SOCIETAL COSTS ASSOCIATED WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE UNITED STATES.

Purpose: The purpose of this study was to use a cross-sectional prevalence-based health care economic survey to ascertain the annual, incremental, societal ophthalmic costs associated with neovascular age-related macular degeneration.

Methods: Consecutive patients (n = 200) with neovascular age-related macular degeneration were studied. A Control Cohort included patients with good (20/20-20/25) vision, while Study Cohort vision levels included Subcohort 1: 20/30 to 20/50, Subcohort 2: 20/60 to 20/100, Subcohort 3: 20/200 to 20/400, and Subcohort 4: 20/800 to no light perception.

Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE.

Objective: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME).

Design: Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits.

Prevalence of and risk factors for diabetic macular edema in the United States.

Importance: Diabetic macular edema (DME) is a leading cause of vision loss in persons with diabetes mellitus. Although there are national estimates for the prevalence of diabetic retinopathy and its risk factors among persons with diabetes, to our knowledge, no comparable estimates are available for DME specifically.

Objectives: To estimate the prevalence of DME in the US population and to identify associated risk factors.

Estimated cases of blindness and visual impairment from neovascular age-related macular degeneration avoided in Australia by ranibizumab treatment.

Intravitreal injections of anti-vascular endothelial growth factor agents, such as ranibizumab, have significantly improved the management of neovascular age-related macular degeneration. This study used patient-level simulation modelling to estimate the number of individuals in Australia who would have been likely to avoid legal blindness or visual impairment due to neovascular age-related macular degeneration over a 2-year period as a result of intravitreal ranibizumab injections. The modelling approach used existing data for the incidence of neovascular age-related macular degeneration in Australia and outcomes from ranibizumab trials.

Underuse of the health care system by persons with diabetes mellitus and diabetic macular edema in the United States.

Importance: Thickening of the center of the retina, diabetic macular edema (DME), is the most common cause of visual loss due to diabetes mellitus. Treatment of DME has improved dramatically, and the prompt diagnosis of DME and referral of these patients have become more critical. Nonetheless, awareness of and care for DME in the US population is uncharacterized.

Reading speed improvements in retinal vein occlusion after ranibizumab treatment.

Importance: Treatment of macular edema secondary to retinal vein occlusion with ranibizumab has been shown to improve visual acuity compared with macular laser or observation. It is important to determine whether these visual acuity improvements translate into measurable improvements in visual function.

Objective: To examine the benefit of ranibizumab (Lucentis) on measured reading speed, a direct performance assessment, through 6 months in eyes of patients with macular edema after retinal vein occlusion (RVO).

Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials.

Purpose: To examine the impact of intravitreal ranibizumab on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) through 6 months in patients with macular edema (ME) secondary to branch or central retinal vein occlusion (RVO).

Design: Two multicenter, double-masked trials, which enrolled participants with ME secondary to branch or central RVO: the RanibizumaB for the Treatment of Macular Edema following BRAnch Retinal Vein Occlusion: Evaluation of Efficacy and Safety (BRAVO) trial or the Central Retinal Vein OcclUsIon Study: Evaluation of Efficacy and Safety (CRUISE) trial.

Participants: Three hundred ninety-seven BRAVO and 392 CRUISE patients.

Estimated cases of legal blindness and visual impairment avoided using ranibizumab for choroidal neovascularization: non-Hispanic white population in the United States with age-related macular degeneration.

Objective: To estimate the number of non-Hispanic white individuals in the United States avoiding legal blindness and visual impairment from neovascular age-related macular degeneration (AMD) with ranibizumab availability.

Methods: Modeling of visual acuity outcomes from phase 3 ranibizumab trials to incidence rates of neovascular AMD from population-based studies.

Results: If no treatment were given, of the 103 582 individuals developing neovascular AMD for which ranibizumab would be indicated and available, 16 268 would become legally blind in 2 years.

Validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in age-related macular degeneration.

Purpose: Patient-reported measures of visual function are increasingly incorporated into clinical trials of new treatments for age-related macular degeneration (AMD). Limited information is available regarding the associations between distance visual acuity (VA), reading speed, or contrast sensitivity and the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) subscales judged relevant to these measures. This study's objective was to evaluate such associations along with questions on restricted activity days.

Telephone assessment of functioning and well-being following stroke: is it feasible?

Stroke can affect the physical, emotional, and social aspects of patients' lives. The purpose of this study was to assess the feasibility and psychometric properties of a telephone-administered version of the Health Utilities Index Mark 2 and 3 (HUI2/3). Subjects included patients who had had an ischemic stroke within the prior 12 months and their unpaid caregivers (n = 76 pairs) and an additional 33 unpaid caregivers of patients who were generally aphasic or severely affected.

Comparing COPD treatment: nebulizer, metered dose inhaler, and concomitant therapy.

Purpose: Patients using albuterol and ipratropium for treating chronic obstructive pulmonary disease (COPD) can use either nebulizers or metered dose inhalers. This study compared the 2 methods of delivering medication and the concomitant use of both nebulizer and inhaler, with respect to health-related quality of life, patient symptoms, and efficacy.

Subjects And Methods: Patients over 50 years old with COPD were randomized into 3 groups: nebulizer, inhaler, or concomitant treatment.

A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials.

Purpose: Overactive bladder (OAB) is a syndrome consisting of urinary urgency with or without urge incontinence, usually with increased urinary frequency and nocturia. In response to current limitations in OAB clinical research a new patient reported measure of urgency severity associated with OAB has been developed, namely the Indevus Urgency Severity Scale (IUSS). We report the measurement properties of the IUSS.

The impact of managed eye care on use of vision services, vision costs, and patient satisfaction.

Objectives: This study was designed to evaluate the impact of introducing a managed vision benefit program on the use and costs of vision services in a managed care setting and also to assess satisfaction with those services after the program was introduced.

Methods: Utilization and costs were compared for two groups of patients. The comparison group (n = 36,168) included all patients enrolled for 18 months before implementation of the managed eye-care plan.

Cross-sectional 7-year follow-up of anxiety in primary care patients.

We describe the longitudinal patterns of anxiety symptoms and mental health treatment among patients recruited from a primary care clinic, and provide a naturalistic view of anxiety symptoms, disorders, and treatment at two time periods 7 years apart. Study participants were originally identified in a primary care setting in 1992 as positive but untreated for the presence of anxiety and/or depressive symptoms and disorders. Data were collected through telephone interviews assessing current psychological status for anxiety and depression symptoms, disorders, and general functioning and well being.

Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease.

Background: The objective of this study was to develop and psychometrically evaluate a general measure of patients' satisfaction with medication, the Treatment Satisfaction Questionnaire for Medication (TSQM).

Methods: The content and format of 55 initial questions were based on a formal conceptual framework, an extensive literature review, and the input from three patient focus groups. Patient interviews were used to select the most relevant questions for further evaluation (n = 31).