University of Texas School of Public Health, 1200 Herman Pressler, RAS E-901, Houston, TX 77030, USA and
1 Department of Epidemiology and Public Health, Institute of Child Health, University College London Medical School, 30 Guilford Street, London WC1N 1EH, UK
Received 2 July 1998; in revised form 16 November 1998; accepted 15 January 1999
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ABSTRACT |
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INTRODUCTION |
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Numerous randomized controlled trials have evaluated a diverse range of interventions to reduce alcohol dependence, misuse or consumption, e.g. pharmacotherapy, individual, couple, and group counselling, exercise, acupuncture, controlled drinking, brief educational interventions (alcohol intake assessment and provision of information and advice), and other in- and out-patient therapies and combinations of treatments. Most such trials have measured effects of treatment on alcohol consumption and maintenance of abstinence. Many trials have also evaluated the effects of treatment on a wide variety of negative consequences linked directly or indirectly to drinking (e.g. hospitalizations, social or occupational maladjustment) (Babor et al., 1994). Because of the increased risk of injuries associated with problem drinking, we undertook a systematic review to evaluate the effectiveness of interventions for problem drinking in preventing injuries.
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METHODS |
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Inclusion criteria
Studies were included if: (1) the study population comprised people with alcohol dependence, alcohol abuse, or other problem drinking; (2) subjects were randomly assigned to experimental and control groups; (3) the intervention was designed to reduce or eliminate alcohol consumption, or to prevent injuries or their antecedents (e.g. falls, motor vehicle crashes, suicide attempts, aggressive/ violent behaviour); (4) outcome measures included injuries or their antecedents.
Data sources
Eligible trials were identified by searching relevant computerized medical databases (see below), reviewing reference lists of relevant trials, contacting national and international agencies for information about unpublished studies, and asking authors of relevant trials to identify additional published or unpublished trials.
Twelve electronic databases were searched: MEDLINE (1966August 1996), EMBASE (1982 January 1997), the Cochrane Controlled Trials Register (The Cochrane Library 1997, issue No. 1), PSYCHINFO (1967January 1997), the Cumulative Index to Nursing and Allied Health (CINAHL) (1982October 1996), the Educational Resource Information Center (ERIC) (1966December 1996), Dissertation Abstracts International (1861 November 1996), International Road Research Documentation (IRRD) (1972January 1997), TRANSDOC (a publication of the European Conference of Ministers of Transport) (1972January 1997), Transportation Research Information Services (TRIS) (1968January 1997), the International Bibliography of the Social Sciences (IBSS) (1961January 1997), and the Index of Scientific and Technical Proceedings (ISTP) (1982January 1997).
MEDLINE was searched by combining the Cochrane Collaboration's optimally sensitive search strategy for controlled trials (Dickersin et al., 1994), with a strategy developed to identify studies of interventions for problem drinking. Search terms included drink* or alcohol* near excessive, binge, heavy, hazard*, problem* or abuse; drink* or drunk* or influence near driv*; (accidents-traffic or automobile-driving) and alcohol*; alcoholi*; and the mesh headings (explode) ALCOHOLIC-INTOXICATION, (explode) ALCOHOLISM, ALCOHOL-DRINKING, and TEMPERANCE, with all subheadings. Similar search strategies were developed for the other databases. We also hand-searched abstracts from the Transport Research Laboratory Database of World-wide Published Information and relevant conference proceedings at the Transport Research Laboratory Library (United Kingdom).
To find other eligible published or unpublished trials, we contacted the National Highway Traffic Safety Administration and the National Institute for Alcohol Abuse and Alcoholism (United States), Federal Office of Road Safety (Australia), Addiction Research Foundation (Canada), Transport Research Laboratory (United Kingdom), University of Auckland's Injury Prevention Research Centre (New Zealand), and Väg-och Trafik-Institutet (Sweden).
Study selection
One author (TD) reviewed all titles and/or abstracts to exclude studies that clearly failed to meet our first three inclusion criteria (e.g. subjects without alcohol problems, observational studies or uncontrolled trials). The full texts of the remaining citations were reviewed to exclude studies that did not meet the first three inclusion criteria. We contacted the corresponding authors of all remaining studies to identify additional potentially relevant trials and to request further details if required to determine eligibility. If studies met the first three inclusion criteria but did not report collecting injury-related outcomes (criterion four), we asked the authors to provide any unpublished data on such outcomes. We attempted to contact additional authors (by mail, telephone, and Internet search) when corresponding authors were deceased or could not be traced.
Data extraction
Two of the authors (TD and CD) independ-ently extracted data and rated the quality of allocation concealment for each eligible study. We extracted data on the number and description of participants, type of intervention, duration of follow-up, method of allocation concealment, and outcomes evaluated. Differences were resolved by discussion. We assessed the quality of allocation concealment as follows: an A rating signified adequate measures to conceal allocation (e.g. central randomization; serially numbered, opaque, sealed envelopes); a B rating signified unclear adequacy of allocation concealment; and a C rating signified inadequately concealed allocation (e.g. open list of random numbers) (Schulz et al., 1995). There was 100% agreement in the allocation concealment ratings. Studies that would have received a C rating based on the use of quasi-random allocation (e.g. alternation) were ineligible under our inclusion criteria.
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RESULTS |
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Non-fatal injuries and their antecedents
Seventeen trials collected data on non-fatal injuries and their antecedents. Those trials collecting outcomes specifically identified as non-fatal violence or motor vehicle crashes and related injuries are summarized separately below. There were nine trials that collected non-fatal injury outcomes (e.g. accidents), that combined injuries due to a variety of causes. Two of these are in progress. Relevant data were available from only two of the seven completed trials. Fitzgerald and Mulford (1985) received an A rating and Kuchipudi et al. (1990) received a B rating for allocation concealment. In both of these trials, the intervention for problem drinking reduced the risk of injuries and their antecedents, compared to no intervention, despite reporting no beneficial effects of treatment on abstinence. All these effect estimates were imprecise, however. In the trial by Fitzgerald and Mulford (1985), the number of subjects differed markedly between the two study groups at Center A, because 43 subjects originally assigned to a second experimental group of patient-initiated aftercare contacts were combined with the no aftercare control group in the analysis after only one patient initiated such contact. The authors stated that there was little effect on their results whether these subjects were included or excluded from the control group.
Non-fatal violence
Eight trials, two of which are still in progress, collected data on non-fatal violence. Data were available for three of the six completed trials. Fitzgerald and Mulford (1985) received an A rating for allocation concealment and the other two (Barber and Crisp, 1995; Sitharthan et al., 1996
) received B ratings. Both trials evaluating intervention vs no intervention suggested a reduction in violence with intervention, while only Barber and Crisp (1995) showed a beneficial effect on drink-related outcomes. The third trial (Sitharthan et al., 1997
) compared two different interventions and reported a reduced risk of committing assault after cognitive behavioural therapy, but a greater reduction in alcohol consumption with cue exposure therapy.
Motor vehicle crashes and related injuries
Seven trials assessed motor vehicle crashes and related injuries. Data were available from three of the four completed trials. The two trials by Reis (1982a,b) received A ratings and the trial by Landrum et al. (1981) a B rating for allocation concealment. In Landrum et al.'s (1981) trial of interventions for persons convicted of DUI, the monthly probation and the rehabilitation interventions were associated with reduced risks of both motor vehicle crashes and crash-related injuries. Effects were greater on injuries than on crashes, although all effect estimates were imprecise. The combination of probation and rehabilitation appeared to have less effect on motor vehicle crashes and a small adverse effect on crash-related injuries. Among persons convicted once of DUI (Reis, 1982a), in-class education reduced the cumulative accident rate, but there appeared to be little beneficial effect from home study. These results are consistent with the stronger effect of in-class education than of home study on alcohol consumption and the slightly stronger effect of the former on DUI arrest recidivism (see Table 1
). In the study (Reis 1982b
) of persons convicted more than once of DUI, only educational counselling combined with disulfiram therapy appeared to reduce the cumulative incidence of alcohol-related crashes and injuries compared to no intervention, despite the fact that all three intervention groups had less DUI arrest recidivism than did the control group receiving no intervention.
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DISCUSSION |
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Although reduced alcohol consumption would seem a likely mechanism for any beneficial effects of treatment on injuries, our review does not provide strong support for this mechanism. Among the seven trials reporting beneficial effects of treatment on injuries or injury antecedents, four reported on abstinence or reduced alcohol consumption and three on the incidence of driving under the influence of alcohol. Reis (1982a) and Barber and Crisp (1995) found a beneficial effect of intervention on drink-related outcomes, whereas Fitzgerald and Mulford (1985) and Kuchipudi et al. (1990) showed slight adverse effects. Similarly, Reis (1982a,b) found significant reductions in DUI recidivism rates in both of his trials, but Landrum et al. (1981) reported only a slight reduction in DUI incidence with intervention and Kuchipudi et al. (1990) found an adverse effect on DUI. We also found four trials that compared different treatment modalities and reported injury outcomes. In two of these, there were significantly greater declines in alcohol consumption with one therapeutic modality compared to the other(s) (Walsh et al., 1991; Sitharthan et al., 1997
). In both trials, however, the treatments that reduced consumption had adverse effects on injury-related outcomes (although effect estimates in both cases were imprecise due to small sample sizes). It is possible that these paradoxical results can be explained by chance, reflecting the nearly universally imprecise effect estimates, or by measurement error in the assessment of the drink- or injury-related outcomes. It is also possible that any beneficial effect on injuries is mediated by other aspects of treatment for problem drinking (e.g. receipt of medical attention and social support).
The aim of our systematic review was to make explicit the totality of the randomized evidence on what appears to be a promising approach to tackling the problem of alcohol-related injuries. The fact that the trials that we found reported imprecise effect estimates and often had important methodological weaknesses is a key finding of the review, indicating that this promising approach requires further research. We considered the possibility of combining the available data from these trials in a meta-analysis to increase the precision of the effect estimates. However, this would have involved combining markedly heterogeneous groups of patients, interventions, and outcomes. In such circumstances, a meta-analysis can produce inappropriate, and even misleading, conclusions (Bailar, 1997; Editorial 1997
).
We limited our critique of the quality of the included studies to an assessment of the quality of allocation concealment, because this is the most important criterion for assessing the validity of a trial (Schulz et al., 1995). Unfortunately, we were able to determine this criterion accurately in only a very small proportion of the trials reviewed. Few trials reported allocation concealment in detail, and among the others, very few researchers provided us with sufficient information to assess adequately this criterion. We cannot, therefore, make firm conclusions about quality for most of the trials.
Publication bias is an important threat to the validity of systematic reviews. Such bias may arise if outcome data are selectively omitted from published reports, because the results fail to reach significance. To avoid the effects of this type of bias, we wrote to the authors of all identified trials that met our first three inclusion criteria, asking them to provide any unpublished outcome data on injuries or their antecedents. Nine additional completed trials, and three trials still in progress, were identified by this approach. Unfortunately, we were able to obtain the unpublished injury-related data from only a few of the completed trials. The difficulties involved in extracting unpublished data and other information for systematic reviews have been reported previously (Roberts and Schierhout, 1997). Many of the authors of studies that met our first three inclusion criteria were untraceable or deceased (7%) or did not respond to our requests for information (55%). While it is likely that some did not respond because they did not measure injury-related outcomes, the inability to identify all unpublished data might have biased our results.
In conclusion, previous reviews have shown that interventions for problem drinking can reduce alcohol consumption (Freemantle et al., 1993) and driving under the influence of alcohol (Wells-Parker et al., 1995
). This review suggests that interventions for problem drinking have the potential to reduce the incidence of injuries and their antecedents, but current data are insufficient to draw firm conclusions. Because injuries account for a large proportion of the morbidity and mortality due to problem drinking, further studies are warranted to evaluate the effect that treating problem drinking may have on injuries and to investigate how any beneficial effects on injuries are mediated.
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ACKNOWLEDGEMENTS |
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FOOTNOTES |
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