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针刺治疗脑卒中后失语症的随机对照试验(RCT)质量如何?报告质量评估。

How is the quality of randomized controlled trials (RCTs) for acupuncture treatment of post-stroke aphasia? A report quality assessment.

机构信息

National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.

出版信息

PLoS One. 2024 Oct 25;19(10):e0308704. doi: 10.1371/journal.pone.0308704. eCollection 2024.

Abstract

OBJECTIVE

This study aimed to assess the quality of randomized controlled trials (RCTs) that have reported the use of acupuncture for the treatment of post-stroke aphasia (PSA).

METHODS

We systematically searched PubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang data Information Site, and China Science and Technology Journal Database from January 2013 to June 2023. RCTs utilizing acupuncture as an intervention for the treatment of post-stroke aphasia were included in this study. The overall quality score (OQS) of RCTs was independently evaluated by two researchers using the Consolidated Standards for Reporting Trials (CONSORT) and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines, with the agreement between researchers calculated using Cohen's kappa statistics.

RESULTS

In conclusion, we included 38 RCTs in this study. The median OQS of the 38 RCTs was 13 (minimum 8, maximum 20) based on the CONSORT statement. Out of all CONSORT items, 10 (27%) had a positive rate of greater than 80%, while 17 (46%) had a positive rate of less than 10%. The median OQS of the 38 RCTs was 12 (minimum 6, maximum 14) based on the STRICTA guideline. Within the STRICTA guideline, 6 items (35%) had a positive rate of greater than 80%, and 3 items (18%) had a positive rate of less than 10%. Most items based on the CONSORT and STRICTA guidelines were observed to have a perfect or good degree of agreement.

CONCLUSIONS

The overall reporting quality of RCTs for acupuncture treatment of PSA was found to be suboptimal. Notably, the reporting quality of the STRICTA guideline is higher compared to the CONSORT statement. Therefore, strict adherence to both the CONSORT and STRICTA statements is recommended to enhance the quality of RCT reports on acupuncture treatment for post-stroke aphasia.

摘要

目的

本研究旨在评估报告使用针刺治疗中风后失语症(PSA)的随机对照试验(RCT)的质量。

方法

我们系统地检索了 PubMed、Embase、Cochrane 图书馆、Web of Science、中国国家知识基础设施(CNKI)、万方数据知识服务平台和中国科技期刊数据库,检索时间从 2013 年 1 月至 2023 年 6 月。纳入使用针刺作为干预措施治疗中风后失语症的 RCT。使用 CONSORT 和 STRICTA 指南,由两名研究人员独立评估 RCT 的总体质量评分(OQS),使用 Cohen's kappa 统计计算研究人员之间的一致性。

结果

本研究共纳入 38 项 RCT。基于 CONSORT 声明,38 项 RCT 的中位数 OQS 为 13(最低 8,最高 20)。在所有 CONSORT 项目中,有 10 个(27%)的阳性率大于 80%,而有 17 个(46%)的阳性率小于 10%。基于 STRICTA 指南,38 项 RCT 的中位数 OQS 为 12(最低 6,最高 14)。在 STRICTA 指南中,有 6 个项目(35%)的阳性率大于 80%,有 3 个项目(18%)的阳性率小于 10%。基于 CONSORT 和 STRICTA 指南的大多数项目观察到具有完美或良好的一致性程度。

结论

针刺治疗 PSA 的 RCT 报告的总体质量较差。值得注意的是,STRICTA 指南的报告质量高于 CONSORT 声明。因此,建议严格遵守 CONSORT 和 STRICTA 声明,以提高针刺治疗中风后失语症 RCT 的报告质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f7a/11508150/c3fa2ba2a8de/pone.0308704.g001.jpg

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