A core outcome set for future endometriosis research: an international consensus development study
James MN Duffy, Martin Hirsch, M Vercoe, Jason Abbott, Claire Barker, Barbara Collura, Richard Drake, JLH Evers, Martha Hickey, Andrew W. Horne, M. Louise Hull, Sharada Kolekar, Sarah Lensen, NP Johnson, Vishakha Mahajan, Ben W. Mol, A.S. Otter, Lucian Pușcașiu, MB Rodriguez, Luk Rombauts, Andy Vail, Rui Wang, Cindy Farquhar
Abstract
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.