Macular Degeneration: Mangione CM

Childs AL, Bressler NM, Bass EB, Hawkins BS, Mangione CM, Marsh MJ, Miskala PH, Anonymous00092. · SST Coordinating Center, 550 North Broadway, 9th Floor, Baltimore, MD 21205, USA. · Ophthalmology. · Pubmed #15522365 links to  free full text

Abstract: PURPOSE: To present and compare findings from health-related quality-of-life (HRQOL) interviews conducted with patients enrolled in the SST Group B Trial evaluating surgical removal of subfoveal choroidal neovascular lesions associated with age-related macular degeneration versus observation. DESIGN: Randomized clinical trial. PARTICIPANTS: Eligible patients had predominantly hemorrhagic subfoveal choroidal neovascular lesions (total lesion size of >3.5 disc areas, area of blood at least 50% of the lesion area, and at least 75% of blood posterior to the equator) and best-corrected visual acuity (VA) of 20/100 to <20/1600 but at least light perception in the study eye. Three hundred thirty-six patients enrolled after baseline quality-of-life interviews, 168 assigned to each of surgery or observation. METHODS: Clinical and HRQOL data were collected before randomization and at 6, 12, 24, 36, and 48 months after enrollment. Baseline clinical evidence was used to stratify patients as having unilateral or bilateral neovascularization at the time of randomization. The HRQOL interviews included the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-item Short Form Health Survey, and the Hospital Anxiety and Depression Scale. MAIN OUTCOMES MEASURE: Two-year change in NEI-VFQ. RESULTS: At 24 months after enrollment, overall NEI-VFQ scores had a median decrease of 1 point from baseline in the observation arm (95% confidence interval [CI]: -4 to 3 points) and no change in the surgery arm (95% CI: -3 to 3 points) (P = 0.70). Changes from baseline on NEI-VFQ subscales also were similar between treatment arms. Differences in scores by unilateral or bilateral involvement seen at baseline in each treatment arm persisted throughout follow-up for most outcomes. Planned analyses stratified by VA showed trends (P = 0.17) in favor of surgery at 24 months in the patients with baseline VA greater than 20/200 for the NEI-VFQ scale (3.5-point median increase from baseline in the surgery arm [95% CI: -4 to 7] vs. a 1-point median loss from baseline in the observation arm [95% CI: -6 to 4]). CONCLUSIONS: No difference was detected with respect to vision-targeted quality-of-life outcomes for patients randomized to surgery or observation in the SST Group B Trial. This article contains additional online-only material available at www.ophsource.com/periodicals/ophtha.

Miskala PH, Bass EB, Bressler NM, Childs AL, Hawkins BS, Mangione CM, Marsh MJ, Anonymous00090. · SST Coordinating Center, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA. · Ophthalmology. · Pubmed #15522363 links to  free full text

Abstract: PURPOSE: To describe health-related quality of life (HRQOL), overall and in patients with unilateral or bilateral choroidal neovascularization (CNV), in a clinical trial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age-related macular degeneration (AMD). DESIGN: Randomized clinical trial. PARTICIPANTS: Eligible patients had untreated subfoveal CNV and AMD, best-corrected visual acuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a total subfoveal lesion size of < or =9.0 disc areas in the study eye. METHODS: Health-related quality of life data (the National Eye Institute Visual Function Questionnaire [NEI-VFQ], 36-item Short Form Health Survey [SF-36], and Hospital Anxiety and Depression Scale [HADS]) and clinical data were collected at baseline and at 6, 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence. MAIN OUTCOME MEASURE: Two-year change in the NEI-VFQ. RESULTS: Of 454 patients enrolled, 228 were assigned to observation and 226 to surgery. At baseline, median overall NEI-VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation group had lost a median of 3 points (95% confidence interval [CI]: -6 to -2), and the surgery group gained a median of 1 point (CI: -1 to 3). The largest difference was observed for the mental health subscale, where the observation group lost a median of 5 points (CI: -5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2-year changes in NEI-VFQ scores favored surgery by up to 10 points for unilateral cases and up to 8 points for bilateral cases. No treatment difference in 2-year change was observed for the SF-36 physical component summary; 2-year change in the mental component summary favored surgery by 2 points. Few patients (2%-4%) had HADS definite anxiety or depression at baseline or at 24 months. CONCLUSIONS: Although HRQOL outcomes were better in the submacular surgery arm than in the observation arm, surgery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Dong LM, Childs AL, Mangione CM, Bass EB, Bressler NM, Hawkins BS, Marsh MJ, Miskala P, Jaffee HA, McCaffrey LA, Anonymous00315. · Wilmer Clinical Trials and Biometry, The Wilmer Ophthalmologic Institute, 550 N. Broadway, 9th Floor, Baltimore, MD 21205-2010, USA. · Am J Ophthalmol. · Pubmed #15234287 No free full text.

Abstract: PURPOSE: To describe the effect of subfoveal choroidal neovascularization (CNV) from age-related macular degeneration (AMD) on health-related quality of life (HRQOL) of patients at enrollment in two randomized clinical trials; to examine the relation of visual acuity to HRQOL; to compare HRQOL scores between participants with unilateral and bilateral CNV independent of other characteristics. DESIGN: Randomized clinical trials. METHODS: Two Submacular Surgery Trials (SST) recruited patients with AMD and either new subfoveal CNV (Group N Trial) or predominantly hemorrhagic CNV (Group B Trial). Health-related quality of life interviews included the National Eye Institute Visual Function Questionnaire [NEI-VFQ], the SF-36 Health Survey, and the Hospital Anxiety and Depression Scale [HADS]. Linear correlation and regression analyses were used to relate baseline HRQOL scores to visual acuity and bilateral disease. RESULTS: Interview data were analyzed for 789 AMD patients: 454 patients in the Group N Trial and 335 patients in the Group B Trial. Participants reported poor vision-related functioning in many domains measured by the NEI-VFQ (mean overall scores of 65 for Group N and 63 for Group B). Visual acuity of the better eye was strongly associated with NEI-VFQ scores but not with SF-36 or HADS scores. After adjusting for visual acuity of the better eye and other factors, bilateral cases had NEI-VFQ overall scores six points lower than unilateral cases in Group N Trial and 10 points lower than unilateral cases in the Group B Trial. CONCLUSIONS: Subfoveal CNV profoundly affects vision-related quality of life. The effect is more pronounced with bilateral disease, even after controlling for visual acuity.

Miskala PH, Hawkins BS, Mangione CM, Bass EB, Bressler NM, Dong LM, Marsh MJ, McCaffrey LD, Anonymous00023. · Submacular Surgery Trials Coordinating Center, Wilmer Clinical Trials and Biometry, Baltimore, MD 21205, USA. · Arch Ophthalmol. · Pubmed #12695250 links to  free full text

Abstract: BACKGROUND: The National Eye Institute Visual Function Questionnaire (NEI-VFQ) measures vision-targeted quality of life, but it is unclear whether it is sensitive to changes within individuals over time. OBJECTIVE: To determine the responsiveness of the NEI-VFQ to "within-individual" changes in visual acuity in patients who had subfoveal choroidal neovascularization in at least one eye secondary to age-related macular degeneration, ocular histoplasmosis syndrome, or idiopathic causes, and who participated in randomized trials of submacular surgery. METHODS: Trained telephone interviewers administered the NEI-VFQ as part of annual follow-up data collection for pilot trials and larger clinical trials of submacular surgery. Best-corrected visual acuity was measured by local vision examiners at 12 months after enrollment and, typically, by central "traveling" vision examiners at 24 months after enrollment. Changes in visual acuity and NEI-VFQ scores from 12 to 24 months were analyzed using linear regression methods. RESULTS: Two-hundred eighteen patients had both interviews and visual acuity measurements at 12 and 24 months after enrollment. Changes in the overall NEI-VFQ score and in 9 of the subscales (near activities, dependency, driving, role difficulties, distance activities, mental health, general vision, peripheral vision, and social functioning) were related to changes in visual acuity of the better-seeing eye based on linear regression analysis (P<.05). In our analysis, a 3-line decrease in the visual acuity of the better-seeing eye was associated with 3.6- to 16.2-point decreases in the overall NEI-VFQ score and 9 subscale scores. CONCLUSIONS: Most of the NEI-VFQ subscales were responsive to changes in the visual acuity of the better-seeing eye over a 12-month interval in this patient population. Thus, the NEI-VFQ can be used to measure change in vision-targeted quality of life over time to augment clinical measurements of visual acuity.

Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD, Anonymous00128. · Division of General Internal Medicine and Health Services Research, Department of Medicine, UCLA, 911 Broxton Plaza, Box 951736, Los Angeles, CA 90095-1736, USA. · Arch Ophthalmol. · Pubmed #11448327 No free full text.

Abstract: OBJECTIVE: To develop and test the psychometric properties of a 25-item version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). DESIGN: Prospective observational cohort study of persons with 1 of 5 chronic eye diseases or low vision who were scheduled for nonurgent visits in ophthalmology practices and a reference sample of persons without eye disease. SETTING: Eleven university-based ophthalmology practices and the NEI Clinical Center. PATIENTS: Eligible participants had to have 1 of the following eye conditions: age-related cataracts, age-related macular degeneration, diabetic retinopathy, primary open-angle glaucoma, cytomegalovirus retinitis, or low vision from any cause. Seven of the 12 sites also enrolled persons in a reference sample. Reference sample participants had no evidence of underlying eye disease but were scheduled for either screening eye examinations or correction of refractive error. All eligible persons had to be 21 years or older, English speaking, and cognitively able to give informed consent and participate in a health status interview. MEASUREMENTS AND MAIN RESULTS: To provide the data needed to create the NEI VFQ-25, all subjects completed an interview that included the 51-item NEI VFQ. Estimates of internal consistency indicate that the subscales of the NEI VFQ-25 are reliable. The validity of the NEI VFQ-25 is supported by high correlations between the short- and long-form versions of the measure, observed between-group differences in scores for persons with different eye diseases of varying severity, and the moderate-to-high correlations between the NEI VFQ-25 subscales that have the most to do with central vision and measured visual acuity. CONCLUSIONS: The reliability and validity of the NEI VFQ-25 are comparable to those of the 51-item NEI VFQ field test version of the survey. This shorter version will be more feasible in settings such as clinical trials where interview length is a critical consideration. In addition, preliminary analyses indicate that the psychometric properties of the NEI VFQ-25 are robust for the eye conditions studied; this suggests that the measure will provide reproducible and valid data when used across multiple conditions of varying severity.

Seitzman RL, Mangione CM, Cauley JA, Ensrud KE, Stone KL, Cummings SR, Hochberg MC, Hillier TA, Yu F, Coleman AL, Anonymous00128. · Department of Ophthalmology, Jules Stein Eye Institute, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California 90095, USA. · J Am Geriatr Soc. · Pubmed #17493194 No free full text.

Abstract: OBJECTIVES: To determine whether bone mineral density (BMD) is associated with age-related maculopathy (ARM) risk in older women. DESIGN: Cross-sectional analysis at Year 10 (1997/98) of the Study of Osteoporotic Fractures (SOF). SETTING: Four clinical centers in the United States. PARTICIPANTS: One thousand forty-two randomly sampled SOF participants who attended the Year 10 clinic visit. MEASUREMENTS: ARM status was determined from fundus photographs using a modification of the Wisconsin Age-Related Maculopathy Grading System 6-level severity scale used in the National Health and Nutrition Examination Survey III. Total hip BMD was measured at Year 10 using dual-energy x-ray absorptiometry. Information on potential confounders, including age, reproductive hormone exposures, body mass index, smoking, alcohol consumption, nutrition, education, diabetes mellitus, hypertension, and physical activity, was ascertained with questionnaires. RESULTS: The prevalence of ARM was 50% (46% had early ARM and 4% had late ARM). After potential confounder adjustment, greater BMD was associated with lower odds of ARM (odds ratio (OR) per 1 standard deviation increase in BMD=0.82, 95% confidence interval (CI)=0.70-0.96). Women in the highest quartile of BMD had lower odds of ARM than those in the lowest quartile (OR=0.63, 95% CI=0.41-0.97) and those in the lowest three quartiles combined (OR=0.66, 95% CI=0.48-0.91). CONCLUSION: Higher levels of BMD may be associated with lower risk for ARM. The underlying mechanism is unknown, although BMD may be a marker for lifetime endogenous estrogen exposure. Future studies are needed to replicate these findings and further investigate the nature of the relationship between BMD and ARM.

Suzukamo Y, Oshika T, Yuzawa M, Tokuda Y, Tomidokoro A, Oki K, Mangione CM, Green J, Fukuhara S. · Department of Epidemiology and Healthcare Research, Kyoto University, Kyoto, Japan. · Health Qual Life Outcomes. · Pubmed #16248900 links to  free full text

Abstract: BACKGROUND: The importance of evaluating the outcomes of health care from the standpoint of the patient is now widely recognized. The purpose of this study is to develop and test a Japanese version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). METHODS: A Japanese version was developed with a previously standardized method. The questionnaire and optional items were completed by 245 patients with cataracts, glaucoma, or age-related macular degeneration, by 110 others before and after cataract surgery, and by a reference group (n = 31). We computed rates of missing data, measured reproducibility and internal consistency reliability, and tested for convergent and discriminant validity, concurrent validity, known-groups validity, factor structure, and responsiveness to change. RESULTS: Based on information from the participants, some items were changed to 2-step items (asking if an activity was done, and if it was done, then asking how difficult it was). The near-vision and distance-vision subscales each had 1 item that was endorsed by very few participants, so these items were replaced with items that were optional in the English version. For example, more than 60% of participants did not drive, so the driving question was excluded. Reliability and validity were adequate for all subscales except driving, ocular pain, color vision, and peripheral vision. With cataract surgery, most scores improved by at least 20 points. CONCLUSION: With minor modifications from the English version, the Japanese NEI VFQ-25 can give reliable, valid, responsive data on vision-related quality of life, for group-level comparisons or for tracking therapeutic outcomes.

Mangione CM, Gutierrez PR, Lowe G, Orav EJ, Seddon JM. · Department of Medicine, UCLA School of Medicine, Los Angeles, California 90024-8012, USA. · Am J Ophthalmol. · Pubmed #10482093 No free full text.

Abstract: PURPOSE: To describe the influence of age-related maculopathy on visual functioning and health-related quality of life. METHODS: A prospective, cross-sectional, observational cohort sample of 201 persons with various stages of age-related maculopathy was recruited from the Massachusetts Eye and Ear Infirmary as part of a longitudinal study of age-related macular degeneration. Persons were considered to have age-related maculopathy if one or more of the following clinical characteristics were present: drusen, retinal pigment epithelial changes, geographic atrophy, or evidence of exudative disease. Median corrected visual acuity for this sample was 20/25 in the better eye, with all subjects having 20/200 or better visual acuity in at least one eye at baseline. All participants underwent a comprehensive ophthalmologic examination with a dilated pupil. In addition to the usual clinical data collection, severity of age-related maculopathy was graded by an ophthalmologist who used standard clinical criteria and was masked to the participants' descriptions of visual functioning and health-related quality of life. All participants completed an interview that included the Activities of Daily Vision Scale, a survey designed to assess difficulties with routine daily activities that require vision, and the Short Form-36 Health Survey, a generic measure of multidimensional health-related quality of life. RESULTS: Severity of age-related maculopathy was associated with poorer scores of the Activities of Daily Vision Scale. This association was most significant for near vision and driving activities. In this sample, the SF-36 Health Survey scales were not significantly correlated with severity of age-related maculopathy. CONCLUSIONS: Reported visual functioning is significantly associated with the clinical severity of age-related maculopathy. However, once visual acuity is taken into consideration, clinical grading of age-related maculopathy did not explain a significant portion of the variation in visual functioning. The lack of significant correlation between severity of age-related maculopathy and the SF-36 Health Survey may have resulted from the small number of participants in our sample with severe bilateral age-related maculopathy.