Abstract
Background: Physical activity (PA) is a relevant outcome in COPD. We developed a conceptual framework on PA. In line with regulatory guidance documents, we used this framework to generate items for the Proactive Patient Reported Outcomes currently being developed to capture PA from the patients' perspective.
Methodology: We conducted 23 one-to-one interviews and 8 focus groups (N=55) with a representative group of COPD patients from 4 European countries (59% male; 40% GOLD III-IV; 55% >65 years). Quotes of patients' PA experiences and potential items were grouped per theme using Atlas TI. Information was supplemented with systematic reviews. Item phrasings, response options and recall period were iteratively discussed amongst experts in PRO development.
Results: Patients experience difficulties related to amount of PA. Climbing stairs and walking are the first activities impacted by the disease, although almost all activities of daily life are affected, such as lifting, chores, and self-care. Patients notice symptoms during PA such as breathlessness, or tiredness. Patients adapt to these restrictions by pacing or slowing down and taking breaks to recover, among others. We developed 2 item pools covering the conceptual framework: for daily use (25 items with 5-point Likert scales); and for clinic visits (7 days recall; 33 items with 5-point Likert scales).
Discussion: Culturally sensitive translations of these item pools are currently undergoing cognitive debriefings in 4 European countries to ensure clarity of instruction and items. A quantitative clinical study will then be conducted to finalize the items for each of the instruments.
Funding IMI-JU PROactive GA#115011
- © 2011 ERS
