REDCap数据库在嗓音外科临床研究中的初步应用

Preliminary application of REDCap database in clinical research of phonosurgery

目的探索REDCap数据库在嗓音外科临床研究中的作用,探讨其可行性及实用性。方法构建并设计REDCap嗓音疾病数据库结构,采集患者基本资料、个人及职业用声史、相关疾病、体格及电子喉镜检查、嗓音检测分析、嗓音障碍指数量表简化中文版、手术相关资料、病理结果、反流症状指数评分量表和反流体征评分量表。收集每位患者入组、手术、术后1周、术后3周、术后2个月及术后1年6个数据收集点。总结2016年7月~2017年1月首都医科大学附属北京友谊医院REDCap嗓音疾病数据库使用情况。结果 REDCap嗓音疾病数据库包含10张工具表,3个随访模块、6个事件采集点构成,可实现多地点多终端同时输入,可实现医疗数据录入、质控及权限管理,可构建随访工作日历。104例行嗓音疾病患者资料录入到REDCap数据库,102例患者完成术后1周及3周随访,98例患者完成术后2个月随访,失访6例。98例患者临床资料完整无误。结论 REDCap嗓音疾病数据库涵盖了嗓音疾病基本流程,可有效用于嗓音医学研究数据收集、整合,保证了临床资料完整性和及时性,并降低了患者失访率。

Objective To explore the feasibility and practicability of research electronic data capture （REDCap） database in clinical research of phonosurgery. Methods REDCap database was designed and constructed to collect the basic information, personal history and history of professional voice use, related diseases, physical examination, voice assessment, voice handicap index（ Simplified Chinese version）, surgical information, pathological result, reflux symptom index, reflux finding score （RFS）. For each patient, 6 data collection time-points were set, including enrollment, operation, one week, 3 weeks, 2 months and one year after operation. The application of REDCap database in our hospital from July 2016 to Jan. 2017 was summarized. Results Consisted of 10 instrument tables, 3 modules and 6 event time- points, our voice REDCap database was able to achieve simultaneous multiple-ended input of medical data, quality control and authority management. 104 patients were enrolled in our REDCap database. Of them, 102 completed their follow up of one-week and three-week, and 98 completed two-month follow up with all instruments complished. Conclusion With advantages of integrity and timeliness of record, decreased lost rate of follow up, our REDCap database can cover the basic flow and meet demands of clinical research of phonosurgery.