Shared decision making and time to exacerbation in children with asthma.

Objective: Although shared decision making (SDM) is a promising approach for improving outcomes for patients with chronic diseases, no evidence currently supports the use of SDM to delay asthma exacerbations. We evaluated the impact of an SDM intervention implemented by providers in a real-world setting on time to exacerbation in children with asthma. Methods: This study used a prospective cohort observed between 2011 and 2013 at five primary care practices that serve vulnerable populations (e.g., Medicaid and uninsured patients) in Charlotte, NC. Patients aged 2 to 17 receiving SDM were matched to those receiving usual care using propensity scores. Time to asthma exacerbation (asthma hospitalization, emergency department visit or oral steroid prescription in the outpatient setting) was compared between groups using Kaplan-Meier curves and conditional Cox proportional hazards models. Results: The cohort included 746 children, 60.5% male and 54.2% African American, with a mean age of 8.6 years. Of these, 625 received usual care and 121 received SDM. The final analysis included 100 matched pairs of children. Kaplan-Meier curves showed longer exacerbation-free time for patients in the SDM intervention compared to those in usual care (p = 0.005). The difference in risk of experiencing an exacerbation was marginally significant between the two groups (HR = 0.56, 95% C.I. = 0.29-1.08, p = 0.08). Conclusions: SDM was found to delay exacerbations among children with asthma. Clinicians should consider incorporating patient preferences in treatment decisions through SDM as a means for longer exacerbation-free time among children with poor asthma control.

Racial differences in antipsychotic use: Claims database analysis of Medicaid-insured patients with schizophrenia.

BACKGROUND: Database analyses have indicated that medical treatment for schizophrenia varies among racial groups. This study assessed antipsychotic use and healthcare utilization across races in Medicaid-insured patients with schizophrenia. METHODS: A Medicaid database of inpatient/outpatient medical claims and outpatient prescription claims for more than 28 million enrollees in 11 geographically diverse states was analyzed. The primary outcome, racial differences in antipsychotic use in 2012, was examined in 5 multivariable logistic regression models: (1) any antipsychotic, (2) first-generation (FG) long-acting injectables (LAIs), (3) FG oral antipsychotics, (4) second-generation (SG) LAIs, and (5) SG oral antipsychotics. RESULTS: Odds ratios and adjusted predicted probabilities were comparable for any antipsychotic use between black and white patients. Black patients were less likely to receive SG oral antipsychotics (P < .001) and more likely to receive SG or FG LAIs (P = .001 and P < .001, respectively) and FG oral antipsychotics (P = .003) vs white patients. Further, black patients had a higher mean number of emergency room visits (P < .001) and a lower mean number of hospitalizations (P < .05) vs white patients; the mean number of physician visits was comparable. CONCLUSIONS: Disparities in antipsychotic use and healthcare utilization across races in patients with schizophrenia warrant further investigation and elimination of these disparities should be a national goal.

A cross-sectional retrospective analysis of the regionalization of complex surgery.

BACKGROUND: The Veterans Health Administration (VHA) system has assigned a surgical complexity level to each of its medical centers by specifying requirements to perform standard, intermediate or complex surgical procedures. No study to similarly describe the patterns of relative surgical complexity among a population of United States (U.S) civilian hospitals has been completed. DESIGN: single year, retrospective, cross-sectional. SETTING/PARTICIPANTS: the study used Florida Inpatient Discharge Data from short-term acute hospitals for calendar year 2009. Two hundred hospitals with 2,542,920 discharges were organized into four quartiles (Q 1, 2, 3, 4) based on the number of complex procedures per hospital. The VHA surgical complexity matrix was applied to assign relative complexity to each procedure. The Clinical Classification Software (CCS) system assigned complex procedures to clinically meaningful groups. For outcome comparisons, propensity score matching methods adjusted for the surgical procedure, age, gender, race, comorbidities, mechanical ventilator use and type of admission. MAIN OUTCOME MEASURES: in-hospital mortality and length-of-stay (LOS). RESULTS: Only 5.2% of all inpatient discharges involve a complex procedure. The highest volume complex procedure hospitals (Q4) have 49.8% of all discharges but 70.1% of all complex procedures. In the 133,436 discharges with a primary complex procedure, 374 separate specific procedures are identified, only about one third of which are performed in the lowest volume complex procedure (Q1) hospitals. Complex operations of the digestive, respiratory, integumentary and musculoskeletal systems are the least concentrated and proportionately more likely to occur in the lower volume hospitals. Operations of the cardiovascular system and certain technology dependent miscellaneous diagnostic and therapeutic procedures are the most concentrated in high volume hospitals. Organ transplants are only done in Q4 hospitals. There were no significant differences in in-hospital mortality rates and the longest lengths of stay were found in higher volume hospitals. CONCLUSIONS: Complex surgery in Florida is effectively regionalized so that small volume hospitals operating within the range of complex procedures appropriate to their capabilities provide no increased risk of post surgical mortality.

Effects of skilled nursing facility structure and process factors on medication errors during nursing home admission.

BACKGROUND: Older adults are at greatest risk of medication errors during the transition period of the first 7 days after admission and readmission to a skilled nursing facility (SNF). PURPOSE: The aim of this study was to evaluate structure- and process-related factors that contribute to medication errors and harm during transition periods at a SNF. METHODOLOGY/APPROACH: Data for medication errors and potential medication errors during the 7-day transition period for residents entering North Carolina SNFs were from the Medication Error Quality Initiative-Individual Error database from October 2006 to September 2007. The impact of SNF structure and process measures on the number of reported medication errors and harm from errors were examined using bivariate and multivariate model methods. FINDINGS: A total of 138 SNFs reported 581 transition period medication errors; 73 (12.6%) caused harm. Chain affiliation was associated with a reduction in the volume of errors during the transition period. One third of all reported transition errors occurred during the medication administration phase of the medication use process, where dose omissions were the most common type of error; however, dose omissions caused harm less often than wrong-dose errors did. Prescribing errors were much less common than administration errors but were much more likely to cause harm. PRACTICE IMPLICATIONS: Both structure and process measures of quality were related to the volume of medication errors.However, process quality measures may play a more important role in predicting harm from errors during the transition of a resident into an SNF. Medication errors during transition could be reduced by improving both prescribing processes and transcription and documentation of orders.

Moderate symptom-based exacerbations as predictors of severe claims-based exacerbations in asthma.

OBJECTIVES: Asthma exacerbations have well-established clinical and economic impact, yet lack consensus on characterization of an episode's severity. Asthma treatment guidelines outline the concept of a moderate asthma exacerbation; however, a clear definition that can be operationalized has not been proposed, METHODS: Adult asthma (ICD-9: 493.XX) patients, with at least 9 months of continuous enrolment in the Fallon Community Health Plan were included in the retrospective cohort study. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) or other lower respiratory tract conditions were excluded. The first reported asthma-related event following a 2-week symptom-free period was designated as the index event. Asthma-related events were categorized as (1) moderate exacerbations (symptom-based) or (2) severe exacerbations (claims-based). Timing between and temporal sequence of asthma-related events along with average costs were calculated, RESULTS: Of 3126 eligible patients, 55% reported an asthma-related event followed by a recurrent event(s). Moderate exacerbations followed by recurrent moderate exacerbations were most frequent (20%) with the shortest interval between exacerbations (mean: 83 days [SD 87]). Moderate exacerbations followed by severe exacerbations occurred in 16% of patients with an average of 176.74 (SD 176.94) days between events, CONCLUSIONS: Patient report of asthma bothersome enough to initiate contact with a clinician, but not requiring oral corticosteroid (OCS), is a definition for a moderate exacerbation that can be operationalized for research purposes. Further work is needed to demonstrate whether identification of moderate exacerbations will allow interventions that impact the frequency and timing of future exacerbations.

The Relative Value of Anti-Obesity Medications Compared to Similar Therapies.

Purpose: To demonstrate a need for improved health insurance coverage for anti-obesity medications (AOMs) by comparing clinical and economic benefits of obesity treatments to covered medications for selected therapeutic areas. Methods: Using a grey literature search, we identified and prioritized therapeutic areas and treatment analogues for comparison to obesity. A targeted literature review identified clinical and economic outcomes research across the therapeutic area analogues. Associated comorbidities, clinical evidence, indirect costs (ie, absenteeism and productivity loss), and direct medical costs were evaluated to determine the relative value of treating obesity. Results: Four therapeutic areas/treatment analogues were selected for comparison to obesity: smoking cessation (varenicline), daytime sleepiness (modafinil), migraines (erenumab), and fibromyalgia (pregabalin). Obesity was associated with 17 comorbidities, more than migraine (9), smoking (8), daytime sleepiness (5), and fibromyalgia (2). Economic burden was greatest for obesity, followed by smoking, with yearly indirect and direct medical costs totaling $676 and $345 billion, respectively. AOMs resulted in cost savings of $2586 in direct medical costs per patient per year (PPPY), greater than that for varenicline at $930 PPPY, modafinil at $1045 PPPY, and erenumab at $468 PPPY; pregabalin utilization increased costs by $924 PPPY. AOMs were covered by 10-16% of United States health insurance plans, compared to 45-59% for the four comparators. Conclusion: Compared to four therapeutic analogues, obesity represented the highest economic burden and was associated with more comorbidities. AOMs provide greater cost savings compared to selected analogues. However, AOMs have limited formulary coverage. Improved coverage of AOMs may increase access to these treatments and may help address the clinical and economic burden associated with obesity and its comorbidities.

Advances in chronic obstructive pulmonary disease among older adults.

PURPOSE OF REVIEW: This review summarizes recent research on chronic obstructive pulmonary disease (COPD) among older adults. RECENT FINDINGS: Recent research on COPD and older adults addresses four key areas: diagnosis and screening, comorbidities, end-of-life care, and management. These key findings include the Rotterdam study's identification of the incidence rate of COPD in older adults being 9.2 per 1000 person-years; a new assessment of FEV1 cut-points associated with increased prevalence of respiratory symptoms and risk of death; development and validation of new mortality scales, the ADO (age, dyspnea, and airflow obstruction) index and the PILE score; older adults with COPD average 9 comorbidities, of which depression, cardiovascular diseases such as hypertension, and chronic renal failure are highly prevalent; nonrespiratory treatments such as proton pump inhibitors, angiotensin-converting enzyme inhibitors, and statins show promise in the management of COPD; and strength may be a protective factor for older adults with COPD. SUMMARY: Findings suggest that more research on older adults and COPD suggest that aging is a determinant of the progression of disease and that management of this population requires different metrics and strategies.

Wood smoke exposure and gene promoter methylation are associated with increased risk for COPD in smokers.

RATIONALE: Wood smoke-associated chronic obstructive pulmonary disease (COPD) is common in women in developing countries but has not been adequately described in developed countries. OBJECTIVES: Our objective was to determine whether wood smoke exposure was a risk factor for COPD in a population of smokers in the United States and whether aberrant gene promoter methylation in sputum may modify this association. METHODS: For this cross-sectional study, 1,827 subjects were drawn from the Lovelace Smokers' Cohort, a predominantly female cohort of smokers. Wood smoke exposure was self-reported. Postbronchodilator spirometry was obtained, and COPD outcomes studied included percent predicted FEV1, airflow obstruction, and chronic bronchitis. Effect modification of wood smoke exposure with current cigarette smoke, ethnicity, sex, and promoter methylation of lung cancer-related genes in sputum on COPD outcomes were separately explored. Multivariable logistic and poisson regression models were used for binary and rate-based outcomes, respectively. MEASUREMENTS AND MAIN RESULTS: Self-reported wood smoke exposure was independently associated with a lower percent predicted FEV1 (point estimate [± SE] -0.03 ± 0.01) and a higher prevalence of airflow obstruction and chronic bronchitis (odds ratio, 1.96; 95% confidence interval, 1.52-2.52 and 1.64 (95% confidence interval, 1.31-2.06, respectively). These associations were stronger among current cigarette smokers, non-Hispanic whites, and men. Wood smoke exposure interacted in a multiplicative manner with aberrant promoter methylation of the p16 or GATA4 genes on lower percent predicted FEV1. CONCLUSIONS: These studies identify a novel link between wood smoke exposure and gene promoter methylation that synergistically increases the risk for reduced lung function in cigarette smokers.

Economic value of nonsurgical weight loss in adults with obesity.

BACKGROUND: Obesity imposes a substantial economic burden on the United States. The short-term value of nonsurgical weight loss (WL) and nonsurgical sustained WL (i.e., WL not resulting from bariatric surgery) is poorly understood. OBJECTIVES: To assess short-term (1 year) effect of nonsurgical WL and sustained nonsurgical WL (i.e., approximately 2 years) on per-patient-per-month (PPPM) total all-cause health care costs among adults with obesity in the United States. METHODS: In this retrospective cohort study, we analyzed data from the IBM MarketScan Explorys Claims-EMR Data Set from January 1, 2012, through June 30, 2018. Adults aged 18-64 years with a body mass index (BMI) measurement ≥ 30 kg/m2 on the index date and BMI measurements at 12, 24, and 36 months were classified into weight-gain (≥ 3%), no-weight-change (within ± 3%), and WL (≥ 3%-≤ 5%, > 5%-≤ 10%, and > 10%-≤ 20%) cohorts based on the change from first to second BMI measurements (baseline), and sustained nonsurgical WL based on WL during baseline and < 3% weight gain from second to third BMI measurement. PPPM all-cause health care costs were calculated for baseline, first year, and second year of follow-up. Generalized linear models were used to examine if PPPM all-cause health care cost change (ΔPPPM) from baseline to follow-up differed significantly between nonsurgical WL/sustained WL and no-weight-change cohorts. Analyses were stratified by index obesity class (class 1: BMI 30- < 34.9 kg/m2, class 2: BMI 35- < 39.9 kg/m2, class 3: BMI ≥ 40 kg/m2). Specific nonsurgical WL treatments used by individuals in the study were not studied. RESULTS: The sample included 20,488 adults who were grouped as follows: weight-gain cohort (24.8%), no-weight-change cohort (56.6%), ≥ 3%- ≤ 5% WL cohort (8.2%), > 5%- ≤ 10% WL cohort (7.7%), and > 10%- ≤ 20% WL cohort (2.8%). Compared with the no-weight-change cohort, adjusted mean ΔPPPM all-cause health care cost from baseline to first year of follow-up was lower in all WL cohorts (≥ 3%- ≤ 5% WL: -$57.36, > 5%- ≤ 10% WL: -$135.35 [P < 0.05], > 10%- ≤ 20% WL: -$193.54 [P < 0.05]). In the second year of follow-up (n = 15,307), the cohorts were weight-gain (43.4%), no-weight-change (59.4%), ≥ 3%- ≤ 5% sustained WL (7.3%), ≥ 5%- ≤ 10% sustained WL (6.3%), and > 10%- ≤ 20% sustained WL (1.8%). Adjusted mean ΔPPPM all-cause health care cost was lower in all sustained WL groups (-$26.38, -$157.41 [P < 0.05], and -$185.41 for ≥ 3%- ≤ 5%, ≥ 5%- ≤ 10%, and > 10%- ≤ 20% WL, respectively). Greater nonsurgical WL and sustained nonsurgical WL were generally associated with larger reduction in short-term all-cause health care costs. Results stratified by index obesity class were mixed, due to small samples. CONCLUSIONS: Substantial all-cause health care cost savings were observed 1 year after nonsurgical WL and after sustained (on average for 2 years) nonsurgical WL in adults with obesity, with greater nonsurgical WL and sustained nonsurgical WL associated with greater cost savings. Comprehensive solutions to chronic weight management, including improved access to antiobesity medications in combination with lifestyle interventions, could be valuable to patients, employers, and payers. DISCLOSURES: This study was sponsored by Novo Nordisk, which also purchased the data. Blanchette is an employee of Novo Nordisk. Smolarz and Ramasamy are employees of Novo Nordisk and hold equity in Novo Nordisk. Ding, Fan, and Weng were employees of Novo Nordisk at the time this study was conducted. The findings from this study were previously presented at Obesity Week 2019; November 3-7, 2019; Las Vegas, NV.

Diabetes and drug-associated hyperkalemia: effect of potassium monitoring.

BACKGROUND: Renin-angiotensin-aldosterone system (RAAS) inhibitors are associated with hyperkalemia, but there is little evidence demonstrating patients who receive potassium monitoring have a lower rate of hyperkalemia. OBJECTIVE: To evaluate the association between potassium monitoring and serious hyperkalemia-associated adverse outcomes among patients with diabetes newly initiating RAAS inhibitor therapy. DESIGN: Retrospective observational study. PARTICIPANTS: Patients with diabetes without end-stage renal disease initiating RAAS inhibitor therapy between 2001 and 2006 at three integrated health care systems. MEASUREMENTS: Potassium monitoring and first hyperkalemia-associated adverse event during the initial year of therapy. Hyperkalemia-associated adverse events included hospitalizations, emergency department visits or deaths within 24 h of hyperkalemia diagnosis and/or diagnostic potassium >or=6 mmol/l. Incidence rates were calculated in person-years (p-y). We used inverse probability propensity score weighting to adjust for differences between patients with and without monitoring; Poisson regression was used to obtain adjusted relative risks. RESULTS: A total of 19,391 of 27,355 patients (71%) received potassium monitoring. Serious hyperkalemia-associated events occurred at an incidence rate of 10.2 per 1,000 p-y. Compared to patients without monitoring, adjusted relative risk of hyperkalemia-associated adverse events among all patients with monitoring was 0.50 (0.37, 0.66); in the subset of patients who also had chronic kidney disease (n = 2,176), adjusted relative risk was 0.29 (0.18, 0.46). CONCLUSIONS: Patients prescribed RAAS inhibitors who have both diabetes and chronic kidney disease and receive potassium monitoring are less likely to experience a serious hyperkalemia-associated adverse event compared to similar patients who did not receive potassium monitoring. This evidence supports existing consensus-based guidelines.

Quarterly assessment of short-acting beta(2)-adrenergic agonist use as a predictor of subsequent health care use for asthmatic patients in the United States.

PURPOSE: An annual time frame for risk assessment may not account for the variable course of asthma. The purpose of this study was to determine whether excessive short-acting beta(2)-adrenergic agonist (SABA) dispensed quarterly was associated with asthma exacerbations in the subsequent quarter. PATIENTS AND METHODS: This retrospective cohort analysis included 93,604 health plan members aged 6-56 years with >or=2 years of continuous enrollment (2003-2007), an asthma diagnosis, and asthma prescription claims. The amount of SABA dispensed in claims (metered-dose inhaler and nebulized) was converted to canister equivalents (CEs) in the first observation quarter and categorized as 0, 0.5-3, and >or=3 (excessive SABA use). Asthma exacerbation risk (hospitalization, emergency department [ED] visit, or oral corticosteroid [OCS] claim in the subsequent quarter) was assessed using logistic regression. Covariates used in the regression models were age, sex, geographic region, comorbidities, specialist consultation, asthma controller medication use, and asthma severity. RESULTS: The cohort included 33,951 patients aged 6-17 years (36%) and 59,653 aged 18-56 years (64%); 64% had 0 SABA CE, and 5% had >3 SABA CEs. Compared with 0 CE, excessive SABA use (>3 CEs) was associated with an increased likelihood of hospitalization (adjusted odds ratio [OR]: 3.15, 95% confidence interval [CI]: 1.89-5.27) and an ED/urgent care (UC) visit (adjusted OR: 3.14, 95% CI: 2.32-4.28). CONCLUSION: The risk of an asthma exacerbation was associated with excessive SABA use in the previous quarter. Assessment of excessive SABA dispensed during a calendar quarter can be used to identify patients at increased exacerbation risk in the subsequent quarter.

The positive predictive value of a hyperkalemia diagnosis in automated health care data.

PURPOSE: Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS: This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or spironolactone. The primary outcome was first hyperkalemia-associated event (hospitalization, emergency department visit or death within 24 hours of coded diagnosis and/or potassium≥6 mmol/L) during the first year of therapy. Medical records were reviewed. RESULTS: Among a random sample of 99 patients not coded as having hyperkalemia, none had hyperkalemia upon record review. Among all 64 patients identified as having hyperkalemia, all had hospitalization or emergency department visit associated with coded diagnosis or elevated potassium. Of 55 with coded diagnosis, 42 (PPV 76%) had clinically evident hyperkalemia; 32 (PPV 58%) had potassium≥6. Of 9 identified using only potassium≥6, 7 (PPV 78%) had clinically evident hyperkalemia. CONCLUSIONS: Nearly one-fourth of patients with coded diagnosis do not have clinically evident hyperkalemia and nearly one-half do not have potassium≥6. Because both false positives and negatives occur with coded diagnoses, medical record validation of hyperkalemia-associated outcomes is necessary.

The role of combination inhaled corticosteroid/long-acting beta-agonist therapy in COPD management.

Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death, affects an estimated 24 million Americans, and accounts for over ten million physician and emergency department (ED) visits and hospitalisations each year. The diagnosis and management of COPD falls largely to primary care practitioners. Previously, COPD management options were limited, but newer treatments have been shown to slow lung deterioration, reduce symptoms and preserve quality of life. Combination therapy with an inhaled corticosteroid and a long-acting beta2-agonist (ICS/LABA) is an effective therapy for COPD that, compared to other therapies, has been shown to reduce exacerbations, hospitalisations, ED visits and health care costs. This review focuses on the role of combination ICS/LABA therapy in managing COPD, including indications, potential benefits and considerations that affect therapy decisions.

Comorbidity Associations with AATD Among Commercially Insured and Medicare Beneficiaries with COPD in the US.

Introduction: Alpha-1 antitrypsin deficiency (AATD) is often not identified in patients with chronic obstructive pulmonary disease (COPD) until advanced stages of disease, despite the availability of genetic testing. While clinical practice guidelines provide recommendations on patients who should be tested, more refined algorithms are needed to identify COPD patients who are likely candidates for AATD testing and to prevent delays in diagnosis and treatment. The objective of this study was to identify comorbid associations with AATD among patients diagnosed with COPD in the United States. Methods: Using data from the 2012-2017 PharMetrics Plus Administrative Claims Database and 2011-2014 Medicare Fee for Service 5% Sample, patients with COPD (ICD-9-CM: 491.xx, 492.xx, or 496, ICD-10-CM J41, J42, J43, J44) and AATD (ICD-9-CM: 273.4, ICD-10-CM: E88.01) were identified. Patient demographic and diagnostic characteristics were assessed. Logistic regression models were developed to identify significant predictors of AATD. Results: A cohort of 344,528 Medicare beneficiaries with COPD (of which 302 (0.09%) also had two diagnoses of AATD) and a cohort of 340,259 commercially insured patients with COPD (of which 1076 (0.3%) also had a diagnosis of AATD) were constructed. Associations with AATD identified in both models included ICD-9-CM and ICD-10-CM codes for chronic pulmonary heart disease, chronic liver disease and cirrhosis, and liver transplant. Discussion: Significant associations with a diagnosis of AATD among patients with COPD were consistently represented in each of the datasets evaluated, which suggests meaningful comorbidity implications in AATD patients. These findings reinforce the need to test individuals with COPD for AATD as early as possible to help reduce the development of associated comorbid conditions.

Burden of blood transfusion in knee and hip surgery in the US and Belgium.

OBJECTIVE: Transfusion services in orthopaedic surgery can lead to unnecessary complications and increased healthcare costs. The objective of this study was to assess treatments and costs associated with blood and blood product transfusions in a historical cohort of 189,457 inpatients in the US and 34,987 inpatients in Belgium undergoing knee or hip surgery. METHODS: Descriptive analysis, logistic regression and ordinary least squares regression were used to describe the factors associated with the use and cost of allogeneic blood transfusion. RESULTS: Hospitalisation costs for joint replacement surgery totalled $12,718 (SD=6,356) and averaged 4.33 days in the US, while costs in Belgium were $6,526 (SD=3,192) and averaged 17.1 days. The use of low molecular weight heparin and tranexamic acid was much higher in Belgium than the US (36% and 99% compared to 0% and 40%, respectively). Patients in the US spent 12.7 (p<0.0001) fewer days in the hospital, 0.3 (p<0.0001) fewer days in the intensive care unit and were 88% less likely to have allogeneic blood transfusions (OR=0.22, 95% CI 0.22-0.23), but incurred $6,483 (p<0.0001) more costs per hospitalisation than patients in Belgium. CONCLUSIONS: While hospital costs for patients were greater in the US, length of stay was shorter and patients were less likely to have transfusion services than those patients in Belgium. While this study is limited by factors inherent to observational studies, such as omitted variable bias, misclassification, and disease comorbidity, there are substantial differences in the use of blood products between Belgium and the US.

Differences in Patient Demographics and Healthcare Costs of Patients with PIDD Receiving Intravenous or Subcutaneous Immunoglobulin Therapies in the United States.

BACKGROUND: Primary immune-deficiency disease (PIDD) is a rare, debilitating disease of the immune system that predisposes the affected individual to infection, autoimmune conditions, and neoplasm. A major component of the cost of treating PIDD is the high price of immunoglobulin drugs, which can be administered via an intravenous (IV) or subcutaneous (SC) route. OBJECTIVE: To compare real-world costs for patients with PIDD who are receiving IV immunoglobulin (IVIG) or SC immunoglobulin (SCIG) treatment, from a US payer perspective, using a large claims database. METHODS: Based on 2011 to 2013 data from the PharMetrics Plus database, a large national healthcare claims database, patients who were newly diagnosed with PIDD were included in the study if they had ≥2 claims for PIDD that were ≥90 days apart, and if they were treatment-naïve for a minimum of 1 year before the study period. Patients who switched the route of immunoglobulin administration were excluded, with the exception of patients who received SCIG who could initially receive ≤2 IV-loading infusions, as directed by treatment guidelines. We used propensity score analysis to match the patients in the SCIG cohort to patients in the IVIG cohort based on age, sex, and all Elixhauser comorbidities. We compared the patient characteristics and direct medical costs (all-cause, PIDD-related, and pharmacy-related) before and after matching, using t-tests for continuous variables, chi-square test for categorical variables, and Wilcoxon rank-sum test for differences in medians. RESULTS: A total of 1639 patients with PIDD (986 who received IVIG and 653 who received SCIG) met all the study inclusion criteria. Compared with the patients who received IVIG, the patients who received SCIG were predominantly female (58% vs 63%, respectively) and significantly younger (mean age, 49.1 vs 40.3 years, respectively). Significantly fewer patients who received SCIG than those receiving IVIG had claims with International Classification of Diseases, Ninth Revision codes for Elixhauser comorbidities, including cardiovascular and pulmonary conditions, diabetes, renal failure, liver disease, cancers, weight loss, fluid and electrolyte disorders, and psychoses (P <.05 for all), and their Charlson Comorbidity Index scores were lower than those receiving IVIG (1.74 vs 3.01, respectively; P ≤.05 for all). After matching the 2 cohorts (N = 553 in each), the 1-year postindex median total PIDD-related costs were significantly lower in the IVIG group than in the SCIG group ($38,064 vs $43,266, respectively; P = .002). CONCLUSIONS: In matched analyses, PIDD-related treatment costs were higher for patients who received SCIG than for those who received IVIG. Furthermore, patients who received SCIG were significantly younger and had significantly less comorbidities than their counterparts who received IVIG, suggesting that patient characteristics that reflect a desire and greater capacity for autonomy may affect physicians' choice of the route of administration for immunoglobulin.

Survival associated with chronic obstructive pulmonary disease among SEER-Medicare beneficiaries with non-small-cell lung cancer.

Objective: We investigated the impact of preexisting COPD and its subtypes, chronic bronchitis and emphysema, on overall survival among Medicare enrollees diagnosed with non-small-cell lung cancer (NSCLC). Methods: Using SEER-Medicare data, we included patients ≥66 years of age diagnosed with NSCLC at any disease stage between 2006 and 2010 and continuously enrolled in Medicare Parts A and B in the 12 months prior to diagnosis. Preexisting COPD in patients with NSCLC were identified using ICD-9 codes. Kaplan-Meier method and log-rank tests were used to examine overall survival by COPD status and COPD subtype. Multivariable Cox proportional hazards models were fit to assess the risk of death after cancer diagnosis. Results: We identified 66,963 lung cancer patients. Of these, 22,497 (33.60%) had documented COPD before NSCLC diagnosis. For each stage of NSCLC, median survival was shorter in the COPD compared to the non-COPD group (Stage I: 692 days vs 1,130 days, P<0.0001; Stage II: 473 days vs 627 days, P<0.0001; Stage III: 224 days vs 229 days; P<0.0001; Stage IV: 106 days vs 112 days, P<0.0001). For COPD subtype, median survival for patients with preexisting chronic bronchitis was shorter compared to emphysema across all stages of NSCLC (Stage I: 672 days vs 811 days, P<0.0001; Stage II 582 days vs 445 days, P<0.0001; Stage III: 255 days vs 229 days, P<0.0001; Stage IV: 105 days vs 112 days, P<0.0001). In Cox proportional hazard model, COPD patients exhibited 11% increase in risk of death than non-COPD patients (HR: 1.11, 95%CI: 1.09-1.13). Conclusion: NSCLC patients with preexisting COPD had shorter survival with marked differences in early stages of lung cancer. Chronic bronchitis demonstrated a greater association with time to death than emphysema.

Two comparative assessments of intravenous immunoglobulin therapy switching patterns in the treatment of chronic inflammatory demyelinating polyneuropathy in the US.

Purpose: For chronic inflammatory demyelinating polyneuropathy (CIDP) patients, each branded intravenous immunoglobulin (IVIG) treatment differs in production processes, virus elimination, formulation, and composition. Given the limited availability of real-world data comparing IVIGs for CIDP, this study evaluated switching patterns between IVIG products in 2 separate retrospective databases. Patients and methods: Two independent analytic teams retrospectively evaluated IVIG treatment-naïve patients with an ICD diagnosis code for CIDP. Study 1 used integrated healthcare claims from IMS LifeLink PharMetrics Plus™ and Study 2 used the Truven MarketScan® Database. All analyses were descriptive, with outcomes assessed during the 2-year post-index period. Results: One-quarter of IVIG patients switched therapies within the 2-year study period. In both studies, switching rates were lowest for IVIG-G (Gamunex®-C) (Study 1: 9.8%, Study 2: 8.9%), followed by IVIG-F (Flebogamma®) (Study 1: 25.0%, Study 2: 18.2%), and highest for IVIG-other (Octagam®/Gammaplex®) (Study 1: 50.0%, Study 2: 33.3%). When patients were switched, most switched to IVIG-G (Study 1: 51.6%, Study 2: 54.3%). Conclusion: The small proportion of CIDP switchers in 2 independent studies suggests that IVIG therapy is generally well tolerated. However, differences existed in switch rates for different IVIG products. The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability.

A secondary analysis of a duration response association between selective serotonin reuptake inhibitor use and the risk of acute myocardial infarction in the aging population.

PURPOSE: We assessed the risk of selective serotonin reuptake inhibitor (SSRI) use on the occurrence of acute myocardial infarction (AMI) based on duration of exposure. METHODS: A historical pooled cohort of all elderly, community-dwelling Medicare beneficiaries not enrolled in health maintenance organizations from the 1997 to 2001 Medicare Current Beneficiary Survey was constructed. SSRI users were compared with non-antidepressant users as well as other non-SSRI antidepressant users on their risk of AMI (ICD-9: 410 or 411). Descriptive statistics and binary logistic regression models were used to assess differences between groups. RESULTS: There were 1,052 SSRI users compared with 762 other antidepressant users and 10,856 nonantidepressant users. Logistic regression models revealed that SSRI users were found to have significantly greater odds of AMI compared with nonantidepressant users when controlling for age, gender, race, smoking history and current status, body mass index, depression, anxiety and diabetes (odds ratio 1.85; 95% confidence intervals 1.13-3.04). Stratification by prescription counts revealed those with more than three prescriptions had greater odds of AMI compared with nonusers (odds ratio 2.02, 95% confidence intervals 1.11-3.66). CONCLUSIONS: SSRI use leads to an increased risk of AMI in comparison with nonantidepressant use in an elderly population. The odds of AMI increased in those with more than three prescriptions in the preceding year, indicating a possible duration response relationship.