Objective: To develop a core outcome set for endometriosis. Design: Consensus development study. Setting: International. Population: One hundred and sixteen healthcare professionals, 31 researchers, and 206 patient representatives. Methods: Modified Delphi method and modified nominal group technique. Results: 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. Conclusions: 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. Tweetable abstract: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.
|Number of pages||8|
|Journal||BJOG: an International Journal of Obstetrics and Gynaecology|
|Publication status||Published - 1 Jul 2020|
- Consensus development study
- core outcome set
- modified Delphi method
- modified nominal group technique