Perception of burden of oral and inhaled corticosteroid adverse effects on asthma-specific quality of life.

BACKGROUND: A multistakeholder core outcome set created for asthma trials showed that asthma specific quality of life (QoL) was a critically meaningful outcome. However, the definition and how to measure it was undetermined. The adverse effects (AEs) of corticosteroids may be a vital clinical trial outcome. Yet, the AE burden from the patient perspective has not yet been elucidated in an asthma population.

OBJECTIVE: To characterize patient burden of AEs in oral (OCS) and inhaled corticosteroids (ICS) and how this relates to QoL within an asthma population.

METHODS: We utilized a convergent parallel mixed-methods design with quantitative surveys of known ICS and OCS AEs which were distributed through the Allergy & Asthma Network's database, social channels, and Asthma UK's newsletter. Participants rated the AEs that were (1) most burdensome and (2) most desired to be eliminated. Qualitative interviews and focus groups were performed to better understand patient views on barriers reported in the quantitative data, and to identify patient important barriers which were not a part of the quantitative survey.

RESULTS: The three most burdensome AEs for OCS were decreased bone mineral density, infectious complications, and weight gain, whereas weight gain was the most desired to be eliminated. The three most burdensome AEs for ICS were pneumonia, hoarse voice, and oral thrush with concordant results for the most desired to be eliminated. In the focus groups, OCS AEs were concordant with quantitative findings. Focus groups identified unmeasured psychosocial effects, such as embarrassment.

CONCLUSION: The most burdensome AEs may not be the AEs that would cause patients to stop therapy. Furthermore, qualitative focus groups suggest a psychosocial burden associated with ICS, which needs further investigation.