Development of the Opioid Use Disorder Severity Scale

阿片类药物使用障碍严重程度量表的制定

• 批准号: 10045652
• 负责人: BRIAN D. KILUK
• 金额: $ 56.86万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045652
• 关键词: Address; Adopted; Ambulatory Care; Award; Caring; Categories; Characteristics; Clinical; Clinical Research; Clinical Trials; Complex; Comprehension; DSM-IV; Development; Diagnosis; Diagnostic; Diagnostic and Statistical Manual of Mental Disorders; Disease; Drug Evaluation; Drug usage; Enrollment; Evaluation; Evaluation Research; Feedback; Gold; Individual; Instruction; Interview; Language; Link; Measurement; Measures; Mental disorders; Methods; Outcome; Outcome Assessment; Outcome Measure; Participant; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Procedures; Psychometrics; Quality of life; Sampling; Self Administration; Severities; Structure; Substance Addiction; Substance Use Disorder; Substance of Abuse; Sum; Symptoms; Testing; Time; Training; Validity and Reliability; Work; addiction; base; clinical care; clinical development; cognitive interview; cost; drug development; drug use behavior; improved; improved outcome; indexing; instrument; novel; opioid epidemic; opioid use; opioid use disorder; response; tool; tool development; treatment research

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.

7。项目摘要/摘要 开发新药物以减少阿片类药物使用障碍（OUD）引起的燃烧的开发很高 优先解决阿片类药物危机。但是，当前可用的工具和端点要评估和 批准治疗阿片类药物使用的新药物是药物开发的障碍。措施 OUD的诊断标准（即符号）的变化很少用作改进的指标 从治疗中，这种方法是其他精神疾病的标准实践。有 来自多个临床试验的初步证据，这些试验会改变精神的诊断和统计手册 疾病（DSM）诊断阈值和标准计数具有潜在的实用性，作为临床上有意义的 结果。但是，唯一经过验证的评估是测量DSM-5 OUD的存在和严重性的评估 是临床管理的半结构化访谈，需要进行广泛的培训和成本 广泛使用不切实际。在这个项目中，我们建议开发一种新的临床结果评估 电子管理，患者自我报告仪器直接链接到DSM-5诊断标准 测量“阿片类药物使用障碍严重程度量表”（OUDSS）的严重程度。 具体目的是：（1）基于结构化临床访谈生成一系列自我报告项目 OUD和现有物品库的使用障碍严重程度，以创建电子，自我管理 与DSM-5中的诊断标准直接相关的仪器； （2）评估内容有效性和 OUDS的管理程序通过对20名OUD患者进行一对一的定性访谈； （3）评估300个人的潜水员样本中OUDS的可靠性和有效性 寻求/招募门诊治疗，以确定结构有效性，测试可靠性和能力 检测变化。 OUDSS的开发和评估将遵循FDA指南报告的预后指南（PRO） 措施。由于制定专业仪器所需的严格方法，我们是针对的 在本奖项期间，OUD而不是通用物质使用障碍进行开发。作为DSM-5 诊断标准在滥用物质的范围内等效，可以修改其他特定的特定条件 努力最少的物质（或通常使用疾病）。经过验证，易于管理， 电子测量OUD严重程度将是治疗研究，临床护理的重要贡献， 和药物开发。