Treatment patterns in patients with type 2 diabetes mellitus treated with glucagon-like peptide-1 receptor agonists: Higher adherence and persistence with dulaglutide compared with once-weekly exenatide and liraglutide.

AIMS: To compare adherence (proportion of days covered [PDC]), persistence, and treatment patterns among patients with type 2 diabetes mellitus (T2DM) newly initiating glucagon-like peptide-1 receptor agonists (GLP-1RAs). More specifically, the main objectives were to compare dulaglutide vs exenatide once weekly and dulaglutide vs liraglutide. METHODS: Patients with T2DM newly initiating dulaglutide, albiglutide, exenatide once weekly, exenatide twice daily and liraglutide between November 2014 and April 2015 were hierarchically selected from Truven Health's MarketScan Research Databases. Propensity score matching was used to account for selection bias. Adherence to and persistence with the index GLP-1RA, and switching and augmentation patterns were assessed during the 6-month post-index period. RESULTS: Mean adherence for the matched cohorts was significantly higher for dulaglutide than for exenatide once weekly (0.72 vs 0.61; P < .0001) and liraglutide (0.71 vs 0.67; P < .0001). The percentage of patients achieving PDC ≥ 0.80 was significantly higher for dulaglutide compared with exenatide once weekly (54.2% vs 37.9%; P < .0001) and liraglutide (53.5% vs 44.3%; P < .0001). The mean (standard deviation) days on treatment for all matched patients was significantly higher for patients in the dulaglutide cohort compared with those in the exenatide once-weekly (148.4 [55.4] vs 123.6 [61.6]; P < .0001) and liraglutide cohorts (146.0 [56.9] vs 137.4 [60.1]; P < .0001). A significantly lower proportion of patients on dulaglutide discontinued treatment compared with those on exenatide once weekly (26.2% vs 48.4%; P < .0001) and those on liraglutide (28.0% vs 35.6%; P < .0001). CONCLUSIONS: Dulaglutide initiators had significantly higher adherence, were more persistent, and had lower discontinuation rates compared with initiators of exenatide once weekly or liraglutide during the 6-month follow-up period.

Liraglutide Versus Exenatide Once Weekly: Persistence, Adherence, and Early Discontinuation.

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.

Osteoporotic fractures and associated hospitalizations among patients treated with teriparatide compared to a matched cohort of patients not treated with teriparatide.

OBJECTIVE: To compare fractures and fracture-related resource utilization (RU) among patients with a recent fracture and treated with teriparatide (TPTD) to a matched cohort of patients not treated with TPTD (non-TPTD). RESEARCH DESIGN AND METHODS: Women aged 50 years or older initiating TPTD (N = 5314; index date between 1 January 2007 and 31 December 2012) were identified in an insurance claims database. Patients with fragility fracture (hip, pelvis, clavicle, humerus, wrist, leg or spine) during the 12 months prior to the index date (N = 1164) were selected to control for unmeasured confounding due to absence of bone mineral density test levels. TPTD patients were matched to the non-TPTD cohort using propensity score and exact matching (N = 912). Relative risk (RR) of fracture and fracture-related RU were estimated by Cox proportional hazard modeling, adjusted for potential fracture risk factors. RESULTS: Fractures were observed in 4.6%, 8.6%, 10.3%, and 11.3% of TPTD patients and in 9.2%, 15.2%, 19.2% and 21.7% of non-TPTD patients over 6, 12, 18, and 24 months, respectively. The adjusted RR reduction in TPTD was 36% (RR = 0.64, 95% CI: 0.44-0.94) during 6 months, 27% (RR = 0.73, 95% CI: 0.54-0.97) during 12 months, 28% (RR = 0.72, 95% CI: 0.55-0.93) during 18 months, and 28% (RR = 0.72, 95% CI: 0.56-0.92) during 24 months versus matched non-TPTD patients. Fracture-related RU followed a similar trend to that observed for fracture risk. CONCLUSIONS: This real-world study found TPTD to be more effective in reducing risk of fragility fractures as early as 6 months with continuous treatment benefit up to 24 months compared to a matched non-TPTD cohort. TPTD patients experienced lower rates of fracture-related RU than non-TPTD patients. Key study limitations include the inability to confirm reported diagnostic and procedural codes and the absence of uninsured and individually insured patients in the claims database.

The importance of unresolved fatigue in depression: costs and comorbidities.

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.

Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone.

Patterns of care following topical testosterone agent (TTA) initiation are poorly understood. This study aimed to characterize care following TTA initiation and compare results between patients with and without a serum testosterone (T) assay within 30 days before and including TTA initiation. Adult men (N=4,146) initiating TTAs from January 1, 2011, to March 31, 2012, were identified from a commercially insured database. Patients were included if they initiated at recommended starting dose (RSD) and had ≥12 and ≥6 months of continuous eligibility preinitiation (baseline) and postinitiation (study period), respectively. Patients were stratified by preinitiation T assay. Maintenance dose attainment month was determined using unadjusted generalized estimating equations regression to compare dose relative to RSD month by month. Outcomes included maintenance dose attainment month, time to stopping of index TTA refills or a claim for nonindex testosterone replacement therapy (TRT), and proportion of patients with study period T assay or diagnosis of hypogonadism (HG) or another low testosterone condition, and were compared using chi-square and Wilcoxon rank-sum tests for categorical and continuous variables, respectively. Maintenance dose was attained in Month 4 postinitiation, at 115.2% of RSD. Approximately 46% of patients had a preinitiation T assay; these men were more likely to receive a diagnosis of HG or another low testosterone condition, to have a follow-up T assay, to continue treatment by filling a nonindex TRT, and less likely to stop refilling treatment with their index TTA. Differences in care following TTA initiation suggest that preinitiation T assays (i.e., guideline-based care) may be helpful in ensuring treatment benefits.

Duloxetine use in employees with low back pain: treatment patterns and direct and indirect costs.

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.

Evaluating the utility of existing patient-reported outcome scales in novel patient populations with pancreatic cancer, lung cancer, and myeloproliferative neoplasms using medicare current beneficiary survey data.

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.

What do network members know? Network members as reporters of depression among Caucasian-American and African-American older women.

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.

A cross-validation of the provisional diagnostic instrument (PDI-4).

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.

The direct and indirect costs among U.S. privately insured employees with hypogonadism.

INTRODUCTION: While previous studies have noted that hypogonadism (HG) may pose a significant economic and quality-of-life burden, no studies have evaluated the impact of HG on healthcare utilization and costs in the United States. AIM: Compare direct (health care) and indirect (disability leave or medical absence) costs between privately insured U.S. employees with HG and controls without HG. METHODS: The study sample included 4,269 male employees, ages 35-64, with ≥ 2 HG diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification: 257.2x) or ≥ 1 HG diagnosis and ≥ 1 claim for testosterone therapy, 1/1/2005-3/31/2009, identified from a large, private insurance administrative database that includes medical, prescription drug, and disability claims data. The index date was the most recent HG diagnosis that had continuous eligibility for at least 1 year before (baseline period) and 1 year after (study period). Employees with HG were matched 1:1 on age, region, salaried vs. nonsalaried employment status, and index year to controls without HG. MAIN OUTCOME MEASURES: Descriptive analyses compared demographic characteristics, comorbidities, resource utilization, direct and indirect costs inflated to USD 2009. Multivariate analyses adjusting for baseline characteristics were used to estimate risk-adjusted costs. RESULTS: HG employees and controls had a mean age of 51 years. HG employees compared with controls had higher baseline comorbidity rates, including hyperlipidemia (50.2% vs. 25.3%), hypertension (37.7% vs. 21.1%), back/neck pain (32.0% vs. 15.7%), and human immunodeficiency virus/acquired immunodeficiency syndrome (7.1% vs. 0.3%) (all P < 0.0001). HG employees had higher mean study period direct ($10,914 vs. $3,823) and indirect costs ($3,204 vs. $1,450); HG-related direct costs were $832 (all P < 0.0001). Risk-adjusted direct ($9,291 vs. $5,248) and indirect ($2,729 vs. $1,840) costs were also higher for HG employees (all P < 0.0001). CONCLUSIONS: Employees with HG had higher comorbidity rates and costs compared with controls. Given the low HG-related costs, a primary driver of costs among HG patients appears to be their comorbidity burden.

Duloxetine use in chronic low back pain: treatment patterns and costs.

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.

Real-world role of tricyclic antidepressants in the treatment of fibromyalgia.

OBJECTIVE: To examine the real-world role of tricyclic antidepressants (TCAs) in fibromyalgia (FM) treatment. METHODS: Using privately insured U.S. administrative claims data, this study examined TCA use for newly diagnosed FM patients. Patients ages 18 to 64 years with ≥ 2 FM diagnoses (ICD-9-CM: 729.1) during Q1:2007 to Q1:2009, no previous FM diagnosis, and continuous eligibility for insurance during the year before and after the first FM diagnosis ("study period") were identified as newly diagnosed (N = 10,129). Treatment with TCAs was examined over the first treatment episode (allowing up to a 45-day gap between refills). A sensitivity analysis was performed excluding patients with depression/anxiety diagnoses during the study period. RESULTS: During the study period, 8.9% of patients with FM used TCAs at anytime, 5.0% used TCAs during the year before FM diagnosis, and 7.2% used TCAs during the year after. The mean (median) duration of the first treatment episode was 150 (58) days. During this episode, 84.0% used other medications concomitantly, with 60.3% using analgesics and 39.6% using other antidepressants. Additionally, 60.8% augmented TCA use with other drugs, 61.8% switched to another drug at the end of their TCA episode, and 22.8% discontinued TCAs without switching. Similar patterns were observed for the subset of patients with no depression or anxiety (N = 7,655). DISCUSSION: Research covering 1999 to 2005 using the same methods found that 15.9% of patients with FM used TCAs during the year before FM diagnosis and 20.7% used TCAs during the year after. These findings suggest that TCA use among the patients with FM is uncommon and may be declining in real-world practice.

A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode.

Some evidence suggests that medications that modulate both serotonin and norepinephrine may be more effective than selective serotonin-reuptake inhibitors (SSRIs) in severe major depressive disorder (MDD). This prospective pragmatic trial tests this hypothesis. Patients with severe MDD were randomly assigned to either duloxetine (a serotonin and norepinephrine-reuptake inhibitor) or physicians' choice of four generic SSRIs. Nonblinded, flexibly dosed treatment was used to mimic clinical practice. To address potential investigator bias, the patient-reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) was used as the primary efficacy outcome measure. A total of 750 outpatients (19.2%, African descent; 14.8%, Hispanic) were randomized. The primary outcome, remission at week 12 by QIDS-SR, was numerically greater for duloxetine compared with SSRIs (36 vs. 32%), but this difference was not statistically significant. Mean changes in secondary outcomes were significantly superior in favor of duloxetine for the Hamilton Depression Scale-17 item, the Brief Pain Inventory, and the Sheehan Disability Scale. Remission superiority on the QIDS-SR was not achieved. Significantly greater benefit for duloxetine compared with SSRIs was demonstrated on measures of pain and functioning. Study demographics suggest a more generalizable racial and ethnic population than is typical in randomized clinical trials.

PDI-4A: an augmented provisional screening instrument assessing 5 additional common anxiety-related diagnoses in adult primary care patients.

Patients with nonpsychotic mental health and emotional problems are commonly seen by primary care physicians. The objective of this study was to expand the Provisional Diagnostic Instrument-4 (PDI-4) to include a short self-report screen for 5 common anxiety-related diagnoses: panic attack (PA), social phobia (SP), obsessive-compulsive disorder (OCD), hypochondriasis, and post-traumatic stress disorder (PTSD). Primary care patients (N = 343) were originally evaluated with a self-report screen comprised of 85 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition symptom-based candidate questions, then interviewed by a trained rater for Structured Clinical Interview Research Version (SCID)/Adult ADHD Clinician Diagnostic Scale version 1.2 (ACDS) assessment and diagnosis. Responses to screening questions were used to calculate sensitivity and specificity for an SCID diagnosis, and to select the optimal cutoffs in symptom frequency for 1 or 2 questions for each additional anxiety-related diagnosis. The PDI-4 Anxiety (PDI-4A) contains 6 items for provisional differential diagnosis of PA, SP, OCD, hypochondriasis, and PTSD in addition to items for the PDI-4. Sensitivities/specificities were: PA, 88%/68%; SP, 57%/70%; OCD, 88%/61%; hypochondriasis, 67%/85%; and PTSD, 71%/72%. Screening for multiple common anxiety diagnoses may be desirable, although limitations may include reduced sensitivity and specificity for selected diagnoses. The PDI-4A may additionally help primary care physicians identify patients with PA, SP, OCD, hypochondriasis, and PTSD.

Real-world practice patterns, health-care utilization, and costs in patients with low back pain: the long road to guideline-concordant care.

BACKGROUND CONTEXT: Treatment guidelines suggest that most acute low back pain (LBP) episodes substantially improve within a few weeks and that immediate use of imaging and aggressive therapies should be avoided. PURPOSE: Assess the actual practice patterns of imaging, noninvasive therapy, medication use, and surgery in patients with LBP, and compare their costs to those of matched controls without LBP. STUDY DESIGN: A retrospective analysis of claims data from 40 self-insured employers in the United States. PATIENT SAMPLE: The study sample included 211,551 patients, aged 18 to 64 years, with one LBP diagnosis or more (per Healthcare Effectiveness Data and Information Set specification) during 2004 to 2006, identified from a claims database. Patients had continuous eligibility for 12 months or more after their index LBP diagnosis (study period), for 6 months or more before their index diagnosis (baseline period), and no other LBP diagnosis during the baseline period. Patients with LBP were matched to a random cohort of patients without LBP by age, gender, employment status, and index year. OUTCOMES MEASURES: Physiological measures (eg, imaging and diagnostic tests), functional measures (eg, pharmacologic and nonpharmacologic treatment for LBP, health-care resource use), and direct (medical and prescription drug) and indirect (disability and medically related absenteeism) costs were assessed within the year after the LBP diagnosis. METHODS: Univariate analyses described treatment patterns and compared baseline characteristics and study period costs. RESULTS: Patients with LBP had significantly higher rates of baseline comorbidities and resource use compared with controls. Of patients with LBP, 41.6% had imaging mean (median) [standard deviation] 34.3 (0) [78.6] days after the LBP diagnosis. Most patients with LBP (69.4%) used medications starting 51.9 (8) [86.2] days after the diagnosis. Opioids were commonly prescribed early (41.6% of patients; after 82.8 (25) [105.9] days). Of patients with LBP, 2.05% had surgery during the study period. Patients with LBP were likely to have chiropractic treatment first, followed by pharmacotherapy with muscle relaxants and nonsteroidal anti-inflammatory drugs. Except for less surgery, these findings also held for patients with only nonspecific LBP. Patients with LBP had higher mean direct costs compared with controls ($7,211 vs. $2,382, respectively; p<.0001), with surgery patients having mean direct costs of $33,931. CONCLUSIONS: Contrary to clinical guidelines, many patients with LBP start incurring significant resource use and associated expenses soon after the index diagnosis. Achieving guideline-concordant care will require substantial changes in LBP practice patterns.

The association between insomnia severity and healthcare and productivity costs in a health plan sample.

STUDY OBJECTIVES: Insomnia is a chronic condition with significant burden on health care and productivity costs. Despite this recognized burden, very few studies have examined associations between insomnia severity and healthcare and productivity costs. DESIGN: A retrospective study linking health claims data with a telephone survey of members of a health plan in the Midwestern region of the United States. PARTICIPANTS: The total healthcare costs study sample consisted of 2086 health plan members who completed the survey and who had complete health claims data. The productivity costs sample consisted of 1329 health plan members who worked for pay-a subset of the total healthcare costs sample. MEASUREMENTS: Subjects' age, gender, demographic variables, comorbidities, and total health care costs were ascertained using health claims. Insomnia severity and lost productivity related variables were assessed using telephone interview. RESULTS: Compared with the no insomnia group, mean total healthcare costs were 75% larger in the group with moderate and severe insomnia ($1323 vs. $757, P<0.05). Compared with the no insomnia group, mean lost productivity costs were 72% larger in the moderate and severe insomnia group ($1739 vs. $1013, P<0.001). Chronic medical comorbidities and psychiatric comorbidities were positively associated with health care cost. In contrast, psychiatric comorbidities were associated with lost productivity; while, medical comorbidities were not associated with lost productivity. CONCLUSIONS: Health care and lost productivity costs were consistently found to be greater in moderate and severe insomniacs compared with non-insomniacs. Factors associated with lost productivity and health care costs may be fundamentally different and may require different kinds of interventions. Future studies should focus on better understanding mechanisms linking insomnia to healthcare and productivity costs and to understanding whether developing targeted interventions will reduce these costs.

Treatment patterns associated with Duloxetine and Venlafaxine use for Major Depressive Disorder.

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.

A provisional screening instrument for four common mental disorders in adult primary care patients.

OBJECTIVE: To develop an adult self-report instrument for provisional diagnosis of four common mental disorders in primary care patients. METHODS: Primary care patients were evaluated during routine clinic visits with a self-report screening tool comprised of 85 DSM-IV symptom-based candidate questions. Patients with a physician-assessed provisional diagnosis for generalized anxiety disorder (GAD), major depressive episode (MDE), past/present mania, and adult attention-deficit/hyperactivity disorder (ADHD), or none of these, completed additional self-report clinical questionnaires, and then were interviewed on the telephone by a trained rater for a SCID/ACDS diagnosis. Responses to the symptom-based candidate questions were used to calculate sensitivity and specificity for a SCID/ACDS diagnosis (GAD, N = 24; MDE, N = 89; Mania, N = 24; ADHD, N = 65) and to select the optimal four questions for each diagnosis to be included in the instrument. RESULTS: Analyses resulted in a 17-item instrument for provisional differential diagnosis of GAD, MDE, past/present mania, and ADHD. Comparison of limited symptom-based versus full DSM-IV criteria-based diagnosis showed minimal differences for relative diagnostic accuracy. Sensitivities and specificities, respectively, were 83% and 75% for GAD, 80% and 80% for MDE, 83% and 82% for mania, and 82%and 73% for ADHD. CONCLUSIONS: Based on this preliminary work, the Provisional Diagnostic Instrument-4 is a brief, easily scored, self-report instrument that may assist primary care physicians to identify potential cases of GAD, MDE, past/present mania, and ADHD.

Comparison of medication adherence and healthcare costs between duloxetine and pregabalin initiators among patients with fibromyalgia.

OBJECTIVE: To examine and compare medication adherence and direct healthcare costs between duloxetine and pregabalin initiators among patients with fibromyalgia. METHODS: A retrospective analysis of commercially insured fibromyalgia patients aged 18 to 64 was conducted among those who initiated duloxetine or pregabalin between January 1, 2006 and December 31, 2006. The first initiation date was defined as the index date. All patients included had continuous enrollment in the 12-month pre- and post-index periods. Each individual was classified in the duloxetine or pregabalin cohort based on the initiating agent. The pregabalin cohort was constructed via propensity scoring controlling for differences in demographics, pre-index clinical and economic characteristics, and pre-index treatment patterns. Medication adherence (ie, medication possession ratio [MPR] and proportion of patients with MPR≥80%) and healthcare costs over the 12 months post-index period were examined between cohorts. RESULTS: The study cohorts included 3,711 duloxetine and 4,111 pregabalin patients with the mean age of 51 years. The common comorbidities included neuropathic pain other than diabetic peripheral neuropathic pain, low back pain, cardiovascular disease, headache, and osteoarthritis. Over 80% of the duloxetine or pregabalin initiators used opioids. Controlling for demographics, pre-index clinical and economic characteristics, and prior medication history, duloxetine patients had significantly higher MPR (0.7 vs. 0.5, P<0.05), higher proportion of patients with MPR≥80% (46.5% vs. 26.4%, P<0.05), but significantly lower total healthcare costs ($19,378 vs. $27,045, P<0.05) over the 12 months post-index period than pregabalin patients. CONCLUSION: Fibromyalgia patients on duloxetine had significantly higher medication adherence, but significantly lower direct healthcare costs than those on pregabalin.

Screening for depression in African American and Caucasian older women.

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.