Development of the Opioid Use Disorder Severity Scale

7.项目总结/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。 优先解决阿片类药物危机。然而，目前可用的工具和终点，以评估和 批准治疗阿片类药物使用的新药是药物开发的障碍。措施 诊断标准的改变（即，OUD的症状）很少被用作改善的指标 尽管这种方法是其他精神疾病的标准做法。有 来自多项临床试验的初步证据表明，精神疾病诊断和统计手册 疾病（DSM）诊断阈值和标准计数具有潜在的实用性，作为一种临床意义 结果。然而，用于测量DSM-5 OUD的存在和严重程度的唯一有效评估 是临床医生管理的，半结构化的采访，需要广泛的培训和成本，使他们 不适合广泛使用。在这个项目中，我们建议开发一种新的临床结果评估， 直接与DSM-5诊断标准相关联的电子管理的患者自我报告工具， 阿片类药物使用障碍严重程度量表（OUDSS）。 具体目标是：（1）根据结构化临床访谈生成一个自我报告项目库， OUD和现有的物质使用障碍严重程度项目库，以创建一个电子的，自我管理的 与DSM-5诊断标准直接相关的工具;（2）评价内容效度， 通过对20例OUD患者的一对一定性访谈，了解OUDSS的管理程序; （3）在300名个体的多元样本中评价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 检测变化。 OUDSS的开发和评价将遵循FDA患者报告结局（PRO）指南 措施由于开发PRO仪器所需的严格方法， OUD而不是一般的物质使用障碍的发展在此期间的奖励。作为DSM-5 诊断标准在滥用物质之间是等同的，OUDSS可以针对其他特定物质进行修改。 物质（或一般物质使用障碍）以最小的努力。一种经过验证的，易于管理的， 测量OUD严重程度的电子PRO将对治疗研究，临床护理， 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.