Search

Background: Little is known about the real-world treatment patterns and costs of patients with chronic low back pain (CLBP) who are treated with duloxetine compared with those receiving other non-surgical treatments.Objective: Our objective was to compare the real-world treatment patterns and costs between patients with CLBP who initiated duloxetine and matched controls who initiated another non-surgical treatment.Methods: The study sample was selected from a US privately insured claims database (2004-8). Selected patients were aged 18-64 years, and had a low back pain (LBP) diagnosis (per Healthcare Effectiveness Data and Information Set [HEDIS] specifications) with a subsequent CLBP-qualifying diagnosis recorded ≥90 days after the initial LBP diagnosis. Duloxetine-treated patients had ≥1 duloxetine prescription within 6 months after CLBP diagnosis, no prior duloxetine claim, and continuous eligibility ≥12 months before first LBP diagnosis and ≥6 months after index duloxetine prescription (study period). Because duloxetine patients had higher rates of co-morbidities, 553 duloxetine-treated patients were matched to 553 control patients who initiated another non-surgical LBP treatment based on propensity score and time from first LBP diagnosis to treatment initiation. A subset (n = 103 each) of matched employees with disability data was also analysed to assess work loss. Main outcomes measures included study period treatment rates and direct (medical and drug) costs from a third-party payer perspective and employee indirect (work-loss) costs. McNemar tests were used to compare LBP treatment rates. Bias-corrected bootstrapping t-tests were used to compare costs.Results: After matching, the two groups had balanced baseline characteristics including demographics, LBP diagnostic categories, co-morbidity profiles, resource use, treatment patterns and mean direct costs. During the 6-month study period, matched duloxetine-treated patients had significantly lower rates of other pharmacological therapy (e.g. 56.2% vs 64.9% narcotic opioids, p = 0.0024; 34.9% vs 49.5% NSAIDs, p < 0.0001) and non-invasive therapy (28.8% vs 38.5% chiropractic therapy, p = 0.0007; 25.5% vs 35.4% physical therapy, p = 0.0004; 17.5% vs 28.4% exercise therapy, p < 0.0001) than controls. Duloxetine-treated patients versus controls had similar back surgery rates (2.2% vs 3.8%; p = 0.1127) and similar direct costs ($US7658 vs $US7439; p = 0.8119). Among CLBP employees, duloxetine-treated employees versus controls had lower rates of other non-surgical therapy, similar back surgery rates (0.0% vs 3.9%; p = 0.1250), lower total direct and indirect costs ($US5227 vs $US7299; p = 0.0418), and similar indirect costs ($US1806 vs $US2664; p = 0.0528).Conclusions: Duloxetine treatment in CLBP patients/employees versus other non-surgical treatment was associated with reduced rates of non-surgical therapies and similar back surgery rates, without increased costs. [ABSTRACT FROM AUTHOR]

Objective: Poststroke depression (PSD) has been linked to negative outcomes, including mortality and decreased functioning. However, the effect of PSD and other mental health conditions on inpatient and outpatient healthcare utilization after stroke has not been examined. The primary objective of this study was to evaluate the relationship between PSD and healthcare utilization after stroke. The secondary objective was to evaluate the relationship between other mental health diagnoses and medical utilization after stroke.Method: We examined 3 years of poststroke healthcare utilization data in a national cohort of veterans with ischemic stroke. Mental health diagnoses were identified with inpatient International Classification of Diseases, 9th Revision codes. Multivariate analysis of variance was used to compare patient characteristics and multivariate linear regression to model utilization in: 1) patients with PSD, 2) patients diagnosed with other mental health conditions poststroke, and 3) patients with no mental health diagnosis.Results: Of 51,119 veterans identified, 2405 (5%) received a PSD diagnosis and 2257 (4%) received a diagnosis of another mental health condition after their stroke. Patients with PSD had significantly more inpatient hospitalization days and outpatient visits than those without any mental health diagnosis, even after adjusting for the number of mental health clinic visits. Likewise, patients diagnosed with other mental health diagnoses had greater medical utilization than patients without any mental health diagnosis. Both PSD and other mental health diagnoses independently predicted medical utilization.Conclusion: Mental health diagnosis after stroke increases inpatient and outpatient healthcare utilization in the first 3 years poststroke. Additional biologic and psychosocial factors should be investigated. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Poststroke depression has been linked to higher mortality after stroke. However, the effect of other mental health conditions on poststroke mortality has not been examined. The objective of this study was to evaluate the effect of poststroke depression and other mental health diagnoses on mortality after ischemic stroke. METHOD: The authors examined a national cohort of veterans hospitalized after an ischemic stroke at any U.S. Department of Veterans Affairs (VA) medical center from 1990 to 1998. Demographic, admission, and all-cause mortality data were abstracted from VA administrative databases. Chronic conditions present at discharge and new poststroke depression and other mental health diagnoses within 3 years after the stroke were identified with ICD-9 codes. Mortality hazard ratios were modeled by using Cox regression models. RESULTS: A total of 51,119 patients hospitalized after an ischemic stroke who survived beyond 30 days afterward were identified; 2,405 (5%) received a diagnosis of depression, and 2,257 (4%) received another mental health diagnosis within 3 years of their stroke. Patients with poststroke depression were younger, more often white, and less likely to be alive at the end of the 3-year follow-up period. Both poststroke depression (hazard ratio=1.13, 95% CI=1.06-1.21) and other mental health diagnoses (hazard ratio=1.13, 95% CI=1.07-1.22) independently increased the hazard for death even after other chronic conditions were controlled. CONCLUSIONS: Despite being younger and having fewer chronic conditions, a higher 3-year mortality risk was seen in patients with poststroke depression and other mental health diagnoses after hospitalization for an ischemic stroke. The biological and psychosocial mechanisms driving this greater risk should be further explored, and the effect of depression treatment on mortality after stroke should be tested. [ABSTRACT FROM AUTHOR]

Objective: To examine the effectiveness of integrating generalist and specialist care for veterans with depression. Method: We conducted a randomized trial of patients screening positive for depression at two Veterans Affairs Medical Center general medicine clinic firms. Control firm physicians were notified prior to the encounter when eligible patients had PRIME-MD depression diagnoses. In the intervention firm, a mental health clinical nurse specialist (CNS) was to: design a treatment plan; implement that plan with the primary care physician; and monitor patients via telephone or visits at two weeks, one month and two months. Primary outcomes (depressive symptoms, patient satisfaction with health care) were collected at 3 and 12 months. Results: Of 268 randomized patients, 246 (92%) and 222 (83%) completed 3- and 12-month follow-up interviews. There were no between-group differences in depressive symptoms or satisfaction at 3 or 12 months. The intervention group had greater chart documentation of depression at baseline (63% versus 33%, p = 0.003) and a higher referral rate to mental health services at 3 months (27% versus 9%, p = 0.019). There was no difference in the rate of new prescriptions for, or adequate dosing of, anti-depressant medications. In 40% of patients, CNSs disagreed with the PRIME-MD depression diagnosis, and their rates of watchful waiting were correspondingly high. Conclusions: Implementing an integrated care model did not occur as intended. Experienced CNSs often did not see the need for treatment in many primary care patients identified by the PRIME-MD. Integrating integrated care models in actual practice may prove challenging. [ABSTRACT FROM AUTHOR]

Purpose: This study examines real-world, evidence-based comparisons of persistence and adherence to daily versus weekly glucagon-like peptide 1 (GLP-1) receptor agonists for the treatment of type 2 diabetes (T2D)., Methods: This retrospective observational study used U.S. insurance claims data to compare persistence and adherence to GLP-1 receptor agonists in patients with T2D initiating once weekly (QW) exenatide or daily liraglutide over a 6-month follow-up period. Eligible patients had ≥2 diagnoses of T2D, were 18 years of age or older, initiated a new prescription of either the index drug between February 1, 2012 (market availability launch date of exenatide QW) and March 31, 2013, and had ≥6 months continuous eligibility in the pre- and postindex periods. A 1:1 propensity score match was used to account for selection bias. Outcome measures included persistence as measured by the percentage of patients who continued to take the index drug over an index period of 182 days with an allowable gap of 60 days and adherence as measured by the proportion of days covered (PDC). The percentage of patients achieving PDC ≥0.8 and ≥0.9 was also calculated., Findings: There were no significant differences between baseline characteristics after propensity score matching. Each matched cohort included 12,306 patients. The overall persistence observed with liraglutide was 66% compared with 63% for exenatide QW. The mean (SD) PDC adherence during the 6-month follow-up period was 0.694 (0.309) for the exenatide QW cohort and 0.689 (0.286) for the liraglutide cohort. The PDC threshold of ≥0.8 during the 6-month follow-up period was met by 6309 (51%) and 5820 (47%) patients in the exenatide QW and liraglutide cohorts, respectively. For the exenatide QW cohort, 76% of patients treated previously with BID exenatide continued treatment in the 6-month follow-up period compared with 59% who were not previously treated with exenatide BID. For the liraglutide cohort, 77% of previous exenatide BID patients continued treatment versus 63% of patients who were not previously treated with exenatide BID., Implications: These results reveal slight differences in persistence and adherence rates in patients receiving exenatide QW versus patients receiving liraglutide daily that vary by outcome and previous incretin-based therapy used. Differences may be due to dosing device differences for exenatide QW and liraglutide, which, in the case of liraglutide, allows the opportunity for daily self-titration dosing. Implications of these findings for clinical practice are that persistence is determined by the broader context of treatment and medications being used and should be considered when prescribing GLP-1 receptor agonists., (Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.)

Objective: To assess the cost outcomes of patients with a history of depression and clinically significant fatigue., Methods: Adults with ≥ 2 claims with depression diagnosis codes identified from the HealthCore Integrated Research Database were invited to participate in this study linking survey data with retrospective claims data (12-mo presurvey and postsurvey periods). Patient surveys included measures for depression (Quick Inventory of Depressive Symptomatology), fatigue (Fatigue Associated with Depression Questionnaire), anxiety (7-item Generalized Anxiety Disorder scale), sleep difficulty (Athens Insomnia Scale), and pain (Brief Pain Inventory). After adjusting for demographic and clinical characteristics using propensity scores, postsurvey costs were compared between patients with and without fatigue using nonparametric bootstrapping methods., Results: Of the 1982 patients who had completed the survey and had complete claims data, 653 patients had significant levels of fatigue. Patients with fatigue reported significantly higher scores, indicating greater severity, on measures of depression, pain, sleep difficulty, and anxiety (all p < 0.05). These patients also had higher levels of overall medication use and were more likely to have lower measures of socioeconomic status than patients without significant levels of fatigue (all p < 0.05). Mean annual total costs were greater for patients with fatigue than those without fatigue ($14,462 vs $9971, respectively, p < 0.001). These cost differences remained statistically significant after adjusting for clinical and demographic differences., Conclusions: Clinically significant fatigue appears to add to the economic burden of depression. This reinforces the need for aggressive treatment of all symptoms and further examination of the variability of this relationship as patients approach remission., (Copyright © 2015 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: The study aims to examine real-world effects of duloxetine treatment for low back pain (LBP)., Methods: The study identified employees with ≥1 LBP diagnosis and ≥1 duloxetine prescription within a year after LBP diagnosis from a privately insured claims database (2004-2007). Duloxetine-treated employees were propensity score matched to employees initiating another pharmacological/noninvasive treatment in the same month from LBP diagnosis. Treatment patterns and costs were compared over the 6 months following treatment initiation., Results: Relative to controls, duloxetine-treated employees (N = 753) had significantly lower rates of other pharmacological/noninvasive therapies and a similar LBP surgery rate (1.7% vs 2.8%, P = 0.1573). Duloxetine-treated employees, despite higher pharmacy costs, had similar direct (health care) costs ($4,935 vs $5,649, P = 0.2662), and significantly lower indirect (workloss) costs ($1,723 vs $2,198, P = 0.0036)., Conclusions: Duloxetine treatment in LBP employees was associated with reduced rates of many nonsurgical therapies and lower indirect costs. The findings are limited by the observational study design and unmeasured potential confounders., (Wiley Periodicals, Inc.)

Background: While there are validated patient-reported outcomes (PRO) instruments for use in specific cancer populations, no validated general instruments exist for use in conditions common to multiple cancers, such as muscle wasting and consequent physical disability. The Medicare Current Beneficiary Survey (MCBS), a survey in a nationally representative sample of Medicare beneficiaries, includes items from three well known scales with general applicability to cancer patients: Katz activities of daily living (ADL), Rosow-Breslau instrumental ADL (IADL), and a subset of physical performance items from the Nagi scale., Objective: This study evaluated properties of the Katz ADL, Rosow-Breslau IADL, and a subset of the Nagi scale in patients with pancreatic cancer, lung cancer, and myeloproliferative neoplasms (MPN) using data from MCBS linked with Medicare claims in order to understand the potential utility of the three scales in these populations; understanding patient-perceived significance was not in scope., Methods: The study cohorts included Medicare beneficiaries aged ≥65 years as of 1 January of the year of their first cancer diagnosis with one or more health assessments in a community setting in the MCBS Access to Care data from 1991 to 2009. Beneficiaries had at least two diagnoses in de-identified Medicare claims data linked to the MCBS for one of the following cancers: pancreatic, lung, or MPN. The Katz ADL, Rosow-Breslau IADL, and Nagi scales were calculated to assess physical functioning over time from cancer diagnosis. Psychometric properties for each scale in each cohort were evaluated by testing for internal consistency, test-retest reliability, and responsiveness by comparing differences in mean scale scores over time as cancer progresses, and differences in mean scale scores before and after hospitalization (for lung cancer cohort)., Results: The study cohorts included 90 patients with pancreatic cancer, 863 with lung cancer, and 135 with MPN. Among each cancer cohort, the Katz ADL, Rosow-Breslau IADL, and Nagi scales had acceptable internal consistency (Cronbach's alpha generally between 0.70 and 0.90) and test-retest reliability for consecutive surveys before diagnosis and consecutive surveys after diagnosis (when patients' functioning was more stable). Compared with mean scale scores at the survey 1-2 years before cancer diagnosis (baseline), mean scale scores at the first survey after cancer diagnosis were significantly higher (P < 0.05), indicating worsening, for Katz ADL, Rosow-Breslau IADL, and Nagi scales (items scored 0-1) (0.54 vs. 1.45, 1.15 vs. 2.20, and 2.29 vs. 3.08, respectively, for pancreatic cancer; 0.73 vs. 1.24, 1.29 vs. 2.01, and 2.41 vs. 2.85 for lung cancer; and 0.44 vs. 0.86, 0.87 vs. 1.36, and 1.87 vs. 2.32 for MPN). Among lung cancer patients, scale scores increased significantly following a hospitalization, suggesting a worsening of functional status., Conclusions: The Katz ADL, Rosow-Breslau IADL, and Nagi scales collected in the MCBS demonstrate acceptable internal consistency and test-retest reliability among patients with pancreatic cancer, lung cancer, and MPN, and are consistent with clinical worsening following diagnosis or hospitalization. These results suggest that using retrospective data may allow researchers to conduct preliminary assessments of existing PRO instruments in new populations of interest and generate useful exploratory disease information before embarking on de novo PRO development.

Objective: To determine whether family members and friends can be accurate reporters of depression in older women and whether their reports predict diagnostic depression concurrently and across a one-year time interval., Method: African-American and Caucasian older women (N = 153; mean age = 75) previously screened for depression nominated network members (NMs) who could be contacted as informants. NMs completed an informant version of the CES-D, described their closeness to the participant, the extent of the participant's support from family and friends, and their assessment of the participant's typical coping strategies. These reports were then used to predict participant CES-D, Hamilton depression scores, and Structured Clinical Interview (SCID) depression diagnoses concurrently and at six-month and one-year intervals., Results: NMs' estimates of participants CES-D status were highly correlated with participants own CES-D scores, and also predicted Hamilton depression scores and SCID diagnoses concurrently and at six months and one year later. NMs' ratings of participants' use of positive coping also predicted depression at six months and one year., Conclusion: NMs knew when elderly women were depressed and their reports were accurate predictors of depression even one year later, which implies that elderly depression does not abate spontaneously. Future research should test the possibility that family and friends might be recruited as allies in encouraging earlier treatment and in providing support to older adults through difficult life transitions.

Background: The Provisional Diagnostic Instrument (PDI-4) is a brief, adult self-report instrument for 4 common psychiatric diagnoses in primary care patients: major depressive episode (MDE), generalized anxiety disorder (GAD), attention deficit hyperactivity disorder (ADHD), and bipolar I disorder based on past or present mania. Our objective was to assess validity of the PDI-4 in a population independent of the study population originally used to develop the scale., Methods: An online version of the 17-item PDI-4 was administered to 1,047 adults in the US; respondents also completed the PHQ-9, HADS-A, CAARS-S, and MDQ within the online survey. Respondents self-reported diagnosis by a healthcare professional with the terms depression (n=221), anxiety (n=218), attention deficit disorder (n=206), bipolar or manic depressive disorder (n=195), or none of these (n=207). Statistical analyses examined convergent and discriminant validity, and operating characteristics of the PDI-4 relative to the individual, validated, self-rated scales PHQ-9, HADS-A, CAARS-S, and MDQ, for each PDI-4 diagnosis., Results: Convergent validity of the PDI-4 was supported by strong correlations with the corresponding individual scales (range of 0.63 [PDI-4 and MDQ] to 0.87 [PDI-4 and PHQ-9]). Operating characteristics of the PDI-4 were similar to results in the previous site-based study. The scale exhibited moderate sensitivities (0.52 [mania] to 0.70 [ADHD]) and strong specificities (0.86 [mania] to 0.92 [GAD]) using the individual scales as the gold standards. ANOVAs demonstrated that PDI-4 discriminated between subsets of patients defined by pre-specified severity level cutoff scores of the individual scales. However, overlapping symptoms and co-morbidities made differentiation between mental diagnoses much weaker than differentiation from the control group with none of the diagnoses., Conclusions: The PDI-4 appears to be a suitable, brief, self-rated tool for provisional diagnoses of common mental disorders. However, the high level of symptom overlap between these diagnoses emphasizes that such brief scales are not a replacement for thorough diagnostic evaluation by trained medical providers.

Background: Duloxetine and venlafaxine extended release (venlafaxine XR) are SNRIs indicated for the treatment of MDD. This study addresses whether duloxetine and venlafaxine XR are interchangeable in their patterns of use with patients who are depressed or are used more selectively based on treatment history, background characteristics, and presenting symptoms., Methods: This was a retrospective analysis of an administrative insurance claims database. We studied patients in managed care with major depressive disorder (MDD) treated with duloxetine or venlafaxine XR. Predictors of treatment and cost were assessed using Chi-square and logistic regression analyses of demographics and past-year medication use and comorbidities., Results: Patients with MDD treated with duloxetine (n = 9,641) versus venlafaxine XR (n = 8,514) tended to be older, slightly more likely to be female, and treated by a psychiatrist (P < 0.0001). In the prior year, more duloxetine patients (vs. venlafaxine XR) received ≥ 3 unique antidepressants (20.8% vs. 16.6%), ≥ 3 unique pain medications (25.5% vs. 15.6%), and had ≥ 8 unique diagnosed comorbid medical and psychiatric conditions (38.6% vs. 29.1%). The prior 6-month total health care costs were $1,731 higher for duloxetine than for venlafaxine XR and declined for both medications in the 6 months after treatment began. Logistic regression analysis revealed that 61% of duloxetine patients and 61% of venlafaxine XR patients were predictable from prior patient and treatment factors., Conclusions: Patients with MDD treated with duloxetine tended to have a more complex and costly antecedent clinical presentation compared with venlafaxine XR patients, suggesting that physicians do not use the medications interchangeably.

Objective: To assess the performance of a two-choice (yes/no), 10-item shortened form of the CES-D in both African American (AA) and Caucasian (CA) older women. The CES-D is a widely used screening instrument, but its use has been questioned for routine screening because of its length and the complexity of its four-choice format. There is also little data available about its suitability low-income AA respondents., Method: Telephone screening for depression followed by in-home diagnostic interviews were conducted in a community sample of 256 CA and 186AA low-income older women who ranged in age from 64 to 94 years. Standard receiver operator curves were plotted to determine the sensitivities and specificities of the screening instrument at different cut-scores against a criterion of SCID-based diagnoses of current major depressive episode (CMDE)., Results: Sensitivity and specificity of the 10-item scale and an even shorter 5-item version was slightly higher for AA than for CA women. While both short forms produced significant numbers of false positives against a criterion of CMDE, many of the women identified by the screen did have significant depressive symptomatology. Significantly, fewer AA women received a diagnosis of CMDE primarily because they did not show diminution of functioning associated with their depressive symptoms., Conclusion: Short, easy to administer forms of the CES-D can provide useful information in working with older patients. Clinicians should be aware of ethnic differences in symptom expression and levels of functional impairment that are likely to occur in follow-up medical and psychiatric exams.

Objective: To examine the relationship between global functional impairment and the treatment of anxious symptoms and painful somatic symptoms (PSS) in patients with generalized anxiety disorder (GAD)., Research Design and Methods: Data from two double-blind, placebo-controlled trials in adult outpatients meeting DSM-IV criteria for GAD were pooled. In the first trial (9-week, fixed-dose treatment period), patients were randomized to duloxetine 60 mg QD (n=168), duloxetine 120 mg QD (n=170), or placebo (n=175). In the second trial (10-week, flexible-dose treatment period), patients were randomized to 60-120 mg QD of duloxetine (n=168) or placebo (n=159). Path analysis was used to assess the relative contributions of changes in psychic and somatic anxiety and PSS on improved functional outcomes., Clinical Trial Registration Information: Study 1: NCT00122824; Study 2: study completed before registration required., Main Outcome Measures: Sheehan Disability Scale (SDS), Hamilton Anxiety Rating Scale (HAMA), and Visual Analog Scale for overall pain (VAS)., Results: There was a moderate correlation (0.45, p<0.05) at endpoint between changes in global functional impairment and changes in psychic anxiety (controlling for somatic anxiety and PSS); whereas the correlation between changes in global functional impairment and changes in somatic anxiety (controlling for psychic anxiety and PSS) was weak (0.09, p<0.05). The correlation between changes in global functional impairment and changes in PSS (controlling for psychic and somatic anxiety) was weak (0.27, p<0.05). Path analysis revealed that 37% of the total improvement in functional impairment (Sheehan Disability Scale total score) due to duloxetine treatment was independent of improvement in the Hamilton Anxiety Rating Scale (HAMA) psychic and somatic anxiety subscale scores or Visual Analog Scale for overall pain (VAS) score. Improvement in psychic anxiety accounted for 47% of the total treatment effect on improvement of functional impairment, whereas 7% and 9% of the improvement in functional impairment was accounted for by improvements in somatic anxiety and overall pain, respectively.

It has been proposed that serotonin and norepinephrine reuptake inhibitors (SNRIs) may result in higher remission rates of major depressive disorder than therapy with selective serotonin reuptake inhibitors (SSRIs). To test this hypothesis, a meta-analysis of individual patient data (N = 1833) was performed for the complete set of 6 phase II/III studies that compared duloxetine (fixed doses; range, 40-120 mg/d) with 2 SSRIs (paroxetine or fluoxetine; 20 mg/d) in outpatients with major depressive disorder. Remission was defined as an end point score of less than or equal to 7 on the 17-item Hamilton Rating Scale for Depression (HAMD17); alternate outcome criteria were also examined, as were remission rates among the 1044 patients with moderate-to-severe depression (HAMD17 total score greater than or equal to 19). The HAMD17 remission rates were 40.3% (351/871), 38.3% (162/423), and 28.4% (144/507) for duloxetine, the 2 SSRIs, and placebo, respectively. Both active treatments were superior to placebo; the difference between duloxetine and SSRIs was not statistically significant. Similar findings were observed for alternate outcomes. Duloxetine therapy was significantly more effective than therapy with the 2 SSRIs for patients with more severe depression, with remission rates of 35.9% (183/510) versus 28.6% (70/245) (P = 0.046). A secondary analysis of dose-response relationships indicated that this advantage was not attributable to the studies using higher doses of duloxetine. Thus, whereas duloxetine and the 2 SSRIs were comparably efficacious overall, therapy with the serotonin and norepinephrine reuptake inhibitor resulted in a significantly higher remission rate among patients with moderate-to-severe depression.

Objective: Generalized anxiety disorder (GAD) is associated with impaired role functioning and diminished well-being. The present work examined the efficacy of duloxetine treatment for improving functional outcomes for patients with GAD in 3 independent clinical studies., Method: Studies were randomized, double-blind, placebo-controlled multicenter trials conducted in adult outpatients with DSM-IV-defined GAD. One study compared 9-week fixed-dose treatment with duloxetine 60 or 120 mg (N = 168 and N = 170, respectively) with placebo (N = 175). The other 2 studies compared 10-week flexible-dose treatment with duloxetine 60-120 mg (study 2, N = 168; study 3, N = 162) with placebo (study 2, N = 159; study 3, N = 161). The main functional outcome measure for each study was the Sheehan Disability Scale (SDS). Additional measures were the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form and the European Quality of Life 5 Dimensions. The 3 studies were conducted in the time period from June 2004 to November 2005., Results: Duloxetine-treated patients improved significantly more than placebo-treated patients on SDS global functioning (study 1, p

Background: Identify a group of adults with 'undiagnosed' attention deficit hyperactivity disorder (ADHD) and compare their personal and family medical histories, psychosocial profiles, functional impairment and quality of life with non-ADHD controls. Additionally, compare adults with undiagnosed and diagnosed ADHD to investigate possible reasons why the undiagnosed avoid clinical detection., Method: ICD-9 codes for ADHD in administrative claims records and responses to a telephone-administered adult ADHD screener [the Adult ADHD Self-Report Scale (ASRS)] were used to classify approximately 21000 members of two large managed health-care plans as 'undiagnosed' (no coded diagnosis; ASRS positive) or 'non-ADHD' controls (no coded diagnosis; ASRS negative). Patients identified as 'undiagnosed' ADHD were compared with samples of non-ADHD controls and 'diagnosed' ADHD patients (ICD-9 coded ADHD diagnoses) on the basis of demographics, socio-economic status, past and present mental health conditions, and self-reported functional and psychosocial impairment and quality of life., Results: A total of 752 'undiagnosed' ADHD subjects, 199 'non-ADHD' controls and 198 'diagnosed' ADHD subjects completed a telephone interview. Overall, the 'undiagnosed' ADHD cohort demonstrated higher rates of co-morbid illness and greater functional impairment than 'non-ADHD' controls, including significantly higher rates of current depression, and problem drinking, lower educational attainment, and greater emotional and interpersonal difficulties. 'Undiagnosed' ADHD subjects reported a different racial composition and lower educational attainment than 'diagnosed' ADHD subjects., Conclusion: Individuals with 'undiagnosed' ADHD manifest significantly greater functional and psychosocial impairment than those screening negative for the disorder, suggesting that ADHD poses a serious burden to adults even when clinically unrecognized.

Objective: To determine if the type of antidepressant drug is related to adherence to National Committee for Quality Assurance (NCQA) Antidepressant Medication Management (AMM) quality measures and to assess the 6-month health care costs among newly diagnosed depressed patients., Methods: The MarketScan Commercial Claims and Encounter database for medical and pharmacy claims from January 2001 to September 2004 was used to assess adherence to the 3 AMM quality-of-care measures. AMM measures include (a) acute phase, the percentage of eligible members who remained on antidepressant medication continuously for 3 months after the initial diagnosis as determined by at least 84 days supply of antidepressant drugs during the first 114 days following receipt of the index antidepressant; (b) continuation phase, the percentage of eligible members who remained on antidepressant medication continuously for the 6 months after the initial diagnosis as determined by at least 180 days supply of antidepressants during the first 214 days following receipt of the index antidepressant; and (c) practitioner contacts, the percentage of members who received at least 3 follow-up office visits or telephone contacts with health care providers, including at least 1 contact with a practitioner licensed to prescribe (may not necessarily be the prescriber of the antidepressant). A fourth measure, overall adherence, was added, if all 3 AMM measures were met. Multivariate regression models determined demographic, clinical (such as receipt of mental health specialty care, the Charlson Comorbidity Index score, and co-occurring bipolar or schizophrenia), and therapy-related factors associated with outcomes of adherence and costs (paid amounts for insurance-reimbursable health care services for inpatient admissions, emergency department services, outpatient services, and outpatient prescription drugs). Health care expenditures (both total and mental-health-specific costs) were measured for each patient for 6 months following the date of service for the index antidepressant., Results: A total of 60,386 adult patients (10.7%) of 562,898 patients with a depression diagnosis met NCQA inclusion criteria in the AMM Technical Specifications (e.g., aged 18 years or older, newly diagnosed with depression and initiating antidepressant therapy, 365 days of continuous enrollment; patients were excluded if there were missing data on dose or quantity of index drug in pharmacy claims or initiated therapy on 2 or more antidepressants as the index medication, exclusion criteria not in the AMM Technical Specifications). Only 19% of patients achieved overall adherence. Rates for the 3 AMM measures were 39% for practitioner contacts, 65% for acute phase, and 44% for continuation phase. Receipt of mental health specialty care was the only factor that was positively associated with greater adherence on all 4 measures (overall measure: odds ratio [OR]=3.895, 95% confidence interval [CI], 3.72-4.07; acute OR=1.38, 95% CI, 1.33-1.43; continuation OR=1.46, 95% CI, 1.41-1.51; contacts OR=5.83, 95% CI, 5.62-6.06). Most patients were initiated on selective serotonin reuptake inhibitors (SSRIs, 69.5%), followed by venlafaxine (21.4%), tricyclic antidepressants (TCAs, 21.4%), bupropion (11.0%), and other antidepressants (e.g., mirtazapine, nefazadone, trazadone; 7.2%). Before adjustment for confounding factors, patients initiated on venlafaxine, TCAs, or other antidepressants had higher rates of adherence on the overall performance measure versus initiators on SSRIs, but the absolute differences were relatively small: 21.4% for venlafaxine and TCAs and 23.1% for other antidepressants versus 18.5% for SSRIs (P <0.001). Patients initiated on venlafaxine, TCAs, or other antidepressants were also more likely to receive care from a mental health specialist, 16.8%, 15.0%, and 54.8%, respectively, compared with SSRIs (13.0%, all P <0.001). Regression analysis showed that only venlafaxine had a higher OR (1.13; 95% CI, 1.05-1.22) compared with SSRIs for adherence on the overall measure. Initiating dose level was in the target range for 70.0% of all patients (24.9% were below target dose and 5.2% above target dose), and adherent patients on all 3 AMM measures were less likely than nonadherent patients (70.4% vs. 68.4%, P <0.001) to be initiated in the target dose range. After multivariate adjustment, the initiating dose (target vs. high) was a significant factor in explaining adherence to the overall measure (OR=1.26; 95% CI, 1.16- 1.37). Adherent patients had 6-month median unadjusted total health care expenses that were nearly 2 times higher compared with nonadherent patients ($5,169 vs. $2,734) and mental health expenditures that were nearly 3 times higher ($1,922 vs. $677). After adjustment, adherent patients compared with nonadherent patients incurred an additional $644 in mental health expenditures and $806 in overall health care expenditures in the 6 months following initiation of antidepressant therapy., Conclusions: Only 19% of depressed patients initiated on antidepressants met all 3 criteria set forth in the NCQA Health Plan Employer Data and Information Set (HEDIS) AMM quality-of-care performance measures. Receipt of mental health specialty care was the single factor most strongly associated with quality treatment by these measures. Type and dosage level of initial antidepressant was associated with adherence to the NCQA HEDIS AMM measures, but the absolute difference in rates of adherence were relatively small among types of antidepressants. Costs were higher for guideline-adherent individuals in the 6 months following treatment initiation. These analyses were limited to administrative claims that lack indicators of depression disease severity.

Background: This study aimed to identify the predictors and outcomes of SSRI antidepressant continuation, discontinuation and switching over a 9-month period of naturalistic observation., Methods: Primary care patients (n=573) with physician-diagnosed depression from 37 practices were randomized to an open-label trial of one of three selective serotonin reuptake inhibitors (SSRIs) managed in their primary care setting. Psychiatric characteristics and treatment course were assessed at baseline and at 1, 3, 6 and 9 months after medication initiation., Results: Nineteen percent of patients switched SSRIs, which occurred significantly sooner than discontinuation (median: 41 vs.100 days). Time to discontinuation was primarily explained by baseline patient skepticism about taking an antidepressant (62% increase in discontinuation risk). In contrast, time to switch was associated with greater impairment at baseline and lesser improvement in impairment during the first month on medication. Patients who discontinued were significantly less likely to be depressed 9 months after starting medication than those who either continued or switched medication, and were less symptomatic and impaired than patients who switched., Conclusions: Baseline impairment may increase the risk for SSRI antidepressant switching. Additionally, patient skepticism about antidepressants predicts early SSRI discontinuation and may predict rapid recovery. Intent-to-treat analyses in nonrandomized clinical trials may paradoxically inflate antidepressant effect sizes.

Sexual and relationship characteristics of men in the general population, particularly those with erectile dysfunction (ED), are not well established. This Internet-based survey (N = 700) examined demographic, sexual, and relationship characteristics of two groups of men aged 40-70: those with no ED (n = 589) and those with probable ED (n = 111). Compared to men without ED, men in the ED sample were significantly older, had more medical conditions, and had significantly worse sexual, psychological, and relationship function. Sexual function and relationship and psychological characteristics were significant predictors of overall sexual satisfaction and relationship satisfaction.

When with at least 95% confidence a new treatment is shown to be not only less costly (LC), but also more effective (ME), than a current treatment, that new treatment can be said to "strictly dominate" the current treatment statistically. But what can be said when head-to-head treatment comparisons turn out to be less clear-cut than this? Here, we propose two additional sets of specific LC and/or ME confidence thresholds to define the concepts of "some dominance" and "much dominance." Confidence levels associated with entire quadrants of the incremental cost-effectiveness (ICE) plane are easily computed using the same bootstrapping techniques used to estimate an "acceptability curve." Our two proposed additional "degrees" of dominance, although less stringent than strict dominance, are nevertheless more stringent than commonly accepted approaches using ICE ratio or net benefit calculations. To illustrate analysis concepts, we use data from a randomized, double-blind, placebo- and active comparator-controlled clinical registration trial for treatment of major depressive disorder (MDD). As is typical, our case study is rather small and short term, providing outcome information for a total of only 264 patients during their initial 8 weeks of acute-phase MDD treatment. Thus, we focus attention on sensitivity analyses, showing that the bootstrap distribution of cost-effectiveness uncertainty is robust across two alternative ways of measuring overall effectiveness and three alternative ways of imputing missing values. Evaluation of the balance between cost and benefit is particularly difficult when a new pharmacological treatment is first introduced, yet information of this sort is highly desired by decision makers. We show that, even with only a relatively modest amount of clinical trial information, sensitivity analyses can still confirm that cost-effectiveness comparisons are being made in a consistent fashion. In contrast, extensive follow-up comparisons using data from actual clinical practice will almost always ultimately be needed to better inform health policy makers.

Erectile dysfunction (ED) is associated with complex psychological and interpersonal issues. A new measure of treatment outcome, the Psychological and Interpersonal Relationship Scales (PAIRS), was developed to evaluate the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Initial items were generated based on literature review, focus groups and market research, interviews with patients and partners, and consultation with expert clinicians. Domains of Sexual Self-Confidence, Spontaneity, and Time Concerns were identified and subsequently confirmed by factor analysis. A series of validation studies was performed with four separate samples, including assessment of internal consistency and test-retest reliability, convergent and discriminant validity, and treatment responsiveness. Samples for these studies included men recruited from clinical trials for ED in several countries ( N =413) and a community sample ( N =801). Findings from these studies indicate that PAIRS demonstrates adequate psychometric properties and appears well suited for use in further clinical studies of treatments for ED. It provides a broader assessment of treatment outcome than current measures of erectile function.

Our purpose was to understand premenstrual symptomatology and treatment-seeking behaviors by examining three subjective measurement approaches for premenstrual syndrome (PMS), their relationship to social functioning interference, and the role of symptom severity in a broader model of help seeking for PMS. Cross-sectional data were obtained from 1022 mail survey respondents who were derived from a nationally representative random sample of women, aged 18-49, experiencing regular menstrual cycles. Statistical analyses included Pearson correlations, chi-square tests, t tests, and logistic regression. The three symptom severity measures (a global self-appraisal, summative symptom counting, and categorical-configural) were strongly intercorrelated, ranging from. 60 to.78 (p < 0.001), and were correlated with interference in social and occupational functioning domains, ranging from.44 to.77 (all p < 0.001). A global self-report measure identified 4.9% of women with severe symptoms, whereas a DSM-IV-adapted approach identified 11.3% with premenstrual dysphoric disorder (PMDD) symptoms (of whom 92% also reported social interference). PMS treatment seeking was predicted by older age, PMS symptoms experienced in most cycles, greater self-reported symptom severity, greater overall use of healthcare services, and less negative attitudes toward PMS (all p < 0.05). These findings support the feasibility of clinician's use of brief screening approaches for PMDD, especially using short summative symptom rating scales. Women underidentify the severity of their PMS difficulties despite the reported difficulties associated with consistent social and occupational interference in most life domains. They are also reluctant to seek help for treatable PMS symptoms because of attitudinal barriers regardless of the severity of their PMS symptoms.

Previous studies have suggested that a considerable number of depressed patients suffer from sustained or repeated episodes of depressive symptoms. We developed a risk factor index based on data obtained at admission to treatment predicting sustained nonremission of depressive symptoms over 4 years for a sample of 370 unipolar depressed inpatients and outpatients. The six risk factors for sustained nonremitted depression are: less education, more severe initial depressive mood and ideation, secondary major depression, prior treatment, comorbid medical conditions, and fewer close relationships. These findings suggest that identification of these risk factors before selecting treatment type and intensity may improve long-term clinical outcomes.

Objective: To identify the characteristics of cost-effective inpatient substance abuse treatment programs., Data Sources/study Setting: A survey of program directors and cost and discharge data for study of 38,863 patients treated in 98 Veterans Affairs treatment programs., Study Design: We used random-effects regression to find the effect of program and patient characteristics on cost and readmission rates. A treatment was defined as successful if the patient was not readmitted for psychiatric or substance abuse care within six months., Principal Findings: Treatment was more expensive when the program was smaller, or had a longer intended length of stay (LOS) or a higher ratio of staff to patients. Readmission was less likely when the program was smaller or had longer intended LOS; the staff to patient ratio had no significant effect. The average treatment cost $3,754 with a 75.0% chance of being effective, a cost-effectiveness ratio of $5,007 per treatment success. A 28-day treatment program was $860 more costly and 3.3% more effective than a 21-day program, an incremental cost-effectiveness of $26,450 per treatment success. Patient characteristics did not affect readmission rates in the same way they affected costs. Patients with a history of prior treatment were more likely to be readmitted but their subsequent stays were less costly., Conclusions: A 21-day limit on intended LOS would increase the cost-effectiveness of treatment programs. Consolidation of small programs would reduce cost, but would also reduce access to treatment. Reduction of the staff to patient ratio would increase the cost-effectiveness of the most intensively staffed programs.

Objective: To develop a case mix model for inpatient substance abuse treatment to assess the effect of case mix on readmission across Veterans Affairs Medical Centers (VAMCs)., Data Sources/study Setting: The computerized patient records from the 116 VAMCs with inpatient substance abuse treatment programs between 1987 and 1992., Study Design: Logistic regression was used on patient data to model the effect of demographic, psychiatric, medical, and substance abuse factors on readmission to VAMCs for substance abuse treatment within six months of discharge. The model predictions were aggregated for each VAMC to produce an expected number of readmissions. The observed number of readmissions for each VAMC was divided by its expected number to create a measure of facility performance. Confidence intervals and rankings were used to examine how case mix adjustment changed relative performance among VAMCs., Data Collection/extraction Methods: Ward where care was provided and ICD-9-CM diagnosis codes were used to identify patients receiving treatment for substance abuse (N = 313,886)., Principal Findings: The case mix model explains 36 percent of the observed facility level variation in readmission. Over half of the VAMCs had numbers of readmissions that were significantly different than expected. There were also noticeable differences between the rankings based on actual and case mix-adjusted readmissions., Conclusions: Secondary data can be used to build a reasonably stable case mix model for substance abuse treatment that will identify meaningful variation across facilities. Further, case mix has a large effect on facility level readmission rates for substance abuse treatment. Uncontrolled facility comparisons can be misleading. Case mix models are potentially useful for quality assurance efforts.

Many health care system, including that of the Department of Veterans Affairs (VA), are facing dramatic changes as they adapt to state-level reform legislation and move into managed care environments. As new costing systems are designed and as researchers seek to conduct cost-effectiveness studies to guide health policy, it is critical to examine the assumed validity of the measurement procedures on which these costing systems are based. The foundation for VA health care costing is the cost distribution report, which is created by combining data on expenditures and workload with local service chiefs' estimates of program staffing and resource use. To evaluate the accuracy of the cost distribution report, the authors compared data from the report to cost data obtained in three multisite studies. Substantial differences were found between the cost distribution report and these independent sources, suggesting that researchers should not place uncritical reliance on the cost distribution report. The accuracy of costing data in information systems being implemented by VA will be limited to the extent they rely on the existing VA cost distribution system. Several strategies can be used in studies with a cost component to compensate for imperfect cost distribution systems.

Assessment of therapeutic orientation is a significant problem in substance abuse program evaluation. This study reports the initial results of a new approach to measuring treatment orientation through a self-report survey that focuses on distinctive features of substance abuse treatment orientations. The Drug and Alcohol Program Treatment Inventory (DAPTI) assesses treatment goals and activities specific to eight orientations: AA/12 Step, Therapeutic Community, Cognitive-Behavioral, Insight/Psychodynamic, Rehabilitation, Dual Diagnosis, Medical and Marital/Family Systems. We present findings from a nationwide assessment of 327 Veterans Administration (VA) Substance Abuse treatment programs that demonstrate promising subscale internal consistency, discriminant validity, and concurrent validity. In addition, the DAPTI distinguishes between programs with independently verified orientations and between inpatient, extended care, outpatient, and methadone maintenance programs. The DAPTI may be helpful in systematically assessing differences in treatment orientations between different types of programs, such as inpatient, community residential, and outpatient care.

This study examined the patient case mix and program determinants of 6-month readmission rates and early treatment dropout for 7,711 VA inpatients with both substance abuse and major psychiatric disorders treated in one of 104 substance abuse programs. Patients were treated in one of three types of inpatient programs: explicitly designed dual diagnosis specialty programs, substance abuse programs with a dual diagnosis psychotherapy group or standard substance abuse programs. Dual diagnosis specialty programs differed from regular substance abuse programs in that they had a more severe case mix, a higher 180-day readmission rate, greater dual diagnosis treatment orientation, used more psychotropic medication, had longer lengths of stay, had greater tolerance of relapse and medication noncompliance, and a higher rate of psychiatric aftercare in the 30 days after discharged. Programs with less severe case mix, longer intended and actual length of stay, lower 7-day dropout rates, greater tolerance of problem behavior, 12-step groups, and higher immediate postdischarge utilization of outpatient mental health treatment lower 180-day readmission rates. Programs with less severe patient case mix, more use of psychotropic medications but less of methadone and antabuse, less varied and diverse treatment activities, and low use of patient-led groups had lower dropout rates.

This study examines program determinants of one aspect of VA inpatient substance abuse treatment program performance. Performance was measured by the ratio of a program's readmission rate to the expected rate for programs with similar patients. Six-month readmission rates in 101 VA treatment programs were analyzed. Preliminary analyses indicated that patient differences across programs accounted for 36% of the variance in readmission rates. Program differences accounted for 47% of the variance in case-mix-adjusted readmission rate. Among program factors selected through a literature review, better than expected readmission performance was associated with having fewer early discharges, a longer intended treatment duration, more patient participation in aftercare, more family or friend assessment interviews, and treating more patients on a compulsory basis. Performance was not related to stress management training, patient attendance at more self-help meetings during treatment, staff characteristics, or average staff costs per patient day. The findings indicate that treatment retention, duration, and increased aftercare may be targeted to reduce high readmission rates. Last, there were only small differences in the model over 30, 60, 90, and 365 day follow-up intervals, suggesting substantial stability of the findings.

The purpose of this paper to describe the Department of Veterans Affairs' (VA) recent expansion and enhancement of its substance abuse treatment services. Several treatment innovations are considered from both clinical and administrative perspectives. These services include extended care programs for multiply impaired patients, programs for substance abuse patients with comorbid psychiatry conditions and services designed to improve continuity of care and community re-entry. Emergent themes include a broadening of services to meet the needs of a changing substance abuse population and an emphasis on providing more cost-efficient treatment.

Little is known about the effects of psychosocial factors on the long-term course of unipolar depression. This article examines the 4-year stability and change in life stressors, social resources, and coping, and their effect on the course of treated unipolar depression among 352 men and women. Depressed patients were assessed at treatment intake and at 1-year and 4-year follow-ups. Over the 4 years, patients improved in symptom outcomes, the quality of social resources, and coping responses; there were some declines in life stressors. Life stressors, social resources, and coping were related to patient functioning concurrently, after controlling for demographics, initial treatment, and initial dysfunction severity. Preintake medical conditions and family conflict consistently predicted poorer long-term outcomes. The findings imply that medical conditions and family conflict are important risk factors that predict poorer long-term outcome of depression.