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BACKGROUND AND OBJECTIVES: Although medical errors in the hospital are a recognized source of morbidity and mortality, less is known about safety events in the prehospital care of children. As part of a multiphase study, we developed and evaluated the reliability and usability of the pediatric prehospital safety event detection system (PEDS), a tool used to identify safety events in prehospital care. METHODS: The tool was based on hospital chart review tools, literature review, and results from focus groups and a national Delphi survey. After reviewer training, preliminary testing, and initial use, we refined the tool on the basis of data analysis and reviewer feedback. Thirty charts were randomly selected from our study population of pediatric transports with lights and sirens in Multnomah County, Oregon, and independently reviewed by 2 pediatric emergency physicians with experience in prehospital care to evaluate interrater reliability and time to completion of the final tool. RESULTS: The PEDS tool contains 36 items, takes reviewers a median of 7 minutes to complete (interquartile range: 4–12), and exists in both paper and electronic formats. When comparing the presence or absence of severe safety events between 2 expert arbiters, we found 87% agreement (κ = 0.68), indicating good agreement. CONCLUSIONS: The PEDS tool is the first chart review tool designed to identify safety events for children receiving prehospital care, and it displayed good usability and reliability in this study. With this tool, we provide a novel mechanism for researchers, clinicians, and prehospital care leaders to identify opportunities to improve care for children.

Context: Urinary tract infections (UTIs) represent a common bacterial infections in children. No guidance on the conduct of pediatric febrile UTI clinical trials (CTs) exist. Objective: To assess the criteria used for patients selection and the efficacy endpoints in febrile pediatric UTI CTs. Data Sources: Medline, Embase, Cochrane central databases and ClinicalTrials.gov between January 1, 1990, and November 24, 2016. Study Selection: We combined MeSH and free-text terms for: “urinary tract infections”, AND “therapeutics”, AND “clinical trials” in children (0–18 years), identifying 3,086 papers. Data Extraction: Two independent reviewers assessed study quality and performed data extraction. Results: Forty CTs investigating 4,381 cases of pediatric febrile UTIs were included. Positive urine culture and fever were the most common inclusion criteria (93% and 78%, respectively). Urine sampling method, pyuria and colonies thresholds were highly variable. Clinical and microbiological endpoints were assessed in 88% and 93% of the studies, respectively. Timing for endpoints assessment was highly variable, and only 3 studies (17%), out of the 18 performed after the Food and Drug Administration 1998 guidance publication, assessed primary and secondary endpoints consistently with this guidance. Limitations: Mixed population of healthy children and with underlying condition. Six trials studied a subgroup of patients with afebrile UTI. Conclusions: We observed a wide variability in the microbiological inclusion criteria and the timing for endpoints assessment. The available guidance for adults appear not to be used by pediatricians and do not seem applicable to the childhood UTI. A harmonized design for pediatric UTIs CT is required.

BACKGROUND AND OBJECTIVES: Many state newborn screening (NBS) programs retain residual NBS bloodspots after the completion of screening. Potential uses for residual specimens include laboratory quality assurance, biomedical research, and, rarely, forensic applications. Our objective was to evaluate public opinion about the policies and practices relevant to the retention and use of residual bloodspots for biomedical research. METHODS: A total of 3855 respondents were recruited using 3 methods: focus groups (n = 157), paper or telephone surveys (n = 1418), and a Knowledge Networks panel (n = 2280). Some participants (n = 1769) viewed a 22-minute movie about the retention and use of residual specimens while other participants were provided only written information about this practice. All participants were surveyed using a 38-item questionnaire. RESULTS: A diverse set of participants was recruited. Respondents were very supportive of NBS in general and accepting of the use of residual bloodspots for important research activities. Respondents were evenly divided on the acceptability of NBS without parental permission, but the majority of respondents supported the use of an “opt-in” process for parental permission for residual bloodspot retention and use. Viewing the educational movie was associated with greater support for bloodspot retention and use. CONCLUSIONS: Our results show that the general public surveyed here was supportive of NBS and residual sample retention and research use. However, there was a clear preference for an informed permission process for parents regarding these activities. Education about NBS was associated with a higher level of support and may be important to maintain public trust in these important programs.