In a study co-authored by a group of researchers including PERF’s Richard Casaburi, Ph.D., M.D., and Janos Porszasz, Ph.D., M.D., and funded by the Patient-Centered Outcomes Research Institute (PCORI), it was found that patient involvement in the design of clinical trials improved the degree to which the needs and concerns of both patients and their caregivers were satisfied.
In the study, patients with chronic obstructive pulmonary disease were involved in the design of a clinical trial to promote adherence to supplemental oxygen therapy.
A total of 25 patients and 5 caregivers provided input via telephone conversations and e-mail regarding the types of interventions used and the outcomes that they felt were most important.
Based on this patient and caregiver input, refinements were made in the length of intervention sessions (20-minute sessions or longer were found by patients to be acceptable), the inclusion of caregivers, the attention given to such factors as social discomfort about using oxygen in public, and the identification of personally relevant reasons to use oxygen. Outcomes that patients ranked as highly important included physical function, fatigue, sleep, anxiety, depression, and the ability to participate in social roles and activities.
Patient involvement resulted in refinements of both the intervention and the clinical trial endpoints, which ultimately better addressed the expressed needs and concerns of patients and their caregivers.
The researchers who initiated this study were:
Hélène A. Gussin
Robert A. Sandhaus
Jamie L. Sullivan
Linda J. Walsh
Jerry A. Krishnan