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In clinical glaucoma research, the measurement of patient reported outcomes, functional assessment of disability, and health economic impact is critical. However, valid, time-efficient and comprehensive tools are not available and several current instruments lack in the appropriate precision for measuring the various dimensions of glaucoma-related quality of life (QoL), including functioning and mobility. Furthermore, statistical methods are inconsistently and sometimes incorrectly used in otherwise sound clinical studies. Standardizing and improving methods of patient-centered data collection and analysis in glaucoma studies are imperative. This paper outlines recommendations and provides a discussion of some of the pertinent issues relating to the optimization of patient-reported outcomes research in glaucoma.

Purpose: We design and evaluate a computer-based objective simulation of activity limitation related to glaucoma., Methods: A cross-sectional study was performed involving 70 glaucoma patients and 14 controls. Mean age was 69.0 ± 10.2 years; 49 (58.3%) were male. The Cambridge Glaucoma Visual Function Test (CGVFT) was administered to all participants. Rasch analysis and criterion, convergent, and divergent validity tests assessed the psychometric properties of the CGVFT. Regression modeling was used to determine factors predictive of CGVFT person measures. Sociodemographic information, better and worse eye visual field parameters, visual acuity, contrast sensitivity, and the Rasch-analyzed Glaucoma Activity Limitation-9 (GAL-9) and Visual Function Questionnaire Utility Index (VFQUI) questionnaire responses were recorded., Results: From 139 pilot CGVFT items, 59 had acceptable fit to the Rasch model, with acceptable precision (person separation index, 2.13) and targeting. Cambridge Glaucoma Visual Function Test person measure (logit) scores increased between controls (-0.20 ± 0.08) and patients with mild (-0.15 ± 0.08), moderate (-0.13 ± 0.10), and severe (-0.05 ± 0.10) glaucoma (P < 0.001, ANOVA) indicating good criterion validity. Correlation coefficients of 0.455 (P < 0.001) between CGVFT and GAL-9 person measures and 0.399 (P = 0.005) between CGVFT and VFQUI person measures demonstrated convergent validity. Divergent validity was suboptimal. On multivariable analysis, lower better eye mean deviation and greater age were associated with worsening CGVFT person measures (P ≤ 0.001)., Conclusions: The CGVFT is a computerized visual challenge test administered to a cohort of glaucoma patients. It may benefit glaucoma patients, careers, health care providers, and policy makers, providing increased awareness of activity limitation due to glaucoma.

Purpose: As health budgets tighten globally, evaluating the cost-effectiveness of glaucoma services is vital; however, there is a lack of validated instruments that measure utility specific to glaucoma patients. We thus evaluated the validity of the Visual Function Questionnaire-Utility Index (VFQ-UI) as a measure of vision-related function and preference-based status in glaucoma., Patients and Methods: Cross-sectional study of 141 volunteer patients over 40 years of age with moderate (n=64) or severe (n=36) glaucoma, and 41 controls. Sociodemographic information, visual acuity, and visual field test parameters were obtained. The VFQ-UI and Glaucoma Activity Limitation-9 patient-reported outcome tools were administered, and their psychometric properties explored using Rasch analysis. Criterion, convergent, and divergent validity of the VFQ-UI were also assessed., Results: Mean age was 69.7 (±10.8) years, with a mean better eye visual acuity (LogMAR) of 0.074 (±0.356) (approximate Snellen acuity of 20/24). Overall, the VFQ-UI had satisfactory fit to the Rasch model, however targeting and precision were suboptimal with a person separation index of 1.72 and person reliability coefficient of 0.75. VFQ-UI scores significantly increased as glaucoma severity worsened between controls (-4.54, ±1.15) and patients with moderate (-3.77, ±1.57) and severe glaucoma (-1.98, ±2.98), indicating good criterion validity (P<0.001). Strong correlation between VFQ-UI and Glaucoma Activity Limitation-9 scores (r=0.764, P<0.001) demonstrated good convergent validity. There was no significant correlation between VFQ-UI scores and age and sex (r=0.150 and 0.026, respectively), demonstrating good divergent validity., Conclusions: The VFQ-UI shows potential to measure preference-based status in a cohort of glaucoma patients, with the means to calculate utility. Although the VFQ-UI displayed reasonable fit to the Rasch model overall and had good criterion, convergent and divergent validity, its lack of precision is a limitation. The difficulty of the VFQ-UI in discriminating among patients with varying glaucoma severity may be improved by including items specific to glaucomatous visual dysfunction.

Background: To assess the impact of cataract on quality of life (QoL) for patients with glaucoma., Design: Cross-sectional study., Participants: Two hundred forty-two patients with mild (n = 67), moderate (n = 80) or severe (n = 45) glaucoma and 50 controls (glaucoma suspects). Patients with cataract of any severity were included., Methods: The following data were collected: sociodemographic information, phakic/pseudophakic status, cataract grade according to the Lens Opacities Classification System (LOCS) III, visual acuity and visual field test parameters. Glaucoma severity was stratified according to binocular visual field loss. Visually significant cataract was defined as: LOCS III criteria nuclear cataract ≥3/6.9, cortical cataract ≥3/5.9 or posterior subcapsular cataract ≥2/5.9., Main Outcome Measures: Patients' QoL was measured using Rasch-transformed scores from the Glaucoma Activity Limitation-9 (GAL-9) questionnaire. Multiple linear regression models were used to determine the association between cataract and GAL-9 (logit) score., Results: Fifty-six (23.1%) patients had at least one visually significant cataract. At least one visually significant cataract (standardized coefficient [β] 1.19, 95% confidence interval 1.04-1.34, P = 0.011) and poor visual field index (better eye) (β 1.47, 95% confidence interval 1.36-1.88, P < 0.001) were independently associated with worse GAL-9 score., Conclusions: Cataract influences glaucoma-related QoL among glaucoma patients of all severity levels and is an important cause of potentially reversible visual impairment among glaucoma patients. The Rasch-analysed GAL-9 questionnaire is a useful metric to quantify visual disability related to cataract in glaucoma patients., (© 2014 Royal Australian and New Zealand College of Ophthalmologists.)

Purpose: To investigate the relationship between ocular surface disease and glaucoma-related quality of life (QoL), glaucoma severity, and treatment in patients with open-angle glaucoma., Design: Cross-sectional study., Setting: Clinical practice., Study Population: One hundred twenty-four participants-patients with mild (n = 48), moderate (n = 34), or severe (n = 19) glaucoma and 23 controls (glaucoma suspects) not receiving glaucoma treatment-were enrolled. Severity was stratified according to binocular visual field loss. OBSERVED PROCEDURES: Demographic information, the Ocular Surface Disease Index (OSDI), and Glaucoma Quality of Life-15 (GQL-15) questionnaires were administered., Main Outcome Measures: OSDI score, GQL-15 score, number and type of glaucoma medications, daily dose of benzalkonium chloride (BAK), and visual field indices., Results: OSDI scores and the number of patients with OSD increased with increasing glaucoma severity (P < .001 and P < .005). GQL-15 scores reflected decreased QoL with increasing glaucoma severity (P < .001). These trends were maintained after sub-stratification for age and sex. On univariate regression OSDI was significantly correlated with GQL-15 summary score, glaucoma severity, multiple topical glaucoma medications, worse eye mean deviation and pattern standard deviation, use of topical beta blockers, topical carbonic anhydrase inhibitors, daily dose of BAK, and glaucoma filtration surgery. On multivariate regression GQL-15 summary score (odds ratio [OR] 4.14, 95% confidence interval [CI] 2.59-6.63, P < .001) and a daily dose of BAK greater than 3 (OR 2.47, 95% CI 1.17-5.21, P = .018) were predictive of OSDI score., Conclusions: OSD is more common in patients with increasing glaucoma severity and is associated with poorer glaucoma-related QoL and higher exposure to BAK., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Abstract: Importance: Targeted education may impact glaucoma patients' clinical experience. Background: The aim of this study was to measure the impact of patient‐centred glaucoma‐related education on knowledge, anxiety and treatment satisfaction. Design: This was a multicentre Australia‐wide randomized clinical trial. Participants: One hundred one newly diagnosed glaucoma patients were randomized 1:1 to intervention or control groups. Methods: Those randomized to the Glaucoma Australia educational intervention received telephone‐based counselling about glaucoma followed by mail‐out information, in addition to usual care and information from their treating ophthalmologist. The control group received only usual care and information from their treating ophthalmologist. Surveys were administered at baseline and 4 weeks following intervention. Main Outcome Measures: The Auckland Glaucoma Knowledge Questionnaire measured glaucoma‐related knowledge. The Hospital Anxiety and Depression Scale and Eye‐Drop Satisfaction Questionnaire measured anxiety and patient treatment satisfaction, respectively. Results: Mean age was 64.7 ± 11.1 years, and 52 (51.5%) were male. There was no noticeable increase in knowledge levels in the control group (mean difference: 0.04 logits, P = 0.7), compared with a 0.49‐logit (P = 0.02) increase in knowledge levels in the intervention group. Between‐group comparison showed a non‐significant increase in knowledge (0.45 logits, P = 0.07) comparing intervention participants with controls. Intervention participants experienced a statistically significant decrease in anxiety compared to controls (−0.60 logits, P = 0.02). No between‐group difference was found in Eye‐Drop Satisfaction Questionnaire scores. Conclusions and Relevance: Patient‐centred glaucoma‐related education and support services may improve knowledge and can reduce anxiety for newly diagnosed glaucoma patients. All glaucoma patients should be adequately counselled about the nature of the disease and its management. [ABSTRACT FROM AUTHOR]