Development of a core outcome set and outcome definitions for studies on uterus-sparing treatments of adenomyosis (COSAR): an international multistakeholder-modified Delphi consensus study

• Published in: Human reproduction (Oxford) 2022-08, Vol.37 (9), p.2012-2031
• Main Authors: Tellum, T, Naftalin, J, Chapron, C, Dueholm, M, Guo, S -W, Hirsch, M, Larby, E R, Munro, M G, Saridogan, E, van der Spuy, Z M, Jurkovic, D
• Format: Article
• Language: English
• Subjects: Adenomyosis - therapy; Consensus; Delphi Technique; Endometriosis - therapy; Female; Humans; Original; Outcome Assessment, Health Care; Uterus
• ISSN: 0268-1161; 1460-2350; 1460-2350
• DOI: 10.1093/humrep/deac166

Abstract STUDY QUESTION What outcomes should be reported in all studies investigating uterus-sparing interventions for treating uterine adenomyosis? SUMMARY ANSWER We identified 24 specific and 26 generic core outcomes in nine domains. WHAT IS KNOWN ALREADY Research reporting adenomyosis treatment is not patient-centred and shows wide variation in outcome selection, definition, reporting and measurement of quality. STUDY DESIGN, SIZE, DURATION An international consensus development process was performed between March and December 2021. Participants in round one were 150 healthcare professionals, 17 researchers and 334 individuals or partners with lived experience of adenomyosis from 48 high-, middle- and low-income countries. There were 291 participants in the second round. PARTICIPANTS/MATERIALS, SETTING, METHODS Stakeholders included active researchers in the field, healthcare professionals involved in diagnosis and treatment, and people and their partners with lived experience of adenomyosis. The core component of the process was a 2-step modified Delphi electronic survey. The Steering Committee analysed the results and created the final core outcome set (COS) in a semi-structured meeting. MAIN RESULTS AND THE ROLE OF CHANCE A total of 241 outcomes was identified and distilled into a ‘long list’ of 71 potential outcomes. The final COS comprises 24 specific and 26 generic core outcomes across nine domains, including pain, uterine bleeding, reproductive outcomes, haematology, urinary system, life impact, delivery of care, adverse events and reporting items, all with definitions provided by the Steering Committee. Nineteen of these outcomes will apply only to certain study types. Although not included in the COS, the Steering Committee recommended that three health economic outcomes should be recorded. LIMITATIONS, REASONS FOR CAUTION Patients from continents other than Europe were under-represented in this survey. A lack of translation of the survey might have limited the active participation of people in non-English speaking countries. Only 58% of participants returned to round two, but analysis did not indicate attrition bias. There is a significant lack of scientific evidence regarding which symptoms are caused by adenomyosis and when they are related to other co-existent disorders such as endometriosis. As future research provides more clarity, the appropriate review and revision of the COS will be necessary. WIDER IMPLICATIONS OF THE FINDINGS Impleme