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.

临床核心研究中心成立于1992年，是在先前的一个计划项目的支持下成立的，是招募、评估和转介受试者参加该计划人类受试者研究的最有效机制，也是建立和管理供研究者使用的患者和对照组临床、人口统计学和心理社会信息永久数据库的最有效机制。生物识别部分将在即将到来的资金中纳入这一核心 期核心将继续进行受试者管理、与入组受试者的季度联系以及基于网络的数据收集，以支持正在进行的TMD发展风险因素的纵向前瞻性研究（Maixner的子项目）。此外，核心将负责参与Maixner、Hollins和Essick子项目的所有疼痛机制研究的受试者的招募、数据库创建和管理。因此，该核心的具体目标和职能是： 1.招募并确认TMD患者、纤维肌痛（FM）患者和健康受试者的诊断。排除标准的电话筛选将在筛选访视之前进行，筛选访视将包括医疗保健专业人员的病史和诊断性体格检查，以及完成人口统计学和健康史问卷。 2.通过安排Maixner、Hollins和Essick的子项目中的筛选访视和检测会议;通过将受试者随机分配至检测方案（如适用）;以及通过监测方案依从性，协调受试者参与人体研究。 3.对于Maixner的子项目，协调随机化并分发β-肾上腺素能受体阻滞剂和安慰剂;并监测受试者的药物副作用。 4.监督患者和健康受试者的数据收集、录入、处理、存储和分发给研究者，以满足其研究要求。 5.协助研究者设计和实施研究数据的统计分析计划，并解释结果。