Validity of ICD-10-based algorithms to identify patients with influenza in inpatient and outpatient settings.

PURPOSE: To evaluate the validity of ICD-10-CM code-based algorithms as proxies for influenza in inpatient and outpatient settings in the USA. METHODS: Administrative claims data (2015-2018) from the largest commercial insurer in New Jersey (NJ), USA, were probabilistically linked to outpatient and inpatient electronic health record (EHR) data containing influenza test results from a large NJ health system. The primary claims-based algorithms defined influenza as presence of an ICD-10-CM code for influenza, stratified by setting (inpatient/outpatient) and code position for inpatient encounters. Test characteristics and 95% confidence intervals (CIs) were calculated using test-positive influenza as a reference standard. Test characteristics of alternative outpatient algorithms incorporating CPT/HCPCS testing codes and anti-influenza medication pharmacy claims were also calculated. RESULTS: There were 430 documented influenza test results within the study period (295 inpatient, 135 outpatient). The claims-based influenza definition had a sensitivity of 84.9% (95% CI 72.9%-92.1%), specificity of 96.3% (95% CI 93.1%-98.0%), and PPV of 83.3% (95% CI 71.3%-91.0%) in the inpatient setting, and a sensitivity of 76.7% (95% CI 59.1%-88.2%), specificity of 96.2% (95% CI 90.6%-98.5%), PPV of 85.2% (95% CI 67.5%-94.1%) in the outpatient setting. Primary inpatient discharge diagnoses had a sensitivity of 54.7% (95% CI 41.5%-67.3%), specificity of 99.6% (95% CI 97.7%-99.9%), and PPV of 96.7% (95% CI 83.3%-99.4%). CPT/HCPCS codes and anti-influenza medication claims were present for few outpatient encounters (sensitivity 3%-10%). CONCLUSIONS: In a large US healthcare system, inpatient ICD-10-CM codes for influenza, particularly primary inpatient diagnoses, had high predictive value for test-positive influenza. Outpatient ICD-10-CM codes were moderately predictive of test-positive influenza.

Ten-Year Trends of Persistent Mortality With Gallstone Disease: A Retrospective Cohort Study in New Jersey.

BACKGROUND AND AIMS: Recent trends in mortality with gallstone disease remain scarce in the United States. Yet multiple changes in clinical management, such as rates of endoscopy, cholecystectomy, and cholecystostomy, and insurance access at the state level, may have occurred. Thus, we evaluated recent secular trends of mortality with gallstone disease in New Jersey. METHODS: We performed a retrospective, cohort study of mortality from 2009 to 2018 using the National Center for Health Statistics, Restricted Mortality Files. The primary outcome was any death with an International Classifications of Disease, 10th Revision, Clinical Modification diagnosis code of gallstone disease in New Jersey. Simple linear regression was used to model trends of incidence of death. RESULTS: 1580 deaths with diagnosed gallstone disease (dGD) occurred from 2009 to 2018. The annual trend of incidence of death was flat over 10 years. The incidence of death with dGD relative to all death changed only from 0.21% to 0.20% over 10 years. These findings were consistent also in 18 of 20 subgroup combinations, although the trend of death with dGD in Latinos 65 years or older increased [slope estimate 0.93, 95% confidence limit 0.42-1.43, P = .003]. CONCLUSION: The rate of death with dGD showed little change over the recent 10 years in New Jersey. This needs to be reproduced in other states and nationally. A closer examination of the changes in clinical care and insurance access is needed to help understand why they did not result in a positive change in this avoidable cause of death.

Impact of the COVID-19 Pandemic on the Management of Juvenile Idiopathic Arthritis: Analysis of United States Commercial Insurance Data.

BACKGROUND/OBJECTIVE: Given limited information on health care and treatment utilization for juvenile idiopathic arthritis (JIA) during the pandemic, we studied JIA-related health care and treatment utilization in a commercially insured retrospective US cohort. METHODS: We studied rates of outpatient visits, new disease-modifying antirheumatic drug (DMARD) initiations, intra-articular glucocorticoid injections (iaGC), dispensed oral glucocorticoids and opioids, DMARD adherence, and DMARD discontinuation by quarter in March 2018-February 2021 (Q1 started in March). Incident rate ratios (IRR, pandemic vs prepandemic) with 95% confidence intervals (CIs) were estimated using multivariable Poisson or Quasi-Poisson models stratified by diagnosis recency (incident JIA, <12 months ago; prevalent JIA, ≥12 months ago). RESULTS: Among 1294 children diagnosed with JIA, total and in-person outpatient visits for JIA declined during the pandemic (IRR, 0.88-0.90), most markedly in Q1 2020. Telemedicine visits, while higher during the pandemic, declined from 21% (Q1) to 13% (Q4) in 2020 to 2021. During the pandemic, children with prevalent JIA, but not incident JIA, had lower usage of iaGC (IRR, 0.60; 95% CI, 0.34-1.07), oral glucocorticoids (IRR, 0.47; 95% CI, 0.33-0.67), and opioids (IRR, 0.44; 95% CI, 0.26-0.75). Adherence to and discontinuation of DMARDs was similar before and during the pandemic. CONCLUSIONS: In the first year of the pandemic, visits for JIA dropped by 10% to 12% in commercially insured children in the United States, declines partly mitigated by use of telemedicine. Pandemic-related declines in intra-articular glucocorticoids, oral glucocorticoids, and opioids were observed for children with prevalent, but not incident, JIA. These changes may have important implications for disease control and quality of life.

Pneumonitis in advanced non-small cell lung cancer: no interaction between immune checkpoint inhibition and radiation therapy.

Background: Radiation pneumonitis and immune-related pneumonitis have been studied independently, but little information has emerged on the interactions between radiation therapy (RT) and immune checkpoint inhibition (ICI). We examine whether RT and ICI are synergistic in causing pneumonitis. Methods: A retrospective cohort was assembled using the Surveillance, Epidemiology, and End Results-Medicare database, including Medicare beneficiaries diagnosed with American Joint Committee on Cancer 7th ed. (AJCC) stages IIIB-IV NSCLC between 2013-2017. Exposures to RT and ICI were determined by evaluating for treatment within 12 months of diagnosis (RT group and ICI group) and for a second exposure (e.g., ICI after RT) within 3 months after the first exposure (RT + ICI group). Untreated controls were matched to treated patients who were diagnosed in the same three-month window. A validated algorithm for identifying cases of pneumonitis in claims data was used to evaluate for the outcome within 6 months after treatment. The primary outcome was the relative excess risk due to interaction (RERI), a quantitative measure of additive interaction between two treatments. Results: There were 18,780 patients included in the analysis with 9,345 (49.8%), 7,533 (40.2%), 1,332 (7.1%), and 550 (2.9%) in the control, RT, ICI, and RT + ICI groups, respectively. Relative to controls, the hazards ratios of pneumonitis were 11.5 (95% CI: 7.9 to 17.0), 6.2 (95% CI: 3.8 to 10.3), and 10.7 (95% CI: 6.0 to 19.2) in the RT, ICI, and RT-ICI groups, respectively. The RERIs were -6.1 (95% CI: -13.1 to -0.6, P=0.97) and -4.0 (95% CI: -10.7 to 1.5, P=0.91) in the unadjusted and adjusted analyses, respectively, consistent with no evidence of additive interaction (RERI ≤0) between RT and ICI. Conclusions: In this study of Medicare beneficiaries with advanced NSCLC, RT and ICI were, at most, additive rather than synergistic in causing pneumonitis. Pneumonitis risk in patients treated with RT and ICI is not more than could be expected from each therapy alone.

Decreased Emergency Cholecystectomy and Case Fatality Rate, Not Explained by Expansion of Medicaid.

INTRODUCTION: Population data on longitudinal trends for cholecystectomies and their outcomes are scarce. We evaluated the incidence and case fatality rate of emergency and ambulatory cholecystectomies in New Jersey (NJ) and whether the Medicaid expansion changed trends. MATERIALS AND METHODS: A retrospective population cohort design was used to study the incidence of cholecystectomies and their case fatality rate from 2009 to 2018. Using linear and logistic regression we explored the trends of incidence and the odds of case fatality after versus before the January 1, 2014 Medicaid expansion. RESULTS: Overall, 93,423 emergency cholecystectomies were performed, with 644 fatalities; 87,239 ambulatory cholecystectomies were performed, with fewer than 10 fatalities. The 2009 to 2018 annual incidence of emergency cholecystectomies dropped markedly from 114.8 to 77.5 per 100,000 NJ population (P < 0.0001); ambulatory cholecystectomies increased from 93.5 to 95.6 per 100,000 (P = 0.053). The incidence of emergency cholecystectomies dropped more after than before Medicaid expansion (P < 0.0001). The odds ratio for case fatality among those undergoing emergency cholecystectomies after versus before expansion was 0.85 (95% CI, 0.72-0.99). This decrease in case fatality, apparent only in those over age 65, was not explained by the addition of Medicaid. CONCLUSIONS: A marked decrease in the incidence of emergency cholecystectomies occurred after Medicaid expansion, which was not accounted for by a minimal increase in the incidence of ambulatory cholecystectomies. Case fatality from emergency cholecystectomy decreased over time due to factors other than Medicaid. Further work is needed to reconcile these findings with the previously reported lack of decrease in overall gallstone disease mortality in NJ.

Childhood asthma diagnoses declined during the COVID-19 pandemic in the United States.

BACKGROUND: Prior studies have documented declines in pediatric asthma exacerbations and asthma-related health care utilization during the COVID-19 pandemic, but less is known about the incidence of asthma during the pandemic. METHODS: We conducted a retrospective cohort study of children under age 18 without a prior diagnosis of asthma within a large US commercial claims database. Incident asthma was defined using a combination of diagnosis codes, location of services, and medication dispensing. Crude quarterly rates of asthma diagnosis per 1000 children were calculated, and the incidence rate ratio and 95% confidence interval were estimated for newly diagnosed asthma during versus before the pandemic using negative binomial regression, adjusted for age, sex, region, and season. RESULTS: Compared with 3 years prior to the pandemic, crude incident diagnosis rates of asthma decreased by 52% across the first four quarters of the US pandemic. The covariate-adjusted pandemic-associated incidence rate ratio was 0.47 (95% confidence interval 0.43, 0.51). CONCLUSIONS: New diagnoses of childhood asthma in the US declined by half during the first year of the pandemic. These findings raise important questions whether pandemic-related changes in infectious or other triggers truly altered the incidence of childhood asthma beyond the well-described disruptions in healthcare access.

Use of a New Prevention Model in Acute Care Surgery: A Population Approach to Preventing Emergency Surgical Morbidity and Mortality.

Whether patients undergo the more morbid and costly emergent rather than an elective type of surgery, may depend on many factors. Since tertiary prevention (preventing poor outcomes from emergency surgery) carries a much higher mortality than secondary prevention (preventing emergency surgery) or primary prevention (preventing the disease requiring surgery), the overall United States mortality might be reduced significantly, if emergency surgery could be avoided via high-quality primary prevention and non-surgical therapy or increasing elective surgery at the expense of emergency procedures, e.g., secondary prevention. The practice and study of acute care surgery then has the potential to broaden from a focus on the patient in the hospital emergency and operating rooms to the patient who no longer requires either, whose disease is treated or prevented in his/her/their community.

Pandemic vaccine testing: Combining conventional and challenge studies.

Early into COVID, human challenge trials were considered, but usually as alternatives to conventional randomized controlled trials. Instead, assessment of authorized COVID vaccines, of further COVID vaccines, and of vaccines against future pandemics should combine both designs, in five different ways, including a wholly novel one that we elaborate, Viz., combining data from both designs to answer a single question.

Mortality Risk of Antipsychotic Augmentation for Adult Depression.

(Reprinted with permission from PLOS ONE 2020).

Validation of a claims-based algorithm for identifying non-infectious pneumonitis in patients diagnosed with lung cancer.

PURPOSE: Non-infectious pneumonitis (NIP) is a common complication of treatments for lung cancer. We know of no existing validated algorithm for identifying NIP in claims databases, limiting our ability to understand the morbidity and mortality of this toxicity in real-world data. METHODS: Electronic health records (EHR), cancer registry, and administrative data from a National Cancer Institute-designated comprehensive cancer center were queried for patients diagnosed with lung cancer between 10/01/2015-12/31/2020. Health insurance claims were searched for ICD-10-CM codes that indicate an inpatient or outpatient diagnosis with possible NIP. A 20-code (Algorithm A) and 11-code (Algorithm B) algorithm were tested with and without requiring prescription with corticosteroids. Cases with a diagnosis of possible NIP in the 6 months before their first lung cancer diagnosis were excluded. The algorithms were validated by reviewing the EHR. The positive predictive value (PPV) for each algorithm was computed with 95% confidence intervals (CI). RESULTS: Seventy patients with lung cancer had a diagnosis code compatible with NIP: 36 (51.4%) inpatients and 34 (48.6%) outpatients. The PPV of Algorithm A was 77.1% (95% CI: 65.6-86.3). The PPV of Algorithm B was 86.9% (95% CI: 75.8-94.2). Requiring a documented prescription for a systemic corticosteroid improved the PPV of both Algorithm A and Algorithm B: 92.5% (95% CI: 79.6-98.4) and 100.0% (95% CI: 90.0-100.0), respectively. CONCLUSIONS: This study validated ICD-10-CM and prescription-claims-based definitions of NIP in lung cancer patients. All algorithms have at least reasonable performance. Enriching the algorithm with corticosteroid prescription records results in excellent performance.

Risk of clinically relevant hyperglycemia with metoprolol compared to carvedilol in older adults with heart failure and diabetes.

BACKGROUND: Although prior literature suggests that metoprolol may worsen glucose control compared to carvedilol, whether this has clinical relevance among older adults with diabetes and heart failure (HF) remains an open question. METHODS: This was a US retrospective cohort study utilizing data sourced from a 50% national sample of Medicare fee-for-service claims of patients with part D prescription drug coverage (2007-2017). Among patients with diabetes and HF, we identified initiators of metoprolol or carvedilol, which were 1:1 propensity score matched on >90 variables. The primary outcome was initiation of a new oral or injectable antidiabetic medication (proxy for uncontrolled diabetes); secondary outcomes included initiation of insulin and severe hyperglycemic event (composite of emergency room visits or hospitalizations related to hyperglycemia). RESULTS: Among 24 239 propensity score-matched pairs (mean [SD] age 77.7 [8.0] years; male [39.1%]), there were 8150 (incidence rate per 100 person-years [IR] = 33.5) episodes of antidiabetic medication initiation among metoprolol users (exposure arm) compared to 8576 (IR = 33.4) among carvedilol users (comparator arm) compared to corresponding to an adjusted hazard ratio (aHR) of 0.97 (95% confidence interval [CI]: 0.94, 1.01). Similarly, metoprolol was not associated with a significant increase in the risk of secondary outcomes including insulin initiation: aHR of 0.98 (95% CI: 0.93, 1.04) and severe hyperglycemic events: aHR of 0.98 (95% CI: 0.93, 1.02). CONCLUSIONS: In this large study of older adults with HF and diabetes, initiation of metoprolol compared to carvedilol was not associated with an increase in the risk of clinically relevant hyperglycemia.

Evaluation of Trapping Schemes to Detect Emerald Ash Borer (Coleoptera: Buprestidae).

Management responses to invasive forest insects are facilitated by the use of detection traps ideally baited with species-specific semiochemicals. Emerald ash borer, Agrilus planipennis Fairmaire, is currently invading North American forests, and since its detection in 2002, development of monitoring tools has been a primary research objective. We compared six trapping schemes for A. planipennis over 2 yr at sites in four U.S. states and one Canadian province that represented a range of background A. planipennis densities, canopy coverage, and ash basal area. We also developed a region-wide phenology model. Across all sites and both years, the 10th, 50th, and 90th percentile of adult flight occurred at 428, 587, and 837 accumulated degree-days, respectively, using a base temperature threshold of 10°C and a start date of 1 January. Most trapping schemes captured comparable numbers of beetles with the exception of purple prism traps (USDA APHIS PPQ), which captured significantly fewer adults. Trapping schemes varied in their trap catch across the gradient of ash basal area, although when considering trap catch as a binary response variable, trapping schemes were more likely to detect A. planipennis in areas with a higher ash component. Results could assist managers in optimizing trap selection, placement, and timing of deployment given local weather conditions, forest composition, and A. planipennis density.

Enhancing Reach Out and Read With a Video and Text Messages: A Randomized Trial in a Low-Income Predominantly Latino Sample.

OBJECTIVE: To determine the effect of adding a video and text messages to Reach Out and Read (ROR) on parent-reported literacy activities compared to the standard version. STUDY DESIGN: We conducted a mixed methods hybrid type I effectiveness-implementation randomized trial in a community health center that serves low-income Latino families. We assessed shared reading frequency and the StimQ Reading subscale, at enrollment and 6-month follow-up and the StimQ Parent Verbal Responsivity subscale, Parent Reading Belief Inventory, and Survey of Wellbeing of Young Children-Milestones at follow-up. We randomized 160 parent-child dyads to ROR or ROR plus video and text messages (enhanced ROR). We collected process data on ROR and engagement with texts. We interviewed 15 enhanced ROR participants. We analyzed quantitative data using regression and qualitative data using immersion/crystallization. RESULTS: One hundred thirty-seven parent-child dyads completed the study (87% Latino, mean child age 9 months). We found differences in the StimQ Reading subscale (B = 0.32; P = .034) and marginal differences in attitudes about reading favoring enhanced ROR. Between-group differences for shared reading frequency, verbal responsivity, and developmental delay were not significant. Qualitative themes provided insight into the enhanced ROR including how it encouraged parents, remaining barriers like competing priorities and lack of social support, and unanticipated benefits (ie, parent appreciation for attention on their families' wellbeing). CONCLUSIONS: A video and text message enhancement to ROR resulted in modest improvements in the home literacy environment over ROR alone. Additional strategies are needed to overcome potent barriers faced by low-income families.

Oral Glucocorticoids and Incident Treatment of Diabetes Mellitus, Hypertension, and Venous Thromboembolism in Children.

Rates of incident treatment were quantified in this study for diabetes mellitus, hypertension, and venous thromboembolism (VTE) associated with oral glucocorticoid exposure in children aged 1-18 years. The retrospective cohort included more than 930,000 children diagnosed with autoimmune diseases (namely, inflammatory bowel disease, juvenile idiopathic arthritis, or psoriasis) or a nonimmune comparator condition (attention-deficit/hyperactivity disorder) identified using US Medicaid claims (2000-2010). Associations of glucocorticoid dose per age- and sex-imputed weight with incident treated diabetes, hypertension, and VTE were estimated using Cox regression models. Crude rates were lowest for VTE (unexposed: 0.5/million person-days (95% confidence interval (CI): 0.4, 0.6); currently exposed: 15.6/million person-days (95% CI: 11.8, 20.1)) and highest for hypertension (unexposed: 6.7/million person-days (95% CI: 6.5, 7.0); currently exposed: 74.4/million person-days (95% CI: 65.7, 83.9)). Absolute rates for all outcomes were higher in unexposed and exposed children with autoimmune diseases compared with those with attention-deficit/hyperactivity disorder. Strong dose-dependent relationships were found between current glucocorticoid exposure and all outcomes (adjusted hazard ratios for high-dose glucocorticoids: for diabetes mellitus, 5.93 (95% CI: 3.94, 8.91); for hypertension, 19.13 (95% CI: 15.43, 23.73); for VTE, 16.16 (95% CI: 8.94, 29.22)). These results suggest strong relative risks, but low absolute risks, of newly treated VTE, diabetes, and especially hypertension in children taking high-dose oral glucocorticoids.

Restructuring of Academic Tracks to Create Successful Career Paths for the Faculty of Rutgers Biomedical and Health Sciences.

BACKGROUND: We report faculty affairs lessons from the formation and academic restructuring of Rutgers Biomedical and Health Sciences. Our approach may be a blueprint for development of a new track system that can be adapted by other institutions, after consideration of their own special circumstances. METHODS: We created new Appointments and Promotions guidelines consisting of one Tenure Track and four Non-Tenure Tracks, each with different missions. We restructured faculty performance evaluations to include mission-based criteria, an expanded rating scale, and specific expectations. After negotiating these new processes with our faculty union, we enacted central oversight to ensure uniform application of these processes and their associated criteria. We communicated the guidelines and the evaluation system widely. We created programs for universal mentoring, publishing education, diversity, and faculty development. RESULTS: All faculty in our seven schools went through track selection. Anxiety and incomplete understanding improved after implementation. Evaluations with expectations for the following year and an expanded scale for more nuanced assessment served as mentoring tools. Requirements for mentor assignments and diversity education created an atmosphere of nurturing and inclusion. Publications, extramural support, and faculty satisfaction increased after implementation of the guidelines. CONCLUSION: Lessons included the need to review and learn from guidelines at other institutions, to create tracks that align with different jobs, the necessity for central oversight for uniform application of criteria, the need for extensive and frequent communication with faculty, and that fear of change is only reduced after evidence of success of a new structure. The most important lesson was that faculty rise to expectations when clear, ambitious criteria are delineated and universally applied.

Mortality risk of antipsychotic augmentation for adult depression.

IMPORTANCE: Randomized controlled trials have demonstrated increased all-cause mortality in elderly patients with dementia treated with newer antipsychotics. It is unknown whether this risk generalizes to non-elderly adults using newer antipsychotics as augmentation treatment for depression. OBJECTIVE: This study examined all-cause mortality risk of newer antipsychotic augmentation for adult depression. DESIGN: Population-based new-user/active comparator cohort study. SETTING: National healthcare claims data from the US Medicaid program from 2001-2010 linked to the National Death Index. PARTICIPANTS: Non-elderly adults (25-64 years) diagnosed with depression who after ≥3 months of antidepressant monotherapy initiated either augmentation with a newer antipsychotic or with a second antidepressant. Patients with alternative indications for antipsychotic medications, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded. EXPOSURE: Augmentation treatment for depression with a newer antipsychotic or with a second antidepressant. MAIN OUTCOME: All-cause mortality during study follow-up ascertained from the National Death Index. RESULTS: The analytic cohort included 39,582 patients (female = 78.5%, mean age = 44.5 years) who initiated augmentation with a newer antipsychotic (n = 22,410; 40% = quetiapine, 21% = risperidone, 17% = aripiprazole, 16% = olanzapine) or with a second antidepressant (n = 17,172). The median chlorpromazine equivalent starting dose for all newer antipsychotics was 68mg/d, increasing to 100 mg/d during follow-up. Altogether, 153 patients died during 13,328 person-years of follow-up (newer antipsychotic augmentation: n = 105, follow-up = 7,601 person-years, mortality rate = 138.1/10,000 person-years; antidepressant augmentation: n = 48, follow-up = 5,727 person-years, mortality rate = 83.8/10,000 person-years). An adjusted hazard ratio of 1.45 (95% confidence interval, 1.02 to 2.06) indicated increased all-cause mortality risk for newer antipsychotic augmentation compared to antidepressant augmentation (risk difference = 37.7 (95%CI, 1.7 to 88.8) per 10,000 person-years). Results were robust across several sensitivity analyses. CONCLUSION: Augmentation with newer antipsychotics in non-elderly patients with depression was associated with increased mortality risk compared with adding a second antidepressant. Though these findings require replication and cannot prove causality, physicians managing adults with depression should be aware of this potential for increased mortality associated with newer antipsychotic augmentation.

Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

BACKGROUND: Off-label drug use in children is common and potentially harmful. In most previous off-label use research, authors studied hospitalized children, specific drug classes, or non-US settings. We characterized frequencies, trends, and reasons for off-label systemic drug orders for children in ambulatory US settings. METHODS: Using nationally representative surveys of office-based physicians (National Ambulatory Medical Care Surveys, 2006-2015), we studied off-label orders of systemic drugs for children age <18 based on US Food and Drug Administration-approved labeling for age, weight, and indication. We characterized the top classes and diagnoses with off-label orders and analyzed factors and trends of off-label orders using logistic regression. RESULTS: Physicians ordered ≥1 off-label systemic drug at 18.5% (95% confidence interval: 17.7%-19.3%) of visits, usually (74.6%) because of unapproved conditions. Off-label ordering was most common proportionally in neonates (83%) and in absolute terms among adolescents (322 orders out of 1000 visits). Off-label ordering was associated with female sex, subspecialists, polypharmacy, and chronic conditions. Rates and reasons for off-label orders varied considerably by age. Relative and absolute rates of off-label orders rose over time. Among common classes, off-label orders for antihistamines and several psychotropics increased over time, whereas off-label orders for several classes of antibiotics were stable or declined. CONCLUSIONS: US office-based physicians have ordered systemic drugs off label for children at increasing rates, most often for unapproved conditions, despite recent efforts to increase evidence and drug approvals for children. These findings can help inform education, research, and policies around effective, safe use of medications in children.

Pre-diagnosis alcohol consumption and mortality risk among black women and white women with invasive breast cancer.

BACKGROUND: Alcohol consumption is associated with increased risk of breast cancer; however, its association with subsequent risk of breast cancer death is unclear. METHODS: We followed 4523 women with complete information on relevant risk factors for mortality; these women were 35 to 64 years of age when diagnosed with incident invasive breast cancer between 1994 and 1998. During follow up (median, 8.6 years), 1055 women died; 824 died from breast cancer. The information on alcohol consumption before diagnosis was collected shortly after breast cancer diagnosis (average: 5.1 months) during an in-person interview which used a structured questionnaire. Multivariable Cox proportional hazards regression models provided hazard ratios (HRs) and 95% confidence intervals (CIs) for breast cancer-specific mortality, mortality due to causes other than breast cancer, and all-cause mortality associated with alcohol consumption from age 15 years until breast cancer diagnosis and during recent periods of time prior to breast cancer diagnosis. RESULTS: Average weekly alcohol consumption from age 15 years until breast cancer diagnosis was inversely associated with breast cancer-specific mortality (Ptrend = 0.01). Compared to non-drinkers, women in the highest average weekly alcohol consumption category (≥7 drinks/week) had 25% lower risk of breast cancer-specific mortality (HR = 0.75, 95% CI = 0.56-1.00). Breast cancer mortality risk was also reduced among women in the highest average weekly alcohol consumption category in two recent time periods (5-year period ending 2-years prior to breast cancer diagnosis, HR = 0.74, 95% CI = 0.57-0.95; 2-year period immediately prior to breast cancer diagnosis: HR = 0.73, 95% CI = 0.56-0.95). Furthermore, analyses of average weekly alcohol consumption by beverage type from age 15 years until breast cancer diagnosis suggested that wine consumption was inversely associated with breast cancer-specific mortality risk (wine Ptrend = 0.06, beer Ptrend = 0.24, liquor Ptrend = 0.74). No association with any of these alcohol consumption variables was observed for mortality risk due to causes other than breast cancer. CONCLUSIONS: Overall, we found no evidence that alcohol consumption before breast cancer diagnosis increases subsequent risk of death from breast cancer.