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1.  Alcohol Harm Reduction: Corporate Capture of a Key Concept 
PLoS Medicine  2014;11(12):e1001767.
Jim McCambridge and colleagues reflect on how the concept of harm reduction may be being usurped by the alcohol industry.
Please see later in the article for the Editors' Summary
doi:10.1371/journal.pmed.1001767
PMCID: PMC4260782  PMID: 25490717
2.  Alcohol assessment and feedback by email for university students: main findings from a randomised controlled trial 
The British Journal of Psychiatry  2013;203(5):334-340.
Background
Brief interventions can be efficacious in changing alcohol consumption and increasingly take advantage of the internet to reach high-risk populations such as students.
Aims
To evaluate the effectiveness of a brief online intervention, controlling for the possible effects of the research process.
Method
A three-arm parallel groups design was used to explore the magnitude of the feedback and assessment component effects. The three groups were: alcohol assessment and feedback (group 1); alcohol assessment only without feedback (group 2); and no contact, and thus neither assessment nor feedback (group 3). Outcomes were evaluated after 3 months via an invitation to participate in a brief cross-sectional lifestyle survey. The study was undertaken in two universities randomising the email addresses of all 14 910 students (the AMADEUS-1 study, trial registration: ISRCTN28328154).
Results
Overall, 52% (n = 7809) of students completed follow-up, with small differences in attrition between the three groups. For each of the two primary outcomes, there was one statistically significant difference between groups, with group 1 having 3.7% fewer risky drinkers at follow-up than group 3 (P = 0.006) and group 2 scoring 0.16 points lower than group 3 on the three alcohol consumption questions from the Alcohol Use Disorders Identification Test (AUDIT-C) (P = 0.039).
Conclusions
This study provides some evidence of population-level benefit attained through intervening with individual students.
doi:10.1192/bjp.bp.113.128660
PMCID: PMC3814613  PMID: 24072758
3.  Mechanisms of Action of Brief Alcohol Interventions Remain Largely Unknown – A Narrative Review 
A growing body of evidence has shown the efficacy of brief intervention (BI) for hazardous and harmful alcohol use in primary health care settings. Evidence for efficacy in other settings and effectiveness when implemented at larger scale are disappointing. Indeed, BI comprises varying content; exploring BI content and mechanisms of action may be a promising way to enhance efficacy and effectiveness. Medline and PsychInfo, as well as references of retrieved publications were searched for original research or review on active ingredients (components or mechanisms) of face-to-face BIs [and its subtypes, including brief advice and brief motivational interviewing (BMI)] for alcohol. Overall, BI active ingredients have been scarcely investigated, almost only within BMI, and mostly among patients in the emergency room, young adults, and US college students. This body of research has shown that personalized feedback may be an effective component; specific MI techniques showed mixed findings; decisional balance findings tended to suggest a potential detrimental effect; while change plan exercises, advice to reduce or stop drinking, presenting alternative change options, and moderation strategies are promising but need further study. Client change talk is a potential mediator of BMI effects; change in norm perceptions and enhanced discrepancy between current behavior and broader life goals and values have received preliminary support; readiness to change was only partially supported as a mediator; while enhanced awareness of drinking, perceived risks/benefits of alcohol use, alcohol treatment seeking, and self-efficacy were seldom studied and have as yet found no significant support as such. Research is obviously limited and has provided no clear and consistent evidence on the mechanisms of alcohol BI. How BI achieves the effects seen in randomized trials remains mostly unknown and should be investigated to inform the development of more effective interventions.
doi:10.3389/fpsyt.2014.00108
PMCID: PMC4143721  PMID: 25206342
brief intervention; alcohol; mechanisms; active ingredients; components; mediators; motivational interviewing
4.  Research participation effects: a skeleton in the methodological cupboard☆ 
Journal of Clinical Epidemiology  2014;67(8):845-849.
Objective
There have been concerns about impacts of various aspects of taking part in research studies for a century. The concerns have not, however, been sufficiently well conceptualized to form traditions of study capable of defining and elaborating the nature of these problems. In this article we present a new way of thinking about a set of issues attracting long-standing attention.
Study Design and Setting
We briefly review existing concepts and empirical work on well-known biases in surveys and cohort studies and propose that they are connected.
Results
We offer the construct of “research participation effects” (RPE) as a vehicle for advancing multi-disciplinary understanding of biases. Empirical studies are needed to identify conditions in which RPE may be sufficiently large to warrant modifications of study design, analytic methods, or interpretation. We consider the value of adopting a more participant-centred view of the research process as a way of thinking about these issues, which may also have benefits in relation to research methodology more broadly.
Conclusion
Researchers may too readily overlook the extent to which research studies are unusual contexts, and that people may react in unexpected ways to what we invite them to do, introducing a range of biases.
doi:10.1016/j.jclinepi.2014.03.002
PMCID: PMC4236591  PMID: 24766858
Research participation; Bias; Research methods; Hawthorne effect; Research assessment; Mixed methods; Surveys; Cohort studies
5.  The alcohol industry, charities and policy influence in the UK 
Background: Charities exist to pursue a public benefit, whereas corporations serve the interests of their shareholders. The alcohol industry uses corporate social responsibility activities to further its interests in influencing alcohol policy. Many charities also seek to influence alcohol and other policy. The aim of this study was to explore relationships between the alcohol industry and charities in the UK and whether these relationships may be used as a method of influencing alcohol policy. Methods: The charity regulator websites for England and Wales and for Scotland were the main data sources used to identify charities involved in UK alcohol policy making processes and/or funded by the alcohol industry. Results: Five charities were identified that both receive alcohol industry funding and are active in UK alcohol policy processes: Drinkaware; the Robertson Trust; British Institute of Innkeeping; Mentor UK and Addaction. The latter two are the sole remaining non-industry non-governmental members of the controversial responsibility deal alcohol network, from which all other public health interests have resigned. Conclusion: This study raises questions about the extent to which the alcohol industry is using UK charities as vehicles to further their own interests in UK alcohol policy. Mechanisms of industry influence in alcohol policy making globally is an important target for further investigations designed to assist the implementation of evidenced-based policies.
doi:10.1093/eurpub/cku076
PMCID: PMC4110957  PMID: 24913316
6.  Patient preferences and performance bias in a weight loss trial with a usual care arm☆☆☆ 
Patient Education and Counseling  2014;95(2):243-247.
Objectives
This qualitative study examines performance bias, i.e. unintended differences between groups, in the context of a weight loss trial in which a novel patient counseling program was compared to usual care in general practice.
Methods
14/381 consecutive interviewees (6 intervention group, 8 control group) within the CAMWEL (Camden Weight Loss) effectiveness trial process study were asked about their engagement with various features of the research study and a thematic content analysis undertaken.
Results
Decisions to participate were interwoven with decisions to change behavior, to the extent that for many participants the two were synonymous. The intervention group were satisfied with their allocation. The control group spoke of their disappointment at having been offered usual care when they had taken part in the trial to access new forms of help. Reactions to disappointment involved both movements toward and away from behavior change.
Conclusion
There is a prima facie case that reactions to disappointment may introduce bias, as they lead the randomized groups to differ in ways other than the intended experimental contrast.
Practice implications
In-depth qualitative studies nested within trials are needed to understand better the processes through which bias may be introduced.
doi:10.1016/j.pec.2014.01.003
PMCID: PMC3994506  PMID: 24492159
Performance bias; Weight loss; Patient preferences; Patient counseling; Behavior change; Research participation; Disappointment
7.  Adapted motivational interviewing to improve the uptake of treatment for glaucoma in Nigeria: study protocol for a randomized controlled trial 
Trials  2014;15:149.
Background
Glaucoma is a chronic eye disease associated with irreversible visual loss. In Africa, glaucoma patients often present late, with very advanced disease. One-off procedures, such as laser or surgery, are recommended in Africa because of lack of or poor adherence to medical treatment. However, acceptance of surgery is usually extremely low. To prevent blindness, adherence to treatment needs to improve, using acceptable, replicable and cost-effective interventions. After reviewing the literature and interviewing patients in Bauchi (Nigeria) motivational interviewing (MI) was selected as the intervention for this trial, with adaptation for glaucoma (MIG). MI is designed to strengthen personal motivation for, and commitment to a specific goal by eliciting and exploring a person’s reasons for change within an atmosphere of acceptance and compassion. The aim of this study is to assess whether MIG increases the uptake of laser or surgery amongst glaucoma patients where this is the recommended treatment. The hypothesis is that MIG increases the uptake of treatment. This will be the first trial of MI in Africa.
Methods
This is a hospital based, single centre, randomized controlled trial of MIG plus an information sheet on glaucoma and its treatment (the latter being “standard care”) compared with standard care alone for glaucoma patients where the treatment recommended is surgery or laser.
Those eligible for the trial are adults aged 17 years and above who live within 200 km of Bauchi with advanced glaucoma where the examining ophthalmologist recommends surgery or laser. After obtaining written informed consent, participants will be randomly allocated to MIG plus standard care, or standard care alone. Motivational interviewing will be delivered in Hausa or English by one of two MIG trained personnel. One hundred and fifty participants will be recruited to each arm. The primary outcome is the proportion of participants undergoing laser or surgery within two months of the date given to re attend for the procedure. MIG quality will be assessed using the validated MI treatment integrity scale.
Discussion
Motivational interviewing may be an important tool to increase the acceptance of treatment for glaucoma. The approach is potentially scalable and may be useful for other chronic conditions in Africa.
Trial registration
ISRCTN79330571 (Controlled-Trials.com).
doi:10.1186/1745-6215-15-149
PMCID: PMC4021714  PMID: 24773760
Glaucoma; Motivational interviewing; Africa; Blindness; Treatment adherence; Randomized clinical trial
8.  The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials 
Trials  2014;15:101.
Background
The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India.
Methods/design
This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat.
Discussion
These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors.
Trial registration
Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238).
doi:10.1186/1745-6215-15-101
PMCID: PMC4230277  PMID: 24690184
Alcohol use disorders; Depression; Low- and middle-income countries; Non-specialist health workers; Psychological treatments
9.  In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials☆ 
Journal of Clinical Epidemiology  2014;67(3):247-253.
Objectives
Behavioral intervention trials may be susceptible to poorly understood forms of bias stemming from research participation. This article considers how assessment and other prerandomization research activities may introduce bias that is not fully prevented by randomization.
Study Design and Setting
This is a hypothesis-generating discussion article.
Results
An additivity assumption underlying conventional thinking in trial design and analysis is problematic in behavioral intervention trials. Postrandomization sources of bias are somewhat better known within the clinical epidemiological and trials literatures. Neglect of attention to possible research participation effects means that unintended participant behavior change stemming from artifacts of the research process has unknown potential to bias estimates of behavioral intervention effects.
Conclusion
Studies are needed to evaluate how research participation effects are introduced, and we make suggestions for how research in this area may be taken forward, including how these issues may be addressed in the design and conduct of trials. It is proposed that attention to possible research participation effects can improve the design of trials evaluating behavioral and other interventions and inform the interpretation of existing evidence.
doi:10.1016/j.jclinepi.2013.09.004
PMCID: PMC3969092  PMID: 24314401
Behavior; Trials; Bias; Research participation; Intervention; Hawthorne effect
10.  Systematic review of the Hawthorne effect: New concepts are needed to study research participation effects☆ 
Journal of Clinical Epidemiology  2014;67(3):267-277.
Objectives
This study aims to (1) elucidate whether the Hawthorne effect exists, (2) explore under what conditions, and (3) estimate the size of any such effect.
Study Design and Setting
This systematic review summarizes and evaluates the strength of available evidence on the Hawthorne effect. An inclusive definition of any form of research artifact on behavior using this label, and without cointerventions, was adopted.
Results
Nineteen purposively designed studies were included, providing quantitative data on the size of the effect in eight randomized controlled trials, five quasiexperimental studies, and six observational evaluations of reporting on one's behavior by answering questions or being directly observed and being aware of being studied. Although all but one study was undertaken within health sciences, study methods, contexts, and findings were highly heterogeneous. Most studies reported some evidence of an effect, although significant biases are judged likely because of the complexity of the evaluation object.
Conclusion
Consequences of research participation for behaviors being investigated do exist, although little can be securely known about the conditions under which they operate, their mechanisms of effects, or their magnitudes. New concepts are needed to guide empirical studies.
doi:10.1016/j.jclinepi.2013.08.015
PMCID: PMC3969247  PMID: 24275499
Hawthorne effect; Reactivity; Observation; Research methods; Research participation; Assessment
11.  Regression to the mean and alcohol consumption: A cohort study exploring implications for the interpretation of change in control groups in brief intervention trials☆ 
Drug and Alcohol Dependence  2014;135(100):156-159.
Background
Reductions in drinking among individuals randomised to control groups in brief alcohol intervention trials are common and suggest that asking study participants about their drinking may itself cause them to reduce their consumption. We sought to test the hypothesis that the statistical artefact regression to the mean (RTM) explains part of the reduction in such studies.
Methods
967 participants in a cohort study of alcohol consumption in New Zealand provided data at baseline and again six months later. We use graphical methods and apply thresholds of 8, 12, 16 and 20 in AUDIT scores to explore RTM.
Results
There was a negative association between baseline AUDIT scores and change in AUDIT scores from baseline to six months, which in the absence of bias and confounding, is RTM. Students with lower baseline scores tended to have higher follow-up scores and conversely, those with higher baseline scores tended to have lower follow-up scores. When a threshold score of 8 was used to select a subgroup, the observed mean change was approximately half of that observed without a threshold. The application of higher thresholds produced greater apparent reductions in alcohol consumption.
Conclusions
Part of the reduction seen in the control groups of brief alcohol intervention trials is likely to be due to RTM and the amount of change is likely to be greater as the threshold for entry to the trial increases. Quantification of RTM warrants further study and should assist understanding assessment and other research participation effects.
doi:10.1016/j.drugalcdep.2013.11.017
PMCID: PMC3929002  PMID: 24342421
Regression to the mean; Brief intervention; Alcohol; Student; Research participation
12.  Exploratory randomized controlled trial evaluating the impact of a waiting list control design 
Background
Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates. This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers, one domain of research in which waiting list control designs are used.
Methods
All participants (N = 185) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime.
Results
A total of 157 participants (85%) were followed-up after 4 weeks. Between-group differences were found in one of four outcomes (proportion within safe drinking guidelines). An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list.
Conclusions
Trials with waiting list control conditions may overestimate treatment effects, though the extent of any such bias appears likely to vary between study populations. Arguably they should only be used where this threat to valid inference has been carefully assessed.
doi:10.1186/1471-2288-13-150
PMCID: PMC4029562  PMID: 24314204
Randomized controlled trials; Research methods; Waiting list control design; Alternate explanation; Alcohol; Brief intervention
13.  The explanatory models and coping strategies for alcohol use disorders: An exploratory qualitative study from India☆ 
Asian Journal of Psychiatry  2013;6(6):521-527.
Purpose
The explanatory models (EM) and coping strategies for mental health problems influence treatment seeking and the subsequent patient journey. The goal of this study was to explore the EMs and coping strategies for alcohol use disorders (AUD).
Methods
We conducted semi structured interviews with 29 men with AUD and 10 significant others (SO) in two sites in India. Thematic analysis was used to analyse data.
Results
The former were predominantly married, literate and employed; the latter were predominantly wives, literate and employed. Alcohol consumption and AUDs are seen to be mainly associated with psychosocial stress, with other factors being peer influences, availability of disposable income and drinking for pleasure. They are perceived to result in a range of adverse impacts on social life, family life, personal health and family finances. Various coping strategies were deployed by men with AUD and their significant others, for example avoidance, substitution, distraction, religious activities, support from AA/friends/family, restricting means to buy alcohol and anger management. Reduction/cessation in drinking, improved family relationships, improved emotional/physical wellbeing and better occupational functioning were the most desired treatment outcomes.
Conclusion
There are considerable similarities, as well as some key differences, observed between the EMs for AUD in India and those reported from other cultures which have implications for the global applicability and contextual adaptations of evidence based interventions for AUD.
doi:10.1016/j.ajp.2013.06.010
PMCID: PMC3878642  PMID: 24309865
Explanatory model; Coping strategy; Alcohol use disorder; India
14.  Alcohol assessment & feedback by e-mail for university student hazardous and harmful drinkers: study protocol for the AMADEUS-2 randomised controlled trial 
BMC Public Health  2013;13:949.
Background
Alcohol is responsible for a large and growing proportion of the global burden of disease, as well as being the cause of social problems. Brief interventions are one component of comprehensive policy measures necessary to reduce these harms. Brief interventions increasingly take advantage of the Internet to reach large numbers of high risk groups such as students. The research literature on the efficacy and effectiveness of online interventions is developing rapidly. Although many studies show benefits in the form of reduced consumption, other intervention studies show no effects, for reasons that are unclear. Sweden became the first country in the world to implement a national system in which all university students are offered a brief online intervention via an e-mail.
Methods/Design
This randomized controlled trial (RCT) aims to evaluate the effectiveness of this national system comprising a brief online intervention among university students who are hazardous and harmful drinkers. This study employs a conventional RCT design in which screening to determine eligibility precedes random allocation to immediate or delayed access to online intervention. The online intervention evaluated comprises three main components; assessment, normative feedback and advice on reducing drinking. Screening is confined to a single question in order to minimise assessment reactivity and to prevent contamination. Outcomes will be evaluated after 2 months, with total weekly alcohol consumption being the primary outcome measure. Invitations to participate are provided by e-mail to approximately 55,000 students in 9 Swedish universities.
Discussion
This RCT evaluates routine service provision in Swedish universities via a delay in offer of intervention to the control group. It evaluates effects in the key population for whom this intervention has been designed. Study findings will inform the further development of the national service provision.
Trial registration
ISRCTN02335307.
doi:10.1186/1471-2458-13-949
PMCID: PMC4029223  PMID: 24456668
15.  Attrition Revisited: Adherence and Retention in a Web-Based Alcohol Trial 
Background
Attrition is a noted feature of eHealth interventions and trials. In 2005, Eysenbach published a landmark paper calling for a “science of attrition,” suggesting that the 2 forms of attrition—nonusage attrition (low adherence to the intervention) and dropout attrition (poor retention to follow-up)—may be related and that this potential relationship deserved further study.
Objective
The aim of this paper was to use data from an online alcohol trial to explore Eysenbach’s hypothesis, and to answer 3 research questions: (1) Are adherence and retention related? If so, how, and under which circumstances? (2) Do adherence and retention have similar predictors? Can these predictors adequately explain any relationship between adherence and retention or are there additional, unmeasured predictors impacting on the relationship? (3) If there are additional unmeasured predictors impacting on the relationship, are there data to support Eysenbach’s hypothesis that these are related to overall levels of interest?
Methods
Secondary analysis of data from an online trial of an online intervention to reduce alcohol consumption among heavy drinkers. The 2 outcomes were adherence to the intervention measured by number of log-ins, and retention to the trial measured by provision of follow-up data at 3 months (the primary outcome point). Dependent variables were demographic and alcohol-related data collected at baseline. Predictors of adherence and retention were modeled using logistic regression models.
Results
Data were available on 7932 participants. Adherence and retention were related in a complex fashion. Participants in the intervention group were more likely than those in the control group to log in more than once (42% vs 28%, P<.001) and less likely than those in the control group to respond at 3 months (40% vs 49%, P<.001). Within each randomized group, participants who logged in more frequently were more likely to respond than those who logged in less frequently. Response rates in the intervention group for those who logged in once, twice, or ≥3 times were 34%, 46%, and 51%, respectively (P<.001); response rates in the control group for those who logged in once, twice, or ≥3 times were 44%, 60%, and 67%, respectively (P<.001). Relationships between baseline characteristics and adherence and retention were also complex. Where demographic characteristics predicted adherence, they tended also to predict retention. However, characteristics related to alcohol consumption and intention or confidence in reducing alcohol consumption tended to have opposite effects on adherence and retention, with factors that predicted improved adherence tending to predict reduced retention. The complexity of these relationships suggested the existence of an unmeasured confounder.
Conclusions
In this dataset, adherence and retention were related in a complex fashion. We propose a possible explanatory model for these data.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/6IEmNnlCn).
doi:10.2196/jmir.2336
PMCID: PMC3815435  PMID: 23996958
Internet; eHealth; attrition; adherence; retention; follow-up
16.  Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial 
Background
Non-adherence to HIV-treatment can have a negative impact on patients’ treatment success rates, quality of life, infectiousness, and life expectancy. Few adherence interventions have shown positive effects on adherence and/or virologic outcomes. The theory- and evidence-based Adherence Improving self-Management Strategy (AIMS) is an intervention that has been demonstrated to improve adherence and viral suppression rates in a randomised controlled trial. However, evidence of its cost-effectiveness is lacking. Following a recent review suggesting that cost-effectiveness evaluations of adherence interventions for chronic diseases are rare, and that the methodology of such evaluations is poorly described in the literature, this manuscript presents the study protocol for a multi-centre trial evaluating the effectiveness and cost-effectiveness of AIMS among a heterogeneous sample of patients.
Methods/design
The study uses a multi-centre randomised controlled trial design to compare the AIMS intervention to usual care from a societal perspective. Embedded in this RCT is a trial-based and model-based economic evaluation. A planned number of 230 HIV-infected patients are randomised to receive either AIMS or usual care. The relevant outcomes include changes in adherence, plasma viral load, quality of life, and societal costs. The time horizon for the trial-based economic evaluation is 12–15 months. Costs and effects are extrapolated to a lifetime horizon for the model-based economic evaluation.
Discussion
The present multicentre RCT is designed to provide sound methodological evidence regarding the effectiveness and cost-effectiveness of a nurse-based counselling intervention (AIMS) to support treatment adherence among a large and heterogeneous sample of HIV-infected patients in the Netherlands. The objective of the current paper is to describe the trial protocol in sufficient detail to allow full evaluation of the quality of the study design. It is anticipated that, if proven cost-effective, AIMS can contribute to improved evidence-based counselling guidelines for HIV-nurses and other health care professionals.
Trial registration
The study has been registered on clinicaltrials.gov (Identifier: NCT01429142).
doi:10.1186/1472-6963-13-274
PMCID: PMC3717053  PMID: 24059292
Adherence; AIMS; Economic evaluation; HIV; Intervention; Randomised controlled trial
17.  Industry Use of Evidence to Influence Alcohol Policy: A Case Study of Submissions to the 2008 Scottish Government Consultation 
PLoS Medicine  2013;10(4):e1001431.
Jim McCambridge and colleagues analyze industry submissions to a Scottish Government consultation on whole-population approaches to alcohol policy.
doi:10.1371/journal.pmed.1001431
PMCID: PMC3635861  PMID: 23630458
18.  Prevalence and Patterns of Hazardous and Harmful Alcohol Consumption Assessed Using the AUDIT among Bhutanese Refugees in Nepal 
Aims: This study sought to ascertain the prevalence of hazardous and harmful alcohol consumption among Bhutanese refugees in Nepal and to identify predictors of elevated risk in order to better understand intervention need. Methods: Hazardous and harmful alcohol consumption was assessed using the Alcohol Use Disorder Identification Test (AUDIT) administered in a face-to-face interview in a census of two camps comprising ∼8000 refugees. Results: Approximately 1/5 men and 1/14 women drank alcohol and prevalence of hazardous drinking among current drinkers was high and comparable to that seen in Western countries with longstanding alcohol cultures. Harmful drinking was particularly associated with the use of other substances including tobacco. Conclusions: Assessment of the alcohol-related needs of Bhutanese refugees has permitted the design of interventions. This study adds to the small international literature on substance use in forced migration populations, about which there is growing concern.
doi:10.1093/alcalc/agt009
PMCID: PMC3633362  PMID: 23443987
19.  Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial 
BMC Public Health  2013;13:152.
Background
There is strong evidence to support the effectiveness of Brief Intervention (BI) in reducing alcohol consumption in primary healthcare.
Methods and design
This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older) will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours) on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT) administered by telephone.
Discussion
The UK Department of Health’s stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design.
Trial registration
Current Controlled Trials ISRCTN95216873
doi:10.1186/1471-2458-13-152
PMCID: PMC3583737  PMID: 23419053
Alcohol; Brief intervention; Community pharmacist; Community pharmacy; Hazardous and harmful drinking
20.  Effectiveness of a Self-Guided Web-Based Cannabis Treatment Program: Randomized Controlled Trial 
Background
Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems.
Objectives
The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully self-guided web-based treatment program for cannabis use disorder consisting of 6 modules based on cognitive, motivational, and behavioral principles.
Methods
225 individuals who wanted to cease or reduce their cannabis use were recruited using both online and offline advertising methods and were randomly assigned to receive: (1) the web-based intervention, or (2) a control condition consisting of 6 modules of web-based educational information on cannabis. Assessments of cannabis use, dependence symptoms, and abuse symptoms were conducted through online questionnaires at baseline, and at 6-week and 3-month follow-ups. Two sets of data analyses were undertaken—complier average causal effect (CACE) modeling and intention to treat (ITT).
Results
Two thirds (149) of the participants completed the 6-week postintervention assessment, while 122 (54%) completed the 3-month follow-up assessment. Participants in the intervention group completed an average of 3.5 of the 6 modules. The CACE analysis revealed that at 6 weeks, the experimental group reported significantly fewer days of cannabis use during the past month (P=.02), significantly lower past-month quantity of cannabis use (P=.01), and significantly fewer symptoms of cannabis abuse (P=.047) relative to controls. Cannabis dependence symptoms (number and severity) and past-month abstinence did not differ significantly between groups (Ps>.05). Findings at 3 months were similar, except that the experimental group reported significantly fewer and less severe cannabis dependence symptoms (Ps<.05), and past-month quantity of cannabis consumed no longer differed significantly between groups (P=.16). ITT analyses yielded similar outcomes.
Conclusion
Findings suggest that web-based interventions may be an effective means of treating uncomplicated cannabis use and related problems and reducing the public health burden of cannabis use disorders.
Trial registration
ACTRN12609000856213, Australian New Zealand Clinical Trials Registry.
doi:10.2196/jmir.2256
PMCID: PMC3636012  PMID: 23470329
marijuana; Internet intervention; computer-assisted therapy; addiction; randomized controlled trial
21.  Post-treatment Stage of Change Predicts 12-month Outcome of Treatment for Alcohol Problems 
Aims: To evaluate relationships between clients' self-reported ‘stage of change’ and outcomes after treatment for alcohol problems. Methods: Using data from the ‘United Kingdom Alcohol Treatment Trial’, clients who had received at least one session of treatment and who had complete data (n = 392) entered the analysis. Two continuous measures of drinking behaviour (% days abstinent (PDA) and drinks per drinking day (DDD)) and categorical outcomes at the 12-month follow-up were compared between clients in Pre-action and Action stages of change at either pre- or post-treatment assessment. Multiple and logistic regression analyses examined the relationships between stage of change and treatment outcomes, evaluating the strength of these relationships by controlling for likely confounders. Results: Pre-treatment stage of change did not predict outcome but post-treatment stage of change predicted PDA and DDD at the 12-month follow-up. In unadjusted and adjusted analyses, clients in Action at post-treatment were two to three times more likely to show a favourable categorical outcome, variously defined, than those in Pre-action. There were no differences between clients who had received Motivational Enhancement Therapy and those who had received Social Behaviour and Network Therapy in proportions maintaining or moving towards Action from before to after treatment. Conclusions: These findings confirm previous reports that motivational variables predict outcome of treatment but add that such a relationship is seen for post-treatment stage of change. For therapists, it would seem important to monitor the client's stage of change—which in good clinical practice often occurs in informal ways—and have strategies to deal with low motivation to change whenever it occurs throughout treatment. The findings are also consistent with a ‘common factors’ perspective on effective treatment for alcohol problems.
doi:10.1093/alcalc/agt006
PMCID: PMC3633361  PMID: 23408241
22.  The hospital outpatient alcohol project (HOAP): protocol for an individually randomized, parallel-group superiority trial of electronic alcohol screening and brief intervention versus screening alone for unhealthy alcohol use 
Background
Electronic screening and brief intervention (e-SBI) is a promising alternative to screening and brief intervention by health-care providers, but its efficacy in the hospital outpatient setting, which serves a large proportion of the population, has not been established. The aim of this study is to estimate the effect of e-SBI in hospital outpatients with hazardous or harmful drinking.
Methods/Design
This randomized controlled trial will be conducted in the outpatient department of a large tertiary referral hospital in Newcastle (population 540,000), Australia. Some 772 adults with appointments at a broad range of medical and surgical outpatient clinics who score 5–9 inclusive on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) subscale will be randomly assigned in a 1:1 ratio to electronic alcohol screening alone (control) or to e-SBI. As randomization will be effected by computer, researchers and participants (who will be invited to participate in a study of alcohol use over time) will be blinded to group assignment. The primary analysis will be based on the intention-to-treat principle and compare weekly volume (grams of alcohol) and the full AUDIT score with a six-month reference period between the groups six months post randomization. Secondary outcomes, assessed six and 12 months after randomization, will include drinking frequency, typical occasion quantity, proportion who report binge drinking, proportion who report heavy drinking, and health-care utilization.
Discussion
If e-SBI is efficacious in outpatient settings, it offers the prospect of systematically and sustainably reaching a large number of hazardous and harmful drinkers, many of whom do not otherwise seek or receive help.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12612000905864.
doi:10.1186/1940-0640-8-14
PMCID: PMC3766680  PMID: 24004498
Alcohol; Screening; Brief intervention; Internet; Intervention; Clinical trials; Hospital outpatients

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