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临床研究中用于启动研究地点的视频会议:可用性、可接受性及对招募影响的混合方法评估

Videoconferencing for site initiations in clinical studies: Mixed methods evaluation of usability, acceptability, and impact on recruitment.

作者信息

Randell Rebecca, Backhouse Michael R, Nelson E Andrea

机构信息

a School of Healthcare, Baines Wing , University of Leeds , Leeds , UK.

b Leeds Institute of Rheumatic and Musculoskeletal Medicine , University of Leeds , Chapel Allerton Hospital, Chapeltown Road, Leeds , UK.

出版信息

Inform Health Soc Care. 2016 Dec;41(4):362-72. doi: 10.3109/17538157.2015.1064424. Epub 2015 Dec 22.

Abstract

BACKGROUND

A critical issue for multicentre clinical studies is conducting site initiations, ensuring sites are trained in study procedures and comply with relevant governance requirements before they begin recruiting patients. How technology can support site initiations has not previously been explored.

OBJECTIVE

This study sought to evaluate use of off-the-shelf web-based videoconferencing to deliver site initiations for a large national multicentre study.

METHODS

Participants in the initiations, including podiatrists, diabetologists, trial coordinators, and research nurses, completed an online questionnaire based on the System Usability Scale (SUS) (N = 15). This was followed by semi-structured interviews, with a consultant diabetologist, a trial coordinator, and three research nurses, exploring perceived benefits and limitations of videoconferencing.

RESULTS

The mean SUS score for the videoconferencing platform was 87.2 (SD = 13.7), suggesting a good level of usability. Interview participants perceived initiations delivered by videoconferencing as being more interactive and easier to follow than those delivered by teleconference. In comparison to face-to-face initiations, videoconferencing takes less time, easily fitting in with the work of staff at the local sites. Perceptions of impact on communication varied according to the hardware used.

CONCLUSION

Off-the-shelf videoconferencing is a viable alternative to face-to-face site initiations and confers advantages over teleconferencing.

摘要

背景

多中心临床研究的一个关键问题是进行研究中心启动工作,确保各中心在开始招募患者之前接受研究程序培训并遵守相关管理要求。此前尚未探讨过技术如何支持研究中心启动工作。

目的

本研究旨在评估使用现成的基于网络的视频会议为一项大型全国性多中心研究进行研究中心启动工作的情况。

方法

参与启动工作的人员,包括足病医生、糖尿病专家、试验协调员和研究护士,完成了一份基于系统可用性量表(SUS)的在线问卷(N = 15)。随后,对一名糖尿病专家顾问、一名试验协调员和三名研究护士进行了半结构化访谈,探讨视频会议的感知益处和局限性。

结果

视频会议平台的平均SUS评分为87.2(标准差 = 13.7),表明可用性水平良好。访谈参与者认为,通过视频会议进行的启动工作比电话会议更具互动性且更易于理解。与面对面启动工作相比,视频会议耗时更少,很容易与当地研究中心工作人员的工作相契合。对沟通影响的看法因所使用的硬件而异。

结论

现成的视频会议是面对面研究中心启动工作的可行替代方案,且比电话会议更具优势。

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