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

项目摘要/摘要 大多数慢性阻塞性肺病患者仍然没有得到认可和治疗；这些人的健康状况受到了损害。 疾病、急性呼吸道疾病恶化、死亡率增加和卫生保健利用率高。目标病例查找 到目前为止，一般都是在没有参考肺活量严重程度或恶化(ECOPD)风险的情况下确定患者。 我们开发了一个简单的病例查找工具，使用五个问题并结合选择性呼气峰流速 测量(捕获)，确定患有“临床上有意义的慢性阻塞性肺疾病”的人，那些最有可能受益的人 从目前可用的治疗方法中。我们的长期目标是有效地识别这些人，以便治疗 改善健康状况，减少经社理事会疾病，降低发病率。这项建议的总体目标是 验证捕获的敏感度、特异度和预测价值，以确定未诊断的、有临床意义的 不同初级保健人群中的慢性阻塞性肺疾病；确认这种方法学方法可以整合到 各种初级临床护理环境；并探索识别这些患者是否会带来改善 慢性阻塞性肺病的特殊护理和健康状况。我们的中心假设是，捕获可以有效和高效地 确定未诊断的、临床上有意义的COPD的初级保健患者。建议的理由是 研究表明，三个简单问题的答案将改变初级COPD诊断的范式 护理：1)捕获有效地识别具有临床意义的COPD患者；2)捕获工作 在初级保健环境中；以及3)捕获是否会改变以前患者的生活 未确诊的、有临床意义的慢性阻塞性肺疾病。在强劲的初步数据指导下，我们将实现三个具体目标： 1)我们将确定捕获在确定临床上有意义的COPD方面的敏感性和特异性 广泛的初级保健门诊实践；2)我们将在10年中定义使用Capture的可行性 代表全美范围广泛的初级保健临床环境的实践；3)我们将探讨 在广泛的初级保健门诊实践中使用我们的病例发现方法，并评估实践和 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5000名受试者队列研究中实现，该研究涉及75家初级保健诊所，隶属于5家 以初级保健为基础的研究网络，为以前未确诊的患者提供访问途径 民族、种族、社会经济和区域多样性。在这些临床实践的子集中，我们将完成 详细分析了实施捕获的可行性。我们的方法具有高度的创新性和临床应用价值。 相关，因为它应用了一种严格开发的、新的COPD病例查找方法来识别COPD患者 最有可能从可用的治疗中受益。这项拟议的研究意义重大，因为研究结果将改变 初级保健中COPD诊断的范例和改变全球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.