The quality of reporting of randomized controlled trials of traditional chinese medicine: A survey of 13 randomly selected journals from mainland China
The quality of reporting of randomized controlled trials of traditional chinese medicine: A survey of 13 randomly selected journals from mainland China
复制标题
中医药随机对照试验报告质量：对中国大陆13种随机期刊的调查
DOI：
10.1016/j.clinthera.2007.07.023
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发表时间：
2007-07-01
影响因子：
3.2
通讯作者：
Li, Ting-Qian
中科院分区：
文献类型：
--
作者：
Wang, Gang;Mao, Bing;Li, Ting-Qian
背景：中医药随机对照试验（RCT）数量不断增加。目的：对1999 ~ 2004年中国大陆中医药期刊中随机对照试验的报道质量进行评价。方法：采用分层抽样的方法，从100种中医药期刊中随机抽取13种中医药期刊，对1999 ~ 2004年中国大陆中医药期刊中随机对照试验的报道质量进行评价。根据科克伦中心的指南，手工检索1999年至2004年出版的所有期刊。所有评价者均在中国循证医学中心接受了RCT评价培训。使用修订版的试验报告统一标准（CONSORT）检查表（共30项）和Jadad量表对每个RCT进行全面质量评估。结果：7422项随机对照试验被确定。在研究期间，已发表的RCT相对于所有类型的已发表临床试验的比例显著增加，从1999年的18.6%增加到2004年的35.9%（P < 0.001）。总体平均（SD）Jadad评分为1.03（0.61）。1项RCT的Jadad评分为5分; 14项为4分; 102项为3分。1999年（746项随机对照试验）的平均（SD）Jadad评分为0.85（0.53），2004年（1634项随机对照试验）的平均（SD）Jadad评分为1.20（0.62）。在所有试验中，报告了改良CONSORT检查表上39.4%的项目，相当于30个项目中的11.82（5.78）个。RCT的一些重要方法学组成部分报道不完整，如样本量计算（1.1%的RCT报告），随机化序列（7.9%），分配隐瞒（0.3%）、随机分配序列的实施（0%）和意向治疗分析（0%）。本研究结果表明，中医药随机对照试验的报告质量有所提高，但仍不高。
Background: The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials.Objective: This study was undertaken to evaluate the quality of reporting of RCTs in TCM Journals published in mainland China from 1999 to 2004.Methods: Thirteen TCM journals were randomly selected by stratified sampling of the similar to 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus.Results: Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3%), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%).Conclusion: The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.