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Validity and Reliability of the CVI Range for Clinical Research: Baseline and One-Year Results
Melinda Y Chang1,2, Mark W Reid1, Christine Roman-Lantzy3
1Division of Ophthalmology, The Vision Center at the Children's Hospital Los Angeles, Los Angeles, California.
Insights
The CVI Range-CR is a reliable and valid functional vision assessment for children with cerebral/cortical visual impairment (CVI). It shows high consistency and reliability, supporting its use in clinical trials for CVI.
Area of Science:
- Ophthalmology
- Pediatric Neurology
- Developmental Pediatrics
Background:
- Cerebral/cortical visual impairment (CVI) is a primary cause of vision impairment in children, affecting both visual function and daily activities.
- Functional vision assessment is crucial for understanding and managing CVI's impact on a child's life.
Purpose of the Study:
- To evaluate the psychometric properties, reliability, and validity of the CVI Range for Clinical Research (CVI Range-CR).
- To establish the CVI Range-CR as a robust tool for CVI clinical trials.
Main Methods:
- A prospective, longitudinal cohort study involving 40 children with CVI.
- CVI Range-CR assessments were conducted at baseline and 1-year follow-up, with recordings analyzed by remote graders.
- Interrater and intrarater reliability were assessed using intraclass correlation coefficients (ICC), and validity was evaluated against the 6-level visual behavior scale (VBS).
Main Results:
- The CVI Range-CR demonstrated high internal consistency (McDonald's ω = 0.96) and excellent intrarater reliability (ICC = 0.88-0.98).
- Good-to-excellent interrater reliability (ICC = 0.74-0.88) and strong correlation with VBS scores (Spearman's ⍴ = 0.76-0.86) were observed.
- The assessment was sensitive to change, showing significant improvements in functional vision over one year.
Conclusions:
- The CVI Range-CR is a reliable and valid measure for assessing functional vision in children with CVI.
- Longitudinal studies should utilize consistent graders, potentially through remote grading via a centralized reading center, to maximize reliability.
Purpose:
Cerebral/cortical visual impairment (CVI) is a leading cause of visual impairment in children and significantly impacts both visual function and functional vision (the ability to use vision during everyday activities). We developed the CVI Range for Clinical Research (CVI Range-CR), a functional vision assessment that can be incorporated in CVI clinical trials. Herein we evaluate the psychometric properties, interrater and intrarater reliability, and validity of the CVI Range-CR.
Design:
A prospective, longitudinal cohort study.
Participants:
Forty children with CVI.
Methods:
Participants underwent CVI Range-CR assessments at baseline and 1-year follow-up. All assessments were recorded. A trained in-person examiner scored in-person assessments; 2 expert remote graders scored recorded assessments. Visual acuity was evaluated by a pediatric neuro-ophthalmologist using the 6-level visual behavior scale (VBS).
Main Outcome Measures:
The CVI Range-CR scores (ranging from 0 to 10) using the Across-CVI Characteristics (rating 1) and Within-CVI Characteristics (rating 2) methods of scoring were compared among graders using the intraclass correlation coefficient (ICC) to assess interrater reliability. A subset of videos was scored twice by the same remote examiner to assess intrarater reliability using the ICC. The CVI Range-CR scores were compared to VBS scores (Spearman's correlation coefficient, ⍴) to evaluate validity. McDonald's ω was used to assess internal consistency of the 10 items on the Within-CVI Characteristics scale.
Results:
The CVI Range-CR demonstrated high internal consistency (McDonald's ω = 0.96), excellent intrarater reliability (ICC = 0.88-0.98), good-to-excellent interrater reliability (ICC = 0.74-0.88), and strong correlation to clinical assessment of visual behavior as measured by VBS scores (Spearman's ⍴ = 0.76-0.86, P < 0.0001). It was also sensitive to change; there were small but significant improvements in both ratings 1 and 2 over 1 year (rating 1 average: +0.35, P = 0.002; rating 2 average: +0.31, P = 0.001).
Conclusions:
The CVI Range-CR is a reliable and valid measure of functional vision in children with CVI. Because intrarater reliability exceeds interrater reliability, longitudinal studies are recommended to use consistent graders over time. This could be accomplished by remote grading of recorded assessments via a centralized reading center.
Financial Disclosures:
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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