基于 Cochrane 偏倚风险评估、CONSORT+STRICTOM 评价灸法治疗支气管哮喘随机对照试验质量
作者:
作者单位:

1.江西中医药大学;2.江西中医药大学附属医院

作者简介:

通讯作者:

中图分类号:

基金项目:

国家自然科学基金项目(面上项目,重点项目,重大项目)


Assessment of Reporting quality in Randomised Controlled Trials of Moxibustion for Bronchial Asthma using the Cochrane Collaboration’s Tool for Assessing Risk of Bias and the CONSORT -STRICTOM Statement
Author:
Affiliation:

Fund Project:

  • 摘要
  • |
  • 图/表
  • |
  • 访问统计
  • |
  • 参考文献
  • |
  • 相似文献
  • |
  • 引证文献
  • |
  • 资源附件
  • |
  • 文章评论
    摘要:

    摘要:目的:评价灸法治疗支气管哮喘随机对照试验方法学及报告质量。方法:采用计算机与手工检索国内外大型文献数据库, 包括中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普(VIP)、万方(WF)、PUBMED、Cochrane Library、EMbase数据库筛选出合格文献,运用Cochrane偏倚风险评估、CONSORT声明和STRICTOM标准进行质量评价。结果:纳入RCT180篇,但多数文献存在偏倚风险较高,且未明确描述具体的随机方法、分配隐藏、盲法、样本估算和艾灸细节等各方面问题,文献报告质量普遍偏低。依照 Cochrane 偏倚风险评估工具进行评估,结果105篇(58.33%)未描述清楚随机序列的产生,165篇(91.67%)分配隐藏不清楚,显示选择偏倚向高风险倾斜。166篇(92.22%)未描述在执行中是否采用盲法。参照 CONSORT 声明对文献进行质量报告,结果显示137 篇(76.11%)描述了准确的干预措施,具有可重复性。但是 177 篇(98.33%)样本量的确定方法不清楚,164篇(91.11%)未采用合适的分配隐藏,166 篇(92.22%)未描述随机化的种类及任何限制。参照STRICTOM声明评价,结果大部分论文对艾灸原理及细节有较为详细的描述,但没有仅有22篇(12.22%)有对防范措施的详细描述,仅一篇文献提及艾灸医生的信息。结论 :目前灸法治疗支气管哮喘的随机对照试验质量普遍较低,临床试验科学性欠缺,应采用高水平设计控制偏倚风险,遵循公认的报告规范,以提高质量。

    Abstract:

    Abstract:Objective: By evaluating the report quality of clinical randomized controlled trials of moxibustion on bronchial asthma in China, we provides evidence and methodological reference for future clinical research practice of moxibustion and improves the quality of the trials.Methods: We use the computer retrieval and manual retrieval of large literature database at home and abroad, including PubMed, the Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Chinese Biomedical database (CBM) and the Wanfang database, the Cochrane Library ,EMbase database selected standard documents.And we use the Cochrane risk of bias tool, CONSORT statement and STRICTOM standard to assess the quality of RCTs.Results:180 articles were included, but most of the literatures had a high risk of bias, and the specific random method, allocation hiding, blind method, sample estimation and moxibustion details were not clearly described, and the quality of the literatures was generally low.According to the Cochrane risk of bias tool, 105 (58.33%) of the results did not describe the generation of random sequences clearly, and 165 (91.67%) of the allocations were not clear, indicating that selection bias was skewed towards high risk.166 (92.22%) did not describe whether blind methods were used in the implementation.A quality report of the literature with reference to the CONSORT statement showed that 137 (76.11%) described accurate interventions which were reproducible.However, the method for determining the sample size of 177 (98.33%) was unclear, 164 (91.11%) did not adopt appropriate allocation concealment, and 166 (92.22%) did not describe the kind of randomization and any restrictions.According to STRICTOM statement, most of the papers described the principle and details of moxibustion in detail, but not only 22 (12.22%) described the preventive measures in detail, and only one paper mentioned the information of moxibustion doctors.Conclusion: At present, the quality of randomized controlled trials of moxibustion therapy for bronchial asthma is generally low, and clinical trials are not scientific enough. Therefore, high level design should be adopted to control the risk of bias, and generally accepted reporting standards should be followed to improve the quality.

    参考文献
    相似文献
    引证文献
引用本文
分享
文章指标
  • 点击次数:
  • 下载次数:
  • HTML阅读次数:
  • 引用次数:
历史
  • 收稿日期:2021-01-03
  • 最后修改日期:2021-04-09
  • 录用日期:2021-05-25
  • 在线发布日期:
  • 出版日期: