TOP 10 - Empowering Patient Voices in Safety: A Comparative Analysis of Patient-Caregiver Reports, Medical Record Documented Adverse Events, and Incident Reports

Publication Number: 3738.TOP 10

Helen Pu, University of California, San Francisco, School of Medicine, San Francisco, CA, United States; Naomi Bardach, University of California, San Francisco, School of Medicine, SF, CA, United States; Alvin D. Hendrix, UCSF Benioff Children's Hospital Oakland, Vallejo, CA, United States; Glenn Rosenbluth, University of California, San Francisco, School of Medicine, San Francisco, CA, United States; Darren Fiore, University of California, San Francisco, School of Medicine, San Francisco, CA, United States; Danea Horn, University of California, San Francisco, San Francisco, CA, United States; Sara S. Kuo, UCSF Benioff Children's Hospital Oakland, Oakland, CA, United States; Leslie Magana, UCSF Benioff Children's Hospital Oakland, Oakland, CA, United States; Christopher P. Landrigan, Boston Children's Hospital, Boston, MA, United States; Deborah Franzon, UCSF Benioff Children's Hospital San Francisco, San Francisco, CA, United States; Srujana Rallabandi, University of California, San Francisco, School of Medicine, San Francisco, CA, United States

Background: Safety for hospitalized patients remains a persistent challenge, in part due to limited data on safety-related events. Inpatient safety data are largely derived from incident reports (IR), which consistently underreport safety events. Medical record review trigger tools such as the Global Assessment of Pediatric Patient Safety (GAPPS) have a higher detection rate, but require time-consuming chart review. Patients and caregivers can provide unique insight into safety events but systems for collecting their input and insights are limited. We developed a mobile-phone interface (the FIQS tool), co-designed with families and unit leadership, to collect patient and caregiver safety observations (Figure 1).

Objective: Compare safety observations reported by patients and caregivers via FIQS to IRs and GAPPS adverse event reports in order to assess the potential added value of the FIQS caregiver and patient reports.

Design/Methods: FIQS was implemented from September 2021 to August 2024 across nine units in three hospitals (IRB #22-37114). Participants (N=1886) were English- or Spanish-speaking caregivers, and patients >=12 years. We randomly chose 252 participants, then collated data from the three safety data sources for one admission per participant and analyzed the data as follows. Qualitative: For FIQS, three physicians reviewed reports to assess whether they were safety-related, met IR criteria, or could have resulted in harm. Medical record abstractors reviewed charts for adverse events, using the GAPPS protocol, followed by physician review to confirm the adverse events. IRs associated with each admission and GAPPS identified adverse events were then reviewed to determine whether any were related to FIQS reports associated with the admission. Quantitative: Descriptive analyses will quantify the number of overlapping events from each of the data sources (Figure 2), and will compare the content categories (e.g., medication, communication, etc.) in each data source using chi-squared tests. This will highlight the different types of safety areas in which FIQS data could provide new or additional insights. Patient and caregiver characteristics associated with overlapping events and non-overlapping events from FIQS will be analyzed using univariate and multivariate analyses, to better understand the types of patients represented in FIQS reports that may not appear in the other data sources. Timeline: Data collection completed September 2025; analysis will be complete December 1 2025.

Preliminary

Results:
See Table 1 for preliminary description of patient population.

Figure 1
Slide1.jpegScreenshots of Mobile Phone Tool Interface to Gather Safety Reports

Figure 2
Slide1.jpegA. Reports found in both FIQS and GAPPS (EHR recorded adverse events)
B. Reports found in both FIQS and IR system


Table 1
Preliminary results showing demographic characteristics of the patients with reports in FIQS, adverse events detected by GAPPS, and incident reports.