PT  - JOURNAL ARTICLE
AU  - Astrid Chevance
AU  - Anneka Tomlinson
AU  - Philippe Ravaud
AU  - Suzanne Touboul
AU  - Catherine Henshall
AU  - Viet-Thi Tran
AU  - Andrea Cipriani
TI  - Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals
AID  - 10.1136/ebmental-2021-300418
DP  - 2022 Dec 01
TA  - Evidence Based Mental Health
PG  - e41--e48
VI  - 25
IP  - e1
4099  - http://mentalhealth.bmj.com//content/25/e1/e41.short
4100  - http://mentalhealth.bmj.com//content/25/e1/e41.full
SO  - Evid Based Ment Health2022 Dec 01; 25
AB  - Background Non-serious adverse events (NSAEs) should be captured and reported because they can have a significant negative impact on patients and treatment adherence. However, the reporting of NSAEs in randomised controlled trials (RCTs) is limited.Objective To identify the most important NSAEs of antidepressants for patients and clinicians, to be evaluated in RCTs and meta-analyses.Methods We conducted online international surveys in English, German and French, including (1) adults prescribed an antidepressant for a depressive episode and (2) healthcare professionals (HCPs) prescribing antidepressants. Participants ranked the 30 most frequent NSAEs reported in the scientific literature. We fitted logit models for sets of ranked items and calculated for each AE the probability to be ranked higher than the least important AE. We also identified additional patient-important AEs not included in the ranking task via open-ended questions.Findings We included 1631 patients from 44 different countries (1290 (79.1%) women, mean age 39.4 (SD 13), 289 (37.1%) with severe depression (PHQ-9 score ≥20)) and 281 HCPs (224 (79.7%) psychiatrists). The most important NSAEs for patients were insomnia (95.9%, 95% CI 95.2% to 96.5%), anxiety (95.2%, 95% CI 94.3% to 95.9%) and fatigue (94.6%, 95% CI 93.6% to 95.4%). The most important NSAEs for HCPs were sexual dysfunction (99.2%, 95% CI 98.5% to 99.6%), weight gain (98.9%, 95% CI 97.7% to 99.4%) and erectile problems (98.8%, 95% CI 97.7% to 99.4%). Participants reported 66 additional NSAEs, including emotional numbing (8.6%), trouble with concentration (7.6%) and irritability (6%).Conclusions These most important NSAEs should be systematically reported in antidepressant trials.Clinical implications The most important NSAEs should contribute to the core outcome set for harms in depression.Data are available upon reasonable request. Deidentified quantitative data will be shared upon reasonable request to the authors. Additional documents not already provided in the online supplemental material section (eg, informed consent and ethical approval) will be available on request to the authors.