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参与者感知,仍是发展中国家临床研究的一大挑战——一项混合方法研究。

Participant perception, still a major challenge to clinical research in developing countries-A mixed methods study.

机构信息

Department of Medicine, University of Mauritius, Moka, Mauritius.

出版信息

PLoS One. 2020 Jul 30;15(7):e0236563. doi: 10.1371/journal.pone.0236563. eCollection 2020.

Abstract

BACKGROUND

With the introduction of the Clinical Trial Act in 2011, Mauritius has witnessed significant progress in the running of clinical trials. Our aim was to provide insights on the perception of clinical trials among Mauritian citizens and highlight areas of opportunities to address gaps in public perception and awareness.

POPULATION, MATERIALS AND METHODS: A mixed study was carried out which consisted of 2 phases: a qualitative, with thematic approach followed by a quantitative study with cross-sectional design. For the qualitative study, computer literate individuals were invited to fill an unstructured, online open-ended questionnaire. Conclusions derived from the latter were used to adapt a validated questionnaire which was then distributed to 400 consented participants.

RESULTS

There were 23 participants who responded to the online qualitative survey, which showed poor knowledge and diverse views on clinical trials. Quantitatively up to 48% of the participants were not aware of clinical trials which included people of older age group, those from low socioeconomic status and those with low literacy level (p<0.050). Majority of respondents agreed with the value of research while a minority had poor perception related to trust in research companies and conduct of clinical trials. Respondents who had previously engaged in clinical research had better knowledge and perception compared to those who did not participate in one (Odds Ratio = 1.7).

CONCLUSION

This novel study provided a foundation of how Mauritian citizens perceive clinical trials. Public awareness and educational programs can be created to address lack of awareness, the negative perceptions and knowledge gaps of clinical trials among Mauritian citizens.

摘要

背景

2011 年临床试验法的出台,使得毛里求斯在临床试验的开展方面取得了显著进展。我们旨在深入了解毛里求斯公民对临床试验的看法,并强调有机会解决公众对临床试验的看法和意识方面的差距。

人群、材料和方法:开展了一项混合研究,包括 2 个阶段:定性阶段采用主题方法,随后是定量阶段采用横断面设计。在定性研究中,邀请计算机熟练的个体填写非结构化的在线开放式问卷。从后者得出的结论用于改编一份经过验证的问卷,然后分发给 400 名同意的参与者。

结果

有 23 名参与者对在线定性调查做出了回应,调查结果显示他们对临床试验的了解程度较差,且观点各异。定量研究中,高达 48%的参与者不知道临床试验,其中包括年龄较大的人群、社会经济地位较低的人群和文化程度较低的人群(p<0.050)。大多数受访者同意研究的价值,但少数人对研究公司的信任和临床试验的实施持负面看法。与未参与临床试验的人相比,曾参与过临床试验的受访者具有更好的知识和认知(优势比=1.7)。

结论

这项新颖的研究为毛里求斯公民对临床试验的看法提供了基础。可以创建公众意识和教育计划,以解决毛里求斯公民对临床试验的认识不足、负面看法和知识差距的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ec7/7392240/85743be738f9/pone.0236563.g001.jpg

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