医疗知情同意书的医疗告知现状调查及评价

Investigation and Evaluation of the Present Situation of Medical Informed Consent

目的了解目前医院手术、特殊检查、特殊治疗知情同意书的医疗告知现状,评价其合法性与合理性,并提出改进建议。方法以《侵权责任法》第55条为依据,采用美国医学会建议的医疗告知标准制订评价指标,对2012年2～5月广西区人民医院的270份及北京大学人民医院《医疗知情同意书汇编》中的331份手术、特殊检查、特殊治疗知情同意书的医疗告知内容、知情同意书格式特征进行调查分析。结果广西区医院及北大医院的手术、特殊检查、特殊治疗知情同意书均存在医疗告知内容不完整和缺项现象;两院对替代医疗方案的告知率均较低,分别为18.52%、4.83%;两院均未告知替代医疗方案的风险、效益以及不接受医疗建议的效益;两院均有部分知情同意书没有告知患者疾病的诊断及拟定医疗方案的性质、目的;在拟定医疗方案的效益告知率两院均不足30%;广西区医院对不接受医疗建议的风险的告知率仅为12.22%,北大医院为48.94%,广西区医院有4.44%没有告知拟定医疗方案的风险。北大医院知情同意书的5项格式特征的合格率均高于广西区医院(P均<0.05)。结论我国现行手术、特殊检查、特殊治疗知情同意书普遍存在告知内容不完整及缺项现象,与当前法律规定及医学伦理原则的要求仍有较大差距,有待进一步完善和改进。

Objective To explore the present situation of medical informed consent on the operation, special examination and special treatment in the hospital, and evaluate its legitimacy and rationality, and put forward some suggestions for improvement. Methods A survey on the medical informed contents and format characteristics of medical informed consent on operation, special examination and special treatment was conducted on the basis of Article 55 of Tort Liability Law. Medical inform standards evaluation indices recommended by the American Medical Association were used in the survey. Two hundred and seventy medical informed consents （Feb. to May in 2012） from the People＇s Hospital of Guangxi Zhuang Autonomous Region（ abbreviated as Guangxi Hospital） and 331 medical informed consents from A Compilation of Medical Informed Consent of the People＇s Hospital of Peking University （abbreviated as Peking University Hospital） were analyzed. Results No complete medical inform content and incomplete items could be found in the medical informed consents on operation, special examination,special treatment Jn both hospitals;18.52% of patients in Guangxi Hospital were informed the alternative medical scheme while 4. 83% in Peking University Hospital,the awareness rates were low in both hospitals;Patients didn＇t be informed the risks, benefits of alternative medical scheme and benefits of rejection of medical advice;There were some informed consents in which the diagnosis of disease and the properties and purpose of medical scheme didn＇t be mentioned in both hospitals;Less than 30% of patients in two hospitals were informed the medical scheme benefits ; 12.22% of patients were irdbrmed the risks of rejection of medical advice in Guangxi Hospital while 48.94% in Peking University Hospital,there were 4.44% of patients didn＇t be informed the risks of medical scheme in Guangxi Hospital. The qualified rates of 5 format characteristics of informed consent in Peking University Hospital were higher than those in Guangxi Hospital（all P 〈 0.05）. Conclusion No complete medical inform content and incomplete items in the current informed consent on operation, special examination and special treatment exists generally in China. Further perfection and improvement is needed to meet the requirement of the current legal provisions and principles of medical ethics.