临床试验质量管理量化测评体系的建立与验证

Establishment and validation of a quantitative evaluation system for quality management in clinical trials

目的建立和验证临床试验质量管理量化测评体系。方法参考国内外指南,结合本院实践对质量问题进行分类、分级与评分,建立测评体系。用相关性与配对符号秩检验分析重测信度与测试员间可信度。结果用本院临床试验项目验证该体系,同一测试员间隔2周重复判定质量问题,分类的相关系数为0.643~1.000,质量评分、重要和一般级别为0.895以上。不同测试员对分类判定的相关系数为0.616~1.000,质量评分、重要和一般级别为0.828以上。所有判定结果间无显著差异(P>0.05)。严重级别的信度虽不高,但不影响整体判定。结论本研究建立了可信度高的量化测评体系,可为临床试验质量管理提供标准化方法。

AIM To establish and verify a quantitative evaluation system for quality management in clinical trials.METHODS With reference to national and international guidelines in combination with the practice of our hospital,the quality issues of clinical trials were classified,graded and scored.An evaluation system was then established.The testretest reliability and inter-rater reliability were further analyzed by correlation and paired signed-rank tests.RESULTS The evaluation system was validated by the clinical trial projects in our hospital.The quality issues were repeatedly assessed by the rater after a two-week interval.The correlation coefficients in terms of classifications were 0.643-1.000,and the coefficients in terms of quality score,major and minor grades were more than 0.895.Meanwhile,the quality issues were assessed by different raters,with correlation coefficients of 0.616-1.000 for classifications and above 0.828 for quality score,major and minor grades.There was no significant difference between assessments(P>0.05).Although the reliability for the determination of critical grading was not high enough,the overall evaluation was not affected.CONCLUSION This study developed a quantitative evaluation system with high reliabilities,which can provide a standardized method for quality management in clinical trials.