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. 2018 Sep 24;18(1):96.
doi: 10.1186/s12874-018-0554-2.

Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study

Zheng Tong  1 , Fangzhou Li  2 , Yusuke Ogawa  1 , Norio Watanabe  1 , Toshi A Furukawa  3
Affiliations

Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study

Zheng Tong et al. BMC Med Res Methodol. .

Abstract

Background: We are witnessing an exponential increase in the number of randomized controlled trials (RCTs) reported from mainland China. The increase is particularly notable in the field of new generation antidepressants and antipsychotics. Several previous studies have raised doubts regarding their quality. However, the quality of most recent RCTs published in China may have improved.

Methods: We searched RCTs that examined new generation antidepressants and antipsychotics published between 2013 and 2016 in the China National Knowledge Infrastructure (CNKI), the largest database of scientific publications in China. We interviewed the authors of a random subset of the identified references. We assessed the methodological rigor of each study based on the published reports and telephone interviews with the authors using six methodological domains adapted from the Cochrane's risk of bias tool.

Results: The final sample consisted of 138 studies, for which we interviewed 58 authors; the authors of 51 studies declined the interview, and the authors of 29 studies could not be contacted. The 51 studies with refused interviews were significantly less likely to be reported from university-affiliated hospitals and were less likely to be published in Chinese core journals. Based on the published reports, most of the 58 studies were assessed to be at unclear risk of bias in most methodological domains. After the interview, only 10 studies were assessed to be at low risk of bias for sequence generation and allocation concealment. Assuming that the studies for which the authors declined interviews had an unclear risk, the proportion of RCTs at low risk of bias in both sequence generation and allocation concealment was 9.2% (10/109, 95% confidence interval [CI]: 5.0 to 16.2). The interviews indicated that the studies were at high risk of bias for most of the other domains.

Conclusion: In general, RCTs that evaluate new generation antidepressants or antipsychotics and are indexed in the CNKI continue to be of low quality. When conducting systematic reviews and meta-analyses in this field, it would be wise to include a specialist from China as a coresearcher to help assess the risk of bias in the identified studies.

Keywords: Antidepressive agents; Antipsychotic agents; China; Randomized controlled trials; Research integrity; Risk of bias.

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Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the ethics committee of Kyoto University Graduate School of Medicine (registration number R1019). All participants provided oral consent over the telephone, as per the ethics committee’s approval, during the telephone interview after full disclosure of the purpose and methods of the study.

Consent for publication

Not applicable.

Competing interests

TAF has received lecture fees from Janssen, Meiji, Mitsubishi-Tanabe, MSD and Pfizer and research support from Mitsubishi-Tanabe and Mochida, all outside the submitted work. The other authors declare no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of search and selection of studies for interviews
Fig. 2
Fig. 2
Risk of bias assessment for 58 successfully interviewed reports
Fig. 3
Fig. 3
“Randomized” clinical trials of antidepressants and antipsychotics conducted in China, identified in the CNKI (yellow) and PubMed (red) after 2000, superimposed on all such trials identified in PubMed (blue)
See this image and copyright information in PMC

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