Functional Reading Independence (Fri) index: A new patient-reported outcome measure for patients with geographic atrophy

Miriam Kimel, Nancy Kline Leidy, Elizabeth Tschosik, Chantal Dolan, Eric H. Souied, Rohit Varma, Neil M Bressler

Research output: Contribution to journalArticle

Abstract

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. Knowngroup 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 mm2/18 months of -0.41 (0.70) vs. -0.13 (0.61) for patients with lesion growth <2.5 mm2/18 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.

Original languageEnglish (US)
Pages (from-to)6298-6304
Number of pages7
JournalInvestigative Ophthalmology and Visual Science
Volume57
Issue number14
DOIs
StatePublished - Nov 1 2016

Fingerprint

Geographic Atrophy
Reading
National Eye Institute (U.S.)
Reproducibility of Results
Vision Tests
Interviews
Patient Reported Outcome Measures
Low Vision
Macular Degeneration
Growth
Referral and Consultation

Keywords

  • Functional reading independence
  • Geographic atrophy
  • Patient-reported outcomes
  • Visual function

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Functional Reading Independence (Fri) index : A new patient-reported outcome measure for patients with geographic atrophy. / Kimel, Miriam; Leidy, Nancy Kline; Tschosik, Elizabeth; Dolan, Chantal; Souied, Eric H.; Varma, Rohit; Bressler, Neil M.

In: Investigative Ophthalmology and Visual Science, Vol. 57, No. 14, 01.11.2016, p. 6298-6304.

Research output: Contribution to journalArticle

Kimel, Miriam ; Leidy, Nancy Kline ; Tschosik, Elizabeth ; Dolan, Chantal ; Souied, Eric H. ; Varma, Rohit ; Bressler, Neil M. / Functional Reading Independence (Fri) index : A new patient-reported outcome measure for patients with geographic atrophy. In: Investigative Ophthalmology and Visual Science. 2016 ; Vol. 57, No. 14. pp. 6298-6304.
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abstract = "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. Knowngroup 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 mm2/18 months of -0.41 (0.70) vs. -0.13 (0.61) for patients with lesion growth <2.5 mm2/18 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.",
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AU - Kimel, Miriam

AU - Leidy, Nancy Kline

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AU - Souied, Eric H.

AU - Varma, Rohit

AU - Bressler, Neil M

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N2 - 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. Knowngroup 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 mm2/18 months of -0.41 (0.70) vs. -0.13 (0.61) for patients with lesion growth <2.5 mm2/18 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.

AB - 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. Knowngroup 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 mm2/18 months of -0.41 (0.70) vs. -0.13 (0.61) for patients with lesion growth <2.5 mm2/18 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.

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