Screening for Addiction Risk in Chronic Opioid Therapy

描述（由研究者提供）：这项I期申请旨在开发阿片类药物成瘾潜力筛选器（SOAP），这是一种自我管理的简短筛选工具，用于考虑阿片类药物治疗的慢性疼痛患者。SOAP将识别可能有成瘾风险的个人。目前不存在用于此目的的经过验证的过程。一个严格的、方法学的方法将建立可靠性和预测有效性，阶段1开始测试开发过程。概念映射程序将整合来自疼痛和成瘾专家、提供者和患者的输入，以创建慢性疼痛患者成瘾的操作定义。概念映射还用于生成项目并对其进行概念评估。使用横截面方法的初始经验可行性测试将产生SOAP的beta版本，并在第二阶段进行前瞻性验证和交叉验证。对于有成瘾史的慢性疼痛患者，将特别注意确保测量的有效性。临界值的敏感性和特异性将根据测试前的成瘾概率进行计算和检查。Endo制药公司已经提供了大量的i期支持。结果测量应该是可靠的，有效的，并且在实际设置中易于使用。

DESCRIPTION (provided by investigator): This Phase I application aims to develop the Screener for Opioid Addiction Potential (SOAP), a self-administered, brief screening tool for chronic pain patients considered for opioid therapy. The SOAP will identify individuals who may be at risk for addiction. No current, validated procedure exists for this purpose. A rigorous, methodological approach will establish reliability and predictive validity Phase I begins the test development process. Concept mapping procedures will integrate input from experts on pain and addiction, providers, and patients to create an operational definition of addiction in chronic pain patients. Concept mapping is also employed to generate items and subject them to a conceptual evaluation. An initial empirical feasibility test, using cross sectional methods, will result in a beta version of the SOAP to be prospectively validated and cross-validated in Phase II. Special attention will be paid to ensure validity of the measure for chronic pain patients with addiction histories. Sensitivity and specificity of cutoff scores will be calculated and examined with respect to pre-test probabilities of addiction Substantial Phase Ill support has been committed by Endo Pharmaceuticals. The resulting measure should be reliable, valid, and easy to use in practice settings.