在临床试验中,对患有抑郁症的老年人进行主要结果报告
Myanca Rodrigues1, Anna Oprea2, Keily Johnson3
1Health Research Methodology Graduate Program, Department of Health Research Methods, Evidence, and Impact, McMaster University, Canada.
BJPsych open
|March 7, 2024
概括
对于患有重大抑郁症 (MDD) 的老年人,随机对照试验 (RCT) 中报告主要结果往往是不完整的. 测量和解释结果的关键细节经常缺失,阻碍了基于证据的实践.
科学领域:
- 老年精神病学是一门精神病学专业.
- 临床试验方法论 临床试验方法论
- 证据综合 证据综合
背景情况:
- 随机对照试验 (RCT) 通过元分析进行合成,以告知基于证据的决策.
- 对试验结果的不完整报告阻碍了知识综合和临床实践的普及.
- 在老年抑郁症RCT中评估初级结果报告对于提高证据质量至关重要.
研究的目的:
- 评估随机对照试验 (RCT) 中的主要结局报告的完整性,针对被诊断患有严重抑郁症 (MDD) 的老年人.
主要方法:
- 包括2011-2021年间发表的RCT,重点关注65岁以上的MDD成年人和单一的初级结局.
- 基于CONSORT-Outcomes声明的58项检查清单被用于独立,重复评估结果报告.
- 试验信息被分类为"完全报告"",部分报告"或"未报告"每个检查清单项目.
主要成果:
- 在49个RCT中,有31个符合纳入标准. 71%的这些试验未能完全报告超过一半的检查清单项目.
- 在65%或更多的试验中,结果分析和解释得到了充分报告.
- 不太频繁地报告的项目包括结果测量仪器属性 (3-30%) 和临床上有意义的变化标准的理由 (23%).
结论:
- 老年抑郁症RCT表现出可变的初级结果报告,在测量,选择,理由和临床意义上的变化定义上有遗漏.
- 报告缺陷可能会阻碍研究可复制性和临床指导方针的证据综合.
- 建议在报告老年抑郁症RCT时遵守CONSORT-Outcomes指南.
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