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The methodological reporting quality in strictly randomized controlled trials for COVID-19 and precise reporting of
Min-Li Chen1, Shi-Yan Qian2, Jiang-Li Yang2
1Science and Technology Innovation Center, Guangzhou University of Chinese Medicine, Guangzhou, China.
Insights
Methodological reporting quality of Chinese herbal medicine (CHM) randomized controlled trials (RCTs) for COVID-19 is inadequate, particularly concerning sample size calculation, allocation concealment, and blinding. Improved reporting is crucial for assessing CHM effectiveness in pandemic response.
Area of Science:
- Integrative Medicine
- Clinical Trial Methodology
- Epidemiology
Background:
- Chinese herbal medicine (CHM) formulas were widely used during the COVID-19 pandemic.
- Numerous randomized controlled trials (RCTs) on CHM for COVID-19 have been published.
- Concerns exist regarding the quality and precise reporting of CHM interventions in these RCTs.
Purpose of the Study:
- To assess the methodological reporting quality of RCTs on CHM for COVID-19.
- To evaluate the precision of reporting for CHM formula interventions.
- To identify areas for improvement in clinical trial reporting for CHM.
Main Methods:
- Searched nine databases for RCTs on CHM formulas for COVID-19.
- Assessed studies using CONSORT 2010, CONSORT-CHM Formulas 2017, and risk of bias tools.
- Utilized a checklist based on CONSORT-CHM Formulas 2017 to evaluate CHM intervention reporting.
- Compared RCTs enrolled during the first wave of the pandemic (Dec 2019-Mar 2020) versus later.
Main Results:
- Average scores for CONSORT 2010, CONSORT-CHM Formulas 2017, and the checklist were 16.4, 15.2, and 17.2, respectively.
- Reporting rates for sample size calculation, allocation concealment, and blinding were below 30%.
- Most studies had an 'unclear risk of bias' due to insufficient information.
- RCTs in English and those enrolling participants during the first pandemic wave showed higher blinding bias (P < 0.05).
Conclusions:
- Methodological reporting quality of CHM RCTs for COVID-19 is inadequate, especially regarding sample size calculation, allocation concealment, and blinding.
- The CONSORT-CHM Formulas 2017 checklist aids precise reporting and assessment of CHM interventions.
- RCTs published in English and conducted during the initial pandemic wave demonstrated poorer methodological quality compared to later studies.
Background:
Chinese herbal medicine (CHM) formulas played an important role during the pandemic of coronavirus disease 2019 (COVID-19). Many randomized controlled trials (RCTs) on CHM for COVID-19 were quickly published. Concerns have been raised about their quality. In addition, inadequate detailed information on CHM formula intervention may arouse suspicion about their effectiveness. We aim to assess the most recent evidence of the methodological reporting quality of these RCTs with strict randomization, and the precise reporting of the CHM formula intervention.
Methods:
RCTs on CHM formulas for COVID-19 were searched from nine databases. The CONSORT 2010, CONSORT-CHM Formulas 2017, and risk of bias were the guidelines used to assess the included RCTs. The checklist of sub-questions based on CONSORT-CHM Formulas 2017 was used to evaluate the precise reporting of CHM formula intervention. A comparison was made between RCTs that enrolled participants during and after the first wave of the pandemic (defined here as December 2019 to March 2020).
Results:
The average score for 66 studies evaluated based on three guidelines, the CONSORT 2010, the CONSORT-CHM Formulas 2017, and the checklist of sub-questions based on the CONSORT-CHM Formulas 2017, is 16.4, 15.2, and 17.2, respectively. The reporting rate of sample size calculation, allocation concealment, and blinding is less than 30%. The checklist of sub-questions based on the CONSORT-CHM formulas 2017 can help report and assess CHM formula intervention more precisely. Most studies assessed an "unclear risk of bias" due to insufficient information. RCTs published in English and recruited subjects during the first wave of the pandemic have a higher risk of participant blinding bias than the studies recruited subjects after that (P < 0.05).
Conclusion:
The methodological reporting quality in strictly randomized RCTs on CHM formulas for COVID-19 is inadequate-the reporting of sample size calculation, allocation concealment, and blinding need to improve especially. The checklist of sub-questions based on CONSORT-CHM formulas 2017 can help report and assess CHM formula intervention more precisely. The methodological reporting quality of RCTs published in English and enrolled participants during the first wave of the pandemic is worse than the studies that recruited subjects after the first wave of the pandemic.
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