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.
J.M.N. Duffy, H. AlAhwany, S. Bhattacharya, B. Collura, C. Curtis, J.L.H. Evers, R.G. Farquharson, S. Franik, L.C. Giudice, Y. Khalaf, J.M.L. Knijnenburg, B. Leeners, R.S. Legro, S. Lensen, J.C. Vazquez-Niebla, D. Mavrelos, B.W.J. Mol, C. Niederberger, E.H.Y. Ng, A.S. Otter, L. Puscasiu, S. Rautakallio-Hokkanen, S. Repping, I. Sarris, J.L. Simpson, A. Strandell, C. Strawbridge, H.L. Torrance, A. Vail, M. van Wely, M.A. Vercoe, N.L. Vuong, A.Y. Wang, R. Wang, J. Wilkinson, M.A. Youssef, C.M. Farquhar, and the Core Outcome Measure for Infertility Trials (COMMIT) initiative
Disease Category: Gynaecology
Disease Name: Infertility
Age Range: 16 - 45
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Conference participants
- Consumers (patients)
- Epidemiologists
- Families
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
An international steering group including healthcare professionals, researchers, and people with lived experience of subfertility, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and will be entered into an online Delphi survey. Key stakeholders, including healthcare professionals, researchers, and people with lived experience of subfertility will be invited to participate. Participants will be invited to score individual outcomes on a nine-point Likert scale anchored between 1 (not important) and 9 (critical). Repeated reflection and rescoring should promote convergence towards consensus ‘core’ outcomes. High-quality outcome measures will be associated with core outcomes.