Computerized Screen Adverse Events Associated SSRI's

描述（由申请人提供）：最近关于抗抑郁药物与自杀意念和行为之间关系的争议突出表明，需要更好的方法来标准化和系统地监测与使用此类药物相关的不良事件。该项目的目的是开发更好的方法，系统地筛选和评估与儿童和青少年使用抗抑郁药物相关的不良事件，包括自杀事件和被认为预示着自杀风险增加的症状/行为。制定的方法对于计划中的R01研究(1)评估抗抑郁药物的风险(2)检查引入标准化安全监测程序对临床实践的影响是必要的。将开发两种方法：(1)计算机筛选工具，用于儿童和青少年服用SSRI和其他抗抑郁药物的不良事件。本文书将：(a)有家长版和青少年版；(b)使用声音技术使计算机“读出”问题，允许阅读能力有限的人使用；(c)产生一份即时报告，指出可能关注的领域；(d)在精神药理学研究试验和繁忙的社区环境中是可行的；(2)可用于系统分类被认为与抑郁症治疗相关的特定不良事件的标准不良事件和材料（包括录像带）的术语表。该术语表将有助于改进不良事件报告的分类。将在80对儿童和青少年/家长中评估计算机化AE筛查仪器的性能特征——重测信度、效度、可行性、临床医生和患者（及家长）的可接受性。该研究的数据将用于改进屏幕，并将作为R01应用程序的基础，该应用程序将在项目的第二年准备。这项研究的第二个长期目标是开发一种用户友好的、心理测量学上合理的评估方法，这种方法可能用于典型的社区环境，以更好地监测儿科患者抗抑郁药物的安全性。

DESCRIPTION (provided by applicant): The recent controversy concerning the relationship between antidepressant medication and suicidal ideation and behavior has highlighted the need for better methods for standardized and systematic monitoring of adverse events associated with the use of such agents. The aim of this project is to develop better methods to systematically screen for and assess adverse events associated with the use of antidepressant medications with children and adolescents, including suicidal events and symptoms/behaviors thought to portend increased suicide risk. The methods to be developed are necessary for a planned R01 study to (1) evaluate the risks of antidepressant medications and (2) examine the impact of introducing a standardized safety monitoring procedure on clinical practice. Two methods will be developed: (1) A computerized screening instrument for adverse events experienced by children and adolescents who take SSRI's and other anti-depressant medications. The this instrument will: (a) have parent and youth versions (b) use sound technology so that the computer "reads" the questions, allowing use with those of limited reading ability, (c) yield an instant report that will indicate areas of possible concern and (d) be feasible to include in psychopharmacological research trials and busy community settings (2) A standard glossary of adverse events and materials (including videotapes) which can be used to systematically classify specific adverse events thought to be associated with treatment of depressive illness. The glossary will help improve the classification of adverse event reports The performance characteristics -- test-retest reliability, validity, feasibility, acceptability to clinicians and patients (and parents) - of the computerized AE screening instrument will be evaluated in 80 child and adolescent/parent pairs. Data from the study will be used to refine the screen and will serve as a foundation for the R01 application, which will be prepared during the second year of the project. A second long term goal of the research is to develop a user friendly, psychometrically sound assessment method that might be used in typical community settings to better monitor the safety of antidepressant medications with pediatric patients.