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大流行或传染病背景下疫苗试验招募的影响因素:定性证据综合。

Factors that impact on recruitment to vaccine trials in the context of a pandemic or epidemic: a qualitative evidence synthesis.

机构信息

Department of Nursing and Midwifery, University of Limerick, Limerick, Ireland.

School of Nursing and Midwifery, National University of Ireland, Galway, Galway, Ireland.

出版信息

Cochrane Database Syst Rev. 2023 Sep 1;9(9):MR000065. doi: 10.1002/14651858.MR000065.pub2.


DOI:10.1002/14651858.MR000065.pub2
PMID:37655964
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10472890/
Abstract

BACKGROUND: The World Health Organization declared the COVID-19 pandemic on 11 March 2020. Vaccine development and deployment were swiftly prioritised as a method to manage and control disease spread. The development of an effective vaccine relies on people's participation in randomised trials. Recruitment to vaccine trials is particularly challenging as it involves healthy volunteers who may have concerns around the potential risks and benefits associated with rapidly developed vaccines. OBJECTIVES: To explore the factors that influence a person's decision to participate in a vaccine trial in the context of a pandemic or epidemic. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was June 2021. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored the perspectives of adults aged 18 years or older who were invited to take part in vaccine trials in the context of a pandemic or epidemic. DATA COLLECTION AND ANALYSIS: We assessed the title, abstracts and full texts identified by the search. We used a sampling frame to identify data-rich studies that represented a range of diseases and geographical spread. We used QSR NVivo to manage extracted data. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool for qualitative studies. We used the 'best-fit framework approach' to analyse and synthesise the evidence from our included studies. We then used the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) assessment to assess our confidence in each finding and develop implications for practice. MAIN RESULTS: We included 34 studies in our review. Most studies related to HIV vaccine trials. The other studies related to Ebola virus, tuberculosis, Zika virus and COVID-19. We developed 20 key findings, under three broad themes (with seven subthemes), that described the factors that people consider when deciding whether to take part in a vaccine trial for a pandemic or epidemic disease. Our GRADE-CERQual confidence was high in nine of the key findings, moderate in 10 key findings and low in one key finding. The main reason for downgrading review findings were concerns regarding the relevance and adequacy of the underlying data. As a result of the over-representation of HIV studies, our GRADE-CERQual assessment of some findings was downgraded in terms of relevance because the views described may not reflect those of people regarding vaccine trials for other pandemic or epidemic diseases. Adequacy relates to the degree of richness and quantity of data supporting a review finding. Moderate concerns about adequacy resulted in a downgrading of some review findings. Some factors were considered to be under the control of the trial team. These included how trial information was communicated and the inclusion of people in the community to help with trial information dissemination. Aspects of trial design were also considered under control of the trial team and included convenience of participation, provision of financial incentives and access to additional support services for those taking part in the trial. Other factors influencing people's decision to take part could be personal, from family, friends or wider society. From a personal perceptive, people had concerns about vaccine side effects, vaccine efficacy and possible impact on their daily lives (carer responsibilities, work, etc.). People were also influenced by their families, and the impact participation may have on relationships. The fear of stigma from society influenced the decision to take part. Also, from a societal perspective, the level of trust in governments' involvement in research and trial may influence a person's decision. Finally, the perceived rewards, both personal and societal, were influencing factors on the decision to participate. Personal rewards included access to a vaccine, improved health and improved disease knowledge, and a return to normality in the context of a pandemic or epidemic. Potential societal rewards included helping the community and contributing to science, often motivated by the memories of family and friends who had died from the disease. AUTHORS' CONCLUSIONS: This review identifies many of the factors that influence a person's decision to take part in a vaccine trial, and these reflect findings from reviews that examine trials more broadly. However, we also recognise some factors that become more important in connection with a vaccine trial in the context of a pandemic or epidemic. These factors include the potential stigma of taking part, the possible adverse effects of a vaccine, the added motivation for helping society, the role of community leaders in trial dissemination, and the level of trust placed in governments and companies developing vaccines. These specific influences need to be considered by trial teams when designing, and communicating about, vaccine trials in the context of a pandemic or epidemic.

摘要

背景:世界卫生组织于 2020 年 3 月 11 日宣布 COVID-19 大流行。疫苗的开发和部署被迅速提上日程,作为管理和控制疾病传播的一种方法。有效疫苗的开发依赖于人们参与随机试验。由于涉及可能对快速开发的疫苗的潜在风险和益处有顾虑的健康志愿者,因此疫苗试验的招募极具挑战性。

目的:探讨在大流行或流行期间,影响一个人参与疫苗试验的决定的因素。

检索方法:我们使用了标准的、广泛的 Cochrane 检索方法。最新的检索日期是 2021 年 6 月。

选择标准:我们纳入了定性研究和混合方法研究,其中包含可识别的定性部分。我们纳入了在大流行或流行期间被邀请参加疫苗试验的 18 岁及以上成年人的观点的研究。

数据收集与分析:我们评估了搜索结果的标题、摘要和全文。我们使用抽样框架来确定代表不同疾病和地理分布的具有丰富数据的研究。我们使用 QSR NVivo 来管理提取的数据。我们使用定性研究的适应版 Critical Skills Appraisal Programme (CASP) 工具来评估方法学局限性。我们使用“最佳拟合框架方法”来分析和综合我们纳入研究的证据。然后,我们使用 Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) 评估来评估我们对每个发现的信心,并制定对实践的影响。

主要结果:我们的综述纳入了 34 项研究。大多数研究与 HIV 疫苗试验有关。其他研究与埃博拉病毒、结核病、寨卡病毒和 COVID-19 有关。我们确定了 20 个关键发现,分为三个广泛的主题(七个子主题),描述了人们在决定是否参加大流行或传染病疫苗试验时考虑的因素。我们对九个关键发现的信心很高,对十个关键发现的信心为中等,对一个关键发现的信心较低。降低审查结果可信度的主要原因是对基础数据的相关性和充分性的担忧。由于 HIV 研究的代表性过高,我们对一些发现的 GRADE-CERQual 评估因描述的观点可能与人们对其他大流行或传染病疫苗试验的看法不一致而降级。充分性涉及支持审查发现的数据的丰富程度和数量。对充分性的适度关注导致一些审查结果的降级。有些因素被认为是试验团队可以控制的。这些因素包括试验信息的沟通方式以及社区中帮助试验信息传播的人员。试验设计的某些方面也被认为是在试验团队的控制之下,包括参与的便利性、提供经济奖励以及为参与试验的人员提供额外的支持服务。影响人们参与决定的其他因素可能来自个人、家庭、朋友或更广泛的社会。从个人的角度来看,人们对疫苗的副作用、疫苗的功效以及对日常生活的可能影响(照顾责任、工作等)表示担忧。人们还受到家庭的影响,以及参与研究可能对人际关系产生的影响。来自社会的耻辱感也影响了参与的决定。此外,从社会的角度来看,人们对政府参与研究和试验的信任程度可能会影响一个人的决定。最后,个人和社会的潜在回报是参与决定的影响因素。个人回报包括获得疫苗、改善健康和提高疾病知识,以及在大流行或流行期间恢复正常生活。潜在的社会回报包括帮助社区和为科学做出贡献,这通常是受到死于该疾病的家人和朋友的记忆的激励。

作者结论:本综述确定了许多影响一个人参与疫苗试验的决定的因素,这些因素反映了更广泛地研究试验的综述结果。然而,我们也认识到在大流行或流行期间,疫苗试验中一些因素变得更加重要。这些因素包括参与的潜在耻辱感、疫苗的可能副作用、帮助社会的额外动机、社区领导人在试验传播中的作用以及对开发疫苗的政府和公司的信任程度。当在大流行或流行期间设计和传达疫苗试验时,试验团队需要考虑这些特定的影响。

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