Impact Evaluation of CONSORT and STRICTA Guidelines on Reporting Quality for Randomized Controlled Trials of Acupuncture Conducted in China
Impact Evaluation of CONSORT and STRICTA Guidelines on Reporting Quality for Randomized Controlled Trials of Acupuncture Conducted in China
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DOI：
10.1007/s11655-016-2451-z
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发表时间：
2017-01-01
影响因子：
2.9
通讯作者：
Pan Hai-hua
中科院分区：
文献类型：
--
作者：
Lu Li-ming;He Jun;Pan Hai-hua
目的：评价和比较《报告试验综合标准》（CONSORT）声明和《针灸对照试验干预报告标准》（STRICTA）两个指南实施前后中国开展的针灸随机对照试验（RCT）的报告质量。方法：比较了这两个指南实施前后几年报告 CONSORT 和 STRICTA 项目的研究比例。此外，还计算了每个项目报告的总分，并比较了不同日期范围内报告的差异。结果：对于 CONSORT 项目（最高分 8 分），有证据表明 1994-1995 年和 1999-2000 年合计（2.5 +/- 0.6）以及 2004-2005 年和 2009-2010 年合计（3.0 +/- 0.9；差异 0.4，95% 置信区间，0.3 至 0.6，P < 0.01）。对于 STRICTA 项目（最高分 17），有证据表明 1994-1995 年和 1999-2000 年合计（8.6 +/- 2.1）以及 2004-2005 年和 2009-2010 年合计（10.1 +/- 1.8；差异 1.5，95% 置信区间，1.1 至 1.9， P<0.01）。结论：自 STRICTA 和 CONSORT 指南出台以来，中国针灸治疗随机对照试验的报告质量总体有所提高。
Objective: To evaluate and compare the reports' qualities of acupuncture randomized controlled trials (RCTs) conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials (CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). Methods: Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item's reporting were calculated and reported differences during different date ranges were compared. Results: For CONSORT items (maximum score 8), there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined (2.5 +/- 0.6) and 2004-2005 and 2009-2010 combined (3.0 +/- 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P < 0.01). For STRICTA items (maximum score 17), there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined (8.6 +/- 2.1) and 2004-2005 and 2009-2010 combined (10.1 +/- 1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P < 0.01). Conclusion: Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.