Bethesda, MD, USA – Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by limited airflow, or difficulty breathing. Dyspnea, usually described as shortness of breath (SOB), affects the lives of patients with COPD and inhibits many daily activities. Researchers at GlaxoSmithKline, in collaboration with United BioSource Corporation (UBC), developed a questionnaire to evaluate the impact of therapy on SOB associated daily activities.
Development of the questionnaire in alignment with the FDA guidance on Patient Reported Outcomes (PRO) consisted of four components. First, an initial review of the literature took place, followed by the creation of seven focus groups of 40 individuals with COPD. These individual were asked to describe their experiences of SOB during daily activities. Then, questions were drafted based on the review of the literature, the focus group findings and discussion among clinical experts. Cognitive interviews of participants were conducted to assess the questions, and their feedback was used to refine the questionnaire. Input was also sought from the FDA and clinicians.
The resulting questionnaire assessed SOB associated with everyday activities, with thirty seven patients participating in cognitive interviews. Participants found the questions clear and easy to understand with relevance to their everyday experiences, as well as easy to use in an electronic format.
“Using PRO and getting participants’ honest input to develop the optimal set of questions to ask is key to developing the best strategies to tackle any medical ailment,” said Kellee Howard, UBC’s Senior Research Associate.
The article, ‘Development of the Shortness of Breath with Daily Activities Questionnaire (SOBDA)‘ is published in Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). This research was funded by GlaxoSmithKline.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research as well as policy papers to help health care leaders make evidence-based decisions. The journal is published bi-monthly and has over 8,000 subscribers (clinicians, decision makers, and researchers worldwide).
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.
For more information: www.ispor.org