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利用肿瘤协作网络和生物医学信息学数据资源,迅速招募农村居民参与肿瘤生活质量临床试验并使其入组。

Leveraging oncology collaborative networks and biomedical informatics data resources to rapidly recruit and enroll rural residents into oncology quality of life clinical trials.

作者信息

Davis Heath A, Hoberg Asher A, Jacobus Laura S, Nepple Kenneth, Seaman Aaron T, Sorensen Jamie, Weiner George J, Gilbertson-White Stephanie

机构信息

Institute for Clinical & Translational Science, University of Iowa, Iowa City, IA, USA.

Carver College of Medicine IT, University of Iowa, Iowa City, IA, USA.

出版信息

J Clin Transl Sci. 2024 Sep 23;8(1):e135. doi: 10.1017/cts.2024.576. eCollection 2024.

Abstract

PURPOSE

This study assesses the feasibility of biomedical informatics resources for efficient recruitment of rural residents with cancer to a clinical trial of a quality-of-life (QOL) mobile app. These resources have the potential to reduce costly, time-consuming, in-person recruitment methods.

METHODS

A cohort was identified from the electronic health record data repository and cross-referenced with patients who consented to additional research contact. Rural-urban commuting area codes were computed to identify rurality. Potential participants were emailed study details, screening questions, and an e-consent link via REDCap. Consented individuals received baseline questionnaires automatically. A sample minimum of = 80 [ = 40 care as usual (CAU) = 40 mobile app intervention] was needed.

RESULTS

= 1298 potential participants ( = 365 CAU; = 833 intervention) were screened for eligibility. For CAU, 68 consented, 67 completed baseline questionnaires, and 54 completed follow-up questionnaires. For intervention, 100 consented, 97 completed baseline questionnaires, and 58 completed follow-up questionnaires. The CAU/intervention reached 82.5%/122.5% of the enrollment target within 2 days. Recruitment and retention rates were 15.3% and 57.5%, respectively. The mean age was 59.5 ± 13.5 years. The sample was 65% women, 20% racial/ethnic minority, and 35% resided in rural areas.

CONCLUSION

These results demonstrate that biomedical informatics resources can be highly effective in recruiting for cancer QOL research. Precisely identifying individuals likely to meet inclusion criteria who previously indicated interest in research participation expedited recruitment. Participants completed the consent and baseline questionnaires with zero follow-up contacts from the research team. This low-touch, repeatable process may be highly effective for multisite clinical trials research seeking to include rural residents.

摘要

目的

本研究评估生物医学信息学资源用于高效招募农村癌症患者参与一项生活质量(QOL)移动应用临床试验的可行性。这些资源有可能减少成本高昂、耗时的面对面招募方法。

方法

从电子健康记录数据存储库中识别出一个队列,并与同意进行额外研究联系的患者进行交叉参考。计算城乡通勤区号以确定农村地区。通过REDCap向潜在参与者发送研究细节、筛查问题和电子同意书链接。同意参与的个体自动收到基线问卷。需要至少80名样本(40名接受常规护理(CAU),40名接受移动应用干预)。

结果

筛查了1298名潜在参与者(365名CAU;833名干预组)的资格。对于CAU组,68人同意,67人完成基线问卷,54人完成随访问卷。对于干预组,100人同意,97人完成基线问卷,58人完成随访问卷。CAU组/干预组在2天内达到了招募目标的82.5%/122.5%。招募率和保留率分别为15.3%和57.5%。平均年龄为59.5±13.5岁。样本中65%为女性,20%为种族/族裔少数群体,35%居住在农村地区。

结论

这些结果表明,生物医学信息学资源在癌症QOL研究招募中可能非常有效。精确识别可能符合纳入标准且之前表示有兴趣参与研究的个体加快了招募速度。参与者在研究团队零后续接触的情况下完成了同意书和基线问卷。这种低接触、可重复的过程对于寻求纳入农村居民的多中心临床试验研究可能非常有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9522/11428118/e9401afbd5a8/S2059866124005764_fig1.jpg

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