Jia Chi-yu, Wang Yun-chuan, Bai Feng
Burn Institute, First Affiliated Hospital to PLA General Hospital (Formerly 304 Hospital), Beijing 100037, PR China.
Zhonghua Shao Shang Za Zhi. 2006 Feb;22(1):38-41.
To investigate the quality of reports of clinical results concerning burn injury, in order to raise the standard of clinical study of burn care in accordance to the standard of evidence-based medicine (EBM), with the aim of improving clinical research in burn care of this country.
All the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard.
There were 89 papers about clinical trials published in the past 5 years, in which 43 (48.3%) of the studies were carried out with random control trials (RCT), and 46 (51.7%) were clinical control trials (CCT). RCT papers increased year by year, while the number of CCT papers fluctuated greatly. The disparity in the quality of research was found as follows. In all the RCT and CCT papers, blinded research was adopted only in 5 papers (5.6%). Strict diagnostic standard including inclusion and exclusion standards were reported in 53 articles (59.6%). The comparison with baselines was not provided in 64 articles (71.9%). P value was given in 10 papers but statistical method was not mentioned (11.2%). Follow-up visits and lost information were only recorded in 2 articles, but no detailed follow-up visiting data were provided. Side effects were reported in 10 articles (11.2%). There were analysis and explanation of mixed interfering factors only in 5 papers (5.6%). There was no explanation of the evaluation of sample size in any one paper.
In summary, the literature concerning clinical studies published in CJB in the past five years has become more extensive. However, the present study indicates that many clinical trials are not designed and ethical consideration is often missing. Therefore, it is deemed imperative to improve the quality of the clinical studies by improving the planning of the protocols of the study and statistical analysis of the research results in future.
调查烧伤临床结果报告的质量，以便按照循证医学（EBM）标准提高烧伤护理临床研究水平，旨在改善我国烧伤护理的临床研究。
依据EBM标准对2000年至2004年发表于《中华烧伤杂志》（CJB）的所有临床研究论文进行评估。
过去5年共发表89篇关于临床试验的论文，其中43项研究（48.3%）采用随机对照试验（RCT），46项研究（51.7%）为临床对照试验（CCT）。RCT论文逐年增加，而CCT论文数量波动较大。研究质量差异如下。在所有RCT和CCT论文中，仅5篇（5.6%）采用了盲法研究。53篇文章（59.6%）报告了包括纳入和排除标准在内的严格诊断标准。64篇文章（71.9%）未提供与基线的比较。10篇论文给出了P值，但未提及统计方法（11.2%）。仅2篇文章记录了随访和失访信息，但未提供详细的随访数据。10篇文章（11.2%）报告了副作用。仅5篇论文（5.6%）对混杂干扰因素进行了分析和解释。没有一篇论文对样本量评估进行解释。
总之，过去五年发表于CJB的临床研究文献更为广泛。然而，目前的研究表明，许多临床试验设计不当且常常缺乏伦理考量。因此，未来必须通过改进研究方案规划和研究结果的统计分析来提高临床研究质量。
