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对疫苗安全联邦监管的信任与参与新冠病毒临床试验意愿之间的关系:对费城居民的一项重复测量研究(2021年9月 - 2023年3月)

The relationship between trust in federal oversight of vaccine safety and willingness to participate in COVID-19 clinical trials: a repeated measures study of Philadelphia residents (September 2021 - March 2023).

作者信息

Yu Hyunmin, Bauermeister José, Oyiborhoro Ufuoma, Morales Knashawn, Aryal Subhash, Glanz Karen, Villarruel Antonia, Bonett Stephen

机构信息

School of Nursing, University of Pennsylvania, 418 Curie Blvd, Philadelphia, PA, 19104, USA.

Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA.

出版信息

BMC Public Health. 2024 Jul 31;24(1):2059. doi: 10.1186/s12889-024-19602-7.

DOI:10.1186/s12889-024-19602-7
PMID:39085794
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11290126/
Abstract

BACKGROUND

The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic.

METHODS

We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants' trust in the federal government's oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance).

RESULTS

On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government's oversight of vaccine safety [β = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (β = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (β = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (β = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness.

CONCLUSION

Willingness to participate in clinical trials may be bolstered by strengthening the public's trust in the federal government's role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

摘要

背景

2019年冠状病毒病(COVID-19)大流行促使人们迫切需要开展临床试验以发现安全有效的治疗方法。我们研究了COVID-19经历、对临床试验的认知以及对疫苗安全流程的信任与参与COVID-19临床试验意愿之间的关联。目的是在COVID-19大流行期间的18个月内,调查四个不同时间点上对联邦疫苗安全监管的信任与参与COVID-19治疗临床试验意愿之间的关系。

方法

我们使用了2021年9月至2023年3月期间从582名费城居民中收集的四轮数据(数据缺失率为0.9%)。广义估计方程估计了参与COVID-19临床试验的意愿与参与者对联邦政府对COVID-19疫苗安全监管的信任、COVID-19相关变量(COVID-19相关健康挑战、COVID-19感染史)、对临床试验及其参与方式的认知以及社会人口学特征(年龄、种族/族裔、性取向、性别、父母身份、教育程度和保险)之间的关联。

结果

平均而言,参与COVID-19临床试验的意愿与对联邦政府疫苗安全监管的更高信任呈正相关[β = 0.34,95%置信区间(CI):0.15 - 0.53]、感染过COVID-19(β = 0.40,95% CI:0.08 - 0.73)、对临床试验的认知(β = 0.38,95% CI:0.04 - 0.73)以及对参与方式的了解(β = 0.83,95% CI:0.44 - 1.23)。在社会人口学特征中,种族/族裔(p = 0.001)和性别(p = 0.018)被确定为COVID-19试验意愿的预测因素。

结论

可以通过增强公众对联邦政府在疫苗安全监管中作用的信任、提高临床试验与个人健康和福祉的感知相关性,以及提供量身定制的信息来教育不同社区了解正在进行的试验及其参与方式,从而提高参与临床试验的意愿。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b967/11290126/a524ccd6494e/12889_2024_19602_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b967/11290126/a524ccd6494e/12889_2024_19602_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b967/11290126/a524ccd6494e/12889_2024_19602_Fig1_HTML.jpg

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