Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals.
Astrid Chevance, Anneka Tomlinson, Philippe Ravaud, Suzanne Touboul, Catherine Henshall, Viet-Thi Tran, Andrea Cipriani
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引用次数: 7
Abstract
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.
背景:非严重不良事件(nsae)应被捕获和报告，因为它们可能对患者和治疗依从性产生重大的负面影响。然而，在随机对照试验(RCTs)中，nsae的报道是有限的。目的:确定抗抑郁药对患者和临床医生最重要的非甾体不良反应，并通过随机对照试验和荟萃分析进行评估。方法:我们进行了英语、德语和法语的在线国际调查，包括(1)为抑郁发作开抗抑郁药的成年人和(2)开抗抑郁药的医疗保健专业人员(HCPs)。参与者对科学文献中报道的30种最常见的nsae进行排名。我们为排序项目集拟合了logit模型，并计算了每个AE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其他未包括在排名任务中的患者重要ae。研究结果:我们纳入了来自44个不同国家的1631例患者(1290例(79.1%)女性，平均年龄39.4岁(SD 13)， 289例(37.1%)重度抑郁症(PHQ-9评分≥20)和281名HCPs(224名(79.7%)精神科医生)。患者最重要的非甾体不良反应是失眠(95.9%，95% CI 95.2% ~ 96.5%)、焦虑(95.2%，95% CI 94.3% ~ 95.9%)和疲劳(94.6%，95% CI 93.6% ~ 95.4%)。HCPs最重要的nsae是性功能障碍(99.2%，95% CI 98.5% ~ 99.6%)、体重增加(98.9%，95% CI 97.7% ~ 99.4%)和勃起问题(98.8%，95% CI 97.7% ~ 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:在抗抑郁药物试验中应系统地报告这些最重要的非甾体抗炎药。临床意义:最重要的非甾体不良反应应有助于抑郁症危害的核心结果集。
期刊介绍：
Evidence-Based Mental Health alerts clinicians to important advances in treatment, diagnosis, aetiology, prognosis, continuing education, economic evaluation and qualitative research in mental health. Published by the British Psychological Society, the Royal College of Psychiatrists and the BMJ Publishing Group the journal surveys a wide range of international medical journals applying strict criteria for the quality and validity of research. Clinicians assess the relevance of the best studies and the key details of these essential studies are presented in a succinct, informative abstract with an expert commentary on its clinical application.Evidence-Based Mental Health is a multidisciplinary, quarterly publication.
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