How to present work productivity loss results from clinical trials for patients and caregivers? A mixed methods approach

Objectives: From the perspectives of patients and caregivers, the objectives were: identifying which result pre-sentations, describing work productivity loss (WPL) outcomes, are most understandable; measuring which pre-sentations are important to report; and investigating which WPL outcomes are viewed as important alongside clinical trials results.Methods: We used a four phased, sequential mixed methods design, guided by patient-oriented research engaging one patient partner. We conducted think-aloud interviews, in British Columbia/Canada, to review WPL results and our survey measuring the understandability and importance of the results, and importance of each WPL outcome. We surveyed a sample representing working Canadians. The findings were summarized and analyzed using linear and logistic regression. We conducted sub-group analyses; one was gender based. All regressions were conducted using generalized estimating equations. Results: In our qualitative phases, 20 patients and caregivers were interviewed. Participants recommended for the results to be brief, simple, and represented visually. Then, 118 patients and 120 caregivers were surveyed. The results presented in days or cost yielded the highest understandability and importance to report. All WPL out-comes were identified as important to somewhat important to report by most. The associations indicated that the more understandable the result presentation was, the more likely it was to be rated as important. Age was the only factor significantly associated with selecting days or cost as the most important result. Conclusion: Presenting WPL results in days and cost, using lay terms and visual supports, were viewed as easiest to understand and most important to report in clinical trials by patients and caregivers. Our findings are sup-portive of clinical trials standardizing the measurement of WPL to include all of its outcomes (absenteeism, presenteeism, employment status changes and total work productivity loss), in addition to tools assessing the comprehensiveness of WPL results to be provided to patients and caregivers.

Automated summary

This study aims to identify the most understandable and important results presentations regarding work productivity loss (WPL) outcomes from the perspectives of patients and caregivers. Using a mixed methods design, including interviews and surveys, the findings suggest that presenting WPL results in days or cost is the easiest to understand and most important to report in clinical trials.