Wells Gudrun, Bowden Janelle, Colyer Duncan, Kay Eleonora, Lukeman Sarah, Newett Lyndsay, Eckstein Lisa
Bellberry Limited, Adelaide, Australia.
Managing Director and Consultant, AccessCR Pty Ltd., Sydney, Australia.
BMC Med Res Methodol. 2024 Dec 26;24(1):319. doi: 10.1186/s12874-024-02417-w.
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.
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.
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.
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.
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.
参与者与其研究团队之间的联系会影响参与者的安全感、知情权、受尊重感，以及他们完成研究项目的意愿。研究人员与参与者之间的沟通是建立这种联系的关键，但很少有已发表的作品评估临床研究中的沟通是如何进行的。
本文探讨了在澳大利亚，研究参与者同意参与临床研究后会发生哪些沟通（以及如何沟通）。它呈现了从事临床研究的澳大利亚人对他们当前与研究参与者沟通的策略，或他们希望采用的沟通策略的思考。
这项探索性的定性描述性研究报告了与20次半结构化访谈相关的结果，这些访谈的对象是在澳大利亚从事临床研究的人员（如面向参与者的工作人员、现场管理人员或申办方代表）。这些访谈采用主题分析法进行归纳分析。
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项目和研究地点之间的实施、接受程度和适用性方面存在差异。访谈中确定了四个主要主题：[1]工作人员采用创新实用主义进行沟通；[2]工作人员根据参与者的情况调整沟通策略；[3]研究地点、其系统和工作人员培训都会影响沟通；[4]成功的沟通需要利益相关者之间的合作。
研究人员目前与试验参与者采用了多种沟通策略、方法和活动，这些策略在目的、方法、所需资源以及研究和地点之间的适用性方面各不相同。充分考虑参与者的情况和研究地点的能力对于设计能够使研究团队与参与者进行有效沟通的研究至关重要。作者鼓励那些开展临床研究项目的人员在规划与参与者的沟通时尽早让研究地点工作人员和消费者代表参与进来。
