中国医疗设备2016，Vol.31Issue(7)：146-148,3.DOI:10.3969/j.issn.1674-1633.2016.07.047
PDCA在我院骨病科医疗器械临床试验知情同意管理中的应用
Application of PDCA in Informed Consent Management in Medical Instrument Clinical Trials in Department of Orthopedics in the Hospital
王磊 1曲新涛 1于秀淳1
作者信息
- 1. 济南军区总医院 骨病科，山东 济南250031
- 折叠
摘要
Abstract
The PDCA (Plan-Do-Check-Action) cycle was utilized in the hospital to carry out special rectiifcation of ICF (Informed Consent Form) in medical instrument clinical trials. Altogether 10 medical instrument clinical trials and 312 ICFs that had been accomplished in Department of Orthopedics in the hospital between January 2011 to December 2012 were selected as Control Group; while, 9 medical instrument clinical trials and 298 ICFs that had been accomplished in Department of Orthopedics in the hospital between January 2013 to December 2014 were selected as Rectification Group. In line with quality evaluation criteria of ICF design and informed consent implementation, the scores of pre-and post-rectiifcation ICF design, informed consent implementation and each element were compared and analyzed. The study result showed feasibility and effectiveness of application of PDCA in special rectiifcation of ICF in medical instrument clinical trials. It could signiifcantly improve informed consent quality of medical instrument clinical trials.关键词
知情同意/医疗器械临床试验/PDCA循环/受试者权益Key words
informed consent/medical instrument clinical trials/plan-do-check-action/rights and interests of the subjects分类
医药卫生引用本文复制引用
王磊,曲新涛,于秀淳..PDCA在我院骨病科医疗器械临床试验知情同意管理中的应用[J].中国医疗设备,2016,31(7):146-148,3.
