Evaluation and Thinking on the Report Quality of N-of-1 Randomized Controlled Trials of Traditional Chinese Medicine Published in Journals in Mainland China
LI Xuanlin, YU Xueqing, XIE Yang, et al. Evaluation and Thinking on the Report Quality of N-of-1 Randomized Controlled Trials of Traditional Chinese Medicine Published in Journals in Mainland China[J]. Journal of Traditional Chinese Medicine2020, 61(15): 1325-1329.
LI Xuanlin, YU Xueqing, XIE Yang, et al. Evaluation and Thinking on the Report Quality of N-of-1 Randomized Controlled Trials of Traditional Chinese Medicine Published in Journals in Mainland China[J]. Journal of Traditional Chinese Medicine2020, 61(15): 1325-1329.DOI: 10.13288/j.11-2166/r.2020.15.010.
并应用中医药单病例随机对照试验的报告规范(CENT for TCM)声明评价纳入研究的报告质量。结果共纳入11篇中医药N-of-1试验文献。CENT for TCM声明的领域1 (标题/摘要/关键词)充分报告比例最高
达84. 85%;领域6 (其他信息)充分报告比例最低为0
未报告比例为96. 97%;领域2 (引言)部分报告比例最高
为57. 58%。多个领域的报告情况存在不足。结论中医药N-of-1试验存在报告欠充分情况
未来建议严格按照CENT for TCM声明进行报告
并加强方法学设计、质量控制
以产出更加规范、透明、高质量的临床证据。
Abstract
Objective To evaluate the report quality of traditional Chinese medicine(TCM) N-of-1 randomized controlled trials published in Chinese Journals in mainland China. Methods China Biomedical Literature Database(CBM)
Wanfang Digital Journal Full Text Data
China Knowledge Network(CNKI)
VIP Chinese Journal Database were searched systematically. Two researchers independently screened the literature and extracted the data
and the quality of the included reports were evaluated with the CONSORT extension for reporting N-of-1 trials(CENT) for TCM statement. Results A total of 11 papers of TCM N-of-1 were included. Field 1(title/abstract/keyword) had the highest percentage of full reports(84.85%). Field 6(other information) with a minimum of 0 full reporting rate and 96.97% unreported rate; The highest reporting rate of partial reports in field 2(introduction) was 57.58%; there were inadequate reporting in multiple areas. Conclusion The N-of-1 trials of TCM is not fully reported in some items and fields. In future
reports should be conducted in strict accordance with the "CENT for TCM" statement and methodology design and quality control should be strengthened to produce more standardized