Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, Kyoto, 606-8501, Japan.
Department of Neurology, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Kyoto, Japan.
BMC Med Res Methodol. 2018 Sep 24;18(1):96. doi: 10.1186/s12874-018-0554-2.
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.
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.
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.
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.
我们见证了中国大陆发表的随机对照试验（RCT）数量呈指数级增长。这种增长在新一代抗抑郁药和抗精神病药领域尤为明显。之前的几项研究对其质量提出了质疑。然而，中国最近发表的 RCT 的质量可能已经有所提高。
我们在国家知识基础设施（CNKI）数据库中检索了 2013 年至 2016 年间发表的评估新一代抗抑郁药和抗精神病药的 RCT。我们采访了确定参考文献的随机样本的作者。我们根据发表的报告和与作者的电话访谈，使用从 Cochrane 偏倚风险工具改编的六个方法学领域来评估每个研究的方法严谨性。
最终样本包括 138 项研究，我们采访了 58 位作者；51 项研究的作者拒绝接受采访，29 项研究的作者无法联系。拒绝接受采访的 51 项研究更不可能来自大学附属医院，也更不可能发表在中文核心期刊上。根据发表的报告，58 项研究中的大多数在大多数方法学领域被评估为偏倚风险不明确。在采访之后，只有 10 项研究在随机序列生成和分配隐藏方面被评估为低偏倚风险。假设拒绝接受采访的研究存在不确定风险，则在随机序列生成和分配隐藏方面处于低偏倚风险的 RCT 比例为 9.2%（10/109，95%置信区间 [CI]：5.0 至 16.2）。访谈表明，这些研究在大多数其他领域存在高偏倚风险。
一般来说，在中国知网（CNKI）索引的评估新一代抗抑郁药或抗精神病药的 RCT 仍然质量较低。在该领域进行系统评价和荟萃分析时，明智的做法是聘请一名中国专家作为核心研究员，以帮助评估已确定研究的偏倚风险。
