Design and Testing of tools to Identify individuals at high risk for COPD 73

描述（由申请人提供）：慢性阻塞性肺疾病是美国发病的主要原因，也是第三大死亡原因。 急性加重（AECOPD）的临床影响、表现、不同气流限制、频率和严重程度。尽管COPD具有公共卫生的重要性，但它的认识和治疗不足。可能支持COPD诊断的测试不是常规进行的。虽然肺功能测定法不推荐用于检测所有有早期COPD风险的人，但筛查那些更可能患有导致不良后果的疾病的人将允许早期治疗，并可能降低发病率和死亡率。许多团体已经开发了问卷调查，以加强诊断生理测试的适当应用，但没有一个被设计用于识别以前未诊断的患者，这些患者具有最高的不良医疗后果风险。我们假设，一个简单的筛选方法，包括一个简单的问卷调查，项目和呼气峰流量（PEF）测量数量有限，将确定受试者有临床意义的COPD。本提案的目的是开发一种用于初级保健的简单筛查方法，以识别1）中度以上气流阻塞和/或2）存在AECOPD风险的受试者，这些受试者需要进行额外评估（包括肺量测定）以诊断COPD。我们认为，这两个风险组可以通过分层的方法，包括PEF和有限的项目问卷确定。这些目标将通过完成三个具体目标来实现：目标1 -使用统计数据挖掘方法，从多个现有数据集中识别和分析候选变量，这些数据集可有效地将受试者分类为1）中度以上气流阻塞和/或2）存在AECOPD风险，其中需要进行额外评价（包括肺量测定）以诊断COPD。 目标2 -开发一个自我报告的问卷，其中包含多个候选项目，内容和结构（内容有效性）基于定量预测变量（目标1）和通过高风险和低风险受试者的定性数据获得的见解。我们将在方法学开发中纳入PEF，以识别具有临床意义的COPD患者。 目标3 -减少项目数量，并测试最终问卷的可靠性，敏感性和特异性，然后准备用于纵向跟踪的基于基层护理的患者队列，以确定其在基层护理实践中的有效性。 我们将独立并同时分析多个候选项目，并评估PEF在识别具有临床意义的COPD患者方面的边际额外预测能力。拟议的调查小组包括心理测量学、呼吸系统疾病、初级保健方面的专家，以及与COPD基金会的创新伙伴关系。我们可以访问大型数据集，这些数据集将提供有关候选项的重要信息。由此产生的，新的筛选方法，结合简单的项目和PEF测量将提高能力，以确定谁是最有可能受益于现有的治疗COPD患者。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease is a leading cause of morbidity and the third leading cause of death in the U.S. It is characterized by variable clinical impact, manifestations, varying airflow limitation, frequency and severity of acute exacerbations (AECOPD). Despite its public health importance COPD is under-recognized and undertreated. Testing that might support the diagnosis of COPD is not routinely performed. Although spirometry is not recommended for detecting all people at risk for early COPD, screening those more likely to have disease resulting in adverse consequences will allow earlier treatment and potentially reduce morbidity and mortality. Numerous groups have developed questionnaires to enhance the appropriate application of diagnostic physiological testing, but none have been designed to identify previously undiagnosed patients at the highest risk for adverse health care consequences. We hypothesize that a simple screening methodology incorporating a simple questionnaire with a limited number of items and peak expiratory flow (PEF) measurement will identify subjects with clinically significant COPD. The purpose of this proposal is to develop a simple screening approach for use in primary care to identify subjects with 1) more than moderate airflow obstruction and/or 2) at risk for an AECOPD in whom additional evaluation, including spirometry, is indicated to diagnose COPD. We believe both risk groups can be identified through a stratified approach incorporating PEF and a limited item questionnaire. These goals will be accomplished by completing three Specific Aims: Aim 1 - Using statistical data mining methodology, identify and analyze candidate variables from multiple existing datasets that efficiently classify subjects with 1) more than moderate airflow obstruction and/or 2) at risk for an AECOPD in whom additional evaluation, including spirometry, is indicated to diagnose COPD. Aim 2 - Develop a self-reported questionnaire with multiple candidate items, with content and structure (content validity) based on quantitative predictive variables (Aim 1) and insight gained through qualitative data from high and low risk subjects. We will incorporate PEF in development of methodology to identify patients having clinically significant COPD. Aim 3 - Reduce the number of items and test the reliability, sensitivity and specificity of the final questionnaire which will then be ready for use in longitudinally followed primary care-based cohorts of patients to identify its effectiveness in primary care practices. We will independently and simultaneously analyze multiple candidate items and evaluate the marginal additional predictive power of PEF in identifying patients with clinically significant COPD. The proposed investigative team includes experts in psychometrics, respiratory disease, primary care and an innovative partnership with the COPD Foundation. We have access to large datasets which will provide important information regarding candidate items. The resulting, novel screening approach incorporating simple items and PEF measurement will enhance the ability to identify COPD patients who are most likely to benefit from available therapies.