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 presentations, describing work productivity loss (WPL) outcomes, are most understandable; measuring which presentations 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 outcomes 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 supportive 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.

Measuring, Analyzing, and Presenting Work Productivity Loss in Randomized Controlled Trials: A Scoping Review.

OBJECTIVES: This study aimed to conduct a scoping review of randomized controlled trials (RCTs) and investigate which work productivity loss outcomes were measured in these RCTs, how each outcome was measured and analyzed, and how the results for each outcome were presented. METHODS: A systematic search was conducted from January 2010 to April 2020 from 2 databases: PubMed and Cochrane Central Register of Controlled Trials. Data on country, study population, disease focus, sample size, work productivity loss outcomes measured (absenteeism, presenteeism, employment status changes), and methods used to measure, report, and analyze each work productivity loss outcome were extracted and analyzed. RESULTS: We found 435 studies measuring absenteeism or presenteeism, of which 155 studies (35.6%) measured both absenteeism and presenteeism and were included in our final review. Only 9 studies also measured employment status changes. The most used questionnaire was the Work Productivity and Activity Impairment Questionnaire. The analysis of absenteeism and presenteeism data was mostly done using regression models (n = 98, n = 98, respectively) for which a normal distribution was assumed (n = 77, n = 89, respectively). Absenteeism results were most often presented in time whereas presenteeism was commonly presented using a percent scale or score. CONCLUSIONS: There is a lack of consensus on how to measure, analyze, and present work productivity loss outcomes in RCTs published in the past 10 years. The diversity of measurement, analysis, and presentation methods used in RCTs may make comparability challenging. There is a need for guidelines providing recommendations to standardize the comprehensiveness and the appropriateness of methods used to measure, analyze, and report work productivity loss in RCTs.