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.
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