[1]赵娜萍,高 越,王 昊,等.公众对健康受试者认知度和参与意愿的调查[J].医学信息,2024,37(10):50-57.[doi:10.3969/j.issn.1006-1959.2024.10.010]
　ZHAO Na-ping,GAO Yue,WANG Hao,et al.A Survey of Public Awareness and Willingness to Participate in Healthy Subjects[J].Journal of Medical Information,2024,37(10):50-57.[doi:10.3969/j.issn.1006-1959.2024.10.010]
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公众对健康受试者认知度和参与意愿的调查()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
37卷
期数:
2024年10期
页码:
50-57
栏目:
公共卫生信息学
出版日期:
2024-05-15

文章信息/Info

Title:
A Survey of Public Awareness and Willingness to Participate in Healthy Subjects
文章编号:
1006-1959（2024）10-0050-08
作者:
赵娜萍; 高 越; 王 昊; 等
（1.海军军医大学第一附属医院临床研究中心，上海 200433；2.上海健康医学院护理与健康管理学院，上海 201318）
Author(s):
ZHAO Na-ping; GAO Yue; WANG Hao; et al.
(1.Clinical Research Center,the First Affiliated Hospital of Naval Military Medical University,Shanghai,200433,China; 2.School of Nursing and Health Management,Shanghai University of Medicine & Health Sciences,Shanghai 201318,China)
关键词:
健康受试者; 药物Ⅰ期临床试验; 认知度; 参与意愿
Keywords:
Health subjects; Phase Ⅰ clinical trial of drugs; Awareness; Paiticipation willingness
分类号:
R197.32
DOI:
10.3969/j.issn.1006-1959.2024.10.010
文献标志码:
A
摘要:
目的 了解公众对健康受试者的认知和参与意愿，为更好地开展和推动药物临床试验高质量发展提供参考。方法 于2022年4月-5月，在海军军医大学第一附属医院通过问卷星调查公众对健康受试者认知程度和参与意愿，结果采用SPSS 23.0软件进行统计分析。结果 调查回收有效问卷448份，有86.16%被调查者对健康受试者有较好的认知，不同认知程度的被调查者在学历、经济压力、年收入、医疗保险以及对研究者信任度比较，差异有统计学意义（P＜0.05）。被调查者中愿意成为健康受试者的仅占15.18%，其主要动机是为医学事业做出贡献（67.65%）和帮助患者获取新的诊疗方法（52.94%）。不愿意成为健康受试者的占52.46%，拒绝的首要原因是怕父母家人担心（74.04%），其次是药物副作用（64.68%），但将试验的经济补偿提高至健康受试者心里预期时，41.70%的不愿意者改变态度选择同意。另有32.36%的被调查者持不确定态度，主要原因是担心药物副作用（80.69%），其次是不知道伤害发生后的保障措施（67.59%）和不了解试验内容（61.38%），但在家庭支持下，78.62%的不确定者也会选择同意。不同参与意愿的被调查者在年龄、民族以及对研究者信任度比较，差异有统计学意义（P＜0.05）。结论 公众对健康受试者的总体认知度较高，但参与意愿偏低。学历、经济压力、年收入、医疗保险待遇以及对研究者信任度是影响公众对健康受试者认知度的人口学因素。影响公众参与意愿的原因包括父母家人的态度、药物副作用、经济补偿、临床试验内容和风险措施等，其中家庭因素和药物安全因素是公众考虑的重要因素。年龄、民族和对研究者信任度是影响公众参与健康受试者的人口学因素。应契合公众需求，开展针对性的药物临床试验科普教育，发挥家庭因素在健康受试者活动中的作用，完善健康受试者权益保护的相关立法，提高我国公众参与药物临床试验的积极性。
Abstract:
Objective To understand the public awareness and willingness to participate in healthy subjects, and to provide reference for better carrying out and promoting the high-quality development of drug clinical trials.Methods From April to May 2022, a questionnaire survey was conducted in the First Affiliated Hospital of Naval Medical University to investigate the public awareness and willingness to participate in healthy subjects. The results were analyzed by SPSS 23.0 software.Results A total of 448 valid questionnaires were collected. 86.16% of the respondents had a good understanding of the healthy subjects. There were statistically significant differences in educational background, economic pressure, annual income, medical insurance and trust in the researchers among the respondents with different level of perception（P<0.05）.Only 15.18% of the respondents were willing to become healthy subjects, 67.65% of whom were primarily motivated by wanting to contribute to medicine and 52.94% of whom were primarily motivated by helping patients obtain new diagnosis and treatment methods. 52.46% of the respondents were unwilling to become healthy subjects, 74.04% of whom mainly for the family worried, followed by 64.68% of whom mainly for the side effects of drugs. However, when the financial compensation of the trial was increased to the psychological expectation of respondents, 41.70% of the unwilling subjects changed their attitudes and agreed. Another 32.36% of the respondents held an uncertain attitude, 80.69% of whom were because of worried about drug side effects, 67.59% and 61.38% of whom were because of that the safeguard measures after the injury and they did not know the test content, respectively. However, when their parents and family supported their participation, 78.62% of the uncertain people would also choose to agree. There were significant differences in age, nationality and trust in researchers among the respondents with different willingness to participate（P<0.05）. Conclusion The public’s overall awareness of healthy subjects is high, but their willingness to participate is low. Educational background, economic pressure, annual income, medical insurance benefits and trust in researchers are the demographic factors that affect the public perception of healthy subjects. The reasons that affect the willingness of the public to participate include: the attitude of family members, drug side effects, economic compensation, clinical trial content and risk measures, among which family factors and drug safety factors are important factors for the public to consider. Age, nationality and trust in researchers are the demographic factors that affect public participation in healthy subjects. The targeted popular science education on drug clinical trials should be undertaken based on the public needs, to make family factors play a role in healthy subject activity, improve the legislation on the protection of the rights and interests of healthy subjects in China, and improve the enthusiasm of the public to participate in drug clinical trials.

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更新日期/Last Update: 1900-01-01