Assessing Drinking Outcomes in Alcohol Treatment Efficacy Studies: Selecting a Yardstick of Success (original) (raw)
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Issues in the definition and measurement of drinking outcomes in alcoholism treatment research
Journal of Studies on Alcohol, Supplement, 1994
This article reviews methodological and conceptual issues regarding the choice of drinking outcome measures in alcoholism treatment research. The following issues are discussed: Should drinking outcomes be conceptualized in terms of an underlying unitary disorder, or should provision be made for independent outcomes that cover a wide variety of dimensions? Which drinking outcomes are typically measured in treatment evaluation studies and how are they operationalized? What are the empirical associations among drinking outcome measures? If multiple outcomes are measured, which should be given primary importance? Over what period of time should treatment outcome be evaluated? What procedures can be used to detect, correct or prevent the response bias associated with verbal report methods? Because outcome measures need to fit the hypotheses and practical needs of a particular study, it is unlikely that complete standardization can be achieved across all studies. Nevertheless, given the importance of drinking outcomes and the need for economy, two primary dependent measures are recommended: (1) proportion of available drinking days abstinent; and (2) intensity of drinking, as defined by the total amount consumed (in ounces absolute alcohol) during the follow-up period divided by the number of actual drinking days. This article also proposes a strategy that may help to guide the selection of outcome measures in future research. (J. Stud. Alcohol, Supplement No. 12:101-111, 1994) N A 1988 EDITORIAL, Arnold Relman stated, "We can no longer afford to provide health care without knowing more about its successes and faiIures." Applying this admonition to the treatment of alcoholism, the Institute of Medicine (1990, p. 326) recommended that "consensus must be achieved on the need for outcome determination, on the parameters to be used in determining outcome, and on the optimal way(s) to go about making outcome determinations." The goal of this article is to review methodological and conceptual issues regarding the choice of alcohol-related outcome measures in alcoholism treatment research. Alcoholrelated outcomes are the measures of drinking behavior, alcohol dependence symptoms and alcohol-related consequences that are directly attributable to drinking following treatment. A secondary goal of this article is to suggest ways that greater standardization could be introduced to the planning, execution and reporting of treatment research. Because
Alcohol treatment outcome evaluation methodology: State of the art 1980–1984
Addictive Behaviors, 1987
The methodology of alcohol treatment outcome studies published during two sequential intervals from 1976 through mid-1984 is critically reviewed. Although considerable methodological improvements have occurred over time, major methodological deficiencies continue to characterize much of the literature, with inadequate reporting of subjects' pretreatment characteristics (e.g., severity of dependence) being the most striking problem. Pervasive differences across studies regarding the types of data gathered and the ways in which findings are reported seriously impede attempts to compare studies and weaken the types of conclusions that can be drawn about treatment efficacy in general. It is suggested that journal editors establish standards of reporting for follow-up studies.
Clinical and Methodological Utility of a Composite Outcome Measure for Alcohol Treatment Research
Alcoholism: Clinical & Experimental Research, 2003
Background: How to capture different response patterns resulting from alcohol treatment has been a troublesome issue for alcohol researchers. A composite measure is one approach to capturing multiple treatment outcomes among diverse client populations. This article provides the rationale, development, and work conducted thus far on the composite outcome index and discusses the clinical utility of the measure.
Trials, 2017
The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the D...
Alcohol treatment outcome methodology: State of the art 1989–1993
Addictive Behaviors, 1997
This article reviews the 61 alcohol treatment outcome studies published from 1989-1993 with respect to methodology. Although better assessment of subjects' pretreatment characteristics was noted, a minority of studies met even the basic requirements of experimental studies. Further. some reversals of methodological progress were observed in several areas. particularly in collecting outcome data from multiple sources. It is suggested that funding agencies and journal editors require that submissions meet minimum standards for adequate outcome evaluation. We would like to thank Karen Hobdon and Mariella DeFilippo for their assistance with this project. Requests for reprints should be sent to Curtis Breslin.
Addictive Behaviors, 2009
Whilst many instruments have been developed for screening and treatment outcome evaluation studies in the alcohol and other drug treatment (AOD) sector, very few are suitable for routine, ongoing use by clinicians. The aim of the current study was to assess the psychometric properties of the Alcohol Treatment Outcome Measure (ATOM). The ATOM was designed to measure the key outcomes of alcohol treatment whilst remaining a brief and easy to use clinical tool. Participants (N = 134) with a concern for their alcohol use were recruited from AOD treatment agencies and interviewed on two occasions one week apart. Results indicate that the ATOM has overall good to excellent test–retest and inter-rater reliability; and satisfactory concurrent validity and internal reliability. The instrument also demonstrated the ability to measure change in client functioning over time. Results suggest that the ATOM can be used successfully and confidently within alcohol treatment services.
Journal of Studies on Alcohol and Drugs
The purpose of this study was to report the "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) recommended core outcome set (COS) to improve efficacy and effectiveness trials/evaluations for alcohol brief interventions (ABIs). Method: A systematic review identified 2,641 outcomes in 401 ABI articles measured by 1,560 different approaches. These outcomes were classified into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This process prioritized 15 of 93 outcome categories for discussion at a consensus meeting of key stakeholders to decide the COS. A psychometric evaluation determined how to measure the outcomes. Results: Ten outcomes were voted into the COS at the consensus meeting: (a) typical frequency, (b) typical quantity, (c) frequency of heavy episodic drinking, (d) combined consumption measure summarizing alcohol use, (e) hazardous or harmful drinking (average consumption), (f) standard drinks consumed in the past week (recent, current consumption), (g) alcohol-related consequences, (h) alcohol-related injury, (i) use of emergency health care services (impact of alcohol use), and (j) quality of life. Conclusions: The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve the synthesis of new findings, reduce redundant/selective reporting (i.e., reporting only some, usually significant outcomes), improve between-study comparisons, and enhance the relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other, additional outcomes.
Alcoholism-clinical and Experimental Research, 2010
Background: Percent subjects with no heavy drinking days (PSNHDDs), an efficacy end point recommended by the Food and Drug Administration, considers abstinent individuals or those engaging in low-risk drinking behavior as successful responders to treatment. As PSNHDD has been used infrequently in previous alcohol clinical trials, we evaluated the utility and validity of the PSNHDD outcome measure in 2 large alcohol clinical trials. Methods: Data sets from 2 alcohol trials, COMBINE and a multisite topiramate trial, were used to analyze PSNHDDs and other traditional end points for the topiramate, naltrexone, acamprosate, and placebo groups. Effect sizes of PSNHDDs were determined for each month of active treatment and by varying grace periods-early periods in the trial where outcome is not considered in the analysis-and were compared with that of other traditional outcome measures. Longterm outcomes were compared for groups that had no heavy drinking days versus those that had heavy drinking days during active treatment. Results: PSNHDD effect sizes were significant for both topiramate (0.34 and 0.25 at months 2 and 3, respectively) and naltrexone (0.24 and 0.26 at months 3 and 4, respectively). Given a 2-month grace period for naltrexone, the effect size of PSNHDDs was comparable to the effect sizes using traditional outcome measures. With a 1-month grace period for topiramate, it was greater than the majority of traditional outcome measures. Little is gained by allowing up to 1, 2, or 3 heavy drinking days as an end point. Subjects with no HDDs during treatment fared better than those with some HDDs on drinking outcomes and alcohol-related consequences during a 1-year follow-up. Conclusions: PSNHDD appears to be a clinically informative end point measure, especially when used with a grace period, and is as sensitive as most traditional outcome measures in detecting differences between the medication and placebo groups. Nonetheless, these findings should be replicated in other clinical data sets, particularly with medications that work via different mechanisms.
Alcoholism Clinical and Experimental Research, 2010
Background: Percent subjects with no heavy drinking days (PSNHDDs), an efficacy end point recommended by the Food and Drug Administration, considers abstinent individuals or those engaging in low-risk drinking behavior as successful responders to treatment. As PSNHDD has been used infrequently in previous alcohol clinical trials, we evaluated the utility and validity of the PSNHDD outcome measure in 2 large alcohol clinical trials. Methods: Data sets from 2 alcohol trials, COMBINE and a multisite topiramate trial, were used to analyze PSNHDDs and other traditional end points for the topiramate, naltrexone, acamprosate, and placebo groups. Effect sizes of PSNHDDs were determined for each month of active treatment and by varying grace periods-early periods in the trial where outcome is not considered in the analysis-and were compared with that of other traditional outcome measures. Longterm outcomes were compared for groups that had no heavy drinking days versus those that had heavy drinking days during active treatment. Results: PSNHDD effect sizes were significant for both topiramate (0.34 and 0.25 at months 2 and 3, respectively) and naltrexone (0.24 and 0.26 at months 3 and 4, respectively). Given a 2-month grace period for naltrexone, the effect size of PSNHDDs was comparable to the effect sizes using traditional outcome measures. With a 1-month grace period for topiramate, it was greater than the majority of traditional outcome measures. Little is gained by allowing up to 1, 2, or 3 heavy drinking days as an end point. Subjects with no HDDs during treatment fared better than those with some HDDs on drinking outcomes and alcohol-related consequences during a 1-year follow-up. Conclusions: PSNHDD appears to be a clinically informative end point measure, especially when used with a grace period, and is as sensitive as most traditional outcome measures in detecting differences between the medication and placebo groups. Nonetheless, these findings should be replicated in other clinical data sets, particularly with medications that work via different mechanisms.
How should the effectiveness of treatment for alcohol problems be evaluated?
Drugs and Alcohol Today, 2007
In times of information overload, researchers have found ways to synthesise a large amount of data from numerous studies bearing on the effectiveness of treatment for alcohol problems. Two of these ways are discussed: formal meta‐analysis and the box‐score ‘mesa grande’. It is concluded that meta‐analysis cannot answer questions regarding which treatments give the best results in the alcohol field. The mesa grande has certain limitations, which are described, but is useful for the formation of treatment policies when a clear summary of the research evidence on treatment effectiveness is needed. By contrast, large multi‐centre randomised controlled trials with enough statistical power to detect small effects of treatment should normally be preferred when a decision has to be made as to which of two or more specified treatments should be implemented in practice. Unfortunately, two multi‐centre trials, one in the USA and one in the UK, have given rise to the ‘dodo bird’ verdict of equi...