Development of a claims-based algorithm to identify potentially undiagnosed chronic migraine patients.

OBJECTIVE: To develop a claims-based algorithm to identify undiagnosed chronic migraine among patients enrolled in a healthcare system. METHODS: An observational study using claims and patient survey data was conducted in a large medical group. Eligible patients had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) migraine diagnosis, without a chronic migraine diagnosis, in the 12 months before screening and did not have a migraine-related onabotulinumtoxinA claim in the 12 months before enrollment. Trained clinicians administered a semi-structured diagnostic interview, which served as the gold standard to diagnose chronic migraine, to enrolled patients. Potential claims-based predictors of chronic migraine that differentiated semi-structured diagnostic interview-positive (chronic migraine) and semi-structured diagnostic interview-negative (non-chronic migraine) patients were identified in bivariate analyses for inclusion in a logistic regression model. RESULTS: The final sample included 108 patients (chronic migraine = 64; non-chronic migraine = 44). Four significant predictors for chronic migraine were identified using claims in the 12 months before enrollment: ≥15 versus <15 claims for acute treatment of migraine, including opioids (odds ratio = 5.87 [95% confidence interval: 1.34-25.63]); ≥24 versus <24 healthcare visits (odds ratio = 2.80 [confidence interval: 1.08-7.25]); female versus male sex (odds ratio = 9.17 [confidence interval: 1.26-66.50); claims for ≥2 versus 0 unique migraine preventive classes (odds ratio = 4.39 [confidence interval: 1.19-16.22]). Model sensitivity was 78.1%; specificity was 72.7%. CONCLUSIONS: The claims-based algorithm identified undiagnosed chronic migraine with sufficient sensitivity and specificity to have potential utility as a chronic migraine case-finding tool using health claims data. Research to further validate the algorithm is recommended.

Effects of OnabotulinumtoxinA treatment for crow's feet lines on patient-reported outcomes.

BACKGROUND: Although millions of aesthetic procedures are performed annually, few patient-reported outcome (PRO) measures have been used in this setting. OBJECTIVE: To evaluate the impact of onabotulinumtoxinA treatment for crow's feet lines (CFL) on relevant psychological variables and self-perception of age/appearance in subgroup populations. MATERIALS AND METHODS: Facial Lines Outcomes (FLO-11) Questionnaire, Self-Perception of Age (SPA), and Subject Global Assessment of Change in CFL (SGA-CFL) were PRO measures administered in 2 Phase 3, double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines (GL). Patient-reported outcome measures were analyzed by subgroups (age, gender, and baseline CFL severity). Subject satisfaction with appearance was also analyzed. RESULTS: Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact (FLO-11 Items 2, 5, and 8) versus placebo at Day 30 (p ≤ .05). OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 (p ≤ .05) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL. Overall, subjects were satisfied with their appearance. CONCLUSION: OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance, attractiveness, tiredness, age, and satisfaction versus placebo. Subjects treated for CFL and GL experienced even greater effects.

Psychometric evaluation of the National Eye Institute Visual Function Questionnaire and Visual Function Questionnaire Utility Index in patients with non-infectious intermediate and posterior uveitis.

OBJECTIVE: To evaluate the psychometric properties of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and Visual Function Questionnaire Utility Index (VFQ-UI) in patients with non-infectious intermediate and posterior uveitis. METHODS: Secondary analysis of pooled data from a 26-week, multicenter, masked, randomized, sham-controlled Phase 3 clinical trial. Health-related quality of life was assessed using the NEI VFQ-25, the EQ-5D, and SF-36. Internal consistency reliability, reproducibility, convergent validity, and known groups of BCVA and vitreous haze severity were assessed. Clinically significant difference was assessed using anchor-based and distribution-based methods. RESULTS: The study included 224 subjects with non-infectious intermediate (80.4 %) or posterior uveitis (19.6 %). The NEI VFQ-25 and the VFQ-UI demonstrated good internal consistency (Cronbach's alpha 0.87-0.94) and test-retest reliability (ICCs 0.58-0.88). Spearman's product-moment rank correlations between the NEI VFQ-25 and VFQ-UI scores and the SF-6D, EQ-5D, and BCVA ranged from small to moderate. There was a significant association between visual functioning and known groups of visual acuity (p < 0.05). Clinical significance, using the anchor-based method (difference between visual acuity groups ≥10-<15 letter better and no change), was 10.2 for change from baseline to week 26 for the NEI VFQ-25 composite score and 0.05 for the VFQ-UI. Using the distribution-based method, the clinical significance was 3.86 for the composite score and 0.04 for the VFQ-UI. CONCLUSION: The NEI VFQ-25 and the VFQ-UI are reliable and valid measures of vision-related functioning and preference-based status in patients with non-infectious intermediate and posterior uveitis.

Effect of the duration of macular edema on clinical outcomes in retinal vein occlusion treated with dexamethasone intravitreal implant.

PURPOSE: To assess the effect of duration of macular edema (ME) on clinical outcomes after treatment with dexamethasone intravitreal implant 0.7 mg (Ozurdex; Allergan, Inc, Irvine, CA) in patients with ME following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). DESIGN: Post hoc analysis of pooled data from 2 randomized, controlled trials. PARTICIPANTS: Patients with vision loss resulting from ME of 6 weeks' duration or more after BRVO or CRVO (n = 690). METHODS: The relationship between ME duration at the time of first treatment and treatment outcomes was assessed using logistic regression. Other factors potentially associated with ME duration or patient outcomes were adjusted for in the analyses. MAIN OUTCOME MEASURES: The proportion of patients achieving at least 15 letters improvement in best-corrected visual acuity (BCVA) or at least 200-µm or more reduction in central retinal thickness 6 or 12 months after the first treatment with dexamethasone intravitreal implant 0.7 mg. RESULTS: In the 6-month analysis, each 1-month increase in ME duration was associated with a significantly lower likelihood of achieving a BCVA improvement of 15 letters or more (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.83-0.94; P<0.001) or a CRT reduction of 200-µm or more (OR, 0.91; 95% CI, 0.86-0.97; P<0.01) 6 months after treatment. In the 12-month analysis, increased ME duration was associated with a significantly lower likelihood of achieving BCVA improvement of 15 letters or more improvement in BCVA (OR, 0.85; 95% CI, 0.76-0.95; P<0.01) 12 months after treatment; duration was not significantly associated with the likelihood of a CRT reduction of 200-µm or more at 12 months. In general, the effect of ME duration on outcomes was stronger and statistically significant in BRVO patients, but weaker and not statistically significant in CRVO patients. CONCLUSIONS: In eyes with retinal vein occlusion, longer ME duration at the time of first treatment with the dexamethasone intravitreal implant 0.7 mg was associated with a significantly lower likelihood of achieving clinically meaningful improvements in vision or CRT 6 or 12 months after treatment. This suggests that prompt treatment for retinal vein occlusion, particularly BRVO, may be associated with improved clinical outcomes. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Rasch analysis in the development of a simplified version of the National Eye Institute Visual-Function Questionnaire-25 for utility estimation.

PURPOSE: Preference-based health measures value how people feel about the desirability of a health state. Generic measures may not effectively capture the impact of vision loss from ocular diseases. Disease-targeted measures could address this limitation. This study developed a vision-targeted health state classification system based on the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). METHODS: Secondary analysis of NEI VFQ-25 data from studies of patients with central (n = 932)- and peripheral-vision loss (n = 2,451) were used to develop a health state classification system. Classical test theory and Rasch analyses were used to identify a smaller set of NEI VFQ-25 items suitable for the central- and peripheral-vision-loss groups. RESULTS: Rasch analysis of the NEI VFQ-25 items using the peripheral vision-loss data indicated that 11 items fit a unidimensional model, while 14 NEI VFQ-25 items fit using the central-vision-loss data. Combining peripheral-vision-loss data and central-vision-loss data resulted in 9 items fitting a unidimensional model. Six items covering near vision, distance vision, social vision, role difficulties, vision dependency, and vision-related mental health were selected for the health-state classification. CONCLUSIONS: The derived health-state classification system covers relevant domains of vision-related functioning and well-being.

The prevalence of retinal vein occlusion: pooled data from population studies from the United States, Europe, Asia, and Australia.

OBJECTIVE: To summarize the prevalence of retinal vein occlusion (RVO) from studies in the United States, Europe, Asia, and Australia. DESIGN: Pooled analysis using individual population-based data. PARTICIPANTS: Individual participant data from population-based studies around the world that had ascertained RVO from fundus photographs. METHODS: Each study provided data on branch RVO and central RVO by age, sex, and ethnicity. Prevalence rates were directly age and sex standardized to the 2008 world population aged 30 years and older. Estimates were calculated by study and, after pooling, by ethnicity. Summary estimates included studies in which RVO was assessed from fundus photographs on >or=2 fields of both eyes. MAIN OUTCOME MEASURES: Any RVO, CRVO, or BRVO. RESULTS: The combined pooled data contained 68,751 individuals from 15 studies, with participants' ages ranging from 30 to 101 years. In analyses of 11 studies that assessed >or=2 fundus fields of both eyes (n=49,869), the age- and sex-standardized prevalence was 5.20 per 1000 (confidence interval [CI], 4.40-5.99) for any RVO, 4.42 per 1000 (CI, 3.65-5.19) for BRVO, and 0.80 per 1000 (CI, 0.61-0.99) for CRVO. Prevalence varied by race/ethnicity and increased with age, but did not differ by gender. The age- and sex-standardized prevalence of any RVO was 3.7 per 1000 (CI, 2.8-4.6) in whites (5 studies), 3.9 per 1000 (CI, 1.8-6.0) in blacks (1 study), 5.7 per 1000 (CI, 4.5-6.8) in Asians (6 studies), and 6.9 per 1000 (CI, 5.7-8.3) in Hispanics (3 studies). Prevalence for CRVO was lower than BRVO in all ethnic populations. On the basis of these data, an estimated 16.4 million (CI, 13.9-18.9) adults are affected by RVO, with 2.5 million (CI, 1.9-3.1) affected by CRVO and 13.9 million (CI, 11.5-16.4) affected by BRVO. Study limitations include non-uniform sampling frames in identifying study participants and in acquisition and grading of RVO data. CONCLUSIONS: Our study provides summary data on the prevalence of RVO and suggests that approximately 16 million people may have this condition. Research on preventive and treatment strategies for this sight-threatening eye disease is needed.

Natural history of central retinal vein occlusion: an evidence-based systematic review.

OBJECTIVE: To describe the natural history of central retinal vein occlusion (CRVO) based on the best available evidence from the literature. CLINICAL RELEVANCE: Central retinal vein occlusion is a common sight-threatening retinal vascular disease. Despite the introduction of new interventions, the natural history of CRVO is unclear. METHODS: Systemic review of all English language articles retrieved using a keyword search of MEDLINE, EMBASE, Current Contents, and the Cochrane Library to November 13, 2008. This was supplemented by hand-searching references of review articles published within the last 5 years. Two investigators independently identified all relevant observational studies evaluating the natural history of RVO and all clinical trials evaluating interventions for CRVO; an untreated control arm was included. RESULTS: Of 5966 citations retrieved, 53 studies were reviewed, providing 3271 eyes with CRVO for analysis of its natural history. Visual acuity (VA) was generally poor at baseline (<20/40) and decreased further over time. Although 6 studies reported an improvement in VA, none of these improvements resulted in VA better than 20/40. Up to 34% of eyes with nonischemic CRVO converted to ischemic CRVO over a 3-year period. In ischemic CRVO cases, neovascular glaucoma developed in at least 23% of eyes within 15 months. In nonischemic CRVO cases, macular edema resolved in approximately 30% of eyes over time, and subsequent neovascular glaucoma was rare. CONCLUSIONS: Untreated eyes with CRVO generally had poor VA, which declined further over time. One quarter of eyes with nonischemic CRVO converted to ischemic CRVO.

Natural history of branch retinal vein occlusion: an evidence-based systematic review.

OBJECTIVE: To describe the natural history of branch retinal vein occlusion (BRVO) based on the best available evidence from the literature. CLINICAL RELEVANCE: Branch retinal vein occlusion is the second most frequent major retinal vascular disease. Although several new treatments for BRVO are currently being introduced, data on its natural history are sparse. METHODS: English language articles were retrieved using a keyword search of MEDLINE, EMBASE, Current Contents, and the Cochrane Library to November 13, 2008, supplemented by manually searching the references of review articles published within the last 5 years. All relevant observational studies evaluating the natural history of BRVO and all clinical trials evaluating BRVO interventions with an untreated control arm were independently identified by 2 investigators. RESULTS: Of a total of 5965 citations retrieved, 24 eligible studies were identified and reviewed, providing 1608 eyes with BRVO with data on natural history. Visual acuity (VA) was moderately poor at baseline (<20/40). Although VA generally improved, with mean improvement ranging from 1 letter at 6 weeks to 28 letters up to 24 months, few studies reported improvement beyond 20/40. Over a 1-year period, 5% to 15% of eyes developed macular edema (ME), but of those with ME at baseline, 18% to 41% resolved. At baseline, 5% to 6% of eyes had bilateral BRVO, with 10% developing fellow eye involvement over time. There were few high-quality studies on other outcomes, including development of new vessels. CONCLUSIONS: Visual acuity generally improved in eyes with BRVO without intervention, although clinically significant improvement beyond 20/40 was uncommon.

Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety.

BACKGROUND: The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been comprehensively assessed relative to placebo. OBJECTIVE: To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis. METHODS: Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study. RESULTS: BoNTA treatment significantly reduced daily activity limitations at 4 weeks after injection. A 2-point improvement on the 4-point Hyperhidrosis Disease Severity Scale (HDSS) was reported in 75% of subjects in the 75-U and 50-U BoNTA groups and in 25% of the placebo group (P < .001). Improvements in HDSS scores were corroborated by gravimetric results. The median duration of effect was 197 days, 205 days, and 96 days in the 75-U, 50-U, and placebo groups, respectively. BoNTA was well tolerated. LIMITATIONS: The effect of total surface area involvement on treatment efficacy was not evaluated. CONCLUSION: BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated.

Comorbidity and Health Care Resource Use Among Commercially Insured Non-Elderly Patients With Diabetic Macular Edema.

BACKGROUND AND OBJECTIVE: Diabetic macular edema (DME) is a leading cause of blindness for non-elderly adults; however, health care-associated burden data from this population is lacking. The authors describe health care-associated burden in non-elderly patients with DME compared to those with diabetes and no DME. PATIENTS AND METHODS: In this retrospective, large-cohort study examines enrollment and health care claims (2007 to 2011) from a national database of insured patients aged 18 to 63 years (mean: 51). Comorbidity and health care utilization differences between patients with DME (n = 24,326) and matched controls with diabetes but no DME (n = 122,710) were analyzed over 1 and 3 years. RESULTS: DME patients had significantly more baseline comorbidities, and generally developed them at a higher rate over the study. Health care resource utilization rates were significantly higher in DME patients for every category analyzed. Patients with DME averaged more than 10 health care visits more than those with diabetes but no DME (25.5 vs 14.9; P < .001). CONCLUSION: Working-age patients with DME exhibit a complicated comorbidity profile and high associated burden of health care consumption. Considering this burden is critical for managing this complex population.

US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey.

BACKGROUND: The current epidemiologic data on hyperhidrosis are scarce and insufficient to provide precise prevalence or impact estimates. OBJECTIVE: We sought to estimate the prevalence of hyperhidrosis in the US population and assess the impact of sweating on those affected by axillary hyperhidrosis. METHODS: A nationally representative sample of 150,000 households was screened by mailed survey for hyperhidrosis and projected to the US population based on US census data. Ascertainment of hyperhidrosis was based on a question that asked whether participants experienced excessive or abnormal/unusual sweating. RESULTS: The prevalence of hyperhidrosis in the survey sample was 2.9% (6800 individuals). The projected prevalence of hyperhidrosis in the United States is 2.8% (7.8 million individuals), and 50.8% of this population (4.0 million individuals) reported that they have axillary hyperhidrosis (1.4% of the US population). Only 38% had discussed their sweating with a health care professional. Approximately one third of individuals with axillary hyperhidrosis (0.5% of the US population or 1.3 million individuals) reported that their sweating is barely tolerable and frequently interferes, or is intolerable and always interferes, with daily activities. CONCLUSION: Hyperhidrosis affects a much larger proportion of the US population than previously reported. More than half of these individuals have axillary hyperhidrosis, in which sweating can result in occupational, emotional, psychological, social, and physical impairment.

Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema.

PURPOSE: To examine the utilization of bevacizumab and ranibizumab and disease monitoring in patients with branch or central retinal vein occlusion (BRVO/CRVO) or diabetic macular edema (DME) in clinical practice. PATIENTS AND METHODS: This retrospective claims analysis included newly diagnosed patients with one or more bevacizumab or ranibizumab injections. Bevacizumab or ranibizumab utilization was assessed by year of first injection: 2008-2010 cohorts (12-month follow-up), January to June 2011 cohort (6-month follow-up). The main outcome measures were mean annual numbers of injections, ophthalmologist visits and optical coherence tomography examinations, and proportion of patients with additional laser or intravitreal triamcinolone (IVTA) use. RESULTS: A total of 885 BRVO, 611 CRVO, and 2,733 DME patients treated with bevacizumab were included, with too few ranibizumab-treated patients for meaningful analysis. Across the 2008, 2009, and 2010 cohorts, mean annual numbers of bevacizumab injections increased, but remained low (BRVO 2.5, 3.1, 3.3; CRVO 3.1, 3.1, 3.5; and DME 2.2, 2.5, 3.6, respectively); mean ophthalmologist visits ranged between 4.4 and 6.5, and mean optical coherence tomography examinations ranged between 3.1 and 3.9 across all conditions. A total of 42.0% of BRVO, 16.5% of CRVO, and 57.7% of DME patients received additional laser or IVTA therapy. The number of bevacizumab injections was positively associated with laser use in BRVO (3.3 versus 2.9, P<0.03), and with laser or IVTA use in DME (laser, 3.3 versus 2.7, P<0.03; IVTA, 3.3 versus 3.0, P<0.05). CONCLUSION: During the study period (2008-2011), bevacizumab was the main anti-VEGF therapy used in clinical practice for BRVO, CRVO, and DME. Patients treated with bevacizumab were monitored less frequently and received fewer injections than patients in major clinical trials of ranibizumab.

Patient adherence and persistence with topical ocular hypotensive therapy in real-world practice: a comparison of bimatoprost 0.01% and travoprost Z 0.004% ophthalmic solutions.

BACKGROUND: Effective control of intraocular pressure is predicated upon patient compliance with pharmacotherapy. We compared patient adherence and persistence with two new ocular hypotensive formulations, using real-world utilization data. METHODS: This observational cohort study employed pharmacy claims data from the Source(®) Lx (Wolters Kluwer Pharma Solutions) database. Patients with an initial (index) prescription for topical bimatoprost 0.01% or travoprost Z (April to June 2011) and no claim for ophthalmic prostaglandin or prostamide analogs within the previous 18 months were identified. Treatment adherence was expressed as proportion of days covered with study medication during the first 365 days after the index prescription. Treatment persistence with study medication was assessed over the first 12 months using Kaplan-Meier survival analyses, allowing a maximum 30-day gap for prescription refill. Treatment status was determined monthly over this period. RESULTS: A total of 12,985 patients were assessed for treatment adherence, and 10,470 for treatment persistence. Adherence was better with bimatoprost 0.01% than with travoprost Z (mean proportion of days covered 0.540 versus [vs] 0.486, P<0.001), and more patients showed high adherence (proportion of days covered >0.80) with bimatoprost 0.01% than travoprost Z (29.1% vs 22.3%, P<0.001). Continuous 12-month persistence was higher with bimatoprost 0.01% than with travoprost Z (29.5% vs 24.2%, P<0.001). At month 12, more patients were on treatment with bimatoprost 0.01% than travoprost Z (48.8% vs 45.7%, P<0.01). Similar findings were demonstrated in cohorts of ocular hypotensive treatment-naïve patients, branded latanoprost switchers, and older patients (age ≥65 years), and after inclusion of patient characteristics as covariates. CONCLUSION: For patients with glaucoma or ocular hypertension, bimatoprost 0.01% offers compliance advantages over travoprost Z.

Clinical monitoring of patients with age-related macular degeneration treated with intravitreal bevacizumab or ranibizumab.

BACKGROUND AND OBJECTIVE: Patients with neovascular age-related macular degeneration (AMD) require frequent follow-up and regular anti-VEGF injections for optimal outcomes. Although studies suggest that injection frequency is suboptimal in clinical practice, monitoring frequency in this setting is unclear. This study evaluates annual monitoring patterns between 2008 and 2011. PATIENTS AND METHODS: This retrospective claims analysis included newly diagnosed neovascular AMD patients with at least one intravitreal bevacizumab or ranibizumab injection (8,811 and 2,877 patients, respectively). Patient monitoring and treatment patterns were assessed at 12-month intervals. RESULTS: From 2008 to 2010, the mean number of injections increased. In the 2010 cohort, among bevacizumab- and ranibizumab-treated patients, respectively, less than 23% and less than 40% had at least 10 ophthalmologist visits, and less than 4% and less than 21% had at least 10 optical coherence tomography scans. CONCLUSION: Patients with neovascular AMD in clinical settings during 2008 to 2011 were monitored less frequently and received fewer anti-VEGF injections than patients in major clinical trials, which may affect outcomes.

Development of a preference-based index from the National Eye Institute Visual Function Questionnaire-25.

IMPORTANCE: Understanding how individuals value health states is central to patient-centered care and to health policy decision making. Generic preference-based measures of health may not effectively capture the impact of ocular diseases. Recently, 6 items from the National Eye Institute Visual Function Questionnaire-25 were used to develop the Visual Function Questionnaire-Utility Index health state classification, which defines visual function health states. OBJECTIVE: To describe elicitation of preferences for health states generated from the Visual Function Questionnaire-Utility Index health state classification and development of an algorithm to estimate health preference scores for any health state. DESIGN, SETTING, AND PARTICIPANTS: Nonintervention, cross-sectional study of the general community in 4 countries (Australia, Canada, United Kingdom, and United States). A total of 607 adult participants were recruited from local newspaper advertisements. In the United Kingdom, an existing database of participants from previous studies was used for recruitment. INTERVENTIONS: Eight of 15,625 possible health states from the Visual Function Questionnaire-Utility Index were valued using time trade-off technique. MAIN OUTCOMES AND MEASURES: A θ severity score was calculated for Visual Function Questionnaire-Utility Index-defined health states using item response theory analysis. Regression models were then used to develop an algorithm to assign health state preference values for all potential health states defined by the Visual Function Questionnaire-Utility Index. RESULTS: Health state preference values for the 8 states ranged from a mean (SD) of 0.343 (0.395) to 0.956 (0.124). As expected, preference values declined with worsening visual function. Results indicate that the Visual Function Questionnaire-Utility Index describes states that participants view as spanning most of the continuum from full health to dead. CONCLUSIONS AND RELEVANCE: Visual Function Questionnaire-Utility Index health state classification produces health preference scores that can be estimated in vision-related studies that include the National Eye Institute Visual Function Questionnaire-25. These preference scores may be of value for estimating utilities in economic and health policy analyses.

Clinical utilization of anti-VEGF agents and disease monitoring in neovascular age-related macular degeneration.

PURPOSE: To examine bevacizumab and ranibizumab utilization and disease monitoring patterns in patients with neovascular age-related macular degeneration (neovascular AMD) in clinical practice. DESIGN: Retrospective medical claims analysis. METHODS: Patients receiving ≥1 ranibizumab or bevacizumab injection during the 12 months after initial neovascular AMD diagnosis were included. Annual bevacizumab and/or ranibizumab injection utilization was assessed by year of first injection cohorts: 2006 and 2007 (received either agent because of billing code overlap), 2008, 2009, and January-June 2010 (received each agent). Outcome measures were time to first injection relative to neovascular AMD diagnosis and mean numbers of intravitreal injections, ophthalmologist visits, and optical coherence tomography (OCT) and fluorescein angiography (FA) examinations in 12 months. RESULTS: In the 2006 and 2007 cohorts (n = 8767), mean annual numbers of bevacizumab or ranibizumab injections were 4.7 and 5.0, respectively. Over 92% of patients in all cohorts received first treatment within 3 months of neovascular AMD diagnosis. In the 2008-2010 cohorts (n = 10 259), mean annual number of injections remained low (bevacizumab: 4.6, 5.1, and 5.5; ranibizumab: 6.1, 6.6, and 6.9), as did mean numbers of ophthalmologist visits (bevacizumab only) and OCT examinations (both agents), but there was no such trend in FA examinations. CONCLUSIONS: Compared with treatment paradigms validated by clinical trials published at the time, in clinical practice, patients with neovascular AMD received fewer bevacizumab or ranibizumab injections and less-frequent monitoring from 2006 to mid-2011. Factors contributing to this lower injection frequency and visual outcomes associated with reduced utilization need to be researched.

An adherence based cost-consequence model comparing bimatoprost 0.01% to bimatoprost 0.03%.

OBJECTIVES: Estimate the long-term direct medical costs and clinical consequences of improved adherence with bimatoprost 0.01% compared to bimatoprost 0.03% in the treatment of glaucoma. METHODS: A cost-consequence model was constructed from the perspective of a US healthcare payer. The model structure included three adherence levels (high, moderate, low) and four mean deviation (MD) defined health states (mild, moderate, severe glaucoma, blindness) for each adherence level. Clinical efficacy in terms of IOP reduction was obtained from the randomized controlled trial comparing bimatoprost 0.01% with bimatoprost 0.03%. Medication adherence was based on observed 12 month rates from an analysis of a nationally representative pharmacy claims database. Patients with high, moderate and low adherence were assumed to receive 100%, 50% and 0% of the IOP reduction observed in the clinical trial, respectively. Each 1 mmHg reduction in IOP was assumed to result in a 10% reduction in the risk of glaucoma progression. Worse glaucoma severity health states were associated with higher medical resource costs. Outcome measures were total costs, proportion of patients who progress and who become blind, and years of blindness. Deterministic sensitivity analyses were performed on uncertain model parameters. RESULTS: The percentage of patients progressing, becoming blind, and the time spent blind slightly favored bimatoprost 0.01%. Improved adherence with bimatoprost 0.01% led to higher costs in the first 2 years; however, starting in year 3 bimatoprost 0.01% became less costly compared to bimatoprost 0.03% with a total reduction in costs reaching US$3433 over a lifetime time horizon. Deterministic sensitivity analyses demonstrated that results were robust, with the majority of analyses favoring bimatoprost 0.01%. Application of 1 year adherence and efficacy over the long term are limitations. CONCLUSIONS: Modeling the effect of greater medication adherence with bimatoprost 0.01% compared with bimatoprost 0.03% suggests that differences may result in improved economic and patient outcomes.

Psychometric performance of the incontinence quality-of-life questionnaire among patients with overactive bladder and urinary incontinence.

BACKGROUND: The Incontinence Quality-of-Life Instrument (I-QOL) is a condition-specific questionnaire that assesses the health-related QOL impact of urinary incontinence, but it has not been validated in patients with overactive bladder (OAB) who have been inadequately managed by anticholinergic therapy. OBJECTIVE: This study assessed the reliability and validity of the I-QOL among patients with OAB with urinary incontinence. METHODS: I-QOL scores were analyzed from a Phase II study that compared the efficacy and tolerability of onabotulinumtoxinA and placebo. Conceptual framework was confirmed via confirmatory factor analysis. Reliability was assessed using Cronbach's alpha and intraclass correlation coefficients (ICCs). Validity was tested by comparing I-QOL scores to tertiles of urinary symptom severity. Effect size statistics estimated the ability of the I-QOL to detect change. Responder analysis with cumulative distribution function was plotted to show differentiation between treatment groups with respect to I-QOL scores. RESULTS: Comparative fit indices ranged from 0.87 to 0.99 on the confirmatory factor analysis. I-QOL scores showed high internal consistency (0.86 ≤ Cronbach's α ≤ 0.93), good test-retest reliability (0.68 ≤ ICC ≤ 0.84), and good differentiation between tertiles of increasing urinary symptom severity (all, P ≤ 0.002). Significant differences in I-QOL change scores were noted between responders and nonresponders across all responder definitions (all, P < 0.001) and corresponded with large effect sizes among responders to treatment (1.34 ≤ effect size ≤ 2.82). CONCLUSION: This study demonstrated that OAB with urinary incontinence affects health-related QOL and that the I-QOL reliably and validly measures these impacts.

Normative comparison of patient-reported outcomes in patients with noninfectious uveitis.

OBJECTIVE: To compare vision-related functioning and health-related quality of life of patients with noninfectious intermediate or posterior uveitis with those of the US general population and normal-vision reference groups. METHODS: Secondary analysis of health-related quality of life measures administered at baseline to patients with noninfectious intermediate or posterior uveitis participating in the HURON trial, a 26-week, multicenter, masked, randomized, sham-controlled trial of a dexamethasone intravitreal implant (n=224) was performed. Patient-reported outcome measures included the National Eye Institute Visual Function Questionnaire-25, the 36-Item Short-Form Health Survey, the Short Form-6 Dimensions, and the EuroQol-5D. The National Eye Institute Visual Function Questionnaire-25 scores from the HURON uveitis population were compared with published National Eye Institute Visual Function Questionnaire-25 scores from a normal-vision reference group (n=122). The 36-Item Short-Form Health Survey, Short Form-6 Dimensions, and EuroQol-5D scores were compared with the US general population using data from the National Health Measurement Study (n=3844) and the Medical Expenditure Panel Survey (n=955). RESULTS: Compared with a normal-vision population, the HURON uveitis population had clinically significant impairments across all National Eye Institute Visual Function Questionnaire-25 subscales and the composite score, with all subscale score differences exceeding 10 points (P< .001). The HURON uveitis population had significantly lower 36-Item Short-Form Health Survey mental component summary and Short Form-6 Dimensions scores compared with a US general population sample (P< .001). No significant differences were found for the 36-Item Short-Form Health Survey physical component summary and EuroQol-5D scores between the uveitis and US general population samples. CONCLUSIONS: Compared with the US general population and normal-vision reference groups, noninfectious intermediate or posterior uveitis results in meaningful reductions in mental health outcomes, health-related quality of life, and vision-related functioning. TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT00333814.

Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis.

PURPOSE: To evaluate the effect of a single treatment with dexamethasone intravitreal implant (DEX implant) on patient-reported visual functioning in patients with noninfectious intermediate or posterior uveitis. METHODS: Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with DEX implant 0.70 mg (n=77), DEX implant 0.35 mg (n=76), or a sham procedure (n=76) and followed for 26 weeks. Vision-related functioning was measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) assessed at baseline and at weeks 8, 16, and 26 or early exit. Analysis of covariance and mixed model analysis of covariance were used to compare vision-related functioning between the DEX implant 0.70 and 0.35 mg groups and the sham group. RESULTS: By 8 weeks, the DEX implant 0.70 mg group demonstrated significant improvements in NEI VFQ-25 subscales near vision (P=0.031), distance vision (P=0.023), peripheral vision (P=0.045), vision-specific social functioning (P=0.019), and the NEI VFQ-25 composite score (P=0.007) compared with sham. After 26 weeks, the DEX implant 0.70 mg group reported significant improvements in NEI VFQ-25 subscales distance vision (P=0.003), vision-specific role difficulties (P=0.038), vision-specific dependency (P=0.017), vision-specific social functioning (P=0.009), vision-specific mental health (P=0.036), and the composite score (P=0.001) compared with sham. CONCLUSIONS: In patients with noninfectious intermediate or posterior uveitis receiving a single treatment of DEX implant 0.70 mg, significant and clinically meaningful improvements in patient-reported visual functioning were observed as early as week 8 and were maintained over 26 weeks. (ClinicalTrials.gov number, NCT00333814.).