Patient responses to passive enrollment into a large, pragmatic clinical trial: A qualitative content analysis.

BACKGROUND: While passive enrollment or "opt-out" recruitment methods facilitate pragmatic clinical trials, they pose unique challenges, and it is unclear how participants feel about them. Here, we describe patient responses to passive enrollment into the Watch the Spot Trial, a pragmatic trial comparing two sets of guidelines for small lung nodule follow-up. METHODS: For this nested qualitative study, we analyzed participant-initiated calls and emails. We performed a qualitative content analysis, using a team-coding approach to identify reasons that eligible participants contacted the study team. We calculated the proportion of contacts containing each code, and how often each code coincided with study opt-outs and other codes. RESULTS: Of 23,412 eligible participants across seven sites, 1494 (6.4%) contacted the study team, with 1560 total contacts. Among the total contacts, the most common codes (i.e., reasons for contacting the team) were study opt-outs (n = 614, 39.0%), clarification of study procedures (n = 328, 21.0%), and unawareness of the nodule prior to research notification (n = 244, 15.6%). The least common codes were concerns about sharing of protected health information with the study team (n = 22, 1.4%) or outside of the healthcare system (n = 26, 1.7%), and disapproval of the opt-out approach (n = 10, 0.6%); most patients with these concerns opted-out. Nodule unawareness sometimes coincided with anger (n = 24) or distress (n = 15), and questions about nodule care sometimes coincided with distress (n = 20) and questions about follow-up surveys (n = 26). CONCLUSION: Most participants did not report concerns about passive enrollment. Patient perspectives are an invaluable resource for minimizing risks and inconveniences of future pragmatic trials using this recruitment method.

Assessing the concurrent validity of days alive and at home metric.

BACKGROUND: Most patients living with serious illness value spending time at home. Emerging data suggest that days alive and at home (DAH) may be a useful metric, however more research is needed. We aimed to assess the concurrent validity of DAH with respect to clinically significant changes in patient- and caregiver-reported outcomes (PROs). METHODS: We drew data from a study that compared two models of home-based palliative care among seriously ill patients and their caregivers in two Kaiser Permanente regions (Southern California and Northwest). We included participants aged 18 years or older (n = 3533) and corresponding caregivers (n = 463). We categorized patients and caregivers into three groups based on whether symptom burden (Edmonton Symptom Assessment System, ESAS) or caregiving preparedness (Preparedness for Caregiving Scale, CPS) showed improvements, deterioration, or no change from baseline to 1 month later. We measured DAH across four time windows: 30, 60, 90, and 180 days, after admission to home palliative care. We used two-way ANOVA to compare DAH across the PRO groups. RESULTS: Adjusted pairwise comparisons showed that DAH was highest for patients whose ESAS scores improved or did not change compared with those with worsening symptoms. Although the mean differences ranged from less than a day to about 3 weeks, none exceeded 0.3 standard deviations. ESAS change scores had weak negative correlations (r = -0.11 to -0.21) with DAH measures. CPS change scores also showed weak, positive correlations (r = 0.23-0.24) with DAH measures. CONCLUSION: DAH measures are associated, albeit weakly, with clinically important improvement or maintenance of patient symptom burden in a diverse, seriously ill population.

Validation of the Pediatric Vision Scanner in a normal preschool population.

PURPOSE: To assess the Pediatric Vision Scanner (PVS), a handheld vision screening device designed to test for amblyopia and strabismus, in a general pediatric population. METHODS: In this prospective study, trained research staff screened 300 eligible children 24-72 months of age with no known eye conditions for amblyopia and strabismus using the PVS. A pediatric ophthalmologist masked to PVS screening results then performed a comprehensive eye examination. Sensitivity and specificity of the PVS was calculated with a 95% confidence interval. RESULTS: Based on the gold standard eye examination, 6 children (2%) had amblyopia and/or strabismus. The PVS detected all 6 cases, yielding a sensitivity rate of 100% (95% CI, 54%-100%). The PVS referred 45 additional children (15%) who had normal ophthalmic findings, yielding a specificity rate of 85% (95% CI, 80%-89%). The median acquisition time for the PVS was 28 seconds. CONCLUSIONS: The PVS detected amblyopia with high sensitivity in a nonenriched pediatric population. The device would allow children with amblyopia and/or strabismus to be referred to an eye care specialist as early as 2 years old. Given its short acquisition time, the PVS can be implemented in a pediatric clinic with minimal impact on workflow.