临床科研项目设计与分析环节的方法学质量研究

摘要

Objective Clinical research is a critical procedure for the development of medicine.Reliability of the clinical research finding is determined by the quality of study design and analysis courses.It will also further impact the guideline development and clinical practice.This study was focus on the evaluation of clinical research quality during its whole process.Methods Subjects of this study were the clinical summary reports from a government funded project which were submitted in 2016.Standardized data collecting form had been used to capture the key features regarding to the quality of study design and data analysis.After the review of data accuracy,descriptive analysis had been carried to interpret the observed findings both for design and analysis aspects.Results There were 67 project summary reports included in our analysis.The top three investigated therapeutic areas were oncology,cardiovascular/cerebrovascular diseases and orthopedics (19.4 ％,11.9 ％ and 11.9 ％).Most of studies fulfilled the evaluation criteria according to their original plan.94 ％ studies were strictly compliance with the original protocol with no interim amendment.Meanwhile,the report on sample size determination and appropriate use of multi-variable analysis should be improved.Conclusions Usually,clinical research program can fulfill the evaluate goal according to funding requirements.But the methodology quality should be paid more attention.It is highly suggested to cooperate with the professional statistical team and do continuous improvement effort to enhance the validity of study findings.%目的 临床研究是医学发展与进步的重要环节,临床研究的设计与分析质量决定其结果的可靠性,并进一步影响到诊疗指南的制定与临床实践的开展,本研究针对国内临床研究开展过程中的质量进行分析与评价.方法 以2016年结题的首都临床特色应用研究为基础,将课题组所提交的正式结题报告为研究对象,制定标准化的信息提取表格,对课题的试验设计与结果分析质量相关的特征指标进行提取,再对数据准确性进行复合的基础上,描述性分析课题的特征、设计与统计特点,对方法学相关内容进行评价.结果 共有67项课题被纳人本次分析,这些研究的主要治疗领域主要集中在肿瘤、心脑血管和骨科(19.4％、11.9％和11.9％),所评价的课题基本能够完成任务书中的考核指标并有相应的科研产出,其中94％的项目能够严格遵照原任务书计划开展研究,同时,也发现科研课题在样本量设计与多因素分析方法使用上有一定的改善空间.结论 临床科研项目在完成结题任务要求的同时,应更加关注方法学质量,建议与专业方法学团队合作共同开展持续性的促进工作,为科研成果的质量提供保障.