Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD 20814, USA.
Value Health. 2010 Dec;13(8):965-75. doi: 10.1111/j.1524-4733.2010.00772.x.
This article describes the qualitative methods used to develop the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome (PRO) instrument for evaluating frequency, severity, and duration of exacerbations of chronic obstructive pulmonary disease (COPD).
Focus groups and interviews were conducted in the United States with COPD patients treated for exacerbations during the past 6 months. Participants were asked to describe exacerbation attributes, care-seeking cues, and indications of progression and recovery. An iterative process was used to identify themes in the data to inform instrument content and structure. Cognitive debriefing interviews were performed to evaluate and revise the draft item pool. Experts in COPD, instrument development, and clinical research participated in the process.
Eighty-three subjects participated in elicitation focus groups or interviews (n=48); elicitation interviews with cognitive debriefing (n=23), or cognitive interviews alone (n=12). Mean age of the sample was 65 years (SD=10); 45% were male; mean FEV-1% predicted was 44% (SD=16). Participants characterized exacerbations as a persistent increase in the severity of respiratory symptoms and other systemic manifestations accompanied by a dramatic reduction in activity. Specific attributes included shortness of breath, chest congestion, cough, sputum, chest discomfort, feeling weak or tired, sleep disturbances, and concern or worry. The diary card of 23 candidate items was debriefed in booklet and electronic format.
Qualitative data from patients and input from experts formed the basis of the EXACT's structure and item pool, ready for empirically based item reduction and reliability and validity testing.
本文描述了开发慢性肺病加重评估工具（EXACT）的定性方法，该工具是一种新的用于评估慢性阻塞性肺疾病（COPD）加重频率、严重程度和持续时间的患者报告结局（PRO）工具。
在美国，对过去 6 个月内因加重而接受治疗的 COPD 患者进行了焦点小组和访谈。要求参与者描述加重的属性、寻求治疗的线索以及进展和恢复的迹象。使用迭代过程确定数据中的主题，以提供仪器内容和结构的信息。进行认知式访谈以评估和修改草案项目池。COPD 专家、仪器开发专家和临床研究专家参与了这一过程。
83 名受试者参加了诱发焦点小组或访谈（n=48）；进行了诱发访谈和认知式访谈（n=23），或单独进行认知式访谈（n=12）。样本的平均年龄为 65 岁（SD=10）；45%为男性；平均 FEV-1%预计为 44%（SD=16）。参与者将加重描述为呼吸症状和其他全身症状的严重程度持续增加，伴有活动能力急剧下降。具体属性包括呼吸急促、胸部充血、咳嗽、咳痰、胸部不适、感到虚弱或疲倦、睡眠障碍以及担忧或担心。23 项候选项目的日记卡以小册子和电子格式进行了介绍。
来自患者的定性数据和专家的意见为 EXACT 的结构和项目池提供了依据，为基于经验的项目减少以及可靠性和有效性测试做好了准备。
