Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups.

OBJECTIVES: The objective was to describe the perspective of research personnel on issues of informed consent in a time-sensitive clinical study under emergency circumstances. METHODS: The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open-ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions. RESULTS: Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research. CONCLUSIONS: From the perspectives of research staff and investigators enrolling patients in a time-sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies.

Epidemiology of a pediatric emergency medicine research network: the PECARN Core Data Project.

OBJECTIVE: To examine the epidemiology of pediatric patient visits to emergency departments (ED). METHODS: We conducted a cross-sectional study of pediatric ED visits at the participating Pediatric Emergency Care Applied Research Network (PECARN) hospitals in 2002. We provide descriptive characteristics of pediatric ED visits and a comparison of the study database to the National Hospital Ambulatory Medical Care Survey (NHAMCS). Bivariate analyses were calculated to assess characteristics associated with hospital admission, death in the ED, and length of ED visit. We also performed multivariate regression to model the likelihood of admission to the hospital. RESULTS: Mean patient age was 6.2 years; 53.5% were boys; 47.5% black; and 43.2% had Medicaid insurance. The most common ED diagnoses were fever, upper respiratory infection, asthma, otitis media, and viral syndromes. The inpatient admission rate was 11.6%. The most common diagnoses requiring hospitalization were asthma, dehydration, fever, bronchiolitis, and pneumonia. In multivariate analysis, patients who were black or Hispanic, had Medicaid insurance or were uninsured, or were older than 1 year were less likely to be hospitalized. Demographics of the PECARN population were similar to NHAMCS, with notable exceptions of a larger proportion of black patients and of admitted patients from the PECARN EDs. CONCLUSION: We describe previously unavailable epidemiological information about childhood illnesses and injuries that can inform development of future studies on the effectiveness, outcomes, and quality of emergency medical services for children. Most pediatric ED patients in our study sought care for infectious causes or asthma and were discharged from the ED. Hospital admission rate differed according to age, payer type, race/ethnicity, and diagnosis.

Availability of pediatric emergency visit data from existing data sources.

OBJECTIVES: To determine the availability and completeness of selected data elements from administrative and clinical sources for emergency department (ED) visits in a national pediatric research network. METHODS: This was a retrospective study of 25 EDs in the Pediatric Emergency Care Applied Research Network. Data were obtained from two sources at each ED: 1) extant electronic administrative data for all visits during a 12-month period in 2002 and 2) data abstracted from medical records by trained abstractors for visits during ten randomly selected days over a three-month period in 2003. Epidemiologic data were obtained for all visits and additional clinical data for patients with two target conditions: asthma and fractures. RESULTS: A total of 749,036 visits were analyzed from administrative sources and 12,756 medical records abstracted. Data availability varied by element, method of capture, and site. From administrative sources, data on insurance type were the most complete (1.3% overall missing; range, 0%-18.5% for individual sites), whereas mode of arrival (25.5% missing) and triage time (65.3%) were the least complete. Disposition was missing in only 1.2% of medical records overall (range, 0%-5%) and diagnosis was missing in 3% (range, 0%-16%); these were missing from 14.4% and 10.5%, respectively, of administrative sources. Among visits with injury diagnoses, E-codes were missing in 27% of cases. For patients with asthma (n = 861), documentation of specific elements of the clinical examination by nurses and physicians was also variable. CONCLUSIONS: Data elements important in emergency medical care for children are frequently missing in existing administrative and medical record sources; completeness varies widely across EDs. Researchers must be aware of these limitations in the use of existing data when planning studies.

Children with special health care needs: a template for prehospital protocol development.

There are 12 million children in the United States with special health care needs. Improvements in medical technology, managed care, and changing social views about the institutionalization of children have all contributed to an increasing number of children with special health care needs (CSHCN) residing primarily in their home communities. Because of the dynamic and fragile nature of the medical conditions typically borne by CSHCN, the need for emergency care is not uncommon and prehospital providers are increasingly likely to encounter this population. Few states have initiated emergency medical services (EMS) protocols addressing field assessment, management, and stabilization of CSHCN and existing model protocols have not yet incorporated a distinct CSHCN component. With the support of grant funding from the federal Emergency Medical Services for Children (EMSC) program, a project was undertaken by investigators in the Center for Prehospital Pediatrics at Children's National Medical Center to develop prehospital protocols for CSHCN. This report details the protocol development process, discusses suggestions for their use, and presents the detailed protocols. The protocols are intended to serve as a resource template for the development and/or revision of jurisdiction-specific, customized practice guidelines.