Data from: Assessment of the quality of reporting in randomized controlled trials of acupuncture in the Korean literature using the CONSORT statement and the STRICTA guidelines

Objectives: This study aimed to assess the completeness of reporting of RCTs of acupuncture in the Korean literature. Design: Systematic review. Methods: We searched 12 Korean databases and 7 Korean journals to identify eligible RCTs of acupuncture published from 1996 to July 2011. We used the Consolidated Standards of Reporting Trials (CONSORT) checklist for parallel RCTs and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to assess the quality of reporting in Korean RCTs. We compared the completeness of reporting of CONSORT and STRICTA items in RCTs published in two time periods (1996-2004 referred to as the early period and 2005-2011 referred to as the late period). Results: We analysed 146 eligible RCTs using the CONSORT statement concerning RCTs of both needling and non-needling acupuncture and the STRICTA guidelines for 90 trials of needling acupuncture. Among the 103 RCTs in the late period, the proportion of RCTs that completely reported the CONSORT items of outcome definition (15.5%), sample size calculation (2.9%), randomisation (56%), allocation concealment (5.8%), implementation of allocation (11.7%), outcome assessor blinding (20.3%), flow of participants (25.2%), number of participants analysed (19.4%), ancillary analyses (0.0%), adverse events (24.3%), generalisability of findings (1.9%) and overall evidence (32.0%) remained small. Among the 61 RCTs of needling acupuncture in the late period, the STRICTA items of setting/context (24.6%) and practitioner background (27.9%) showed incomplete reporting. The completeness of reporting improved over time in several CONSORT and STRICTA items. Conclusion: The completeness of reporting of Korean RCTs of acupuncture was suboptimal according to the CONSORT and revised STRICTA statements. Trial authors and journal editors should use the CONSORT statement and the STRICTA guidelines for transparent reporting in Korean RCTs of acupuncture. The endorsement of the CONSORT and revised STRICTA statements in author instructions is also required.

研究目的：本研究旨在评估韩国文献中针灸随机对照试验（Randomized Controlled Trial, RCT）报告的完整性。研究设计：系统评价。方法：我们检索了12个韩国数据库与7种韩国期刊，以筛选1996年至2011年7月间发表的合格针灸随机对照试验。我们采用平行组随机对照试验报告统一标准（Consolidated Standards of Reporting Trials, CONSORT）清单，以及修订版《针灸临床试验干预报告标准》（STandards for Reporting Interventions in Clinical Trials of Acupuncture, STRICTA），评估韩国针灸随机对照试验的报告质量。我们对比了两个时间段（1996-2004年记为早期，2005-2011年记为晚期）发表的随机对照试验中CONSORT与STRICTA条目报告的完整性。结果：我们针对针刺与非针刺针灸的随机对照试验采用CONSORT声明分析了146项合格研究，并针对90项针刺针灸随机对照试验采用STRICTA指南进行评估。在晚期发表的103项随机对照试验中，完全报告CONSORT条目的比例均处于较低水平：结局定义（15.5%）、样本量计算（2.9%）、随机化（56%）、分配隐藏（5.8%）、分配方案执行（11.7%）、结局评价者设盲（20.3%）、受试者流程图（25.2%）、分析受试者人数（19.4%）、辅助分析（0.0%）、不良事件（24.3%）、研究结果外推性（1.9%）以及整体证据（32.0%）。在晚期发表的61项针刺针灸随机对照试验中，STRICTA条目中的研究场景/背景（24.6%）与从业者背景（27.9%）仍存在报告不完整的问题。部分CONSORT与STRICTA条目的报告完整性随时间推移有所提升。结论：依据CONSORT声明与修订版STRICTA指南，韩国针灸随机对照试验的报告完整性未达理想标准。试验作者与期刊编辑应在韩国针灸随机对照试验中采用CONSORT声明与STRICTA指南，以实现研究报告的透明化。此外，还需在作者投稿须知中明确推广CONSORT声明与修订版STRICTA指南的使用。