Development of the Opioid Use Disorder Severity Scale

7.项目摘要/摘要 开发新的药物来减轻阿片类药物使用障碍(OUD)造成的负担是一个很高的目标 解决阿片类药物危机的优先事项。然而，目前可用于评估和 批准治疗阿片类药物使用的新药是药物开发的障碍。衡量标准 OUD诊断标准(即症状)的改变很少被用作改善的指标 治疗，尽管这种方法是其他精神障碍的标准做法。的确有 来自多个临床试验的初步证据，这些试验改变了《精神病学诊断和统计手册》 精神障碍(DSM)的诊断阈值和标准计数具有潜在的临床意义 结果。然而，衡量DSM-5的存在和严重性的唯一有效评估是OUD 是由临床医生管理的半结构化访谈，需要广泛的培训和成本 广泛使用是不切实际的。在这个项目中，我们建议开发一种新的临床结果评估，即 直接链接到DSM-5诊断标准的电子管理的患者自我报告仪 测量OUD的严重程度，使用“阿片类药物使用障碍严重程度量表”(OUDSS)。 具体目标是：(1)根据结构化的临床访谈生成自我报告项目池 OUD和现有的物质库使用障碍严重程度创建了一个电子的，自我管理的 与DSM-5诊断标准直接相关的工具；(2)评估内容效度和 通过对20例OUDSS患者的一对一定性访谈了解OUDSS的给药程序； (3)在300人的不同样本中评估OUDSS的信度和效度 寻求/参加门诊治疗以确定结构效度、重测信度和能力 检测更改。 OUDSS的开发和评估将遵循FDA关于患者报告结果(PRO)的指南 措施。由于PRO仪器的开发需要严格的方法，我们的目标是 而不是一般的物质使用障碍，在本奖项期间用于发展。AS DSM-5 滥用物质的诊断标准是相同的，OUDSS可以针对其他特定物质进行修改 物质(或一般的物质使用障碍)以最小的努力。经过验证的、易于管理的 电子专业测量严重程度将对治疗研究、临床护理、 和药物开发。

7. PROJECT SUMMARY/ABSTRACT The development of new medications to reduce the burden caused by opioid use disorder (OUD) is a high priority in addressing the opioid crisis. However, the currently available tools and endpoints to evaluate and approve new medications to treat opioid use is an impediment to medication development. Measures of change in the diagnostic criteria (i.e., symptoms) of OUD have rarely been used as indicators of improvement from treatment, despite this approach being standard practice for other psychiatric disorders. There is preliminary evidence from multiple clinical trials that change in Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic threshold and criteria counts has potential utility as a clinically meaningful outcome. However, the only validated assessments for measuring the presence and severity of DSM-5 OUD are clinician-administered, semi-structured interviews, requiring extensive training and cost making them impractical for broad use. In this project, we propose to develop a new clinical outcome assessment that is an electronically-administered, patient self-report instrument directly linked to DSM-5 diagnostic criteria for measuring the severity of OUD, the ‘Opioid Use Disorder Severity Scale’ (OUDSS). The specific aims are to: (1) generate a pool of self-report items based on structured clinical interviews for OUD and existing items banks of substance use disorder severity to create an electronic, self-administered instrument directly linked to the diagnostic criteria in DSM-5; (2) evaluate the content validity and administration procedures of the OUDSS through one-on-one qualitative interviews with 20 patients with OUD; and (3) evaluate the reliability and validity of the OUDSS in a diverse sample of 300 individuals seeking/enrolled in outpatient treatment to determine construct validity, test-retest reliability, and ability to detect change. Development and evaluation of the OUDSS will follow the FDA Guidance for Patient Reported Outcome (PRO) measures. Because of the rigorous methods required for development of a PRO instrument, we are targeting OUD rather than general substance use disorders for development during the period of this award. As DSM-5 diagnostic criteria are equivalent across substances of abuse, the OUDSS could be modified for other specific substances (or substance use disorders in general) with minimal effort. A validated, easy to administer, electronic PRO measuring OUD severity would be a significant contribution to treatment research, clinical care, and medication development.