基于CDASH标准设计的CRF表在改良八式太极拳对中老年脑卒中患者姿势控制中的应用研究

An application research of CRF table designed based on CDASH standard in posture control of middle-aged and elderly stroke patients by modified eight-form Tai Chi

中文关键词: 中老年, 脑卒中, 太极拳, 姿势控制, 临床研究表格, 临床数据采集标准

英文关键词: middle-aged and elderly  stroke  Tai Chi  postural control  clinical research form  clinical data collection standard

中文摘要:

      目的 研究从提升数据采集工具CRF表的质量入手,探讨为脑卒中康复治疗提供高质量循证依据的思路及方法.方法 以2022年8月-12月复旦大学附属华东医院康复科一项改良八式太极拳对中老年脑卒中患者姿势控制的临床研究为对象,设计基于CDASH标准的临床研究表格(CDASH-based CRF).将以往经验构建的传统临床研究表格(Traditional CRF)作为对照,分别从数据收集完整度和编码列表的映射度进行比较分析.结果 与Traditional CRF相比,CDASH-based CRF在CM、EC、MK域的字段中,数据收集完整度(P＜0.05,P＜0.01)较高;H/R、R/C和O类型的字段表现出更高的数据收集完整度(P＜0.01).CDASH-based CRF编码列表的映射度整体高于Traditional CRF.结论 基于CDASH标准设计CRF,有助于康复临床研究数据采集的规范化,具有一定的临床应用价值.

英文摘要:

      Objective To start from improving the quality of data collection tool—the Case Report Form(CRF),and explore the ideas and methods to provide high-quality evidence-based basis for stroke rehabilitation treatment.Methods A clinical study of the modified eight-form Tai Chi on postural control of middle-aged and elderly stroke patients was conducted in Department of Rehabilitation Medicine of Huadong Hospital Affiliated to Fudan University from August to December 2022.A clinical research form(CDASH-based CRF)based on Clinical Data Acquisition Standards Harmonization(CDASH)standard was designed.A traditional clinical study form(traditional CRF)constructed based on previous experience was used as a con-trol.The two tables were compared and analyzed from the aspects of data collection completeness and mapping degree of coding list,respectively.Results Compared with the traditional CRF,the CDASH-based CRF demonstrated higher data collection completeness in the fields of CM,EC and MK domains(P＜0.05,P＜0.01).The data collection completeness was also sig-nificantly higher in the fields of the H/R,R/C,and O type fields(P＜0.01).Overall,the mapping accuracy of coding list of the CDASH-based CRF was higher than that of the traditional CRF.Conclusion The CRF based on CDASH standard is help-ful to the standardization of data collection in rehabilitation clinical research and has certain clinical application value.