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

描述(申请人提供)：慢性阻塞性肺病是美国发病率的主要原因和第三大死亡原因。它的特点是多变的 临床影响、表现、不同的气流限制、急性加重的频率和严重程度(AECOPD)。尽管慢性阻塞性肺病对公众健康很重要，但人们对其认识不足，治疗不足。可能支持COPD诊断的测试并不是常规进行的。虽然肺活量测定法不推荐用于检测所有有早期COPD风险的人，但筛查那些更有可能患有导致不良后果的疾病的人将使患者能够更早地接受治疗，并有可能降低发病率和死亡率。许多小组开发了调查问卷，以加强诊断生理测试的适当应用，但没有一个小组的设计是为了确定先前未诊断的患者具有最高的不良卫生保健后果风险。我们假设，一种简单的筛查方法，结合一份包含有限数量项目的简单问卷和最大呼气流量(PEF)测量，将识别出具有临床意义的COPD受试者。这项建议的目的是开发一种简单的筛查方法，用于初级保健，以确定有1)中度以上气流阻塞和/或2)AECOPD风险的受试者，在这些受试者中，需要进行包括肺活量测定在内的额外评估来诊断COPD。我们相信，这两个风险群体都可以通过结合PEF和有限项目问卷的分层方法来识别。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，有效地对患有1)中度以上气流障碍和/或2)AECOPD风险的受试者进行分类，在这些受试者中，表明有包括肺活量测定在内的额外评估来诊断COPD。目的2-根据定量预测变量(目标1)和从高风险和低风险受试者获得的定性数据获得的洞察力，编制一份具有多个候选项目的自填式问卷，具有内容和结构(内容效度)。我们将把PEF纳入方法学的发展中，以确定具有临床意义的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，然后将其用于以初级保健为基础的纵向队列患者，以确定其在初级保健实践中的有效性。我们将独立和同时分析多个候选项目，并评估PEF在识别临床上有意义的COPD患者方面的边际附加预测能力。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，以及与慢性阻塞性肺病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目的重要信息。由此产生的新的筛查方法结合了简单的项目和PEF测量，将增强识别最有可能从现有治疗中受益的COPD患者的能力。

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.