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多中心临床研究中的招募与留住参与者的挑战。

Challenges of recruitment and retention in multisite clinical research.

作者信息

Cooley Mary E, Sarna Linda, Brown Jean K, Williams Roma D, Chernecky Cynthia, Padilla Geraldine, Danao Leda Layo

机构信息

Dana-Farber Cancer Institute, Phyllis E Cantor Center for Research in Nursing and Patient Care Services, Boston, Mass 02115, USA.

出版信息

Cancer Nurs. 2003 Oct;26(5):376-84; quiz 385-6. doi: 10.1097/00002820-200310000-00006.

DOI:10.1097/00002820-200310000-00006
PMID:14710799
Abstract

This article reviews recruitment and retention issues in a multisite, multistate (California, New York, Connecticut, Georgia, Alabama) 6-month prospective cross-sectional study focused on quality of life among 230 women with lung cancer. Recruitment of women into clinical trials and their retention are important, yet understudied. To date, few articles have described the challenges associated with recruiting women with lung cancer to participate in clinical research. Data from this trial were used to investigate the most effective strategies for recruitment across sites, to identify the most common reasons for refusal and attrition, and to identify challenges and potential solutions to recruitment and retention issues associated with multisite clinical research studies. Strategies for recruitment included letters from physicians, posters, announcements in community support groups, and newspaper and radio advertisements. Three sites allowed the researchers to contact potential participants directly, whereas 2 sites required the potential participants to contact the researchers for further information. Enrollment included 63% of the women eligible for the study (n = 230). The most common reasons for refusal were health limitations (n = 60), lack of interest (n = 46), and inconvenience (n = 16). The most common reasons for attrition (24% of the sample) were death (n = 21) and severity of illness (n = 13). Challenges related to recruitment and retention varied by geographic location.

摘要

本文回顾了一项多地点、多州(加利福尼亚州、纽约州、康涅狄格州、佐治亚州、阿拉巴马州)的为期6个月的前瞻性横断面研究中的招募和保留问题,该研究聚焦于230名肺癌女性患者的生活质量。将女性纳入临床试验及其保留情况很重要,但却研究不足。迄今为止,很少有文章描述招募肺癌女性参与临床研究所面临的挑战。该试验的数据被用于调查跨地点招募的最有效策略,确定拒绝和退出的最常见原因,并识别与多地点临床研究相关的招募和保留问题的挑战及潜在解决方案。招募策略包括医生的信件、海报、社区支持小组的公告以及报纸和电台广告。三个地点允许研究人员直接联系潜在参与者,而两个地点要求潜在参与者联系研究人员获取更多信息。纳入研究的女性占符合研究条件女性的63%(n = 230)。拒绝的最常见原因是健康限制(n = 60))、缺乏兴趣(n = 46)和不便(n = 16)。退出(占样本的24%)的最常见原因是死亡(n = 21)和疾病严重程度(n = 13)。与招募和保留相关的挑战因地理位置而异。

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