Risk of relapse and readmission among hospitalized adults with carbapenem non-susceptible gram-negative infections.

BACKGROUND: Infections caused by carbapenem-nonsusceptible gram-negative (C-NS) pathogens are associated with increased mortality and high treatment costs. Identification of potentially modifiable factors that may improve patient outcomes is important for better management of C-NS GN infections. METHODS: This was a retrospective study of hospitalized adults with electronic health record evidence of complicated urinary tract infection (cUTI), bacterial pneumonia (BP), complicated intra-abdominal infection (cIAI), or bacteremia (BAC) due to C-NS GN organisms from January 2013 to March 2018. Treatment patterns and clinical characteristics during the index hospitalization were analyzed descriptively and stratified by infection site(s). The effect of patient characteristics on index infection relapse during the postdischarge period and on readmission with 30 days was modeled using logistic regression. RESULTS: The study included 2,862 hospitalized patients with C-NS GN infections. Index infection sites were 38.4% cUTI ± BAC, 21.5% BP ± BAC, 18.7% cUTI + BP ± BAC, 14.7% any cIAI, and 6.7% BAC only. The majority of patients (83.6%) received an antibiotic during their index hospitalization; among these, the most common classes given were penicillins (52.9%), fluoroquinolones (50.7%), and carbapenems (38.9%). During the postdischarge period, 21.7% of patients had a relapse of the index infection and 63.9% of patients were readmitted to the hospital. Factors associated with increased adjusted odds ratio (OR) for relapse or readmission included Charlson comorbidity score of ≥3 relative to 0 (relapse: OR [95% CI] = 1.34 [1.01-1.76], p = .040; readmission: OR [95% CI] 1.92 [1.50-2.46], p < .001), preindex immunocompromised status (relapse: OR [95% CI] 1.37 [1.05-1.79], p = .019; readmission: OR [95% CI] = 1.60 [1.27-2.02], p < .001), and preindex carbapenem use (relapse: OR [95% CI] = 1.35 [1.07-1.72], p = .013; readmission: OR [95% CI] = 1.25 [1.00-1.57], p = .048). CONCLUSIONS: Adverse postdischarge outcomes were common among hospitalized patients with C-NS GN infections and were significantly associated with previous carbapenem use and patient clinical characteristics such as higher comorbidity burden and immunocompromised status. Adoption of antimicrobial stewardship and consideration of individual patient risk factors in making treatment decisions may help improve clinical outcomes.

Treatment patterns and burden of complications associated with sickle cell disease: A US retrospective claims analysis.

Complications associated with sickle cell disease (SCD) that are highly impactful for patients but until recently have been less understood include priapism, nephropathy, and neurologic injury. We conducted a retrospective study using US administrative claims data from July 01, 2013 through March 31, 2020 to analyze incidence of these complications, SCD treatment patterns, and healthcare resource utilization (HCRU) and costs among 2524 pediatric and adult patients with SCD (mean [SD] age 43.4 [22.4] years). The most common treatments during follow-up were short-acting opioids (54.0% of patients), red blood cell transfusion (15.9%), and hydroxyurea (11.0%). SCD complications occurred frequently; in the overall population, the highest follow-up incidences per 1000 person-years were for acute kidney injury (53.1), chronic kidney disease (40.6), and stroke (39.0). Complications occurred across all age groups but increased in frequency with age; notably, acute kidney injury was 69.7 times more frequent among ages 65+ than ages 0-15 (p < 0.001). Follow-up per-patient-per-month HCRU also increased with age; however, all-cause healthcare costs were similarly high for all age groups and were driven primarily by inpatient stays. Patients with SCD across the age spectrum have a high burden of complications with the use of current treatments, suggesting unmet needs for treatment management.

Characterization of Heavily Treatment-Experienced People With HIV and Impact on Health Care Resource Utilization in US Commercial and Medicare Advantage Health Plans.

BACKGROUND: This retrospective administrative claims study aimed to describe clinical characteristics, health care resource utilization (HCRU), and costs of people with HIV (PWH) in US commercial and Medicare Advantage health plans by antiretroviral treatment (ART) experience and CD4+ cell count. METHODS: Data from the national Optum Research Database between January 1, 2014, and March 31, 2018, for adult PWH continuously enrolled 6 months before and ≥12 months after the first ART identified (follow-up) were summarized by treatment (heavily treatment-experienced [HTE] with limited remaining ART options, treatment-experienced but not HTE [non-HTE], or treatment-naive starting a first antiretroviral regimen) and index CD4+ cell count (<200, 200-500, or >500 cells/mm3). RESULTS: Compared with non-HTE (n=7604) and treatment-naive PWH (n=4357), HTE PWH (n=2297) were older (53.5 vs 48.8 and 42.3 years), were more likely to have HIV-related emergency department visits (22.3% vs 12.4% and 18.6%) and inpatient stays (15.8% vs 7.1% and 10.3%), and had a higher mean (SD) daily pill burden (9.7 [7.7] vs 5.1 [5.9] and 3.6 [5.3] pills/d) and a higher mortality rate (5.9% vs 2.9% and 2.3%) during follow-up (all P<.001). More HTE (21.8%) and treatment-naive PWH (27.0%) had <200 CD4+ cells/mm3 vs non-HTE PWH (8.0%; P<.001). All-cause and HIV-related costs were higher among HTE PWH in all CD4+ cell count strata and treatment-naive PWH with CD4+ cell counts <200 cells/mm3 vs non-HTE PWH in all CD4+ cell count strata. CONCLUSIONS: Improved support and clinical monitoring of HTE PWH are needed to prevent worsening outcomes and increased costs.

Clinical characteristics and treatment patterns of patients with venous thromboembolism (VTE) transitioning from hospital to post-discharge settings.

OBJECTIVE: This study examined anticoagulant use during and after a hospital encounter for venous thromboembolism (VTE), a transition of care largely uncharacterized in the literature. METHODS: Adults with a VTE diagnosis code during a hospital encounter (emergency department [ED], observation area [OBS], or inpatient hospital [IP]) from January 2012 to August 2017 were identified in an electronic health records database. The first such hospital encounter was defined as the index VTE encounter. Patients were linked to a claims database and required to be continuously enrolled for six months before the index admission date through six months after the index discharge date. Anticoagulants administered during the index VTE encounter and filled on or within 30 days of discharge were summarized descriptively overall, and by the type of index VTE encounter (IP, No IP) and anticoagulants administered during the index VTE encounter. RESULTS: Among 2,968 eligible patients, mean (SD) age was 64 (16) years, 51% were female, 67% had an IP index VTE encounter, and 77% received anticoagulation therapy during the index VTE encounter. In total, 60% filled a prescription order for anticoagulant within 30 days post-discharge. Of those who received a direct oral anticoagulant (DOAC), warfarin, or parenteral anticoagulant only during the index VTE encounter, 74%, 69%, and 34%, respectively, filled a prescription for the same anticoagulant post-discharge. Patients treated with a DOAC or warfarin during an ED or OBS VTE encounter without a subsequent inpatient hospitalization were more likely to remain on the same anticoagulation therapy post-discharge than those with an inpatient hospitalization (81% vs 69% for DOAC and 75% vs 68% for warfarin). CONCLUSIONS: Many patients treated with anticoagulation therapy during a VTE hospital encounter did not fill a prescription for an anticoagulant within 30 days post-discharge, highlighting an opportunity for improved management of care transitions in this patient population.

Clinical characteristics and treatment patterns among US patients with HIV.

OBJECTIVES: Describe the clinical characteristics and treatment patterns of patients with HIV-1 who have commercial or Medicare health insurance in the United States. STUDY DESIGN: Retrospective cohort study. METHODS: Administrative claims for adult commercial and Medicare health plan enrollees with evidence of HIV-1 and antiretroviral therapy (ART) between January 1, 2007, and March 31, 2017, were assessed. Current and previous complete ART regimens were identified using a claims-based algorithm. Results were stratified by treatment status and insurance type. RESULTS: Of 18,699 eligible patients, 5027 (27%) had no previous ART regimens; 15,275 (82%) had commercial insurance. Mean age was 47.5 years. Common comorbidities included hyperlipidemia, cardiovascular disease, hypertension, depression, and anxiety. The mean number of ART regimens was 1.43, with 31% of patients having 2 or more regimens. Mean (SD) daily pill burden was higher in patients with more than 1 ART regimen over time (5.7 [6.0] pills) or with Medicare insurance (9.2 [8.0] pills) than in patients with no previous ART (1.9 [4.4] pills) or with commercial insurance (3.7 [4.7] pills). Overall, 60% of patients achieved 90% or greater adherence to their ART regimen and 16% had a prescription filled for any contraindicated medication to an ART during their regimen. CONCLUSIONS: This descriptive study demonstrated that people living with HIV enrolled in Medicare have a significant amount of comorbidities and total pill burden. Although advancements in ART have significantly improved life expectancy and quality of life for people living with HIV, it is important to take into account individual complexities such as comorbidities and pill burden when selecting ART regimens.

Validation of a claims-based algorithm to identify patients with chronic thromboembolic pulmonary hypertension using electronic health record data.

This study aimed to validate an algorithm developed to identify chronic thromboembolic pulmonary hypertension (CTEPH) among patients with a history of pulmonary embolism. Validation was halted because too few patients had gold-standard evidence of CTEPH in the administrative claims/electronic health records database, suggesting that CTEPH is underdiagnosed.

Economic analysis of inadequate symptom control in carcinoid syndrome in the United States.

AIM: We investigated the healthcare resource utilization and costs of patients with dose escalations beyond recommended levels of long-acting octreotide for persistent carcinoid syndrome (CS) symptoms. MATERIALS & METHODS: A retrospective study of US health insurance claims included 358 adults with ≥1 medical claim for CS and ≥6 claims for long-acting octreotide (10-30 mg) between 1 July 2006 and 31 December 2013. RESULTS: Pre-escalation per-patient per-month outcomes and costs were lower versus post-escalation, including vascular conditions (0.11 vs 0.21), metastasis/secondary neoplasms (0.45 vs 0.74), total all-cause costs (US$4116 vs US$8305; p < 0.001) and CS-related costs (US$3156 vs US$7101; p < 0.001). CONCLUSION: Higher mean pre-escalation per-patient per-month resource use and costs post-escalation primarily attributable to CS-related ambulatory care suggests continuing challenges in managing CS despite octreotide dose escalation.

Burden of Illness Associated with Tenosynovial Giant Cell Tumors.

PURPOSE: Little is known about the burden of illness in patients with tenosynovial giant cell tumors (TGCT), which are rare, typically benign, lesions of the synovial tissue including giant cell tumor of the tendon sheath (GCT-TS) and pigmented villonodular synovitis (PVNS). The objective of this study was to describe health care resource use and costs for patients with GCT-TS and PVNS, which are rare and typically benign TGCT. METHODS: A retrospective cohort study design was used to analyze administrative claims for adult commercial and Medicare Advantage health plan enrollees with evidence of GCT-TS and PVNS from January 1, 2006 through March 31, 2015. Participants were continuously enrolled for 12 months before (pre-index period) and 12 months after (post-index period) the date of the first tenosynovial giant cell tumor (TGCT) claim (index date). Preindex and postindex measures were compared using the McNemar test and Wilcoxon signed-rank test. Results were stratified by TGCT type. FINDINGS: The study identified 4664 patients with TGCT, 284 with GCT-TS, and 4380 with PVNS. Mean age (GCT-TS group: 50 years; PVNS group: 51 years) and sex distributions (GCT-TS group: 60.2% female; PVNS group: 59.5% female) were similar for each group. Most patients with GCT-TS (78.2%) had at least one postindex surgery, compared with 38.7% of patients with PVNS. Mean total health care costs increased from $8943 in the preindex period to $14,880 in the postindex period (P < 0.001) for GCT-TS and from $13,221 in the preindex period to $17,728 in the postindex period (P < 0.001) for PVNS. Preindex to postindex ambulatory costs increased nearly 120% for patients with GCT-TS ($4340 to $9570, P < 0.001) and 50% for patients with PVNS ($6782 to $10,278, P < 0.001), and physical therapy use increased significantly during the same period (GCT-TS: 18% to 40%, P < 0.001; PVNS: 38% to 60%, P < 0.001). IMPLICATIONS: Costs increased substantially 1 year after the first TGCT claim, with more than half the costs covering ambulatory care. These results suggest a high health care burden once TGCT is identified.

Effect of 2013 ACC/AHA Blood Cholesterol Guidelines on Statin Treatment Patterns and Low-Density Lipoprotein Cholesterol in Atherosclerotic Cardiovascular Disease Patients.

BACKGROUND: Preceding release of the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol guidelines, prescribers aimed for specific low-density lipoprotein cholesterol (LDL-C) goals in patients with atherosclerotic cardiovascular disease (ASCVD). The 2013 guidelines changed this focus to treating patients with appropriate statin intensity given their ASCVD risk. We examined statin use and LDL-C levels before and after the 2013 ACC/AHA guidelines in patients with clinical ASCVD as defined in the guidelines. METHODS AND RESULTS: We conducted a retrospective cohort study of adult commercial and Medicare Advantage health plan enrollees in the Optum Research Database. Patients had ≥1 claim with a diagnosis of clinical ASCVD between November 1, 2012 and December 31, 2014 and were continuously enrolled 6 months before (baseline) and 7 months after (follow-up) the first ASCVD visit. Patients were assigned to monthly cohorts based on ASCVD event month. Statin use and intensity were measured at baseline and first month of follow-up. LDL-C changes were assessed using ordinary least squares regression. For 90 287 patients, mean (SD) age was 68 (12) years; 50% were female; and 30% had commercial insurance. Statin use remained consistent before and after guidelines (32% and 31%, respectively). Of patients receiving statins, high-intensity use increased by 4 percentage points 1 year after guidelines (P<0.001). Mean LDL-C levels were 2.4 mmol/L (94 mg/dL) both pre- and postguidelines. CONCLUSIONS: Statin use and mean monthly LDL-C before and after the guidelines remained largely unchanged; statin intensity increased modestly. More effort may be needed to increase guideline understanding and adherence to improve treatment of high-risk patients.

Clinical and economic outcomes by first-line treatment among women with HR+/HER2- metastatic breast cancer in a large US health plan database.

BACKGROUND: Guidelines recommend that women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. METHODS: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008-April 30, 2013. Subjects had evidence of a HR+/HER2- tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. RESULTS: Three hundred and twenty-four women with HR+/HER2- mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82-3.46; adjusted IRR = 0.64, 95% CI = 0.32-1.27). Adjusted average total all-cause healthcare costs were $11 090 for women with CT-1L and $6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36-1.99). CONCLUSIONS: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2- mBC population.

Incidence and prevalence of acromegaly in a large US health plan database.

PURPOSE: Incidence and prevalence estimates of acromegaly in the United States (US) are limited. Most existing reports are based on European data sources. The objective of this study was to estimate the annual incidence and prevalence of acromegaly in a large US managed care population, overall and stratified by age, sex, and geographic region, using data from 2008 to 2012. METHODS: Using administrative claims data, commercial health plan enrollees were identified with acromegaly if they had two or more medical claims with an acromegaly diagnosis code (ICD-9-CM: 253.0×) or one medical claim with an acromegaly diagnosis code in combination with one other claim for a pituitary tumor or pituitary procedure. The first date for an acromegaly-related claim set the index year. Incidence rates for each year were calculated by dividing the number of new acromegaly cases by the calculated person-time at risk. Annual prevalence estimates were calculated by dividing the number with any evidence of acromegaly by the total number of health plan enrollees enrolled for at least 1 day during each calendar year. Incidence and prevalence estimates were stratified by age (0-17, 18-44, 45-64, 65+ years), sex (male, female), and US geographic region of the health plan (Midwest, Northeast, South, West). RESULTS: Overall annual incidence rates of acromegaly were relatively constant across 2008-2012 with ~11 cases per million person-years (PMPY). Rates increased with age, ranging from 3-8 cases PMPY among children aged 0-17 years old to 9-18 cases PMPY among adults aged 65 and older. Females had 12 cases PMPY on average compared to 10 cases PMPY among men. On average, the Midwest had the lowest incidence rates (7 cases PMPY) compared to the Northeast, South and West (14, 12, and 10 cases PMPY, respectively). The overall annual prevalence of acromegaly was relatively constant across the 5 years from 2008 to 2012 with approximately 78 cases per million each year. Annual prevalence estimates increased with age, ranging from 29-37 cases per million among children aged 0-17 years old to 148-182 cases per million among adults aged 65 years and older. Males and females were similarly affected; each with approximately 77 cases per million each year. The Northeast and South had the highest prevalence estimates (92 and 89 cases per million, respectively); while the estimates for the West and Midwest were lower (65 and 57 cases per million, respectively) each year. CONCLUSION: This study examined 5 years of recent data to estimate the incidence and prevalence of acromegaly in a large geographically-diverse managed care population. The incidence rates were higher on average than published rates outside the US (11 vs. 3.3 PMPY), but prevalence estimates were consistent with previous reports. Incidence and prevalence both increased by age, did not differ for males and females, and varied slightly by US geographic region. The age and sex distribution of the selected population matched the known epidemiology of the disease. Using a claims-based approach, this analysis only captured acromegaly cases with an acromegaly-related medical claim. As a result, these estimates may underestimate the incidence and prevalence of acromegaly in US commercial health plans as they did not include individuals who were undiagnosed, in remission, undertreated, or not monitored during the study period. At the same time, these estimates may be viewed as an upper bound on the incidence of acromegaly in the US as the estimates did not include individuals who were in other health plans or uninsured during the study period. Additional evaluations are needed to identify the full extent of acromegaly in the US.

Algorithm development and the clinical and economic burden of Cushing's disease in a large US health plan database.

PURPOSE: This study aimed to develop an algorithm to identify patients with CD, and quantify the clinical and economic burden that patients with CD face compared to CD-free controls. METHODS: A retrospective cohort study of CD patients was conducted in a large US commercial health plan database between 1/1/2007 and 12/31/2011. A control group with no evidence of CD during the same time was matched 1:3 based on demographics. Comorbidity rates were compared using Poisson and health care costs were compared using robust variance estimation. RESULTS: A case-finding algorithm identified 877 CD patients, who were matched to 2631 CD-free controls. The age and sex distribution of the selected population matched the known epidemiology of CD. CD patients were found to have comorbidity rates that were two to five times higher and health care costs that were four to seven times higher than CD-free controls. CONCLUSION: An algorithm based on eight pituitary conditions and procedures appeared to identify CD patients in a claims database without a unique diagnosis code. Young CD patients had high rates of comorbidities that are more commonly observed in an older population (e.g., diabetes, hypertension, and cardiovascular disease). Observed health care costs were also high for CD patients compared to CD-free controls, but may have been even higher if the sample had included healthier controls with no health care use as well. Earlier diagnosis, improved surgery success rates, and better treatments may all help to reduce the chronic comorbidity and high health care costs associated with CD.

Persistence and compliance among U.S. patients receiving pazopanib or sunitinib as first-line therapy for advanced renal cell carcinoma: a retrospective claims analysis.

BACKGROUND: For first-line therapy options for advanced renal cell carcinoma (RCC), clinical trials have demonstrated similar efficacy for pazopanib and sunitinib as well as differing side-effect profiles, which may affect patient persistence in self-administration of these oral medications. However, the treatment patterns of each drug in real-world clinical practice, as opposed to the controlled environment of a trial, have not been directly compared. OBJECTIVE: To compare persistence and compliance (adherence) with pazopanib versus sunitinib in a real-world setting. METHODS: This was a retrospective claims analysis using 2 databases: Optum Research Database and Impact National Benchmark Database. Eligible patients included adult patients (aged ≥ 18 years) with ≥ 2 RCC diagnoses and evidence of first-line therapy with ≥ 1 subsequent pharmacy claim for pazopanib or sunitinib between October 2009 and July 2012. The date of the first pazopanib or sunitinib claim was defined as the index date. Additional requirements included continuous enrollment in the health plan for 2 months prior (baseline period) through 6 months after (follow-up period) the index date and no cancers other than those associated with RCC. Propensity score matching was used to minimize selection bias. Persistence with the index drug was compared using days to discontinuation, estimated level of persistence (ELPT) at 180 days, and proportion of days covered (PDC). PDC was defined by dividing the number of days covered with the index drug by the number of follow-up days. Compliance was estimated using medication possession ratio (MPR). For matched cohort pairs with > 1 fill, MPR was defined by dividing the number of days covered with the index drug by the number of days between the first and last index medication fill. RESULTS: We identified 84 matched pairs among 97 patients prescribed pazopanib and 349 prescribed sunitinib. Among the matched population, mean comorbidity index score was 5.8 (95% CI = 1.8-6.0) for pazopanib, and 6.1 (95% CI =1.8-6.0) for sunitinib (P = 0.133). Evidence of any radiation therapy during the baseline period was significantly higher among the sunitinib cohort prior to matching (9% vs. 18%, P = 0.043), and evidence of surgery was higher in the pazopanib cohort after matching (12% vs. 7%, P = 0.046). Cohorts were balanced according to demographic and clinical characteristics with mean (SD) age of 63.0 (9.0) years and 77.4% male. During the 6-month period after drug initiation, there was no significant difference (P > 0.05) by drug cohort in the duration of index drug therapy or the percentage of patients who discontinued their index drugs. The mean (SD) time to discontinuation was 133.4 (62.8) days and 139.9 (55.6) days among the matched pazopanib and sunitinib cohorts, respectively (P = 0.445). In both cohorts, more than 40% of patients discontinued their index drugs (46.4% pazopanib and 44.1% sunitinib, P = 0.732). In addition, there was no significant difference by drug cohort in the ELPT at any time examined between 30 and 180 days after initiation of therapy. PDC with the index drug during the fixed 6-month follow-up was also examined. Although the mean PDC was significantly higher among the sunitinib cohort (0.77 vs. 0.68 for pazopanib, P = 0.037), there was no difference by cohort in the percentage of patients with high PDC (defined as ≥ 80%): 52.4% versus 56.0% for pazopanib and sunitinib, respectively (P = 0.622). Mean MPR among matched pairs with at least 2 fills for the index drug was significantly higher among the sunitinib cohort, although there was no difference by cohort in the percentage of patients with high MPR (defined as ≥ 80%): 81.4% versus 93.2% for pazopanib and sunitinib, respectively (P > 0.071). CONCLUSIONS: In the first 6 months of treatment, persistence and compliance to pazopanib and sunitinib were similar. Future studies are needed, including those assessing larger cohorts and longer follow-up periods.

Real-world comorbidities and treatment patterns of patients with acromegaly in two large US health plan databases.

Acromegaly is a rare, chronic, and debilitating disease that results from excessive growth hormone production. Clinically, this disease is associated with enlargement of soft tissue, excessive skeletal growth, and increased risk of cardiovascular disease. Acromegaly is often diagnosed late, when a wide range of comorbidities may already be present. First-line therapy for acromegaly is typically surgery; but a number of highly-specific pharmacological agents have recently enabled a more aggressive medical management of acromegaly. Since surgical cure of acromegaly is low for macroadenomas, medical control of active acromegaly is an important component of treatment. There are no published US data currently available regarding real-world rates of comorbidities and treatment patterns among patients with acromegaly. This retrospective study examined the comorbidities and treatment patterns of 949 health plan enrollees, who had acromegaly diagnosis and/or procedure codes in an administrative claims database from July 1, 2002 through June 30, 2010. Acromegaly was associated with high rates of hypertension and diabetes along with a number of other comorbidities. The incidence of comorbidities was highest among patients with acromegaly-related treatment, which may have resulted, in part, from inadequate disease management and/or poor disease control. Unexpectedly, 55% of patients identified with acromegaly received no treatment for acromegaly (i.e., surgery, radiotherapy, and medication) and only 28% received a medication treatment during the observation period. However, some patients may have received a curative surgery prior to the observation period, which may have reduced the use of other acromegaly-related treatments during the study period. Of those treated with medications, the most common first medications were octreotide, cabergoline, and bromocriptine. Given the high incidence of serious comorbidities associated with active acromegaly, earlier diagnosis and treatment, along with appropriate follow-up care, may potentially avoid the life-long consequences of uncontrolled disease.

Predicting waist circumference from body mass index.

BACKGROUND: Being overweight or obese increases risk for cardiometabolic disorders. Although both body mass index (BMI) and waist circumference (WC) measure the level of overweight and obesity, WC may be more important because of its closer relationship to total body fat. Because WC is typically not assessed in clinical practice, this study sought to develop and verify a model to predict WC from BMI and demographic data, and to use the predicted WC to assess cardiometabolic risk. METHODS: Data were obtained from the Third National Health and Nutrition Examination Survey (NHANES) and the Atherosclerosis Risk in Communities Study (ARIC). We developed linear regression models for men and women using NHANES data, fitting waist circumference as a function of BMI. For validation, those regressions were applied to ARIC data, assigning a predicted WC to each individual. We used the predicted WC to assess abdominal obesity and cardiometabolic risk. RESULTS: The model correctly classified 88.4% of NHANES subjects with respect to abdominal obesity. Median differences between actual and predicted WC were -0.07 cm for men and 0.11 cm for women. In ARIC, the model closely estimated the observed WC (median difference: -0.34 cm for men, +3.94 cm for women), correctly classifying 86.1% of ARIC subjects with respect to abdominal obesity and 91.5% to 99.5% as to cardiometabolic risk.The model is generalizable to Caucasian and African-American adult populations because it was constructed from data on a large, population-based sample of men and women in the United States, and then validated in a population with a larger representation of African-Americans. CONCLUSIONS: The model accurately estimates WC and identifies cardiometabolic risk. It should be useful for health care practitioners and public health officials who wish to identify individuals and populations at risk for cardiometabolic disease when WC data are unavailable.

One-year follow-up healthcare costs of patients hospitalized for transient ischemic attack or ischemic stroke and discharged with aspirin plus extended-release dipyridamole or clopidogrel.

OBJECTIVE: To examine healthcare costs among patients hospitalized for transient ischemic attack or ischemic stroke (TIA/stroke) and prescribed aspirin plus extended-release dipyridamole (ASA-ERDP) or clopidogrel (CLOPID) within 30 days post-discharge using a retrospective claims database from a large US managed care organization. METHODS: Adult patients with ≥1 hospitalizations for TIA/stroke between January 2007-July 2009 and ≥1 claims for an oral anti-platelet (OAP) were observed for 1 year before and after the first TIA/stroke hospitalization or until death, whichever came first. Cohorts were defined by the first claim for ASA-ERDP or CLOPID within 30 days post-discharge. A generalized linear model, adjusting for demographics, baseline comorbidities and costs, compared total follow-up costs (medical + pharmacy) between ASA-ERDP and CLOPID patients. RESULTS: Of 6377 patients (2085 ASA-ERDP; 4292 CLOPID) who met the selection criteria, mean (SD) age was 69 (13) years and 50% were male. Unadjusted mean total follow-up costs were lower for ASA-ERDP than CLOPID ($26,201 vs $30,349; p=0.002), of which average unadjusted medical and pharmacy costs were $22,094 vs $26,062 (p=0.003) and $4107 vs $4288 (p=0.119), respectively. Multivariate modeling indicated that the following were associated with higher total costs (all p<0.05): higher baseline Quan-Charlson comorbidity score, history of atrial fibrillation and myocardial infarction, index stroke hospitalization, death post-discharge, and index CLOPID use. Adjusted mean total follow-up costs for CLOPID were 9% higher than ASA-ERDP (cost ratio: 1.09; p=0.038). CONCLUSION: In this study, compared to CLOPID patients, ASA-ERDP patients were observed to have lower total costs 1 year post-discharge TIA/stroke hospitalization, driven primarily by lower medical costs. Further research into the real-world impact of OAP therapies on clinical and economic outcomes of patients with stroke/TIA is warranted. The findings of this study should be considered within the limitations of an administrative claims analysis, as claims data are collected for the purpose of payment.

Recent trends in exposure to secondhand smoke in the United States population.

BACKGROUND: Previous research using the National Health and Nutrition Examination Surveys (NHANES) data documented a significant downward trend in secondhand smoke (SHS) exposure between 1988 and 2002. The objective of this study was to assess whether the downward trend in exposure continued from 2001 through 2006. METHODS: We analyzed data from the 2001-2006 NHANES to estimate exposure of nonsmokers to SHS. Geometric means of serum cotinine levels for all nonsmokers were computed. RESULTS: Overall serum cotinine levels (95% Confidence Intervals) in 2001-2002, 2003-2004, and 2005-2006 were 0.06 ng/mL (0.05-0.07), 0.07 ng/mL (0.06-0.09), and 0.05 ng/mL (0.05-0.06), respectively. Subgroup analysis by age, gender, and race/ethnicity groups showed similar trends in cotinine levels. Children, males, and non-Hispanic Blacks had higher cotinine levels than adults, females, and non-Hispanic Whites and Mexican Americans, respectively. Insignificant P values from the Wald test indicate that serum cotinine levels did not differ over time. CONCLUSIONS: The long-term trend of declining exposure to SHS among nonsmokers appears to have leveled off. However, disparities noted in previous research persist today, with the young, non-Hispanic Blacks, and males experiencing higher levels of exposure.

Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel).

Objective To determine whether a diabetes case management telemedicine intervention reduced healthcare expenditures, as measured by Medicare claims, and to assess the costs of developing and implementing the telemedicine intervention. Design We studied 1665 participants in the Informatics for Diabetes Education and Telemedicine (IDEATel), a randomized controlled trial comparing telemedicine case management of diabetes to usual care. Participants were aged 55 years or older, and resided in federally designated medically underserved areas of New York State. Measurements We analyzed Medicare claims payments for each participant for up to 60 study months from date of randomization, until their death, or until December 31, 2006 (whichever happened first). We also analyzed study expenditures for the telemedicine intervention over six budget years (February 28, 2000- February 27, 2006). Results Mean annual Medicare payments (SE) were similar in the usual care and telemedicine groups, $9040 ($386) and $9669 ($443) per participant, respectively (p>0.05). Sensitivity analyses, including stratification by censored status, adjustment by enrollment site, and semi-parametric weighting by probability of dropping-out, rendered similar results. Over six budget years 28 821 participant/months of telemedicine intervention were delivered, at an estimated cost of $622 per participant/month. Conclusion Telemedicine case management was not associated with a reduction in Medicare claims in this medically underserved population. The cost of implementing the telemedicine intervention was high, largely representing special purpose hardware and software costs required at the time. Lower implementation costs will need to be achieved using lower cost technology in order for telemedicine case management to be more widely used.

Psychometric analysis of the systemizing quotient (SQ) scale.

The psychometric properties of the systemizing quotient (SQ) developed by Baron-Cohen (2003) are investigated in three studies. Furthermore, we examine the notion that the ability to systemize should be independent of intelligence. In Studies 1 and 2, confirmatory factor analyses are used to examine the factor structure of the SQ. Study 3 examines the relationship between systemizing, mental rotation and intelligence. Studies 1 and 2 indicate that the SQ does not possess a unifactorial structure but is best considered as four related factors; Study 3 found that SQ was not related to intelligence, although mental rotation was. A four factor structure using fewer items was a better fit for the data than either the original version of the SQ or Wakabayashi et al.'s (2006) revised version. Overall these results support Baron-Cohen's view that SQ is not related to intelligence. Although mental rotation is correlated to SQ, it is not the main determinant of SQ. The problems of self-report measures are discussed along with the difficulties related to measuring systemizing.

Prediction of first events of coronary heart disease and stroke with consideration of adiposity.

BACKGROUND: Prediction of coronary heart disease (CHD) and cerebrovascular disease (CeVD) can aid healthcare providers and prevention programs. Previous reports have focused on traditional cardiovascular risk factors; less information has been available on the role of overweight and obesity. METHODS AND RESULTS: Baseline data from 4780 Framingham Offspring Study adults with up to 24 years of follow-up were used to assess risk for a first CHD event (angina pectoris, myocardial infarction, or cardiac death) alone, first CeVD event (acute brain infarction, transient ischemic attack, and stroke-related death) alone, and CHD and CeVD events combined. Accelerated failure time models were developed for the time of first event to age, sex, cholesterol, high-density lipoprotein cholesterol, diabetes mellitus (DM), systolic blood pressure, smoking status, and body mass index (BMI). Likelihood-ratio tests of statistical significance were used to identify the best-fitting predictive functions. Age, sex, smoking status, systolic blood pressure, ratio of cholesterol to high-density lipoprotein cholesterol, and presence of DM were highly related (P<0.01 for all) to the development of first CHD events, and all of the above except sex and DM were highly related to the first CeVD event. BMI also significantly predicted the occurrence of CHD (P=0.05) and CeVD (P=0.03) in multivariable models adjusting for traditional risk factors. The magnitude of the BMI effect was reduced but remained statistically significant when traditional variables were included in the prediction models. CONCLUSIONS: Greater BMI, higher systolic blood pressure, higher ratio of cholesterol to high-density lipoprotein cholesterol, and presence of DM were all predictive of first CHD events, and all but the presence of DM were predictive of first CeVD events. These results suggest that common pathophysiological mechanisms underlie the roles of BMI, DM, and systolic blood pressure as predictors for first CHD and CeVD events.