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
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
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.
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
Key words
middle-aged and elderly/stroke/Tai Chi/postural control/clinical research form/clinical data collection standard
维普
万方数据