非标准信息传单对急性护理中患者招募的影响：嵌入式整群随机对照试验。

Effects of a non-standard information leaflet on patient recruitment in acute care: Embedded cluster-randomised controlled trial.

作者信息

Höckelmann Carolin, Roos Marcelina, Müller Wiebke, Dichter Martin N, Köpke Sascha

机构信息

University of Cologne, Faculty of Medicine and University Hospital Cologne, Institute of Nursing Science, Cologne, Germany.

University of Cologne, Faculty of Medicine and University Hospital Cologne, Institute of Medical Statistics and Computational Biology, Cologne, Germany.

出版信息

PLoS One. 2025 Aug 1;20(8):e0327634. doi: 10.1371/journal.pone.0327634. eCollection 2025.

DOI:10.1371/journal.pone.0327634

PMID:40748950

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12316219/

Abstract

BACKGROUND

Recruiting study participants is a key component and major challenge in clinical research. Evidence shows that the design of written study information can influence recruitment success. However, there is a lack of research on the effectiveness and acceptability of different written study information.

OBJECTIVE

We aimed to investigate the effectiveness and acceptability of an information leaflet including an information video compared to a formal information letter in patient recruitment in acute care.

DESIGN

We conducted a cluster-randomised controlled trial embedded in a cross-sectional study ("Sleep Acute host study") addressing patients' sleep in hospitals.

METHODS

In a stratified random sample of hospitals, we allocated selected wards either to the intervention group (information leaflet including a link to an information video) or the control group (formal information letter) using external concealed randomisation. Adult patients hospitalised for at least 48 hours were eligible for participation. Our primary endpoint was recruitment success measured by the participation rate in the Sleep Acute host study. The secondary endpoint was acceptability of the written study information. Persons involved in the analyses were blinded concerning group allocation.

RESULTS

In total, 53 wards with 498 patients were cluster-randomised, 28 wards with 262 patients were allocated to the intervention group and 25 wards with 236 patients to the control group. The participation rate in the Sleep Acute host study was 51.1% (134 of 262) for the intervention and 47.5% (112 of 236) for the control group (OR 1.186 (0.698 to 2.013), p = 0.528). There were no significant differences concerning the acceptability of the written study information between both groups.

CONCLUSIONS

More patients who received an information leaflet including a link to an information video participated in the host study, although the difference is not statistically significant.

STUDY REGISTRATION

DRKS-ID: DRKS00029707. Registered on 30. August 2022.

摘要

背景

招募研究参与者是临床研究的关键组成部分和主要挑战。有证据表明，书面研究信息的设计会影响招募的成功率。然而，对于不同书面研究信息的有效性和可接受性缺乏研究。

目的

我们旨在调查与正式信息信函相比，包含信息视频的信息手册在急性护理患者招募中的有效性和可接受性。

设计

我们在一项关于患者在医院睡眠情况的横断面研究（“睡眠急性宿主研究”）中进行了一项整群随机对照试验。

方法

在医院的分层随机样本中，我们使用外部隐蔽随机化将选定的病房分配到干预组（包含信息视频链接的信息手册）或对照组（正式信息信函）。住院至少48小时的成年患者有资格参与。我们的主要终点是通过“睡眠急性宿主研究”的参与率衡量的招募成功率。次要终点是书面研究信息的可接受性。参与分析的人员对分组情况不知情。

结果

总共53个病房的498名患者进行了整群随机化，28个病房的262名患者被分配到干预组，25个病房的236名患者被分配到对照组。干预组在“睡眠急性宿主研究”中的参与率为51.1%（262人中的134人），对照组为47.5%（236人中的112人）（比值比1.186（0.698至2.013），p = 0.528）。两组之间在书面研究信息的可接受性方面没有显著差异。