在高影响期刊中对阶段子集群随机试验进行系统审查:评估设计,理由和分析
Elizabeth Varghese1, Anny Briola1, Titouan Kennel1
1Edinburgh Clinical Trials Unit, Usher Institute, The University of Edinburgh, Usher Building, 5-7 Little France Road, Edinburgh BioQuarter - Gate 3, Edinburgh EH16 4UX, UK.
逐步集群随机试验 (SW-CRTs) 越来越多地使用. 这次审查发现,大多数SW-CRT具有图表,但缺乏明确的时间周期持续时间和强大的设计理由,表明报告改进的领域.
科学领域:
- 临床试验方法论 临床试验方法论
- 流行病学 流行病学
- 生物统计学 生物统计学
背景情况:
- 步骤集群随机试验 (SW-CRT) 为顺序干预推广提供了后勤优势.
- 评估SW-CRT的报告质量对于研究可重复性和有效性至关重要.
研究的目的:
- 评估SW-CRT在高影响期刊 (2020-2023) 中发表的设计理由,特征,图表和分析.
- 评估是否遵守报告准则,特别是SW-CRT的汇总报告试验标准 (CONSORT) 扩展.
主要方法:
- 系统搜索PubMed和Cochrane中央注册表的SW-CRT发表于2020年1月至2023年12月的八个高影响力期刊.
- 纳入标准:同行评审,随机SW-CRT涉及人类参与者,以英语出版.
主要成果:
- 审查了23个SW-CRT;70%的标题中提到"渐进子".
- 96%的图表包含了阶梯形图,但只有65%的图表清楚地显示了时间段的持续时间.
- 设计的可变性 (序列:中位数7;集群:中位数15),其中78%为SW-CRT设计提供了强有力的理由.
结论:
- 需要改进的是,在阶段形图中清楚地呈现时间周期的持续时间.
- 在出版物中应该始终提供选择SW-CRT设计的强有力的理由.
- 加强SW-CRT的报告将提高清晰度和遵守方法标准.
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