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| Evaluation on methodological and reporting quality of randomized controlled trials of Chinese patent medicines for acute upper respiratory infection in children based on Cochrane risk bias assessment tool and CONSORT-CHM Formulas |
| Hits 1409 Download times 1069 Received:November 10, 2019 |
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| DOI
10.11656/j.issn.1672-1519.2020.03.17 |
| Key Words
acute upper respiratory infection;Chinese patent medicine;children;Cochrane;CONSORT-CHM Formulas;methodology;report quality |
| Author Name | Affiliation | E-mail | | XU Yaqian | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | CAI Qiuhan | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | WANG Hui | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | HU Siyuan | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | husiyuan1963@sina.com |
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| Abstract
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| [Objective] To evaluate the methodological quality and report quality of randomized controlled trials of Chinese patent medicine for the treatment of acute upper respiratory infection in children during the past five years,providing reference for future researches.[Methods] We identified RCT by electronic searches of the Chinese Net work Knowledge Information(CNKI),Wan fang Data,Chinese Science Journal Database(VIP),Pub Med database,EMBASE,the Cochrane library. We used the Cochrane handbook for systematic reviews and the CONSORT-CHM Formulas to evaluate the methodological quality and reporting quality of RCT,then counted the outcome measures.[Results] The 43 articles were included,23(53.5%) articles were judged as uncertain in the risk of bias,and 20 (46.5%) articles were judged as high-risk,without low-risk articles. The overall quality of the report was low,and the reporting rates such as sample size calculation,mid-term analysis,trial registration,and method of obtaining trial protocols are all 0%. The report rates in terms of methods for generating random allocation sequences,description of random methods in detail,methods of allocation concealment,implementation of blind methods,screening of subjects,description of baseline conditions,outcomes and estimates,and limitations of studies were 58.1%,4.7%,14.0%,20.9%,16.3%,23.3%,9.3%,16.3%. The other entries were related but incomplete. There were still some shortcomings in the design of the trial protocol in terms of subject selection,course setting,and outcome index selection and evaluation.[Conclusion] At present,the methodological quality and reporting quality of RCT of Chinese patent medicine for the treatment of acute upper respiratory infection in children was low,and need to be improved. |
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