Liza M. Reifler

Chronic use of opioid medications before and after bariatric surgery.

IMPORTANCE 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. OBJECTIVES 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. DESIGN, SETTING, AND PARTICIPANTS 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. MAIN OUTCOMES AND MEASURES 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. RESULTS 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. CONCLUSIONS AND RELEVANCE 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.

Statin Prescribing Patterns in a Cohort of Cancer Patients with Poor Prognosis

BACKGROUND 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. OBJECTIVES 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. DESIGN AND SETTING 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. RESULTS 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. CONCLUSIONS 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.

Longitudinal study of implantable cardioverter-defibrillators: methods and clinical characteristics of patients receiving implantable cardioverter-defibrillators for primary prevention in contemporary practice

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.

Patterns of Care and Persistence After Incident Elevated Blood Pressure

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.

Age and Sex Differences in Long‐Term Outcomes Following Implantable Cardioverter‐Defibrillator Placement in Contemporary Clinical Practice: Findings From the Cardiovascular Research Network

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.

Competing risks of cancer mortality and cardiovascular events in individuals with multimorbidity

Background Cancer patients with cardiovascular and other comorbidities are at concurrent risk of multiple adverse outcomes. However, most treatment decisions are guided by evidence from single-outcome models, which may be misleading for multimorbid patients. Objective We assessed the interacting effects of cancer, cardiovascular, and other morbidity burdens on the competing outcomes of cancer mortality, serious cardiovascular events, and other-cause mortality. Design We analyzed a cohort of 6,500 adults with initial cancer diagnosis between 2001 and 2008, SEER 5-year survival ≥26%, and a range of cardiovascular risk factors. We estimated the cumulative incidence of cancer mortality, a serious cardiovascular event (myocardial infarction, coronary revascularization, or cardiovascular mortality), and other-cause mortality over 5 years, and identified factors associated with the competing risks of each outcome using cause-specific Cox proportional hazard models. Results Following cancer diagnosis, there were 996 (15.3%) cancer deaths, 328 (5.1%) serious cardiovascular events, and 542 (8.3%) deaths from other causes. In all, 4,634 (71.3%) cohort members had none of these outcomes. Although cancer prognosis had the greatest effect, cardiovascular and other morbidity also independently increased the hazard of each outcome. The effect of cancer prognosis on outcome was greatest in year 1, and the effect of other morbidity was greater in individuals with better cancer prognoses. Conclusion In multimorbid oncology populations, comorbidities interact to affect the competing risk of different outcomes. Quantifying these risks may provide persons with cancer plus cardiovascular and other comorbidities more accurate information for shared decision-making than risks calculated from single-outcome models.

Device Therapies Among Patients Receiving Primary Prevention Implantable Cardioverter‐Defibrillators in the Cardiovascular Research Network

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 <9 months’ duration; and New York Heart Association class IV heart failure with cardiac resynchronization therapy defibrillator. Among 2540 patients, 35% were <65 years old, 26% were women, and 59% were white. During 27 (median) months, 738 (29%) received ≥1 therapy. Three‐year therapy risk was 36% (appropriate, 24%; inappropriate, 12%). Appropriate therapy was more common in men (adjusted hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.43–2.35). Inappropriate therapy was more common in patients with atrial fibrillation (adjusted HR, 2.20; 95% CI, 1.68–2.87), but less common among patients ≥65 years old versus younger (adjusted HR, 0.72; 95% CI, 0.54–0.95) and in recent implants (eg, in 2009 versus 2006; adjusted HR, 0.66; 95% CI, 0.46–0.95). In Centers for Medicare and Medicaid Services Coverage With Evidence Development analysis, inappropriate therapy was less common with cardiac resynchronization therapy defibrillator versus single chamber (adjusted HR, 0.55; 95% CI, 0.36–0.84); therapy risk did not otherwise differ for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups. 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.

PS1-21: Development and Dissemination of Quality Review Tools for Data Management and Analysis

Background/Aims Within 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. Methods We 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. Results Four 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. Conclusions Identification 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.

PS1-31: Processes of Cardiovascular Care Relevant to Complex Patients

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. Methods Study design: Historical cohort analysis. Population: 10,313 persons with a cancer diagnosis between January, 2001 and December, 2008 and a range of SEER 5-year survival categories. We assessed LDL cholesterol (LDL) control, blood pressure control, and hemoglobin A1c control each as a function of morbidity burden (using Charlson score), cancer 5-year survival, and the interaction between them in specific at-risk sub-populations. We used linear mixed models with random intercept for each patient and splines at cancer diagnosis and 6- and 12- months post cancer diagnosis to model each outcome occurring less than 2 years prior and 5 years post cancer diagnosis. Results Better LDL goal attainment was associated with higher morbidity in sub-populations characterized by need for cholesterol treatment. For persons with a diagnosis of hypertension, better blood pressure control was associated with lower morbidity burden. Neither LDL nor blood pressure goal attainment was associated with cancer stage at diagnosis. Both blood pressure and LDL control improved in the 6 months after cancer diagnosis. In persons with diabetes, attainment of hemoglobin A1c goal was not associated with either morbidity burden or cancer stage. Discussion In these sub-cohorts characterized by indications for cardiovascular risk factor control, control of risk factors was a function of morbidity, but not cancer stage. This raises the possibility that guideline-driven care of cardiovascular risk factors is neither intensified in the face of good cancer prognoses nor decreased in the face of poor cancer prognoses. These findings should be further explored with attention to detailed patient and clinician factors in order to make appropriate recommendations for patient-centered care delivery in complex patient populations.