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在一项多中心生物库研究中,招募新诊断的卵巢癌患者颇具挑战性。

Recruitment of newly diagnosed ovarian cancer patients proved challenging in a multicentre biobanking study.

机构信息

Gynaecological Cancer Research Centre, EGA Institute for Women's Health, University College London, London W1T 7DN, UK.

出版信息

J Clin Epidemiol. 2011 May;64(5):525-30. doi: 10.1016/j.jclinepi.2010.07.008. Epub 2010 Nov 13.

Abstract

OBJECTIVE

To explore the challenges of recruiting ovarian cancer patients and healthy controls to a cancer biobanking study.

STUDY DESIGN AND SETTING

The study was set up in gynecological cancer centers in 10 National Health Service trusts across the United Kingdom. Women were approached if they were undergoing investigations/awaiting treatment for ovarian cancer, had a previous diagnosis of ovarian cancer, or were attending for annual screening in an ovarian cancer screening trial. Those who consented completed a detailed epidemiologic questionnaire, provided blood and tissue samples if appropriate.

RESULTS

The overall proportion of those recruited compared with the expected targets was 76.4% for healthy controls, 86.0% for old cases, and 46.9% for new cases. Only 4 of 10 (40%) centers recruited over 50% of their target for new cases. Unwillingness to participate was reported as primarily because of patients being too unwell, wanting to focus only on their treatment, or having insufficient time because of conflicting medical appointments. Concerns about use of personal data or tissue and blood samples for genetic research and lack of direct benefit were reported as significant challenges to recruitment.

CONCLUSION

When setting recruitment targets for patients undergoing investigations or awaiting treatment for cancer (new cases), it is important to consider lower response rates because of various patient, logistical, and trial-specific challenges.

摘要

目的

探讨在癌症生物样本库研究中招募卵巢癌患者和健康对照者所面临的挑战。

研究设计和设置

本研究在英国 10 个国民保健服务信托的妇科癌症中心进行。如果女性正在接受卵巢癌的检查/等待治疗、曾被诊断为卵巢癌,或正在参加卵巢癌筛查试验的年度筛查,则对其进行招募。同意参加的患者完成详细的流行病学问卷,如果合适,提供血液和组织样本。

结果

与预期目标相比,健康对照者的招募比例为 76.4%,旧病例为 86.0%,新病例为 46.9%。仅 10 个中心中的 4 个(40%)招募到了超过 50%的新病例目标。不愿参与的主要原因是患者身体状况不佳、只想专注于治疗,或因医疗预约冲突而时间不足。对个人数据或组织和血液样本用于遗传研究以及缺乏直接受益的担忧被认为是招募的重大挑战。

结论

在为接受癌症检查或治疗的患者(新病例)设定招募目标时,由于各种患者、后勤和试验特定的挑战,需要考虑较低的响应率。

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