High-Acuity Alcohol-Related Complications During the COVID-19 Pandemic.

Importance: Research has demonstrated an association between the COVID-19 pandemic and increased alcohol-related liver disease hospitalizations and deaths. However, trends in alcohol-related complications more broadly are unclear, especially among subgroups disproportionately affected by alcohol use. Objective: To assess trends in people with high-acuity alcohol-related complications admitted to the emergency department, observation unit, or hospital during the COVID-19 pandemic, focusing on demographic differences. Design, Setting, and Participants: This longitudinal interrupted time series cohort study analyzed US national insurance claims data using Optum's deidentified Clinformatics Data Mart database from March 2017 to September 2021, before and after the March 2020 COVID-19 pandemic onset. A rolling cohort of people 15 years and older who had at least 6 months of continuous commercial or Medicare Advantage coverage were included. Subgroups of interest included males and females stratified by age group. Data were analyzed from April 2023 to January 2024. Exposure: COVID-19 pandemic environment from March 2020 to September 2021. Main Outcomes and Measures: Differences between monthly rates vs predicted rates of high-acuity alcohol-related complication episodes, determined using claims-based algorithms and alcohol-specific diagnosis codes. The secondary outcome was the subset of complication episodes due to alcohol-related liver disease. Results: Rates of high-acuity alcohol-related complications were statistically higher than expected in 4 of 18 pandemic months after March 2020 (range of absolute and relative increases: 0.4-0.8 episodes per 100 000 people and 8.3%-19.4%, respectively). Women aged 40 to 64 years experienced statistically significant increases in 10 of 18 pandemic months (range of absolute and relative increases: 1.3-2.1 episodes per 100 000 people and 33.3%-56.0%, respectively). In this same population, rates of complication episodes due to alcohol-related liver disease increased above expected in 16 of 18 pandemic months (range of absolute and relative increases: 0.8-2.1 episodes per 100 000 people and 34.1%-94.7%, respectively). Conclusions and Relevance: In this cohort study of a national, commercially insured population, high-acuity alcohol-related complication episodes increased beyond what was expected in 4 of 18 COVID-19 pandemic months. Women aged 40 to 64 years experienced 33.3% to 56.0% increases in complication episodes in 10 of 18 pandemic months, a pattern associated with large and sustained increases in high-acuity alcohol-related liver disease complications. Findings underscore the need for increased attention to alcohol use disorder risk factors, alcohol use patterns, alcohol-related health effects, and alcohol regulations and policies, especially among women aged 40 to 64 years.

Acute Diabetes Complications After Transition to a Value-Based Medication Benefit.

Importance: The association of value-based medication benefits with diabetes health outcomes is uncertain. Objective: To assess the association of a preventive drug list (PDL) value-based medication benefit with acute, preventable diabetes complications. Design, Setting, and Participants: This cohort study used a controlled interrupted time series design and analyzed data from a large, national, commercial health plan from January 1, 2004, through June 30, 2017, for patients with diabetes aged 12 to 64 years enrolled through employers that adopted PDLs (intervention group) and matched and weighted members with diabetes whose employers did not adopt PDLs (control group). All participants were continuously enrolled and analyzed for 1 year before and after the index date. Subgroup analysis assessed patients with diabetes living in lower-income and higher-income neighborhoods. Data analysis was performed between August 19, 2020, and December 1, 2023. Exposure: At the index date, intervention group members experienced employer-mandated enrollment in a PDL benefit that was added to their follow-up year health plan. This benefit reduced out-of-pocket costs for common cardiometabolic drugs, including noninsulin antidiabetic agents and insulin. Matched control group members continued to have cardiometabolic medications subject to deductibles or co-payments at follow-up. Main Outcomes and Measures: The primary outcome was acute, preventable diabetes complications (eg, bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis) measured as complication days per 1000 members per year. Intermediate measures included the proportion of days covered by and higher use (mean of 1 or more 30-day fills per month) of antidiabetic agents. Results: The study 10 588 patients in the intervention group (55.2% male; mean [SD] age, 51.1 [10.1] years) and 690 075 patients in the control group (55.2% male; mean [SD] age, 51.1 [10.1] years) after matching and weighting. From baseline to follow-up, the proportion of days covered by noninsulin antidiabetic agents increased by 4.7% (95% CI, 3.2%-6.2%) in the PDL group and by 7.3% (95% CI, 5.1%-9.5%) among PDL members from lower-income areas compared with controls. Higher use of noninsulin antidiabetic agents increased by 11.3% (95% CI, 8.2%-14.5%) in the PDL group and by 15.2% (95% CI, 10.6%-19.8%) among members of the PDL group from lower-income areas compared with controls. The PDL group experienced an 8.4% relative reduction in complication days (95% CI, -13.9% to -2.8%; absolute reduction, -20.2 [95% CI, -34.3 to -6.2] per 1000 members per year) compared with controls from baseline to follow-up, while PDL members residing in lower-income areas had a 10.2% relative reduction (95% CI, -17.4% to -3.0%; absolute, -26.1 [95% CI, -45.8 to -6.5] per 1000 members per year). Conclusions and Relevance: In this cohort study, acute, preventable diabetes complication days decreased by 8.4% in the overall PDL group and by 10.2% among PDL members from lower-income areas compared with the control group. The results may support a strategy of incentivizing adoption of targeted cost-sharing reductions among commercially insured patients with diabetes and lower income to enhance health outcomes.

Quantifying cancer risk from exposures to medical imaging in the Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC) Study: research methods and cohort profile.

PURPOSE: The Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC) Study is quantifying the association between cumulative radiation exposure from fetal and/or childhood medical imaging and subsequent cancer risk. This manuscript describes the study cohorts and research methods. METHODS: The RIC Study is a longitudinal study of children in two retrospective cohorts from 6 U.S. healthcare systems and from Ontario, Canada over the period 1995-2017. The fetal-exposure cohort includes children whose mothers were enrolled in the healthcare system during their entire pregnancy and followed to age 20. The childhood-exposure cohort includes children born into the system and followed while continuously enrolled. Imaging utilization was determined using administrative data. Computed tomography (CT) parameters were collected to estimate individualized patient organ dosimetry. Organ dose libraries for average exposures were constructed for radiography, fluoroscopy, and angiography, while diagnostic radiopharmaceutical biokinetic models were applied to estimate organ doses received in nuclear medicine procedures. Cancers were ascertained from local and state/provincial cancer registry linkages. RESULTS: The fetal-exposure cohort includes 3,474,000 children among whom 6,606 cancers (2394 leukemias) were diagnosed over 37,659,582 person-years; 0.5% had in utero exposure to CT, 4.0% radiography, 0.5% fluoroscopy, 0.04% angiography, 0.2% nuclear medicine. The childhood-exposure cohort includes 3,724,632 children in whom 6,358 cancers (2,372 leukemias) were diagnosed over 36,190,027 person-years; 5.9% were exposed to CT, 61.1% radiography, 6.0% fluoroscopy, 0.4% angiography, 1.5% nuclear medicine. CONCLUSION: The RIC Study is poised to be the largest study addressing risk of childhood and adolescent cancer associated with ionizing radiation from medical imaging, estimated with individualized patient organ dosimetry.

Risk factors for suicide attempt in children, adolescents, and young adults hospitalized for mental health disorders.

BACKGROUND: Suicide is a leading cause of death among children, adolescents, and young adults (AYA), and mental health disorders are a major contributing factor. Yet, suicidal behaviors among children and AYA with mental health concerns remain understudied and age-specific risk factors are poorly understood. We examined the risk factors for suicide attempt in children and AYA with mental health disorders across three age groups: pre-adolescent children (aged ≤ 12), adolescents (aged 13-17), and young adults (aged 18-25). METHODS: A cross-sectional study of children and AYA hospitalized for a mental health disorder (n = 18,018) at a private hospital system with 141 facilities across the United States (year 2014). RESULTS: Suicide attempts six months prior to hospitalization were reported in 12.1% (n = 177) pre-adolescent children, 22% (n = 1476) adolescents, and 17.9% (n = 1766) young adults. Evidence of psychological trauma was present in 55.4% of pre-adolescent children, 51.2% of adolescents, and 44.5% of young adults. Predictors for suicide attempt observed across all three age groups included the following: female sex, depressive disorder, and being a victim of bullying. Risk factors for suicide attempt specific to pre-adolescent children included being uninsured and having an unsafe home or school environment. Among AYA, suicide attempt was associated with non-Hispanic white, family history of suicide, emotional traumas, and other traumatic experiences. Alcohol use disorder was also a significant predictor of suicide attempt in young adults. CONCLUSIONS: Suicide attempts among children and AYA admitted to a hospital with mental health concerns are highly prevalent. Socioeconomic stressors appeared to be an important contributing factor of suicidal behavior in pre-adolescent children but not in older AYA. Effective suicide prevention strategies targeting children and AYA would need to consider age-specific risk factors.

Impact of ICD-10-CM Transition on Mental Health Diagnoses Recording.

OBJECTIVE: This study examines the impact of the transition from ICD-9-CM to ICD-10-CM diagnosis coding on the recording of mental health disorders in electronic health records (EHRs) and claims data in ten large health systems. We present rates of these diagnoses across two years spanning the October 2015 transition. METHODS: Mental health diagnoses were identified from claims and EHR data at ten health care systems in the Mental Health Research Network (MHRN). Corresponding ICD-9-CM and ICD-10-CM codes were compiled and monthly rates of people receiving these diagnoses were calculated for one year before and after the coding transition. RESULTS: For seven of eight diagnostic categories, monthly rates were comparable during the year before and the year after the ICD-10-CM transition. In the remaining category, psychosis excluding schizophrenia spectrum disorders, aggregate monthly rates of decreased markedly with the ICD-10-CM transition, from 48 to 33 per 100,000. We propose that the change is due to features of General Equivalence Mappings (GEMS) embedded in the EHR. CONCLUSIONS: For most mental health conditions, the transition to ICD-10-CM appears to have had minimal impact. The decrease seen for psychosis diagnoses in these health systems is likely due to changes associated with EHR implementation of ICD-10-CM coding rather than an actual change in disease prevalence. It is important to consider the impact of the ICD-10-CM transition for all diagnostic criteria used in research studies, quality measurement, and financial analysis during this interval.

Variability in antimicrobial use in pediatric ventilator-associated events.

OBJECTIVE: To assess variability in antimicrobial use and associations with infection testing in pediatric ventilator-associated events (VAEs). DESIGN: Descriptive retrospective cohort with nested case-control study. SETTING: Pediatric intensive care units (PICUs), cardiac intensive care units (CICUs), and neonatal intensive care units (NICUs) in 6 US hospitals.PatientsChildren≤18 years ventilated for≥1 calendar day. METHODS: We identified patients with pediatric ventilator-associated conditions (VACs), pediatric VACs with antimicrobial use for≥4 days (AVACs), and possible ventilator-associated pneumonia (PVAP, defined as pediatric AVAC with a positive respiratory diagnostic test) according to previously proposed criteria. RESULTS: Among 9,025 ventilated children, we identified 192 VAC cases, 43 in CICUs, 70 in PICUs, and 79 in NICUs. AVAC criteria were met in 79 VAC cases (41%) (58% CICU; 51% PICU; and 23% NICU), and varied by hospital (CICU, 20-67%; PICU, 0-70%; and NICU, 0-43%). Type and duration of AVAC antimicrobials varied by ICU type. AVAC cases in CICUs and PICUs received broad-spectrum antimicrobials more often than those in NICUs. Among AVAC cases, 39% had respiratory infection diagnostic testing performed; PVAP was identified in 15 VAC cases. Also, among AVAC cases, 73% had no associated positive respiratory or nonrespiratory diagnostic test. CONCLUSIONS: Antimicrobial use is common in pediatric VAC, with variability in spectrum and duration of antimicrobials within hospitals and across ICU types, while PVAP is uncommon. Prolonged antimicrobial use despite low rates of PVAP or positive laboratory testing for infection suggests that AVAC may provide a lever for antimicrobial stewardship programs to improve utilization.

Trends in Outpatient Antibiotic Use in 3 Health Plans.

OBJECTIVES: Previous analyses of data from 3 large health plans suggested that the substantial downward trend in antibiotic use among children appeared to have attenuated by 2010. Now, data through 2014 from these same plans allow us to assess whether antibiotic use has declined further or remained stable. METHODS: Population-based antibiotic-dispensing rates were calculated from the same health plans for each study year between 2000 and 2014. For each health plan and age group, we fit Poisson regression models allowing 2 inflection points. We calculated the change in dispensing rates (and 95% confidence intervals) in the periods before the first inflection point, between the first and second inflection points, and after the second inflection point. We also examined whether the relative contribution to overall dispensing rates of common diagnoses for which antibiotics were prescribed changed over the study period. RESULTS: We observed dramatic decreases in antibiotic dispensing over the 14 study years. Despite previous evidence of a plateau in rates, there were substantial additional decreases between 2010 and 2014. Whereas antibiotic use rates decreased overall, the fraction of prescribing associated with individual diagnoses was relatively stable. Prescribing for diagnoses for which antibiotics are clearly not indicated appears to have decreased. CONCLUSIONS: These data revealed another period of marked decline from 2010 to 2014 after a relative plateau for several years for most age groups. Efforts to decrease unnecessary prescribing continue to have an impact on antibiotic use in ambulatory practice.

Factors Associated With Pediatric Ventilator-Associated Conditions in Six U.S. Hospitals: A Nested Case-Control Study.

OBJECTIVES: A newly proposed surveillance definition for ventilator-associated conditions among neonatal and pediatric patients has been associated with increased morbidity and mortality among ventilated patients in cardiac ICU, neonatal ICU, and PICU. This study aimed to identify potential risk factors associated with pediatric ventilator-associated conditions. DESIGN: Retrospective cohort. SETTING: Six U.S. hospitals PATIENTS:: Children less than or equal to 18 years old ventilated for greater than or equal to 1 day. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We identified children with pediatric ventilator-associated conditions and matched them to children without ventilator-associated conditions. Medical records were reviewed for comorbidities and acute care factors. We used bivariate and multivariate conditional logistic regression models to identify factors associated with ventilator-associated conditions. We studied 192 pairs of ventilator-associated conditions cases and matched controls (113 in the PICU and cardiac ICU combined; 79 in the neonatal ICU). In the PICU/cardiac ICU, potential risk factors for ventilator-associated conditions included neuromuscular blockade (odds ratio, 2.29; 95% CI, 1.08-4.87), positive fluid balance (highest quartile compared with the lowest, odds ratio, 7.76; 95% CI, 2.10-28.6), and blood product use (odds ratio, 1.52; 95% CI, 0.70-3.28). Weaning from sedation (i.e., decreasing sedation) or interruption of sedation may be protective (odds ratio, 0.44; 95% CI, 0.18-1.11). In the neonatal ICU, potential risk factors included blood product use (odds ratio, 2.99; 95% CI, 1.02-8.78), neuromuscular blockade use (odds ratio, 3.96; 95% CI, 0.93-16.9), and recent surgical procedures (odds ratio, 2.19; 95% CI, 0.77-6.28). Weaning or interrupting sedation was protective (odds ratio, 0.07; 95% CI, 0.01-0.79). CONCLUSIONS: In mechanically ventilated neonates and children, we identified several possible risk factors associated with ventilator-associated conditions. Next steps include studying propensity-matched cohorts and prospectively testing whether changes in sedation management, transfusion thresholds, and fluid management can decrease pediatric ventilator-associated conditions rates and improve patient outcomes.

A Pediatric Approach to Ventilator-Associated Events Surveillance.

OBJECTIVE Adult ventilator-associated event (VAE) definitions include ventilator-associated conditions (VAC) and subcategories for infection-related ventilator-associated complications (IVAC) and possible ventilator-associated pneumonia (PVAP). We explored these definitions for children. DESIGN Retrospective cohort SETTING Pediatric, cardiac, or neonatal intensive care units (ICUs) in 6 US hospitals PATIENTS Patients ≤18 years old ventilated for ≥1 day METHODS We identified patients with pediatric VAC based on previously proposed criteria. We applied adult temperature, white blood cell count, antibiotic, and culture criteria for IVAC and PVAP to these patients. We matched pediatric VAC patients with controls and evaluated associations with adverse outcomes using Cox proportional hazards models. RESULTS In total, 233 pediatric VACs (12,167 ventilation episodes) were identified. In the cardiac ICU (CICU), 62.5% of VACs met adult IVAC criteria; in the pediatric ICU (PICU), 54.2% of VACs met adult IVAC criteria; and in the neonatal ICU (NICU), 20.2% of VACs met adult IVAC criteria. Most patients had abnormal white blood cell counts and temperatures; we therefore recommend simplifying surveillance by focusing on "pediatric VAC with antimicrobial use" (pediatric AVAC). Pediatric AVAC with a positive respiratory diagnostic test ("pediatric PVAP") occurred in 8.9% of VACs in the CICU, 13.3% of VACs in the PICU, and 4.3% of VACs in the NICU. Hospital mortality was increased, and hospital and ICU length of stay and duration of ventilation were prolonged among all pediatric VAE subsets compared with controls. CONCLUSIONS We propose pediatric AVAC for surveillance related to antimicrobial use, with pediatric PVAP as a subset of AVAC. Studies on generalizability and responsiveness of these metrics to quality improvement initiatives are needed, as are studies to determine whether lower pediatric VAE rates are associated with improvements in other outcomes. Infect Control Hosp Epidemiol 2017;38:327-333.

Psychotropic Medication Use among Insured Children with Autism Spectrum Disorder.

This study examined psychotropic medication use among 7901 children aged 1-17 with autism spectrum disorder (ASD) in five health systems, comparing to matched cohorts with no ASD. Nearly half (48.5 %) of children with ASD received psychotropics in the year observed; the most common classes were stimulants, alpha-agonists, or atomoxetine (30.2 %), antipsychotics (20.5 %), and antidepressants (17.8 %). Psychotropic treatment was far more prevalent among children with ASD, as compared to children with no ASD (7.7 % overall), even within strata defined by the presence or absence of other psychiatric diagnoses. The widespread use of psychotropics we observed, particularly given weak evidence supporting the effectiveness of these medications for most children with ASD, highlights challenges in ASD treatment and the need for greater investment in its evaluation.

Missing clinical and behavioral health data in a large electronic health record (EHR) system.

OBJECTIVE: Recent massive investment in electronic health records (EHRs) was predicated on the assumption of improved patient safety, research capacity, and cost savings. However, most US health systems and health records are fragmented and do not share patient information. Our study compared information available in a typical EHR with more complete data from insurance claims, focusing on diagnoses, visits, and hospital care for depression and bipolar disorder. METHODS: We included insurance plan members aged 12 and over, assigned throughout 2009 to a large multispecialty medical practice in Massachusetts, with diagnoses of depression (N = 5140) or bipolar disorder (N = 462). We extracted insurance claims and EHR data from the primary care site and compared diagnoses of interest, outpatient visits, and acute hospital events (overall and behavioral) between the 2 sources. RESULTS: Patients with depression and bipolar disorder, respectively, averaged 8.4 and 14.0 days of outpatient behavioral care per year; 60% and 54% of these, respectively, were missing from the EHR because they occurred offsite. Total outpatient care days were 20.5 for those with depression and 25.0 for those with bipolar disorder, with 45% and 46% missing, respectively, from the EHR. The EHR missed 89% of acute psychiatric services. Study diagnoses were missing from the EHR's structured event data for 27.3% and 27.7% of patients. CONCLUSION: EHRs inadequately capture mental health diagnoses, visits, specialty care, hospitalizations, and medications. Missing clinical information raises concerns about medical errors and research integrity. Given the fragmentation of health care and poor EHR interoperability, information exchange, and usability, priorities for further investment in health IT will need thoughtful reconsideration.

Prevalence of Parental Misconceptions About Antibiotic Use.

BACKGROUND: Differences in antibiotic knowledge and attitudes between parents of Medicaid-insured and commercially insured children have been previously reported. It is unknown whether understanding has improved and whether previously identified differences persist. METHODS: A total of 1500 Massachusetts parents with a child <6 years old insured by a Medicaid managed care or commercial health plan were surveyed in spring 2013. We examined antibiotic-related knowledge and attitudes by using χ(2) tests. Multivariable modeling was used to assess current sociodemographic predictors of knowledge and evaluate changes in predictors from a similar survey in 2000. RESULTS: Medicaid-insured parents in 2013 (n = 345) were younger, were less likely to be white, and had less education than those commercially insured (n = 353), P < .01. Fewer Medicaid-insured parents answered questions correctly except for one related to bronchitis, for which there was no difference (15% Medicaid vs 16% commercial, P < .66). More parents understood that green nasal discharge did not require antibiotics in 2013 compared with 2000, but this increase was smaller among Medicaid-insured (32% vs 22% P = .02) than commercially insured (49% vs 23%, P < .01) parents. Medicaid-insured parents were more likely to request unnecessary antibiotics in 2013 (P < .01). Multivariable models for predictors of knowledge or attitudes demonstrated complex relationships between insurance status and sociodemographic variables. CONCLUSIONS: Misconceptions about antibiotic use persist and continue to be more prevalent among parents of Medicaid-insured children. Improvement in understanding has been more pronounced in more advantaged populations. Tailored efforts for socioeconomically disadvantaged populations remain warranted to decrease parental drivers of unnecessary antibiotic prescribing.

Predictors of timing of transfer from pediatric- to adult-focused primary care.

IMPORTANCE: A timely, well-coordinated transfer from pediatric- to adult-focused primary care is an important component of high-quality health care, especially for youths with chronic health conditions. Current recommendations suggest that primary-care transfers for youths occur between 18 and 21 years of age. However, the current epidemiology of transfer timing is unknown. OBJECTIVE: To examine the timing of transfer to adult-focused primary care providers (PCPs), the time between last pediatric-focused and first adult-focused PCP visits, and the predictors of transfer timing. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of patients insured by Harvard Pilgrim Health Care (HPHC), a large not-for-profit health plan. Our sample included 60 233 adolescents who were continuously enrolled in HPHC from 16 to at least 18 years of age between January 2000 and December 2012. Pediatric-focused PCPs were identified by the following provider specialty types, but no others: pediatrics, adolescent medicine, or pediatric nurse practitioner. Adult-focused PCPs were identified by having any provider type that sees adult patients. Providers with any specialty provider designation (eg, gastroenterology or gynecology) were not considered PCPs. MAIN OUTCOMES AND MEASURES: We used multivariable Cox proportional hazards regression to model age at first adult-focused PCP visit and time from the last pediatric-focused to the first adult-focused PCP visit (gap) for any type of office visit and for those that were preventive visits. RESULTS: Younger age at transfer was observed for female youths (hazard ratio [HR], 1.32 [95% CI, 1.29-1.36]) who had complex (HR, 1.06 [95% CI, 1.01-1.11]) or noncomplex (HR, 1.08 [95% CI, 1.05-1.12]) chronic conditions compared with those who had no chronic conditions. Transfer occurred at older ages for youths who lived in lower-income neighborhoods compared with those who lived in higher-income neighborhoods (HR, 0.89 [95% CI, 0.83-0.95]). The gap between last pediatric-focused to first adult-focused PCP visit was shorter for female youths than male youths (HR, 1.57 [95% CI, 1.53-1.61]) and youths with complex (HR, 1.35 [95% CI, 1.28-1.41]) or noncomplex (HR, 1.24 [95% CI, 1.20-1.28]) chronic conditions. The gap was longer for youths living in lower-income neighborhoods than for those living in higher-income neighborhoods (HR, 0.80 [95% CI, 0.75-0.85]). Multivariable models showed an adjusted median age at transfer of 21.8 years for office visits and 23.1 years for preventive visits and an adjusted median gap length of 20.5 months for office visits and 41.6 months for preventive visits. CONCLUSIONS AND RELEVANCE: Most youths are transferring care later than recommended and with gaps of more than a year. While youths with chronic conditions have shorter gaps, they may need even shorter transfer intervals to ensure continuous access to care. More work is needed to determine whether youths are experiencing clinically important lapses in care or other negative health effects due to the delayed timing of transfer.

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.

Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study.

OBJECTIVE: To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people. DESIGN: Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends. SETTING: Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network. PARTICIPANTS: Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million). MAIN OUTCOME MEASURES: Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides. RESULTS: Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were -31.0% (95% confidence interval -33.0% to -29.0%) among adolescents, -24.3% (-25.4% to -23.2%) among young adults, and -14.5% (-16.0% to -12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100,000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, -6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100,000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group. CONCLUSIONS: Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.

Impact of 13-Valent Pneumococcal Conjugate Vaccination on Streptococcus pneumoniae Carriage in Young Children in Massachusetts.

BACKGROUND: In April 2010, a 13-valent pneumococcal conjugate vaccine (PCV13) replaced PCV7 for use in the United States. We evaluated rates of pneumococcal colonization, by serotype and antibiotic resistance, in Massachusetts communities where serial cross-sectional surveillance has been conducted for the past decade. METHODS: Nasopharyngeal swabs were obtained from children 0 to <7 years of age and seen by primary care providers for well child or acute illness visits in 2001, 2004, 2007, 2009, and 2011. Pneumococcal isolates were serotyped by Quellung reaction and classified as PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), additional PCV13 serotypes (1, 3, 5, 6A, 7F, 19A), or non-PCV13 serotypes. Changes in colonization and impact of PCV13 were assessed using generalized linear mixed models, adjusting for known risk factors and accounting for clustering by community. RESULTS: Introduction of PCV13 did not affect the rate of overall pneumococcal colonization (31% in 2011). Colonization with non-PCV13 serotypes increased between 2001 and 2011 for all children (odds ratio [OR] per year, 1.12; 95% confidence interval [CI], 1.10, 1.15; P < .0001). 19A remained the second most common serotype in 2011, although a decline from 2009 was observed. Penicillin (7%), erythromycin (28%), ceftriaxone (10%), and clindamycin (10%) nonsusceptibility were commonly identified, concentrated among a small number of serotypes (including 19A, 35B, 15B/C, and 15A). Among healthy children 6-23 months old, colonization with PCV13 serotypes was lower among recipients of PCV13 vaccine (adjusted OR, 0.30; 95% CI, 0.11, 0.78). This effect was not observed in 6- to 23-month-old children with a concomitant respiratory tract infection (adjusted OR 1.36; 95% CI, 0.66, 2.77) or children 2 to <7 years old (adjusted OR, 1.17; 95% CI, 0.58, 2.34). CONCLUSIONS: 13-Valent pneumococcal conjugate vaccine reduced the prevalence of colonization with PCV13 serotypes among children 6-23 months old, but its efficacy was not shown among older children.

Recent trends in outpatient antibiotic use in children.

OBJECTIVE: The goal of this study was to determine changes in antibiotic-dispensing rates among children in 3 health plans located in New England [A], the Mountain West [B], and the Midwest [C] regions of the United States. METHODS: Pharmacy and outpatient claims from September 2000 to August 2010 were used to calculate rates of antibiotic dispensing per person-year for children aged 3 months to 18 years. Differences in rates by year, diagnosis, and health plan were tested by using Poisson regression. The data were analyzed to determine whether there was a change in the rate of decline over time. RESULTS: Antibiotic use in the 3- to <24-month age group varied at baseline according to health plan (A: 2.27, B: 1.40, C: 2.23 antibiotics per person-year; P < .001). The downward trend in antibiotic dispensing slowed, stabilized, or reversed during this 10-year period. In the 3- to <24-month age group, we observed 5.0%, 9.3%, and 7.2% annual declines early in the decade in the 3 plans, respectively. These dropped to 2.4%, 2.1%, and 0.5% annual declines by the end of the decade. Third-generation cephalosporin use for otitis media increased 1.6-, 15-, and 5.5-fold in plans A, B, and C in young children. Similar attenuation of decline in antibiotic use and increases in use of broad-spectrum agents were seen in other age groups. CONCLUSIONS: Antibiotic dispensing for children may have reached a new plateau. Along with identifying best practices in low-prescribing areas, decreasing broad-spectrum use for particular conditions should be a continuing focus of intervention efforts.

Trends in antibiotic use in Massachusetts children, 2000-2009.

OBJECTIVE: Antibiotic use rates have declined dramatically since the 1990s. We aimed to determine if, when, and at what level the decline in antibiotic-dispensing rates ended and which diagnoses contributed to the trends. METHODS: Antibiotic dispensings and diagnoses were obtained from 2 health insurers for 3- to <72-month-olds in 16 Massachusetts communities from 2000 to 2009. Population-based antibiotic-dispensing rates per person-year (p-y) were determined according to year (September-August) for 3 age groups. Fit statistics were used to identify the most likely year for a change in trend. Rates for the first and last years were compared according to antibiotic category and associated diagnosis. RESULTS: From 2000-2001 to 2008-2009, the antibiotic-dispensing rate for 3- to <24-month-olds decreased 24% (2.3-1.8 antibiotic dispensings per p-y); for 24- to <48-month-olds, it decreased 18% (1.6-1.3 antibiotic dispensings per p-y); and for 48- to <72-month-olds, it decreased 20% (1.4-1.1 antibiotic dispensings per p-y). For 3- to <48-month-olds, rates declined until 2004-2005 and remained stable thereafter; the downward trend for 48- to <72-month-olds ended earlier in 2001-2002. Among 3- to <24-month-olds, first-line penicillin use declined 26%. For otitis media, the dispensing rate decreased 14% and the diagnosis rate declined 9%, whereas the treatment fraction was stable at 63%. CONCLUSIONS: The downward trend in antibiotic dispensings to young children in these communities ended by 2004-2005. This trend was driven by a declining otitis media diagnosis rate. Continued monitoring of population-based dispensing rates will support efforts to avoid returning to previous levels of antibiotic overuse.

Early-life mental disorders and adult household income in the World Mental Health Surveys.

BACKGROUND: Better information on the human capital costs of early-onset mental disorders could increase sensitivity of policy makers to the value of expanding initiatives for early detection and treatment. Data are presented on one important aspect of these costs: the associations of early-onset mental disorders with adult household income. METHODS: Data come from the World Health Organization (WHO) World Mental Health Surveys in 11 high-income, five upper-middle income, and six low/lower-middle income countries. Information about 15 lifetime DSM-IV mental disorders as of age of completing education, retrospectively assessed with the WHO Composite International Diagnostic Interview, was used to predict current household income among respondents aged 18 to 64 (n = 37,741) controlling for level of education. Gross associations were decomposed to evaluate mediating effects through major components of household income. RESULTS: Early-onset mental disorders are associated with significantly reduced household income in high and upper-middle income countries but not low/lower-middle income countries, with associations consistently stronger among women than men. Total associations are largely due to low personal earnings (increased unemployment, decreased earnings among the employed) and spouse earnings (decreased probabilities of marriage and, if married, spouse employment and low earnings of employed spouses). Individual-level effect sizes are equivalent to 16% to 33% of median within-country household income, and population-level effect sizes are in the range 1.0% to 1.4% of gross household income. CONCLUSIONS: Early mental disorders are associated with substantial decrements in income net of education at both individual and societal levels. Policy makers should take these associations into consideration in making health care research and treatment resource allocation decisions.