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Toward Identifying Clinically Useful Definitions of Treatment Success

确定治疗成功的临床有用定义

基本信息

批准号：
9352672
负责人：
Megan Kirouac
金额：
$ 1.62万
依托单位：
UNIVERSITY OF NEW MEXICO
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-11 至 2017-08-06
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9352672
关键词：
Abstinence Address Aftercare Alcohol consumption Alcohols American Psychiatric Association Behavioral Mechanisms Characteristics Client Clinical Clinical Trials Complex Consumption Data Data Analyses Development Diagnostic European Future Goals Gold Harm Reduction Health Personnel Heavy Drinking Measurement Measures Medicine Mental Health Modeling Outcome Outcome Measure Pharmaceutical Preparations Population Process Property Provider Psychometrics Quality of life Receiver Operating Characteristics Recovery Research Research Personnel Risk Self Efficacy Sensitivity and Specificity Series Testing Time Treatment outcome United States United States Food and Drug Administration United States Substance Abuse and Mental Health Services Administration Validation World Health Organization alcohol abstinence alcohol abuse therapy alcohol related problem alcohol use disorder base behavior change consumption measures craving drinking high risk drinking improved functioning loved ones outcome prediction physical conditioning prevent primary outcome psychosocial public health relevance research study standard measure success treatment effect

项目摘要

DESCRIPTION (provided by applicant): Treatments for alcohol use disorder (AUD) have been historically evaluated by consumption-based outcomes, such as the percentage of days abstinent from alcohol (PDA). There are many advantages of alcohol consumption as a primary outcome, given that it is easily quantified (e.g., via standard drinks) and because alcohol consumption is inherently associated with AUD. However, researchers, clients, and treatment providers have all agreed that the process of recovering from AUD involves more than consumption alone (e.g., Donovan et al., 2005; Kaskutas et al., 2014; Neale et al., 2015). Recent efforts have called for a shift away from defining consumption as the marker of AUD treatment success (Witkiewitz, 2013a), given that defining treatment success primarily by amount of consumption often fails to adequately portray the recovery process (e.g., Donovan et al., 2012; Substance Abuse and Mental Health Services Administration, 2012; Tiffany et al., 2012). Yet, efforts to move toward including non-consumption outcome measures have been stymied for two primary reasons. First, it is assumed that consumption measures are more sensitive and, therefore, consumption must be used as a "surrogate" measure for more clinically meaningful non- consumption measures (FDA, 2015, p. 2). Second, research is needed to direct researchers toward the best "gold standard" measures to use among AUD populations and studies of measurement invariance over time of these measures are largely non-existent. The aims of the proposed study will address these two concerns via secondary data analysis of two of the largest AUD treatment research studies conducted in the United States: the COMBINE Study and Project MATCH (Anton et al., 2006; Project MATCH Research Group, 1997). The present study will examine the sensitivity and specificity (Aim 1), as well as the reliability, validity, and measurement invariance (Aim 2), of non-consumption measures available in the COMBINE study and Project MATCH. The non-consumption outcome variables to be examined are consistent with the variables identified as important to researchers, clients and their loved ones, and treatment providers: 1) alcohol-related problems, 2) mental health, 3) craving/temptation, 4) psychosocial functioning/quality of life, 5) physical health, 6) financial status, and 7) self-efficacy. Sensitivity and specificity will be evaluated using Receiver Operatin Characteristic (ROC) curve analyses (Hanley & McNeil, 1982) predicting outcome data from immediately post- and 12-month post-treatment for: 1) abstinence, 2) no heavy drinking days (Falk et al., 2010), 3) the World Health Organization risky drinking levels (European Medicines Agency, 2010), and 4) a composite clinical outcome defined by consumption and alcohol-related problems (Cisler & Zweben, 1999). Reliability, validity, and measurement invariance will be assessed using latent variable modeling approaches. The two aims of this study will address longstanding and untested assumptions that have prevented researchers from shifting toward more clinically meaningful definitions of treatment success that include non-consumption outcomes.

描述(由申请人提供)：酒精使用障碍(AUD)的治疗历来是通过基于消费的结果进行评估的，例如戒酒天数(PDA)。酒精消费作为主要结果有许多好处，因为它很容易量化(例如，通过标准饮料)，而且因为酒精消费与澳元有内在联系。然而，研究人员、客户和治疗提供者都一致认为，从澳大利亚疾病中恢复的过程不仅仅涉及消费(例如，Donovan等人，2005年；Kaskutas等人，2014年；Neale等人，2015年)。最近的努力呼吁改变将消费定义为AUD治疗成功的标志(Witkiewitz，2013a)，因为主要根据消耗量来定义治疗成功往往不能充分描述康复过程(例如，Donovan等人，2012年；物质滥用和精神卫生服务管理局，2012年；Tiffany等人，2012年)。然而，纳入非消费结果指标的努力因两个主要原因而受阻。首先，假设消费措施更敏感，因此，必须将消费作为更具临床意义的非消费措施的“替代”措施(FDA，2015，第2页)。其次，需要进行研究来指导研究人员在AUD人群中使用最佳的“黄金标准”指标，而关于这些指标随时间变化的测量不变性的研究基本上是不存在的。拟议研究的目的将通过对在美国进行的两项最大的AUD治疗研究的次级数据分析来解决这两个问题：联合研究和项目匹配(Anton等人，2006年；项目匹配研究小组，1997年)。本研究将检验在联合研究和项目匹配中可用的非消费测量的灵敏度和特异度(目标1)以及可靠性、效度和测量不变性(目标2)。要检查的非消费结果变量与被确定为对研究人员、客户及其亲人和治疗提供者重要的变量是一致的：1)与酒精有关的问题，2)精神健康，3)渴望/诱惑，4)心理社会功能/生活质量，5)身体健康，6)经济状况，7)自我效能。敏感性和特异性将通过受试者操作特征(ROC)曲线分析(Hanley&McNeil，1982)预测治疗后和12个月后立即出现的结果数据来评估：1)戒酒，2)不酗酒天(Falk等人，2010年)，3)世界卫生组织危险饮酒水平(欧洲药品管理局，2010年)，以及4)由消费和酒精相关问题定义的综合临床结果(Cisler&Zweben，1999)。信度、效度和测量不变性将使用潜变量建模方法进行评估。这项研究的两个目标将解决长期存在和未经检验的假设，这些假设阻止研究人员转向包括非消费结果在内的更具临床意义的治疗成功定义。