Performance of a targeted methylation-based multi-cancer early detection test by race and ethnicity.

Disparities in cancer screening and outcomes based on factors such as sex, socioeconomic status, and race and ethnicity in the United States are well documented. A blood-based multi-cancer early detection (MCED) test that detects a shared cancer signal across multiple cancer types and also predicts the cancer signal origin was developed and validated in the Circulating Cell-free Genome Atlas study (CCGA; NCT02889978). CCGA is a prospective, multicenter, case-control, observational study with longitudinal follow-up (overall N = 15,254). In this pre-specified, exploratory, descriptive analysis, test performance was evaluated among racial and ethnic groups. Overall, 4077 participants comprised the independent validation set with confirmed cancer status (cancer: n = 2823; non-cancer: n = 1254). Participants were stratified into the following racial/ethnic groups: Black (non-Hispanic), Hispanic (all races), Other (non-Hispanic), Other/unknown and White (non-Hispanic). Cancer and non-cancer participants were predominantly White (n = 2316, 82.0% and n = 996, 79.4%, respectively). Across groups, specificity for cancer signal detection ranged from 98.1% [n = 103; 95% CI: 93.2-99.5%] to 100% [n = 85; 95% CI: 95.7-100.0%]. The sensitivity for cancer signal detection across groups ranged from 43.9% [n = 57; 95% CI: 31.8-56.7%] to 63.0% [n = 192; 95% CI: 56.0-69.5%] and generally increased with clinical stage. The MCED test had consistently high specificity and similar sensitivity across racial and ethnic groups, though results are limited by sample size for some groups. Results support the broad applicability of this MCED test and clinical implementation on a population scale as a complement to standard screening.

COMPARING CLINICAL OUTCOMES AND COSTS FOR DIFFERENT TREATMENT INTENSIFICATION APPROACHES IN PATIENTS WITH TYPE 2 DIABETES UNCONTROLLED ON BASAL INSULIN: ADDING GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONISTS VERSUS ADDING RAPID-ACTING INSULIN OR INCREASING BASAL INSULIN DOSE.

OBJECTIVE: Not all patients with type 2 diabetes achieve recommended glycated hemoglobin A1c (A1C) levels after adequate titration of basal insulin (BI). Current intensification approaches include addition of rapid-acting insulin (RAI) or a glucagon-like peptide 1 receptor agonist (GLP-1 RA), but it is not clear which strategy results in better long-term outcomes. METHODS: This retrospective analysis of health insurance claims data in the U.S. MarketScan database compared glycemic control and healthcare resource utilization and costs 12 months after adding a GLP-1 RA to BI versus adding a RAI or increasing BI doses. Propensity score matching was used in the comparative effectiveness analysis. RESULTS: A total of 8,034 patients underwent treatment intensification within 6 months of showing poor glycemic control; 4,134 patients had their BI dose adjusted, and 2,076 and 331 received RAI and GLP-1 RA, respectively. A1C changes were similar for the GLP-1 RA and RAI cohorts but higher for the GLP-1 RA versus the dose-adjustment group. The hypoglycemia rate was lower after adding GLP-1 RA versus RAI or increasing BI dose. No overall changes in utilization of healthcare resources or diabetes-related costs were observed between intensification strategies, although prescription costs were higher for the GLP-1 RA cohort. CONCLUSION: BI in combination with GLP-1 RAs appears to be an effective intensification strategy, further reducing A1C levels and hypoglycemia frequency compared to increasing BI doses. GLP-1 RA addition also decreases hypoglycemia frequency versus BI dose increases and RAI addition, without raising overall healthcare costs. ABBREVIATIONS: A1C = hemoglobin A1c; BI = basal insulin; CAD = coronary artery disease; ED = emergency department; FPG = fasting plasma glucose; GLP-1 RA = glucagon-like peptide 1 receptor agonist; ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification; NPH = neutral protamine Hagedorn; OAD = oral antidiabetes drug; PSM = propensity score matching; RAI = rapid-acting insulin; T2D = type 2 diabetes.

Potential drug-drug and drug-condition interactions among fibromyalgia patients initiating pregabalin or duloxetine: prevalence and health care expenditure impact.

OBJECTIVE: To quantify the prevalence of potential drug-drug/drug-condition interactions (DDI/DCI) among fibromyalgia patients initiating pregabalin or duloxetine, and to determine the impact of potential DDI/DCI on health care expenditures. DESIGN: Retrospective cohort study. SETTING: U.S. clinical practice, as reflected within a large administrative claims database. SUBJECTS: Fibromyalgia patients newly initiating pregabalin or duloxetine between July 1, 2008 and October 1, 2010 (initiation date = index). OUTCOME MEASURES: Potential DDI measured using clinical software that identifies co-prescription of medications that potentially interact with pregabalin or duloxetine. Potential DCI, drawn from the contraindications and warnings and precautions sections of pregabalin and duloxetine prescribing information, measured using administrative claims-based algorithms. All-cause health care expenditures measured throughout a 6-month postindex period. Analyses included univariate, bivariate, and multivariable statistical approaches. RESULTS: Seven thousand seven hundred fifty-one pregabalin and 7,785 duloxetine initiators were selected for study: mean age 49 years, 88% female. Only 1.4% of pregabalin initiators had ≥1 potential pregabalin DCI; none had potential pregabalin DDI. In contrast, 67% of duloxetine initiators had potential duloxetine DDI/DCI, driven mostly by potential duloxetine DDI (62% of duloxetine initiators). Compared between pregabalin and duloxetine initiators, differences in the prevalence of potential DDI/DCI were statistically significant (P < 0.001). Multivariable analyses indicated that, among duloxetine initiators, those with potential duloxetine DDI/DCI had postinitiation health care expenditures that were $670 higher (P < 0.001) than those without potential duloxetine DDI/DCI. Among pregabalin initiators, potential pregabalin DDI/DCI were not associated with health care expenditures. CONCLUSIONS: Among fibromyalgia patients initiating pregabalin or duloxetine, potential duloxetine DDI could be highly prevalent. Among duloxetine initiators, potential duloxetine DDI/DCI were significantly associated with increased health care expenditures.

Patterns and correlates of linkage to appropriate HIV care after HIV diagnosis in the US Medicaid population.

BACKGROUND: Timely linkage to appropriate care after human immunodeficiency virus (HIV) diagnosis is critical to optimizing patient outcomes. Medicaid is the largest source of health care coverage for patients with HIV in the United States, yet no studies of linkage to appropriate HIV care have focused solely on the Medicaid population. METHODS: This is a retrospective study using Medicaid claims data from 15 states. Study sample comprised patients aged 18 to 64 years with 1 or more HIV tests between January 1, 2003, to May 1, 2010, followed or accompanied by HIV diagnosis. The "Test Index" corresponded to the HIV test that was temporally proximate to first HIV diagnosis. Study end point was linkage to appropriate HIV care, defined as receipt of CD4 and viral load tests as per US treatment guidelines. Time-to-event analyses characterized patterns and correlates of linkage to appropriate care. RESULTS: This study included 6684 patients, with a mean age of 35 years, 70% female, and 47% black race. Overall, 21.0% of patients linked to appropriate care within 1 year of the Test Index and 26.4% within 5 years. Compared with whites, blacks had a significantly shorter time to linkage to HIV appropriate care (hazard ratio, 2.034; P < 0.001). CONCLUSIONS: These findings in Medicaid patients newly diagnosed with HIV contrast with prior research show disparities in access to HIV care favoring whites. Overall, the proportion of patients who linked to appropriate HIV care was very low given the availability of effective treatment, suggesting a need for more effective interventions promoting timely linkage to appropriate care after diagnosis.

Comparative incidence and health care costs of medically attended adverse effects among U.S. Medicaid HIV patients on atazanavir- or darunavir-based antiretroviral therapy.

OBJECTIVES: This is the first study to compare the incidence and health care costs of medically attended adverse effects in atazanavir- and darunavir-based antiretroviral therapy (ART) among U.S. Medicaid patients receiving routine HIV care. METHODS: This was a retrospective study using Medicaid administrative health care claims from 15 states. Subjects were HIV patients aged 18 to 64 years initiating atazanavir- or darunavir-based ART from January 1, 2003, to July 1, 2010, with continuous enrollment for 6 months before (baseline) and 6 months after (evaluation period) ART initiation and 1 or more evaluation period medical claim. Outcomes were incidence and health care costs of the following medically attended (International Classification of Diseases, Ninth Revision, Clinical Modification-coded or treated) adverse effects during the evaluation period: gastrointestinal, lipid abnormalities, diabetes/hyperglycemia, rash, and jaundice. All-cause health care costs were also determined. Patients treated with atazanavir and darunavir were propensity score matched (ratio = 3:1) by using demographic and clinical covariates. Multivariable models adjusted for covariates lacking postmatch statistical balance. RESULTS: Propensity-matched study sample included 1848 atazanavir- and 616 darunavir-treated patients (mean age 41 years, 50% women, 69% black). Multivariable-adjusted hazard ratios (HRs) (for darunavir, reference = atazanavir) and per-patient-per-month health care cost differences (darunavir minus atazanavir) were as follows: gastrointestinal, HR = 1.25 (P = 0.04), $43 (P = 0.13); lipid abnormalities, HR = 1.38 (P = 0.07), $3 (P = 0.88); diabetes/hyperglycemia, HR = 0.84 (P = 0.55), $13 (P = 0.69); and rash, HR = 1.11 (P = 0.23), $0 (P = 0.76); all-cause health care costs were $1086 (P<0.001). Too few instances of jaundice (11 in atazanavir and 1 in darunavir) occurred to support multivariable modeling. CONCLUSIONS: Medication tolerability can be critical to the success or failure of ART. Compared with darunavir-treated patients, atazanavir-treated patients had significantly fewer instances of medically attended gastrointestinal issues and more instances of jaundice and incurred significantly lower health care costs.

Fractures in women treated with raloxifene or alendronate: a retrospective database analysis.

BACKGROUND: Raloxifene and alendronate are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is also indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. A definitive study comparing the fracture effectiveness and rate of breast cancer for raloxifene and alendronate has not been published. The purpose of this retrospective cohort study was to evaluate fracture and breast cancer rates among patients treated with raloxifene or alendronate. METHODS: Females ≥45 years who initiated raloxifene or alendronate in 1998-2006 Truven Health Analytics MarketScan® Databases, had continuous enrollment 12 months prior to and at least 12 months after the index date, and had a treatment medication possession ratio ≥80% were included in this study. Rates of vertebral and nonvertebral fractures and breast cancer during 1, 3, 5, 6, 7, and 8 years of treatment with raloxifene or alendronate were evaluated. Fracture rates were adjusted for potential treatment bias using inverse probability of treatment weights. Multivariate hazard ratios were estimated for vertebral and nonvertebral fractures. RESULTS: Raloxifene patients had statistically significantly lower rates of vertebral fractures in 1, 3, 5, and 7 years and for nonvertebral fractures in 1 and 5 years. There were no statistically significant differences in the adjusted fracture rates between raloxifene and alendronate cohorts, except in the 3-year nonvertebral fracture rates where raloxifene was higher. Multivariate hazard ratios of raloxifene versus alendronate cohorts were not significantly different for vertebral and nonvertebral fracture in 1, 3, 5, 6, 7, and 8 years. Unweighted and weighted breast cancer rates were lower among raloxifene recipients. CONCLUSIONS: Patients treated with alendronate and raloxifene had similar adjusted fracture rates in up to 8 years of adherent treatment, and raloxifene patients had lower breast cancer rates.

Agreement between Internet-based self- and proxy-reported health care resource utilization and administrative health care claims.

OBJECTIVES: Although Internet-based surveys are becoming more common, little is known about agreement between administrative claims data and Internet-based survey self- and proxy-reported health care resource utilization (HCRU) data. This analysis evaluated the level of agreement between self- and proxy-reported HCRU data, as recorded through an Internet-based survey, and administrative claims-based HCRU data. METHODS: The Child and Household Influenza-Illness and Employee Function study collected self- and proxy-reported HCRU data monthly between November 2007 and May 2008. Data included the occurrence and number of visits to hospitals, emergency departments, urgent care centers, and outpatient offices for a respondent's and his or her household members' care. Administrative claims data from the MarketScan® Databases were assessed during the same time and evaluated relative to survey-based metrics. Only data for individuals with employer-sponsored health care coverage linkable to claims were included. The Kappa (κ) statistic was used to evaluate visit concordance, and the intraclass correlation coefficient was used to describe frequency consistency. RESULTS: Agreement for presence of a health care visit and the number of visits were similar for self- and proxy-reported HCRU data. There was moderate to substantial agreement related to health care visit occurrence between survey-based and claims-based HCRU data for inpatient, emergency department, and office visits (κ: 0.47-0.77). There was less agreement on health care visit frequencies, with intraclass correlation coefficient values ranging from 0.14 to 0.71. CONCLUSIONS: This study's agreement values suggest that Internet-based surveys are an effective method to collect self- and proxy-reported HCRU data. These results should increase confidence in the use of the Internet for evaluating disease burden.

Real-world prognostic factors for survival among treated patients with metastatic pancreatic ductal adenocarcinoma.

BACKGROUND: Many real-world studies of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) are restricted to single centers, limiting the generalizability of their insights. This study aimed to identify important population-based predictors for survival in patients diagnosed with mPDAC in a broader setting. METHODS: Data between 1 January 2017 and 31 December 2019 were extracted from the Flatiron Health EHR database. Treatment-specific predictive models were generated for patients treated with first-line gemcitabine+nab-paclitaxel (GNP), FOLFIRINOX, gemcitabine monotherapy (gem-mono), and second-line liposomal irinotecan-based regimens. The holdout method was used for cross-validation. Age at diagnosis, sex, BMI, smoking status, and ECOG performance score were included in all models with additional demographic, clinical characteristics, and hematological function assessed for inclusion. RESULTS: Of the 3625 patients, 43% received GNP, 26% received FOLFIRINOX, 7% received gem-mono, and 23% received other regimens; 40% (n = 1448) advanced to the second line. Among all first-line patients, the following were included in the final model: prior surgery, white blood cell (WBC) counts, serum albumin (SA), liver function tests (LFTs), serum bilirubin, serum carbohydrate antigen 19-9, and ascites. Models for patients receiving specific therapies differed from the overall model, GNP (ascites removed), FOLFIRINOX (stage at initial diagnosis added), and gem-mono (LFTs omitted). Alkaline phosphatase (ALP), SA, and WBC counts were important predictors of survival among patients treated with second-line liposomal irinotecan. Across all regimens, the strongest predictors of survival were ECOG score, SA, and ALP. CONCLUSIONS: In this real-world study of patients with mPDAC, important population prognostic factors of survival were identified in a large cohort of patients receiving systemic treatment.

Effectiveness of durvalumab versus chemotherapy in metastatic urothelial cancer: an observational, indirect comparison.

Aim: To compare the overall survival of patients with metastatic urothelial carcinoma (mUC) who failed platinum-based chemotherapy and received durvalumab or chemotherapy. Patients & methods: In an indirect comparison of patients with mUC who failed platinum-based chemotherapy, those who received durvalumab in a single-arm study were matched to patients from the Flatiron oncology electronic medical record database who received chemotherapy (n = 158 for each cohort). Matching was based on propensity scores. Kaplan-Meier methods and Cox regression models were utilized. Results: Median overall survival was 11.2 months (95% CI: 7.2-16.9) for durvalumab versus 8.2 months (95% CI: 6.7-9.8) for chemotherapy (hazard ratio: 0.63; 95% CI: 0.48-0.84). Conclusion: As a second-line therapy for mUC, durvalumab was associated with longer overall survival than chemotherapy.

Drinking patterns and myocardial infarction: a linear dose-response model.

BACKGROUND: The relation of alcohol intake to cardiovascular health is complex, involving both protective and harmful effects, depending on the amount and pattern of consumption. Interpretation of data available on the nature of these relations is limited by lack of well-specified, mathematical models relating drinking patterns to alcohol-related consequences. Here we present such a model and apply it to data on myocardial infarction (MI). METHODS: The dose-response model derived assumes: (1) each instance of alcohol use has an effect that either increases or decreases the likelihood of an alcohol-related consequence, and (2) greater quantities of alcohol consumed on any drinking day add linearly to these increases or decreases in risk. Risk was reduced algebraically to a function of drinking frequency and dosage (volume minus frequency, a measure of the extent to which drinkers have more than 1 drink on days when they drink). In addition to estimating the joint impact of frequency and dosage, the model provides a method for calculating the point at which risk related to alcohol consumption is equal to background risk from other causes. A bootstrapped logistic regression based on the dose-response model was conducted using data from a case-control study to obtain the predicted probability of MI associated with current drinking patterns, controlling for covariates. RESULTS: MI risk decreased with increasing frequency of drinking, but increased as drinking dosage increased. Rates of increasing MI risk associated with drinking dosage were twice as high among women as they were among men. Relative to controls, lower MI risk was associated with consuming < 4.55 drinks per drinking day for men (95% CI: 2.77 to 7.18) and < 3.08 drinks per drinking day for women (95% CI: 1.35 to 5.16), increasing after these cross-over points were exceeded. CONCLUSIONS: Use of a well-specified mathematical dose-response model provided precise estimates for the first time of how drinking frequency and dosage each contribute linearly to the overall impact of a given drinking pattern on MI risk in men and women.

Temporal Trends in Survival and Healthcare Costs in Patients with Multiple Myeloma in the United States.

BACKGROUND: In recent years, the development of new therapies for multiple myeloma has improved the survival of patients, but newer treatments may also affect healthcare costs. To date, no real-world study has examined the concurrent changes in survival and total healthcare costs over time in patients with multiple myeloma. OBJECTIVE: To examine the temporal changes in survival and healthcare costs among patients with multiple myeloma in the United States. METHOD: This retrospective claims-based cohort study is based on death files in the Truven Health MarketScan Research Commercial and Medicare Supplemental databases. The study included adults who had at least 1 inpatient or 2 outpatient claims with a diagnosis of multiple myeloma between January 1, 2006, and December 31, 2014; continuous insurance enrollment for at least 12 months before and at least 30 days after the first diagnosis (ie, index date); and no previous malignancy. Patients were followed from the index date through the earliest among (1) the date of death recorded in the death files, (2) the end of enrollment in the MarketScan database, or (3) end of the study (September 30, 2015). The mortality rates and the total all-cause and multiple myeloma-specific healthcare costs per patient per month were compared between patients diagnosed in 2006-2010 and those diagnosed in 2011-2014. RESULTS: A total of 5199 patients were included in the study (2597 diagnosed between 2006 and 2010 and 2602 diagnosed between 2011 and 2014). We found a 35% decrease in the risk for death (hazard ratio, 0.65; 95% confidence interval, 0.57-0.74) among patients diagnosed in 2011-2014 compared with those diagnosed in 2006-2010. In addition, 18% and 26% increases were found in all-cause and multiple myeloma-specific healthcare costs, respectively, over the same time period (adjusted mean all-cause costs, $13,960 vs $16,449, respectively; adjusted mean multiple myeloma-specific costs, $7476 vs $9422, respectively). CONCLUSION: The percent decrease in mortality in patients with multiple myeloma has been greater than the percent increase in healthcare costs in recent years, which may be attributable to improved treatments for multiple myeloma and changes in disease management. With the mortality rate having decreased more than the increase in healthcare costs over the same time period, the results of this study suggest that although healthcare spending has increased over time, there is a survival benefit.

Societal burden of cluster headache in the United States: a descriptive economic analysis.

AIM: To estimate direct and indirect costs in patients with a diagnosis of cluster headache in the US. METHODS: Adult patients (18-64 years of age) enrolled in the Marketscan Commercial and Medicare Databases with ≥2 non-diagnostic outpatient (≥30 days apart between the two outpatient claims) or ≥1 inpatient diagnoses of cluster headache (ICD-9-CM code 339.00, 339.01, or 339.02) between January 1, 2009 and June 30, 2014, were included in the analyses. Patients had ≥6 months of continuous enrollment with medical and pharmacy coverage before and after the index date (first cluster headache diagnosis). Three outcomes were evaluated: (1) healthcare resource utilization, (2) direct healthcare costs, and (3) indirect costs associated with work days lost due to absenteeism and short-term disability. Direct costs included costs of all-cause and cluster headache-related outpatient, inpatient hospitalization, surgery, and pharmacy claims. Indirect costs were based on an average daily wage, which was estimated from the 2014 US Bureau of Labor Statistics and inflated to 2015 dollars. RESULTS: There were 9,328 patients with cluster headache claims included in the analysis. Cluster headache-related total direct costs (mean [standard deviation]) were $3,132 [$13,396] per patient per year (PPPY), accounting for 17.8% of the all-cause total direct cost. Cluster headache-related inpatient hospitalizations ($1,604) and pharmacy ($809) together ($2,413) contributed over 75% of the cluster headache-related direct healthcare cost. There were three sub-groups of patients with claims associated with indirect costs that included absenteeism, short-term disability, and absenteeism + short-term disability. Indirect costs PPPY were $4,928 [$4,860] for absenteeism, $803 [$2,621] for short-term disability, and $3,374 [$3,198] for absenteeism + disability. CONCLUSION: Patients with cluster headache have high healthcare costs that are associated with inpatient admissions and pharmacy fulfillments, and high indirect costs associated with absenteeism and short-term disability.

Comparative Effectiveness of Clostridial Collagenase Ointment to Medicinal Honey for Treatment of Pressure Ulcers.

Objective: Compare enzymatic debridement using clostridial collagenase ointment (CCO) with autolytic debridement using medicinal honey in the hospital outpatient setting for treating pressure ulcers (PUs). Approach: Retrospective deidentified electronic health records from 2007-2013 were extracted from the U.S. Wound Registry. Propensity score matching followed by multivariable analyses was used to adjust for selection bias and assess treatment effects comparing CCO-treated versus honey-treated PUs. Key outcomes included 100% granulation and epithelialization at 1 year. Results: Five hundred seventeen CCO-treated PUs (446 patients) were matched to corresponding honey-treated PUs (341 patients). The majority of PUs were stage III (CCO 56%, honey 55%). CCO users had significantly fewer total visits (9.1 vs. 12.6; p < 0.001), fewer total selective sharp debridements (2.7 vs. 4.4; p < 0.001), and fewer PUs receiving negative pressure wound therapy (29% vs. 38%; p = 0.002) compared with honey. Innovation: CCO-treated PUs were 38% more likely to achieve 100% granulation compared to honey-treated PUs at 1 year, p = 0.018. Mean days to 100% granulation were significantly lower for CCO-treated PUs (255 vs. 282 days, p < 0.001). CCO-treated PUs were 47% (p = 0.024) more likely to epithelialize at 1 year compared to PUs treated with honey. Mean days to epithelialization were significantly lower for PUs treated with CCO at 1 year (288 vs. 308 days; p = 0.011). Conclusion: All stages of PUs treated with CCO achieved faster rates of granulation and subsequent epithelialization compared to PUs treated with medicinal honey as measured by real-world data collected in the hospital outpatient department care setting.

No Evidence of an Association Between Efavirenz Exposure and Suicidality Among HIV Patients Initiating Antiretroviral Therapy in a Retrospective Cohort Study of Real World Data.

Recently, published studies have reported conflicting results regarding the association between efavirenz exposure and the risk of suicidality among patients with human immunodeficiency virus. The objective of this analysis was to compare the rate of suicidality among patients initiating efavirenz-containing versus efavirenz-free antiretroviral (ARV) regimens.This retrospective cohort study used US administrative claims data for commercially and Medicaid-insured individuals for the years 2006 to 2013. ARV-naive patients aged ≥12 years initiating an efavirenz-containing or efavirenz-free ARV regimen with ≥6 months of continuous insurance enrollment prior to ARV initiation were selected. The primary outcome was suicidality, defined as the occurrence of any medical claim with a diagnosis code for suicidal ideation or an inpatient or emergency department medical claim for suicide attempt. Unadjusted incidence rates were calculated and propensity score-adjusted hazard ratios were estimated to account for differences in patient characteristics.There were 19,983 patients (efavirenz-containing, n = 11,187; efavirenz-free, n = 8796) in the commercial database and 5154 patients (efavirenz-containing, n = 2224; efavirenz-free, n = 2930) in the Medicaid database. Unadjusted incidence rates (95% confidence interval [CI]) of suicidality per 1000 person-years were: commercial, efavirenz-containing (3.3 [2.4-4.4]), efavirenz-free (4.0 [2.7-5.8]); Medicaid, efavirenz-containing (25.7 [18.8-34.4]), efavirenz-free (40.6 [31.9-50.9]). In propensity score-adjusted analyses, efavirenz use was not associated with suicidality: adjusted hazard ratio (95% CI) of suicidality compared with efavirenz-free regimen, commercial, 1.029 (0.636-1.665); Medicaid, 0.902 (0.617-1.319).This analysis found no conclusive evidence of an increased risk of suicidality among patients initiating an efavirenz-containing ARV regimen. However, channeling bias may exist even after adjusting for measured patient characteristics.

Preventive services and health behaviors among people with spinal cord injury.

BACKGROUND/OBJECTIVE: To document receipt of certain understudied preventive services and health behaviors in spinal cord injury (SCI) and to compare them to the general adult population. METHODS: Cross-sectional survey. PARTICIPANTS: One hundred ninety-nine community-living adults with SCI residing in New Jersey. MAIN OUTCOME MEASURES: Receipt of recommended general preventive health services, such as screening for colorectal and prostate cancer and dental examinations, and health-related behaviors, including injury prevention, obesity, and tobacco use, as assessed by survey items in the Behavioral Risk Factors Surveillance System. RESULTS: Deficiencies in provision of needed preventive services were evident but were similar to those noted in the general adult population. Among participants 50 years of age or older, 47% had not had either a stool test for occult blood in the last year or a sigmoidoscopy/colonoscopy in the last 5 years. While 43.9% of participants were overweight or obese and 46.3% of these were trying to lose weight, only 1 3.8% had been counseled to lose weight. Twenty-two percent smoked on at least some days. Safety problems were evident: 15.5% did not use seatbelts consistently; 44% had not discussed a fire escape plan at home; and smoke detectors were often not checked adequately. Twelve and a half percent of participants reported having injuries during the last year, and fully 75% of these were related to SCI. Emergency room use and hospitalization were frequent. Participants had a median of 3 to 5 current doctors. CONCLUSIONS: Persons with SCI need the general screening and safety services recommended for all persons. Enhanced efforts will be needed to meet national goals in Healthy People 2010 in SCI.

Retrospective study comparing healthcare costs and utilization between commercially insured patients with type 2 diabetes mellitus who are newly initiating exenatide once weekly or liraglutide in the United States.

OBJECTIVE: To compare healthcare costs and utilization between commercially insured patients with type 2 diabetes mellitus (T2DM) in the United States newly initiating exenatide once weekly (QW) or liraglutide. METHODS: This retrospective cohort study used US administrative claims data to study patients with T2DM initiating exenatide QW or liraglutide (initiated therapy = index therapy). Patients were included if they had T2DM, were glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve, initiated exenatide QW or liraglutide from 1 February 2012 to 1 October 2012 (date of initiation = index), were ≥18 years at index, and had continuous enrollment for 12 months before (baseline) to 6 months after index (follow-up). Study outcomes were overall and diabetes-specific healthcare utilization and costs. Multivariable regressions compared the study outcomes between exenatide QW and liraglutide, adjusting for potential confounders. Sensitivity analyses were performed to assess liraglutide by dose (1.2 mg/1.8 mg). RESULTS: The study sample included 9106 liraglutide (4188, 1.2 mg; 4918, 1.8 mg) patients and 2445 exenatide QW patients. In multivariable-adjusted analyses, compared with liraglutide patients, exenatide QW patients had statistically significantly lower odds of overall inpatient admissions (odds ratio [OR] = 0.80, p = 0.046) and diabetes-specific (OR = 0.83, p = 0.026) inpatient admissions, similar overall total costs ($7833 exenatide QW, $8296 liraglutide, p = 0.069) and diabetes-specific total costs ($3610 exenatide QW, $3736 liraglutide, p = 0.298), and statistically significantly lower overall medical costs ($3939 exenatide QW, $4652 liraglutide, p = 0.008) and diabetes-specific medical costs ($1161 exenatide QW, $1469 liraglutide, p = 0.007). Sensitivity analyses assessing liraglutide by dose were directionally consistent. Unadjusted exploratory analyses showed that exenatide QW patients obtained a greater median number of days supplied for their GLP-1RA during follow-up (141 days) than liraglutide patients (124 days). CONCLUSIONS: In this 6 month follow-up study, patients receiving exenatide QW had similar total healthcare costs but lower odds of inpatient admission and lower medical costs compared with patients receiving liraglutide.

State agency policy and program coordination in response to the co-occurrence of HIV, chemical dependency, and mental illness.

UNLABELLED: The co-occurrence of HIV infection, chemical dependency, and mental illness challenges federal and state governments to develop flexible and coordinated health policy and financing for public health services. State agencies play a critical role in the organization and support of these services at the local level. With emerging stress upon state government budgets and concomitant increasing need for publicly funded services, state agency coordination may be an important policy safety net to assure services for populations at the margins of health systems. Despite this important potential role, nothing is known about the degree to which state HIV, substance abuse, and mental health agencies coordinate policies and/or programs in response to these co-morbid conditions. OBJECTIVE: This study sought to establish a conservative and initial understanding of state HIV, substance abuse, and mental health agency coordination of policy and program in response to the co-occurrence of HIV, chemical dependency, and mental illness. METHOD: Estimation of coordination was accomplished through the comparison of three surveys conducted among state substance abuse directors (1998), state AIDS directors (1999), and state mental health directors (2000). Data from 38 states were reviewed. RESULTS: The most frequently reported state agency activities included coordinating funding, engaging in integrative planning activities, and conducting staff cross-training. When compared for association with state characteristics, coordination among state agencies was found to be associated with Early Intervention Services (EIS) designation, higher rates of AIDS generally, higher rates of AIDS among African Americans, and higher rates of AIDS among Hispanic populations. Given the limitations of comparing three disparate surveys, we determined the estimate of interagency coordination to be conservative and preliminary. CONCLUSION: While this study was useful as an initial step toward identifying state interagency policy and program coordination in response to the co-occurrence of HIV, chemical dependency, and mental illness, there were methodological challenges that should be addressed in future studies of state agency coordination. Several recommendations were advanced.

Comparison between guideline-preferred and nonpreferred first-line HIV antiretroviral therapy.

OBJECTIVES: To compare antiretroviral therapy (ART) adherence and persistence and total healthcare expenditures in Medicaid-insured patients with human immunodeficiency virus (HIV) initiating preferred or nonpreferred first-line ART based on March 2012 HHS HIV treatment guidelines. STUDY DESIGN: Retrospective observational study using Medicaid administrative healthcare claims from 15 states. METHODS: Subjects were HIV patients 18 to 64 years who initiated first-line HIV-related ART between January 1, 2007, and September 30, 2011, with continuous enrollment for 6 months prior to and at least 3 months following ART initiation. Patients were classified as having initiated preferred or nonpreferred ART based on March 2012 HHS HIV treatment guidelines. Outcomes were: ART adherence (proportion of days covered dichotomized at ≥80% and ≥95%), time to ART nonpersistence, and per patient per month (PPPM) total healthcare expenditures. Outcomes were evaluated using multivariable regressions. RESULTS: Sample included 1979 patients initiating preferred ART regimens and 1614 patients initiating nonpreferred ART; overall mean age was 41 years; 48% of subjects were female. In the multivariable analyses, patients initiating preferred ART regimens had significantly greater odds of adherence ≥80% (odds ratio [OR], 1.38; 95% CI, 1.07-1.77) and adherence ≥95% (OR, 1.26; 95% CI, 1.05-1.51), and a significantly lower hazard of nonpersistence (HR, 0.48; 95% CI, 0.44-0.52). PPPM total healthcare expenditures were numerically lower for patients initiating preferred ART regimens (-$341; 95% CI, -$888 to $255) but the difference was not deemed significant. CONCLUSIONS: This study reinforces the value of HHS recommendations for first-line ART. The potential impact of these findings will grow as more HIV patients become Medicaid-eligible under the Patient Protection and Affordable Care Act.

Effectiveness of antiepileptic drug combination therapy for partial-onset seizures based on mechanisms of action.

IMPORTANCE: To our knowledge, the current study is the first to describe antiepileptic drug (AED) combination therapy patterns according to their mechanism of action (MOA) in a real-world setting and to evaluate the differences in outcomes comparing different-MOA combination therapy with same-MOA combination therapy for patients with partial-onset seizure. OBJECTIVE: To compare treatment persistence and health care use with AED combinations categorized by MOA in patients with partial-onset seizures. DESIGN, SETTING, AND PARTICIPANTS: Using the Truven Health MarketScan Commercial Claims Database containing 96 million covered lives from July 1, 2004, through March 31, 2011, adults with concomitant use of 2 different AEDs and a recent partial-onset seizure diagnosis were selected. Antiepileptic drugs were categorized by MOA: sodium channel blockers (SC), gamma-aminobutyric acid analogs (G), synaptic vesicle protein 2A binding (SV2), and multiple mechanisms (M). Patients were assigned a combination category based on their concomitant AED use. MAIN OUTCOMES AND MEASURES: Treatment persistence was measured from the start of AED combination therapy until the end of the combination. Health care resource use was measured during the combination treatment duration. Multivariate analyses evaluated AED discontinuation risk and health care use according to MOA combinations. RESULTS: Distribution of 8615 selected patients by combination was 3.3% for G+G, 7.5% for G+SV2, 8.6% for G+M, 13.9% for SC+SC, 19.0% for G+SC, 21.5% for SC+M, and 26.3% for SC+SV2. The same-MOA (G+G and SC+SC) combinations had the shortest persistence (mean [SD], 344 [345] days and 513 [530] days, respectively) and greater hazard of discontinuation compared with different-MOA combinations. Patients with different-MOA G combinations had a significantly lower risk for inpatient admission (odds ratio, 0.716; 95% CI, 0.539-0.952; P = .02) compared with G+G combinations. Patients with different-MOA SC combinations had significantly lower risks for emergency department visits (odds ratio, 0.853; 95% CI, 0.742-0.980; P = .03) compared with SC+SC combinations. CONCLUSIONS AND RELEVANCE: The findings suggest that AED combinations with different MOAs have greater effectiveness as measured by treatment persistence and lower risks for hospitalization and emergency department visits. Further research is needed to more fully understand the role of the MOA in achieving optimal outcomes.

Retrospective study of adherence to glucagon-like peptide-1 receptor agonist therapy in patients with type 2 diabetes mellitus in the United States.

INTRODUCTION: Greater adherence to medications has been broadly demonstrated to be associated with improved clinical outcomes. However, there is limited real-world evidence on adherence to glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy in patients with type 2 diabetes mellitus (T2DM). METHODS: This retrospective cohort study used United States administrative claims data to compare adherence to GLP-1RAs in T2DM patients initiating exenatide once weekly (QW), exenatide twice daily (BID), or once-daily liraglutide (initiated therapy = index therapy). Patients were included if they had T2DM, were GLP-1RA-naïve, initiated a GLP-1RA from 02/01/2012-01/31/2013 (date of initiation = index), were ≥18 years at index, and had continuous enrollment for 12 months before (baseline) to 6 months after index (follow-up). Study outcome was index GLP-1RA adherence (proportion of days covered [PDC] during follow-up, dichotomized at ≥80% vs. <80%, and at ≥90% vs. <90%). Multivariable logistic regressions compared adherence between the GLP-1RAs, adjusting for potential confounders. Sensitivity analyses were performed separating liraglutide by dose (1.2 mg/1.8 mg). RESULTS: Study sample included 4,041 exenatide QW, 4,586 exenatide BID, and 14,211 liraglutide (6,641 1.2 mg, 7,570 1.8 mg) patients. Median unadjusted PDC values were 0.783 for exenatide QW, 0.500 exenatide BID, 0.722 liraglutide, 0.761 liraglutide 1.2 mg, and 0.683 liraglutide 1.8 mg. Compared with patients treated with either exenatide BID or liraglutide, patients treated with exenatide QW had a statistically significantly greater multivariable-adjusted odds of achieving adherence of ≥80% (odds ratio vs. exenatide QW (OR) = 0.41 for exenatide BID; 0.80, liraglutide; 0.87, liraglutide 1.2 mg; 0.75, liraglutide 1.8 mg) and ≥90% (OR = 0.31 for exenatide BID; 0.60 liraglutide; 0.66 liraglutide 1.2 mg; 0.56 liraglutide 1.8 mg) (all P < 0.001). CONCLUSION: Patients initiating exenatide QW had significantly higher adjusted odds of adherence compared with patients initiating other GLP-1RAs. Given differences in adherence across the GLP-1RAs, research correlating these factors with clinical and economic outcomes is warranted.