RESUMO
BACKGROUND: To improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding. AIM: As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable-that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length. METHODS: A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift. RESULTS: Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were "comfortable" (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours. CONCLUSIONS: Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.
RESUMO
BACKGROUND AND OBJECTIVES: Pediatric ambulatory asthma control is suboptimal, reducing quality of life (QoL) and causing emergency department (ED) and hospital admissions. We assessed the impact of the electronic-AsthmaTracker (e-AT), a self-monitoring application for children with asthma. METHODS: Prospective cohort study with matched controls. Participants were enrolled January 2014 to December 2015 in 11 pediatric clinics for weekly e-AT use for 1 year. Analyses included: (1) longitudinal changes for the child (QoL, asthma control, and interrupted and missed school days) and parents (interrupted and missed work days and satisfaction), (2) comparing ED and hospital admissions and oral corticosteroid (OCS) use pre- and postintervention, and (3) comparing ED and hospital admissions and OCS use between e-AT users and matched controls. RESULTS: A total of 327 children and parents enrolled; e-AT adherence at 12 months was 65%. Compared with baseline, participants had significantly (P < .001) increased QoL, asthma control, and reduced interrupted and missed school and work days at all assessment times. Compared with 1 year preintervention, they had reduced ED and hospital admissions (rate ratio [RR]: 0.68; 95% confidence interval [CI]: 0.49-0.95) and OCS use (RR: 0.74; 95% CI: 0.61-0.91). Parent satisfaction remained high. Compared with matched controls, participants had reduced ED and hospital admissions (RR: 0.41; 95% CI: 0.22-0.75) and OCS use (RR: 0.65; 95% CI: 0.46-0.93). CONCLUSIONS: e-AT use led to high and sustained participation in self-monitoring and improved asthma outcomes. Dissemination of this care model has potential to broadly improve pediatric ambulatory asthma care.