Quality of life outcomes in prescription and injection opioid dependence

描述（由申请人提供）：生活质量作为慢性病治疗结果的衡量标准越来越重要。尽管越来越多的人认识到物质滥用是一种慢性疾病，而且越来越多的人认识到非医疗处方药使用的增长对生活质量的负面影响，但生活质量很少在物质滥用治疗研究中进行衡量。阿片类药物依赖治疗通常根据戒断措施进行评估。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成本进行经济补偿，例如在法律的系统中。由于阿片类药物依赖性，迫切需要生活质量数据 提供新的药物治疗（丁丙诺啡-纳洛酮和注射纳洛酮）。生活质量的权重是需要比较的成本效益的新的治疗方法，以其他类型的护理所涵盖的私人和公共健康保险。这一办法承认，治疗的价值应与卫生系统的额外费用相称，但与其他医疗干预措施相比，不一定要节省费用。经济理论和标准实践要求成本效益分析的生活质量指标从社区的角度出发，仅考虑身体和精神症状，并将阿片类药物依赖与合并症分开评估。相比之下，一个包括类阿片依赖治疗的社会福利福利并结合患者共病经历的定义可能更相关，也更容易为治疗提供者和决策者所接受。我们建议使用社区调查和从患者收集的二级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，包括如何解释合并症的指导。我们的具体目标是：1）通过开发和进行互联网调查，直接从美国居民的代表性样本中得出生活质量权重，为阿片类药物依赖健康状态（有和没有社会福利考虑）创建一个“现成”的生活质量权重列表; 2）估计患者的生活质量权重-报告的阿片类药物依赖的健康状况，并确定社会福利考虑的影响，使用的数据，从注射和处方阿片类药物使用者登记在两个多-网站国家药物滥用治疗临床试验网络随机试验，与“现成”的权重进行比较;和3）使用来自多中心BHIVES队列中登记的HIV感染的阿片类药物依赖患者的自我报告数据，评估控制不良的HIV和慢性HCV对阿片类药物依赖生活质量的影响，并将这些结果与公开的用于组合共病的“现成”权重的算法进行比较。这项研究具有高度创新性和重要性，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方面的关键空白，这是评估经济和患者报告结果所必需的，并解决了卫生系统和社会福利观点之间的接口。

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.