Departments of Psychiatry and Neurology, Jefferson Medical College, Jefferson Hospital for Neuroscience, 900 Walnut Street, 4th Floor, Philadelphia, PA 19107, United States.
Contemp Clin Trials. 2011 Mar;32(2):196-203. doi: 10.1016/j.cct.2010.10.008. Epub 2010 Oct 23.
Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in older adults and impairs the ability to read, drive, and live independently and increases the risk for depression, falls, and earlier mortality. Although new medical treatments have improved AMD's prognosis, vision-related disability remains a major public health problem. Improving Function in AMD (IF-AMD) is a two-group randomized, parallel design, controlled clinical trial that compares the efficacy of Problem-Solving Therapy (PST) with Supportive Therapy (ST) (an attention control treatment) to improve vision function in 240 patients with AMD. PST and ST therapists deliver 6 one-hour respective treatment sessions to subjects in their homes over 2 months. Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects). The primary outcome is targeted vision function (TVF), which refers to specific vision-dependent functional goals that subjects highly value but find difficult to achieve. TVF is an innovative outcome measure in that it is targeted and tailored to individual subjects yet is measured in a standardized way. This paper describes the research methods, theoretical and clinical aspects of the study treatments, and the measures used to evaluate functional and psychiatric outcomes in this population.
年龄相关性黄斑变性（AMD）是导致老年人严重视力丧失的主要原因，它会损害阅读、驾驶和独立生活的能力，增加抑郁、跌倒和早亡的风险。尽管新的医疗方法改善了 AMD 的预后，但与视力相关的残疾仍然是一个主要的公共卫生问题。改善 AMD 患者的功能（IF-AMD）是一项两臂随机、平行设计、对照临床试验，比较了问题解决疗法（PST）与支持性疗法（ST）（一种注意力对照疗法）在 240 名 AMD 患者中改善视力功能的疗效。PST 和 ST 治疗师在 2 个月内为患者的家庭提供 6 次 1 小时的各自治疗课程。在 3 个月（主要试验终点）和 6 个月（维持效果）时，对治疗分配进行盲法评估结局。主要结局是目标视力功能（TVF），它是指患者高度重视但难以实现的特定视力依赖性功能目标。TVF 是一种创新的结局测量方法，因为它是针对个体患者的目标和量身定制的，但以标准化的方式进行测量。本文介绍了研究方法、研究治疗的理论和临床方面，以及用于评估该人群功能和精神结局的措施。
