Clinical Suspicion of TB: A Technology Assessment Tool

一种新的结核病（TB）诊断测试，价格低廉，易于执行，既敏感又特异，是一种 最高优先级由于结核病的诊断需要将实验室和临床性能标准相结合， 新的结核病诊断检测方法是一项挑战。此外，由于结核病有许多表现， 测试可能在某些结核病表现中比在其他表现中更有效。医生评估可以帮助识别集群，或 患者的子集，其中特定测试可能是最有用的。结核病的临床怀疑（CSTB）仪器 根据公认的流行病学、临床、放射学、免疫学、免疫学和免疫学等， 建立肺结核（PTB）推定诊断的图形学和细菌学标准。CSTB已 该小组在初步研究中使用了这一数据，以确定结核病治疗前的患病率。的第一个目标 本研究旨在描述医生使用CSTB在不同环境下对PTB先验概率的估计 作为技术评估工具。第二个目标是应用该工具评价临床性能 血清诊断作为经验性治疗决策的辅助手段。结核病的血清诊断试验提供了一个很好的测试案例， 许多评估这些试验的研究人员发现，CSTB具有良好的操作特性，但 对于日常使用来说足够好了。在这项前瞻性、随机、对照试验中，3,040例结核病疑似患者（预期540例 将在六个国际代表性临床研究中心入组。CSTB将在每个 将评估两种新的结核病血清学诊断检测方法的临床性能。患者将被- 选择CSTB和测试性能的诊断和筛查PTB的适应症。之间 随机接受现场血清学诊断或标准检查（无血清学诊断）的患者，CSTB评分和 将比较经验性治疗决定的准确性。补充的实验室研究将评估抗原受体- 不同人群的认知特征。具体目标是：（1）。评价CSTB的信度和效度， 一种用于估计医生治疗前患病可能性的工具。2.）的情况。评价敏感性、特异性和预测性， 不同检测指征下的血清学诊断价值。3.）第三章为了表征血清素的操作特性， 使用CSTB进行诊断。4.）评价血清学诊断对医生估计疾病可能性的影响 和经验性的治疗决定。5.）建立一个评估血清学诊断临床效用的决策模型， 本试验中收集的血清将用于建立血清库，用于检测新的、尚待开发的血清， 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，使丰富的 临床检查的评估和使用实验室测试结核病，2）提供了深入了解如何两个血清学诊断测试 可用于辅助结核病的快速诊断，3）建立血清库，用于筛选未来的血清学试验， TB.这将有助于明确血清学检测在PTB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.