对澳大利亚临床研究人员进行探索性访谈,了解他们如何与参与者沟通。

IF 3.9 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES BMC Medical Research Methodology Pub Date : 2024-12-26 DOI:10.1186/s12874-024-02417-w
Gudrun Wells, Janelle Bowden, Duncan Colyer, Eleonora Kay, Sarah Lukeman, Lyndsay Newett, Lisa Eckstein
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引用次数: 0

摘要

背景:参与者和他们的研究团队之间的联系会影响参与者的安全感、知情权和受尊重程度,以及他们完成研究项目的意愿。研究人员和参与者之间的沟通是建立这种联系的关键,但很少有发表的作品评估临床研究期间如何进行沟通。目的:本文探讨了在澳大利亚同意参加临床研究后,与研究参与者发生了什么交流(以及如何交流)。它提供了从事临床研究的澳大利亚人对他们当前策略的反思,或者他们想要使用的策略,以与研究参与者交流。方法:本探索性定性描述性研究报告了与20个半结构化访谈相关的发现,这些访谈是与澳大利亚临床研究工作人员(如面向参与者、现场管理或赞助商代表角色的工作人员)进行的。这些访谈是进行和分析归纳使用专题分析。研究人员报告使用了一系列沟通策略,这些策略在临床研究和地点之间的实施、吸收和适用性各不相同。在采访中确定了四个主要主题:[1]员工使用创新的实用主义进行沟通;[2]员工根据参与者的情况量身定制沟通策略;[3]网站、其系统和员工培训都影响沟通;[4]成功的沟通需要利益相关者之间的协作。结论:研究人员目前与试验参与者的沟通策略、方法和活动多种多样,其目的、方法、所需资源以及研究和地点之间的适用性各不相同。全面考虑参与者的背景和研究地点的能力对于研究设计至关重要,这使得研究团队和参与者之间能够进行有效的沟通。作者鼓励那些开发临床研究项目的人在与参与者沟通的计划中尽早让现场工作人员和消费者代表参与进来。
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Exploratory interviews with Australian clinical research staff on how they communicate with participants.

Background: The connection between participants and their research team can affect how safe, informed, and respected a participant feels, and their willingness to complete a research project. Communication between researchers and participants is key to developing this connection, but there is little published work evaluating how communication during clinical research is conducted.

Purpose: This paper explores what communications happen (and how) with research participants in Australia post consenting to participate in clinical research. It provides reflections from Australians working in clinical research about their current strategies, or those they would like to use, to communicate with research participants.

Methods: This exploratory, qualitative descriptive study reports findings associated with twenty semi-structured interviews that were undertaken with people who work in clinical research in Australia (such as staff in participant facing, site management, or sponsor representative roles). These interviews were conducted and analysed inductively using thematic analysis.

Findings: Research staff reported using a range of communication strategies which varied in implementation, uptake, and suitability between clinical research studies and sites. Four major themes were identified in the interviews: [1] staff use innovative pragmatism to communicate; [2] staff tailor the communication strategies to fit the participants' context; [3] the site, its systems, and staff training all impact communication; [4] successful communication requires collaboration between stakeholders.

Conclusion: There are a variety of communication strategies, methods and activities research staff currently employ with trial participants, which vary in purpose, method, resources required, and suitability between studies and sites. Thorough consideration of the participants' contexts and the capacity of research sites is crucial for the design of studies which allow for effective communication between the research team and participants. The authors encourage those developing clinical research projects to involve site staff and consumer representatives early in planning for communication with participants.

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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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