Abstract
BackgroundThe 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.MethodsLiterature 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.ResultsThe 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.ConclusionsA 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.
Highlights
The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions
Literature review and clinician interviews Results of the literature review and clinician interviews suggested that to understand patients’ experience of nighttime symptoms of COPD, it is important to evaluate their experience of COPD symptoms as well as the consequences of these symptoms on sleep
The results informed the development of the protocol for these studies; for example, the necessary exclusion of conditions other than COPD that often result in the experience of respiratory symptoms at nighttime
Summary
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. Chronic obstructive pulmonary disease (COPD) is defined by persistent airflow limitation that is usually progressive and is associated with an enhanced chronic inflammatory response in the airways and the lungs to noxious particles or gases [1]. These changes result in breathlessness and other respiratory symptoms such as cough, sputum production, wheezing and chest tightness, which are associated with impaired quality of life of COPD patients [2]. The experience of symptoms at night was even more pronounced among the subgroup of patients with severe COPD, with 34% reporting a worsening of symptoms at night [4]
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