‘Nothing is More Practical Than a Good Theory’: Outcome Measures in Addictions Treatment Research (original) (raw)
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Outcomes of treatment interventions in drug abuse
Current Opinion in Psychiatry, 2001
This review examines the recent research on the outcomes of treatment in the field of drug addiction. The question of who does better in treatment is addressed, along with a consideration of the domains of outcome, such as the use of substances, retention in treatment and severity of addiction; physical and mental health; and economic costs to society, including crime and employment. Curr Opin Psychiatry 14:201±205.
Addiction, 2012
Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.
The Evaluation of Substance User Treatment—A Jubilee Proposal for the 21st Century
Substance Use & Misuse, 2015
This article recommends a longitudinal, national study of the outcomes of substance user treatment, plus a cohort of users who do not enter treatment. Viewing addiction primarily as a brain disease has provided interesting descriptive information but dismisses the psychological, social, political, economic, and legal dimensions of substance user dependence. An increased emphasis on behavioral study of treatment outcomes with a decreased emphasis on brain-focused research on substance use is overdue.
Addictive Behaviors
Although several critiques of the methodology of alcohol treatment outcome studies have been published, similar reviews of the methodology of drug treatment outcome studies are lacking. This paper reviews the methodology of drug treatment outcome studies published from 1993 through 1997 and draws comparisons with the most recent methodological review of alcohol treatment outcome studies. Each drug study was evaluated as to whether the following types of data were reported: (1) demographic, (2) drug use, (3) study characteristics, and (4) outcome and follow-up information. Although results for drug studies showed some areas of strength compared to alcohol studies, in general, the weaknesses were similar to or worse than in the alcohol field, including inadequate reporting of demographic and drug use variables. Weaknesses in follow-up procedures were particularly notable. Suggestions for improving the reporting of methodological and outcome variables for drug treatment outcome studies...
Outcome Measures in Medication Trials for Substance Use Disorders
Current Treatment Options in Psychiatry, 2015
There are multiple therapeutic options to treat tobacco (e.g., nicotine replacement therapies, varenicline) and alcohol (e.g., naltrexone, acamprosate) use disorders. In contrast, there are currently no FDA-approved pharmacotherapies to treat stimulant (e.g., cocaine, methamphetamine) use disorders. Based on a commentary published by FDA staff, a period of sustained abstinence appears required for regulatory approval of a first-in-class medication to treat stimulant use disorders. Certainly, achieving abstinence remains the goal of treatment in both real world medical practice and clinical trials. However, if a medication can help patients to significantly reduce stimulant use (short of achieving a sustained abstinence) while attempting to quit, such reductions could confer meaningful benefit. The FDA has adopted the Bpercentage of subjects with no heavy drinking days^as an endpoint for pharmacotherapy trials in alcohol use disorders; this suggests there may be a potential path forward for developing analogous, non-abstinence endpoints for stimulant use disorder trials. However, reductions in drug use per se (short of abstinence) must have prognostic value in order to be considered an acceptable basis for FDA approval. Thus, even if a medication can provide sustained reductions in drug use, the challenge ahead is to demonstrate that this Bsuccess^is accompanied by benefits that accrue in dimensions readily understood by patients and their families, and of sufficient value to be reimbursed by third party payers. Emerging data sets discussed in this paper indicate that endpoints other than abstinence may ultimately be validated as outcome measures in pharmacotherapy trials for stimulant use disorders.
Substance Abuse and Rehabilitation, 2012
The fields of addiction medicine and addiction research have long sought an efficient yet comprehensive instrument to assess patient progress in treatment and recovery. Traditional tools are expensive, time consuming, complex, and based on topics that clinicians or researchers think are important. Thus, they typically do not provide patient-centered information that is meaningful and relevant to the lives of patients with substance use disorders. To improve our ability to understand patients' progress in treatment from their perspectives, the authors and colleagues developed a patient-oriented assessment instrument that has considerable advantages over existing instruments: brevity, simplicity, ease of administration, orientation to the patient, and cost (none). The resulting Treatment Effectiveness Assessment (TEA) elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains established by prior research. Patients provide both numerical responses and representative details on their substance use, health, lifestyle, and community. No software is required for data entry or scoring, and no formal training is required to administer the TEA. This article describes the development of the TEA and the initial phases of its application in clinical practice and in research.
Reliability and Validity of the Substance Abuse Outcomes Module
Psychiatric Services, 2006
The study sought to determine the validity and reliability of the Substance Abuse Outcomes Module (SAOM), a self-report tool designed to assess patient characteristics, process of care, and outcomes of care, using a minimum amount of information, in order to improve treatment. Methods: A longitudinal field test (baseline and three-month follow-up) compared the SAOM to seven other research instruments in the assessment of 100 substance-abusing patients who were entering a new treatment episode. Quota samples of patients were drawn from two private inpatient substance abuse treatment facilities and an outpatient methadone clinic. The study's primary outcome measures were diagnostic accuracy, internal and test-retest reliability of key constructs, concurrent and predictive validity, and sensitivity to change. Cronbach's alpha coefficients were calculated to examine internal consistency and reliability. Intraclass correlation coefficients and kappa coefficients were used to examine testretest reliability. Concurrent validity of outcomes measures was examined with Pearson or Spearman correlation coefficients and chi square and kappa statistics. Changes between baseline and follow-up were examined as a function of case-mix measures with ordinary least-squares multiple regression. Sensitivity to change was examined by calculating effect size scores. Results: The SAOM had high internal consistency and a high level of agreement with research diagnoses at baseline and follow-up. The SAOM was found to be highly reliable, to have very strong validity, and to be sensitive to clinical change. Conclusions: The SAOM appears to be a reasonably reliable and valid self-report instrument when used to monitor substance abuse treatment among patients with a primary substance use diagnosis.