Web-based Training & Reliability for Psychiatric Trials

描述(由申请人提供)培训评分员的重要任务和 在精神病治疗期间建立和维持可靠性 临床试验是一个经常被忽视的主要问题。这个问题是 尤其令人烦恼的是，涉及多个地点的多名评分员的审判。 此外，影响评分者期望(偏差)的因素与标准 精神病学评分工具从来没有得到充分的探索。这项建议 将开发一种交互式视频系统，可以培训研究评分员使用 具有共享评级约定的评级工具和评估评级机构 跨站点、随时间推移的可靠性。将编写的程序将 使该视频系统可用作(I)交互式的“教程”系统 这可以向受训者提供即时反馈，以及(2)可靠性 测试“系统，使用集成数据库记录评级和计算 在确定的评分者组内或在预设的情况下评分员之间的可靠性 收视率(“黄金标准”)。第一阶段将创建用于评估的原型 汉密尔顿抑郁量表(HDRS)评分员间的信度。vbl.使用 来自真实病人采访的剧本，一男一女演员将各自 描述了反映抑郁症状的三个独立的HDRS访谈 严重程度不一。将对原型系统的功能进行评估。 在准备第二阶段时，将通过以下方式确定可行性：1)具备 经验丰富的评分员评估HDRS对两位演员和 真实的病人，以确定演员的刻画的有效性。2) 在一组有经验的评分员和一组评分员中评估评分员之间的可靠性 使用该系统的新手评分者，以及3)评估正面和负面 系统的属性，既有经验丰富的评分者，也有新手评分者。第二阶段将 使用6种不同的方法开发一个包含30个I-IDR变体的完整库 不同年龄、性别和族裔的行为者，并实行导师制。 第二阶段的研究将评估可变性和评分者偏见作为 评分者和“患者”的人口统计和职业特征。 未来的产品开发将利用该软件和统计 其他评级工具的方法，包括用于评估 精神分裂症、焦虑症和痴呆症。 拟议的商业应用：该产品的主要市场包括任何参与进行精神病学临床试验的大型组织，包括学术医学中心、制药公司和合同研究组织。另一个潜在的市场是管理式医疗公司，它们使用越来越多的评级标准来评估跨多个临床站点的精神和行为健康服务的结果和质量。

DESCRIPTION (provided by applicant) The important task of training raters and establishing and maintaining reliability for the duration of a psychiatric clinical trial is a major problem that is often ignored. This problem is particularly vexing for trials involving many raters at multiple sites. Furthermore, factors effecting rater expectancy (bias) with standard psychiatric rating instruments has never been fully explored. This proposal will develop an interactive video system that can train research raters to use rating instruments with shared rating conventions and assess interrater reliability across sites and over time. Programs will be written that will enable this video system to be used as (I) an interactive "tutorial" system that can provide immediate feedback to trainees, and (2) a "reliability testing" system, that uses an integrated database to record ratings and compute interrater reliability within an identified group of raters or with preset ratings ("a gold standard"). Phase I will create a prototype for assessing interrater reliability for the Hamilton Depression Rating Scale (HDRS). Using scripts from actual patient interviews, a male and a female actor will each portray three separate HDRS interviews reflecting depressive symptoms of various severity. The functionality of the prototype system will be assessed. In preparation for Phase II, feasibility will be established by 1) having experienced raters assess videos of the HDRS interviews of both actors and actual patients to establish the validity of the actors' portrayals. 2) assessing interrater reliability in a group of experienced raters and a group of novice raters using the system, and 3) assessing the positive and negative attributes of the system with both experienced and novice raters. Phase II will develop a complete library of 30 variations of the I-IDRS using 6 different actors of diverse age, gender and ethnicity and implement the tutorial system. The Phase II study will assess variability and rater bias as an interaction of demographic and professional characteristics of the raters and "patients." Future product development will utilize the software and statistical methodology with other rating instruments, including those used to assess schizophrenia, anxiety disorders, and dementia. PROPOSED COMMERCIAL APPLICATION: The primary market for this product consists of any large organization involved in the conduct of psychiatric clinical trials, including academic medical centers, pharmaceutical companies, and contract research organizations. Another potential market is the managed care companies that use a growing number of rating scales to assess outcomes and quality of psychiatric and behavioral health services across multiple clinical sites.