The CAPTURE Study: Validating a unique COPD screening tool in primary care

项目概要/摘要 大多数COPD患者仍未被认识和治疗不足;这些人的健康状况受损 健康状况恶化、急性呼吸系统恶化、死亡率增加和保健利用率高。有针对性的病例发现 迄今为止，该方法通常在不参考肺量测定严重程度或加重（ECOPD）风险的情况下识别患者。 我们开发了一个简单的病例发现工具，使用五个问题结合选择性呼气峰流量 测量（CAPTURE），识别患有“临床显著COPD”的个体，这些个体最有可能受益于 从目前可用的疗法。我们的长期目标是有效地识别这些个体， 改善健康状况，减少COPD，降低发病率。本提案的总体目标是 验证CAPTURE的敏感性、特异性和预测值，以识别未诊断的、有临床意义的 COPD在不同的初级保健人群中;确认这种方法可以整合到 各种初级临床护理环境;并探索识别这些患者是否会改善 COPD的具体护理和健康状况。我们的中心假设是，捕获可以有效地和高效地 识别未确诊的、具有临床意义的COPD患者。建议的理由 研究表明，三个简单问题的答案将改变COPD诊断的范式， 护理：1）CAPTURE在识别具有临床意义的COPD患者方面是否有效; 2）CAPTURE是否有效 在初级保健环境中;和3）CAPTURE是否会改变先前患有 未确诊的有临床意义的COPD在强有力的初步数据的指导下，我们将追求三个具体目标： 1)我们将确定CAPTURE在识别临床显著COPD中的敏感性和特异性， 广泛的初级保健门诊实践; 2）我们将在10年内确定使用CAPTURE的可行性 代表美国各地广泛的初级保健临床环境的实践; 3）我们将探讨 我们的病例发现方法在广泛的初级保健门诊实践和评估实践， 与COPD相关护理实施和临床结果相关的患者水平特征。 这些目标将在一项5,000名受试者的队列研究中实现，该研究涉及75个初级保健实践， 以初级保健为基础的研究网络，提供访问以前未确诊的患者， 民族、种族、社会经济和区域多样性。在这些临床实践的一个子集中，我们将完成 CAPTURE实施的详细可行性分析。我们的方法是高度创新和临床 相关性，因为它应用了严格开发的新型COPD病例发现方法来识别COPD患者 最有可能从现有的治疗中受益。这项研究的意义重大，因为研究结果将改变 在初级保健中的COPD诊断范例，并在全球范围内改变COPD建议。

PROJECT SUMMARY/ABSTRACT Most COPD patients remain unrecognized and undertreated; these individuals experience impaired health status, acute respiratory deteriorations, increased mortality and high health care utilization. Targeted case finding to date has generally identified patients without reference to spirometric severity or exacerbation (ECOPD) risk. We have developed a simple case finding tool using five questions combined with selective peak expiratory flow measurement (CAPTURE) that identifies individuals with “clinically significant COPD,” those most likely to benefit from currently available therapies. Our long-term goal is to effectively identify these individuals so therapy can improve health status, reduce ECOPD, and decrease morbidity. The overall objectives of this proposal are to validate the sensitivity, specificity, and predictive value of CAPTURE to identify undiagnosed, clinically significant COPD in a diverse primary care population; to confirm that this methodological approach can be integrated into a variety of primary clinical care settings; and explore whether identifying these patients results in improved COPD specific care and health status. Our central hypothesis is that CAPTURE can effectively and efficiently identify primary care patients with undiagnosed, clinically significant COPD. The rationale for the proposed research is that the answer to three simple questions will change the paradigm for COPD diagnosis in primary care: 1) Is CAPTURE effective in identifying patients with clinically significant COPD; 2) Does CAPTURE work in primary care settings; and 3) does CAPTURE make a difference in the lives of patients with previously undiagnosed, clinically significant COPD. Guided by strong preliminary data we will pursue three specific aims: 1) We will determine the sensitivity and specificity of CAPTURE in identifying clinically significant COPD in a broad range of primary care outpatient practices; 2) We will define the feasibility of using CAPTURE in 10 practices representing a wide range of primary care clinical settings across the US; 3) We will explore the impact of our case finding approach in a broad range of primary care outpatient practices and evaluate practice and patient level characteristics that are associated with COPD related care implementation and clinical outcomes. These aims will be accomplished in a 5,000 subject cohort study in 75 primary care practices affiliated with five primary care based research networks that provide access to previously undiagnosed patients who exhibit ethnic, racial, socioeconomic and regional diversity. In a subset of these clinical practices we will complete a detailed feasibility analysis of CAPTURE implementation. Our approach is highly innovative and clinically relevant as it applies a rigorously developed, novel COPD case finding approach to identifying COPD patients most likely to benefit from available therapy. The proposed research is significant, as the results will change the paradigm for COPD diagnosis in primary care and change COPD recommendations globally.