参加基于 COVID-19 环的暴露后预防试验的动机:对参与者经历的定性研究。

IF 3.9 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Julien Brisson, Rebecca Balasa, Andrea Bowra, David C Hill, Aarti S Doshi, Darrell H S Tan, Amaya Perez-Brumer
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引用次数: 0

摘要

背景:环状研究是一种新颖的研究设计,常用于涉及传染病的研究:新感染者的接触者组成一个环,作为干预(如疫苗、暴露后预防)的目标。鉴于该研究设计的新颖性,从参与者处获得他们对基于环的研究的经验反馈至关重要,这有助于未来试验的发展:2021 年,我们在加拿大对 COVID-19 环基暴露后预防试验的成年参与者进行了 26 次半结构化访谈。我们采用了有目的的抽样方法,并通过电子方式招募了 COVID-19 检测呈阳性且同意或拒绝研究小组与其潜在接触者联系的参与者(索引病例)。我们还纳入了在可能暴露于指数病例后参与试验的个人(称为环状成员),以及在可能暴露后拒绝参与试验的个人。半结构式访谈的方法设计允许参与者分享他们在试验中的意见和经验(例如,他们喜欢和不喜欢参与研究的因素):大部分参与者为女性(62%),平均年龄为 37.3 岁(SD = 13.2)。总体而言,参与者对参加环基试验非常满意。值得注意的是,参与者对试验中涉及暴露后接触的设计没有提出实质性的抱怨。最常见的满意原因是知道自己有可能通过增进知识来帮助他人,从而实现更大的目标(例如,开发预防 SARS-CoV-2 感染的潜在治疗方法)。其他原因包括对参与试验的好奇心,以及在大流行期间填补空闲时间的活动。不喜欢试验的一个主要原因是对试验说明(如在家独立进行 SARS-CoV-2 检测)感到困惑。此外,保密也是参与者非常关心的一个问题,他们希望得到保证,他们的数据不会在研究范围之外被共享:我们的研究结果有可能为未来的研究提供参考,包括临床试验,如基于环的研究,将参与者的经验纳入研究方案的制定中。尽管存在一些与方案相关的挑战,但参与者在推动科学发展和帮助他人的愿望驱使下表示非常满意。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Motivations for enrollment in a COVID-19 ring-based post-exposure prophylaxis trial: qualitative examination of participant experiences.

Background: Ring-based studies are a novel research design commonly used for research involving infectious diseases: contacts of newly infected individuals form a ring that is targeted for interventions (e.g., vaccine, post-exposure prophylaxis). Given the novelty of the research design, it is critical to obtain feedback from participants on their experiences with ring-based studies to help with the development of future trials.

Methods: In 2021, we conducted 26 semi-structured interviews with adult participants of a COVID-19 ring-based post-exposure prophylaxis trial based in Canada. We applied a purposive sampling approach and electronically recruited participants who tested positive for COVID-19 (Index Cases) and either agreed or declined for the study team to contact their potentially exposed contacts. We also included individuals who participated in the trial after being potentially exposed to an Index Case (known as Ring Members), and those who declined to participate after potential exposure. The methodological design of semi-structured interviews allowed participants to share their opinions and experiences in the trial (e.g., elements they enjoyed and disliked regarding their participation in the study).

Results: The majority of participants in our study were women (62%) and the average age was 37.3 years (SD = 13.2). Overall, participants reported being highly satisfied with partaking in the ring-based trial. Notably, no substantial complaints were voiced about the trial's design involving contact after exposure. The most common reason of satisfaction was the knowledge of potentially helping others by advancing knowledge for a greater cause (e.g., development of potential treatment to prevent SARS-CoV-2 infection). Other reasons were curiosity about participating in a trial, and an activity to fill free time during the pandemic. A central element of dislike was confusion about instructions with the trial (e.g., independent at home SARS-CoV-2 testing). Additionally, maintaining confidentiality was a crucial concern for participants, who sought assurance that their data would not be shared beyond the scope of the study.

Conclusions: Our results have the potential to inform future research, including clinical trials such as ring-based studies, by incorporating insights from participants' experiences into the development of study protocols. Despite some protocol-related challenges, participants expressed high satisfaction, driven by the desire to advance science and potentially aid others.

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来源期刊
BMC Medical Research Methodology
BMC Medical Research Methodology 医学-卫生保健
CiteScore
6.50
自引率
2.50%
发文量
298
审稿时长
3-8 weeks
期刊介绍: BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
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