背景：由于肿瘤的高致死率，临床中对肿瘤患者的知情往往由家属代替。家属代替知情，存在患者知情同意与有利原则的伦理冲突，同时也损害了患者的隐私权。了解肿瘤患者的知情同意权利的行使现状，对于保护患者的自身利益至关重要。目的：调查肿瘤专科医院患者、患者家属及医护人员的知情情况及其相关因素，分析患者、家属及医护人员是否满意肿瘤患者的知情现状及可能的解决方案，从而有助于我国肿瘤患者更好的行使知情同意权。方法：本研究纳入北京某三甲肿瘤专科医院的住院患者326名、同期患者家属245名、医护人员147名作为研究对象，通过问卷调查及面对面访谈的混合研究方法，了解患者、家属及医护人员的肿瘤知情状况。本研究通过了医院伦理委员会的批准并征得了每一位研究对象的同意。应用SPSS 25.0 软件进行统计分析。结果: 1. 90.8%的肿瘤专科医院的患者对自己病情知情，68.2%为完全知情。2.肿瘤患者的学历、年龄及经济负担是参与医疗决策的影响因素。以下家属：与患者一起居住、年龄超过50岁、经常和患者聊天的家属，患者每月收入2000元以上，家属更容易接受医护直接将病情告知患者，而且在医疗决策中会让患者参与更多。3.肿瘤患者知情以家属替代知情为主，90.2%的患者对目前知情现状满意。患者目前知情现状与患者的意愿无差异。87.8%的患者配合治疗。4.93.9%的医护人员表示需要首先征得家属的同意后，方可告知患者病情。53.7%的医护认为直接告知患者病情很难避免不利后果。36.7%的医护对目前肿瘤患者知情状况不满。5.患者和家属关注的问题不同。患者关注疾病的诊疗情况、更渴望疗效、延长生命。家属关注治疗副作用及疾病带来的痛苦，家属更希望可以减少患者痛苦。结论：目前我国肿瘤专科医院患者的知情现状，符合我国现阶段的国情，肿瘤患者家属在患者的医疗诊疗决策中发挥着重要作用。重视对家属观念的引导需要引起全社会的关注。
Background:Due to the high mortality of cancer, family members often take the place of the cancer patients to be informed in clinical reality. The substitution of informed consent by family members is an ethical conflict between informed consent of patients and the principle of advantage, which also damages the privacy of patients. It is very important to understand the status of informed consent of cancer patients to protect their own interests.Purpose:To investigate the informed status and related factors of cancer patients, their families and medical staffs in an oncology specialized hospital, analyze whether patients, their families and medical staffs are satisfied with the informed status of cancer patients and possible solutions to help the better informed consent status of the cancer patients in China.Methods:In this research, 326 inpatients, 245 family members and 147 medical staffs were enrolled in an oncology hospital in Beijing. Through a mixed research method of questionnaire survey and face-to-face interview to study the informed consent status of cancer patients, family members and medical staffs. The study was approved by the Hospital Ethics Committee and the consent of each study subject was obtained. SPSS 25.0 software was used for statistical analysis.Results:1. 90.8% of patients in the oncology hospital were informed of their own conditions, 68.2% of whom were fully informed .2. Educational background, age and financial burden of tumor patients are the influencing factors for participating in medical decision-making. The following characteristics of patients' family members: live with the patients, over 50 years old and often chat with the patients, and the patients have an income of more than 2000 yuan per month are more likely to accept the medical staffs to directly inform the patients of their illness, and the patients will be more involved in the medical decision-making.3. The information of cancer patients was mainly informed by their family members, and 90.2% of patients were satisfied with the current information. There was no difference between the status and the patients' willingness to be informed of their condition by medical staffs at present. 87.8% of patients cooperated with treatment.4. 93.9% of the medical staffs indicated that the consent of the patient's family should be obtained before informing the patient of his or her illness. 53.7% of doctors and nurses thought it was difficult to avoid adverse consequences by directly informing the patients. 36.7% of doctors and nurses were dissatisfied with the current status of informed consent among cancer patients.5. Patients and their families have different concerns. Patients pay attention to the diagnosis and treatment of the disease and are more eager for curative effect and surviving. The families are concerned about the side effects of treatment and the pain caused by the disease, hoping the less pain of the patients.Conclusions: At present, the informed consent of cancer patients is adapted to China's national conditions. Patients' family members play an important role in patients' medical diagnosis and treatment decisions. Attaching importance to the guidance of the family members should arouse the attention of the whole society.
