作者
Lucy-Ann Turner, Kavita Singh, Chantelle Garritty, Alexander Tsertsvadze, Eric Manheimer, L Susan Wieland, James Galipeau, David Moher
发表日期
2011/12
期刊
BMC Complementary and Alternative Medicine
卷号
11
页码范围
1-10
出版商
BioMed Central
简介
Background
Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting.
Methods
Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and …
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