Lymphocyte CpG methylation changes and brain pathology in Restless Legs Syndrome

不宁腿综合征中淋巴细胞 CpG 甲基化的变化和脑病理学

• 批准号: 10121614
• 负责人: CHRISTOPHER J EARLEY
• 金额: $ 15.01万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10121614
• 关键词: Address; Administrative Supplement; Advertisements; Advertising; Applications Grants; Brain Pathology; Clinic; Clinical; Enrollment; Financial Support; Funding; Grant; Hematology; Hospitals; Lymphocyte; Methylation; Online Systems; Patient Recruitments; Restless Legs Syndrome; Sample Size; Television; United States National Institutes of Health; base; college; cost; expectation; posters; preservation; recruit; screening

This is a Administrative Supplement grant submission requesting supplemental financial support for the fourth year of the ongoing NIH grant, R01-NS 101283. In the originally funded grant application, we had planned for recruitment through a single Hematology clinic with expectations to screen about 250 subjects per year from which an estimated 60 subjects would be fully enrolled in the study. Based on these estimates, we expected to achieve the necessary 240 subjects (120 RLS and 120 control) over the first 4 years of the grant. However, recruitment through a single Hematology clinic has failed to provide adequate subject enrollment. We addressed this problem by developing a wide range of broad-based recruitment endeavors including: increasing the number and types of clinics involved, placement of flyers and posters across local hospitals and colleges, web-based and television advertisement. With the broader range of recruitment endeavors, we have demonstrated that we can increase the rate of recruitments, which we feel will be sufficient to achieve appropriate sample size, though that may require continuation of the recruitment into the fifth year of the grant. The increased recruitment of patients outside the clinical setting has increased the number of screening labs required and therefore the cost. This was not foreseen in the original grant application. The cost of advertising and lab screening has been an unanticipated but necessary expense within the scope of the original project. We are requesting a cost increase in this supplemental grant to preserve the overall impact of the project consistent with its originally approved objectives and purposes.

这是一份行政补充拨款申请，要求为第四个月提供补充财政支持 国家卫生研究院正在进行的拨款的年份，R01-NS 101283。在最初的拨款申请中，我们原计划 通过一家血液学诊所招募，预计每年从 据估计，将有60名受试者完全参与这项研究。基于这些估计，我们预计 在资助金的头4年内完成所需的240名受试者(120名RLS和120名对照)。然而， 通过单一的血液学诊所进行招募，未能提供足够的学科招生。我们解决了 通过开展广泛的招聘努力解决这一问题，包括：增加人数 和涉及的诊所类型，在当地医院和大学放置传单和海报，基于网络 和电视广告。通过更广泛的招聘努力，我们已经证明了我们 可以提高招聘率，但我们认为这将足以实现适当的样本量 这可能需要在赠款的第五年继续征聘。招聘人数的增加 临床环境之外的患者增加了所需筛查实验室的数量，从而增加了成本。 在最初的赠款申请中没有预见到这一点。广告和实验室筛查的成本一直是 在原项目范围内发生的意外但必要的费用。我们要求增加成本 在这项补充拨款中，以保持项目的整体影响与其最初批准的 目标和目的。