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学科主题: 护理学
题名:
健康志愿者与住院患者对临床研究的认知及其相关因素的研究
作者: 魏豫东
答辩日期: 2013-12-31
导师: 孙玉梅
专业: 护理学
授予单位: 北京大学
授予地点: 北京大学护理学院
学位: 硕士
关键词: 健康志愿者 ; 住院患者 ; 临床研究 ; 认知
其他题名: A Study on Perception of Healthy Volunteers and Inpatients towards Clinical Research and Other Relevant Factors
分类号: R395
摘要:

目的

       了解健康志愿者和住院患者对临床研究的认知及参与意愿,分析健康志愿者和住院患者对临床研究认知的影响因素,分析住院患者临床研究参与意愿的影响因素,为提高健康志愿者和住院患者对临床研究的认知和参与意愿提供建议。

方法

       本研究采用方便取样,分别选取北京市某三甲医院药物临床试验机构100例曾参与I期临床研究的健康志愿者和北京市某三甲医院200例住院患者,采用美国杜克大学设计的PARTAKEPublic Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)问卷就有关对临床研究的认知及参与意愿等进行问卷调查。

结果

1100例健康志愿者均听说过临床研究,其中99.0%知道“临床研究是做什么的”,其听说临床研究主要是通过朋友(68.0%)、互联网(17.0%)等途径;200例住院患者中,66.0%听说过临床研究,37.5%知道“临床研究是做什么的”,其听说临床研究主要是通过媒体(38.1%)、医生(31.1%)等途径。

2健康志愿者和住院患者对于临床研究的意义及必要性的认可比例较高:“临床研究对社会有益”(96.0%87.0%)、“临床研究是开发新的治疗方法的必经环节”(94.0%82.0%)、“人体试验对于开发新的治疗方法是必要的”(91.0%68.5%),其中健康志愿者的认可比例高于住院患者,差异有统计学意义(P0.05);而两者对于“利他主义是参与研究的唯一理由”的认可比例均较低(分别为20.0%15.5%),其差异无统计学意义(P0.05);两者对多数临床研究受试者保护性的问题认可比例较高:“参与临床研究完全是自愿”(98.0%82.0%)、“研究参与者的个人信息得到了充分的保护”(98.0%79.5%)、“对于研究参与者来说,保密是一件非常重要的事情”(96.0%84.5%),而在“在临床试验中发生的伤害事件,肯定是由于试验治疗造成的”(18.0%17.5%);“医生强迫病人参加研究”(1.0%2.5%)、“研究人员会像对待试验中的动物一样对待参与临床研究的志愿者(“人类小白鼠”)”(8.0%9.5%)等问题的认可比例较低;在对临床研究各参与方的态度方面:“学术机构提供的临床研究信息是可信的”的认可比例较高(87.0%58.0%),而对“媒体正确的报道了临床研究”的认可比例较低(35.0%31.5%)。

3、卡方检验显示,不同文化程度及收入的健康志愿者在对临床研究的认知方面差异有统计学意义(P0.05);而不同年龄段、性别的健康志愿者对临床研究认知的各条目之间差异均无统计学意义(P0.05)。不同年龄段、收入、工作情况、科别、是否知道临床研究的住院患者对临床研究的认知差异有统计学意义(P0.05);不同性别、文化程度的住院患者对临床研究认知之间的差异无统计学意义(P0.05)。

499.0%的健康志愿者表示愿意参加临床研究;56.3%的住院患者表示愿意参加临床研究。住院患者不愿意参加临床研究的主要原因是年龄太大(12.0%)、没足够时间或精力(11.0%)、不了解(10.0%)等。

5、卡方检验显示,住院患者对临床研究的认知与其临床研究的参与意愿有关P0.05);未发现住院患者的年龄、性别、收入、文化程度、工作情况、是否知道临床研究与其临床研究参与意愿的关系(P0.05)。

6、健康志愿者SCL-90症状自评量表平均阳性症状数为(10.25±14.39),显著低于国内常模阳性症状数(24.92±18.41),差异有统计学意义(P0.05)。各因子的评分数均低于国内常模(P0.05)。

7、健康志愿者艾森克人格问卷E得分(4.82±2.48)和N得分(7.07±5.20)低于国内常模P0.05P得分(12.85±4.26)和L得分(13.58±4.18)高于国内常模P0.05

结论

1、健康志愿者参与临床研究的意愿很强,对于临床研究的大部分问题有正确的认知,但对于临床研究中伤害赔偿的问题的认知有所不足。

2、住院患者对于临床研究的认知及参与意愿尚有待提高,尤其是对受试者保护问题的认识有所欠缺。

3、社会人口学因素对健康志愿者和住院患者对临床研究的认知有一定影响。在今后的工作中,可针对不同类型人群的认知特点,进行相应的干预。

4、住院患者对临床研究的认知程度与其参与临床研究的意愿相关,通过提高住院患者对临床研究的认知程度,有助于提高临床研究志愿者的征募成功率,从而降低临床研究可能存在的选择偏倚,进一步提高临床研究的效率。

英文摘要:

Objective:

Understand the perception of healthy volunteers and inpatients and their participation willingness towards Clinical Research; discuss the influencing factors of their perception; discuss the influencing factors of participation willingness of inpatients; provide suggestions for improving the perception level and their participation willingness.

Methods:

A convenient sampling is used in this study by choosing 100 healthy volunteers who has participated Phase I Clinical Research from a top three hospital’s drug clinical trial institution in Beijing, and 200 inpatients in this hospital, respectively. PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment) questionnaire which was designed by Duke University was used to investigate the perception and participation willingness towards Clinical Research.

Results:

1. Among 100 healthy volunteers, all heard Clinical Research and 99.0% knew the purposes of Clinical Research through their friends (68.0%), internet (17.0%), etc. Among 200 inpatients, 66.0% heard Clinical Research and 37.5% knew Clinical Research through media (38.1%), doctors (31.1%), etc.

2. A high percentage of healthy volunteers and inpatients accept the significance and

necessity of Clinical Research (data are reported by healthy volunteers and inpatients’ percentage): Clinical Research benefits society (96.0% and 87.0%); Clinical Research is necessary to develop new therapeutic methods (94.0% and 82.0%); human clinical trial is necessary to develop new therapeutic methods (91.0% and 68.5%), a higher percentage of healthy volunteers was obtained than that of inpatients (P<0.05); altruism is the only reason to participate research (20.0% and 15.0%) (P>0.05); participation of research is completely voluntary (98.0% and 82.0%); personal information of participants are fully protected (98.0% and 79.5%); confidentiality is a very important thing to participants (96.0% and 84.5%); the harmful events occurred in clinical trial result from the research (18.0% and 17.5%); patients were foced to participate research (1.0% and 2.5%);volunteers will be treated like animals “human guinea pig” in research (8.0% and 9.5%); information provided by academic institutions is credible (87.0% and 58.0%); medias report Clinical Research correctly (35.0% and 31.5%).

3. The Chi-square test shows that healthy volunteers’ perception towards Clinical Research is affected by the degree of education and level of income (P<0.05), other than age and gender (P>0.05); inpatients’ perception towards Clinical Research is affected by age, income, department, working situation (P<0.05), other than gender and degree of education (P>0.05).

4. 99.0% of healthy volunteers and 56.3% of inpatients are willing to participate in Clinical Research. The reasons why inpatients are not willing to participate are aging (12.0%), lack of time or energy (11.0%) and lack of understanding (10.0%).

5. Chi-square test indicates that the participation willingness of healthy volunteers (P<0.05) is affected by the perception towards Clinical Research, other than age, gender, income, degree of education, working situation, knowledge of Clinical Research (P>0.05).

6. SCL-90 positive symptoms of healthy volunteers (10.25±14.39) and factor scores were lower than that in china.

7. Healthy volunteers’ scores of Eysenck Personality Questionnaire: E, P scores were

lower than the standard in china (P<0.05); P, L scores were higher than the standard in china (P<0.05).

Conclusions

1. Healthy volunteers have a very strong willingness to participate Clinical Research and they have correct judgment to most problems in Clinical Research. However, their awareness to the compensation for damage in Clinical Research is insufficient.

2. The inpatients’ perception towards Clinical Research is insufficient, especially for the protection of volunteers.

3. Social and demographic factors have effects on the degree of perception of the healthy volunteers and the inpatients. According to the perception characteristics of different types of people, appropriate interventions should be applied in the future work.

4. The inpatients’ degree of perception towards clinical research is related to their willingness to participate in clinical trials. Improving the hospitalized patients’ perception to Clinical Research can help to improve the success rate of recruiting clinical study participants, which thereby reduces the possible selection bias in clinical research and further improves the efficiency of clinical research.

语种: 中文
相关网址: 查看原文
内容类型: 学位论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/108180
Appears in Collections:北京大学护理学院_学位论文

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作者单位: 北京大学护理学院

Recommended Citation:
魏豫东. 健康志愿者与住院患者对临床研究的认知及其相关因素的研究[D]. 北京大学护理学院. 北京大学. 2013.
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