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目的评估儿科补充与替代医学(Complementaryandalternativemedicine,CAM)随机对照试验报告的质量,检验报告质量是否随时间而变化。方法以包含251篇CAM干预的RCT报告作为系统样本,对每一篇报告质量用CONSORT清单的部分项目,如分配隐藏不清楚的比例和5级质量评价来进行评估。结果有近一半(40%)的CONSORT清单项目在所有RCT报告中列出,且有增多趋势。大多数RCT(81.3%)未清楚报告分配隐藏方案,且多年无改进。报告质量评分约为Jadad评估最高总评分的40%,且多年无改进。仅有约1/4(22%)的RCT报道了不良反应,而关于医疗成本的报道仅占很小比例(4%)。结论RCT是循证卫生保健决策的重要工具。如果这些研究要作为对CAM评估的一部分,那么高质量地实施和报告这些试验就显得十分重要。应加倍努力以确保儿童及其家庭进入实施和报告偏倚最小的RCT。这样的研究可以让利益共享者的范围更宽广,更具使用价值。
Objectives To assess the quality of RCT reports for Complementary and Alternative Medicine (CAM) and to check if the quality of the reports changes over time. Methods A RCT report containing 251 CAM interventions was used as a systematic sample to assess the quality of each report using a portion of the CONSORT inventory, such as the proportion of hidden assignments and the level 5 quality assessment. As a result, nearly half (40%) of the CONSORT inventory items are listed in all RCT reports and there is an increasing trend. Most RCTs (81.3%) did not clearly report the allocation of hidden options and did not improve for years. The report quality score was about 40% of the highest total Jadad assessment score, with no improvement over the years. Only about 1 in 4 (22%) of the RCTs reported adverse events, while only a small percentage (4%) reported medical costs. Conclusion RCT is an important tool for evidence-based health care decision-making. If these studies are to be part of a CAM assessment, it is important to implement and report these trials with good quality. Efforts should be redoubled to ensure that children and their families access the RCT that implements and reports the least bias. Such research can broaden the scope of benefit-sharing and make it more valuable.