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Oct 6, 2013 - Cochrane systematic reviews in the field of addiction: past ... Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Journal of Evidence-Based Medicine ISSN 1756-5391

ORIGINAL ARTICLE

Cochrane systematic reviews in the field of addiction: past and future Laura Amato, Zuzana Mitrova and Marina Davoli on behalf of the Cochrane Drugs and Alcohol Group Department of Epidemiology, Lazio Regional Health Service, Rome, Italy

Keywords Cochrane Review; drug and alcohol; efficacy of intervention; randomized trial; systematic review. Correspondence Laura Amato, Department of Epidemiology, Lazio Regional Health Service, via di S. Costanza 53, Rome 00198, Italy. Tel: 0039-0683060483; Fax: 0039-0683060374; Email: [email protected] Received 13 August 2013; accepted for publication 6 October 2013. doi: 10.1111/jebm.12067

Abstract Background and Objective: The Cochrane Drugs and Alcohol Group aims to produce, update, and disseminate systematic reviews on the prevention, treatment, and rehabilitation of problematic drug and alcohol use. This paper describes what the Group has done since the 1990s to produce evidence to guide policy, practice, and research. Method: We analyze the coverage of topics by our reviews, the body of studies they have included, and the evidence produced. Results: By July 2013, the Group had published 67 reviews, with 376 authors from 25 different countries. These reviews included 906 studies, of 3061 studies considered for inclusion. Most (90%) included studies were randomized trials. Considering the ‘Implications for practice’ section of each review, 41% interventions were classified as ‘do it’, 15% as ‘do not do’, and 44% as ‘do only in research’. These proportions varied according to the type of substance of abuse studied. The proportion of ‘do it’ interventions were 46% for alcohol, 40% for opioids, 20% for psychostimulants, 40% for polydrugs, and 62% for prevention. Conclusion: Cochrane Reviews produced by the Drugs and Alcohol Group provide evidence on the effectiveness of several interventions, and identify areas of uncertainty where new research is needed.

Introduction The importance of the drug and alcohol problem is well established, in terms of frequency and health and social impact. Substance use disorders are associated with a wide range of serious health, social, and economic complications. The health status of alcohol and drug users is generally affected by their pattern of consumption (1) and, consequently, their life expectancy is often significantly lower than that of the general population (2–4), with a great impact on the mortality of young adults (5). People who abuse drugs are less likely to be working (6), and alcohol dependence is associated with premature retirement due to health (7). Housing, relationship, and judicial problems are also well documented among people who are substance dependent. Drug and alcohol dependence incurs high costs, due to multiple hospitalizations and treatment episodes (8).

Different interventions are offered for the prevention and treatment of substance use and dependence. The choice is often guided by common sense, intuition, experience, beliefs, or ideology, but not always by evidence. Clinicians and policy makers need accessible, up-to-date, objective evidence regarding the effectiveness of different interventions if they are to make well informed decisions about the variety of interventions available. The Cochrane Collaboration has been working for 20 years to produce evidence for decision-makers, by attempting to control for variable quality and provide a robust, even if sometimes limited, commentary on tightly defined interventions. Cochrane Reviews are the result of a complex process that includes: formulating an appropriate question, comprehensively searching for studies, objectively selecting and extracting data, critically evaluating potentially eligible studies, and synthesizing and updating results. In the last few years,

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grading the quality of the evidence has been added to this process. As the potential use and value of Cochrane Reviews were recognized, particularly in the UK, Canada, and Australia, substantial investment was made to try to produce reviews which were not only good quality but also relevant for different stakeholders (clinicians, consumers, policy makers, etc). While there is a wide range of literature showing that the quality of Cochrane Reviews is consistently better on average than that of other systematic reviews (9–15), there is less evidence about the relevance and ability of Cochrane Reviews to meet the needs of the different stakeholders. In fact, some recent papers have raised issues about potential limits of Cochrane Reviews (16–18). This paper reviews the experience of one of the Cochrane Review Groups, the Cochrane Drugs and Alcohol Group (CDAG) in producing evidence to guide policy and practice and to inform the research agenda. For this purpose, we analyzed the contribution of the systematic reviews published by the CDAG as of 31 July 2013, exploring the scope of the group, coverage of topics, body of research reviewed, and the implications for practice and for research of the findings of the reviews.

Methods The CDAG, as part of The Cochrane Collaboration, aims to produce, update, and disseminate systematic reviews of research on the prevention, treatment, and rehabilitation of problematic drug and alcohol use. In January 1997, more than 50 researchers from all over the world convened in Rome to explore the possibility of establishing a Cochrane Review Group in this area (19). They were among the highest scientific authorities in the field of addiction. There was a full recognition of the gap between evidence and practice, and the need to conduct, maintain, and disseminate systematic reviews to address the overwhelming role of ideology in informing practice. A year later, in 1998, the CDAG was registered formally with The Cochrane Collaboration. At that time, there was little knowledge of the amount of randomized evidence in the area. The editorial base was established, and remains, in Rome, Italy and, at present, is composed of a co-ordinator, a managing editor, a trial search co-ordinator, and a quality advisor. There are nine editors, in different part of the world (Australia, China, Italy, UK, and USA). Further information is available at www.cdag.cochrane.org. The systematic reviews published by CDAG are based primarily on randomized trials and quasi-randomized trials that investigate an active intervention (including prevention, treatment, and rehabilitation) aimed at reducing the potential for harm or the actual harm directly related to the use of different dependence-producing substances. The inclusion of other study designs is considered in limited circumstances (20), such as in reviews that consider long-term outcomes (eg, 222

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mortality), which are difficult to analyze in randomized trials because of sample size and power limitations, or in reviews on preventive interventions for which non-randomized trials often represent the only available source of evidence.

Results From 1998 to July 2013, a total of 376 authors have published with the CDAG: 233 from the European Union, 42 from Australia, 39 from North America, 38 from Asia, 11 from South America, 8 from South Africa, and 5 from the Middle East.

Topics covered by the reviews By July 2013, the CDAG has published 67 full reviews covering pharmacological and psychosocial treatments for abuse or dependence of opioid (24 reviews), alcohol (15), cocaine and other psychostimulants (11), polidrug (5), prevention (8), cannabis, benzodiazepine, inhalants, and metaqualone (1 review each). The effectiveness of preventive interventions across different substances was considered in eight reviews (Table 1). The number of protocols and reviews has steadily grown since 1999 (Fig 1), but growth has varied across different substances of abuse. In the early years, most of the reviews assessed the effectiveness of treatments for opiate dependence, while, more recently, we have published more reviews evaluating interventions for psychostimulants, alcohol, and prevention. One of the main features of Cochrane Reviews is the comprehensiveness of the search, which builds on an explicit transparent search strategy to find both published and unpublished trials (21). For this purpose, CDAG created and maintains a specialized register of trials on the evaluation of treatment effectiveness. We search systematically for studies in electronic databases (MEDLINE, EMbase, and CINAHL), conference proceedings from the main conferences in addiction, and trial registries of ongoing trials. When the CDAG was created, in 1998, there was little knowledge of the body of research available for systematic reviews in this area, with a general belief that only a few trials had been published. Actually, the body of research on the effectiveness of interventions for alcohol and drug addiction proved to be quite substantial. In July 2013, there were 8132 references in the CDAG register, with the number having increased from 3580 in 2000. As with our reviews, there have been different rates of increase for different substances. For example, relatively few trials on cocaine were published in the 1990s, but references related to cocaine dependence doubled to 916 in the year 2000. A total of 906 studies have been included in our 67 published reviews, and 91% of these studies were found in electronic databases. The remaining 9% were from

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11 0 0 0 0 0 11 1% 78 112 1 4 8 7 209 23%

152 103 122 9 87 144 598 66%

0 4 2 0 0 0 6 0.5%

0 6 0 0 0 0 6 0.5%

conference proceedings, sections or books, thesis dissertations, or unpublished trials, which were identified by looking through major conference proceedings, reference lists of retrieved studies, and by contacting the authors of included studies. Seventeen journals contributed half of the 906 studies, with the other half published in 196 different journals. The 67 reviews considered a total of 3061 trials for inclusion, of which only the afore-mentioned 906 (30%), with a total of 522,336 participants, satisfied the quality criteria for inclusion (Table 1). Although the proportion of eligible studies varies between reviews and can be attributed, in part, to the sensitivity of the search strategy for the relevant review, the proportion of studies that satisfy the criteria is low overall. Therefore, despite the considerable number of trials carried out on the treatment of addiction, our findings seem to confirm that only a few of them contribute to the cumulative knowledge on the effectiveness of interventions (22).

Internal and external validity

Other = cannabis, benzodiazepine mono dependence, metaqualone, inhalants, one review each. a

22 studies in common between two reviews

24 15 11 4 5 8 67 Opiate Alcohol Psychostimulants Other Poly drug Prevention Total adjusteda

975 657 309 82 356 704 3061

701 413 177 63 253 543 2150

274 244 132 14 103 161 906

28 37 43 17 29 23 30

44,869 38,409 12,073 1791 33,193 396,580 522,336

13 9 4 0 0 1 27 3%

20 10 3 1 8 9 49 5%

Middle East Europe Australia/ New Zealand Asia No. of participants Percentage of included studies (%) No. of included studies No. of excluded studies Total studies considered No. of reviews Substance of abuse

Table 1 Studies included and excluded in the Cochrane Reviews published by CDAG and Country of origin of included studies (The Cochrane Library, 7, 2013)

North America

South America

South Africa

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The extent to which a Cochrane Review can draw conclusions about the effects of an intervention depends on whether the data and results from the included studies are valid. However, systematic reviews should evaluate and take into account not only the internal validity (eg, the extent to which systematic errors or bias are avoided) of each trial, but also their applicability and generalizability, or external validity (eg, whether the results of a trial can be reasonably applied to a definable group of people in a particular setting in routine practice) (23). With regards to the internal validity, the proportion of trials included in our reviews with documented low risk of bias is low, but has improved over time from 14% (in the 2000) to 24% (in 2012). The main threat to external validity comes from the clinical setting, and the social and cultural context in which the studies were conducted. This is particularly true in addiction, where these contexts can have a substantial impact on the overall treatment outcome. The studies included in our reviews, as shown in Table 1, were conducted in North America (66%), Europe (23%), Australia/New Zealand (5%), Asia (3%), the Middle East (1%), South America (0.5%), and South Africa (0.5%). The distribution, however, was heterogeneous across substances of abuse. For example, studies in North America varied from 92% and 84% for psychostimulants abuse and polydrug, respectively, to 55% for opioid dependence and 42% for alcohol.

Implication for practice To measure the extent to which Cochrane Reviews in the field of drug and alcohol do provide evidence for

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Figure 1 Reviews and protocols published by year (Collaborative Review Group on Drugs and Alcohol, CDAG).

each intervention they evaluated, we considered the ‘Implications for practice” section of each review, following a similar classification to that used by the UK National Institute of Health and Clinical Excellence and the UK Cochrane Centre (24). We classified the reviews as providing sufficient evidence to implement the intervention into clinical practice (Do it), to avoid the intervention in clinical practice (Do not do it), and insufficient evidence (Only for research). Based on these criteria, for the interventions considered in the 67 reviews, 26 (41%) were classified as Do it, 10 (16%) as Do not do it, and 28 (44%) as only in research. These proportions varied according to the type of substance of abuse studied (Fig 2) and the results should be considered cautiously, because they refer only to the interventions, comparisons, and outcomes considered in the studies included in the reviews, and we are aware that the evidence presented is not thorough and definitive. Furthermore, the assessment of the methodological quality of the included studies showed relevant weaknesses in the information available to judge their quality. This is not considered in this summary of the available evidence.

Impact, dissemination strategies, and partnerships The impact factor for our Cochrane Reviews has increased each year since this was first made available. The CDAG 2012 impact factor is 5.000. This is higher than that for most important journals publishing in the same subject area: Addiction (4.746), Drug and Alcohol Dependence (3.141), and Substance Abuse (1.985).

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The CDAG reviews are being used by national and international agencies and guidelines groups to inform clinical guidelines (25–30). For instance, in 2009, the World Health Organization (WHO) published a guideline on psychosocially assisted pharmacological treatment of opioid dependence, based on the results of Cochrane Reviews summarized using the GRADE methodology (31). This guideline was one of the first by WHO to use this method, following the establishment of the WHO Guideline Review Committee after the lack of a evidence-based approach was highlighted for the existing WHO guidelines (32). The CDAG undertakes intense activity to disseminate the evidence we produce, through websites (http://www.iss.it/ ofad/; www.partecipasalute.it/), books, pamphlets, articles, and conferences (20, 33–40). We also conduct training activity, targeted to people involved in the treatment of drug addicts. The CDAG has a stable collaboration with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). In particular, the EMCDDA has developed the Best Practice Portal to increase the effectiveness of Europe’s response to drug problems. The EMCDDA Best Practice Portal is aimed at synthesizing the evidence, describing the existing projects and making available an array of evaluation instruments (http://www.emcdda.europa.eu/best-practice).

Implications for research and partnership outside The Cochrane Collaboration The aim of Cochrane Reviews is not only to provide evidence on the effects of interventions but also to identify

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Figure 2 Evidence of effectiveness of interventions considered in the CDAG reviews (The Cochrane Library, 7, 2013).

knowledge gaps. Each review contains a section on its implications for research, where further needs are identified. The identification of research gaps should be considered as the first step for research priority setting. For this purpose, the CDAG, in collaboration with the James Lind Alliance, has been supporting the EMCDDA in suggesting priorities to the Horizontal Drug Group’s Annual Dialogue on Research of the European Union. Different stakeholders have been consulted to select research priorities among the gaps identified through the Cochrane Reviews. The priorities identified reflected both the available evidence and the changes in the drug situation, such as the need for more evidence on aging cohorts of opioid users or use of new substances. Other areas of uncertainty identified are those related to the organization and management of health and social care, evidence about matching interventions with people, and a more systemic approach concerning the target population, which would lead to the inclusion of both family members and health professionals in research projects, along with drug users. Furthermore, in the vast field of psychotherapeutic interventions, a comparison is needed between the different approaches that would allow greater understanding of what is best for whom, when and in what context. Finally, more attention needs to be given to reporting social outcomes, such as criminal activity and quality of life. The gap analysis conducted by the EMCDDA should be considered as a pilot study, and further involvement with organizations conducting systematic reviews on the effects of

interventions in crime and justice, education, international development, and social welfare, such as the Campbell Collaboration, should be considered.

Future challenges The idea that people, clinicians, and decision-makers should work together to identify a shared agenda for future research was one that the late Alessandro Liberati felt passionately about. Alessandro became increasingly convinced that what clinicians and people need to know to make well informed decisions was often not provided by the research being done. He felt it was necessary to realign the research agenda to a greater extent with people’, clinicians’, and policy maker’s needs (41). As part of the Italian Cochrane network, we propose an initiative, named after Alessandro, in which The Cochrane Collaboration would make a key contribution to informing the process of establishing and updating future research agendas. The Liberati Initiative will seek to identify individuals and organizations, all over the world, which share the vision summarized in Alessandro Liberati’s final publication (41); work collaboratively to identify and prioritize the major clinical and health services questions, and identify which of these are associated with evidence supporting practice; inform the process of establishing and updating the future international and local research agendas, using evidence from Cochrane Reviews; support the users of research in identifying where there are uncertainties and

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how they can influence research priorities; and inform The Cochrane Collaboration and others preparing systematic reviews where updated, extended, or new reviews are needed. Within our Group, 26 of our 67 reviews are more than five years old but only three of these are judged relevant. In the future, we need to develop a policy that will allow us to prioritize updating of the relevant ones.

Linda Gowing (Australia), Mattew Hickman (UK), Walter Ling (USA), PierPaolo Pani (Italy), Min Zhao (China); Past Managing Editors: Annette Verster (Switzerland), Marica Ferri (Portugal); Past Trial Search Coordinator: Simona Vecchi (Italy); and Quality Advisor: Silvia Minozzi (Italy).

Discussion

1. de Alba I, Samet JH, Saitz R. Burden of medical illness in drugand alcohol dependent persons without primary care. American Journal of Addiction 2004; 13(1): 33–45. 2. Price RK, Risk NK, Murray KS, Virgo KS, Spitznagel EL. Twenty-five year mortality of us servicemen deployed in Vietnam: predictive utility of early drug use. Drug and Alcohol Dependence 2001; 64(3): 309–18. 3. Sørensen HJ, Jepsen PW, Haastrup S, Juel K. Drug-use pattern, comorbid psychosis and mortality in people with a history of opioid addiction. Acta Psychiatrica Scandinavica 2005; 111(3): 244–9. 4. Wahren CA, Brandt L, Allebeck P. Has mortality in drug addicts increased? A comparison of two hospitalized cohorts in Stockholm. International Journal of Epidemiology 1997; 26(6): 1219–26. 5. Bargagli AM, Hickman M, Davoli M, Perucci CA, Schifano P, Buster M, et al.; for the COSMO European Group. Drug related mortality and its impact on adult mortality in eight European countries. European Journal of Public Health 2006; 16(2): 198–202. 6. Ettner SL, Frank RG, Kessler RC. The impact of psychiatric disorder on labor market outcomes. Industrial and Labor Relations Review 1997; 51(1): 64–81. 7. Romelsjo A, Stenbacka M, Lundberg M, Upmark M. A population study of the association between hospitalization for alcoholism among employees in different socio-economic classes and the risk of mobility out of, or within, the workforce. European Journal of Public Health 2004; 14(1): 53–57. 8. Rehm J, Gnam W, Popova S, Baliunas D, Brochu S, Fischer B, et al. The costs of alcohol, illegal drugs, and tobacco in Canada. Journal of Studies on Alcohol and Drugs 2007; 68(6): 886–95. 9. Delaney A, Bagshaw SM, Ferland A, Laupland K, Manns B, Doig C. The quality of reports of critical care meta-analyses in the Cochrane Database of Systematic Reviews: an independent appraisal. Critical Care Medicine 2007; 35(2): 589–94. 10. Jadad AR, Moher M, Browman GP, Booker L, Sigouin C, Fuentes M, et al. Systematic reviews and meta-analyses on treatment of asthma: critical evaluation. British Medical Journal 2000; 320(7234): 537–40. 11. Jørgensen AW, Katja L, Maric KL, Tendal B, Faurschou A, Gøtzsche PC. Industry-supported meta-analyses compared with meta-analyses with non-profit or no support: differences in methodological quality and conclusions. BMC Medical Research Methodology 2008; 8(1): 60. 12. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG. Epidemiology and reporting characteristics of systematic reviews. PLoS Medicine 2007; 4(3): e78.

Systematic reviews published by the CDAG cover a wide range of substances and interventions, and provide evidence on the effectiveness of several interventions. However, if Cochrane Reviews are developed ‘to provide the type of information that is needed by physicians to make clinical decisions’ there is still some work to be done, at least in the way they are presented. Most reviews are too long, containing many sections, most of which describe the adherence of the review to the standardized methodology of the Collaboration. This can make their consultation too time-consuming with respect to the clinical content that is of interest to clinicians. A more user-friendly format of Cochrane Reviews should be developed to overcome this limitation. Systematic reviews could also be improved by making them more applicable in clinical practice, by developing high-impact reviews. A highimpact review is likely to generate considerable interest in the international public health community, have the potential to change policy or treatments, be frequently cited in scientific literature and be of public interest and likely to capture press coverage. In addition, guideline developing agencies should be consulted in order to prioritize new reviews on the basis of their forthcoming guidelines. The other side of the coin that should be considered is the potential role of Cochrane Reviews to inform the research agenda. There are no empirical data describing the extent to which this occurs, at least in the field of addiction. Cochrane Reviews, in fact, do underline areas of uncertainty (42), and the high proportion of trials excluded from the reviews highlights a major issue of the relevance of individual pieces of research in this field. But Cochrane Reviews should also be considered as a tool to inform the research agenda in terms of setting priorities, identifying areas of uncertainty, and promoting multicentre high-quality studies that address questions which will progress knowledge on the effectiveness of treatments and, consequently, meet the needs of people, their caregivers, and policy makers.

Acknowledgements We thank all the people who have contributed to the birth and growth of the CDAG: Past and present Editors: Robert Ali (Australia), Zhao Chengzheng (China), Fabrizio Faggiano (Italy), Michael Farrel (Australia), David Foxcroft (UK),

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