Clinical Suspicion of TB: A Technology Assessment Tool

结核病的临床怀疑：技术评估工具

• 批准号: 6852683
• 负责人: ANTONINO CATANZARO
• 金额: $ 60.96万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-01 至 2007-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6852683
• 关键词: clinical research; clinical trials; diagnosis design /evaluation; diagnosis quality /standard; diagnostic tests; human subject; patient care planning; patient oriented research; respiratory disorder diagnosis; serology /serodiagnosis; tuberculosis

DESCRIPTION: (provided by applicant) A new diagnostic test for tuberculosis (TB) that is inexpensive, easy to perform and is both sensitive and specific is a high priority. Since the diagnosis of TB requires integrating laboratory and clinical performance standards, the evaluation of new diagnostic tests for TB is a challenge. Further, since there are many presentations of TB, a new diagnostic test may work better in some presentations of TB than in others. Physician evaluations can help to identify clusters, or subsets, of patients where a particular test can be most useful. The Clinical Suspicion of TB (CSTB) instrument provides a summary estimate of the pre-treatment likelihood of TB based on recognized epidemiologic, clinical, radiographic, and bacteriologic criteria for establishing a presumptive diagnosis of pulmonary TB (PTB). The CSTB has been used by this group in preliminary studies to determine the pre-treatment prevalence of TB. The first objective of this study is to characterize the physician's estimation of prior probability of PTB in different settings using the CSTB form as a technology assessment tool. The second objective is to apply this tool in evaluating the clinical performance of serodiagnosis as an aid to empiric treatment decisions. Serodiagnostic tests for TB provide an excellent test case for the CSTB in that many investigators who have evaluated these tests have found good operating characteristics, but not quite good enough for routine use. In this prospective, randomized, controlled trial, 3,540 TB suspects (600 expected to have PTB) will be enrolled at seven internationally representative clinical sites. The CSTB will be characterized at each site and the clinical performance of two new test formats for serodiagnosis of TB will be evaluated. Patients will be selected so as to study CSTB and test performance under both diagnostic and screening indications for PTB. Among patients randomized to receive on-site serodiagnosis or standard work-up without serodiagnosis, CSTB scores and the accuracy of empiric treatment decisions will be compared. Complementary laboratory studies will evaluate antigen recognition profiles in different populations. The specific aims are: 1) to evaluate the reliability and validity of the CSTB as a tool for estimating physicians' pre-treatment likelihood of disease, 2) to evaluate sensitivity, specificity, and predictive values of serodiagnosis under different testing indications, 3) to characterize operating characteristics of serodiagnosis using the CSTB, 4) to evaluate the impact of serodiagnosis on physicians' estimates of disease likelihood and empiric treatment decisions, and 5) to develop a decision model for estimating the clinical utility of serodiagnostic tests. Serum collected in this trial will be used to create a serum bank for testing of newer, as yet to be developed, serodiagnostic tests. This study will: 1) validate and streamline the CSTB as a simple tool to bring the richness of the clinical exam to the evaluation and use of laboratory tests for TB, 2) provide insights into how two serodiagnostic tests can be used to assist in rapid diagnosis of TB, and 3) establish a serum bank for screening of future serologic tests for TB. It will help define the role of serologic testing in the diagnosis of PTB.

描述：（由申请人提供）一种廉价、易于执行且灵敏且特异的新型结核病诊断测试是当务之急。由于结核病的诊断需要整合实验室和临床表现标准，因此对结核病新诊断测试的评估是一个挑战。此外，由于结核病有多种表现，因此新的诊断测试在某些结核病表现中可能比其他表现更有效。医生评估可以帮助识别特定测试最有用的患者群体或子集。结核病临床可疑 (CSTB) 工具根据公认的流行病学、临床、放射学和细菌学标准，对治疗前结核病的可能性进行汇总估计，以建立肺结核 (PTB) 的推定诊断。该小组已在初步研究中使用 CSTB 来确定治疗前结核病的患病率。本研究的第一个目标是使用 CSTB 表格作为技术评估工具来描述医生在不同环境下对 PTB 先验概率的估计。第二个目标是应用该工具评估血清诊断的临床表现，以辅助经验性治疗决策。结核病血清诊断测试为 CSTB 提供了一个极好的测试案例，因为许多评估这些测试的研究人员发现了良好的操作特性，但对于常规使用来说还不够好。在这项前瞻性、随机、对照试验中，将在 7 个具有国际代表性的临床中心招募 3,540 名结核病嫌疑人（其中 600 名预计患有 PTB）。将在每个地点对 CSTB 进行表征，并将评估用于结核病血清诊断的两种新测试形式的临床表现。将选择患者以研究 CSTB 以及在 PTB 诊断和筛查指征下的测试表现。 在随机接受现场血清诊断或无血清诊断的标准检查的患者中，将比较 CSTB 评分和经验性治疗决策的准确性。补充实验室研究将评估不同人群的抗原识别特征。具体目标是：1) 评估 CSTB 作为估计医生治疗前疾病可能性的工具的可靠性和有效性，2) 评估不同测试适应症下血清诊断的敏感性、特异性和预测值，3) 描述使用 CSTB 进行血清诊断的操作特征，4) 评估血清诊断对医生估计疾病的影响 可能性和经验性治疗决策，5) 开发决策模型来估计血清诊断测试的临床效用。本试验中收集的血清将用于创建血清库，用于测试尚未开发的新型血清诊断测试。这项研究将：1）验证和简化 CSTB 作为一个简单的工具，将临床检查的丰富性带入结核病实验室检测的评估和使用中，2）深入了解如何使用两种血清诊断检测来协助结核病的快速诊断，3）建立一个血清库，用于筛选未来的结核病血清学检测。它将有助于明确血清学检测在 PTB 诊断中的作用。