Core--Clinical and biometric

核心--临床和生物识别

• 批准号: 6876998
• 负责人: CEIB PHILLIPS
• 金额: $ 31.24万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6876998
• 关键词: biomedical facility; connective tissue disorder diagnosis; data management; female; fibromyalgia; human subject; information systems; medical outreach /case finding; muscle disorder diagnosis; pain; questionnaires; statistics /biometry; temporomandibular joint syndrome

The Clinical Core was founded in 1992 under the auspices of a previous Program Project as the most efficient mechanism for recruiting, evaluating and referring subjects to the Program's human subjects investigations and for establishing and managing a permanent database of clinical, demographic, and psychosocial information on patients and controls for use by the investigators. A biometric section will be incorporated in this core in the upcoming funding period. The core will continue subject management, quarterly contacts with enrolled subjects, and web-based data collection to support the ongoing, longitudinal prospective study of risk factors in the development of TMD (Subproject by Maixner). In addition the core will be responsible for the recruitment of, and database creation and management of subjects participating in all the Pain Mechanisms Studies of Subprojects by Maixner, Hollins, and Essick. Accordingly, the specific aims and function of this core are to: 1. Recruit and confirm a diagnosis for TMD patients, fibromyalgia (FM) patients, and healthy subjects. A phone screening for exclusion criteria will precede a screening visit that will include a medical history and diagnostic physical exam by a health care professional, as well as completion of demographic and health history questionnaires. 2. Coordinate subjects' participation in the human studies by scheduling screening visits and testing sessions in Subprojects by Maixner, Hollins, and Essick; by randomizing subjects to testing protocol, where appropriate; and by monitoring compliance with protocols. 3. For Subproject by Maixner, coordinate randomization and dispensing the beta-adrenergic blockade agent and placebo; and monitor subjects for drug side effects. 4. Oversee data collection, entry, processing, storage, and distribution to the investigators from patients and healthy subjects relevant to their research inquiries. 5. Assist investigators in designing and implementing plans for statistical analyses of research data, and in the interpretation of results.

该临床核心于1992年建立在先前程序项目的主持下，是招募，评估和引用该计划的人类受试者研究的最有效机制，并建立和管理和管理有关临床，人口统计学和心理社会信息的永久数据库，这些数据库在患者和对照中使用研究者，以供研究人员使用。生物识别部分将在即将到来的资金中纳入该核心 时期。核心将继续受试者管理，与已注册受试者的季度联系以及基于Web的数据收集，以支持TMD开发中持续的纵向前瞻性研究（Maixner副标题）。此外，核心将负责参与Maixner，Hollins和Essick参与所有参与所有疼痛机制研究的受试者的招聘，以及创建和管理。因此，该核心的具体目的和功能是： 1。招募并确认对TMD患者，纤维肌痛（FM）患者和健康受试者的诊断。在筛查访问之前，手机筛查将在筛查之前进行，其中包括医疗保健专业人员的病史和诊断身体检查，以及填写人口统计学和健康史问卷。 2。通过安排Maixner，Hollins和Essick对筛选的筛查和测试会议来协调人类研究的参与；在适当的情况下，通过随机将受试者随机分配为测试协议；并通过监视对协议的遵守。 3。对于Maixner的子标记，协调随机分配并分配β-肾上腺素能阻断剂和安慰剂；并监测受试者的药物副作用。 4。监督与研究调查有关的患者和健康受试者的研究人员的数据收集，输入，处理，存储和分发。 5.协助研究人员设计和实施计划的研究数据，并解释结果。