |
| Issue number | 1 |
| Early online date | 30 Nov 2020 |
| DOIs | |
| Publication status | Published - Jan 2021 |
Bibliographical note
Acknowledgements:We would like to thank the Delphi survey and consensus development meeting participants and colleagues at the Cochrane Gynaecology and Fertility Group, University of Auckland, New Zealand.
Funding:
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. Ben Mol is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). Siladitya Bhattacharya was supported by University of Auckland Foundation Seelye Travelling Fellowship.
This article has not been externally peer reviewed.
This article has been published simultaneously in Human Reproduction
Keywords
- Consensus development study
- core outcome sets
- modified Delphi method
- modified Nominal Group Technique
- outcome measures
- outcomes
- CLINICAL-TRIALS
- PROTOCOL
Access to Document
- Duffy_et_al_Developing_core_Fertility_and_Sterility_vor
The article has been co-published with permission in Human Reproduction and Fertility and Sterility. © The Authors, 2020. Published by Elsevier This is an Open Access article distributed under the terms of the Creative Commons Attributian-Non Commercial licence (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non commercial reproduction and distribution of the work, in any medium, provided the original work is properly cited. For commercial re use, please contact permissions@elsevier.com. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style