To develop a core outcome set for endometriosis.
Consensus development study.
One hundred and sixteen healthcare professionals, 31 researchers, and 206 patient representatives.
Modified Delphi method and modified nominal group technique.
The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment.
Using robust consensus science methods, healthcare professionals, researchers, and women with endometriosis have developed a core outcome set to standardise outcome selection, collection, and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis.
@coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.
endo:outcomes – an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research
- COS for clinical trials or clinical research
- Delphi process
- Consensus meeting
- Nominal group technique (NGT)
- Systematic review
Potential core outcomes were identi?ed through a systematic review of previously published endometriosis trials. The long list of potential core outcomes was entered into a modi?ed Delphi method, which facilitated individual stakeholder group convergence towards consensus outcomes. These outcomes were entered into a face-to-face consensus development meeting. Using a modi?ed nominal group technique, consensus outcomes were further prioritised to identify the ?nal core outcome set for endometriosis.