With the aging of the population, vision loss is a growing public health problem affecting more than 3 million Americans. The impact of eye disease on health-related quality of life (HRQOL) and the benefits of new treatments are not well understood and have not been compared with those for other medical conditions. Although self-assessment tools for measuring the impact of visual disorders (e.g., VF-14, ADVS, NEI-VFQ) are available, the development of instruments that are more efficient in measuring the impact of visual disorders over a wide range of functional health levels and comprehensive domains has not kept pace with advancements achieved for generic HRQOL tools. We propose to use Item Response Theory (IRT) and Computerized Adaptive Testing (CAT) techniques, proven in studies of other conditions, to build a more efficient Patient-Reported Outcomes (PRO) instrument (VISION-QOL-CAT) to measure the impact of adult visual disorders. CATs tailor questions administered to each individual for each domain, thereby increasing precision and range of measurement without increasing respondent burden. Our Phase I aims are to: (1) construct and administer (N=300) new vision-specific HRQOL item banks to measure the impact of visual disorders and perform preliminary psychometric and clinical evaluations of their usefulness;(2) develop a comprehensive (vision-specific and generic HRQOL) and flexible VISION-QOL-CAT prototype solution;and (3) pilot test (N=100) the prototype tool in comparison with existing """"""""legacy"""""""" full-length static questionnaires in a vision clinic setting. We will partner with the UMass Memorial Eye Center in fielding surveys of adult patients differing in severity of vision loss, including both """"""""wet"""""""" and """"""""dry"""""""" types of age- related macular degeneration. The product of Phase I will be a prototype comprehensive VISION-QOL- CAT with preliminary evidence regarding feasibility, acceptability, and empirical performance in comparison with static generic and vision-specific HRQOL tools. In Phase II, the system will be expanded (content) and improved (administration efficiency, reliable range, psychometric and utility index scoring options, patient and provider reports, user-friendly documentation) and further evaluated in both qualitative and quantitative terms (psychometrics, clinical responsiveness) across different platforms (e.g., iPod/iPhone/iPad, Internet-based, PC, telephone IVR), and normed in general populations and among those with eye disease. By lowering data collection costs, reducing response burden, eliminating """"""""ceiling"""""""" and """"""""floor"""""""" effects and increasing the precision of individual scores, the HRQOL outcomes observed in clinical research may be monitored and managed to improve care for adults with visual disorders.

Public Health Relevance

The VISION-QOL-CAT is a new tool for assessing the impact of visual disorders on quality of life (QOL). The prototype study will provide preliminary evidence regarding feasibility and acceptability of the new tool in a clinical setting. The tool's performance will be compared to other patient-reported QOL tools for measuring generic and vision-specific health outcomes. More practical and useful tools will make it possible to consider functional health and well-being in making treatment decisions and in enabling patients to play a more active role in managing their eye disease.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43EY021390-01
Application #
8057033
Study Section
Special Emphasis Panel (ZRG1-HDM-K (10))
Program Officer
Wujek, Jerome R
Project Start
2011-02-01
Project End
2012-12-31
Budget Start
2011-02-01
Budget End
2012-12-31
Support Year
1
Fiscal Year
2011
Total Cost
$98,632
Indirect Cost
Name
John Ware Research Group, Inc.
Department
Type
DUNS #
831513820
City
Worcester
State
MA
Country
United States
Zip Code
01605