Background Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is noninferior to the standard 12-month treatment regarding disease-free survival. Methods This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered every 3 weeks intravenously (loading dose of 8 mg/kg followed by maintenance doses of 6 mg/kg) or subcutaneously (600 mg), given in combination with chemotherapy (concurrently or sequentially). The primary endpoint was disease-free survival, analysed by intention to treat, with a non-inferiority margin of 3% for 4-year disease-free survival. Safety was analysed in all patients who received trastuzumab. This trial is registered with EudraCT (number 2006-007018-39), ISRCTN (number 52968807), and ClinicalTrials.gov (number NCT00712140).
IMPORTANCE Updated estimates of the prevalence and incidence rates of low vision and blindness are needed to inform policy makers and develop plans to meet the future demands for low vision rehabilitation services.OBJECTIVE To provide updated estimates of the incidence and prevalence of low vision and blindness in the United States. DESIGN, SETTING, AND PARTICIPANTSVisual acuity measurements as a function of age from the 2007-2008 National Health and Nutrition Examination Survey, with representation of racial and ethnic groups, were used to estimate the prevalence and incidence of visual impairments. Data from 6016 survey participants, ranging in age from younger than 18 years to older than 45 years, were obtained to estimate prevalence rates for different age groups. Incidence and prevalence rates of low vision (best-corrected visual acuity [BCVA] in the better-seeing eye of <20/40 and <20/60) and blindness (BCVA of Յ20/200) in older adults were estimated from exponential models, fit to prevalence rates as a function of age (specified in 5-year age bins). The prevalence and annual incidence of low vision and blindness in the United States were estimated, using the 2010 US census data by age, from the rate models applied to the census projections
There is a need for a comprehensive, supported and sustained approach to implementation of evidence-based practice for pressure ulcer prevention and treatment, greater understanding of organization-specific barriers, and mechanisms for addressing the barriers.
Purpose In an observational clinical outcome study, we tested the effectiveness and use of the combination of two innovative approaches to magnification: a virtual bioptic telescope and a virtual projection screen, implemented with digital image processing in a head-mounted display (HMD) equipped with a high-resolution video camera and head trackers. Methods We recruited 30 participants with best-corrected visual acuity <20/100 in the better-seeing eye and bilateral central scotomas. Participants were trained on the HMD system, then completed a 7- to 10-day in-home trial. The Activity Inventory was administered before and after the home trial to measure the effect of system use on self-reported visual function. A simulator sickness questionnaire (SSQ) and a system-use survey were administered. Rasch analysis was used to assess outcomes. Results Significant improvements were seen in functional ability measures estimated from goal difficulty ratings (Cohen's d = 0.79, P < 0.001), and reading ( d = 1.28, P < 0.001) and visual information ( d = 1.11, P < 0.001) tasks. There was no improvement in patient-reported visual motor function or mobility. One participant had moderately severe discomfort symptoms after SSQ item calibration. The average patient rating of the system's use was 7.14/10. Conclusions Use of the system resulted in functional vision improvements in reading and visual information processing. Lack of improvement in mobility and visual motor function is most likely due to limited field of view, poor depth perception, and lack of binocular disparity. Translational Relevance We determine if these new image processing approaches to magnification are beneficial to low vision patients performing everyday activities.
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