IDENTIFICATION OF CLINICALLY RELEVANT CHANGES IN HRQOL

本研究的具体目的是：（1）完善和扩展三种疾病特异性和一种通用健康相关生活质量（HRQoL）测量的最小临床重要差异（MCID）;以及（2）确定测量标准误（SEM;即，每个域的标准偏差乘以1的平方根减去其可靠性系数）。 疾病特异性指标为慢性心脏问卷（CHQ;经修改用于冠状动脉疾病和/或充血性心力衰竭[CAD/CHF]患者）、慢性呼吸问卷（CRQ;用于慢性阻塞性肺病[COPD]患者）和哮喘生活质量问卷（AQLQ;用于哮喘患者）。 一般的衡量标准是SF-36。 为了实现这些具体目标，我们将收集三个数据流。 第一批数据来自三个国家的专家医生小组，他们治疗患有目标疾病的中年或老年人。 一个小组将关注CAD/CHF，一个小组将关注COPD，一个小组将关注哮喘。每个小组将审查适当的疾病特异性HRQoL指标和SF-36，并遵循先前开发的方法，确定两者的MCID。 第二个数据流来自于招募1,800名患者（印第安纳波利斯和圣路易斯初级保健中心的每个疾病组各300例），该纵向研究包括简短的门诊筛选访谈，30分钟的基线电话访谈，以及6次30分钟的电话随访，固定间隔2个月，除非病情加重-在他们的日常初级保健医生的推动下或定期安排的访问发生，在这些访问的48小时内触发后续访谈。 第三个数据流来自这些患者的常规初级保健医生，他们将在基线访视时完成一份关于患者当前健康状况的简短问卷，并在每次加重驱动或定期安排的随访访视时完成另一份关于患者健康状况变化和这些变化引起的治疗措施的简短问卷。 有两个主要的分析阶段。 使用先前开发的方法，我们将：（1）从专家小组、患者和初级保健医生的角度整合CHQ、CRQ、AQLQ和SF-36测量的MCID;（2）确定与整合MCID对应的SEM值。

The specific aims of this study are to: (1) refine and extend minimal clinically important differences (MCIDs) for three disease-specific and one generic health related quality of life (HRQoL) measures; and, (2) determine the values of the standard error of measurement (SEM; i.e., standard deviation of each domain multiplied by the square root of one minus its reliability coefficient) that correspond to these MCIDs. The disease- specific measures are the Chronic Heart Questionnaire (CHQ; modified for use with coronary artery disease and/or congestive heart failure [CAD/CHF] patients), the Chronic Respiratory Questionnaire (CRQ; used with chronic obstructive pulmonary disease [COPD] patients), and the Asthma Questionnaire of Life Quality (AQLQ; used with asthma patients). The generic measure is the SF-36. To accomplish these specific aims we will collect three streams of data. The first stream of data comes from three national panels of expert physicians who treat middle aged or older adults with the target diseases. One panel will focus on CAD/CHF, one will focus on COPD, and one will focus on asthma. Each panel will review the appropriate disease-specific HRQoL measure and the SF-36, and following previously developed methods, will determine MCIDs for both. The second stream of data comes from enrolling 1,800 patients (300 in each disease group at both the Indianapolis and St. Louis primary care sites) in a longitudinal study that includes a brief in-clinic screening interview, a 30-minute baseline telephone interview, and six 30-minute follow-up telephone interviews at fixed two-month intervals unless exacerbation-driven or regularly scheduled visits to their regular primary care physician occur that trigger follow-up interviews within 48 hours of these visits. The third stream of data comes from the regular primary care physicians of these patients, who will complete a brief questionnaire at the baseline visit about the patient's current health status, and another brief questionnaire at each exacerbation-driven or regularly scheduled follow-up visit concerning changes in the patient's health status and the treatment actions that these changes prompted. There are two major analytic phases. Using previously developed methods we will: (1) consolidate MCIDs for the CHQ, CRQ, AQLQ, and SF-36 measures from the expert panel, patient, and primary care physician perspectives; and, (2) determine the SEM values that correspond to the consolidated MCIDs.