Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: Validation studies from two phase 3 clinical trials

Investigative Ophthalmology and Visual Science

Volumn 50, Issue 8, 2009, Pages 3629-3635

  Suñer, Ivan J ^a   Kokame, Gregg T ^b   Yu, Elaine ^c   Ward, James ^c   Dolan, Chantal ^c   Bressler, Neil M ^d  

^a University of Hawaii School of Medicine ^*  (United States)

^b UNIVERSITY OF HAWAII   (United States)

^c GENENTECH INC   (United States)

^d JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RANIBIZUMAB; VERTEPORFIN; ANGIOGENESIS INHIBITOR; MONOCLONAL ANTIBODY;

ARTICLE; CLINICAL TRIAL; HUMAN; NATIONAL EYE INSTITUTE VISUAL FUNCTION QUESTIONNAIRE 25; PHOTODYNAMIC THERAPY; PRIORITY JOURNAL; QUESTIONNAIRE; RETINA MACULA AGE RELATED DEGENERATION; SCORING SYSTEM; SUBRETINAL NEOVASCULARIZATION; VALIDATION STUDY; VISUAL ACUITY; VISUAL SYSTEM FUNCTION; AGED; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; INJECTION; MALE; MIDDLE AGED; MULTICENTER STUDY; NATIONAL HEALTH ORGANIZATION; PATHOPHYSIOLOGY; PHASE 3 CLINICAL TRIAL; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; RETINA MACULA DEGENERATION; SENSITIVITY AND SPECIFICITY; SICKNESS IMPACT PROFILE; UNITED STATES; VITREOUS BODY;

AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; CHOROIDAL NEOVASCULARIZATION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS; MACULAR DEGENERATION; MALE; MIDDLE AGED; NATIONAL INSTITUTES OF HEALTH (U.S.); QUESTIONNAIRES; SENSITIVITY AND SPECIFICITY; SICKNESS IMPACT PROFILE; UNITED STATES; VISUAL ACUITY; VITREOUS BODY;

EID: 68349113753     PISSN: 01460404     EISSN: 15525783     Source Type: Journal    
DOI: 10.1167/iovs.08-3225     Document Type: Article

References (32)

1. Friedman DS, O'Colmain BJ, Munoz B, et al. Prevalence of agerelated macular degeneration in the United States. Arch Ophthalmol. 2004;122:564-572.
2. Klaver CC, Wolfs RC, Vingerling JR, Hofman A, de Jong PT. Agespecific prevalence and causes of blindness and visual impairment in an older population: the Rotterdam Study. Arch Ophthalmol. 1998;116:653-658.
3. Chang TS, Bressler NM, Fine JT, Dolan CM, Ward J, Klesert TR. Improved vision-related function after ranibizumab treatment of neovascular AMD: results of a randomized clinical trial. Arch Ophthalmol. 2007;125:1460-1469.
4. Bressler NM, Bressler SB, Congdon NG, et al. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003;121:1621-1624.
5. de Jong PT. Mechanisms of disease: age-related macular degeneration. N Engl J Med. 2006;355:1474-1485.
6. Olsen TW, Feng X, Kasper TJ, Rath PP, Steuer ER. Fluorescein angiographic lesion type frequency in neovascular age-related macular degeneration. Ophthalmology. 2004;111:250-255.
7. Williams RA, Brody BL, Thomas RG, Kaplan RM, Brown SI. The psychosocial impact of macular degeneration. Arch Ophthalmol. 1998;116:514-520.
8. Margolis MK, Coyne K, Kennedy-Martin T, Baker T, Schein O, Revicki DA. Vision-specific instruments for the assessment of health-related quality of life and visual functioning: a literature review. Pharmacoeconomics. 2002;20:791-812.
9. Miskala PH, Bressler NM, Meinert CL. Relative contributions of reduced vision and general health to NEI-VFQ scores in patients with neovascular age-related macular degeneration. Arch Ophthalmol. 2004;122:758-766.
10. Mangione CM, Berry S, Spritzer K, et al. Identifying the content area for the 51-item National Eye Institute Visual Function Questionnaire: results from focus groups with visually impaired persons. Arch Ophthalmol. 1998;116:227-233.
11. Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001;119:1050-1058.
12. Mangione CM, Lee PP, Pitts J, Gutierrez P, Berry S, Hays RD. Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Arch Ophthalmol. 1998;116:1496-1504.
13. Berdeaux GH, Nordmann JP, Colin E, Arnould B. Vision-related quality of life in patients suffering from age-related macular degeneration. Am J Ophthalmol. 2005;139:271-279.
14. Clemons TE, Chew EY, Bressler SB, McBee W. National Eye Institute Visual Function Questionnaire in the Age-Related Eye Disease Study (AREDS): AREDS Report No. 10. Arch Ophthalmol. 2003; 121:211-217.
15. Dong LM, Childs AL, Mangione CM, et al. Health-and vision-related quality of life among patients with choroidal neovascularization secondary to age-related macular degeneration at enrollment in randomized trials of submacular surgery: SST report no. 4. Am J Ophthalmol. 2004;138:91-108.
16. Finger RP, Fleckenstein M, Holz FG, Scholl HP. Quality of life in age-related macular degeneration: a review of available visionspecific psychometric tools. Qual Life Res. 2008;17(4):559-574.
17. Maguire M. Baseline characteristics, the 25-Item National Eye Institute Visual Functioning Questionnaire, and their associations in the Complications of Age-Related Macular Degeneration Prevention Trial (CAPT). Ophthalmology. 2004;111:1307-1316.
18. Miskala PH, Hawkins BS, Mangione CM, et al. Responsiveness of the National Eye Institute Visual Function Questionnaire to changes in visual acuity: findings in patients with subfoveal choroidal neovascularization. SST Report No. 1. Arch Ophthalmol. 2003;121:531-539.
19. Hays RD, Hadorn D. Responsiveness to change: an aspect of validity, not a separate dimension. Qual Life Res. 1992;1:73-75.
20. Miskala PH. Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ): SST Report No. 19. Ophthalmic Epidemiol. 2007; 14:205-215.
21. Lindblad AS, Clemons TE. Responsiveness of the National Eye Institute Visual Function Questionnaire to progression to advanced age-related macular degeneration, vision loss, and lens opacity: AREDS Report No. 14. Arch Ophthalmol. 2005;123: 1207-1214.
22. Toth CA, Lapolice DJ, Banks AD, Stinnett SS. Improvement in near visual function after macular translocation surgery with 360-degree peripheral retinectomy. Graefes Arch Clin Exp Ophthalmol. 2004;242:541-548.
23. Cahill MT, Stinnett SS, Banks AD, Freedman SF, Toth CA. Quality of life after macular translocation with 360 degrees peripheral retinectomy for age-related macular degeneration. Ophthalmology. 2005;112:144-151.
24. Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432-1444.
25. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration N Engl J Med. 2006;355: 1419-1431.
26. U.S. Food and Drug Administration. FDA approves new biologic treatment for wet age-related macular degeneration. June 30, 2006. Available at: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html. Accessed April 17, 2008.
27. Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J. Quality of life outcomes improved more often with ranibizumab than photodynamic therapy in a randomized clinical trial. Arch Ophthalmol. 2009;127(1):13-21.
28. National Eye Institute. The National Eye Institute Visual Function Questionnaire-25 (VFQ-25). Interviewer Administered Format. Version 2000. Available at: http://www.nei.nih.gov/resources/visionfunction/vfq_ia.pdf. Accessed April 17, 2008.
29. National Eye Institute. The National Eye Institute 25-Item Visual Function Questionnaire-25. Version 2000. Scoring Algorithm. Available at: http://www.nei.nih.gov/resources/visionfunction/manual_cm2000.pdf
30. Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40:171-178.
31. Fayers P, Hayes R, eds. Assessing Quality of Life in Clinical Trials. 2nd ed. New York: Oxford University Press; 2005.
32. Cohen J. A power primer. Psychol Bull. 1992;112:155-159.