Patient-reported outcomes and pharmacist actions in patients with multiple sclerosis managed by health-system specialty pharmacies.

PURPOSE: This study evaluated patient-reported outcomes (PROs) and pharmacist actions for patients on disease-modifying therapies (DMTs) for multiple sclerosis (MS) through health-system specialty pharmacies (HSSPs). METHODS: A multisite, prospective cohort study of patients utilizing an HSSP for DMT fulfillment was performed. Primary outcomes were affirmative answers to PRO questions regarding impacted productivity, hospitalization, and relapse and pharmacist actions. Rates of pharmacist actions were reported as the number of person-years of treatment per action. Univariate and multivariate logistic regression were used to evaluate the association between each PRO and covariates, including the number of pharmacist actions performed, age, sex, insurance, site, and route of administration. RESULTS: The 968 patients included had 10,562 fills and 6,946 PRO assessments. The most common affirmative PRO was impacted productivity (14.6%). Pharmacists performed 3,683 actions, most commonly general medication education (42.6%) and safety (33.3%). Rates of general medication education and nonfinancial coordination of care actions were similar across medication classes; other pharmacist actions varied by medication class. Insurance type was significantly associated with reporting impacted productivity; patients with Medicare and Medicaid were 2.2 and 3.1 times more likely to have reported impacted productivity, respectively (P < 0.001) than commercially insured patients. Patients who reported impacted productivity had more pharmacist actions (P < 0.001). CONCLUSION: Patients on DMTs through an HSSP reported low rates of impacted productivity, relapse, and hospitalization due to MS, although patients with noncommercial insurance were more likely to have impacted productivity. Patients reporting impacted productivity and those taking certain DMTs may require more frequent pharmacist actions.

Self-Reported Anxiety and Perception of Safety Following School Lockdown Drills among Adolescent Youth.

BACKGROUND: Lockdown drills are mandated within many educational settings in the US; they may contribute to adverse mental health and there is little to suggest their effectiveness. We describe factors associated with post-drill anxiety and perceived effectiveness of drills. METHODS: We surveyed youth-caregiver dyads presenting to the pediatric emergency department. Nonparametric tests compared factors across groups of child anxiety and caregiver perceived effectiveness of drills. Kappa statistics (κ) measured child-caregiver agreement on post-drill anxiety and depression symptoms. RESULTS: 108 child-caregiver dyads were included. Post-lockdown drill anxiety was reported by 27% of children; those reporting anxiety were more likely to have histories of bullying or skipping school for safety (p = 0.0004). Of caregivers, 47% believed drills effectively prevent firearm injury. There was a significant disparity between child and caregiver report of post-drill mental health symptomatology (κ anxiety = 0.19; κ depression = 0.30). Implications for School Health, Policy, Practice, and Equity: Understanding factors contributing to anxiety surrounding lockdown drills and perception of drill effectiveness may aid policy decisions and resource allocation. CONCLUSIONS: Lockdown drills may increase mental health symptoms in children, while caregivers may not recognize this occurrence. Studies to identify risk factors of acute and chronic post-lockdown drill anxiety will help determine how to better serve youth.

Adherence and persistence to self-administered disease-modifying therapies in patients with multiple sclerosis: A multisite analysis.

BACKGROUND: Though there are several disease-modifying therapy (DMT) options for patients with multiple sclerosis (MS), treatment outcomes rely on patient adherence and persistence. Previous studies have demonstrated suboptimal adherence rates and high rates of early treatment discontinuation. Health-system specialty pharmacies (HSPPs) are a growing practice model that have demonstrated adherence and persistence benefits through single site evaluations. Research is needed across multiple HSSPs to understand and validate the outcomes of this practice model. METHODS: A multisite prospective cohort study was performed including patients with at least three fills of a DMT between January 2020 and June 2021 at an HSSP. Patients were excluded due to pregnancy or death. Enrollment occurred for 6 months followed by 12 months of follow-up. Adherence was measured using pharmacy claims to calculate proportion of days covered (PDC) during the follow-up period. Time to non-persistence was calculated as the time from an index DMT fill to the first date of a gap of >60 days between medication exhaust and fulfillment dates. Adherence and persistence calculations were assessed at the therapeutic class level (any self-administered DMT dispensed by the HSSPs). The Kaplan-Meier method was used to present the probability of being persistent, and Cox proportional hazards regression analysis was used to estimate hazard ratios of factors associated with non-persistence, which included age, sex, study site, insurance type, and whether the patient switched medication as potential factors. RESULTS: The most common self-administered DMTs filled among 968 patients were glatiramer acetate (32%), fingolimod (18%), and dimethyl fumarate (18%). Most patients (96%) did not switch DMT during the study period. The median PDC was 0.97 (interquartile range 0.90-0.99), which was similar across all sites. Patients who had at least one DMT switch were 76% less likely to have a higher PDC than those who did not have any switch after adjusting for other covariates (Odds ratio: 0.24, 95% confidence interval [CI]: 0.14-0.40, p<0.001). Most patients (86%) were persistent to DMT over the 12-month study period. Among those non-persistent, median time to non-persistence was 231 (IQR 177-301) days. Patients who switched medications were 2.4 times more likely to be non-persistent (95% CI: 1.3 - 4.5, p = 0.005). The most common reasons for non-persistence were discontinuation/medication held for an extended period (30%), often due to patient or prescriber decision (75%). CONCLUSION: High rates of DMT adherence and persistence were seen among patients serviced by HSSPs, indicating potential benefits of this model for patients with MS. Switching DMTs was associated with lower adherence and persistence and may be an opportunity for added care coordination or resources to optimize therapy transitions.

Quality Indicators for Children With Traumatic Brain Injury After Transition to an American College of Surgeons Level I Pediatric Trauma Center.

OBJECTIVE: The aim of the study was to compare quality indicators, including frequency of acute surgical and emergent interventions, and resource utilization before and after American College of Surgeons (ACS) level I trauma verification among children with moderate or severe traumatic brain injury (TBI). METHODS: This is a retrospective review of patients younger than 18 years treated for moderate or severe TBI, as determined by International Classification of Disease codes. Our institution obtained ACS level I trauma verification in 2013. Outcomes during the pre-ACS (June 2003-May 2008), interim (June 2008-May 2013), and post-ACS (June 2013-May 2018) periods were compared via nonparametric tests. Tests for linear trend were conducted using Cochran-Armitage tests for categorical data and by linear regression for continuous variables. RESULTS: There were 677 children with moderate or severe TBIs (pre-ACS, 125; interim, 198; post-ACS, 354). Frequency of any surgical intervention increased significantly in the post-ACS period (12.2%) compared with interim (5.1%) and pre-ACS periods (5.6%, P = 0.007). More children in the post-ACS period required intracranial pressure monitoring (P = 0.017), external ventricular drain placement (P = 0.003), or endotracheal intubation (P = 0.001) compared with interim and pre-ACS periods. There was no significant change in time to operating room (P = 0.514), frequency of decompression (P = 0.096), or time to decompression (P = 0.788) between study periods. The median time to head CT decreased significantly in the post-ACS period (26 minutes; interquartile range [IQR], 9-60) compared with interim (36 minutes; IQR, 21-69) and pre-ACS periods (53 minutes; IQR, 36-89; P < 0.001). Frequency of repeat head computed tomography decreased significantly in the post-ACS period (30.2%) compared with interim (56.1%) and pre-ACS periods (64.0%, Ptrend = 0.044). CONCLUSIONS: Transition to an ACS level I trauma verification was associated with improvements in quality indicators for children with moderate or severe TBI.

Streptococcal Pharyngitis: Compliance With National Testing Guidelines in a Pediatric Emergency Department.

OBJECTIVES: The Infectious Diseases Society of America (IDSA) guidelines regarding group A streptococcal (GAS) pharyngitis advise against routine testing for patients younger than 3 years, patients without pharyngitis, and patients with symptoms suggesting a viral infection. Group A streptococcal testing may be overused in some clinical settings; thus, we conducted this study to evaluate compliance with the IDSA guidelines in a pediatric emergency department (ED) setting. METHODS: This retrospective cohort study describes patients younger than 18 years presenting to 2 urban pediatric EDs in 2016 who underwent rapid antigen detection testing for GAS pharyngitis. Testing was classified as noncompliant with the IDSA guidelines if the chief complaint was not indicative of GAS infection and/or the patient age was younger than 3 years. Appropriate nonparametric tests compared groups by IDSA testing compliance status. RESULTS: A total of 13,585 patient encounters met inclusion criteria; 5255 (39%) were noncompliant with the IDSA testing guidelines, the majority due to a chief complaint inconsistent with GAS pharyngitis (67%) and secondarily due to the age of younger than 3 years (48%). Among the patients with noncompliant testing, 51% were prescribed an antibiotic, and return encounters were more likely to occur (13% vs 10%, P < 0.001). Return encounters more commonly resulted in respiratory diagnoses in those with noncompliant GAS testing (60% vs 45%, P < 0.001). CONCLUSIONS: Nearly 40% of all pediatric ED encounters with GAS testing were noncompliant with the IDSA guidelines and were associated with greater return encounter rates. Potential negative outcomes from noncompliant GAS testing include misdiagnosis, inappropriate use of antibiotics, allergic reactions, and loss of school days. Informed interventions to reduce unnecessary GAS testing are warranted.

A Pharmacist-Driven Education and Intervention Program that Improves Outcomes for Hypertensive Patients.

Purpose: Uncontrolled hypertension is serious and may lead to severe cardiovascular events and death. To better educate and empower patients to meet their blood pressure (BP) management goals, a large, integrated academic healthcare system implemented the Blood Pressure Goals Achievement Program (BPGAP), a longitudinal intervention embedding community pharmacists within healthcare teams. This study evaluated BPGAP on its ability to promote patient BP management goals. Methods: A pre-/post-intervention analysis was conducted whereby BP measurements were evaluated longitudinally within acuity groups determined by k-means clustering. Generalized linear mixed models evaluated trends in BP by time period, and proportions of patients meeting BP management goals (<140/90 mmHg) were assessed in relation to BPGAP enrollment date. Results: There were 5,125 patients who were clustered into Uncontrolled, Borderline, and Controlled blood pressure groups; 2,108 patients had BP measurements across 4 time periods before and after BPGAP enrollment. Groups differed by patient age, sex, and other demographics (p<0.0001). Patients in the Uncontrolled and Borderline BP clusters demonstrated significant BP decreases after BPGAP enrollment, continuing at least to 1-year post-intervention; Controlled cluster patients maintained BPs throughout the study period. The proportion of patients with controlled BPs increased from 56% immediately pre-BPGAP to 74% in the 3- to 6-months following enrollment. Conclusion: BPGAP is effective at helping patients achieve their BP management goals. Pharmacists may play a key role in hypertension control through measuring BPs and including updates and recommendations in the electronic health record, educating patients, and engaging in communication with healthcare teams.

Emergency Department Visits for Pediatric Firearm Injuries by Trauma Center Type.

OBJECTIVES: This study aimed to characterize pediatric visits to emergency departments (EDs) for firearm injuries and examine differences by trauma center type. METHODS: Analyses included all patients younger than 19 years from the National Trauma Data Bank, years 2009 to 2014. Trauma centers were categorized as adult, mixed adult and pediatric, or pediatric based on certification level. Baseline characteristics were compared between subgroups using χ2 tests. Multivariable logistic regression was used to examine risk of death. RESULTS: Of 466,403 pediatric ED visits, 21,416 (4.6%) resulted from a firearm injury. Most firearm injuries were treated at an adult (64.9%) or mixed trauma center (29.1%) and involved patients that were male (87.1%), in the 15- to 18-year age group (83.2%), and black or African American (61.3%). Most visits were for injuries resulting from assault (78.1%), followed by unintentional (12.6%) and self-inflicted (4.7%) injuries, undetermined intent (3.7%), and legal intervention (0.8%). Patients visiting EDs for firearm injuries had more than 7 times the odds of dying compared with patients with other injuries (odds ratio, 7.30; 95% confidence interval, 6.82-7.72), and firearm injuries were responsible for more than a quarter (26.1%) of the total pediatric deaths in the National Trauma Data Bank (n = 2866). Assault-related injuries resulted in the most deaths (n = 2010; 70.1%), but the case fatality rate was highest for self-inflicted (n = 453; 44.6%). CONCLUSION: We identified more than 20,000 firearm-related ED visits by pediatric patients from 2009 to 2014, averaging nearly 10 visits per day. Findings from this study can inform strategic planning in hospitals focused on preventing firearm injuries in children and adolescents.

Avoiding Cribari gridlock 2: The standardized triage assessment tool outperforms the Cribari matrix method in 38 adult and pediatric trauma centers.

OBJECTIVES: The Cribari Matrix Method (CMM) is the current standard to identify over/undertriage but requires manual trauma triage reviews to address its inadequacies. The Standardized Triage Assessment Tool (STAT) partially emulates triage review by combining CMM with the Need For Trauma Intervention, an indicator of major trauma. This study aimed to validate STAT in a multicenter sample. METHODS: Thirty-eight adult and pediatric US trauma centers submitted data for 97,282 encounters. Mixed models estimated the effects of overtriage and undertriage versus appropriate triage on the odds of complication, odds of discharge to a continuing care facility, and differences in length of stay for both CMM and STAT. Significance was assessed at p <0.005. RESULTS: Overtriage (53.49% vs. 30.79%) and undertriage (17.19% vs. 3.55%) rates were notably lower with STAT than with CMM. CMM and STAT had significant associations with all outcomes, with overtriages demonstrating lower injury burdens and undertriages showing higher injury burdens than appropriately triaged patients. STAT indicated significantly stronger associations with outcomes than CMM, except in odds of discharge to continuing care facility among patients who received a full trauma team activation where STAT and CMM were similar. CONCLUSIONS: This multicenter study strongly indicates STAT safely and accurately flags fewer cases for triage reviews, thereby reducing the subjectivity introduced by manual triage determinations. This may enable better refinement of activation criteria and reduced workload.

Organ Donation Authorization After Brain Death Among Patients Admitted to PICUs in the United States, 2009-2018.

OBJECTIVES: To identify trends in and factors associated with pediatric organ donation authorization after brain death. DESIGN: Retrospective cohort study of data from Virtual Pediatric Systems, LLC (Los Angeles, CA). SETTING: Data from 123 PICUs reporting to Virtual Pediatric Systems from 2009 to 2018. PATIENTS: Patients less than 19 years old eligible for organ donation after brain death. MEASUREMENTS AND MAIN RESULTS: Of 2,777 eligible patients, 1,935 (70%) were authorized for organ donation; the authorization rate remained unchanged over time (ptrend = 0.22). In a multivariable logistic regression model, hospitalizations lasting greater than 7 days had lower odds of authorization (adjusted odds ratio, 0.5; p < 0.001 vs ≤ 1 d) and White patients had higher odds than other race/ethnicity groups. Authorization was higher for trauma-related encounters (adjusted odds ratio, 1.5; p < 0.001) and when donation was discussed with an organ procurement organization coordinator (adjusted odds ratio, 1.7; p < 0.001). Of 123 hospitals, 35 (28%) met or exceeded a 75% organ donation authorization target threshold; these hospitals more often had an organ procurement organization coordinator discussing organ donation (85% vs 72% of encounters; p < 0.001), but no difference was observed by PICU bed size. CONCLUSIONS: Organ donation authorization after brain death among PICU patients was associated with length of stay, race/ethnicity, and trauma-related encounter, and authorization rates were higher when an organ procurement organization coordinator was involved in the donation discussion. This study identified factors that could inform initiatives to improve the authorization process and increase pediatric organ donation rates.

Rethinking the definition of major trauma: The need for trauma intervention outperforms Injury Severity Score and Revised Trauma Score in 38 adult and pediatric trauma centers.

BACKGROUND: Patients' trauma burdens are a combination of anatomic damage, physiologic derangement, and the resultant depletion of reserve. Typically, Injury Severity Score (ISS) >15 defines major anatomic injury and Revised Trauma Score (RTS) <7.84 defines major physiologic derangement, but there is no standard definition for reserve. The Need For Trauma Intervention (NFTI) identifies severely depleted reserves (NFTI+) with emergent interventions and/or early mortality. We hypothesized NFTI would have stronger associations with outcomes and better model fit than ISS and RTS. METHODS: Thirty-eight adult and pediatric U.S. trauma centers submitted data for 88,488 encounters. Mixed models tested ISS greater than 15, RTS less than 7.84, and NFTI's associations with complications, survivors' discharge to continuing care, and survivors' length of stay (LOS). RESULTS: The NFTI had stronger associations with complications and LOS than ISS and RTS (odds ratios [99.5% confidence interval]: NFTI = 9.44 [8.46-10.53]; ISS = 5.94 [5.36-6.60], RTS = 4.79 [4.29-5.34]; LOS incidence rate ratios (99.5% confidence interval): NFTI = 3.15 [3.08-3.22], ISS = 2.87 [2.80-2.94], RTS = 2.37 [2.30-2.45]). NFTI was more strongly associated with continuing care discharge but not significantly more than ISS (relative risk [99.5% confidence interval]: NFTI = 2.59 [2.52-2.66], ISS = 2.51 [2.44-2.59], RTS = 2.37 [2.28-2.46]). Cross-validation revealed that in all cases NFTI's model provided a much better fit than ISS greater than 15 or RTS less than 7.84. CONCLUSION: In this multicenter study, NFTI had better model fit and stronger associations with the outcomes than ISS and RTS. By determining depletion of reserve via resource consumption, NFTI+ may be a better definition of major trauma than the standard definitions of ISS greater than 15 and RTS less than 7.84. Using NFTI may improve retrospective triage monitoring and statistical risk adjustments. LEVEL OF EVIDENCE: Prognostic, level IV.

Trends in Pediatric Emergency Department Visits for Mental Health Conditions and Disposition by Presence of a Psychiatric Unit.

OBJECTIVE: To examine trends in mental health (MH) visits to pediatric emergency departments (EDs) and identify whether ED disposition varies by presence of a hospital inpatient psychiatric unit (IPU). STUDY DESIGN: Cross-sectional study of 8,479,311 ED visits to 35 children's hospitals from 2012 to 2016 for patients aged 3 to 21 years with a primary MH or non-MH diagnosis. Multivariable generalized estimating equations and bivariate Rao-Scott chi-square tests were used to examine trends in ED visits and ED disposition by IPU status, adjusted for clustering by hospital. RESULTS: From 2012 to 2016, hospitals experienced a greater increase in ED visits with a primary MH versus non-MH diagnosis (50.7% vs 12.7% cumulative increase, P < .001). MH visits were associated with patients who were older, female, white non-Hispanic, and privately insured compared with patients of non-MH visits (all P < .001). Forty-four percent of MH visits in 2016 had a primary diagnosis of depressive disorders or suicide or self-injury, and the increase in visits was highest for these diagnosis groups (depression: 109.8%; suicide or self-injury: 110.2%). Among MH visits, presence of a hospital IPU was associated with increased hospitalizations (34.6% vs 22.5%, P < .001) and less transfers (9.2% vs 16.2%, P < .001). CONCLUSION: The increase in ED MH visits from 2012 to 2016 was 4 times greater than non-MH visits at US children's hospitals and was primarily driven by patients diagnosed with depressive disorders and suicide or self-injury. Our findings have implications for strategic planning in tertiary children's hospitals dealing with a rising demand for acute MH care.

Pediatric Farm Injuries Presenting to United States Emergency Departments, 2001-2014.

PURPOSE: While it is well-known that injuries are a common cause of morbidity among children, limited information is available on injuries that occur in agricultural settings. This study characterizes pediatric farm injuries that present to United States emergency departments and compares them to injuries that occur in the normal course of childhood, at homes and residences. METHODS: A retrospective analysis of the National Electronic Injury Surveillance System-All Injury Program, 2001-2014, compared injuries occurring on farms to those at homes in youth ages <20 years. Linear regression models assessed injuries over the time period among demographic subgroups. FINDINGS: Between 2001 and 2014, there were an estimated 279,279 injuries that occurred on farms in youth <20 years. Farm injuries most commonly occurred among youth ages from 15 to 19 years (44%, 95% confidence interval [CI]: 39%-49%), whereas home injuries were often among children <5 years (42%, 95% CI: 39%-45%). After adjusting for confounders, farm injuries were 60 times more likely to be caused by machinery and 4 times more likely to result in hospitalization than home injuries. Overall, the number of farm injuries decreased by 44% between 2001 and 2014. CONCLUSIONS: Characteristics of youth farm injuries are much different from injuries occurring at homes. Although the overall number of farm injuries among youth has decreased substantially over time, injury prevention initiatives targeted toward these particular injuries are important to continue due to the significant morbidity of these injuries.

Unintentional Injuries in Primary and Secondary Schools in the United States, 2001-2013.

BACKGROUND: Unintentional injuries are the leading cause of youth morbidity. However, limited nationally representative data are available to characterize the occurrence of unintentional injuries at US schools. Given this paucity, we characterized secular trends in unintentional injuries at schools that led to emergency department (ED) visits. METHODS: A retrospective analysis of the National Electronic Injury Surveillance System-All Injury Program from 2001 to 2013 compared injuries occurring at schools to injuries occurring elsewhere in youth ages 5-18 years. Incidence rates were calculated using weighted frequency estimates as numerators and US population estimates as denominators. RESULTS: School injuries accounted for 21% of unintentional injury-related ED visits, with an estimated annual incidence rate of 1385 injuries per 100,000 5- to 18-year-olds. Middle school-aged youth (10-13 years) had the highest annual incidence rate (1640 per 100,000 youth) compared with younger and older counterparts. School injuries were more likely to be due to sports/recreation than nonschool injuries (55% vs 41%, p < .0001). Importantly, no detectable change in incidence rates of school injuries between 2001 and 2013 was found (p = .11). CONCLUSIONS: Stagnant annual incidence rates of unintentional injuries at schools and large numbers of school-based injuries demonstrate that school-based injuries are a notable opportunity for future prevention efforts.

Epigenomic Indicators of Age in African Americans.

Age is a well-established risk factor for chronic diseases. However, the cellular and molecular changes associated with aging processes that are related to chronic disease initiation and progression are not well-understood. Thus, there is an increased need to identify new markers of cellular and molecular changes that occur during aging processes. In this study, we use genome-wide DNA methylation from 26,428 CpG sites in 13,877 genes to investigate the relationship between age and epigenetic variation in the peripheral blood cells of 972 African American adults from the Genetic Epidemiology Network of Arteriopathy (GENOA) study (mean age=66.3 years, range=39-95). Age was significantly associated with 7,601 (28.8%) CpG sites after Bonferroni correction for α=0.05 (p<1.89×10-6). Due to the extraordinarily strong associations between age and many of the CpG sites (>7,000 sites with p-values ranging from 10-6 to 10-43), we investigated how well the DNA methylation markers predict age. We found that 2,095 (7.9%) CpG sites were significant predictors of age after Bonferroni correction. The top five principal components of the 2,095 age-associated CpG sites accounted for 69.3% of the variability in these CpG sites, and they explained 26.8% of the variation in age. The associations between methylation markers and adult age are so ubiquitous and strong that we hypothesize that DNA methylation patterns may be an important measure of cellular aging processes. Given the highly correlated nature of the age-associated epigenome (as evidenced by the principal components analysis), whole pathways may be regulated as a consequence of aging.

Epigenetic markers of renal function in african americans.

Chronic kidney disease (CKD) is an increasing concern in the United States due to its rapidly rising prevalence, particularly among African Americans. Epigenetic DNA methylation markers are becoming important biomarkers of chronic diseases such as CKD. To better understand how these methylation markers play a role in kidney function, we measured 26,428 DNA methylation sites in 972 African Americans from the Genetic Epidemiology Network of Arteriopathy (GENOA) study. We then evaluated (1) whether epigenetic markers are associated with estimated glomerular filtration rate (eGFR), (2) whether the significantly associated markers are also associated with traditional risk factors and/or novel biomarkers for eGFR, and (3) how much additional variation in eGFR is explained by epigenetic markers beyond established risk factors and biomarkers. The majority of methylation markers most significantly associated with eGFR (24 out of the top 30) appeared to function, at least in part, through pathways related to aging, inflammation, or cholesterol. However, six epigenetic markers were still able to significantly predict eGFR after adjustment for other risk factors. This work shows that epigenetic markers may offer valuable new insight into the complex pathophysiology of CKD in African Americans.