IDENTIFICATION OF CLINICALLY RELEVANT CHANGES IN HRQOL

本研究的具体目的是：(1)改进和扩展三种疾病特异性和一种一般健康相关生活质量（HRQoL）测量的最小临床重要差异（MCIDs）；(2)确定与这些mcid对应的测量标准误差（SEM，即每个域的标准差乘以1减去其可靠性系数的平方根）的值。疾病特异性测量方法是慢性心脏问卷（CHQ，修改后用于冠心病和/或充血性心力衰竭[CAD/CHF]患者）、慢性呼吸问卷（CRQ，用于慢性阻塞性肺疾病[COPD]患者）和哮喘生活质量问卷（AQLQ，用于哮喘患者）。通用的测量方法是SF-36。为了实现这些具体目标，我们将收集三种数据流。第一批数据来自三个国家专家组，这些专家组负责治疗患有目标疾病的中老年人。一个小组将专注于CAD/CHF，一个小组将专注于COPD，一个小组将专注于哮喘。每个小组将审查适当的疾病特异性HRQoL测量和SF-36，并按照先前开发的方法确定两者的mcid。第二组数据来自一项纵向研究，该研究招募了1800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分别有300名患者），其中包括简短的门诊筛查访谈、30分钟的基线电话访谈、每隔两个月进行6次30分钟的电话随访，除非病情恶化或定期去看初级保健医生，在随访后48小时内进行随访。第三个数据流来自这些患者的常规初级保健医生，他们将在基线就诊时填写一份关于患者当前健康状况的简短问卷，并在每次病情恶化或定期随访时填写另一份简短问卷，内容涉及患者健康状况的变化以及这些变化引发的治疗行动。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)确定与综合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.