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通过多媒体呈现患者信息能否提高临床试验的招募效果?一项“试验内研究”(SWATs)的荟萃分析。

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

机构信息

Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.

Department of Health Sciences, University of York & the Hull York Medical School, York, YO10 5DD, UK.

出版信息

BMC Med. 2023 Nov 8;21(1):425. doi: 10.1186/s12916-023-03081-5.

Abstract

BACKGROUND

People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment.

METHODS

Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part.

RESULTS

Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I = 0%). There was no effect on any other outcomes.

CONCLUSIONS

Multimedia alongside written information did not improve trial recruitment rates.

TRIAL REGISTRATION

ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

摘要

背景

人们需要高质量的信息来做出参与研究的决策。仅以书面形式提供信息是传统的方法,但可能不是最有效和可接受的方法。我们开发了一种使用多媒体呈现信息的结构,其中包括通用和试验特定的内容。我们的目的是在多个正在进行的试验中嵌入“试验内研究”(SWATs),以测试患者信息的多媒体呈现是否会导致更高的招募率。

方法

五个试验包括一个 SWAT,并将参与者随机分配接受多媒体演示和标准信息,或仅接受标准书面信息。我们收集了试验招募、接受和保留的数据,并使用随机效应荟萃分析对汇总结果进行了分析,主要结果定义为邀请参与者参与后随机分配的参与者比例。

结果

五个 SWAT 提供了关于参与者随机分配比例的主要结果数据。多媒体与书面信息结合使用对招募率几乎没有影响(汇总优势比=0.96,95%CI:0.79 至 1.17,p 值=0.671,I=0%)。对任何其他结果都没有影响。

结论

多媒体与书面信息结合使用并未提高试验招募率。

试验注册

ISRCTN71952900、ISRCTN06710391、ISRCTN17160087、ISRCTN05926847、ISRCTN62869767。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a3e/10634086/47e5b313a1dc/12916_2023_3081_Fig1_HTML.jpg

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