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

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

Psychometric validation of the cancer therapy satisfaction questionnaire.

PURPOSE: To assess the domain structure and to evaluate the psychometric properties of the Cancer Therapy Satisfaction Questionnaire (CTSQ) and the relation between the CTSQ and health-related quality of life (HRQOL). METHODS: Three hundred sixty-one individuals with breast, colorectal, lung cancer, or melanoma who had received in the last 6 months or were currently receiving more than one cycle of chemo, biological, or hormonal therapy completed the 21-item CTSQ, with a random subsample of 88 patients completing it again 1 week later. Participants also completed quality of life, treatment satisfaction, and other self-reported questions on each occasion. Demographics, ECOG performance status, and clinical information were collected. CTSQ responses were submitted to multitrait analyses and exploratory factor analysis. Psychometric properties and the correlations between the CTSQ and the Quality of Life Questionnaire -- Core 30 (QLQ-C30) were evaluated. RESULTS: Analyses revealed three domains with good psychometric properties: Feelings about Side Effects, Satisfaction with Therapy, and Expectations of Therapy. Correlations with the QLQ-C30 domains were low to moderate. CONCLUSION: The CTSQ is a newly developed 16-item patient-reported measure with strong psychometric properties and constructs not captured by the QLQ-C30. It can be used to evaluate cancer patients' experiences with intravenous and/or oral chemo, biological, and hormonal therapies.

The relative burden of dry eye in patients' lives: comparisons to a U.S. normative sample.

PURPOSE: To assess the relative burden of dry eye in daily life by comparing Short Form-36 (SF-36) responses from individuals with and without dry eye against U.S. norms. METHODS: Assessment of 210 people, 130 with non-Sjogren's keratoconjunctivitis sicca (non-SS KCS), 32 with Sjogren's Syndrome (SS), and 48 control subjects. The study population data and published normative SF-36 data were compared. Dry eye severity was assessed by recruited severity (control, non-SS KCS, SS), patient self-report (none, very mild/mild, moderate, severe/extremely severe), and clinician-report (none, mild, moderate, severe). Age- and gender-matched norms were compared with all defined severity groups. RESULTS: Compared with the norms, control subjects scored higher on all SF-36 scales. Effect size (ES) ranged from 0.15 to 0.52. Non-SS KCS patients had lower Role-Physical (ES=-0.07), Bodily Pain (ES=-0.08), and Vitality (ES=-0.11) scores, indicating more dry eye impact on those areas versus the norm. All SF-36 scale scores except Mental Health (ES=0.12) were lower in the SS group than the adjusted norm (ES range: -0.16 to -0.99). Regardless of severity classification, mild patients consistently had lower Role-Physical and Bodily Pain scores than the norm, suggesting impact on daily roles (ES < 0.2). Patients with moderately severe disease also experienced less vitality and poorer general health. The group with severe disease scored lower than the norm across all domains (ES range: -0.14 to -0.91) except Role-Emotional (ES=0.13) and Mental Health (ES=0.23). CONCLUSIONS: These results indicate dry eye's negative impact on everyday life, particularly in daily activities. Further research using disease-specific measures to examine dry eye's impact is underway.

Quality-of-life improvements in cataract patients with bilateral blue light-filtering intraocular lenses: clinical trial.

PURPOSE: To compare change in patient-reported vision-related and health-related functioning and quality of life (HRQOL) following bilateral implantation with a new blue light-filtering intraocular lens (IOL) with the results of a similar IOL that does not filter blue light. SETTING: Six clinical sites in the United States. METHODS: Patients were from 6 clinical sites in the United States that performed a high volume of cataract surgeries. The HRQOL assessments occurred via telephone while patients were at home. Patients requiring bilateral cataract extraction were randomly assigned to 1 of the 2 IOL groups for the first eye. The second eye was later implanted with the same type of IOL. Patients and HRQOL data collectors were treatment-masked, but investigators could not be. Health-related functioning and quality of life was measured with the 39-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-39) and 12-item Short Form Health Survey (SF-12). Assessments were at baseline before implantation in the first eye and 30 to 60 days and 120 to 180 days after implantation of the lens in the second eye. RESULTS: Both IOL types improved most aspects of patients' HRQOL including color vision and driving. The largest gains occurred on the VFQ composite, general vision, near activities, distance activities, driving, mental health, peripheral vision, and role difficulties scales. Significant gains also occurred on color vision and other vision-specific scales as well as the SF-12 physical component summary score. There were no significant differences in HRQOL gains between the IOLs. CONCLUSION: The blue light-filtering IOL improved color vision, driving, and other aspects of HRQOL in a manner similar to that of a lens that does not filter blue light.

The direct and indirect costs of long bone fractures in a working age US population.

OBJECTIVE: Information regarding the burden of fractures is limited, especially among working age patients. The objective of this study was to evaluate the direct and indirect costs associated with long bone fractures in a working age population using real-world claims data. METHODS: This was a claims-based retrospective analysis, comparing adult patients in the 6 months before and 6 months after a long bone fracture between 1/1/2001 and 12/31/2008 using the MarketScan Research Databases. Outcomes included direct medical costs and utilization, as well as work absenteeism and short term disability, which was available for a sub-set of the patients. Observed and adjusted incremental costs (i.e., the difference in costs before and after a fracture) were evaluated and reported in 2008 US$. RESULTS: A total of 208,094 patients with at least one fracture were included in the study. Six, mutually exclusive fracture cohorts were evaluated: tibia shaft (n = 49,839), radius (n = 97,585), hip (n = 11,585), femur (n = 6788), humerus (n = 29,884), and those with multiple long bone fractures (n = 12,413). Average unadjusted direct costs in the 6-months before a long bone fracture ranged from $3291 (radius) to $12,923 (hip). The average incremental direct cost increase in the 6-months following a fracture ranged from $5707 (radius) to $39,041 (multiple fractures). Incremental absenteeism costs ranged from $950 (radius) to $2600 (multiple fractures), while incremental short-term disability costs ranged from $2050 (radius) to $4600 (multiple fractures). CONCLUSIONS: The results of this study indicate that long bone fractures are costly, both in terms of direct medical costs and lost productivity. Workplace absences and short-term disability represent a significant component of the burden of long bone fractures. These results may not be generalizable to all patients with fractures in the US, and do not reflect the burden of undiagnosed or sub-clinical fractures.

Association between prescription cost sharing and adherence to initial combination antiretroviral therapy in commercially insured antiretroviral-naïve patients with HIV.

BACKGROUND: In treatment of human immunodeficiency virus (HIV), high levels of adherence to combination antiretroviral therapy (cART) are required to prevent failure of virologic suppression, development of drug resistance, and permanent loss of therapeutic options. No published research has assessed the association between cART prescription cost sharing and adherence to cART. OBJECTIVE: To analyze the association between cART prescription cost sharing and adherence to initial cART in commercially insured antiretroviral (ARV)-naïve patients with HIV. METHODS: This retrospective observational cohort study used 2002-2008 data from a large U.S. claims database of more than 56 million commercially insured individuals. Study subjects were patients aged 18 years or older who initiated cART during the period January 1, 2003, to December 31, 2007, had no ARV claims during the 6-month period prior to the initiation date, and had at least 1 ICD-9-CM diagnosis code for HIV infection (042, 795.71, V08) from 12 months before to 12 months after cART initiation. A minimum 12-month period of continuous enrollment after cART initiation was used to construct a patient-quarter repeated measures panel dataset in which each quarter of data that a patient contributed represented an observation. The evaluation period extended from cART initiation until the occurrence of 1 of the following events: addition of an ARV that was not part of the initial cART regimen, 30-day gap in possession of an ARV within the initiated cART regimen, hospitalization of 30 or more days, loss to follow-up due to study end (December 31, 2008), or disenrollment. The study's outcome was quarterly adherence to cART, defined as the number of days within the quarter that a patient possessed all components of the initial cART regimen. Each patient's cART cost-sharing amount was calculated per 30-day supply of the entire cART regimen. Adherence was dichotomized for analysis at the clinically meaningful thresholds of 95% and 78%. The dichotomized adherence outcomes were separately modeled using population-averaged generalized estimating equations (GEEs) with time-varying and time-constant covariates and an exchangeable working correlation structure. Independent variables included cost-sharing amount; sequential quarter number after cART initiation; interaction between cost-sharing amount and sequential quarter number (to capture any changes in the association of cost sharing with adherence that may occur over time after initiation of cART); and patient demographic, clinical, and insurance characteristics. For each sequential quarter after cART initiation, the GEE models were used to generate average predicted probabilities of adherence reaching each threshold (95% and 78%) at cost-sharing levels of $25, $75, and $144, which represented the 25th, 75th, and 90th percentiles of the cost-sharing distribution, respectively. RESULTS: The study sample included 19,199 patient-quarters and 3,731 patients: mean age 41.1 years; 83.2% male; mean (SD) duration of post-index period 5.1 (4.2) quarters; mean (SD) daily cART pill count 3.2 (2.2); mean (median) cost sharing per 30-day supply of the entire cART regimen $67 ($40). In the unadjusted analyses of patient-quarters, mean adherence ranged from 97.2% for cost-sharing levels within the 0-20th percentiles (from $0 to $20 per 30-day cART supply) to 94.0% for cost-sharing levels exceeding the 80th percentile (from $84 to $3,832 per 30-day cART supply). In the adjusted analyses for the second quarter (25th percentile of follow-up duration, n = 3,117 cases still under observation) at the cost-sharing levels of $25, $75, and $144, the predicted probabilities of at least 95% adherence were 0.782, 0.770, and 0.752, respectively, and the predicted probabilities of at least 78% adherence were 0.936, 0.931, and 0.924, respectively. The differences in the predicted probabilities of adherence grew over time. By the seventh quarter (the 75th percentile of follow-up duration, n = 1,096 cases still under observation), the predicted probabilities were 0.773, 0.746, and 0.707 for 95% adherence and 0.933, 0.922, and 0.904 for 78% adherence at cost-sharing levels of $25, $75, and $144, respectively. CONCLUSION: Increasing cART prescription cost sharing was associated with modestly decreased probability of maintaining clinically meaningful levels of cART adherence.

Development and validation of the Overactive Bladder Satisfaction (OAB-S) Questionnaire.

AIMS: To develop and validate a measure of patient satisfaction with treatment in overactive bladder: the Overactive Bladder Satisfaction Questionnaire (OAB-S). METHODS: Development of the questionnaire included a comprehensive literature review, development of a conceptual model, item elicitation and cognitive debriefing interviews with US-English and US-Spanish patients, and assessment of the questionnaire's translatability in other languages. Psychometric validation of the questionnaire was run on a longitudinal, non-randomized study involving 201 OAB patients. Analyses included construct validity, concurrent validity, tests of reliability, known-group validity, and responsiveness (exploratory). RESULTS: The OAB-S is a patient-completed questionnaire including five scales: OAB Control Expectations (ten items); Impact on Daily Living with OAB (ten items); OAB Control (ten items); OAB Medication Tolerability (six items); and Satisfaction with Control (ten items) and five single-item overall assessments of patient's fulfillment of OAB medication expectations, interruption of day-to-day life due to OAB, overall satisfaction with OAB medication; willingness to continue OAB medication and improvement in day-to-day life due to OAB medication. The hypothesized structure of the questionnaire was supported by statistical analyses. Internal consistency reliability coefficients (ranging from 0.76 to 0.94) and test-retest reliability coefficients (ranging from 0.72 to 0.87) were good for all dimensions. All dimensions except tolerability discriminated well according to self-reported OAB severity level and incontinence status. CONCLUSION: The OAB-S is a valid, comprehensive instrument to assess satisfaction with treatment of OAB based on independent scales that have demonstrated satisfactory psychometric performance.

Comparing the discriminative validity of two generic and one disease-specific health-related quality of life measures in a sample of patients with dry eye.

OBJECTIVE: The purpose of this study was to compare the discriminative properties of two generic health-related quality of life (QoL) instruments (SF-36 and EQ-5D) and a newly developed disease-specific patient-reported outcomes instrument (Impact of Dry Eye on Everyday Life (IDEEL)) to distinguish between different levels of dry eye severity. METHODS: Assessment of 210 people: 130 with non-Sjogren's Keratoconjunctivitis Sicca (non-SS KCS), 32 with Sjögren's Syndrome (SS) and 48 controls; comparison of SF-36, EQ-5D, and IDEEL age-adjusted data by dry eye severity levels. Severity was assessed based on diagnosis (non-SS KCS, SS, control), patient-report (none, very mild, mild, moderate, severe, extremely severe) and clinician-report (none, mild, moderate, severe). RESULTS: Discriminative validity results were consistent for all instruments. Significant differences between severity levels were found with most SF-36 scales (P < 0.05), all EQ-5D scales (P < 0.05), and all IDEEL scales (P < 0.0001), except for Treatment Satisfaction. IDEEL scales consistently outperformed the generic QoL measures regardless of the severity criterion used. Most SF-36 scales outperformed the EQ-5D QoL scale, but the EQ-5D visual analog scale outperformed the SF-36 scales, except for General Health Perceptions. CONCLUSIONS: The disease-specific IDEEL scales are better able to discriminate between severity levels than the majority of the generic QoL scales. Preliminary evidence demonstrates that the IDEEL will be sensitive to QoL changes over time, although further testing in controlled longitudinal studies is needed.