Search

To determine whether a multicomponent intervention focused on early peanut introduction was associated with a lower peanut allergy incidence in young children.The study cohort comprised all children born January 1, 2013 through December 31, 2018 receiving care at a large health care organization. Intervention activities occurred over 16 months and included provider educational programs, electronic health record tools, and new patient instructions. We used an interrupted time series design to assess whether peanut allergy incidence differed across 3 time periods (preintervention, interim, postintervention) among high- and low-risk children. The primary outcome was incident peanut allergy by age 24 months, defined as peanut allergy in the allergy field or active problem list plus a positive supportive test. Severe eczema and/or egg allergy presence defined high-risk. Because the study was conducted as part of routine care, it was not feasible to measure what counseling clinicians provided, or how and when parents fed their children peanut-containing foods.In a cohort of 22,571 children, the percent with peanut allergy by age 24 months was 17.3% (116 of 671) among high-risk and 0.8% (181 of 21,900) among low-risk children. In multivariate analyses, the adjusted peanut allergy rate per 100 person-years was not significantly different across study periods among high-risk (9.6 preintervention, 11.7 interim, and 9.9 postintervention, P = .70) or low-risk (0.5 preintervention, 0.7 interim, and 0.5 postintervention, P = .17) children.In a community-based setting, the incidence of peanut allergy did not decline following a multicomponent intervention focused on early peanut introduction.

Objectives: Having accurate influenza vaccination coverage estimates can guide public health activities. The objectives of this study were to (1) validate the accuracy of electronic health record (EHR)–based influenza vaccination data among pregnant women compared with survey self-report and (2) assess whether survey respondents differed from survey nonrespondents by demographic characteristics and EHR-based vaccination status. Methods: This study was conducted in the Vaccine Safety Datalink, a network of 8 large medical care organizations in the United States. Using EHR data, we identified all women pregnant during the 2018-2019 or 2019-2020 influenza seasons. Surveys were conducted among samples of women who did and did not appear vaccinated for influenza according to EHR data. Separate surveys were conducted after each influenza season, and respondents reported their influenza vaccination status. Analyses accounted for the stratified design, sampling probability, and response probability. Results: The survey response rate was 50.5% (630 of 1247) for 2018-2019 and 41.2% (721 of 1748) for 2019-2020. In multivariable analyses combining both survey years, non-Hispanic Black pregnant women had 3.80 (95% CI, 2.13-6.74) times the adjusted odds of survey nonresponse; odds of nonresponse were also higher for Hispanic pregnant women and women who had not received (per EHR data) influenza vaccine during current or prior influenza seasons. The sensitivity, specificity, and positive predictive value of EHR documentation of influenza vaccination compared with self-report were ≥92% for both survey years combined. The negative predictive value of EHR-based influenza vaccine status was 80.5% (95% CI, 76.7%-84.0%). Conclusions: EHR-based influenza vaccination data among pregnant women were generally concordant with self-report. New data sources and novel approaches to mitigating nonresponse bias may be needed to enhance influenza vaccination surveillance efforts.

Introduction Continuing medical education (CME) interventions often evaluate participant commitment to change (CTC) clinical practice. Evidence linking CTC to actual practice change is limited. Methods In an intervention that combined live CME with changes to the electronic health record to promote judicious antibiotic use for children with urinary tract infections (UTIs), we evaluated CTC and subsequent prescribing behavior in Kaiser Permanente Colorado, an integrated health care system. CTC was assessed immediately after the session using closed-ended questions about session learning objectives and open-ended questions to elicit specific practice changes. Perceived barriers to implementing recommended changes were also assessed. Results Among 179 participants, 80 (45%) completed postsession evaluations and treated one or more child with a UTI in the subsequent 17 months (856 UTIs in total). In closed-ended responses about session learning objectives, 45 clinicians (56%) committed to changing practice for antibiotic choice and duration, whereas 37 (46%) committed to implementing new practice guidelines. When asked open-ended questions to identify specific practice changes, 32 (40%) committed to antibiotic choice change and 29 (36%) committed to treatment duration change. Participants who made specific CTC statements had greater improvement in antibiotic choice (relative rate ratio 1.56, 95% CI 1.16-2.09) and duration (relative rate ratio 1.59, 95% CI 1.05-2.41) than participants who did not make specific commitments. Few perceived barriers affected subsequent prescribing. Discussion Commitments to changing specific clinical behaviors were associated with sustained changes in prescribing for children with UTIs. Linking self-evaluations with clinical data in integrated health care systems is an important tool for CME evaluators.

To assess the association between cumulative aluminum exposure from vaccines before age 24 months and persistent asthma at age 24 to 59 months.A retrospective cohort study was conducted in the Vaccine Safety Datalink (VSD). Vaccination histories were used to calculate cumulative vaccine-associated aluminum in milligrams (mg). The persistent asthma definition required one inpatient or 2 outpatient asthma encounters, and ≥2 long-term asthma control medication dispenses. Cox proportional hazard models were used to evaluate the association between aluminum exposure and asthma incidence, stratified by eczema presence/absence. Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) per 1 mg increase in aluminum exposure were calculated, adjusted for birth month/year, sex, race/ethnicity, VSD site, prematurity, medical complexity, food allergy, severe bronchiolitis, and health care utilization.The cohort comprised 326,991 children, among whom 14,337 (4.4%) had eczema. For children with and without eczema, the mean (standard deviation [SD]) vaccine-associated aluminum exposure was 4.07 mg (SD 0.60) and 3.98 mg (SD 0.72), respectively. Among children with and without eczema, 6.0% and 2.1%, respectively, developed persistent asthma. Among children with eczema, vaccine-associated aluminum was positively associated with persistent asthma (aHR 1.26 per 1 mg increase in aluminum, 95% CI 1.07, 1.49); a positive association was also detected among children without eczema (aHR 1.19, 95% CI 1.14, 1.25).In a large observational study, a positive association was found between vaccine-related aluminum exposure and persistent asthma. While recognizing the small effect sizes identified and the potential for residual confounding, additional investigation of this hypothesis appears warranted.

Clinical specialty societies recommend long-acting reversible contraceptives (LARCs) as first-line contraception for adolescent women. We evaluated whether a combined educational and process improvement intervention enhanced LARC placement in primary care within an integrated health care system.The intervention included journal clubs, live continuing education, point-of-care guidelines, and new patient materials. We conducted a retrospective cohort study across 3 time periods: baseline (January 2013-September 2015), early implementation (October 2015-March 2016), and full implementation (April 2016-June 2017). The primary outcome was the proportion of LARCs placed by primary care clinicians among women aged 13 to 18 years compared with gynecology clinicians.Kaiser Foundation Health Plan of Colorado cared for approximately 20,000 women aged 13 to 18 years in each calendar quarter between 2013 and 2017. Overall, LARC placement increased from 7.0 per 1000 members per quarter at baseline to 13.0 per 1000 during the full intervention. Primary care clinicians placed 6.2% of all LARCs in 2013, increasing to 32.1% by 2017 (P.001), including 45.5% of contraceptive implants. Clinicians who attended educational sessions were more likely to adopt LARCs than those who did not (17.9% vs 6.4% respectively, P = .009). Neither overall LARC placement rates (relative risk, 1.9; 95% confidence interval, 0.7-5.6) nor contraceptive implant rates (relative risk, 3.0; 95% confidence interval, 0.9-9.8) increased significantly in clinicians who attended educational activities.This multimodal intervention was associated with increased LARC placement for adolescent women in primary care. The combination of education and process improvement is a promising strategy to promote clinician behavior change.

It is not known whether drugs with different anticholinergic ratings contribute proportionately to overall anticholinergic score. Our objective was to assess the risk of falls or fall-related injuries as a function of the overall anticholinergic score resulting from drugs with different anticholinergic ratings among people with impaired cognition. This was a retrospective cohort study of adults aged ≥ 65 years with mild cognitive impairment (MCI) or dementia and two or more additional chronic conditions (N = 10,698) in an integrated delivery system. Electronic health record data, including pharmacy fills and diagnosis claims, were used to assess anticholinergic medication use, quantified using the anticholinergic cognitive burden (ACB) scale, falls and fall-related injuries. During a median follow-up of 366 days, 63% of the cohort used one or more ACB drug; 2015 (18.8%) people experienced a fall or fall-related injury. Among patients with a daily ACB score of 5, the greatest increase in risk of falls or fall-related injuries was seen when level 2 and level 3 drugs were used in combination [hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.51–2.83]. Multiple ACB level 1 drugs taken together also increased the hazard of a fall or fall-related injury (HR 1.16; 95% CI 1.03–1.32). The risk of fall or fall-related injury as a function of exposure to ACB level 2 drugs (HR 1.56; 95% CI 1.16–2.10) was higher than that for ACB level 1 or 3 drugs. The same daily ACB score was associated with a different degree of risk, depending on the ACB ratings of the individual drugs comprising the score. Combinations of level 2 and level 3 drugs had the greatest risk of fall or fall-related injury relative to other individuals with the same daily ACB score. Low-potency anticholinergic drugs taken together modestly increased the hazard of a fall or fall-related injury.

INTRODUCTION: Monitoring the trends in undervaccination, including that because of parental vaccine refusal or delay, can inform public health responses directed at improving vaccine confidence and vaccination coverage. METHODS: A retrospective cohort study was conducted in the Vaccine Safety Datalink. The cohort included all children born in 2004–2017 with ≥3 well-child visits between ages 2 and 23 months. Using electronic health record–based vaccination data, the average days undervaccinated was calculated for each child. Undervaccination patterns were assessed through age 23 months. Temporal trends were inspected for inflection points and were analyzed using linear regression. Nested within the cohort study, a survey was conducted to compare parent reports of vaccine refusal or delay with observed vaccination patterns. Data were analyzed in 2020. RESULTS: The study cohort consisted of 808,170 children. The percentage of children with average days undervaccinated=0 (fully vaccinated, no delays) rose from a nadir of 47.1% for the birth year 2008 to 68.4% for the birth year 2017 (p(trend)

OBJECTIVES: To determine if a multicomponent intervention was associated with increased use of first-line antibiotics (cephalexin or sulfamethoxazole and trimethoprim) among children with uncomplicated urinary tract infections (UTIs) in outpatient settings. METHODS: The study was conducted at Kaiser Permanente Colorado, a large health care organization with ∼127 000 members RESULTS: During January 2014 to September 2018, 2142 incident outpatient UTIs were identified (1636 preintervention and 506 postintervention). Pyelonephritis was diagnosed for 7.6% of cases. Adjusted for clustering of UTIs within clinicians, the proportion of UTIs treated with first-line antibiotics increased from 43.4% preintervention to 62.4% postintervention (P < .0001). The use of cephalexin (first-line, narrow spectrum) increased from 28.9% preintervention to 53.0% postintervention (P < .0001). The use of cefixime (second-line, broad spectrum) decreased from 17.3% preintervention to 2.6% postintervention (P < .0001). Changes in prescribing practices persisted through the end of the study period. CONCLUSIONS: A multicomponent intervention with educational and process-improvement elements was associated with a sustained change in antibiotic prescribing for uncomplicated pediatric UTIs.

Objective To develop a model to predict hypertension risk among children with incident elevated blood pressure (BP); to test the external validity of the model. Methods A retrospective cohort study was conducted in 3 organizations: Kaiser Permanente Colorado was the model derivation site; HealthPartners of Minnesota and Kaiser Permanente Northern California served as external validation sites. During study years 2006 through 2012, all children aged 3 through 17 years with incident elevated BP in an outpatient setting were identified. The predictor variables were demographic and clinical characteristics collected during routine care. Cox proportional hazards regression was used to predict subsequent hypertension, and diagnostic statistics were used to assess model performance. Results Among 5598 subjects at the derivation site with incident elevated BP, 160 (2.9%) developed hypertension during the study period. Eight characteristics were used to predict hypertension risk: age, sex, race, BP preceding incident elevated BP, body mass index percentile, systolic BP percentile, diastolic BP percentile, and clinical setting of the incident elevated BP. At the derivation site, the model discriminated well between those at higher versus lower risk of hypertension (c-statistic = 0.77). At external validation sites, the observed risk of hypertension was higher than the predicted risk, and the model showed poor discrimination (c-statistic ranged from 0.64 to 0.67). Conclusions Among children with incident elevated BP, a risk model demonstrated good internal validity with respect to predicting subsequent hypertension. However, the risk model did not perform well at 2 external validation sites, which might limit transportability to other settings.

Context Although local childhood obesity prevalence estimates would be valuable for planning and evaluating obesity prevention efforts in communities, these data are often unavailable. Objective The primary objective was to create a multi-institutional system for sharing electronic health record (EHR) data to produce childhood obesity prevalence estimates at the census tract level. A secondary objective was to adjust obesity prevalence estimates to population demographic characteristics. Design/setting/participants The study was set in Denver County, Colorado. Six regional health care organizations shared EHR-derived data from 2014 to 2016 with the state health department for children and adolescents 2 to 17 years of age. The most recent height and weight measured during routine care were used to calculate body mass index (BMI); obesity was defined as BMI of 95th percentile or more for age and sex. Census tract location was determined using residence address. Race/ethnicity was imputed when missing, and obesity prevalence estimates were adjusted by sex, age group, and race/ethnicity. Main outcome measure(s) Adjusted obesity prevalence estimates, overall, by demographic characteristics and by census tract. Results BMI measurements were available for 89 264 children and adolescents in Denver County, representing 73.9% of the population estimate from census data. Race/ethnicity was missing for 4.6%. The county-level adjusted childhood obesity prevalence estimate was 13.9% (95% confidence interval, 13.6-14.1). Adjusted obesity prevalence was higher among males, those 12 to 17 years of age, and those of Hispanic race/ethnicity. Adjusted obesity prevalence varied by census tract (range, 0.4%-24.7%). Twelve census tracts had an adjusted obesity prevalence of 20% or more, with several contiguous census tracts with higher childhood obesity occurring in western areas of the city. Conclusions It was feasible to use a system of multi-institutional sharing of EHR data to produce local childhood obesity prevalence estimates. Such a system may provide useful information for communities when implementing obesity prevention programs.

Background Primary prevention implantable cardioverter‐defibrillators (ICDs) reduce mortality in selected patients with left ventricular systolic dysfunction by delivering therapies (antitachycardia pacing or shocks) to terminate potentially lethal arrhythmias; inappropriate therapies also occur. We assessed device therapies among adults receiving primary prevention ICDs in 7 healthcare systems. Methods and Results We linked medical record data, adjudicated device therapies, and the National Cardiovascular Data Registry ICD Registry. Survival analysis evaluated therapy probability and predictors after ICD implant from 2006 to 2009, with attention to Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups: left ventricular ejection fraction, 31% to 35%; nonischemic cardiomyopathy Conclusions In this community cohort of primary prevention patients receiving ICD, therapy delivery varied across demographic and clinical characteristics, but did not differ meaningfully for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups.

BACKGROUND: Drugs with anticholinergic properties are considered potentially inappropriate in patients with cognitive impairment because harms – including delirium, falls and fractures – may outweigh benefits. OBJECTIVE: To highlight opportunities to improve clinical decision making and care for patients with cognitive impairment and multiple chronic conditions, we identified distinct subgroups of patients with mild cognitive impairment (MCI) and dementia who had high cumulative anticholinergic burden and specific patterns of anticholinergic use. PATIENTS AND METHODS: Retrospective cohort study in a not-for-profit, integrated delivery system. Participants included community-dwelling adults aged 65 and older (N=13,627) with MCI or dementia and at least 2 other chronic diseases. We calculated the Anticholinergic Cognitive Burden (ACB) score for each participant from pharmacy and electronic health record (EHR) data. Among individuals with a mean 12 month ACB score ≥2, we used agglomerative hierarchical clustering to identify groups, or clusters, of individuals with similar anticholinergic prescription patterns. RESULTS: 3,257 (24%;) had high anticholinergic burden, defined as an ACB score ≥2. Clinically meaningful clusters based upon anchoring medications or drug classes included: a cluster of cardiovascular medications (n = 1497; 46%); two clusters of antidepressant medications (n = 633; 20%); and a cluster based on use of bladder antimuscarinics (n = 431; 13%). Several clusters were comprised of multiple central nervous system-active drugs. CONCLUSIONS: Cardiovascular and central nervous system-active medications comprise a substantial portion of anticholinergic burden in people with cognitive impairment and multiple chronic conditions. Antidepressants were highly prevalent. Clinical profiles elucidated by these clusters of anticholinergic medications can inform targeted approaches to care.

BACKGROUND AND OBJECTIVE: Screening for hypertension in children occurs during routine care. When blood pressure (BP) is elevated in the hypertensive range, a repeat measurement within 1 to 2 weeks is recommended. The objective was to assess patterns of care after an incident elevated BP, including timing of repeat BP measurement and likelihood of persistently elevated BP. METHODS: This retrospective study was conducted in 3 health care organizations. All children aged 3 through 17 years with an incident elevated BP at an outpatient visit during 2007 through 2010 were identified. Within this group, we assessed the proportion who had a repeat BP measured within 1 month of their incident elevated BP and the proportion who subsequently met the definition of hypertension. Multivariate analyses were used to identify factors associated with follow-up BP within 1 month of initial elevated BP. RESULTS: Among 72 625 children and adolescents in the population, 6108 (8.4%) had an incident elevated BP during the study period. Among 6108 with an incident elevated BP, 20.9% had a repeat BP measured within 1 month. In multivariate analyses, having a follow-up BP within 1 month was not significantly more likely among individuals with obesity or stage 2 systolic elevation. Among 6108 individuals with an incident elevated BP, 84 (1.4%) had a second and third consecutive elevated BP within 12 months. CONCLUSIONS: Whereas >8% of children and adolescents had an incident elevated BP, the great majority of BPs were not repeated within 1 month. However, relatively few individuals subsequently met the definition of hypertension. * Abbreviations: AOR — : adjusted odds ratio BP — : blood pressure CI — : confidence interval EHR — : electronic health record ICD-9-CM — : International Classification of Diseases, Ninth Revision, Clinical Modification KPCO — : Kaiser Permanente Colorado KPNC — : Kaiser Permanente Northern California

Objective. Prescription monitoring programs (PMPs) are statewide databases containing prescriber and patient-level prescription data on select drugs of abuse. These databases are used by medical professionals or law enforcement officials to identify patients with prescription drug use patterns indicative of abuse or providers engaging in illegal activities. Most states have implemented PMPs in an attempt to curb prescription drug abuse and diversion. However, assessment of their impact on drug abuse is only beginning. This study aimed to evaluate the relationship between PMPs and opioid misuse over time in two drug abuse surveillance data sources. Methods. Data from the RADARS® System Poison Center and Opioid Treatment surveillance databases were used to obtain measures of abuse and misuse of opioids. Repeated measures negative binomial regression was applied to quarterly surveillance data (from 2003 to mid-2009) to estimate and compare opioid abuse and misuse trends. PMP presence was modeled as a time varying covariate for each state. Results. Results support an association between PMPs and mitigated opioid abuse and misuse trends. Without a PMP in place, Poison Center intentional exposures increased, on average, 1.9% per quarter, whereas opioid intentional exposures increase 0.2% (P = 0.036) per quarter with a PMP in place. Opioid treatment admissions increase, on average, 4.9% per quarter in states without a PMP vs 2.6% (P = 0.058) in states with a PMP. In addition to the time trend, population and a measure of drug availability were also significant predictors. A secondary analysis that classified PMP based upon ideal characteristic showed consistent though not significant results. Conclusions. Two observational data sources offer preliminary support that PMPs are effective. Future efforts should evaluate what PMP characteristics are most effective and which opioids are most impacted. Language: en

ACADEMIC EMERGENCY MEDICINE 2012; 19:121–131 © 2012 by the Society for Academic Emergency Medicine Abstract Objectives: Crotalidae polyvalent immune Fab (ovine) (FabAV) is commonly used in the treatment of symptomatic North American crotaline snake envenomation. When approved by the U.S. Food and Drug Administration in 2000, the incidences of immediate hypersensitivity reactions and serum sickness were reported as 0.14 and 0.18, respectively. The objective of this meta-analysis was to evaluate the incidence of immediate hypersensitivity reactions and serum sickness reported in studies of patients treated with FabAV therapy after North American crotaline envenomation. Methods: The authors searched PubMed, Ovid MEDLINE, and EMBASE from January 1, 1997, to September 20, 2010, for English-language medical literature and cross-referenced bibliographies of reviewed articles. The published abstracts of the major toxicology conferences were also searched. All prospective and retrospective cohort studies with patients receiving FabAV therapy for North American crotaline envenomations were eligible for data abstraction. Two content experts reviewed full-text articles and extracted relevant study design and outcome data. Proportions of immediate hypersensitivity and serum sickness for each study were analyzed in a random-effects model to produce an overall estimate of immediate hypersensitivity and serum sickness incidence associated with FabAV administration. Results: The literature search revealed 11 unique studies of patients who received FabAV that contained information on immediate hypersensitivity reactions and serum sickness. The meta-analysis produced a combined estimate of the incidence of immediate hypersensitivity of 0.08 (95% confidence interval [CI] = 0.05 to 0.11) and a combined estimate of the incidence of serum sickness of 0.13 (95% CI = 0.07 to 0.21). Conclusions: In this systematic literature review and meta-analysis, the combined estimates of the incidence of immediate hypersensitivity reactions and serum sickness from FabAV in the treatment of symptomatic North American crotaline envenomations appear to be lower than previously reported, at 0.08 and 0.13, respectively.

Background Serum transaminase activity is a common measure of liver injury used in clinical trials. The use of a point of care device to monitor serum transaminases would allow immediate evaluation of this safety endpoint and may be less expensive than standard laboratory testing. Purpose The objective of this study was to compare a point of care transaminase test to a standard laboratory measurement. Methods Subjects were healthy adults participating in a clinical trial measuring the effects of therapeutic doses of acetaminophen on serum transaminase activity. For this study, serum transaminase activity was determined every 3 days for 14 days. At each measurement, a sample was sent to the clinical laboratory for measurement and also analyzed using a point of care device (Cholestech LDX, Hayward CA). The results were compared using a Bland–Altman plot to identify bias and we also measured the agreement between the techniques for categorizing samples as “low”, “normal” or “elevated”. Results One hundred thirty three samples from 35 subjects were compared. The 95% confidence interval for the limits of agreement between the LDX and the clinical laboratory was − 8.46 to 27.09 IU/L. Agreement for classification as low, normal or elevated was moderate between the two methods (Kappa = 0.37). Conclusion The point of care device provided moderate agreement with the laboratory transaminase measurement. However, use of the device would have resulted in misclassification of approximately 1/3 of samples. We do not recommend this point of care device for the measurement of serum transaminases in clinical trials.

Introduction: Primary prevention implantable cardioverter defibrillators (ICDs) reduce mortality in select patients with left ventricular systolic dysfunction (LVSD). The occurrence of device therapies after ICD implantation in contemporary clinical practice is not well described, especially in patient subgroups designated in the Centers for Medicare and Medicaid Services (CMS) 2005 Coverage with Evidence Development (CED). Methods: The Longitudinal Study of ICDs assessed rates and correlates of device therapies (overall and those requiring shock) up to 3 years post-implant among 2540 patients with LVSD receiving first-time primary prevention ICDs in 7 US health care systems from 2006-2009. Implant data from the National Cardiovascular Data Registry ICD Registry were linked to electronic longitudinal health care system data and a novel centrally adjudicated repository of device therapies abstracted from medical records. Proportional hazard models evaluated associations with device therapies by appropriateness, adjusted for demographic and clinical factors. Results: Subjects were 26% women, 35% =65 years (1.40, 1.04-1.88), and lower among 2009 implants compared to 2006 (0.66, 0.46-0.95). Regarding the 3 CMS CED patient subgroups, neither ejection fraction nor heart failure symptom severity was associated with device therapy; for LVSD etiology, the rate of inappropriate therapy was nominally but not significantly higher among subjects with non-ischemic cardiomyopathy of < 9 months duration (1.38, 0.88-2.18). Conclusions: In a representative cohort of primary prevention ICD patients in usual care, rates of device therapies were somewhat lower than in landmark trials, differed by some patient characteristics, but did not differ meaningfully for CMS CED subgroups.

Background Patient sex and age may influence rates of death after receiving an implantable cardioverter‐defibrillator for primary prevention. Differences in outcomes other than mortality and whether these differences vary by heart failure symptoms, etiology, and left ventricular ejection fraction are not well characterized. Methods and Results We studied 2954 patients with left ventricular ejection fraction ≤0.35 undergoing first‐time implantable cardioverter‐defibrillator for primary prevention within the Cardiovascular Research Network; 769 patients (26%) were women, and 2827 (62%) were aged >65 years. In a median follow‐up of 2.4 years, outcome rates per 1000 patient‐years were 109 for death, 438 for hospitalization, and 111 for heart failure hospitalizations. Procedure‐related complications occurred in 8.36%. In multivariable models, women had significantly lower risks of death (hazard ratio 0.67, 95% CI 0.56 to 0.80) and heart failure hospitalization (hazard ratio 0.82, 95% CI 0.68 to 0.98) and higher risks for complications (hazard ratio 1.38, 95% CI 1.01 to 1.90) than men; patients aged >65 years had higher risks of death (hazard ratio 1.55, 95% CI 1.30 to 1.86) and heart failure hospitalization (hazard ratio 1.25, 95% CI 1.05 to 1.49) than younger patients. Age and sex differences were generally consistent in strata according to symptoms, etiology, and severity of left ventricular systolic dysfunction, except the higher risk of complications in women, which differed by New York Heart Association classification ( P =0.03 for sex–New York Heart Association interaction), and the risk of heart failure hospitalization in older patients, which differed by etiology of heart failure ( P =0.05 for age–etiology interaction). Conclusions The burden of adverse outcomes after receipt of an implantable cardioverter‐defibrillator for primary prevention is substantial and varies according to patient age and sex. These differences in outcome generally do not vary according to baseline heart failure characteristics.

Background/AimsWithin embedded HMO research groups, analytic teams are heavily involved with many key stages of research studies. Individual analytic team members use a variety of processes for ensuring work quality. Identification and standardization of analytic quality review best practices may lead to greater efficiencies and fewer errors. The objective of this quality improvement project was to develop and implement tools to enhance the quality and consistency of analytic work within a HMO-based research group.MethodsWe used a multi-modal approach to develop and assess analytic quality review tools. We first conducted four in-depth interviews with principal investigators to collect experiences and suggestions for improving analytic processes. Using an online survey, we collected best practices from analytic team members. We also interviewed analytic leads with 6 HMO and academic partner research groups on their best practices. We integrated all information and developed analytic quality review best practice documentation and tools. We tested and revised the tools, estimated time requirements, and provided basic training to our analytic team. Nine months later, we conducted an anonymous online survey to gauge uptake of these tools and to collect initial feedback from early adopters.ResultsFour analytic quality review tools were developed to help formalize best practices for cohort-building/data pulls, data preparation (code review), analytic dataset preparation and documentation, and manuscript methods and results review. In initial assessments, implementing the code review was the most resource-intensive, taking upwards of 14 hours. Nine months after introducing these tools, the most commonly reported challenges to using the tools included lack of time/funding, using other processes to ensure work quality, and lack of knowledge on when or how to use the tools. Early adopters gave qualitative feedback that the tools helped structure analytic processes and encouraged documentation of analytic decisions.ConclusionsIdentification and standardization of best practices may have the potential to improve analytic work processes for HMO research groups. Future efforts should focus on quality review tool revisions, policies for tool use, data collection on errors found using review tools, and strategies to overcome identified barriers to using the tools.

Background: Implantable cardioverter defibrillators (ICDs) are commonly used for the primary prevention of sudden cardiac death. Controversies persist, however, about outcomes in representative cohorts and in clinically important patient subgroups. Observational studies of outcomes following primary prevention ICD implantation are typically limited to relatively restricted cohorts (e.g. Medicare) or with short follow up. Methods: In the Cardiovascular Research Network (CVRN), we conducted a study in 7 integrated health care delivery systems to identify patients undergoing primary prevention ICD implantation for left ventricular systolic dysfunction between 2006-2010. Baseline procedural and clinical data were obtained from the NCDR ICD Registry; longitudinal data to ascertain outcomes after implantation were obtained through clinical health system data from the CVRN Virtual Data Warehouse. We assessed the occurrence of complications at 90 days and mortality, all-cause hospitalization, and heart failure hospitalization up to 5 years after implantation in clinical strata designated a priori. Multivariable models accounting for clustering of patients within site were used to assess the relationship between clinical variables and each outcome. Clinical variables of interest (Table) were included in all models; additional variables were assessed with forward selection to account for possible confounders. Results: Among 2953 eligible patients, median age was 69 years and 26% were women Coexisting conditions, including hypertension (74%), atrial fibrillation (32%), COPD (20%), and diabetes (42%), were common. Overall event rates (per 1000 patient years) were 110 for death, 438 for any hospitalization, and 58 for heart failure hospitalization. The association between clinically important variables and outcomes are shown in the Table. Conclusions: In a diverse population of patients undergoing ICD implantation in contemporary practice we identified specific clinical variables associated with adverse outcomes. These data can inform prognosis in clinical care and guide the design of future trials of this therapy.

Obesity is associated with chronic noncancer pain. It is not known if opioid use for chronic pain in obese individuals undergoing bariatric surgery is reduced.To determine opioid use following bariatric surgery in patients using opioids chronically for pain control prior to their surgery and to determine the effect of preoperative depression, chronic pain, or postoperative changes in body mass index (BMI) on changes in postoperative chronic opioid use.Retrospective cohort study in a distributed health network (10 demographically and geographically varied US health care systems) of 11,719 individuals aged 21 years and older, who had undergone bariatric surgery between 2005 and 2009, and were assessed 1 year before and after surgery, with latest follow-up by December 31, 2010.Opioid use, measured as morphine equivalents 1 year before and 1 year after surgery, excluding the first 30 postoperative days. Chronic opioid use is defined as 10 or more opioid dispensings over 90 or more days or as dispensings of at least a 120-day supply of opioids during the year prior to surgery.Before surgery, 8% (95% CI, 7%-8%; n = 933) of bariatric patients were chronic opioid users. Of these individuals, 77% (95% CI, 75%-80%; n = 723) continued chronic opioid use in the year following surgery. Mean daily morphine equivalents for the 933 bariatric patients who were chronic opioid users before surgery were 45.0 mg (95% CI, 40.0-50.1) preoperatively and 51.9 mg (95% CI, 46.0-57.8) postoperatively (P .001). For this group with chronic opiate use prior to surgery, change in morphine equivalents before vs after surgery did not differ between individuals with loss of more than 50% excess BMI vs those with 50% or less (50% BMI loss: adjusted incidence rate ratio [adjusted IRR, 1.17; 95% CI, 1.07-1.28] vs ≤50% BMI loss [adjusted IRR, 1.03; 95% CI, 0.93-1.14] model interaction, P = .06). In other subgroup analyses of preoperative chronic opioid users, changes in morphine equivalents before vs after surgery did not differ between those with or without preoperative diagnosis of depression or chronic pain (depression only [n = 75; IRR, 1.08; 95% CI, 0.90-1.30]; chronic pain only [n = 440; IRR, 1.17; 95% CI, 1.08-1.27]; both depression and chronic pain [n = 226; IRR, 1.11; 95% CI, 0.96-1.28]; neither depression nor chronic pain [n = 192; IRR, 1.22; 95% CI, 0.98-1.51); and P values for model interactions when compared with neither were P = .42 for depression, P = .76 for pain, and P = .48 for both.In this cohort of patients who underwent bariatric surgery, 77% of patients who were chronic opioid users before surgery continued chronic opioid use in the year following surgery, and the amount of chronic opioid use was greater postoperatively than preoperatively. These findings suggest the need for better pain management in these patients following surgery.

There are no evidence-based recommendations for statin continuation or discontinuation near the end of life. However, some expert opinion recommends continuing statins prescribed for secondary versus primary prevention of cardiovascular disease.Our aim was to explore statin prescribing patterns in a longitudinal cohort of individuals with life-limiting illness, and to evaluate differences in these patterns based on secondary versus primary prevention of cardiovascular disease.This study was a retrospective cohort analysis of 539 persons in an integrated, not-for-profit health maintenance organization (HMO) setting who were receiving statins at diagnosis of a cancer with 0% to 25% predicted 5-year survival. Of the cohort patients, 343 were taking statins for secondary prevention and 196 for primary prevention of cardiovascular disease. Measurements included number and timing of statin refills between diagnosis and date of death, disenrollment, or the end of the observation period.Four hundred and ninety-six cohort members died within the observation period. Fifty-eight percent of the secondary prevention and 62% of the primary prevention group had at least one statin refill after diagnosis. There were no significant differences between groups for number of days between diagnosis and last refill, or between last refill and death. Two deaths were attributable to cardiovascular causes in each group.Our retrospective cohort analysis of persons with incident poor-prognosis cancer describes diminished, but persistent statin refills after diagnosis. Neither timing of statin discontinuation nor cardiovascular mortality differed by prescribing indication. There may be an opportunity to reevaluate medication burden in persons taking statins for primary prevention, and it is unclear whether continuing statins prescribed for secondary prevention affects cardiovascular outcomes.

Background— Implantable cardioverter-defibrillators (ICDs) are increasingly used for primary prevention after randomized, controlled trials demonstrating that they reduce the risk of death in patients with left ventricular systolic dysfunction. The extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with left ventricular systolic dysfunction undergoing primary prevention ICD implantation in a real-world setting compare with those enrolled in the randomized, controlled trials is not well characterized. This study is being conducted to address these questions. Methods and Results— The study cohort includes consecutive patients undergoing primary prevention ICD placement between January 1, 2006 and December 31, 2009 in 7 health plans. Baseline clinical characteristics were acquired from the National Cardiovascular Data Registry ICD Registry. Longitudinal data collection is underway, and will include hospitalization, mortality, and resource use from standardized health plan data archives. Data regarding ICD therapies will be obtained through chart abstraction and adjudicated by a panel of experts in device therapy. Compared with the populations of primary prevention ICD therapy randomized, controlled trials, the cohort (n=2621) is on average significantly older (by 2.5–6.5 years), more often female, more often from racial and ethnic minority groups, and has a higher burden of coexisting conditions. The cohort is similar, however, to a national population undergoing primary prevention ICD placement. Conclusions— Patients undergoing primary prevention ICD implantation in this study differ from those enrolled in the randomized, controlled trials that established the efficacy of ICDs. Understanding a broad range of health outcomes, including ICD therapies, will provide patients, clinicians, and policy makers with contemporary data to inform decision-making.

Background/Aims Clinicians commonly face decisions about prevention of coronary heart disease following a new diagnosis of cancer. Such decisions must take into account cancer prognosis, cardiovascular risk status, overall burden of morbidity, and the patient’s goals, preferences and values. In cases of favorable cancer prognosis and elevated CHD risk, continued or intensified treatment of risk factors is warranted. In cases of poor cancer prognosis and/or high morbidity burden, a less intensive approach may be appropriate.

Crotalidae polyvalent immune Fab (ovine) (FabAV) is commonly used in the treatment of symptomatic North American crotaline snake envenomation. When approved by the U.S. Food and Drug Administration in 2000, the incidences of immediate hypersensitivity reactions and serum sickness were reported as 0.14 and 0.18, respectively. The objective of this meta-analysis was to evaluate the incidence of immediate hypersensitivity reactions and serum sickness reported in studies of patients treated with FabAV therapy after North American crotaline envenomation. The authors searched PubMed, Ovid MEDLINE, and EMBASE from January 1, 1997, to September 20, 2010, for English-language medical literature and cross-referenced bibliographies of reviewed articles. The published abstracts of the major toxicology conferences were also searched. All prospective and retrospective cohort studies with patients receiving FabAV therapy for North American crotaline envenomations were eligible for data abstraction. Two content experts reviewed full-text articles and extracted relevant study design and outcome data. Proportions of immediate hypersensitivity and serum sickness for each study were analyzed in a random-effects model to produce an overall estimate of immediate hypersensitivity and serum sickness incidence associated with FabAV administration. The literature search revealed 11 unique studies of patients who received FabAV that contained information on immediate hypersensitivity reactions and serum sickness. The meta-analysis produced a combined estimate of the incidence of immediate hypersensitivity of 0.08 (95% confidence interval [CI] = 0.05 to 0.11) and a combined estimate of the incidence of serum sickness of 0.13 (95% CI = 0.07 to 0.21). In this systematic literature review and meta-analysis, the combined estimates of the incidence of immediate hypersensitivity reactions and serum sickness from FabAV in the treatment of symptomatic North American crotaline envenomations appear to be lower than previously reported, at 0.08 and 0.13, respectively.