OBJECTIVES: Patient reporting of symptom improvement is often the primary or key secondary outcome in US product labeling in diseases that are primarily symptomatic in nature; however, patients still report a report a variety of physical and emotional impacts in these diseases. The objective of this study was to understand which factors patient weigh as most important when determining if their disease status is improving.

METHODS: A total of 419 participants with diabetes (n=104), chronic obstructive pulmonary disease (COPD) (n=104), depression (n=107) or osteoarthritis (OA) (n=104) were recruited through Boston media sources; eligible participants were screened to confirm diagnosis. Participants were asked to choose from a list of four possible reasons how they would be able to tell a symptom was improving if they were taking a medication to help reduce a specific disease symptom. Responses were analyzed to determine the frequency with which participants endorsed each option.

RESULTS: Participants across all disease groups most commonly reported a reduction in severity would constitute an improvement in a symptom (n=249, 59.4%). This was followed by a reduction in the frequency of symptom occurrence (n=246, 58.7%), less interruption in daily activities, and/or reduced symptom duration (n=157, 37.5%). Participants could select multiple responses and n=99 participants (23.6%) selected all four response options offered.

CONCLUSIONS: In line with current FDA labels, a reduction in symptom severity was considered the main outcome of interest to patients. However, a substantial number of patients considered reductions in the frequency of symptoms, improvement in daily activities or some combination of factors to be an improvement. This research suggests that product labeling could be extended to include other factors beyond a reduction in symptom severity to more fully characterize the experience of patients in clinical trials.