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

在许多医学领域，人们对评估PRO越来越感兴趣，特别是在HRQoL是干预或治疗总体评价的重要组成部分的临床试验中。 随着计算机使用的增加和互联网可访问性的扩大，未来利用这项技术作为一种具有成本效益的有效方式来收集PRO的临床数据，用于未来的眼科临床试验和研究，具有巨大的潜力。 世界卫生组织将生活质量（QoL）定义为个人在其生活的文化和价值体系中以及与其目标，期望，标准和关注相关的生活中的位置的感知。这是一个范围广泛的概念，受个人的身体健康、心理状态、独立程度、社会关系及其与环境显著特征的关系的复杂影响。 最常见的OSD类型是干眼综合征，其特征在于泪液的数量或质量不足、泪膜不稳定、角膜或结膜上皮损伤以及令人烦恼的症状，如眼部刺激、干燥、恐惧症、疲劳和波动的视觉障碍。 干眼症的症状是寻求眼科护理的主要原因：2000年，据报道，1.3%的医疗保险患者的初步诊断为干燥性角膜结膜炎。干眼症对QoL的影响通过以下途径介导：1）疼痛和刺激性症状，2）对眼部和一般健康和福祉的影响（一般QoL），3）对感知视觉功能的影响（视觉相关QoL），以及4）对视觉相关任务表现的影响。 据报道，干眼症对患者的相对重要性与心绞痛相似（干眼症的平均效用评分为0.72至0.78，心绞痛的平均效用评分为0.71至0.75）。干眼症的风险因素包括年龄、女性、性激素失衡、特异性免疫紊乱、绝经后雌激素治疗、放射治疗、骨髓移植、维生素A缺乏、ω 3脂肪酸摄入、某些感染和药物治疗以及屈光手术。眼表疾病的经济影响包括由于卫生保健系统利用、手术干预、处方药和非处方药、补充和替代疗法以及购买专门的眼镜和其他非药物疗法，如加湿器。间接成本包括工作时间和生产力的损失，工作类型或环境的改变，干眼的疼痛导致无形成本，包括休闲时间减少，对社会交往以及心理和一般健康的影响。考虑到这些因素和美国人口的老龄化，干眼病的患病率及其对整体医疗保健费用的影响在可预见的未来可能会上升。 评估干眼症对生活质量的影响将是重要的，在评估潜在的治疗和确定其成本效益，这两个重要的考虑因素，在规划提供医疗保健，以日益受到影响的患者群。 在临床研究中，患者报告的结局通常通过访谈者管理或自我管理的纸质问卷进行评估。 随着互联网越来越多地用于获取有关医疗保健问题的信息，使用计算机化的在线网络系统管理问卷可能更有效（时间和资源方面）。 计算机的普及和使用使研究人员能够使用计算机辅助的方法来收集数据，许多人认为这很容易而且没有威胁。计算机辅助接口（CASI）是一种越来越流行的方法，在调查研究，并可能对仪器的可靠性有重要影响。 本研究将比较OSD受试者和无OSD对照受试者接受经验证的眼科问卷的电子和纸笔调查所获得的结果。 本研究将利用几个经验证的工具领域，这些领域已被开发用于评估眼部疾病对QoL的影响，包括：1）眼表疾病指数（OSDI）的第一个领域 2)国家眼科研究所屈光不正生活质量量表（NEI-RQL）的特定领域，包括：视力清晰度、近视力、远视力、眩光、症状、担忧和矫正满意度3）来自国家眼科研究所视觉功能问卷（NEI-VFQ）的问题#15。研究队列将由80例诊断为OSD的受试者和40例无OSD的对照者组成，其中男性和女性的数量相似。本方案的入组已完成，数据分析正在进行中。

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.