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一项针对从事贸易和体力劳动职业男性的减肥临床试验招募信息的随机比较。

A randomized comparison of recruitment messages for a weight loss clinical trial targeting men working in trade and labor occupations.

作者信息

Crane Melissa M, Appelhans Bradley M

机构信息

Department of Family and Preventive Medicine, Rush University Medical Center, 1700 W. Van Buren St., Ste 470, Chicago, IL 60612, USA.

出版信息

Contemp Clin Trials Commun. 2024 Mar 27;39:101289. doi: 10.1016/j.conctc.2024.101289. eCollection 2024 Jun.

Abstract

BACKGROUND

Engaging diverse populations in clinical trials is vital to research. This study evaluated the effects of varying recruitment messages for a clinical trial.

METHODS

The messages were evaluated in a randomly assigned, factorial design that tested enhanced trust (vs. standard) and participant endorsement (vs. standard) messaging.Four postcards were developed and randomly assigned to 4000 potential participants' addresses. Except for the messages of interest, the cards were identical, and participants were directed to four identical study websites and screening forms. Outcomes include unique website visits, visit conversion rate, screening forms completed, and participants randomized into the parent study.

RESULTS

Study websites received 74 visits (range by message type 9 to 34). There was no significant difference by message type (p = 0.79). Online screening forms were completed by 15 participants (range by message type 0-6), representing a conversion rate of 20.3% of website visits. Seven participants were randomized into the study in response to the postcards (range by message type 0 to 3; 46.7% of screenings). Overall, 0.2% of individuals who received a postcard were randomized into the study.

CONCLUSION

Despite developing recruitment messages with participant input, the enhanced messages did not yield a greater response than standard messages. However, this method of evaluating recruitment messages shows promise.

摘要

背景

让不同人群参与临床试验对研究至关重要。本研究评估了针对一项临床试验的不同招募信息的效果。

方法

这些信息在一项随机分配的析因设计中进行评估,该设计测试了增强信任(与标准相比)和参与者认可(与标准相比)的信息传递方式。制作了四张明信片,并随机分配到4000个潜在参与者的地址。除了感兴趣的信息外,明信片是相同的,参与者被引导至四个相同的研究网站和筛查表格。结果包括独特的网站访问量、访问转化率、完成的筛查表格数量以及随机进入母研究的参与者。

结果

研究网站收到74次访问(按信息类型范围为9至34次)。信息类型之间没有显著差异(p = 0.79)。15名参与者完成了在线筛查表格(按信息类型范围为0至6名),占网站访问量的转化率为20.3%。有7名参与者因明信片而被随机纳入研究(按信息类型范围为0至3名;占筛查的46.7%)。总体而言,收到明信片的个体中有0.2%被随机纳入研究。

结论

尽管在参与者参与下制定了招募信息,但增强后的信息并未比标准信息产生更大的反应。然而,这种评估招募信息的方法显示出了前景。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/daac/10990703/bf39b12955b0/gr1.jpg

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