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.

这是一项行政补充赠款提交，要求为第四支付补充财政支持 正在进行的NIH赠款年度，R01-NS 101283。在最初资助的赠款申请中，我们曾计划 通过单个血液学诊所招募，期望每年筛查约250名受试者 估计有60名受试者将被完全参与研究。根据这些估计，我们期望 在赠款的前4年中，实现必要的240名受试者（120 RLS和120个控制）。然而， 通过单个血液学诊所的招募未能提供足够的受试者入学率。我们解决了 通过开发广泛的基于广泛的招聘努力，包括：增加数字，这一问题 涉及的诊所的类型，位于当地医院和学院的传单和海报的位置，基于Web 和电视广告。随着招募范围的广泛努力，我们证明了我们 可以提高招聘率，尽管如此，我们认为这足以达到适当的样本量 这可能需要将招聘延续到赠款的第五年。增加的招聘 临床环境以外的患者增加了所需的筛查实验室的数量，因此增加了成本。 这不是在原始赠款申请中预见的。广告和实验室筛查的成本一直是 在原始项目的范围内，意外但必要的费用。我们要求增加成本 在这项补充赠款中，以保留与最初批准的项目的整体影响 目标和目的。