糖尿病足病早期社区筛查及数据库标准建设

Early community screening program of diabetic foot disease and database standard construction

目的探讨糖尿病足病(DFD)早期社区筛查和数据库标准建设经验。方法参考国内外相关领域指南,在多学科专家指导与规范化整理下统一数据元,编制病例报告表(CRF),并在电子数据管理系统(EDC)内建设DFD数据库,根据不同社区(中心)实地调研结果进行岗位分类分配和筛查前统一培训,保证各岗位流水线工作信息实时录入系统,同时监察员实时和抽查质控,例会和总结讨论会及时反馈修订。结果DFD早期筛查指标包括54个子项目共7个表单(基本信息、病史信息、体格检查、实验室检查、辅助检查、生活情况、随访记录);根据表单不同层级分类编制基本信息表、入组信息表和随访信息表3张CRF;根据DFD数据库记录汇总的周围动脉病变、保护性感觉丧失、足部畸形、足部溃疡史、下肢截趾(肢)史和终末期肾脏疾病史信息进行糖尿病高危足风险分级,并根据分级进行不同频率的随访。结论DFD早期社区筛查及数据库建设尚不够成熟,流程较为繁琐,需要不断完善。

Objective To explore and summarize the experience of early screening of diabetic foot disease(DFD)in community and the construction of DFD database standard.Methods Electronic data capture system(EDC)was established to input and collect data to build DFD database,after unifying data elements by referring to domestic and foreign guidelines in related fields under the guidance of multidisciplinary experts and standardized collation,compilation of case report forms(CRF),classification of tasks and unified pre-screening training according to the results of field research in different communities.It had to ensure that the work information from each post-assembly line was input into the EDC in real time,and at the same time,the Clinical Research Associate(CRA)conducted real-time and spot checks for quality control,and regular meetings and summary seminars provided timely feedback and revision.Results In this study,the early screening indicators of DFD included 54 sub-items and 7 forms,which were divided into basic information,medical history information,physical examination,laboratory examination,auxiliary examination,living conditions and follow-up records.According to the different levels of the forms,three CRF were compiled:basic,enrolment and follow-up information form.Information from DFD database such as peripheral artery disease(PAD),loss of protective sensation(LOPS),foot deformity,history of foot ulcer,history of lower limb amputation and history of end-stage renal disease were summarized and used to classify the high risk of diabetic foot,and follow-up was carried out at different frequencies according to the classification.Conclusion The early community screening and database construction of DFD are not mature enough and the process is complicated,which needs to be standardized,adapted to local conditions,simplified and constantly updated.