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Objective To create a functional status outcome measure for large outcome studies that is well defined, quantitative, sufficiently rapid, reliable, minimally dependent on subjective assessments, and applicable to hospitalized pediatric patients across a wide spectrum of ages and inpatient environments. Patients and Methods The Functional Status Scale (FSS) was developed by a multidisciplinary consensus process. Domains of functioning included mental status, sensory, communication, motor, feeding, and respiratory categorized from normal (1) to very severe dysfunction (5). The Adaptive Behavior Assessment System (ABAS) II established construct validity and calibration within domains. Seven institutions provided pediatric intensive care unit (PICU) patients within 24 hours of PICU discharge, high-risk non-PICU patients within 24 hours of admission, and technology-dependent children. Primary care nurses completed the ABAS II based on patient’s functioning when the FSS was completed. Patients from 10% of the study days were used to evaluate inter-rater reliability. Data were randomly split into estimation and validation sets. Statistical analyses included Pearson correlations, construct validity, linear regression analysis, receiver operating characteristic (ROC) curve analysis for discriminant validity, and the intraclass correlation for inter-rater reliability. Results A total of 836 children with a mean FSS of 10.3 (standard deviation 4.4) were studied. Eighteen percent had the minimum possible FSS = 6, 44% had FSS ≥ 10, 14% had a FSS ≥ 15, and 6% had FSS scores ≥ 20. Each FSS domain was associated with mean ABAS II (p<.0001). Cells in each domain were collapsed and reweighted, which improved correlations with ABAS II from −0.58 to −0.62 in the estimation sample, and −0.60 to −0.63 in the validation sample (p<0.001 for improvements). Discrimination was very good for moderate and severe dysfunction (ABAS II categories) and improved with FSS weighting (area under the ROC curve > 0.8). Intraclass correlations of original and weighted total FSS were 0.95 and 0.94 respectively. Conclusions The FSS met our objectives and is well suited for large outcome studies.

Objectives To describe a large multicenter cohort of pediatric cardiac arrest (CA) with return of circulation (ROC) from either the in-hospital (IH) or out-of-hospital (OH) setting in order to determine if significant differences related to pre-event, arrest event, early post-arrest event characteristics and outcomes exist that would be critical in planning a clinical trial of therapeutic hypothermia (TH). Design Retrospective cohort study Setting Fifteen Pediatric Emergency Care Applied Research Network (PECARN) sites. Patients Patients from 24 hours (h) to 18 years with either IH or OH CA who had a history of at least 1 minute of chest compressions and ROC for at least 20 minutes were eligible. Interventions None Measurements and Main Results A total of 491 patients met study entry criteria with 353 IH cases and 138 OH cases. Major differences between the IH and OH cohorts were observed for patient pre-arrest characteristics; arrest event initial rhythm described; and arrest medication use. Several post-arrest interventions were utilized differently, however, the use of TH was similar (<5%) in both cohorts. During the 0–12 h interval following ROC, OH cases had lower minimum temperature and pH, and higher maximum serum glucose recorded. Mortality was greater in the OH cohort (62% vs. 51%, p=0.04) with the cause attributed to a neurological indication much more frequent in the OH than IH cohort (69% vs. 20%; p < 0.01). Conclusions For pediatric CA with ROC, several major differences exist between IH and OH cohorts. The finding that the etiology of death was attributed to neurological indications much more frequently in OH arrests has important implications for future research. Investigators planning to evaluate the efficacy of new interventions such as TH should be aware that the IH and OH populations differ greatly and require independent clinical trials.