肝癌高危人群队列研究的质量控制

QUALITY CONTROL AT HIGH RISK OF LIVER CANCER COHORT STUDY

目的:探讨肝癌(HCC)高危人群队列研究的质量控制体系。方法:采用血清乙肝两对半作为筛查手段,乙肝表面抗原和核心抗体均呈阳性者定义为HCC高危人群,建立HCC高危人群队列并追踪随访,从标准化质量控制文件制定、研究人员培训、具体操作流程及质量反馈4个方面对队列研究进行整体质量控制。结果:截至2014年12月31日,HCC高危人群基础队列规范化参与随访的依从性为20.59%,成功构建HCC高危人群动态队列人群共2 085例,血样本6 021例,确诊HCC 8例。结论:HCC高危人群队列研究质量控制虽已取得一定成果,但仍需进一步加强以提高随访依从性,为后续研究提供可靠的数据资料。

Objective：To investigate the quality control system at high risk of liver cancer （HCC） cohort study. Methods：Serum hepatitis B two pairs of semi means was used for screening. People with positive hepatitis B surface antigen and core antibody was defined as high risk group of HCC. The cohort of HCC high-risk groups was established and followed up. The quality control of the entire cohort was conducted in four aspects： documentation of standardized quality control, training of research staff, specifying opera- tional procedures, and quality feedback. Results：By December 31, 2014, the follow-up compliance of standardized HCC risk groups based queue was 20.59%. A dynamic cohort of HCC high risk groups was successfully constructed, of which there were 2085 cases, 6021 blood samples, and 8 diagnosed HCC cases. Conclusion：Further investigation is need in order to improve the follow-up compliance, which might provide reliable data for future study.