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从英国多中心队列研究招募中吸取的经验教训,该研究旨在探索结直肠癌(CREW 研究)后健康和幸福感的恢复情况。

Lessons learnt recruiting to a multi-site UK cohort study to explore recovery of health and well-being after colorectal cancer (CREW study).

机构信息

Faculty of Health Sciences, University of Southampton, Southampton SO17 1BJ, UK.

出版信息

BMC Med Res Methodol. 2013 Dec 28;13:153. doi: 10.1186/1471-2288-13-153.

DOI:10.1186/1471-2288-13-153
PMID:24373214
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3877869/
Abstract

BACKGROUND

The UK leads the world in recruitment of patients to cancer clinical trials, with a six-fold increase in recruitment during 2001-2010. However, there are large variations across cancer centres. This paper details recruitment to a large multi-centre prospective cohort study and discusses lessons learnt to enhance recruitment.

METHODS

During CREW (ColoREctal Wellbeing) cohort study set up and recruitment, data were systematically collected on all centres that applied to participate, time from study approval to first participant recruited and the percentage of eligible patients recruited into the study.

RESULTS

30 participating NHS cancer centres were selected through an open competition via the cancer networks. Time from study approval to first participant recruited took a median 124 days (min 53, max 290). Of 1350 eligible people in the study time frame, 78% (n = 1056) were recruited into the study, varying from 30-100% eligible across centres. Recruitment of 1056 participants took 17 months.

CONCLUSION

In partnership with the National Cancer Research Network, this successful study prioritised relationship building and education. Key points for effective recruitment: pre-screening and selection of centres; nurses as PIs; attendance at study days; frequent communication and a reduced level of consent to enhance uptake amongst underrepresented groups.

摘要

背景

英国在癌症临床试验患者招募方面处于世界领先地位,2001 年至 2010 年间招募人数增加了六倍。然而,各癌症中心之间存在很大差异。本文详细介绍了一项大型多中心前瞻性队列研究的招募情况,并讨论了为提高招募效率而吸取的经验教训。

方法

在 CREW(结直肠健康)队列研究的设立和招募过程中,系统地收集了所有申请参与的中心的数据,包括从研究批准到招募第一名参与者的时间以及符合条件的患者中有多少百分比被招募到研究中。

结果

通过癌症网络的公开竞争,选择了 30 个参与的 NHS 癌症中心。从研究批准到招募第一名参与者的时间中位数为 124 天(最短 53 天,最长 290 天)。在研究时间框架内的 1350 名符合条件的人中,有 78%(n=1056)被招募到研究中,各中心的符合条件比例从 30%到 100%不等。招募 1056 名参与者用了 17 个月。

结论

与国家癌症研究网络合作,这项成功的研究优先考虑建立和教育关系。有效招募的关键要点:中心的预筛选和选择;护士作为 PI;参加研究日;频繁的沟通和简化同意书,以提高代表性不足群体的参与度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80cb/3877869/4d7ea10d8c43/1471-2288-13-153-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80cb/3877869/01846c159f3a/1471-2288-13-153-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80cb/3877869/4d7ea10d8c43/1471-2288-13-153-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80cb/3877869/01846c159f3a/1471-2288-13-153-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80cb/3877869/4d7ea10d8c43/1471-2288-13-153-2.jpg

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本文引用的文献

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BMC Health Serv Res. 2012 Apr 4;12:90. doi: 10.1186/1472-6963-12-90.
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Successful recruitment to trials: a phased approach to opening gates and building bridges.成功招募试验参与者:分阶段的方法,打开大门并架起桥梁。
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Strengthening clinical cancer research in the United Kingdom.加强英国的癌症临床研究。
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Pre-Surgery Depression and Confidence to Manage Problems Predict Recovery Trajectories of Health and Wellbeing in the First Two Years following Colorectal Cancer: Results from the CREW Cohort Study.术前抑郁及应对问题的信心预测结直肠癌后两年健康与幸福的恢复轨迹:CREW队列研究结果
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