Quality of life outcomes in prescription and injection opioid dependence

描述(由申请人提供)：生活质量作为衡量慢性病治疗结果的指标越来越重要。尽管越来越多的人认识到药物滥用是一种慢性病，而且越来越多的人认识到非医疗处方药的使用对生活质量的负面影响，但在药物滥用治疗研究中很少测量生活质量。阿片依赖治疗通常是根据戒断措施进行评估的。相关的经济研究经常使用成本效益方法，强调对医疗保健以外的治疗费用进行经济补偿，例如在法律制度中。由于阿片类药物依赖的原因，迫切需要生活质量数据 提供新的药物治疗方法(丁丙诺啡-纳洛酮和纳曲酮注射剂)。需要生活质量权重来比较新治疗与私人和公共医疗保险覆盖的其他类型护理的成本效益。这种方法认识到，治疗的价值应该与卫生系统的额外费用相适应，但与其他医疗干预措施相比，不必节省成本。经济理论和标准实践要求成本-效果分析的生活质量衡量标准从社区的角度出发，只考虑身体和精神症状，并将阿片类药物依赖与共病分开评估。相比之下，包括阿片依赖治疗的社会福利好处并将患者的共病经验纳入其中的定义可能更相关，更容易被治疗提供者和政策制定者接受。我们建议使用社区调查和从患者那里收集的二次数据来衡量阿片类药物依赖的生活质量，比较有和没有社会福利考虑的结果，并为研究人员开发“现成”工具，其中包括如何解释并存疾病的指导。我们的具体目标是1)通过开发和进行互联网调查，直接从具有代表性的美国居民样本中获得生活质量重量，创建有和没有社会福利考虑的阿片依赖健康状态的“现成”生活重量列表；2)估计患者报告的阿片依赖健康状态的生活质量重量，并使用参加两个多地点全国药物滥用治疗临床试验网络随机试验的数据，确定社会福利考虑的影响，以便与“现成”体重进行比较；3)使用在多地点BHIVES队列中登记的艾滋病毒感染阿片依赖患者的自我报告数据，评估控制不佳的艾滋病毒和慢性丙型肝炎患者的生活质量对阿片依赖的影响，并将这些结果与已发表的合并共病“现成”权重的算法进行比较。这项研究具有很高的创新性和重大意义，因为它填补了对处方和注射阿片类药物依赖的生活质量的认识的一个关键空白，这是评估经济和患者报告的结果所必需的，并解决了卫生系统和社会福利观点之间的联系。

DESCRIPTION (provided by applicant): Quality of life is increasingly important as a measure of chronic disease treatment outcomes. Despite growing recognition that substance abuse is a chronic disease, and the increasingly recognized negative effects on quality of life caused by the growth of nonmedical prescription drug use, quality of life is rarely measured in substance abuse treatment studies. Opioid dependence treatment is usually evaluated based on measures of abstinence. Related economic research has frequently used a cost-benefit approach that emphasizes economic offsets to treatment costs found outside of health care, such as in the legal system. There is a critical need for quality of life data in opioid dependence because of the availability of new pharmaceutical treatments (buprenorphine-naloxone and injection naltrexone). Quality of life weights are required to compare the cost- effectiveness of the new treatments to other types of care covered by private and public health insurance. This approach recognizes that the value of treatment should be appropriate to the additional cost to the health system, but need not be cost saving when compared to other medical interventions. Economic theory and standard practice require quality of life measures for cost-effectiveness analysis to take the perspective of the community, only consider physical and mental symptoms, and value opioid dependence separately from co- morbidities. In contrast, a definition that includes social welfare benefits of opioid dependence treatment and integrates patient experience of co morbidities may be more relevant and acceptable to treatment providers and policy makers. We propose to measure quality of life in opioid dependence using a community survey and secondary data collected from patients, compare outcomes with and without social welfare considerations, and develop "off the shelf" tools for researchers that include guidance on how to account for co-morbidities. Our specific aims are 1) to create an "off the shelf" list of quality o life weights for opioid dependence health states with and without social welfare considerations by developing and conducting an internet survey to directly elicit quality of life weights from a representative sample of US residents; 2) to estimate quality of life weights for patient-reported opioid dependence health states and determine the impact of social welfare considerations using data from injection and prescription opioid users enrolled in two multi-site National Drug Abuse Treatment Clinical Trials Network randomized trials, for comparison with the "off the shelf" weights; and 3) to assess the impact on opioid dependence quality of life weights of poorly controlled HIV and of chronic HCV using self-reported data from HIV-infected opioid dependent patients enrolled in the multi-site BHIVES cohort, and to compare these results with published algorithms for combining "off the shelf" weights for co-morbidities. This research is highly innovative and significant because it fills a critical gap in knowledge about quality of lif in prescription and injection opioid dependence necessary to assess economic and patient-reported outcomes, and addresses the interface between health system and social welfare perspectives.