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
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 regardi...
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| Format: | Article |
| Language: | English |
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BMC
2018-09-01
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| Series: | BMC Medical Research Methodology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12874-018-0554-2 |
| _version_ | 1818599674037141504 |
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| author | Zheng Tong Fangzhou Li Yusuke Ogawa Norio Watanabe Toshi A. Furukawa |
| author_facet | Zheng Tong Fangzhou Li Yusuke Ogawa Norio Watanabe Toshi A. Furukawa |
| author_sort | Zheng Tong |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-16T12:23:20Z |
| format | Article |
| id | doaj.art-3e2fc369d7404a2589f5eee389ef998d |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-12-16T12:23:20Z |
| publishDate | 2018-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-3e2fc369d7404a2589f5eee389ef998d2022-12-21T22:31:54ZengBMCBMC Medical Research Methodology1471-22882018-09-0118111110.1186/s12874-018-0554-2Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview studyZheng Tong0Fangzhou Li1Yusuke Ogawa2Norio Watanabe3Toshi A. Furukawa4Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public HealthDepartment of Neurology, Kyoto University Graduate School of MedicineDepartment of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public HealthDepartment of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public HealthDepartment of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public HealthAbstract 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.http://link.springer.com/article/10.1186/s12874-018-0554-2Randomized controlled trialsAntidepressive agentsAntipsychotic agentsRisk of biasResearch integrityChina |
| spellingShingle | Zheng Tong Fangzhou Li Yusuke Ogawa Norio Watanabe Toshi A. Furukawa 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 BMC Medical Research Methodology Randomized controlled trials Antidepressive agents Antipsychotic agents Risk of bias Research integrity China |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Randomized controlled trials Antidepressive agents Antipsychotic agents Risk of bias Research integrity China |
| url | http://link.springer.com/article/10.1186/s12874-018-0554-2 |
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