Observational Behavioral Coding in the Pediatric Emergency Department: Development of the Emergency Department Child Behavior Coding System.

BACKGROUND: Despite improvements over the past decade, children continue to experience significant pain and distress surrounding invasive procedures in the emergency department (ED). To assess the impact of newly developed interventions, we must create more reliable and valid behavioral assessment tools that have been validated for the unique settings of pediatric EDs. OBJECTIVE: This study aimed to create and test the Emergency Department Child Behavior Coding System (ED-CBCS) for the assessment of child distress and nondistress behaviors surrounding pediatric ED procedures. METHODS: Via an iterative process, a multidisciplinary expert panel developed the ED-CBCS, an advanced time-based behavioral coding measure. Inter-rater reliability and concurrent validity were examined using 38 videos of children aged from 2 to 12 years undergoing laceration procedures. Face, Legs, Activity, Cry, Consolability (FLACC) scale scores were used to examine concurrent validity. RESULTS: The final ED-CBCS included 27 child distress and nondistress behaviors. Time-unit κ values from 0.64 to 0.98 and event alignment κ values from 0.62 to 1.00 indicated good to excellent inter-rater reliability for all but one of the individual codes. ED-CBCS distress (B = 1.26; p < 0.001) and nondistress behaviors (B = -0.69, p = 0.025) were independently significantly associated with FLACC scores, indicating concurrent validity. CONCLUSIONS: We developed a psychometrically sound tool tailored for pediatric ED procedures. Future work could use this measure to better identify behavioral targets and test the effects of interventions to relieve pediatric ED pain and distress.

Evaluation of Quantitative Pupillometry in Acute Postinjury Pediatric Concussion.

BACKGROUND: Although millions of children sustain concussions each year, a rapid and objective test for concussion has remained elusive. The aim of this study was to investigate quantitative pupillometry in pediatric patients in the acute, postinjury setting. METHODS: This was a prospective case-control study of concussed patients presenting to the emergency department within 72 hours of injury. Pupillary measurements were gathered using NeurOptics' PLR 3000; evaluation included a symptom checklist and neurocognitive assessment. Data were analyzed using descriptive statistics and regression models. RESULTS: A total of 126 participants were enrolled. One significant difference in pupillometry between concussed and control participants was found: left minimum pupil diameter in 12- to 18 year-olds (P = 0.02). Models demonstrating odds of a concussion revealed significant associations for time to 75% recovery (T75) of the left pupil in five- to 11-year-olds and average dilation velocity of the left pupil in 12- to 18-year-olds (P = 0.03 and 0.02 respectively). Models predicting symptom improvement showed one significant association: percent change of the right pupil in five-to-11-year-olds (P = 0.02). Models predicting neurocognitive improvement in 12- to 18-year-olds demonstrated significant association in T75 in the left pupil for visual memory, visual motor processing speed, and reaction time (P = 0.002, P = 0.04, P = 0.04). CONCLUSIONS: The limited statistically significant associations found in this study suggest that pupillometry may not be useful in pediatrics in the acute postinjury setting for either the diagnosis of concussion or to stratify risk for prolonged recovery.

9-1-1 Activations from Ambulatory Care Centers: A Sicker Pediatric Population.

BACKGROUND: Pediatric patients transferred by Emergency Medical Services (EMS) from urgent care (UC) and office-based physician practices to the emergency department (ED) following activation of the 9-1-1 EMS system are an under-studied population with scarce literature regarding outcomes for these children. The objectives of this study were to describe this population, explore EMS level-of-care transport decisions, and examine ED outcomes. METHODS: This was a retrospective review of patients zero to <15 years of age transported by EMS from UC and office-based physician practices to the ED of two pediatric receiving centers from January 2017 through December 2019. Variables included reason for transfer, level of transport, EMS interventions and medications, ED medications/labs/imaging ordered in the first hour, ED procedures, ED disposition, and demographics. Data were analyzed with descriptive statistics, X test, point biserial correlation, two-sample z test, Mann-Whitney U test, and 2-way ANOVA. RESULTS: A total of 450 EMS transports were included in this study: 382 Advanced Life Support (ALS) runs and 68 Basic Life Support (BLS) runs. The median patient age was 2.66 years, 60.9% were male, and 60.7% had private insurance. Overall, 48.9% of patients were transported from an office-based physician practice and 25.1% were transported from UC. Almost one-half (48.7%) of ALS patients received an EMS intervention or medication, as did 4.41% of BLS patients. Respiratory distress was the most common reason for transport (46.9%). Supplemental oxygen was the most common EMS intervention and albuterol was the most administered EMS medication. There was no significant association between level of transport and ED disposition (P = .23). The in-patient admission rate for transported patients was significantly higher than the general ED admission rate (P <.001). CONCLUSION: This study demonstrates that pediatric patients transferred via EMS after activation of the 9-1-1 system from UC and medical offices are more acutely ill than the general pediatric ED population and are likely sicker than the general pediatric EMS population. Paramedics appear to be making appropriate level-of-care transport decisions.

Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis.

OBJECTIVE: This study aimed to evaluate safety (infusion-related reactions [IRRs]) and patient satisfaction (patient-reported outcomes [PROs]) for at-home ocrelizumab administration for patients with multiple sclerosis (MS). METHODS: This open-label study included adult patients with an MS diagnosis who had completed a ≥ 600-mg ocrelizumab dose, had a patient-determined disease steps score of 0 to 6 and had completed PROs. Eligible patients received a 600-mg ocrelizumab home-based infusion over 2 h, followed by 24-h and 2-week post-infusion follow-up calls. IRRs and adverse events (AEs) were documented during infusions and follow-up calls. PROs were completed before and 2 weeks post infusion. RESULTS: Overall, 99 of 100 expected patients were included (mean [SD] age, 42.3 [7.7] years; 72.7% female; 91.9% White). The mean (SD) infusion time was 2.5 (0.6) hours, and 75.8% of patients completed their ocrelizumab infusion between 2 to 2.5 h. The IRR incidence rate was 25.3% (95% CI: 16.7%, 33.8%)-similar to other shorter ocrelizumab infusion studies-and all AEs were mild/moderate. In total, 66.7% of patients experienced AEs, including itch, fatigue, and grogginess. Patients reported significantly increased satisfaction with the at-home infusion process and confidence in the care provided. Patients also reported a significant preference for at-home infusion compared with prior infusion center experiences. INTERPRETATION: IRRs and AEs occurred at acceptable rates during in-home infusions of ocrelizumab over a shorter infusion time. Patients reported increased confidence and comfort with the home infusion process. Findings from this study provide evidence of the safety and feasibility of home-based ocrelizumab infusion over a shorter infusion period.

Validation of the functional assessment of chronic illness therapy - General treatment satisfaction (FACIT-TS-G) in multiple sclerosis.

BACKGROUND: Patient-reported treatment satisfaction is associated with medication adherence and persistence, making it increasingly important in the multiple sclerosis (MS) population, where disease modifying treatments (DMTs) can be vital in preventing accumulation of disability. Therefore, the valid assessment of treatment satisfaction is critical in MS care. The current study aimed to examine the validity of the Functional Assessment of Chronic Illness Therapy - General Treatment Satisfaction (FACIT-TS-G) in an MS population. METHODS: Patient-reported outcome (PRO) data were collected from 555 MS patients (mean age 47.99±11.57; 76.4% female; 78.7% White/Caucasian) as part of routine clinical care. The FACIT-TS-G reliability, validity, and factor structure were examined. FACIT-TS-G scores were compared between DMT administration type (oral, injection, infusion) and examined as a possible predictor of switching DMT type at 1-to-2-year follow-up. RESULTS: The FACIT-TS-G showed good internal consistency (Cronbach's α=0.836), convergent validity, and known-group validity. Confirmatory factor analyses supported a single factor. DMT infusion administration was associated with slightly greater FACIT-TS-G scores than injection (p = 0.013, 95% CI: 0.269, 2.273) and oral administration (p = 0.030, 95% CI: 0.087, 1.717). FACIT-TS-G scores did not predict the likelihood of switching DMT type at follow-up (p>0.05). CONCLUSION: Our findings support the use of the FACIT-TS-G as a PRO measure of treatment satisfaction in MS. Moreover, results suggest DMT administration via infusion is associated with greater treatment satisfaction. Future research is needed to examine treatment satisfaction in the context of other outcomes.

Patient-reported outcomes in multiple sclerosis: Validation of the Quality of Life in Neurological Disorders (Neuro-QoL™) short forms.

BACKGROUND: Patient-reported outcome (PRO) measures have been shown to be effective for tracking treatment outcomes in multiple sclerosis (MS). However, collecting PROs as part of the clinical standard of care can be time-consuming and examination of their validity for use in an MS sample has been limited. OBJECTIVE: To determine the discriminant validity of the Quality of Life in Neurological Disorders (Neuro-QoL™) short forms in a real-world MS clinic population. DESIGN/METHODS: Neuro-QoL is a series of questionnaires for tracking physical function, emotional/cognitive health, and social abilities in clinical populations. Neuro-QoL data from 902 MS patients were analyzed for psychometric properties and factor structure. RESULTS: Neuro-QoL demonstrated acceptable reliability in the moderate-to-good ranges. Moderate support for convergent validity was observed with other measures of MS quality of life, disease severity, and symptoms. However, results from a confirmatory factor analysis suggested poor model fit for most of the 12 domains tested. CONCLUSIONS: These findings support the utility of some of the Neuro-QoL questionnaires in evaluating MS-related PROs. However, additional research may help abridge and strengthen these measures for use in this population.

Subjective cognitive concern in multiple sclerosis is associated with reduced thalamic and cortical gray matter volumes.

OBJECTIVE: Brain atrophy has been correlated with objective cognitive dysfunction in multiple sclerosis but few studies have explored self-reported subjective cognitive concerns and their relationship to brain volume changes. This study explores the relationship between subjective cognitive concerns in multiple sclerosis and reduced brain volume in regions of interest implicated in cognitive dysfunction. METHODS: A total of 158 patients with multiple sclerosis completed the Quality of Life in Neurologic Disorders Measures (Neuro-QoL) short forms to assess subjective cognitive concerns and underwent brain magnetic resonance imaging. Regional brain volumes from regions of interest implicated in cognitive dysfunction were measured using NeuroQuant automated volumetric quantitation. Linear regression was used to analyze the relationship between subjective cognitive concerns and brain volume. RESULTS: Controlling for age, disease duration, gender, depression and fatigue, increased subjective cognitive concerns were associated with reduced thalamic volume (standardized ß = 0.223, t150 =2.406, P = 0.017) and reduced cortical gray matter volume (standardized ß = 0.240, t150 = 2.777, P = 0.006). Increased subjective cognitive concerns were not associated with any other regions of interest that were analyzed. CONCLUSIONS: Subjective cognitive concern in MS is associated with reduced thalamic and cortical gray matter volumes, areas of the brain that have been implicated in objective cognitive impairment. These findings may lend neuroanatomical significance to subjective cognitive concerns and patient-reported outcomes as measured by Neuro-QoL.

Rituximab vs placebo induction prior to glatiramer acetate monotherapy in multiple sclerosis.

OBJECTIVE: To examine whether rituximab induction followed by glatiramer acetate (GA) monotherapy is more effective than GA alone for the treatment of relapsing multiple sclerosis with active disease. METHODS: This was a single-center, double-blind, placebo-controlled study. Fifty-five participants were randomly assigned (1:1 ratio) to either rituximab (R-GA) or placebo (P-GA) induction, followed by GA therapy initiated in all participants. Participants were followed up to 3 years. The primary endpoint was the number of participants with no evidence of disease activity (NEDA): those without relapse, new MRI lesions, and sustained change in disability. RESULTS: Twenty-eight and 27 participants received rituximab and placebo induction, respectively, with one participant in each arm withdrawing before 6-month MRI. There were no significant differences in baseline characteristics. At end of study, 44.44% of R-GA participants demonstrated NEDA vs 19.23% of P-GA participants (p = 0.049). Treatment failed for a smaller proportion of R-GA participants (37.04% R-GA vs 69.23% P-GA, p = 0.019), and time to treatment failure was longer (23.32 months R-GA vs 11.29 months P-GA, p = 0.027). Fewer participants in the R-GA arm had new lesions (25.93% R-GA vs 61.54% P-GA, p = 0.009), and there were fewer new T2 lesions (0.48 R-GA vs 1.96 P-GA, p = 0.027). Probability of demonstrating NEDA in the R-GA arm returned to baseline within the study period. There were no differences in adverse events. CONCLUSIONS: Induction therapy with rituximab followed by GA may provide superior efficacy in the short term than GA alone in relapsing multiple sclerosis, but this benefit appears to wane within the study period. Larger studies are needed to assess sustainability of results. CLINICALTRIALSGOV IDENTIFIER: NCT01569451.