临床与转化科学奖（CTSA）机构的积累和招募实践：呼吁期望、专业知识和评估。
Accrual and recruitment practices at Clinical and Translational Science Award (CTSA) institutions: a call for expectations, expertise, and evaluation.
机构信息
Dr. Kost is clinical research officer and director, Regulatory Knowledge and Support Core, Rockefeller University Center for Clinical and Translational Science, New York, New York. She was co-chair of the CTSA Consortium's Regulatory Knowledge and Support Key Function Committee and Recruitment and Retention Taskforce at the time the work was conducted. Ms. Mervin-Blake is assistant director for recruitment and special projects, Duke University Clinical Translational Science Institute, Chapel Hill, North Carolina. She was director of operational programs and research recruitment, University of North Carolina Translational and Clinical Sciences Institute, Chapel Hill, North Carolina, at the time the research was conducted. Ms. Hallarn is program director, Clinical Trials Recruitment Center, Clinical and Translational Science, Ohio State University, Columbus, Ohio. Mr. Rathmann was director, Recruitment Enhancement Core, Institute of Clinical and Translational Science Regulatory Support Center, Center for Clinical Studies, Washington University School of Medicine in St. Louis, St Louis, Missouri, at the time the research was conducted. Mr. Kolb is research participant advocate, Clinical and Translational Science Institute, University of Florida, Gainesville, Florida. Dr. Dennison Himmelfarb is associate professor, Department of Health Systems and Outcomes, Johns Hopkins University School of Nursing, and Division of Health Sciences Informatics, Johns Hopkins University School of Medicine, Baltimore, Maryland. Ms. D'Agostino is assistant vice president, Sponsored Programs and Pre-Award Management, and assistant director, Clinical and Translational Science Award Regulatory Knowledge and Support Resource, University of Texas Medical Branch at Galveston, Galveston, Texas. Mr. Rubinstein is executive director for research services, University of Rochester Clinical Translational Science Institute, Rochester, New York. Dr. Dozier is associate professor, Department of Public He
出版信息
Acad Med. 2014 Aug;89(8):1180-9. doi: 10.1097/ACM.0000000000000308.
PURPOSE
To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examined participant recruitment practices at Clinical and Translational Science Award (CTSA) sites and make recommendations for performance metrics and accountability.
METHOD
The CTSA Recruitment and Retention taskforce in 2010 invited representatives at 46 CTSAs to complete an online 48-question survey querying accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted.
RESULTS
Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78%-91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to institutional review board (IRB) review (30%) or contract approval (22%). All respondents' IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness.
CONCLUSIONS
Many CTSAs lack the necessary frame work to support study accrual. Recom men dations to enhance accrual include articulating institutional expectations and policy for routine recruitment plan ning; providing recruitment expertise to inform feasibility assessment and recruit ment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices.
目的
为了满足公众和项目对解决临床转化研究研究参与率低的需求增加，作者研究了临床与转化科学奖（CTSA）站点的参与者招募实践，并为绩效衡量和问责制提出建议。
方法
2010 年，CTSA 招募和保留工作组邀请 46 个 CTSA 的代表完成了一项在线 48 个问题的调查，询问了入组和招募结果、实践、评估方法、政策以及相关知识/实践中的差距。进行了描述性统计和主题分析。
结果
46 名代表 44 个 CTSA 完成了调查。由研究团队进行的招募是报告最多的常见做法（78%-91%，按研究类型）；39%的机构表示提供招募服务给研究人员。受访者重视研究可行性评估是一种成功的做法（39%）；希望增加的资源包括可行性评估（49%）和参与者登记（44%）。没有一个机构系统地要求对可行性进行论证；一些机构表示，在机构审查委员会（IRB）审查（30%）或合同批准（22%）之前就考虑了相关信息。所有受访者的 IRB 都在跟踪研究进展，但只有 10%的受访者可以报告及时入组的结果数据。很少有受访者报告有书面政策来解决入组率低的问题，也没有提供数据来支持招募实践的有效性。
结论
许多 CTSA 缺乏支持研究入组的必要框架。增强入组率的建议包括明确机构对常规招募计划的期望和政策；提供招募专业知识，以告知可行性评估和招募计划；以及发展部门间协调和综合信息学基础设施，以推动招募实践的开展、评估和改进。
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