Article type
Year
Abstract
Background: randomized controlled trials (RCT) have been increasingly used to assess the efficacy of traditional Chinese medicine (TCM) interventions, yet the quality of these trials is generally low, which might hamper the implementation and synthesis of the trial results.
Objectives: to investigate the factors influencing the reporting of randomization in TCM clinical trials using a longitudinal dataset.
Methods: we searched four main Chinese electronic databases (China National Knowledge Infrastructure, VIP, Sinomed and Wanfang Database) from their inception to June 2017 for all RCTs of TCM interventions for cancer and cancer-related symptoms published in the Chinese language. We assessed key methodological items and factors that may affect reporting quality. Multiple logistic regression was applied to identify the influencing factors.
Results: the study included 5623 RCTs of TCM for cancer from 1984 to 2016. Table 1 and 2 report descriptive results. Logistic regression showed that publishing in core journals, reporting funding and having a sample size of more than 100 participants were positively and significantly associated with the reporting of random sequence generation, sequence concealment and the use of blinding (Table 1). For the reporting of diagnostic standards, cancer detection, inclusion/exclusion criteria of patients and cancer stages, publishing in core journals, reporting funding, and using herbal interventions were associated with a higher likelihood of proper reporting (Table 2). We also found that dissertations had a much higher chance of reporting methodological items compared to journal articles and conference papers.
Conclusions: being published in core journals and reporting funding were significant influencing factors for proper reporting, pointing out the potential to improve reporting quality by stressing the adherence to reporting standards among Chinese publishers and the importance of having adequate resource to conduct the trials. Publication after 2010 and sample sizes larger than 100 were not always associated with a higher reporting rate, indicating that the awareness and understanding on standardized reporting should be further and constantly stressed among TCM researchers in China.
Patient or healthcare consumer involvement: no patients or consumers directly participated in this study. However, the results of this study may eventually benefit patients by improving the reporting quality of primary studies.
Objectives: to investigate the factors influencing the reporting of randomization in TCM clinical trials using a longitudinal dataset.
Methods: we searched four main Chinese electronic databases (China National Knowledge Infrastructure, VIP, Sinomed and Wanfang Database) from their inception to June 2017 for all RCTs of TCM interventions for cancer and cancer-related symptoms published in the Chinese language. We assessed key methodological items and factors that may affect reporting quality. Multiple logistic regression was applied to identify the influencing factors.
Results: the study included 5623 RCTs of TCM for cancer from 1984 to 2016. Table 1 and 2 report descriptive results. Logistic regression showed that publishing in core journals, reporting funding and having a sample size of more than 100 participants were positively and significantly associated with the reporting of random sequence generation, sequence concealment and the use of blinding (Table 1). For the reporting of diagnostic standards, cancer detection, inclusion/exclusion criteria of patients and cancer stages, publishing in core journals, reporting funding, and using herbal interventions were associated with a higher likelihood of proper reporting (Table 2). We also found that dissertations had a much higher chance of reporting methodological items compared to journal articles and conference papers.
Conclusions: being published in core journals and reporting funding were significant influencing factors for proper reporting, pointing out the potential to improve reporting quality by stressing the adherence to reporting standards among Chinese publishers and the importance of having adequate resource to conduct the trials. Publication after 2010 and sample sizes larger than 100 were not always associated with a higher reporting rate, indicating that the awareness and understanding on standardized reporting should be further and constantly stressed among TCM researchers in China.
Patient or healthcare consumer involvement: no patients or consumers directly participated in this study. However, the results of this study may eventually benefit patients by improving the reporting quality of primary studies.
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