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.
Original language | English |
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Pages (from-to) | 967-974 |
Number of pages | 8 |
Journal | BJOG: An International Journal of Obstetrics and Gynaecology |
Volume | 127 |
Issue number | 8 |
Early online date | 30 Mar 2020 |
DOIs | |
Publication status | Published - Jul 2020 |
Keywords
- Consensus development study
- core outcome set
- endometriosis
- modified Delphi method
- modified nominal group technique
- Prospective Studies
- Humans
- Endometriosis
- Consensus
- Delphi Technique
- Research Personnel
- Health Personnel
- Endpoint Determination
- Biomedical Research
- Female
- Research Design