Long-Term Outcomes Associated With ß-Lactam Allergies.

Importance: ß-lactam (BL) allergies are the most common drug allergy worldwide, but most are reported in error. BL allergies are also well-established risk factors for adverse drug events and antibiotic-resistant infections during inpatient health care encounters, but the understanding of the long-term outcomes of patients with BL allergies remains limited. Objective: To evaluate the long-term clinical outcomes of patients with BL allergies. Design, Setting, and Participants: This longitudinal retrospective cohort study was conducted at a single regional health care system in western Pennsylvania. Electronic health records were analyzed for patients who had an index encounter with a diagnosis of sepsis, pneumonia, or urinary tract infection between 2007 and 2008. Patients were followed-up until death or the end of 2018. Data analysis was performed from January 2022 to January 2024. Exposure: The presence of any BL class antibiotic in the allergy section of a patient's electronic health record, evaluated at the earliest occurring observed health care encounter. Main Outcomes and Measures: The primary outcome was all-cause mortality, derived from the Social Security Death Index. Secondary outcomes were defined using laboratory and microbiology results and included infection with methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, or vancomycin-resistant Enterococcus (VRE) and severity and occurrence of acute kidney injury (AKI). Generalized estimating equations with a patient-level panel variable and time exposure offset were used to evaluate the odds of occurrence of each outcome between allergy groups. Results: A total of 20 092 patients (mean [SD] age, 62.9 [19.7] years; 12 231 female [60.9%]), of whom 4211 (21.0%) had BL documented allergy and 15 881 (79.0%) did not, met the inclusion criteria. A total of 3513 patients (17.5%) were Black, 15 358 (76.4%) were White, and 1221 (6.0%) were another race. Using generalized estimating equations, documented BL allergies were not significantly associated with the odds of mortality (odds ratio [OR], 1.02; 95% CI, 0.96-1.09). BL allergies were associated with increased odds of MRSA infection (OR, 1.44; 95% CI, 1.36-1.53), VRE infection (OR, 1.18; 95% CI, 1.05-1.32), and the pooled rate of the 3 evaluated antibiotic-resistant infections (OR, 1.33; 95% CI, 1.30-1.36) but were not associated with C difficile infection (OR, 1.04; 95% CI, 0.94-1.16), stage 2 and 3 AKI (OR, 1.02; 95% CI, 0.96-1.10), or stage 3 AKI (OR, 1.06; 95% CI, 0.98-1.14). Conclusions and Relevance: Documented BL allergies were not associated with the long-term odds of mortality but were associated with antibiotic-resistant infections. Health systems should emphasize accurate allergy documentation and reduce unnecessary BL avoidance.

Does correction of carpal malalignment influence the union rate of scaphoid nonunion surgery?

The aim of this retrospective study was to assess the relation between carpal malalignment correction and radiological union rates in surgery for scaphoid nonunions. A total of 59 scaphoid waist fracture nonunions treated with open reduction and palmar tricortical autograft were divided according to their pre- and postoperative scapholunate (SL) and radiolunate (RL) angles. We found that carpal malalignment failed to correct in 32 of 59 (54.2%) patients despite meticulous surgical technique and placement of an appropriately sized wedge-shaped graft. In total, 43 (72.9%) fractures united at a mean of 4.47 months (range 3-11). Of the 27 fractures with postoperative SL and RL angles within the normal range, 21 united, whereas 22 of the 32 remaining fractures that failed to achieve postoperative angles within the normal range went on to union. The postoperative SL and RL angles were not related to union. Our findings suggest that in scaphoid fracture nonunion surgery, carpal malalignment may not be corrected in a substantial proportion of patients, but such correction may not be essential for bony union. Our findings also show that there is no marked collapse of the scaphoid graft in the early postoperative period. LEVEL OF EVIDENCE: IV.

Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study.

Objective: Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS). Research Design and Methods: A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class. Results: 127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Conclusion: Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.

Adverse drug reactions reported for antidiabetic medications Introduction: This study investigated the trends in voluntary reporting of adverse drug reactions for recently approved antidiabetic medications. Methods: Data from the FDA Adverse Events Reporting System were evaluated. The top 10 adverse drug reactions were compared between antidiabetic medications in the same therapeutic class. Results: We identified 127,525 adverse drug reaction reports for the newer approved antidiabetic medications. For SGLT-2 inhibitors, empagliflozin was associated with greater reports of blood glucose increase, nausea, and dizziness; weight decreased was reported more often for dapagliflozin; and diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis were reported more commonly for canagliflozin. Assessing GLP-1 receptor agonists, the odds of gastrointestinal adverse drug reactions being reported was greater for dulaglutide and semaglutide. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Conclusion: Medication safety studies using a large publicly available dataset allows an essential opportunity to evaluate the safety profile of antidiabetic drugs in the real-world setting. Additional research is needed to determine if the reported safety concerns for recently approved antidiabetic medications to determine causality.

Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method.

INTRODUCTION: The approach to evaluating nephrotoxins in studies of drug-associated acute kidney injury varies. Some studies use a list of under ten drugs for evaluation whereas others include over 100 drugs. Drugs are typically assigned a binary classification, nephrotoxic or not nephrotoxic. This oversimplifies the nephrotoxic potential of the drugs under investigation. OBJECTIVE: This study aimed to assign a nephrotoxin potential for 167 drugs used in the adult critical care setting. METHODS: A three-round, international, interdisciplinary, web-based modified-Delphi study was used to evaluate nephrotoxins used in adult critically ill patients. Twenty-four international experienced clinicians were identified through the Acute Disease Quality Initiative group and professional affiliations. Included individuals represented the fields of intensive care, nephrology, and pharmacy. One hundred and fifty-nine medications were identified from the literature, with eight additional medications added after the first round, for a total of 167 medications. The primary outcome was consensus achieved for nephrotoxicity ratings. Scores were evaluated each round to determine if a consensus was met. RESULTS: Our nephrotoxin potential index rating indicated that 20 drugs were nephrotoxicity probable or probable/definite per consensus. Nephrotoxic potential was assessed based on the standard use of medications in intensive care and the following consensus scores: 0 = no nephrotoxic potential, 1 = possible nephrotoxic potential, 2 = probable nephrotoxic potential, 3 = definite nephrotoxic potential. CONCLUSIONS: The nephrotoxin potential index rating allows for prioritization of targeted drugs with greater nephrotoxic potential for institutional nephrotoxin stewardship programs. Furthermore, the nephrotoxin potential index rating provides homogeneity for research and guidance on detailed assessments by severity for each drug.

A Pharmacovigilance Study of Adverse Drug Reactions Reported for Cardiovascular Disease Medications Approved Between 2012 and 2017 in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

PURPOSE: Between 2012 and 2017, the FDA approved 29 therapies for a cardiovascular disease (CVD) indication. Due to the limited literature on patient safety outcomes for recently approved CVD medications, this study investigated adverse drug reports (ADRs) reported in the FDA Adverse Event Reporting System (FAERS). METHODS: A disproportionality analysis of spontaneously reported ADR was conducted. Reports in FAERS from Quarter 1, 2012, through Quarter 1, 2019, were compiled, allowing a 2-year buffer following drug approval in 2017. Top 10 reported ADRs and reporting odds ratios (ROR; confidence interval (CI)), a measure of disproportionality, were analyzed and compared to drugs available prior to 2012 as appropriate. RESULTS: Of 7,952,147 ADR reports, 95,016 (1.19%) consisted of reports for newly approved CVD medications. For oral anticoagulants, apixaban had significantly lower reports for anemia and renal failure compared to dabigatran and rivaroxaban but greater reports for neurological signs/symptoms, and arrhythmias. Evaluating heart failure drugs, sacubitril/valsartan had greater reports for acute kidney injury, coughing, potassium imbalances, and renal impairment but notably, lower for angioedema compared to lisinopril. Assessing familial hypercholesterolemia drugs, alirocumab had greater reports for joint-related-signs/symptoms compared to other agents in this category. A newer pulmonary arterial hypertension treatment, selexipag, had greater reports of reporting for bone/joint-related-signs/symptoms but riociguat had greater reports for hemorrhages and vascular hypotension. CONCLUSION: Pharmacovigilance studies allow an essential opportunity to evaluate the safety profile of CVD medications in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved CVD medications.

Quality Improvement Project to Improve the Timeliness of Care for Children With Testicular Torsion in the Emergency Department.

Introduction: Testicular torsion (TT) is a urologic emergency that requires timely diagnosis and surgery. We noted variation in the door-to-detorsion times for patients with TT at our institution and our orchiectomy rate was 25.8%. We aimed to decrease the mean door-to-detorsion time from 124.6 to 114.6 minutes or less over 12 months. Methods: A multidisciplinary team of pediatric emergency medicine, radiology, urology physicians, and nurses, was formed. Our key drivers were use of Testicular Workup for Ischemia and Suspected Torsion (TWIST) score, prompt urology consultation, and efficient transfer from emergency department (ED) to operating room. Our process measures were TWIST score documentation rate and early urology consultation rate, outcome measures were door-to-detorsion time and orchiectomy rate, and balancing measure was ultrasound utilization rate. Early urology consultation occurred when the ED provider documented telephone communication with urology, immediately after placing a testicular doppler ultrasound (TDUS) order and before TDUS result. Results: Over 2 years, 45 cases of TT were diagnosed. TWIST score documentation was implemented and was sustained at 78%. This improved early urology consultations from 40% to 60%. The mean door-to-detorsion time improved from 124.6 to 114.2 minutes. There was no reduction in the orchiectomy rate or TDUS utilization rate. Conclusions: A quality improvement project to improve the timeliness of care for children with TT resulted in expedited ED care but did not impact the orchiectomy rate.

Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database.

BACKGROUND: Between 2012 and 2017, 25 new medications or combination products were approved by the Food and Drug Administration (FDA) for use in treatment of chronic lower respiratory diseases (CLRDs). With limited data on post-marketing patient exposure to these drugs, their safety profiles remain unknown. This study aims to provide post-marketing surveillance of these medications. METHODS: A list of new CLRD medications approved between 2012 and 2017 was generated through searches on Drugs.com (https://www.drugs.com), FDA.gov (https://www.fda.gov), and IBM Micromedex (https://www.micromedexsolutions.com/home/dispatch/ssl/true). Data describing adverse drug reactions (ADRs) were collected from the FDA Adverse Event Reporting System for analysis. Of the 25 identified medications, we selected 4 medications indicated for asthma or COPD with at least 500 reports. Only ADRs catalogued with these medications as the primary suspect were analyzed. Reporting odds ratios were calculated for the top 10 ADRs of each CLRD medication. RESULTS: A total of 61,682 ADR reports were collected for newly approved CLRD medications (n = 27,190 older adults; n = 30,502 male). Reports of COPD medications (umeclidinium and umeclidinium/vilanterol) indicate that umeclidinium/vilanterol yielded a higher reporting odds ratio than umeclidinium alone for reports of pain. Fluticasone furoate/vilanterol had higher reporting odds ratios for cough, pain, and dizziness than budesonide/formoterol and fluticasone propionate/salmeterol. CONCLUSIONS: Our findings suggest that the incidence of different adverse events experienced by patients in post-marketing reports resembles the incidence reported in pre-marketing clinical trials for COPD medications, except for fluticasone furoate/vilanterol, which has several differences.

Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

INTRODUCTION: Drug-induced QTc-prolongation is a well-known adverse drug reaction (ADR), however there is limited knowledge of other drug-induced arrhythmias. PURPOSE: The objective of this study is to determine the drugs reported to be associated with arrhythmias other than QTc-prolongation using the FAERS database, possibly identifying potential drug causes that have not been reported previously. METHODS: FAERS reports from 2004 quarter 1 through 2019 quarter 1 were combined to create a dataset of approximately 11.6 million reports. Search terms for arrhythmias of interest were selected from the Standardized MedDRA Queries (SMQ) Version 12.0. Frequency of the cardiac arrhythmias were determined for atrial fibrillation, atrioventricular block, bradyarrhythmia, bundle branch block, supraventricular tachycardia, and ventricular fibrillation and linked to the reported causal medications. Reports were further categorized by prior evidence associations using package inserts and established drug databases. A reporting odds ratio (ROR) and confidence interval (CI) were calculated for the ADRs for each drug and each of the 6 cardiac arrhythmias. RESULTS: Of the 11.6 million reports in the FAERS database, 68,989 were specific to cardiac arrhythmias of interest. There were 61 identified medication-reported arrhythmia pairs for the 6 arrhythmia groups with 33 found to have an unknown reported association. Rosiglitazone was the most frequently medication reported across all arrhythmias [ROR 6.02 (CI: 5.82-6.22)]. Other medications with significant findings included: rofecoxib, digoxin, alendronate, lenalidomide, dronedarone, zoledronic acid, adalimumab, dabigatran, and interferon beta-1b. CONCLUSION: Upon retrospective analysis of the FAERS database, the majority of drug-associated arrhythmias reported were unknown suggesting new potential drug causes. Cardiac arrhythmias other than QTc prolongation are a new area of focus for pharmacovigilance and medication safety. Consideration of future studies should be given to using the FAERS database as a timely pharmacovigilance tool to identify unknown adverse events of medications.

Vaccinating in the Emergency Department, a Novel Approach to Improve Influenza Vaccination Rates via a Quality Improvement Initiative.

INTRODUCTION: Annual influenza vaccination is recommended for all US children 6 months and older to prevent morbidity and mortality. Despite these recommendations, only ~50% of US children are vaccinated annually. Influenza vaccine administration in the pediatric emergency department (ED) is an innovative solution to improve vaccination rates. However, during the 2017-2018 influenza season, only 75 influenza vaccinations were given in this tertiary care ED. We aimed to increase the number of influenza vaccines administered to ED patients from 75 to 1,000 between August 2018 and March 2019.s. METHODS: Process mapping identified potential barriers and solutions. Key interventions included mandatory vaccine screening, creation of a vaccine administration protocol, education for family, provider, and nursing, a revised pharmacy workflow, and weekly staff feedback. Interventions were tested using plan-do-study-act cycles. The process measure was the percent of patients screened for vaccine status. The primary outcome was the number of influenza vaccines administered. The balancing measures were ED length of stay (LOS), wasted vaccines, and financial impact on the institution. RESULTS: We included 33,311 children in this study. Screening for vaccine status improved from 0% to 90%. Of those screened, 58% were eligible for vaccination, and 8.5% of eligible patients were vaccinated in the ED. In total, 1,323 vaccines were administered with no significant change in ED LOS (139 min) and no lost revenue to the hospital. CONCLUSIONS: We implemented an efficient, cost-effective, influenza vaccination program in the pediatric ED and successfully increased vaccinations in a population that might not otherwise receive the vaccine.

Safety concerns reported by consumers, manufacturers and healthcare professionals: A detailed evaluation of opioid-related adverse drug reactions in the FDA database over 15 years.

To perform an in-depth analysis of opioid-related ADRs reported by consumers, manufacturers and healthcare professionals. Delving into the depth and breadth of reported opioid-related adverse drug reactions (ADRs) provides an opportunity to strategize better clinical management and alleviate safety concerns. Retrospective pharmacovigilance disproportionality analysis for opioid-related ADRs in the FDA Adverse Event Reporting System (FAERS) database was performed. Detailed analysis of patient (sex, age) and report (year of report; reporter: healthcare worker vs consumer) characteristics were conducted using reports from 2004 quarter 1 to 2018 quarter 4. Reporting odds ratios and confidence intervals (RORs,CI) were calculated. Of the 1 916 674 ADR reports, 300 985 indicated opioids as the primary medication. There was a surge in opioid-related ADRs reported in 2018 with six times more reports compared to 2004 and twice the number of reports compared to 2017. The largest ROR among the 20 common ADRs was depression and suicide-self-injury (ROR 3.12, 95% CI 3.01-3.22) for reports in age group ≥65 compared to age group 18 to 64, and lack of efficacy (ROR 6.80, 95% CI 6.61-7.00) for males compared to females. ADRs with the largest RORs for consumers included lack of efficacy/effect (ROR 3.37, 95% CI 3.28-3.46), administration site reactions (ROR 3.21, 95% CI 3.11-3.32), depression and suicide self-injury (ROR 2.26, 95% CI 2.14-2.38) compared to healthcare professionals. Important aspects of opioid ADR voluntary reporting included suicidal ideation in elderly patients and lack of efficacy, especially in male patients. This examination provides insight to better manage safety concerns of opioids.

Impact of direct-to-consumer drug advertising during the Super Bowl on drug utilization.

BACKGROUND: Direct-to-consumer advertising (DTCA) of prescription drugs impacts patients' requests for medications, and clinician prescribing. However, the impact of DTCA during the Super Bowl has not been previously described. OBJECTIVE: Evaluate the impact of prescription drug DTCA during the Super Bowl on drug utilization using 2014-2016 Medicare data. METHODS: Efinaconazole was advertised during Super Bowls XLIX (02/01/2015) and L (02/07/2016). The number of prescriptions for efinaconazole and for a comparator drug, tavaborole, were calculated in 31-day intervals from July 2014-December 2016. Interrupted time-series analysis models were created to test changes in trends of prescriptions for efinaconazole and tavaborole. RESULTS: Following Super Bowl XLIX, the number of prescriptions per 100,000 Medicare beneficiaries increased by 91% for efinaconazole, and 275% for tavaborole. After Super Bowl L, the number of prescriptions increased significantly for efinaconazole (p-value<0.001), but not for tavaborole (p = 0.70). Interrupted time-series analyses estimated that, in the absence of DTCA during Super Bowl XLIX, prescriptions for efinaconazole would have increased by 40%, instead of the observed 91%. For tavaborole, prescriptions would have increased by 90% instead of 275%. CONCLUSIONS: DTCA during the Super Bowl resulted in sharp increases in utilization of the prescription drug advertised, which supports further regulation of DTCA.

Improving Emergency Department Management of Diabetic Ketoacidosis in Children.

BACKGROUND: Diagnostic delays in the pediatric emergency department (ED) can lead to unnecessary interventions and prolonged ED length of stay (LOS), especially in patients with diabetes mellitus evaluated for diabetic ketoacidosis (DKA). At our institution, baseline DKA determination time (arrival to diagnosis) was 86 minutes, and 61% of patients did not meet DKA criteria. Subsequently, intravenous (IV) placement occurred in 85% of patients without DKA. We aimed to use point-of-care (POC) testing to reduce DKA determination time from 86 to 30 minutes and to reduce IV placements in patients without DKA from 85% to 20% over 18 months. METHODS: Four key interventions (POC tests, order panels, provider guidelines, and nursing guidelines) were tested by using plan-do-study-act cycles. DKA determination time was our primary outcome, and secondary outcomes included the percentage of patients receiving IV placement and ED LOS. Process measures included the rate of use of POC testing and order panels. All measures were analyzed on statistical process control charts. RESULTS: Between January 2015 and July 2018, 783 patients with diabetes mellitus were evaluated for DKA. After all 4 interventions, DKA determination time decreased from 86 to 26 minutes (P < .001). In patients without DKA, IV placement decreased from 85% to 36% (P < .001). ED LOS decreased from 206 to 186 minutes (P = .009) in patients discharged from the hospital after DKA evaluation. POC testing and order panel use increased from 0% to 98% and 90%, respectively. CONCLUSIONS: Using quality-improvement methodology, we achieved a meaningful reduction in DKA determination time, the percentage of IV placements, and ED LOS.

A Systematic Review of Hospital Trauma Team Activation Criteria for Children.

OBJECTIVES: Hospital trauma activation criteria are intended to identify children who are likely to require aggressive resuscitation or specific surgical interventions that are time sensitive and require the resources of a trauma team at the bedside. Evidence to support criteria is limited, and no prior publication has provided historical or current perspectives on hospital practices toward informing best practice. This study aimed to describe the published variation in (1) highest level of hospital trauma team activation criteria for pediatric patients and (2) hospital trauma team membership and (3) compare these finding to the current ACS recommendations. METHODS: Using an Ovid MEDLINE In-Process & Other Non-Indexed Citations search, any published description of hospital trauma team activation criteria for children that used information captured in the prehospital setting was identified. Only studies of children were included. If the study included both adults and children, it was included if the number of children assessed with the criteria was included. RESULTS: Eighteen studies spanning 20 years and 13,184 children were included. Hospital trauma team activation and trauma team membership were variable. Nearly all (92%) of the trauma criteria used physiologic factors. Penetrating trauma (83%) was frequently included in the trauma team activation criteria. Mechanisms of injury (52%) were least likely to be included in the highest level of activation. No predictable pattern of criterion adoption was found. Only 2 of the published criteria and 1 of published trauma team membership are consistent with the current American College of Surgeons recommendations. CONCLUSIONS: Published hospital trauma team activation criteria and trauma team membership for children were variable. Future prospective studies are needed to define the optimal hospital trauma team activation criteria and trauma team membership and assess its impact on improving outcomes for children.

Assessing Adverse Drug Reactions from Psychotropic Medications Reported to the U.S. Food and Drug Administration in Older Adults.

OBJECTIVE: Identify trends in adverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration's Adverse Event Reporting System in three subpopulations of older adults (ages 55-64, 65-74, 75+) receiving psychotropic medications. METHODS: Almost 12 years of ADR reports were compiled for adults over 55 years of age receiving psychotropic medications with known side effect profiles. A comparison of the frequency of ADRs reported, odds ratios (ORs), and 95% confidence intervals (CIs) between subpopulations to the whole population of patients aged 55+ was conducted. RESULTS: ADRs reported in three subpopulations of older adults differed significantly when receiving the same psychotropic medications. For example, reports of increased blood glucose (OR, 1.8, CI, 1.4-2.2) were all significantly increased in the youngest population (55-64). CONCLUSION: Current classification of age greater than 65 years when evaluating likely ADRs in older adults using psychotropic medications may be inadequate and require further assessment by subpopulations of older adults.

Consensus-based Criterion Standard for the Identification of Pediatric Patients Who Need Emergency Medical Services Transport to a Hospital with Higher-level Pediatric Resources.

BACKGROUND: Emergency medical services (EMS) providers must be able to identify the most appropriate destination facility when treating children with potentially severe medical illnesses. Currently, no validated tool exists to assist EMS providers in identifying children who need transport to a hospital with higher-level pediatric care. For such a tool to be developed, a criterion standard needs to be defined that identifies children who received higher-level pediatric medical care. OBJECTIVE: The objective was to develop a consensus-based criterion standard for children with a medical complaint who need a hospital with higher-level pediatric resources. METHODS: Eleven local and national experts in EMS, emergency medicine (EM), and pediatric EM were recruited. Initial discussions identified themes for potential criteria. These themes were used to develop specific criteria that were included in a modified Delphi survey, which was electronically delivered. The criteria were refined iteratively based on participant responses. To be included, a criterion required at least 80% agreement among participants. If an item had less than 50% agreement, it was removed. A criterion with 50% to 79% agreement was modified based on participant suggestions and included on the next survey, along with any new suggested criteria. Voting continued until no new criteria were suggested and all criteria received at least 80% agreement. RESULTS: All 11 recruited experts participated in all seven voting rounds. After the seventh vote, there was agreement on each item and no new criteria were suggested. The recommended criterion standard included 13 items that apply to patients 14 years old or younger. They included IV antibiotics for suspicion of sepsis or a seizure treated with two different classes of anticonvulsive medications within 2 hours, airway management, blood product administration, cardiopulmonary resuscitation, electrical therapy, administration of specific IV/IO drugs or respiratory assistance within 4 hours, interventional radiology or surgery within 6 hours, intensive care unit admission, specific comorbid conditions with two or more abnormal vital signs, and technology-assisted children seen for device malfunction. CONCLUSION: We developed a 13-item consensus-based criterion standard definition for identifying children with medical complaints who need the resources of a hospital equipped to provide higher-level pediatric services. This criterion standard will allow us to create a tool to improve pediatric patient care by assisting EMS providers in identifying the most appropriate destination facility for ill children.

Outcomes of Patients With Atrial Fibrillation Newly Recommended for Oral Anticoagulation Under the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline.

BACKGROUND: In March 2014, the American Heart Association updated their guidelines for the management of oral anticoagulation (OAC) in atrial fibrillation, recommending OAC for all patients with CHA2DS2-VASc ≥2. Previously, only patients with CHADS2 ≥2 were recommended for anticoagulation. This study compared effectiveness and safety outcomes of OAC among patients who would receive OAC using the 2014 guidelines but not the 2011 guidelines. METHODS AND RESULTS: Using claims data from a 5% sample of 2013-2014 Medicare beneficiaries, we identified patients with initially diagnosed atrial fibrillation between 2013 and 2014 and selected those who would receive OAC under the 2014 guidelines but not the 2011 guidelines (those with CHA2DS2-VASc score ≥2 or CHADS2 score <2). Patients were categorized according to their use of OAC after first atrial fibrillation diagnosis (2937 users and 2914 nonusers). Primary outcomes included the composite of ischemic stroke, systemic embolism and death, and any bleeding event. Cox proportional hazard models were constructed to compare the risk of primary outcomes between the 2 groups, while controlling for patient demographic and clinical characteristics. There was no difference in the combined risk of stroke, systemic embolism, and death between the treatment groups (hazard ratio, 1.00; 95% confidence interval, 0.84-1.20). The risk of bleeding was higher for patients receiving OAC than for patients not receiving OAC (hazard ratio, 1.70, 95% confidence interval, 1.46-1.97). CONCLUSIONS: The benefit of OAC is not well defined in this patient population, and new studies that minimize residual confounding are needed to fully understand the risk/benefit of OAC in patients with atrial fibrillation and low to moderate stroke risk.

Reducing Unnecessary Imaging for Patients With Constipation in the Pediatric Emergency Department.

OBJECTIVES: Constipation is a common diagnosis in the pediatric emergency department (ED). Children diagnosed with constipation may undergo an abdominal radiograph (AXR) as part of their diagnostic workup despite studies that suggest that an AXR in a patient suspected of being constipated is unnecessary and potentially misleading. We aimed to decrease the percentage of low-acuity patients aged between 6 months and 18 years diagnosed with constipation who undergo an AXR in our pediatric ED from 60% to 20% over 12 months. METHODS: We conducted an interventional improvement project at a large, urban pediatric ED by using the Institute for Healthcare Improvement's Model for Improvement. The primary outcome was the proportion of patients ultimately diagnosed with constipation who had an AXR during their ED visit. Analysis was performed by using rational subgrouping and stratification on statistical process control (SPC) charts. RESULTS: Process analysis was performed by using a cause-and-effect diagram. Four plan-do-study-act cycles were completed over 9 months. Interventions included holding Grand Rounds on constipation, sharing best practices, metrics reporting, and academic detailing. Rational subgrouping and stratification on SPC charts were used to target the interventions to different ED provider groups. Over 12 months, we observed a significant and sustained decrease from a mean rate of 62% to a mean rate of 24% in the utilization of AXRs in the ED for patients with constipation. CONCLUSIONS: The use of rational subgrouping and stratification on SPC charts to study different ED provider groups resulted in a substantial and sustained reduction in the rate of AXRs for constipation.

Improving Guideline-Based Care of Acute Asthma in a Pediatric Emergency Department.

BACKGROUND AND OBJECTIVE: Rapid repetitive administration of short-acting ß-agonists (SABA) is the most effective means of reducing acute airflow obstruction in asthma. Little evidence exists that assesses process measures (ie, timeliness) and outcomes for asthma. We used quality improvement (QI) methods to improve emergency department care in accordance with national guidelines including timely SABA administration and use of asthma severity scores. METHODS: The Model for Improvement was used and interventions were targeted at 4 key drivers: knowledge, engagement, decision support, and workflow enhancement. Time series analysis was performed and outcomes assessed on statistical process control charts. RESULTS: Asthma severity scoring increased from 0% to >95% in triage and to >75% for repeat scores. Time to first SABA (T1) improved by 32.8 minutes (47%). T1 for low severity patients improved by 17.6 minutes (28%). T1 for high severity patients improved by 3.1 minutes to 18.1 minutes (15%). Time to third SABA (T3) improved by 30 minutes (24%). T3 for low severity patients improved by 42.5 minutes (29%) and T3 for high severity patients improved by 21 minutes (23%). Emergency department length of stay for low severity patients discharged to home improved by 29.3 minutes (15%). The number of asthma-related visits between 48-hour return hospitalizations increased from 114 to 261. The admission rate decreased 6.0%. CONCLUSIONS: We implemented standardized asthma severity scoring with high rates of compliance, improved timely administration of ß-agonist treatments, demonstrated early improvements in Emergency department length of stay, and reduced admission rates without increasing unplanned return admissions.

Recurrence rates after intussusception enema reduction: a meta-analysis.

BACKGROUND AND OBJECTIVE: Reported rates of recurrence after enema reduction for intussusception are variable. Concerns for recurrence influence postreduction management. The objective of this study was to conduct a systematic review and meta-analysis to estimate overall, 24-hour, and 48-hour recurrence rates after enema reduction in children. METHODS: PubMed, Cochrane Database, and OVID Medline were searched from 1946 through December 2011 using the search terms: intussusception, recurrence, and enema. Sixty-nine studies of patients age 0 to 18 years with radiographically proven intussusception reduced by enema that report the number of enema reductions and the number of recurrences were included. Extraction was done by the primary author (M.P.G.) with 10% of included studies independently audited to ensure concordance. RESULTS: Overall recurrence rates were 12.7% (95% confidence interval [CI]: 11.1%-14.4%, I2 = 28.8%) for contrast enema (CE), 7.5% (95% CI: 5.7%-9.8%, I2 = 52.4%) for ultrasound-guided noncontrast enema (UGNCE), and 8.5% (95% CI: 6.9%-10.4%, I2 = 50.1%) for fluoroscopy-guided air enema (FGAE). Recurrence rates within 24 hours were 3.9% (95% CI: 2.2%-6.7%, I2 = 47.0%) for CE, 3.9% (95% CI: 1.5%-10.1%, I2 = 0.0%) for UGNCE, and 2.2% (95% CI: 0.7%-6.5%, I2 = 59.8%) for FGAE. Recurrence rates within 48 hours were 5.4% (95% CI 3.7%-7.8%, I2 = 32.3%) for CE, 6.6% (95% CI: 4.0%-10.7%, I2 = 0.0%) for UGNCE, and 2.7% (95% CI: 1.2%-6.5%, I2 = 73.8%) for FGAE. Most included studies are retrospective and vary in quality of reporting. Few studies reported detailed patient characteristics including timing of recurrences. CONCLUSIONS: The risk of early (within 48 hours) recurrence after enema reduction is low, suggesting outpatient management of well-appearing patients should be considered.