与转化医学有关的临床研究质量及研究报告质量的评价工具

客观、公正的临床研究是对实验室研究产物临床有效性评价的主要方法,转化医学的发展有赖于高质量的临床研究,也和研究报告的科学表达有关.临床研究质量与研究报告质量虽然在定义上有所不同,但在科学诚信的环境下,两者密切相关,在绝大多数情况下是一致.论文报告质量可从论文外部特征和内部特征进行初步评价.随机研究可采用Jadad量表及Cochrane偏倚风险评价工具等评价,非随机研究可采用偏倚风险评价工具及Newcastle-Ottawa量表等评价.由于Jadad量表存在缺乏隐蔽分组的评估及对盲法评估简单等问题,所以必须增加隐蔽分组的评估.对于随机对照研究的质量,采用Jadad量表结合Schulz隐蔽分组来评价在当前是被国内外主流期刊接受的一组可行的方法.对于非随机研究的队列研究及病例对照研究,采用Newcastle-Ottawa量表评价可能较为合适.

Abstract：

Objective and fair clinical trials are the main methods for assessing the clinical significances of the experimental findings. The development of translational medicine highly relies on high-quality clinical trials as well as trial reports. Although the definition of"quality of clinical trials"and"quality of trial reports"differs from each other, they are closely related and can be consistent in most circumstance in the context of"scientific integrity". The quality of trial reports can be basically assessed by their internal and external properties. The quality of a randomized trial can be assessed by Jadad scale and Cochrane collaboration's tool for assessing risk of bias, and the quality of a non-randomized trial by risk of bias tool and Newcastle-Ottawa scale. However, since Jadad scale lacks appropriate appraisal of allocation concealment and is too simple in evaluating blind method, assessment of allocation concealment should be added. A more widely accepted approach for assessing the quality of random trials is the combination of Jadad scale and Schulz's approach to allocation concealment till recent years.For non-randomized cohort studies and case-control studies, Newcastle-Ottawa scale might be suitable at present time.

Translational medicine-related tools for quality assessments of clinical trials and the trial reports.

Objective and fair clinical trials are the main methods for assessing the clinical significances of the experimental findings. The development of translational medicine highly relies on high-quality clinical trials as well as trial reports. Although the definition of"quality of clinical trials"and"quality of trial reports"differs from each other, they are closely related and can be consistent in most circumstance in the context of"scientific integrity". The quality of trial reports can be basically assessed by their internal and external properties. The quality of a randomized trial can be assessed by Jadad scale and Cochrane collaboration's tool for assessing risk of bias, and the quality of a non-randomized trial by risk of bias tool and Newcastle-Ottawa scale. However, since Jadad scale lacks appropriate appraisal of allocation concealment and is too simple in evaluating blind method, assessment of allocation concealment should be added. A more widely accepted approach for assessing the quality of random trials is the combination of Jadad scale and Schulz's approach to allocation concealment till recent years.For non-randomized cohort studies and case-control studies, Newcastle-Ottawa scale might be suitable at present time.