Overall survival associated with CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer in the United States: A SEER-Medicare population-based study.

BACKGROUND: Evidence on overall survival (OS) with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors is generally limited to data from clinical trials or a few observational studies with limited generalizability to Medicare population. The aim of this study was to determine OS benefits associated with CDK4/6 inhibitors in older Medicare patients with hormone receptor (HR)-positive and human epidermal growth factor receptor-2 overexpressing (HER2-) metastatic breast cancer (MBC). METHODS: In a retrospective cohort design, female patients aged ≥65 years with diagnosis of HR+/HER2- MBC from 2015 to 2017 who initiated first-line systemic therapy within 12 months of MBC diagnosis were selected from the Survey Epidemiology and End Results-Medicare database. The effect of treatment type (endocrine therapy [ET]+CDK4/6 inhibitor vs. ET alone) on OS was analyzed using Kaplan-Meier methods and multivariable Cox regression models. Adjusted hazard ratio (aHR) and 95% CIs were estimated. RESULTS: A total of 630 eligible patients were identified (169 patients treated with ET+CDK4/6 inhibitor and 461 patients treated with ET alone). In the Kaplan-Meier analysis, OS rate at 3 years after first-line treatment initiation was 73.0% for ET+CDK4/6 inhibitor versus 49.1% for ET alone (log-rank p < .0001). In Cox regression analysis, first-line ET+CDK4/6 inhibitor therapy was associated with 41% lower rate of mortality versus ET alone (aHR, 0.590; 95% CI, 0.423-0.823). CONCLUSIONS: The findings of this real-world study demonstrate significant OS benefit associated with ET+CDK4/6 inhibitor therapy over ET alone in an older Medicare population of patients with HR+/HER2- MBC, largely consistent with the evidence from clinical trials.

Impact of CDK4/6 inhibitors on chemotherapy utilization in earlier therapy lines for HR+/HER2- metastatic breast cancer in the United States.

PURPOSE: Delaying chemotherapy remains a vital goal in therapeutic management of HR+/HER2- metastatic breast cancer (MBC). However, recent reports continue to highlight substantially high chemotherapy utilization in earlier therapy lines. In this study, we explored the impact of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy class, introduced in 2015, on early chemotherapy utilization in an older population of patients with HR+/HER2- MBC in the United States (US). METHODS: Using an interrupted time series design, patients with a confirmed diagnosis of MBC aged ≥ 65 years initiating systemic therapy during 2010-2019 were selected from the SEER-Medicare database. The proportion of chemotherapy use was summarized quarterly based on the date of treatment initiation separately in the first, second, and third lines. Segmented regression models adjusted for autocorrelation over time were fitted to estimate trends before and after the availability of CDK4/6 inhibitors in the first quarter of 2015. RESULTS: Of the 3244 eligible women (median age at diagnosis: 74 years), all initiated first-line therapy; 47.9% (n = 1581) initiated second-line therapy, and 50.1% (n = 792) initiated third-line therapy. Overall utilization of chemotherapy (alone or in combination) during the study period was 15.7% for the first line, 19.6% for the second line, and 24.8% for the third line. Chemotherapy utilization in the period immediately after introduction of CDK4/6 inhibitor therapy decline by estimated 2.5% in the first line (P = 0.408), 15.5% in the second line (P = 0.005), and 16.3% in the third line (P = 0.003). CONCLUSIONS: This population-based study illustrates that chemotherapy utilization in earlier therapy lines for HR+/HER2- MBC declined steadily between 2010 and 2019. These declines were significantly accelerated by the introduction of CDK4/6 therapy class in 2015, notably in the second- and third-line settings.

Clinical management patterns of advanced and metastatic gastro-oesophageal carcinoma after fluoropyrimidine/platinum treatment in France, Germany, Spain and the United Kingdom.

OBJECTIVE: To describe treatment patterns and resource utilisation in France, Germany, Spain and the United Kingdom (UK) in patients with unresectable locally advanced and/or metastatic gastro-oesophageal adenocarcinoma (GEA), who failed first-line fluoropyrimidine/platinum treatment. METHODS: Treating physicians completed a web-based chart review (2013-2015). Eligible patients were ≥ 18 years old; had unresectable locally advanced and/or metastatic gastric adenocarcinoma including the gastro-oesophageal junction; received first-line fluoropyrimidine/platinum-based therapy; and had ≥ 3 months of follow-up after first-line discontinuation. Data were summarised descriptively for each country. RESULTS: There were n = 201 patients in France, n = 202 in Germany, n = 208 in Spain and n = 200 in the UK whose charts were reviewed. Percentages of patients receiving second-line therapy were 55% (France), 48% (Germany), 54% (Spain) and 29% (UK). At the start of second-line therapy, most patients had an ECOG performance status of 1 (range 0-3). Second-line therapy was primarily monotherapy, but agents used varied within and across countries. Supportive care use and resource utilisation were frequent whether receiving additional therapy or not; >60% patients had clinic visits unrelated to chemotherapy administration, and > 30% has ≥ 1 hospital admission. CONCLUSIONS: For the time of study, established GEA treatment guidelines were generally followed. However, therapies varied widely in the second-line setting.

Time trends in utilization of G-CSF prophylaxis and risk of febrile neutropenia in a Medicare population receiving adjuvant chemotherapy for early-stage breast cancer.

PURPOSE: The purpose of this study is to assess temporal trends in the use of granulocyte colony-stimulating factor (G-CSF) prophylaxis and risk of febrile neutropenia (FN) among older women receiving adjuvant chemotherapy for early-stage breast cancer. METHODS: Women aged ≥ 66 years with diagnosis of early-stage breast cancer who initiated selected adjuvant chemotherapy regimens were identified using the SEER-Medicare data from 2002 to 2012. Adjusted, calendar-year-specific proportions were estimated for use of G-CSF primary prophylaxis (PP) and secondary prophylaxis and FN risk in the first and the second/subsequent cycles during the first course of chemotherapy, using logistic regression models. calendar-year-specific mean probabilities were estimated with covariates set to modal values. RESULTS: Among 11,107 eligible patients (mean age 71.7 years), 74% received G-CSF in the first course of chemotherapy. Of all patients, 5819 (52%) received G-CSF PP, and among those not receiving G-CSF PP, only 5% received G-CSF secondary prophylaxis. The adjusted proportion using G-CSF PP increased from 6% in 2002 to 71% in 2012. During the same period, the adjusted risk of FN in the first cycle increased from 2% to 3%; the adjusted risk increased from 1.5% to 2.9% among those receiving G-CSF PP and from 2.3% to 3.5% among those not receiving G-CSF PP. CONCLUSION: The use of G-CSF PP increased substantially during the study period. Although channeling of higher-risk patients to treatment with G-CSF PP is expected, the adjusted risk of FN among patients treated with G-CSF PP tended to be lower than among those not receiving G-CSF PP.

Antiretroviral Treatment Switching and Its Association With Economic Outcomes and Adverse Treatment Effects Among Commercially Insured and Medicaid-Enrolled Patients With HIV in the United States.

BACKGROUND: Antiretroviral therapy (ART) of HIV typically involves the use of 2 nucleoside reverse transcriptase inhibitors plus a third agent (eg, protease inhibitor). It has been shown that over the course of treatment, a proportion of patients switch their ART for various reasons (eg, tolerability, long-term toxicities). We hypothesize that there is a relationship between ART treatment switching and economic and clinical outcomes among HIV patients. OBJECTIVE: To determine whether switching ART regimens is associated with greater health care costs, resource use, and adverse treatment effects. METHODS: Administrative health care claims were used to identify commercially insured and Medicaid-enrolled patients in the United States who had ≥2 claims containing an HIV/AIDS diagnosis from 2006 to 2011 and received an ART prescription from 2007 to 2010. The final population included patients who were ≥18 years old on their index date (ie, date of first ART prescription) and had continuous health plan enrollment for ≥12 months before and after their index date. Treatment characteristics (eg, switching), adverse treatment effects, and health care resource utilization and costs, were evaluated during a 12-month follow-up period. Multivariable models assessed the relationship between ART switching and economic outcomes (ie, costs, number of health care encounters) and adverse treatment effects. RESULTS: A total of 14 590 commercially insured patients met all inclusion criteria and 12% had an ART switch; further, 5744 Medicaid-enrolled patients met all inclusion criteria, and 14% switched treatment. After adjusting for confounders, ART switching was associated with 64% and 36% (P < 0.0001) increases in hospitalizations, 36% and 25% (P < 0.0001) increases in nonpharmacy costs, and 15% and 18% (P < 0.0001) increases in pharmacy costs, among commercially insured and Medicaid-enrolled patients, respectively. ART switching increased the risk of adverse treatment effects, overall and for specific conditions of interest (eg, gastrointestinal intolerance). CONCLUSIONS: This study suggests that ART switching is associated with economic outcomes and certain adverse treatment effects. Efforts to put patients on an optimal ART regimen initially, therefore reducing the need for subsequent switching, may have a positive effect on patients specifically and the health care system in general.

Social Determinants of Health and Other Predictors in Initiation of Treatment with CDK4/6 Inhibitors for HR+/HER2- Metastatic Breast Cancer.

In hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC), cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) have replaced endocrine therapy alone as the standard of care; however, several barriers to treatment initiation still exist. We assessed social determinants of health (SDOH) and other factors associated with the initiation of CDK4/6i for HR+/HER2- MBC in the Medicare population. Using a retrospective cohort design, patients aged ≥65 years and diagnosed during 2015-2017 were selected from the SEER-Medicare database. Time from MBC diagnosis to first CDK4/6i initiation was the study outcome. The effect of SDOH measures and other predictors on the outcome was assessed using the multivariable Fine and Gray hazard modeling. Of 752 eligible women, 352 (46.8%) initiated CDK4/6i after MBC diagnosis (median time to initiation: 27.9 months). In adjusted analysis, SDOH factors significantly associated with CDK4/6i initiation included high versus low median household income (HHI) (hazard ratio [HR] = 1.70; 95% CI = 1.03-2.81) and the percentage of population with high versus low Medicare-only coverage (HR = 1.54; 95% CI = 1.04-2.27). In summary, older Medicare patients with HR+/HER2- MBC residing in areas with high median HHI and a high proportion of Medicare-only coverage had higher rates of initiating CDK4/6i, suggesting inequitable access to these novel, effective treatments and a need for policy intervention.

Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalization.

BACKGROUND: This study aimed to assess antipsychotic adherence patterns and all-cause and schizophrenia-related health care utilization and costs sequentially during critical clinical periods (i.e., before and after schizophrenia-related hospitalization) among Medicaid-enrolled patients experiencing a schizophrenia-related hospitalization. METHODS: All patients aged ≥ 18 years with a schizophrenia-related inpatient admission were identified from the MarketScan Medicaid database (2004-2008). Adherence (proportion of days covered [PDC]) to antipsychotics and schizophrenia-related and all-cause health care utilization and costs were assessed during preadmission (182- to 121-day, 120- to 61-day, and 60- to 0-day periods; overall, 6 months) and postdischarge periods (0- to 60-day, 61- to 120-day, 121- to 180-day, 181- to 240-day, 241- to 300-day, and 301- to 365-day periods; overall, 12 months). Health care utilization and costs (2010 US dollars) were compared between each adjacent 60-day follow-up period after discharge using univariate and multivariable regression analyses. No adjustment was made for multiplicity. RESULTS: Of the 2,541 patients with schizophrenia (mean age: 41.2 years; 57% male; 59% black) who were identified, approximately 89% were "discharged to home self-care." Compared with the 60- to 0-day period before the index inpatient admission, greater mean adherence as measured by PDC was observed during the 0- to 60-day period immediately following discharge (0.46 vs. 0.78, respectively). The mean PDC during the overall 6-month preadmission period was lower than during the 6-month postdischarge period (0.53 vs. 0.69; P < 0.001). Compared with the 0- to 60-day postdischarge period, schizophrenia-related health care costs were significantly lower during the 61- to 120-day postdischarge period (mean: $2,708 vs. $2,102; P < 0.001); the primary cost drivers were rehospitalization (mean: $978 vs. $660; P < 0.001) and pharmacy (mean: $959 vs. $743; P < 0.001). Following the initial 60-day period, both all-cause and schizophrenia-related costs declined and remained stable for the remaining postdischarge periods (days 121-365). CONCLUSIONS: Although long-term (e.g., 365-day) adherence measures are important, estimating adherence over shorter intervals may clarify the course of vulnerability to risk and enable clinicians to better design adherence/risk-related interventions. The greatest risk of rehospitalization and thus greater resource utilization were observed during the initial 60-day postdischarge period. Physicians should consider tailoring management and treatment strategies to help mitigate the economic and humanistic burden for patients with schizophrenia during this period.

Recent Trends in Hypoparathyroidism-Related Inpatient and Emergency Department Admissions and Costs in the United States.

Hypoparathyroidism (HypoPT) is a rare disease associated with high morbidity. Its economic impact is not well understood. This retrospective, cross-sectional study used data from the United States-based National Inpatient Sample and the Nationwide Emergency Department Sample from 2010 to 2018 to quantify overall trends in number, cost, charges, and length of stay (LOS) for inpatient hospitalizations and number and charges for emergency department (ED) visits for HypoPT-related and for non-HypoPT-related causes. Additionally, the study estimated the marginal effect of HypoPT on total inpatient hospitalization costs and LOS as well as ED visit charges. Over the observed period, a mean of 56.8-66.6 HypoPT-related hospitalizations and 14.6-19.5 HypoPT-related ED visits were recorded per 100 000 visits per year. Over this period, the rate of HypoPT-related inpatient hospitalizations and ED visits increased by 13.5% and 33.6%, respectively. The mean LOS for HypoPT-related hospitalizations was consistently higher than for non-HypoPT-related causes. Total annual HypoPT-related inpatient hospitalization costs increased by 33.6%, and ED visit charges increased by 96.3%. During the same period, the annual costs for non-HypoPT-related hospitalizations and charges for ED visits increased by 5.2% and 80.3%, respectively. In all years, HypoPT-related hospital encounters resulted in higher charges and costs per individual visit than non-HypoPT-related encounters. The marginal effect of HypoPT on inpatient hospitalization costs and LOS, and on ED charges, increased over the period of observation. This study demonstrated that HypoPT was associated with substantial and increasing healthcare utilization in the United States between 2010 and 2018.

Evaluating Real-World Characteristics of Patients With Advanced Urothelial Carcinoma Eligible for Avelumab Maintenance Therapy: A Multicountry Retrospective Medical Chart Review.

INTRODUCTION: Urothelial carcinoma (UC) is a malignancy of the urothelium that encompasses the renal pelvis, bladder, and urethra. Current treatment guidelines for advanced (ie, locally advanced or metastatic) UC recommend using avelumab maintenance therapy in patients with nonprogressive disease following first-line platinum-based chemotherapy. This study aimed to assess the representativeness of the patient population in the JAVELIN Bladder 100 (JB-100) trial, which examined the efficacy and safety of avelumab first-line maintenance, vs. real-world patients with advanced UC that had not progressed with first-line platinum-based chemotherapy treated between 2015 and 2018 by reviewing demographic and clinical characteristics. PATIENTS AND METHODS: A medical chart review (MCR) study collected demographics and treatment characteristics for patients with advanced UC in the United States, the United Kingdom, and France. Data were analyzed descriptively for review with data collected from patients enrolled in JB-100. RESULTS: Clinical characteristics were consistent between JB-100 and the MCR. Most patients were male, received 4 to 6 cycles of platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients in the MCR had either stable disease or a response with platinum-based chemotherapy (∼75% achieved a complete or partial response). Fewer than half (42.5%) of all patients in the MCR received subsequent therapy. CONCLUSION: Patient demographics, clinical characteristics, and treatment patterns from a MCR of patients with advanced UC that had not progressed following first-line platinum-based chemotherapy appeared similar to data from patients enrolled in JB-100. Future studies should examine whether real-world outcomes are consistent with findings from JB-100. GOV IDENTIFIER: NCT02603432.

Characteristics, treatment patterns, health care resource utilization and costs in patients with bullous pemphigoid: A retrospective analysis of US health insurance claims data.

Background: Real-world data describing the impact of incident bullous pemphigoid (BP) on patients and health care resource utilization (HCRU) are limited. Objective: To examine characteristics, treatment patterns, HCRU, and costs for incident BP. Methods: Retrospective analysis of 2015 to 2019 US health insurance claims for patients ≥18 years with an incident BP diagnosis. Patients with BP were matched to those without on demographic and clinical characteristics. Statistics were descriptive. Results: The mean Charlson Comorbidity Index score was higher for patients with BP (n = 1108) than without (n = 4621) at baseline (mean [SD]: 3.3 [2.7] vs 2.8 [2.4]) and during follow-up (5.0 [4.9] vs 3.7 [3.0]). Hypertension, diabetes, skin ulcers, chronic pulmonary disease, dyslipidemia, sleep disorders, and congestive heart failure were higher with BP. Most patients with BP received antibiotics (>80%) and/or corticosteroids (>90%). Hospitalizations were more common (44.0% vs 17.1%) and monthly all-cause health care costs more than double ($3214 vs $1353) in patients with BP than without. Limitations: Diagnoses were based on billing codes. HCRU claims data may not reflect the true number of encounters. Conclusion: Incident BP is associated with considerable morbidity, HCRU, and costs. More effective, targeted treatments are needed to improve quality of life, while minimizing exposure to systemic corticosteroids.

Healthcare utilization and comorbidity burden among children and young adults in the United States with systemic lupus erythematosus or inflammatory bowel disease.

OBJECTIVE: We sought to assess the feasibility of using a health insurance claims database to estimate the prevalence and health care utilization and costs among children diagnosed with systemic lupus erythematosus (SLE) and inflammatory bowel disease (IBD). STUDY DESIGN: This was a retrospective analysis of the LifeLink insurance claims database for the years 2000-2006. Children (0-15 years) and young adults (16-25 years) with ≥ 2 diagnosis claims for SLE or IBD were selected as the 2 cohorts of interest. For each member of the SLE and IBD cohorts, 2 individuals were randomly selected for a matched comparison group. All the analyses were descriptive in nature, CI for differences between means and 2 proportions for measures including health care utilization, comorbidity burden were based on t tests and 2-group tests of proportions. RESULTS: We identified 278 patients with SLE (prevalence estimate: 7.9 per/100000 population) and 1174 patients with IBD (33.2 per/100000 population). The mean annual total medical costs was substantially higher for the SLE (difference: $22223; 95% CI: $14961-$29485) and IBD (difference: $16238; 95% CI: $14395-$18082) cohorts compared with those of the comparator cohort. We observed higher comorbidity burdens in the SLE and IBD cohorts than we saw in the comparator cohort. CONCLUSIONS: Administrative claims data can be a useful tool for assessing the comparative prevalence and associated resource utilization of rare conditions such as SLE and IBD.

Immunonutrition for patients undergoing elective surgery for gastrointestinal cancer: impact on hospital costs.

BACKGROUND: Oral or enteral dietary supplementation with arginine, omega 3 fatty acids and nucleotides (known as immunonutrition) significantly improve outcomes in patients undergoing elective surgery. The objective of the study was to determine the impact on hospital costs of immunonutrition formulas used in patients undergoing elective surgery for gastrointestinal cancer. METHODS: US hospital costs of stay with and without surgical infectious complications, and average cost per day in the hospital for patients undergoing elective surgery for gastrointestinal cancer were estimated using data from the Healthcare Cost and Utilization Project's 2008 Nationwide Inpatient Sample. These costs were then used to estimate the impact of perioperative immunonutrition on hospital costs using estimates of reduction in infectious complications or length of stay from a meta-analysis of clinical trials in patients undergoing elective surgery for gastrointestinal cancer. Sensitivity of the results to changes in baseline complication rates or length of stay was tested. RESULTS: From the meta-analysis estimates, use of immunonutrition resulted in savings per patient of $3,300 with costs based on reduction in infectious complication rates or $6,000 with costs based on length of hospital stay. Cost savings per patient were present for baseline complication rates above 3.5% or when baseline length of stay and infectious complication rates were reduced to reflect recent US data for those with upper and lower GI elective cancer surgery (range, $1,200 to $6,300). CONCLUSIONS: Use of immunonutrition for patients undergoing elective surgery for gastrointestinal cancer is an effective and cost-saving intervention.

Health care resource utilization and costs associated with restless legs syndrome among managed care enrollees treated with dopamine agonists.

PURPOSE: This study assessed the direct economic burden of restless legs syndrome (RLS) among patients treated with dopamine agonists (DAs) using a large United States managed care database. DESIGN: Retrospective database analysis. METHODOLOGY: Patients were required to have > or =1 prescriptions for a DA (i.e., pergolide, pramipexole, ropinirole) between 1/1/2005 and 12/31/2007 (date of first DA, or "index"); continuous enrollment for > or =6 months before and > or =12 months after index; > or =1 diagnosis of RLS, before and after index; and no diagnosis of Parkinson's disease. Study measures included annual all-cause and RLS-related costs by care setting (hospitalizations, emergency room, office, pharmacy, other, total) and treatment-pattern events (discontinuations, switches, adjunctive treatments, titrations). PRINCIPAL FINDINGS: A total of 7,796 patients met the inclusion criteria. About 70% of patients received ropinirole, and 30% received pramipexole at index. Approximately 91% had >1 RLS-related office visits, and patients filled an average of 6.5 RLS-related prescriptions (DAs, gabapentin, carbidopa/levodopa) during the 1-year follow-up period. Mean (SD) all-cause health care costs were $11,485 ($21,362) per patient, mostly due to multiple medical conditions occurring with RLS. RLS-related costs were 6.7% of total all-cause costs (mean [SD] $774 [$1,504]), consisting of office visits (16%), pharmacy (63%), and other costs (20%). Approximately 58% had a treatment-pattern event suggesting a dopamine-related side effect. Opioids were the most commonly used adjunctive therapy (13% of patients). CONCLUSION: We found relatively low costs associated with RLS treatment. These findings should encourage expanding the coverage of treatment to reduce the suffering and costs associated with RLS.

Potential reduction in neural tube defects associated with use of Metafolin-fortified oral contraceptives in the United States.

OBJECTIVE: The objective of the study was to estimate the potential reduction of neural tube defects (NTDs) through the use of Metafolin-fortified oral contraceptives (OCs) in the United States. STUDY DESIGN: A population-based decision analytic model was developed to estimate the benefits of increased red blood cell (RBC) folate levels through the use of Metafolin-fortified OCs on NTD risk during pregnancy. We modeled women who began the year taking Metafolin-fortified or traditional OCs. Folate levels were derived from the National Health and Nutrition Examination Survey and clinical trial data. NTD risk was estimated by applying a published risk equation to respective RBC folate levels. RESULTS: The number of predicted NTD cases declined by 23.7% to 31.4%, depending on median baseline folate levels in women taking a fortified OC compared with taking a traditional OC. CONCLUSION: Metafolin-fortified OCs have the potential to reduce the number of folate-dependent NTDs among current and recent OC users.

Hydroxyurea adherence and associated outcomes among Medicaid enrollees with sickle cell disease.

While laboratory and clinical benefits of hydroxyurea for patients with sickle cell disease (SCD) are well-established, few data describe the extent and implications of non-adherence. We sought to assess adherence to hydroxyurea among patients with SCD and investigate associations between adherence and clinical and economic outcomes. Insurance claims of North Carolina Medicaid enrollees (6/2000-8/2008) with SCD were analyzed. Inclusion criteria included age < 65 years, continuous Medicaid enrollment ≥ 12 months before and following hydroxyurea initiation, and ≥ 2 hydroxyurea prescriptions. Three hundred twelve patients, mean age 21 (± 12.2) years, met inclusion criteria and 35% were adherent, defined as a medication possession ration (MPR) ≥ 0.80; mean MPR was 0.60. In the 12 months following hydroxyurea initiation, adherence was associated with reduced risk of SCD-related hospitalization (hazard ratio [HR] = 0.65, p = .0351), all-cause and SCD-related emergency department visit (HR = 0.72, p = .0388; HR = 0.58, p =.0079, respectively), and vaso-occlusive event (HR = 0.66, p = .0130). Adherence was associated with reductions in health care costs such as all-cause and SCD-related inpatient (-$5,286, p < .0001; -$4,403, p < .0001, respectively), ancillary care (-$1,336, p < .0001; -$836, p < .0001, respectively), vaso-occlusive event-related (-$5,793, p < .0001), and total costs (-$6,529, p < .0001; -$5,329, p <.0001, respectively). Adherence to hydroxyurea among SCD patients appears suboptimal and better adherence is associated with improved clinical and economic outcomes.

In the absence of a central venous catheter, risk of venous thromboembolism is low in critically injured children, adolescents, and young adults: evidence from the National Trauma Data Bank.

OBJECTIVE: To describe the incidence and risk factors of venous thromboembolism in a large sample of critical care pediatric, adolescent, and young adult trauma patients. DATA SOURCE: The National Trauma Data Bank-the largest and most complete aggregation of trauma registry data in the United States. SETTING: Seven hundred eighty-four level I to level IV trauma centers. PATIENTS: Patients ≤ 21 yrs of age who spent at least 1 day in a critical care unit during a trauma admission between 2001 and 2005. MEASUREMENTS AND MAIN RESULTS: To characterize differences between patients with and without venous thromboembolism, we extracted variables regarding patient demographics, injury pattern and severity, procedures, total length of stay, and intensive care unit and ventilator days. Odds ratios for predictors of venous thromboembolism were estimated with a logistic regression model. Among the 135,032 critical care patients analyzed, venous thromboembolism was uncommon (6 per 1,000 discharges). Placement of a central venous catheter was a significant predictor of venous thromboembolism (odds ratio = 2.24; p < .0001) when populations were analyzed collectively. When we narrowed our focus to injuries associated with venous thromboembolism, such as lower-extremity fractures, the effects of central venous catheter were of even greater magnitude, particularly in adolescents and young adults. The risk of venous thromboembolism in critical care patients without a central venous catheter was <1% even in adolescents/young adults. CONCLUSIONS: Venous thromboembolism is rare in young critical care trauma patients, even older adolescents. The absence of published data on both the baseline risk of venous thromboembolism in pediatric critical care patients and the efficacy and safety of venous thromboembolism prophylaxis preclude the ability to make definitive recommendations for the use of venous thromboembolism prophylaxis in this setting. Our results, however, suggest that venous thromboembolism prophylaxis may need to be considered only in critically injured adolescents and young adults with a continuing need for central venous access.

The inpatient burden of abdominal and gynecological adhesiolysis in the US.

BACKGROUND: Adhesions are fibrous bands of scar tissue, often a result of surgery, that form between internal organs and tissues, joining them together abnormally. Postoperative adhesions frequently occur following abdominal surgery, and are associated with a large economic burden. This study examines the inpatient burden of adhesiolysis in the United States (i.e., number and rate of events, cost, length of stay [LOS]). METHODS: Hospital discharge data for patients with primary and secondary adhesiolysis were analyzed using the 2005 Healthcare Cost and Utilization Project's Nationwide Inpatient Sample. Procedures were aggregated by body system. RESULTS: We identified 351,777 adhesiolysis-related hospitalizations: 23.2% for primary and 76.8% for secondary adhesiolysis. The average LOS was 7.8 days for primary adhesiolysis. We found that 967,332 days of care were attributed to adhesiolysis-related procedures, with inpatient expenditures totaling $2.3 billion ($1.4 billion for primary adhesiolysis; $926 million for secondary adhesiolysis). Hospitalizations for adhesiolysis increased steadily by age and were higher for women. Of secondary adhesiolysis procedures, 46.3% involved the female reproductive tract, resulting in 57,005 additional days of care and $220 million in attributable costs. CONCLUSIONS: Adhesiolysis remain an important surgical problem in the United States. Hospitalization for this condition leads to high direct surgical costs, which should be of interest to providers and payers.

Outcomes and costs associated with initial maintenance therapy with fluticasone propionate-salmeterol xinafoate 250 microg/50 microg combination versus tiotropium in commercially insured patients with COPD.

PURPOSE: To compare, in commercially-insured individuals 240 years old, the risk of chronic obstructive pulmonary disease (COPD) exacerbations and COPD-related health care utilization and costs in patients initiating maintenance treatment with fluticasone propionate/salmeterol xinafoate 250 microg/50 microg (FSC) with those in patients initiating treatment with tiotropium bromide (TIO). DESIGN: Retrospective observational cohort study. METHODOLOGY: The risk of COPD exacerbation (moderate, severe, and any), COPD-related health care utilization, and COPD-related costs (overall and by service setting) were assessed over 12 months after the initiation of treatment with FSC or TIO in commercially-insured patients > or =40 years old diagnosed with COPD. PRINCIPAL FINDINGS: After adjusting for covariates, treatment with FSC compared with treatment with TIO was associated with a 14% reduction in risk of severe exacerbation (p = 0.0406), defined as the occurrence of a COPD-related hospitalization; with less health care utilization across several categories of care; with 25% lower COPD-related medical costs ($1814 versus $2258 per patient, p < 0.0001); and with 10% lower COPD-related total costs ($2991 versus $3304 per patient, p < 0.0001) over a 12-month follow-up period. Pharmacy costs were equivalent between FSC and TIO. CONCLUSION: Initiation of maintenance therapy with FSC compared with TIO was associated with significant reductions in the risk of severe exacerbations, health care utilization, and COPD-related medical and total costs. Considered in the context of other findings, these data suggest that earlier maintenance treatment with FSC offers clinical and economic benefits over maintenance treatment with TIO.

Opioid use patterns and health care resource utilization in patients prescribed opioid therapy with and without constipation.

PURPOSE: The main objective of this study was to compare the opioid use patterns, resource utilization, and costs of patients on opioid therapy who have constipation with those who do not. DESIGN: Retrospective, observational matched cohort design METHODOLOGY: Patients initiating opioid therapy between Jan. 1, 1999 and Dec. 31, 2005 were identified from a longitudinal insurance claims database. Patients had > or = 30 days of opioid use and continuous plan coverage for > or = 6 months before and > or = 12 months after their index date, defined as the date of the first pharmacy claim for an opioid. Constipation was defined as having one or more ICD-9 codes of 564.0 during the follow-up period. Patterns of opioid use and resource utilization were compared between patients with constipation and a demographically matched (1:1) cohort of opioid initiators without consti- pation using t-tests and Chi-square (chi2) tests. PRINCIPAL FINDINGS: We identified 39,485 patients, of whom 2,519 (6.4%) had constipation. Most patients with constipation were female (66%) and > or = 45 years old (68%). Compared to controls, the constipation group had significantly higher rates of concurrent use of > or = 2 opioids (p < 0.0001), discontinuation, and switching between opioids. Patients with constipation had statistically significant higher hospital admissions, emergency room visits, home health services, nursing home care, physician office visits, other outpatient/ ancillary care, and laboratory tests. Patients with constipation had significantly higher mean all-cause costs for emergency, physician visits, nursing facility, home health, and prescription drug services compared to patients without constipation. CONCLUSION: Opioid-treated patients with constipation were found to have significant differences in opioid use patterns and significantly higher health care utilization and associated costs.

Corrigendum to: Longitudinal, Nationwide, Cohort Study to Assess Incidence, Outcomes, and Costs Associated With Complicated Urinary Tract Infection.

[This corrects the article DOI: 10.1093/ofid/ofz446.].