Clinical Suspicion of TB: A Technology Assessment Tool

一种新的结核病诊断测试是一种廉价、易于执行、既敏感又特异的检测方法 高优先级。由于结核病的诊断需要结合实验室和临床表现标准，评估- 开发新的结核病诊断测试是一项挑战。此外，由于有许多关于结核病的报告，一种新的诊断方法 在结核病的某些情况下，检测可能比在其他情况下效果更好。医生评估可以帮助识别集群，或者 患者的子集，其中特定的测试可能最有用。结核分枝杆菌(CSTB)检测工具的临床疑点 根据公认的流行病学、临床、放射学对结核病治疗前可能性的汇总估计- 建立肺结核(PTB)推定诊断的图解和细菌学标准。公务员培训局已 在初步研究中被该小组用来确定治疗前结核病患病率。的第一个目标 本研究旨在探讨医生在不同环境下使用CSTB对肺结核先验概率的估计 表格作为一种技术评估工具。第二个目标是将该工具应用于临床表现的评估。 血清诊断作为经验性治疗决策的辅助手段。结核病的血清诊断测试提供了一个很好的测试案例 CSTB在评估这些测试的许多调查人员中发现了良好的操作特性，但并不是 对日常使用来说已经足够好了。在这项前瞻性、随机、对照试验中，3040名疑似结核病患者(预计为540名 将在六个具有国际代表性的临床地点登记。CSTB将在每个 将评估用于结核病血清诊断的两种新检测形式的现场和临床表现。病人将会被忽视 选择以研究CSTB，并在诊断和筛查肺结核的指征下进行测试。其中 患者随机接受现场血清诊断或标准检查，没有血清诊断、CSTB评分和 将比较经验性治疗决策的准确性。补充的实验室研究将评估抗原重组- 不同人群的认知特征。具体目标是：1.评估CSTB的信度和效度为 一种估计医生治疗前疾病可能性的工具。2.)评估敏感度、特异度和预测性 不同检测指征下的血清学诊断价值3.)为了表征SERODI的作用特征- 使用CSTB进行诊断。4.)评估血清诊断对医生对疾病可能性的估计的影响 和经验性的治疗决定。5.)为评估血清学诊断的临床应用开发决策模型 试验中收集的血清将用于建立一个血清库，用于检测尚未开发的较新的Se-Se-1。 诊断试验。这项研究将1)验证和简化CSTB作为一个简单的工具，以带来丰富的 临床检查，以评估和使用结核病的实验室检测，2)提供对两种血清诊断测试如何 可用于辅助结核病的快速诊断，以及3)建立血清库，用于筛选未来的血清学测试 结核病。这将有助于明确血清学检测在肺结核诊断中的作用。

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 evalua- tion 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 pro- vides a summary estimate of the pre-treatment likelihood of TB based on recognized epidemiologic, clinical, radio- graphic, 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, 3,040 TB suspects (540 expected to have PTB) will be enrolled at six 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 se- lected 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 rec- ognition 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 predic- tive values of serodiagnosis under different testing indications. 3.) To characterize operating characteristics of serodi- agnosis using the CSTB. 4.) To evaluate the impact of serodiagnosis on physicians' estimates of disease likelihood and empiric treatment decisions. 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, se- rodiagnostic 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.