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.

中文翻译：

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在抑郁症的抗抑郁试验和荟萃分析中评估的重要不良事件：一项包括患者和医疗保健专业人员的大型国际偏好研究

背景 应捕获和报告非严重不良事件 (NSAE)，因为它们会对患者和治疗依从性产生重大负面影响。然而，随机对照试验 (RCT) 中 NSAE 的报告是有限的。目的 确定对患者和临床医生最重要的抗抑郁药 NSAE，以在随机对照试验和荟萃分析中进行评估。方法 我们用英语、德语和法语进行了在线国际调查，包括 (1) 成年人为抑郁发作开抗抑郁药，以及 (2) 医疗保健专业人员 (HCP) 开抗抑郁药。参与者对科学文献中报告的 30 种最常见的 NSAE 进行了排名。我们为排序项目集安装了 Logit 模型，并为每个 AE 计算了排名高于最不重要 AE 的概率。我们还通过开放式问题确定了未包含在排名任务中的其他对患者重要的 AE。结果 我们纳入了来自 44 个不同国家的 1631 名患者（1290 名 (79.1%) 女性，平均年龄 39.4 (SD 13)，289 名 (37.1%) 患有严重抑郁症（PHQ-9 评分≥20））和 281 名医护人员（224 (79.7%) ）精神科医生）。患者最重要的 NSAE 是失眠（95.9%，95% CI 95.2% 至 96.5%）、焦虑（95.2%，95% CI 94.3% 至 95.9%）和疲劳（94.6%，95% CI 93.6% 至 95.4%） ). HCP 最重要的 NSAE 是性功能障碍（99.2%，95% CI 98.5% 至 99.6%）、体重增加（98.9%，95% CI 97.7% 至 99.4%）和勃起问题（98.8%，95% CI 97.7%）到 99.4%）。参与者报告了 66 种额外的 NSAE，包括情绪麻木 (8.6%)、注意力不集中 (7.6%) 和易怒 (6%)。结论 应在抗抑郁试验中系统地报告这些最重要的 NSAE。临床意义 最重要的 NSAE 应该有助于抑郁症危害的核心结果集。可根据合理要求提供数据。将根据作者的合理要求共享去识别化的定量数据。在线补充材料部分尚未提供的其他文件（例如，知情同意和伦理批准）将应要求提供给作者。