Patient Experience of Moderate Exacerbations in Asthma: Development of a Conceptual Model
Author(s)
Chandler D1, Wells J2, Zhang W3, Meeraus W4, Fowler A5, Slade D6, Abetz-Webb L7, Tabberer M5
1Adelphi Values Ltd, Bollington, CHE, Great Britain, 2Adelphi Values Ltd, Bollington, CHE, UK, 3GSK, Collegeville, PA, USA, 4GlaxoSmithKline, R&D Global Medical (at time of study), Brentford, UK, 5GSK, Uxbridge, UK, 6GSK, Research Triangle Park, NC, USA, 7Patient-Centred Outcomes Assessments, Cheshire, UK
Objective: Exacerbations of asthma present a significant burden to patients and health-care systems and are common endpoints in clinical studies. Whilst severe exacerbations are well understood, moderate exacerbations of asthma (requiring a temporary change in treatment although not requiring hospitalization) are less so, making their interpretation as endpoints difficult. Concept elicitation interviews were conducted to characterize patient experience of moderate exacerbations and develop a conceptual model. Methods: 20 US patients, with clinician confirmed diagnosis of moderate/severe asthma and experience of a moderate exacerbation =<30 days prior to the interview, participated in 60-minute semi-structured interviews about their experience. Interview transcripts were analyzed using thematic analysis. Results: Conceptual saturation was achieved within 20 interviews. The resulting conceptual model relates exacerbation triggers (similar to those of severe exacerbations) to symptoms of moderate exacerbations and the subsequent impact of these events. The model suggests moderate asthma exacerbations are characterized by increased severity, frequency and duration of symptoms above day-to-day experience. Two key symptoms were reported as most important; shortness of breath and wheezing, as well as coughing, chest tightness, phlegm/mucus and chest pain. Patients increased rescue/maintenance medication use. Night-time awakenings or difficulty falling asleep were also reported. Impacts on health-related quality of life included fatigue and anxiety/fear/panic. Patients stopped or slowed down physical, daily and social activities, missed work or were less productive. Conclusion: Increased frequency, severity and duration of core asthma symptoms, sleep disturbances and increased medication use define a moderate exacerbation from the patient perspective. Symptoms lead to fatigue, emotional distress and avoidance of physical, daily, work, and social activities. Although challenges may exist in identifying moderate exacerbations in clinical practice as patients may not seek healthcare, this conceptual model of moderate asthma exacerbation will be used to plan a patient focused measurement strategy for future clinical development. Funding: GlaxoSmithKline (study 209379)
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Code
PRS33
Topic
Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods
Disease
Respiratory-Related Disorders