IDENTIFICATION OF CLINICALLY RELEVANT CHANGES IN HRQOL

这项研究的具体目标是：(1)提炼和扩展三种特定疾病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(MCID)；以及(2)确定与这些MCID对应的测量标准误差(即每个领域的标准差乘以一的平方根减去其可靠性系数)的值。针对疾病的测量是慢性心脏问卷(CHQ；修改后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；用于慢性阻塞性肺疾病[COPD]患者)和哮喘生活质量问卷(AQLQ；用于哮喘患者)。通用的衡量标准是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定的HRQOL测量和SF-36，并遵循先前开发的方法，将确定两者的MCID。第二个数据流来自一项纵向研究，招募了1800名患者(印第安纳波利斯和圣路易斯两个初级保健地点的每个疾病组300人)，其中包括一次简短的门诊筛查访谈、一次30分钟的基线电话访谈，以及六次30分钟的电话随访，每隔两个月固定一次，除非病情恶化或定期拜访他们的常规初级保健医生，从而在这些访问的48小时内触发后续访谈。第三份数据来自这些患者的常规初级保健医生，他们将在基线访问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安排的后续访问中填写另一份简短问卷，内容涉及患者健康状况的变化和这些变化引发的治疗行动。有两个主要的分析阶段。使用以前开发的方法，我们将：(1)从专家小组、患者和初级保健医生的角度合并CHQ、CRQ、AQLQ和SF-36措施的MCID；以及(2)确定与合并的MCID相对应的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.