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在英国制作通用型临床试验动画解释视频:一项调查及案例研究结果

Developing generic clinical trial animated explainer videos in the UK: results of a survey and case study.

作者信息

Calvert Clare, Barber Vicki S, Appelbe Duncan, Sprange Kirsty, Nollett Claire, Lugg-Widger Fiona, Tanner Samantha, Richards Duncan B

机构信息

Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.

Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.

出版信息

Trials. 2025 Jan 21;26(1):25. doi: 10.1186/s13063-024-08687-5.

Abstract

BACKGROUND

Animated short videos used to explain a concept or project are often called animated explainer videos (AEVs). AEVs can supplement or provide an alternative to participant information sheets as a means of giving information about clinical research to potential participants. Current use of AEVs tends to focus on the specifics of a particular trial, yet there are many common aspects of clinical research regardless of the interventions being investigated that can be poorly covered in current trial materials. The EXPLAIN initiative aimed to determine the top generic clinical trial topics considered most important by different UK trial stakeholders. The top three topics were then turned into AEVs and have been made freely available for use.

METHOD

A list of generic clinical trial topics which often need explaining to potential trial participants when they are approached to take part in research was developed. Using a two-round Delphi survey of stakeholder groups (trial participants, patients, members of the public, site staff and clinical trials unit staff), the list of topics was expanded and prioritised to identify the topics most in need of clear explanation. The top three topics formed the basis of three AEVs, co-developed with patient and public partners.

RESULTS

Two hundred twenty-eight responses were received to the first round of the Delphi survey, and 167 of these respondents also completed the second round of the survey. The three topics prioritised for creation of animated explainer videos were as follows: (1) What is consent? (2) Who decides what treatment I get/What is randomisation? (3) Is it safe to take part in a trial/How do you know a trial is safe? Following virtual meetings with patient and public partners recruited from the Delphi respondents, a script for each AEV was co-produced before being developed into an AEV by a company specialising in animated video production.

CONCLUSION

There are a wide range of generic concepts in which the use of animated explainer videos could be useful to improve participant understanding of clinical research. Via consensus survey across multiple stakeholders, we have determined a hierarchy of the importance of explaining these concepts. We envisage that the three AEVs created from this project will form the basis of a readily accessible library of animations to be utilised by trialists.

摘要

背景

用于解释某个概念或项目的动画短视频通常被称为动画解释视频(AEV)。AEV可以作为向潜在参与者提供临床研究信息的一种方式,补充参与者信息表或提供其替代形式。目前AEV的使用往往侧重于特定试验的细节,但临床研究有许多共同方面,而当前的试验材料可能对这些方面的涵盖不足,无论所研究的干预措施如何。EXPLAIN倡议旨在确定英国不同试验利益相关者认为最重要的通用临床试验主题。然后将前三个主题制作成AEV,并已免费提供以供使用。

方法

制定了一份通用临床试验主题清单,当潜在试验参与者被邀请参与研究时,这些主题通常需要向他们解释。通过对利益相关者群体(试验参与者、患者、公众、研究点工作人员和临床试验单位工作人员)进行两轮德尔菲调查,对主题清单进行了扩展和排序,以确定最需要清晰解释的主题。前三个主题构成了三个与患者和公众合作伙伴共同开发的AEV的基础。

结果

第一轮德尔菲调查共收到228份回复,其中167名受访者也完成了第二轮调查。优先制作动画解释视频的三个主题如下:(1)什么是知情同意?(2)谁决定我接受什么治疗/什么是随机分组?(3)参加试验安全吗/你们如何知道试验是安全的?在与从德尔菲调查受访者中招募的患者和公众合作伙伴进行虚拟会议后,共同制作了每个AEV的脚本,然后由一家专门从事动画制作公司将其制作成AEV。

结论

有广泛的通用概念,使用动画解释视频可能有助于提高参与者对临床研究的理解。通过对多个利益相关者进行共识调查,我们确定了这些概念解释的重要性层次结构。我们设想,从该项目中创建的三个AEV将构成一个易于获取的动画库的基础,供试验者使用。

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