Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy

被引:29
|
作者
Kimel, Miriam [1 ]
Leidy, Nancy Kline [1 ]
Tschosik, Elizabeth [2 ]
Dolan, Chantal [3 ]
Souied, Eric H. [4 ]
Varma, Rohit [5 ]
Bressler, Neil M. [6 ]
机构
[1] Evidera, Bethesda, MD USA
[2] Genentech Inc, 1 DNA Way, San Francisco, CA 94080 USA
[3] CMD Consulting Inc, Sandy, UT USA
[4] Ctr Hosp Intercommunal, Creteil, France
[5] Univ Southern Calif, Keck Sch Med, USC Eye Inst, Los Angeles, CA USA
[6] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
关键词
geographic atrophy; functional reading independence; patient-reported outcomes; visual function; AGE-RELATED MACULOPATHY; VISUAL FUNCTION; PRO INSTRUMENTS; RISK-FACTORS; PREVALENCE; SCOTOMAS; DISEASE;
D O I
10.1167/iovs.16-20361
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Purpose: To develop and validate the Functional Reading Independence (FRI) Index, a new patient-reported outcome measure assessing reading activities in individuals with geographic atrophy (GA) due to age-related macular degeneration. Methods: The Index was developed through expert consultation and qualitative patient interviews. Reliability, validity, and responsiveness were tested with data from the Mahalo study (NCT01229215) of lampalizumab in patients with GA. Results: Qualitative interviews (n = 40) yielded a 10-item FRI Index, which was refined to seven items in quantitative testing (n = 100). Strong internal consistency (marginal reliability = 0.90) and reproducibility (intraclass correlation coefficient = 0.86) were shown. Known-group validity testing for baseline mean FRI Index scores showed differences (mean [SD]) between patients with Minnesota Low-Vision Reading test reading speed >= 80 vs. <80 words per minute (3.0 [0.7] vs. 1.9 [0.7]; P < 0.001), and between patients above vs. below median values on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) score (2.9 [0.7] vs. 2.1 [0.8]; P < 0.001). Convergent validity with binocular measures was strong (Spearman's correlation = 0.66 for reading speed, 0.72 for NEI-VFQ-25). Analysis of sensitivity to change revealed mean FRI Index score changes for patients with GA lesion size growth >= 2.5 mm(2)/18 months of -0.41 (0.70) vs. -0.13 (0.61) for patients with lesion growth <2.5 mm(2)/18 months (P = 0.07). Conclusions: The FRI Index demonstrated good reliability and validity in patients with GA. Further study in a broader GA population is warranted to confirm responsiveness.
引用
收藏
页码:6298 / 6304
页数:7
相关论文
共 50 条
  • [1] Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy (vol 57, pg 6298, 2016)
    Kimel, Miriam
    Leidy, Nancy Kline
    Tschosik, Elizabeth
    Dolan, Chantal
    Souied, Eric H.
    Varma, Rohit
    Bressler, Neil M.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2017, 58 (09) : 3825 - 3825
  • [2] Quantifying functional reading independence in geographic atrophy: the FRI Index
    Tschosik, Elizabeth
    Leidy, Nancy Kline
    Kimel, Miriam
    Dolan, Chantal
    Souied, Eric
    Varma, Rohit
    Bressler, Neil M.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2015, 56 (07)
  • [3] SENSITIVITY OF FUNCTIONAL READING INDEPENDENCE (FRI) INDEX TO CHANGE IN SIZE OF GEOGRAPHIC ATROPHY
    Kapre, A. W.
    Kimel, M.
    Bressler, N.
    Varma, R.
    Souied, E. H.
    Dolan, C.
    Tschosik, E.
    Leidy, N.
    [J]. VALUE IN HEALTH, 2015, 18 (03) : A184 - A184
  • [4] Development of a New Patient-Reported Outcome Measure in Sarcopenia
    Evans, Christopher J.
    Chiou, Chiun-Fang
    Fitzgerald, Kristina A.
    Evans, William J.
    Ferrell, Betty R.
    Dale, William
    Fried, Linda P.
    Gandra, Shravanthi R.
    Dennee-Sommers, Brooke
    Patrick, Donald L.
    [J]. JOURNAL OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION, 2011, 12 (03) : 226 - 233
  • [5] A CONCEPTUAL FRAMEWORK OF FUNCTIONAL READING INDEPENDENCE IN GEOGRAPHIC ATROPHY
    Tschosik, E. A.
    Bressler, N. M.
    Colman, S.
    Dolan, C.
    Leidy, N. K.
    Oestreicher, N.
    Sunness, J. S.
    Varma, R.
    Kimel, M.
    [J]. VALUE IN HEALTH, 2013, 16 (03) : A178 - A179
  • [6] Pain Index: A new prospective hidradenitis suppurativa patient-reported outcome measure instrument
    Zouboulis, Christos C.
    [J]. EXPERIMENTAL DERMATOLOGY, 2021, 30 : 35 - 36
  • [7] Pain Index: a new prospective hidradenitis suppurativa patient-reported outcome measure instrument
    Zouboulis, C. C.
    [J]. BRITISH JOURNAL OF DERMATOLOGY, 2021, 184 (06) : 1203 - 1204
  • [8] The Elderly Functional Index (ELFI), a patient-reported outcome measure of functional status in patients with cancer: a multicentre, prospective validation study
    Soo, Wee Kheng
    King, Madeleine
    Pope, Alun
    Steer, Christopher
    Devitt, Bianca
    Chua, Susan
    Parente, Phillip
    Davis, Ian D.
    Darzins, Peteris
    [J]. LANCET HEALTHY LONGEVITY, 2021, 2 (01): : E24 - E33
  • [9] Reading speed in geographic atrophy: Change over time and relation to patient-reported functioning
    Varma, Rohit
    Souied, Eric
    Tschosik, Elizabeth
    Leidy, Nancy Kline
    Kimel, Miriam
    Dolan, Chantal
    Bressler, Neil M.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2015, 56 (07)
  • [10] Development of a new patient-reported outcome measure for patients with complex cryptoglandular fistulas
    McCurdy, J.
    Crooks, P.
    Gwaltney, C.
    Krupnick, R.
    Cadogan, K. A.
    Gonzalez, S.
    Karki, C.
    [J]. JOURNAL OF CROHNS & COLITIS, 2021, 15 : S208 - S208