RESEARCH DIAGNOSTIC CRITERIA-- RELIABILITY AND VALIDITY

研究诊断标准——可靠性和有效性

• 批准号: 6773915
• 负责人: ERIC L SCHIFFMAN
• 金额: $ 163.7万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6773915
• 关键词: biomarker; biopsy; clinical research; diagnosis design /evaluation; diagnosis quality /standard; enzyme linked immunosorbent assay; facial muscles; gas chromatography mass spectrometry; human subject; inflammation; interview; magnetic resonance imaging; mastication; musculoskeletal disorder diagnosis; oral facial pain; pain threshold; psychobiology; questionnaires; radioimmunoassay; sign /symptom; statistics /biometry; synovial fluid; temporomandibular joint syndrome; tissue /cell culture

DESCRIPTION: (adapted from the applicant?s abstract): Temporomandibular disorders (TMD) are common problems in the general population. The Research Diagnostic Criteria (RDC) for TMD were developed to establish specific operationalized examination procedures and diagnostic criteria for 8 Axis I biomedical diagnoses of TMD, as well as Axis II biobehavioral assessment procedures. Procedural reliability testing has been established for the RDC Axis I examination items, but full acceptance of the RDC requires confirmation of the temporal stability, validity, generalizability and clinical utility of the examination items, biomedical diagnoses, biobehavioral assessments, and general protocol. In order to accomplish these overall goals, a multi-center project is proposed that will first reassess at the University of Minnesota the reliability of 6 examiners (2 examiners each from 3 participating universities) to collect clinical Axis I examination data using the RDC operational definitions. In a second step, reliable blinded examiners will collect clinical examination data and formulate RDC diagnoses, which will be compared to criterion diagnoses made by an expert imaging. New clinical exam items will also be assessed. Subject to expert consensus, they will be added to yield a final exam protocol that will include all current RDC examination items as well as the new items. With this new protocol, the 6 examiners will continue examining normal and TMD subjects at their respective centers in order to test the temporal stability and diagnostic validity of the new and existing examination items, patient history items, and TMJ imaging by plain film and MRI. Discriminant analyses and decision tree analyses will be used to determine the best diagnostic algorithms for rendering RDC diagnoses. Masticatory muscle biopsies and TMJ synovial fluid will be collected from subjects at the University of Minnesota to evaluate biological markers for their role as potential mediators underlying the biomedical diagnoses. Simultaneously, Axis II biobehavioral assessment procedures will be tested for temporal reliability, compared with other accepted self-report instruments for concurrent validity, and, at two centers, evaluated for criterion validity against highly structured psychiatric interviews. The clinical and health services utility of adding Axis II biobehavioral assessments, imaging and biopsy results to Axis I clinical examination findings will be appraised. Advancement in our understanding of the prevalence, etiologies, natural progression, and treatment of TMD is dependent on having reliable and valid diagnostic criteria for these disorders.

描述：（改编自申请人？s abstract）：颞下颌关节 TMD是普通人群中常见的问题。研究 TMD的诊断标准（RDC）的制定，以建立具体的 8轴I的操作性检查程序和诊断标准 TMD的生物医学诊断，以及Axis II生物行为评估 程序.已经为RDC建立了程序可靠性测试 轴I检查项目，但RDC的完全验收需要确认 的时间稳定性，有效性，普遍性和临床实用性， 检查项目、生物医学诊断、生物行为评估，以及 一般协议。为了实现这些总体目标，多中心 该项目提出，将首先在明尼苏达大学重新评估 6名考官的可靠性（3所参与大学各2名考官） 使用RDC操作收集临床Axis I检查数据 定义.第二步，可靠的设盲检查员将收集临床数据 检查数据，并制定RDC诊断，这将与 标准诊断由专家成像。新的临床检查项目将 也要评估。在专家达成共识的情况下，它们将被添加到 期末考试协议，将包括所有当前RDC考试项目以及 作为新的项目。根据新的协议，6名检查员将继续 在他们各自的中心检查正常和TMD受试者， 新的和现有的时间稳定性和诊断有效性 检查项目、病史项目和TMJ平片成像， 核磁共振判别分析和决策树分析将用于确定 用于渲染RDC诊断的最佳诊断算法。咀嚼肌 将在第二天收集受试者的活检和TMJ滑液。 明尼苏达大学评估生物标记物作为 潜在的介体的生物医学诊断。与此同时，Axis 将测试生物行为评估程序的时间可靠性， 与其他公认的自我报告工具的同时有效性相比， 并在两个中心，评估标准效度对高度结构化的 精神病学访谈添加Axis的临床和健康服务实用程序 II生物行为评估、成像和活检结果与Axis I临床 考试结果将予评核。增进我们对 TMD的患病率、病因、自然进展和治疗依赖于 对这些疾病有可靠和有效的诊断标准。