Background: Early investigation suggested patients' level of awareness regarding clinical trials was related with willingness to participation. This study was intended to evaluate the level of awareness of cancer patients regarding clinical trials and related influencing factors, and to compare the differences of awareness between patients who attended clinical trials before and not.
Methods: From Jun, 2018 to April, 2019, standardized question-naires were gathered from cancer patients (attended clinical trials vs not attended clinical trials) in our hospital regarding basic information and 10 other questions about awareness. The level of awareness was evaluated and patients were classified into "low cognition" and "high cognition" groups. Logistic regression analysis was performed to determine whether certain characteristics would predict for awareness.
Results: Of the 617 participants, 38.6% have attended clinical trials before. 338 (54.6%) patients had a correct overall understanding of clinical trials, while 44 (7.1%) patients still thought participants were the victim of scientific research. Except for the compensation of medical expenses (51.5% vs 48.7%) and related laws of clinical trials (52.3% vs 45.5%), other parts of understanding were elevated in patients attended clinical trials before comparing with patients who didn't, including significance (86.2% vs 77.6%), risk disclosure (91.2% vs 71.6%), confidentiality (73.2% vs 59.7%), voluntariness (95.8% vs 76.3%), withdrawal (86.6% vs 68.2%) and expenses (62.8% vs 39.2%). The proportion of participants who understand these components did not increase even in 239 patients who had attended clinical trials before. Participants who attended clinical trials before (OR=1.83, 95%CI: 1.11-3.00), unmarried/divorced (OR=5.04, 95%CI: 1.73-14.66), retired (OR=2.53, 95%CI: 1.16-5.50) had a higher level of awareness, while patients who had bad impression with doctors (OR=0.43, 95%CI: 0.26-0.72) had lower awareness.
Conclusions: The current level of awareness for clinical trials of cancer patients in our hospital was relatively low, even in patients who had attended clinical trials before. It's necessary to improve patients' awareness of clinical trial by promoting harmony relationship between patients and doctors, as well as by enhancing related propagation. Strengthening the adequacy and efficacy of informed consent in clinical trials also needs to be achieved in the future.
【中文题目：肿瘤患者对临床试验认知度及其影响因素的调查分析】 【中文摘要：背景与目的 早期研究表明患者对临床试验的认知度是影响其参与度的重要因素。本文主要为掌握中国肿瘤患者临床试验的认知度情况并探索相关影响因素，比较参加过和未参加试验患者认知度差异。方法 2018年6月-2019年4月，采用标准化问卷收集中国医学科学院肿瘤医院肿瘤患者（参加过vs未参加过试验）基本信息、对临床试验整体看法及其他认知相关的10个维度，计算认知度合计得分，重新分为“认知较高组”和“认知较低组”，采用二元Logistics进行认知度的单因素和多因素影响分析。结果 共纳入617例肿瘤患者， 38.6%患者参加过试验。338例（54.6%）对试验整体看法认知正确，但仍有44例（7.1%）患者认为“参与临床试验患者是科学研究的牺牲品”。除外试验补偿维度（51.5% vs 48.7%）和法律法规（52.3% vs 45.5%）维度，参加过试验患者在研究意义（86.2% vs 77.6%）、风险收益告知（91.2% vs 71.6%）、资料保密（73.2% vs 59.7%）、自愿参与（95.8% vs 76.3%）、随时退出（86.6% vs 68.2%）、费用影响（62.8% vs 39.2%）6个维度相比未参加过试验患者认知正确比例均有一定提高。多因素分析结果显示，参加过试验（OR=1.83, 95%CI: 1.11-3.00）、未婚/离异（OR=5.04, 95%CI: 1.73-14.66）、退休（OR=2.53, 95%CI: 1.16-5.50）患者认知度较高，对医务人员印象一般/差（OR=0.43, 95%CI: 0.26-0.72）者认知度较低。结论 我国肿瘤患者对临床试验的认知度较为有限，包括参加过试验患者。促进医患和谐、开展临床试验知识普及对提高患者认知度十分有必要；同时，针对性地加强临床试验知情同意告知的充分性和有效性也是未来工作的重要方向。】 【中文关键词：临床试验；认知度；知情同意；癌症】.
Keywords: Awareness; Cancer; Clinical trial; Informed consent.