United BioSource Corporation, 26-28 Hammersmith Grove, Floor 5E, London W6 7HA, UK.
Health Qual Life Outcomes. 2013 Jun 25;11:104. doi: 10.1186/1477-7525-11-104.
The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument.
Literature review and clinician interviews were conducted to inform discussion guides to explore patients' nighttime COPD symptom experience. Data from focus groups with COPD patients was used to develop a conceptual framework and the content of a new PRO instrument. Patient understanding of the new instrument was assessed via cognitive interviews with COPD patients.
The literature review confirmed that there is no instrument with evidence of content validity currently available to assess nighttime symptoms of COPD. Additionally, the literature review and clinician interviews suggested the need to understand patients' experience of specific symptoms in order to evaluate nighttime symptoms of COPD. Analyses of patient focus group data (N = 27) supported saturation of concepts and aided in development of a conceptual framework. Items were generated using patients' terminology to collect data on concepts in the framework including the occurrence and severity of COPD symptoms, use of rescue medication at night, and nocturnal awakening. Response options were chosen to reflect concepts that were salient to patients. Subsequent cognitive interviewing with ten COPD patients demonstrated that the items, response options, recall period, and instructions were understandable, relevant, and interpreted as intended.
A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content validity. The NiSCI is ready for empirical testing, including item reduction and evaluation of psychometric properties.
评估慢性阻塞性肺疾病（COPD）的症状对于监测和管理疾病以及评估干预措施的结果非常重要。COPD 患者在白天和晚上都会经历症状，晚上经历的症状常常会干扰睡眠。本文的目的是描述开发一种用于评估 COPD 夜间症状的患者报告结局（PRO）工具的方法，并记录该工具内容效度的证据。
进行文献回顾和临床医生访谈，以提供讨论指南，探讨患者夜间 COPD 症状体验。使用 COPD 患者的焦点小组数据来开发新概念框架和新 PRO 工具的内容。通过与 COPD 患者进行认知访谈来评估患者对新工具的理解。
文献综述证实，目前尚无具有内容效度证据的工具可用于评估 COPD 的夜间症状。此外，文献综述和临床医生访谈表明，需要了解患者特定症状的体验，以便评估 COPD 的夜间症状。对患者焦点小组数据（N=27）的分析支持了概念的饱和，并有助于开发概念框架。使用患者的术语生成项目，以收集框架中包括 COPD 症状的发生和严重程度、夜间使用急救药物以及夜间觉醒等概念的数据。选择响应选项以反映对患者重要的概念。随后对十名 COPD 患者进行认知访谈表明，这些项目、响应选项、回忆期和说明是可以理解的、相关的并且可以按预期进行解释。
开发了一种新的 PRO 工具，即夜间 COPD 症状量表（NiSCI），并记录了内容效度的证据。NiSCI 已准备好进行实证测试，包括项目减少和心理测量特性评估。
