The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease

Health and Quality of Life Outcomes

Barry Make⁴  Robyn Carson²  Juliana Setyawan²  Michael L Schaefer³  Michelle Mocarski²  Andrew C Palsgrove³  Asha Hareendran¹ 

[1] United BioSource Corporation, 26-28 Hammersmith Grove, Floor 5E, London W6 7HA, UK;Forest Research Institute, Harborside Financial Center, Plaza V, Jersey City, NJ 07311, USA;United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA;National Jewish Health, 1400 Jackson St., Denver, CO 80206, USA

关键词: Awakening;    Nighttime;    PRO;    Symptoms;    COPD;   

Others  :  823529
DOI  :  10.1186/1477-7525-11-104

 received in 2012-12-12, accepted in 2013-06-20,  发布年份 2013

【 摘 要 】

Background

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.

Methods

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.

Results

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.

Conclusions

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.

【 授权许可】

   
2013 Hareendran et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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