Healthcare Resource Utilization and Costs in Celiac Disease: A US Claims Analysis.

INTRODUCTION: Celiac disease (CeD) is a lifelong immune-mediated enteropathy in which dietary gluten triggers an inflammatory reaction in the small intestine. This retrospective cohort study examines healthcare resource utilization (HRU) and costs between patients with CeD and matched controls. METHODS: Patients with CeD (cases) with an endoscopic biopsy and ≥2 medical encounters with a CeD diagnosis between January 1, 2010, and October 1, 2015, were identified in the MarketScan databases. The date of the first claim with a CeD diagnosis on or after the endoscopic biopsy was the index date. Cases were matched 1:1 to patients without CeD (controls) on demographic characteristics and Deyo-Charlson Comorbidity Index score. Clinical characteristics, all-cause, and CeD-related HRU and costs (adjusted to 2017 US dollars) were compared between cases and controls during the 12 months before (baseline) and 24 months after (follow-up) the index date. RESULTS: A total of 11,008 cases (mean age 40.6 years, 71.3% women) were matched to 11,008 controls. During the follow-up, a higher proportion of cases had all-cause and CeD-related HRU including inpatient admissions, emergency department visits, gastroenterologist visits, dietician visits, endoscopic biopsies, and gastroenterology imaging (all P ≤ 0.002). Incremental all-cause and CeD-related costs were in the first ($7,921 and $2,894) and second ($3,777 and $935) year of follow-up, driven by outpatient services costs. DISCUSSION: In this US national claims database analysis, there was evidence of an increase in both all-cause and CeD-related HRU and related costs in patients with CeD compared with matched patients without CeD, suggesting a significant economic burden associated with CeD.

Comparison Of Methods To Estimate Disease-Related Cost And Healthcare Resource Utilization For Autoimmune Diseases In Administrative Claims Databases.

BACKGROUND: Establishing disease-related cost and/or healthcare resource utilization (HCRU) is an important aspect of health outcomes research, particularly when considering the cost offset of novel treatments. However, few studies have compared methodologies used to assess disease-related cost/HCRU. METHODS: Data from the United States IBM® MarketScan® Research Databases were used to compare four different methods of calculating disease-related cost and HCRU in patients with rheumatoid arthritis (RA). The analysis was repeated, in part, for patients with ulcerative colitis (UC) to explore the generalizability of findings to a second autoimmune disease. Four methods of disease-related cost/HCRU attribution were selected following a literature search for potential methods: Method 1, claim-wide cost/HCRU attribution based on claim-listed diagnosis codes and a predetermined disease-related medication list (pharmacy claims only); Method 2, line-item cost/HCRU attribution based on procedures/medications more likely to occur in disease cases than in matched controls at two likelihood ratio cutoffs (1.5× and 3.5×); Method 3, disease-related cost/HCRU calculated as the difference in total average cost/HCRU between cases and matched controls; Method 4, line-item cost/HCRU attribution based on clinician manual determination of procedures/medications related to the disease. RESULTS AND CONCLUSION: Overall, 24,373 patients with RA and 9665 with UC were included. Average total cost during 2015 was $US28,750 per patient with RA and $US20,480 per patient with UC. Disease-related cost and HCRU for RA calculated using Method 4 were most closely approximated by Methods 1 and 2 (3.5×), with Method 2 (3.5×) the closest approximation. However, in certain research scenarios, the simplest method compared in this analysis, Method 1, may provide an adequate approximation of disease-related cost and HCRU. Although Method 4 was not executed in the UC analysis because of its labor-intensive nature, similar patterns of disease-related cost and HCRU were observed for Methods 1-3 in patients with UC and RA.

Healthcare utilization and costs of children with attention deficit/hyperactivity disorder initiating atomoxetine versus extended-release guanfacine.

OBJECTIVES: To compare 1-year direct healthcare costs and utilization among children and adolescents initiating non-stimulant medications atomoxetine (ATX) or extended-release guanfacine (GXR). METHODS: In this retrospective, observational cohort study, children and adolescents aged 6-17 years with attention deficit/hyperactivity disorder (ADHD) who had ≥1 prescription claim for ATX or GXR between December 31, 2009 and January 1, 2011 were identified in the MarketScan Commercial or Multi-State Medicaid claims databases. The first claim was set as the index. Patients with no claims for other ADHD medications that overlapped with the days' supply for the index therapy during the post-period were classified as initiating monotherapy. All-cause and ADHD-related utilization and costs (2011 US$) and treatment patterns (adherence and persistence) were evaluated during the 12 months following index. Propensity score adjustment accounted for differences in patient characteristics, and bootstrapping was used for comparisons. RESULTS: A total of 13,239 children and adolescents with ADHD met the study criteria (4,411 ATX initiators and 8,828 GXR initiators). There were 2,699 ATX monotherapy patients. In propensity-score-adjusted analyses, mean all-cause total costs were significantly less for monotherapy ATX initiators than for GXR initiators ($7,553 vs $10,639; difference = -$3,086, p < .0001), as were mean ADHD-related total costs ($3,213 vs $4,544; difference = -$1,330, p < .0001). Monotherapy ATX initiators had significantly fewer all-cause and ADHD-related total medical visits and ∼22 days shorter persistence to index therapy (p < .0001). Results were similar for secondary analyses comparing all ATX with all GXR initiators, regardless of monotherapy or combination regimen, and comparing only monotherapy initiators. CONCLUSIONS: Children and adolescents with ADHD who initiated ATX monotherapy incurred lower all-cause and ADHD-related total healthcare costs than patients who initiated GXR. This was due in part to less healthcare resource utilization and slightly shorter persistence for ATX patients. These findings may aid decision-making and inform future studies, but must be tempered due to inherent observational research limitations.

Predictors of 30 day hospital readmission in patients with type 2 diabetes: a retrospective, case-control, database study.

OBJECTIVE: To assess factors predictive of all-cause, 30 day hospital readmission among patients with type 2 diabetes in the United States. METHODS: A retrospective, case-control study using deidentified Humedica electronic health record data was conducted to identify patients ≥18 years old with ≥6 months of data prior to index hospitalization (pre-period) and ≥30 days of data after discharge (post-period). Combined methods of bootstrap resampling and stepwise logistic regression were used to identify factors associated with readmission. RESULTS: Among 52,070 patients with type 2 diabetes and an initial hospitalization for any reason, 5201 (10.0%) patients were readmitted within 30 days and 46,869 (90.0%) patients showed no evidence of readmission. Diabetic treatment escalation; race; type 2 diabetes diagnosis prior to the index stay; pre-period heart failure; and number of pre-period, inpatient healthcare visits were among the strongest predictors of 30 day readmission. From a receiver-operating characteristic plot (mean area under curve of 0.693), the predictive accuracy of the final logistic regression model is considered modest. This result might be due to the unavailability of some variables or data. CONCLUSIONS: These results highlight the importance of the appropriate recognition of and treatment for type 2 diabetes, prior to and during hospitalization and following discharge, in order to impact a subsequent hospitalization. In our analysis, escalation of diabetic treatments (especially those escalated from having no records of anti-diabetic medications to treatment with insulin) was the strongest predictor of 30 day readmission. Limitations of this study include the fact that hospitalizations and other encounters, outside the Humedica network, were not captured in this analysis.

Initial duloxetine prescription dose and treatment adherence and persistence in patients with major depressive disorder.

Adherence and persistence with medication therapy are important in the management of major depressive disorder. This study examined the association between initial prescription dosage of duloxetine and its adherence and persistence. In a large commercial managed-care claims database, 6132 patients with major depressive disorder were initiated on duloxetine between 1 July 2005 and 30 June 2006 at low dose (<60 mg/day, n=1989), mid dose (60 mg/day, n=3733), or high dose (>60 mg/day, n=410). Adherence was defined as medication possession ratio more than or equal to 0.8, and persistence was defined as the length of therapy without exceeding a 15-day gap. Over a 6-month period after duloxetine initiation, mid-dose initiated patients had a higher adherence rate (42.2%) than low-dose (35.6%, P<0.001) or high-dose initiated patients (36.1%, P<0.001). Mid-dose duloxetine-initiated patients stayed significantly longer with the medication (107.3 days) compared with low-dose (95.8 days, P<0.01) or high-dose patients (95.4 days, P<0.01). After adjustment for baseline demographics, comorbid conditions, and prior medications, mid-dose initiated patients remained to have better adherence and longer persistence than low-dose or high-dose initiators. The findings suggest that patients initiated with a dose of 60 mg/day of duloxetine seem to be more adherent to and persistent with the medication than those initiated with less or more than 60 mg/day.

Optimizing the ability of the Hamilton Depression Rating Scale to discriminate across levels of severity and between antidepressants and placebos.

Efforts to improve the Hamilton Rating Scale for Depression (HRSD) have included shortening the scale by selecting the best performing items, lengthening the scale by assessing additional symptoms, modifying the format and scoring of existing items, and developing structured interview guides for administration. We defined item performance exclusively in terms of the ability of items to discriminate differences among levels of depressive severity which has not be used to guide any revisions of the HRSD conducted to date. Two techniques derived from item response theory were used to improve the ability of the HRSD to discriminate among individuals with different degrees of depressive severity. Item response curves were used to quantify the ability of items to discriminate among individual differences in depressive severity, on the basis of which the most discriminating items were selected. Maximum likelihood estimates were used to compute an optimal depressive severity score, using all items, but which weighted highly discriminating items more so than items that did not discriminate well. The utility of each method was evaluated by comparing a subset of optimally discriminating items and maximum likelihood estimates of depressive severity to the Maier Philipp subscale of the HRSD, in terms of how well scales discriminate treatment effects. Effect sizes for overall change in depression severity as well as effect sizes differentiating response to treatment versus placebo were evaluated in a sample of 491 patients receiving fluoxetine and 494 patients receiving placebo. Results of analyses identified a new subset of items (IRT-6), selected on the basis of their ability to discriminate among differences in depressive severity, that accounted for more variance in full-scale HRSD scores and was better at detecting change in illness severity than the Maier Philipp subscale of the HRSD. The IRT-6 subscale was equally good as the Maier Philipp subscale in differentiating treatment from placebo response. No evidence supporting the benefits of using maximum likelihood estimates to develop optimally performing subscales was found. Implications of the results are discussed in terms of strategies for optimizing the assessment of change in overall depression severity as well as differentiating treatment response.

Cost-effectiveness of duloxetine versus routine treatment for U.S. patients with diabetic peripheral neuropathic pain.

UNLABELLED: The purpose of this study was to compare the cost-effectiveness of duloxetine versus routine treatment in management of diabetic peripheral neuropathic pain (DPNP). Two hundred thirty-three patients with DPNP who completed a 12-week, double-blind, placebo-controlled, randomized, multicenter duloxetine trial were re-randomized into a 52-week, open-label trial of duloxetine 60 mg twice daily versus routine treatment. Routine treatment included pain management therapies. Effectiveness was measured by using the bodily pain domain (BP) of the Medical Outcomes Study Short Form 36 (SF-36). Costs were analyzed from 3 perspectives: third party payer (direct medical costs), employer (direct and indirect medical costs), and societal (patient's out-of-pocket costs and total medical costs). Costs of study medications were not included because of limited data. Bootstrap method was applied to calculate statistical inference of the incremental cost-effectiveness ratio (ICER). Routine treatment most frequently used included gabapentin (56%), venlafaxine (36%), and amitripytline (15%). From employer and societal perspectives, duloxetine was cost-effective (ICER= -342 dollars and -429 dollars, respectively, per unit of SF-36 BP; both P

An Item Response analysis of the Hamilton Depression Rating Scale using shared data from two pharmaceutical companies.

Although the Hamilton Depression Rating Scale (HAMD) remains the most widely used outcome measure in clinical trials of Major Depressive Disorder, the psychometric properties of the individual HAMD items have not been extensively studied. In the present paper, data from four separate clinical trials conducted independently by two pharmaceutical companies were analyzed to determine the relationship between scores on the individual HAMD items and overall depressive severity in an outpatient population. Option characteristic curves (the probability of scoring a particular option in relation to overall HAMD scores) were generated in order to illustrate the relationship between scoring patterns for each item and the range of total HAMD scores. Results showed that Items 1 (Depressed Mood) and 7 (Work and Activities), and to a lesser degree, Items 2 (Guilt), 10 (Anxiety/Psychic), 11 (Anxiety/Somatic), and 13 (Somatic/General) demonstrated a good relationship between item responses and overall depressive severity. However, other items (e.g. Insight, Hypochondriasis) appeared to be more problematic with regard to their ability to discriminate over the full range of depression severity. The present results illustrate that co-operative data sharing between pharmaceutical companies can be a useful tool for improving clinical methods.