Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors

Purpose In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. Methods We analyzed data (2005–2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). Findings The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. Implications The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes

Infant sex differences in human milk intake and composition from 1- to 3-month post-delivery in a healthy United States cohort

Background Macronutrient composition of human milk differs by infant sex, but few studies have examined sex differences in other milk components, or their potential modification by maternal body mass index (BMI). Aim We compared milk intake and human milk hormone and cytokine concentrations at 1- and 3-month post-delivery and tested infant sex by maternal BMI (OW/OB vs. NW) interactions. Subjects and method Data were analysed for 346 mother–infant dyads in the Mothers and Infants Linked for Healthy Growth (MILk) Study at 1- and 3-month post-delivery. Infant milk intake was estimated by the change in infant weight after test feedings. Concentrations of glucose, insulin, leptin, adiponectin, interleukin-6 (IL-6), and C-reactive protein (CRP) were measured using ELISA. Multivariable linear regression and linear mixed models were used to estimate sex main effects and their interaction with maternal BMI. Results Mean glucose concentration at 1 month was 2.62 mg/dl higher for male infants, but no difference at 3 months was observed. Milk intake and concentrations for the other milk components were similar for males and females at both time points. Associations with infant sex did not differ significantly by maternal BMI. Conclusions Among healthy United States mother–infant dyads, appetite, and growth-regulating factors in human milk did not differ significantly by infant sex

Development and Validation of a Risk Equation for Appendicitis in Children Presenting With Abdominal Pain

Background: Appendicitis is a common surgical emergency in children, yet the diagnosis remains challenging. A widely used risk score, the Pediatric Appendicitis Score, is not sufficiently sensitive or specific to be used alone, with many patients classified as “intermediate risk.” Goals of this study were to develop and validate an improved appendicitis risk calculator for children with acute abdominal pain to aid in clinical decision-making. Methods: We developed our risk calculator using data from a multicenter cohort of children 5 to 18 years old presenting to the emergency department (ED) with acute abdominal pain. We validated the risk calculator in two independent cohorts with similar enrollment criteria. Patient history, physical examination and laboratory data were prospectively recorded by clinicians during ED visits. Appendicitis was confirmed by pathology reports and follow-up telephone survey. Variables evaluated for inclusion in the risk calculator were: age, sex, pain duration, pain with walking, migration of pain, temperature, heart rate, guarding, maximal tenderness in right lower quadrant, white blood cell count, and absolute neutrophil count. A step-wise regression approach was followed to select the best model, using Akaike information criteria and the C-statistic. We forced inclusion of age and sex, including first-order interaction terms. Laboratory values were evaluated for nonlinear associations with appendicitis, and a two-step linear association was included. Validation included calibration and discrimination analyses. Results: The development sample included 2,423 children, of whom 40% had appendicitis; the validation sample included 1,426, and 35% had appendicitis. Our final risk calculator included sex, age, duration of pain, guarding, migration of pain and absolute neutrophil count. In the validation sample, calibration plot and Hosmer and Lemeshow test (P \u3c 0.0001) showed high calibration and a high discrimination (C-statistic = 0.86). Among 248 (17%) patients in the validation sample at \u3c 5% predicted risk, we observed 4% had appendicitis. Of an additional 318 (22%) patients with predicted risk 5% to \u3c 15%, appendicitis occurred in 8%. Of 48 (3.4%) patients in the validation sample at predicted risk of \u3e 90%, 96% had appendicitis. Conclusion: Our validated pediatric appendicitis risk calculator can accurately quantify risk for appendicitis and can identify children with acute abdominal pain at high or low risk for appendicitis

Development and Validation of a Risk Equation for Appendicitis in Children Presenting With Abdominal Pain

Background: Appendicitis is a common surgical emergency in children, yet the diagnosis remains challenging. A widely used risk score, the Pediatric Appendicitis Score, is not sufficiently sensitive or specific to be used alone, with many patients classified as “intermediate risk.” Goals of this study were to develop and validate an improved appendicitis risk calculator for children with acute abdominal pain to aid in clinical decision-making. Methods: We developed our risk calculator using data from a multicenter cohort of children 5 to 18 years old presenting to the emergency department (ED) with acute abdominal pain. We validated the risk calculator in two independent cohorts with similar enrollment criteria. Patient history, physical examination and laboratory data were prospectively recorded by clinicians during ED visits. Appendicitis was confirmed by pathology reports and follow-up telephone survey. Variables evaluated for inclusion in the risk calculator were: age, sex, pain duration, pain with walking, migration of pain, temperature, heart rate, guarding, maximal tenderness in right lower quadrant, white blood cell count, and absolute neutrophil count. A step-wise regression approach was followed to select the best model, using Akaike information criteria and the C-statistic. We forced inclusion of age and sex, including first-order interaction terms. Laboratory values were evaluated for nonlinear associations with appendicitis, and a two-step linear association was included. Validation included calibration and discrimination analyses. Results: The development sample included 2,423 children, of whom 40% had appendicitis; the validation sample included 1,426, and 35% had appendicitis. Our final risk calculator included sex, age, duration of pain, guarding, migration of pain and absolute neutrophil count. In the validation sample, calibration plot and Hosmer and Lemeshow test (P \u3c 0.0001) showed high calibration and a high discrimination (C-statistic = 0.86). Among 248 (17%) patients in the validation sample at \u3c 5% predicted risk, we observed 4% had appendicitis. Of an additional 318 (22%) patients with predicted risk 5% to \u3c 15%, appendicitis occurred in 8%. Of 48 (3.4%) patients in the validation sample at predicted risk of \u3e 90%, 96% had appendicitis. Conclusion: Our validated pediatric appendicitis risk calculator can accurately quantify risk for appendicitis and can identify children with acute abdominal pain at high or low risk for appendicitis

Text message alerts to emergency physicians identifying potential study candidates increase clinical trial enrollment.

Prospective enrollment of research subjects in the fast-paced emergency department (ED) is challenging. We sought to develop a software application to increase real-time clinical trial enrollment during an ED visit. The Prospective Intelligence System for Clinical Emergency Services (PISCES) scans the electronic health record during ED encounters for preselected clinical characteristics of potentially eligible study participants and notifies the treating physician via mobile phone text alerts. PISCES alerts began 3 months into a cluster randomized trial of an electronic health record-based risk stratification tool for pediatric abdominal pain in 11 Northern California EDs. We compared aggregate enrollment before (2577 eligible patients, October 2016 to December 2016) and after (12 049 eligible patients, January 2017 to January 2018) PISCES implementation. Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001). PISCES significantly increased study enrollment and can serve as a valuable tool to assist prospective research enrollment in the ED

Racial disparities in family-provider interactions for pediatric asthma care

OBJECTIVE: Black and Latino children experience significantly worse asthma morbidity than their white peers for multifactorial reasons. This study investigated differences in family-provider interactions for pediatric asthma, based on race/ethnicity. METHODS: This was a cross-sectional study of parent surveys of asthmatic children within the Population-Based Effectiveness in Asthma and Lung Diseases Network. Our study population comprised 647 parents with survey response data. Data on self-reported race/ethnicity of the child were collected from parents of the children with asthma. Outcomes studied were responses to the questions about family-provider interactions in the previous 12 months: (1) number of visits with asthma provider; (2) number of times provider reviewed asthma medications with patient/family; (3) review of a written asthma treatment plan with provider; and (4) preferences about making asthma decisions. RESULTS: In multivariate adjusted analyses controlling for asthma control and other co-morbidities, black children had fewer visits in the previous 12 months for asthma than white children: OR 0.63 (95% CI 0.40, 0.99). Additionally, black children were less likely to have a written asthma treatment plan given/reviewed by a provider than their white peers, OR 0.44 (95% CI 0.26, 0.75). There were no significant differences by race in preferences about asthma decision-making nor in the frequency of asthma medication review. CONCLUSION: Black children with asthma have fewer visits with their providers and are less likely to have a written asthma treatment plan than white children. Asthma providers could focus on improving these specific family-provider interactions in minority children

Results of a Cluster-Randomized Trial Testing the Effects of TeenBP, an Electronic Health Record-Based Clinical Decision Support Tool, on Recognition of Adolescent Hypertension

Background: Hypertension occurs in 1%–3% of adolescents and is associated with long-term cardiovascular morbidity. Although blood pressure (BP) is routinely measured, hypertension in adolescents is often missed during outpatient visits. This study sought to evaluate whether “TeenBP,” an electronic health record (EHR)-linked, web-based clinical decision support tool, could improve recognition and early management of hypertension in adolescents. Methods: We randomized 20 primary care clinics to receive the CDS or to continue usual care. At intervention sites, TeenBP was activated at the point of care when a BP was elevated. TeenBP graphically displayed systolic and diastolic BP values and percentiles over the prior 2 years, identified patients meeting criteria for hypertension (3 or more BPs ≥ 95th percentile), provided a summary of comorbidities and medications that may affect BP, and offered patient-specific order sets. Hypertension recognition, within 6 months of meeting criteria, was defined as adding hypertension or elevated BP (EBP) to the problem list or clinical notes, indicating hypertension or EBP as an outpatient visit diagnosis, prescribing a medication to lower BP, or diagnostic testing related to hypertension, and was identified through chart review. Generalized linear mixed models were used to test the effect of the intervention. Results: Among 21,618 patients aged 10–17 years with a primary care visit at the 20 study clinics over one year (May 2014–April 2015), 315 (1.5%) met criteria for new-onset hypertension. Most BPs were modestly elevated (\u3c 99th percentile). Clinical recognition of hypertension within 6 months occurred for 36.2% (27.7%–45.8%) of patients in usual care clinics and 68.0% (56.6%–77.6%) in the CDS clinics (P = 0.0003). Clinical recognition of hypertension in the TeenBP clinics was most often met by adding hypertension or EBP as an outpatient visit diagnosis (52.2%) or to the text of the clinical note (52.4%). Within 6 months of meeting criteria for hypertension, less than 10% of TeenBP or usual care subjects had an echocardiogram or renal ultrasound and only one patient initiated an antihypertensive medication. Conclusion: We observed a large and statistically significant beneficial effect of this clinical decision support system on recognition of new-onset hypertension, without increasing diagnostic workups or early initiation of antihypertensive medication

Development of a Clinical Decision Support System for Pediatric Abdominal Pain in Emergency Department Settings Across Two Health Systems Within the HCSRN.

BackgroundAppendicitis is a common surgical emergency in children, yet diagnosis can be challenging. An electronic health record (EHR) based, clinical decision support (CDS) system called Appy CDS was designed to help guide management of pediatric patients with acute abdominal pain within the Health Care Systems Research Network (HCSRN).ObjectivesTo describe the development and implementation of a clinical decision support tool (Appy CDS) built independently but synergistically at two large HCSRN affiliated health systems using well-established platforms, and to assess the tool's Triage component, aiming to identify pediatric patients at increased risk for appendicitis.ResultsDespite differences by site in design and implementation, such as the use of alerts, incorporating gestalt, and other workflow variations across sites, using simple screening questions and automated exclusions, both systems were able to identify a population with similar appendicitis rates (11.8 percent and 10.6 percent), where use of the full Appy CDS would be indicated.DiscussionThese 2 HCSRN sites designed Appy CDS to capture a population at risk for appendicitis and deliver CDS to that population while remaining locally relevant and adhering to organizational preferences. Despite different approaches to point-of-care CDS, the sites have identified similar cohorts with nearly identical background rates of appendicitis.Next stepsThe full Appy CDS tool, providing personalized risk assessment and tailored recommendations, is undergoing evaluation as part of a pragmatic cluster randomized trial aiming to reduce reliance on advanced diagnostic imaging. The novel approaches to CDS we present could serve as the basis for future ED interventions