Elizabeth A Sugar1, Alyce E Burke2, Vidya Venugopal3, Jennifer E Thorne4, Janet T Holbrook2. 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, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Clinical Trials, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. 3. Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania. 4. 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.
Abstract
PURPOSE: To evaluate the responsiveness of quality of life (QoL) metrics to ocular and systemic events in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. METHODS: Data on the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), EuroQol Questionnaire (EQ-5D), and Short Form Survey Instrument (SF-36) were evaluated semiannually during the first 3 years after randomization. The impact of ocular (e.g., changes in visual acuity [VA], activity status, cataract surgery) and systemic events (e.g., infections requiring treatment) on the 6-month changes in QoL was assessed for each metric using generalized estimating equations. MAIN OUTCOME MEASURES: The primary outcomes were the 6-month changes in vision-related (NEI-VFQ-25) and general health-related (EQ-5D index, SF-36 physical component summary [PCS]) QoL. RESULTS: Changes in VA (adjusted change [aΔ]: 2.70 units per 5 letter change, P < 0.001), implant placement in at least 1 eye (aΔ: 5.50, P < 0.001), cataract surgery (aΔ: 3.01, P = 0.017), and quieting of all eyes active at the beginning of the interval (aΔ: 2.20, P < 0.010) were associated with improvements in the NEI-VFQ-25. Reductions in VA (aΔ: -0.014 per 5 letter decline, P = 0.003), infections requiring a prescription (aΔ: -0.024, P = 0.021), and incident uveitis activity in at least 1 eye (aΔ: -0.023, P = 0.031) were associated with declines in the EQ-5D index. Hospitalization (aΔ: -2.24, P = 0.019), infections requiring a prescription (aΔ: -1.00, P = 0.024), and vitreous hemorrhage in at least 1 eye (aΔ: -1.92, P = 0.021) were associated with declines in the SF-36 PCS. Declines in VA, initiation in IOP medication, and age were associated with changes in SF-36 PCS; however, the magnitude of the change was less than a single point. CONCLUSIONS: The NEI-VFQ-25 was more sensitive to ocular changes than the general QoL metrics but less sensitive to acute systemic events. When performing QoL or cost-effectiveness analyses, it is important to consider the expected outcomes (e.g., ocular vs. systemic) to ensure that the selected measurement is sensitive enough to detect clinically important changes in disease status or effects of treatment.
PURPOSE: To evaluate the responsiveness of quality of life (QoL) metrics to ocular and systemic events in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. METHODS: Data on the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), EuroQol Questionnaire (EQ-5D), and Short Form Survey Instrument (SF-36) were evaluated semiannually during the first 3 years after randomization. The impact of ocular (e.g., changes in visual acuity [VA], activity status, cataract surgery) and systemic events (e.g., infections requiring treatment) on the 6-month changes in QoL was assessed for each metric using generalized estimating equations. MAIN OUTCOME MEASURES: The primary outcomes were the 6-month changes in vision-related (NEI-VFQ-25) and general health-related (EQ-5D index, SF-36 physical component summary [PCS]) QoL. RESULTS: Changes in VA (adjusted change [aΔ]: 2.70 units per 5 letter change, P < 0.001), implant placement in at least 1 eye (aΔ: 5.50, P < 0.001), cataract surgery (aΔ: 3.01, P = 0.017), and quieting of all eyes active at the beginning of the interval (aΔ: 2.20, P < 0.010) were associated with improvements in the NEI-VFQ-25. Reductions in VA (aΔ: -0.014 per 5 letter decline, P = 0.003), infections requiring a prescription (aΔ: -0.024, P = 0.021), and incident uveitis activity in at least 1 eye (aΔ: -0.023, P = 0.031) were associated with declines in the EQ-5D index. Hospitalization (aΔ: -2.24, P = 0.019), infections requiring a prescription (aΔ: -1.00, P = 0.024), and vitreous hemorrhage in at least 1 eye (aΔ: -1.92, P = 0.021) were associated with declines in the SF-36 PCS. Declines in VA, initiation in IOP medication, and age were associated with changes in SF-36 PCS; however, the magnitude of the change was less than a single point. CONCLUSIONS: The NEI-VFQ-25 was more sensitive to ocular changes than the general QoL metrics but less sensitive to acute systemic events. When performing QoL or cost-effectiveness analyses, it is important to consider the expected outcomes (e.g., ocular vs. systemic) to ensure that the selected measurement is sensitive enough to detect clinically important changes in disease status or effects of treatment.
Keywords:
EQ-5D index; NEI-VFQ-25; SF-36; Visual acuity; general quality of life; noninfectious intermediate; or panuveitis; physical component score; posterior; vision-related quality of life
Authors: Kevin D Frick; Lea T Drye; John H Kempen; James P Dunn; Gary N Holland; Paul Latkany; Narsing A Rao; H Nida Sen; Elizabeth A Sugar; Jennifer E Thorne; Robert C Wang; Janet T Holbrook Journal: Invest Ophthalmol Vis Sci Date: 2012-03-09 Impact factor: 4.799
Authors: John H Kempen; Michael M Altaweel; Janet T Holbrook; Douglas A Jabs; Elizabeth A Sugar Journal: Am J Ophthalmol Date: 2010-01-25 Impact factor: 5.258
Authors: David S Friedman; Janet T Holbrook; Husam Ansari; Judith Alexander; Alyce Burke; Susan B Reed; Joanne Katz; Jennifer E Thorne; Susan L Lightman; John H Kempen Journal: Ophthalmology Date: 2013-04-16 Impact factor: 12.079
Authors: Ivan J Suñer; Gregg T Kokame; Elaine Yu; James Ward; Chantal Dolan; Neil M Bressler Journal: Invest Ophthalmol Vis Sci Date: 2009-02-28 Impact factor: 4.799
Authors: Nicole K Kelly; Aheli Chattopadhyay; S R Rathinam; John A Gonzales; Radhika Thundikandy; Anuradha Kanakath; S Bala Murugan; R Vedhanayaki; Dean Cugley; Lyndell L Lim; Eric B Suhler; Hassan A Al-Dhibi; Caleb D Ebert; Elyse J Berlinberg; Travis C Porco; Nisha R Acharya Journal: Ophthalmology Date: 2021-03-04 Impact factor: 14.277