Elizabeth A Sugar1, Vidya Venugopal2, Jennifer E Thorne3, Kevin D Frick4, Gary N Holland5, Robert C Wang6, Robert Almanzor5, Douglas A Jabs7, Janet T Holbrook8. 1. Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Clinical Trials, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Division of Biostatistics and Bioinformatics, The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins School of Medicine, Baltimore, Maryland. Electronic address: esugar2@jhu.edu. 2. Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania. 3. Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, Maryland. 4. The Johns Hopkins Carey Business School, The Johns Hopkins University, Baltimore, Maryland. 5. Jules Stein Eye Institute, Department of Ophthalmology, The David Geffen School of Medicine at UCLA, Los Angeles, California. 6. Texas Retina Associates, Dallas, Texas. 7. Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Department of Ophthalmology, The Icahn School of Medicine at Mount Sinai, New York, New York; Department of Medicine, The Icahn School of Medicine at Mount Sinai, New York, New York. 8. Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Clinical Trials, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Abstract
PURPOSE: To evaluate longitudinal vision-related quality of life (VRQoL) in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate uveitis, posterior uveitis, or panuveitis enrolled in the Multicenter Steroid Treatment Trial and Follow-up Study. METHODS: Data from the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) for the first 3 years after randomization were evaluated semiannually. Analyses were stratified by assigned treatment (129 implants vs. 126 systemic therapies) because of substantial differences in the trajectories of VRQoL. The impact of baseline measurements of visual function (visual acuity and visual field), demographics, and disease characteristics was assessed using generalized estimating equations. MAIN OUTCOME MEASURES: Primary outcome was the NEI-VFQ-25 composite score over 3 years after randomization. RESULTS: Individuals in both treatment groups showed similar improvement in NEI-VFQ-25 scores after 3 years of follow-up (implant: 11.9 points; 95% confidence interval [CI], 8.6-15.2; P < 0.001; systemic: 9.0 points; 95% CI, 5.6-12.3; P < 0.001; P = 0.21 for interaction). Individuals in the implant group showed a substantial improvement during the first 6 months followed by stable scores, whereas individuals in the systemic group showed a steady improvement over the course of follow-up. Worse initial visual acuity and visual fields were associated with lower initial NEI-VFQ-25 scores for both treatment groups. In the systemic group, these differences were maintained throughout follow-up. In the implant group, individuals with initial visual acuity worse than 20/40 showed additional improvement in NEI-VFQ-25 score to come within -7 points (95% CI, -15.0 to 0.9) of those with visual acuity 20/40 or better initially, a clinically meaningful but not statistically significant difference (P = 0.081). Results based on sensitivity analyses showed similar patterns. CONCLUSIONS: Both treatment groups demonstrated significant improvements in NEI-VFQ-25 scores; however, the improvement was immediate for the implant group as opposed to gradual for the systemic group. Poorer visual function was associated significantly with initial differences in NEI-VFQ-25 scores. However, only individuals in the implant group with poor visual acuity were able to overcome their initial deficits by the end of 3 years.
PURPOSE: To evaluate longitudinal vision-related quality of life (VRQoL) in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate uveitis, posterior uveitis, or panuveitis enrolled in the Multicenter Steroid Treatment Trial and Follow-up Study. METHODS: Data from the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) for the first 3 years after randomization were evaluated semiannually. Analyses were stratified by assigned treatment (129 implants vs. 126 systemic therapies) because of substantial differences in the trajectories of VRQoL. The impact of baseline measurements of visual function (visual acuity and visual field), demographics, and disease characteristics was assessed using generalized estimating equations. MAIN OUTCOME MEASURES: Primary outcome was the NEI-VFQ-25 composite score over 3 years after randomization. RESULTS: Individuals in both treatment groups showed similar improvement in NEI-VFQ-25 scores after 3 years of follow-up (implant: 11.9 points; 95% confidence interval [CI], 8.6-15.2; P < 0.001; systemic: 9.0 points; 95% CI, 5.6-12.3; P < 0.001; P = 0.21 for interaction). Individuals in the implant group showed a substantial improvement during the first 6 months followed by stable scores, whereas individuals in the systemic group showed a steady improvement over the course of follow-up. Worse initial visual acuity and visual fields were associated with lower initial NEI-VFQ-25 scores for both treatment groups. In the systemic group, these differences were maintained throughout follow-up. In the implant group, individuals with initial visual acuity worse than 20/40 showed additional improvement in NEI-VFQ-25 score to come within -7 points (95% CI, -15.0 to 0.9) of those with visual acuity 20/40 or better initially, a clinically meaningful but not statistically significant difference (P = 0.081). Results based on sensitivity analyses showed similar patterns. CONCLUSIONS: Both treatment groups demonstrated significant improvements in NEI-VFQ-25 scores; however, the improvement was immediate for the implant group as opposed to gradual for the systemic group. Poorer visual function was associated significantly with initial differences in NEI-VFQ-25 scores. However, only individuals in the implant group with poor visual acuity were able to overcome their initial deficits by the end of 3 years.
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