SARS-CoV-2 疫苗试验参与者的动机是什么?参与前后的调查研究。

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-11-06 DOI:10.1186/s13063-024-08582-z
Olivia A C Lamers, Meta Roestenberg, Martine C de Vries, Marie-Astrid Hoogerwerf
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引用次数: 0

摘要

背景:科学进步,包括新药的测试和许可,在很大程度上依赖于健康人的临床试验。临床试验参与者的动机已被广泛讨论,因为有些人担心经济补偿可能会分散对临床研究内在风险的注意力。在此,我们调查了影响 SARS-CoV-2 临床试验参与者的动机和决策因素。此外,由于大多数调查都是在参与临床试验后进行的,因此我们对调查结果是否会受到回忆偏差的影响很感兴趣:这是一项横断面观察研究。参加者分别在参加临床试验之前和之后接受了两次调查。主要结果是SARS-CoV-2疫苗试验参与者的动机和决策因素,以及参与临床试验前后所收集的调查问卷之间的差异:调查回复率为 149/200(75%)。SARS-CoV-2 疫苗试验参与者的主要动机是希望为科学做出贡献并帮助他人。试验前后收集到的答案没有统计学差异,表明不存在回忆偏差:结论:临床试验参与者的决策过程是复杂和多方面的。以往的研究表明,临床试验参与者的动机不一,但从未达到本次调查报告的程度。在此,我们提出了一个理论框架,试图解释不同的动机因素是如何促成决策形成的。
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What motivates SARS-CoV-2 vaccine trial participants? A pre- and post-participation survey study.

Background: Scientific advancement, including the testing and licensing of new drugs, relies heavily on clinical trials with healthy individuals. The motivations of clinical trial participants have been discussed intensively, as some worry that financial compensation may distract from the intrinsic risk of clinical research. Herein, we investigated the motivations and decisional factors influencing SARS-CoV-2 clinical trial participants. Moreover, since most surveys are administered after clinical trial participation, we were interested in whether the results were tainted by recall bias.

Methods: This was a cross-sectional observational study. Participants were administered a survey on two occasions, once before and once after participation in a clinical trial. The primary outcomes were the motivations and decisional factors of SARS-CoV-2 vaccine trial participants and the difference between the surveys collected before and after clinical trial participation.

Results: The survey response rate was 149/200 (75%). SARS-CoV-2 vaccine trial participants were mostly motivated by the desire to contribute to science and help others. Answers collected before and after the trial were not statistically different, indicating the absence of recall bias.

Conclusion: The decision-making process of clinical trial participants is complex and multi-faceted. Previous studies have shown that clinical trial participants have mixed motivations but never to the extent reported in the current survey. Here, we present a theoretical framework that attempts to explain how different motivational factors may contribute to decision forming.

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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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