Abstract
Background: Although physical activity (PA) is a relevant concept for patients with COPD, no Patient Reported Outcome (PRO) exists to measure PA from the patient's perspective. Regulatory guidance requires that PROs should be underpinned by a conceptual framework. In absence of such framework on PA, the IMI PROactive consortium aimed to develop a new framework to guide the item generation of the PROactive instruments to measure PA in COPD. In this study, PA includes all activities requiring bodily movement, not just exercise or sports.
Methodology: The conceptual framework used a) content analysis of interviews and focus groups undertaken in 4 European countries with patients sampled to include diverse demographic and COPD phenotypes, b) systematic reviews; and c) iterative discussions with experts in COPD and PRO development.
Results: 78 patients (59% male; 40% GOLD III-IV; 55% >65 years) provided 23 one-to-one interviews and 8 focus groups (N= 55). Three overarching themes emerged from the qualitative interviews, explaining the concept PA from the patients' perspective, i.e. 1) what activities patients with COPD actually do (amount of PA); 2) how they feel when physically active (symptoms); and 3) how they organize their PA (adaptations patients make to facilitate PA).
Discussion: This conceptual framework provides comprehensive insight on the concept of PA from a patient perspective. It will guide the item generation for new PROs aiming to assess PA in COPD. A prospective study, using factor analysis, is planned to evaluate whether these 3 themes of the PROactive instruments indeed represent different domains of PA or rather one central concept, i.e. physical activity.
Funding IMI-JU PROactive GA#115011
- © 2011 ERS
