随机试验中的报告实施：对试验报告统一标准的拟议补充内容。
Reporting implementation in randomized trials: proposed additions to the consolidated standards of reporting trials statement.
作者信息
Mayo-Wilson Evan
机构信息
Centre for Evidence-Based Intervention, Department of Social Policy and Social Work, University of Oxford, Oxford, England, UK.
出版信息
Am J Public Health. 2007 Apr;97(4):630-3. doi: 10.2105/AJPH.2006.094169. Epub 2007 Feb 28.
Abstract
Randomized controlled trials of public health interventions are often complex: practitioners may not deliver interventions as researchers intended, participants may not initiate interventions and may not behave as expected, and interventions and their effects may vary with environmental and social context. Reports of randomized controlled trials can be misleading when they omit information about the implementation of interventions, yet such data are frequently absent in trial reports, even in journals that endorse current reporting guidelines. Particularly for complex interventions, the Consolidated Standards of Reporting Trials (CONSORT) statement does not include all types of information needed to understand the results of randomized controlled trials. CONSORT should be expanded to include more information about the implementation of interventions in all trial arms.
摘要
公共卫生干预措施的随机对照试验往往很复杂
从业者可能不会按照研究人员的意图实施干预措施，参与者可能不会启动干预措施，行为也可能不符合预期，而且干预措施及其效果可能会因环境和社会背景而有所不同。当随机对照试验报告遗漏有关干预措施实施的信息时，可能会产生误导，但此类数据在试验报告中经常缺失，即使在认可当前报告指南的期刊中也是如此。特别是对于复杂的干预措施，《报告试验的统一标准》（CONSORT）声明并未涵盖理解随机对照试验结果所需的所有信息类型。CONSORT应加以扩展，以纳入所有试验组中有关干预措施实施的更多信息。
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