摘要
目的 了解肿瘤患者对临床研究及相关伦理知识的认识程度,为提高患者对临床研究认识采取相应的对策奠定 基础。方法 对武汉大学中南医院肿瘤放化疗科住院治疗的肿瘤患者随机进行问卷调查,对调查结果统计分析。结果 发 放调查问卷90 份,有效问卷为81 份,回收率为95.6%。96.30%(78/81)的患者表示想要知晓自身病情,且在知晓病 情的情况下,仍有75.31% 的患者认为自己有治愈的希望。目前,仍有70.37%(57/81)的患者对临床研究是否有益持 怀疑态度。在调查的所有肿瘤患者中,对临床研究的参与意愿仅为40.7%。82.72%(67/81)的患者对签署知情同意书 持没必要、无所谓或不知道态度。多因素分析显示,受教育程度的高低是影响患者对临床试验了解程度的重要因素(P < 0.05,OR=2.559,95%CI=1.037~6.314),差异具有统计学意义。年龄因素影响患者对知情权的要求程度(P < 0.05, OR=3.450,95%CI=1.684~7.067)。结论 目前住院肿瘤患者有强烈的病情知晓需求,对临床研究及相关伦理知识认识欠缺。 应在肿瘤患者治疗群体中扩大对临床研究及其伦理内容的宣传与讲解,强调临床研究伦理审查的意义及对受试者的保护作 用,提高肿瘤患者参与临床研究的意愿与参与度。
Abstract
Objective To investigate the level of awareness of cancer patients on clinical research and related ethical knowledge, so as to lay the foundation for improving patients’ understanding of clinical research. Methods A random questionnaire survey was conducted among cancer patients in the department of oncology and radiotherapy in Zhongnan Hospital of Wuhan University, and make a statistical analysis of the results. Results A total of 90 questionnaires were issued, of which 81 were valid questionnaires, with a recovery rate of 95.6%. 96.30% (78/81) of the patients indicated that they wanted to know their condition, and 75.31% of them believed that they had the hope of cure when they were aware of the disease. At present, 70.37% (57/81) of patients were still sceptical about whether the clinical research is beneficial or not. Among all the cancer patients surveyed, the willingness to participate in clinical research was only 40.7%. 82.72% (67/81) of the patients believed that signing the informed consent was unnecessary or indifferent. Multifactor analysis showed that the degree of education was an important factor affecting the patients’ understanding of clinical trials (P<0.05, OR=2.559, 95%CI=1.037~6.314), and the difference was statistically significant. Age factor affected patients’ demand for the right of informed consent (P<0.05, OR=3.450, 95%CI=1.684~7.067). Conclusions At present, hospitalized cancer patients have strong demands o know their conditions, but they lack the knowledge of clinical research and related ethical knowledge. The publicity and explanation of clinical research and its ethical content in the treatment group of cancer patients should be expanded. The significance of the ethical review of clinical research and the protection of the subjects should be emphasized to improve the willingness of the cancer patients to participate in the clinical study.
关键词
肿瘤 /
临床试验 /
伦理审查 /
知情同意
Key words
Cancer /
Clinic trial /
Ethical review /
Informed consent
魏艳,彭晋,柳麒,周福祥.
对肿瘤患者临床研究认识的调查与思考[J]. 肿瘤代谢与营养电子杂志. 2018, 5(2): 179-183
WEI Yan, PENG Jin, LIU Qi, ZHOU Fu-xiang.
Investigation and consideration of cancer patients’ understanding of clinical research[J]. Electronic Journal of Metabolism and Nutrition of Cancer. 2018, 5(2): 179-183
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