Pilot Validation Study of Computer Admin. of Vision Targeted Qual. of Life Instr

National Eye Institute

Investigators

Abstract

There has been an increasing interest in assessing PROs in many fields of medicine, especially in the context of clinical trials where HRQoL is an important component of the overall evaluation of an intervention or treatment. As the use of computers increases and accessibility to the internet broadens, there is a tremendous potential in harnessing this technology in the future as a cost-effective, efficient way to gather clinical data on PROs for future ophthalmic clinical trials and studies. Quality of life (QoL) is defined by the World Health Organization as an individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns. It is a broad-ranging concept affected in a complex way by the persons physical health, psychological state, level of independence, social relationships, and their relationship to salient features of their environment. The most common type of OSD is dry eye syndrome which is characterized by a deficiency in the quantity or quality of tears, an unstable tear film, damage to the corneal or conjunctival epithelium, and bothersome symptoms, such as ocular irritation, dryness, photophobia, fatigue, and fluctuating visual disturbances. Symptoms of dry eye are a major reason to seek ophthalmic care: in 2000, it was reported that 1.3% of Medicare patients had a primary diagnosis of keratoconjunctivitis sicca. The impact of dry eye on QoL is mediated through 1) pain and irritative symptoms, 2) effect on ocular and general health and well-being (general QoL), 3) effect on perceived visual function (vision-related QoL), and 4) impact on performance of vision-related tasks. The relative importance of dry eye to patients has been reported to be similar to that of angina (the mean utility score of dry eye disease is 0.72 to 0.78 and the mean utility score of angina is 0.71 to 0.75). Risk factors for dry eye include age, female sex, sex hormone imbalances, specific immunologic disorders, postmenopausal estrogen therapy, radiation treatment, bone marrow transplantation, Vitamin A deficiency, omega 3 fatty acid intake, certain infections and medications and refractive surgery The economic impact of ocular surface disease includes costs due to health care system utilization, surgical interventions, prescription and over the counter medications, complementary and alternative therapeutics and purchase of specialized eye wear and other non-pharmacologic therapies such as humidifiers. Indirect costs include lost work time and productivity, alteration in work type or environment, and the pain of dry eye results in intangible costs including decreased leisure time, impact on social interactions and mental and general health. Given these factors and the aging of the United States population, the prevalence of dry eye disease and its impact on overall health care costs will likely rise in the foreseeable future. Assessing the impact of dry eye disease on QoL will be important in evaluating potential treatments and in determining their cost-effectiveness, both important considerations in planning delivery of health care to an ever increasingly affected patient base. In clinical studies, patient-reported outcomes are usually assessed by an interviewer-administered or self-administered paper questionnaire. It may be more efficient (time- and resource-wise) to administer questionnaires using a computerized, online, web-based system as the internet is increasingly being used to access information on health care issues. Widespread availability and use of computers has permitted researchers to use computer-assisted approaches to data collection that many people find easy and non-threatening. Computer-assisted interfaces (CASI) are an increasingly popular method in survey research and may have important effects on instrument reliability. This study will compare the results obtained from electronic and paper-and-pencil administration of validated ophthalmic questionnaires administered to subjects with OSD and controls without OSD. The study will utilize several validated domains of instruments, which have been developed to assess the impact of ocular disease on QoL including: 1) the 1st domain of The Ocular Surface Disease Index (OSDI) 2) specific domains of the The National Eye Institute Refractive Error Quality of Life Instrument (NEI-RQL) including: clarity of vision, near vision, far vision, glare, symptoms, worry, and satisfaction with correction 3) question #15 from The National Eye Institute Visual Function Questionnaire (NEI-VFQ). The study cohort will be comprised of eighty (80) participants diagnosed with OSD and 40 controls without OSD comprised of similar numbers of men and women. Enrollment has been completed for this protocol and data analysis is underway.