Restricted mean survival time versus conventional effect summary for treatment decision-making: A mixed-methods study

Background: Treatment effect is typically summarized in terms of relative risk reduction or number needed to treat ("conventional effect summary"). Restricted mean survival time (RMST) summarizes treatment effect in terms of a gain or loss in event-free days. Older adults' preference between the two effect summary measures has not been studied. Methods: We conducted a mixed methods study using a quantitative survey and qualitative semi-structured interviews. For the survey, we enrolled 102 residents with hypertension at five senior housing facilities (mean age 81.3 years, 82 female, 95 white race). We randomly assigned respondents to either RMST-based (n = 49) or conventional decision aid (n = 53) about the benefits and harms of intensive versus standard blood pressure-lowering strategies and compared decision conflict scale (DCS) responses (range: 0 [no conflict] to 100 [maximum conflict]; <25 is associated with implementing decisions). We used a purposive sample of 23 survey respondents stratified by both their random assignment and DCS from the survey. Inductive qualitative thematic analysis explored complementary perspectives on preferred ways of summarizing treatment effects. Results: The mean (standard deviation) total DCS was 22.0 (14.3) for the conventional decision aid group and 16.7 (14.1) for the RMST-based decision aid group (p = 0.06), but the proportion of participants with a DCS <25 was higher in the RMST-based group (26 [49.1%] vs 34 [69.4%]; p = 0.04). Qualitative interviews suggested that, regardless of effect summary measure, older individuals' preference depended on their ability to clearly comprehend quantitative information, clarity of presentation in the visual aid, and inclusion of desired information. Conclusions: When choosing a blood pressure-lowering strategy, older adults' perceived uncertainty may be reduced with a time-based effect summary, although our study was underpowered to detect a statistically significant