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.During the conduct of this research, John Cunningham was supported as the Canada Research Chair on Brief Interventions for Addictive Behaviours. Kypros Kypri is supported by a National Health & Medical Research Council Senior Research Fellowship (APP1041867) and a Senior Brawn Fellowship from the University of Newcastle Jim McCambridge is supported by a Wellcome Trust Research Career Development fellowship in Basic Biomedical Science (WT086516MA)

Symposium - How effective are brief motivational interviewing interventions : Are they necessary? Do they require enhancement? Can they be translated into routine clinical practice? [Conference Abstract]

Brief interventions are effective for problem drinking and reductions are known to occur in association with screening and assessment. Design and methods: This study aimed to determine how much change occurred between baseline assessment and a one-session brief intervention (S1), and the predictors of early change among adults with comorbid depression and alcohol misuse (n=202) participating in a clinical trial. The primary focus was on changes in Beck Depression Inventory fastscreen scores and alcohol consumption (standard drinks per week) prior to random allocation to nine further sessions addressing either depression, alcohol, or both problems. Results: There were large and clinically significant reductions between baseline and S1, with the strongest predictors being baseline scores in the relevant domain and change in the other domain. Client engagement was also predictive of early depression changes. Discussion and Conclusion: Monitoring progress in both domains from first contact, and provision of empathic care, followed by brief intervention appear to be useful for this high prevalence comorbidity..

Tertiary student hazardous drinking : epidemiology and development of a brief intervention trial

The misuse of alcohol is one of New Zealand's major social and health concerns. The cost of alcohol misuse, after adjustment for the economic benefits of consumption, was estimated at $16.1 billion in 1990,4% of gross domestic product. Young people (aged 15-24 years) account for a disproportionate amount of this burden, suffering high rates of alcohol-involved road traffic injuries, drownings, falls, assaults, and suicide. In recent time, the access of young people to alcohol in New Zealand has greatly increased, with liberalisation of the Sale of Liquor Act in 1989, removal of restrictions on the advertising of alcohol in the early 1990s, and a reduction in the minimum purchase age in 1999. Furthermore, the real price of alcohol is at its lowest in over 20 years. There is no sign in the current political climate of an impending shift to greater alcohol control. Consequently, there is a need for prevention approaches outside the legislative arena that are deliverable to many. There is now compelling evidence that brief intervention (BI), consisting of assessment and feedback or advice given by a health professional, can reduce alcohol consumption and related harm. There is, however, little research on the application of BI to young people. The aims of this research were to develop a BI that is acceptable to young people and to evaluate its efficacy in reducing hazardous drinking. Tertiary students, who comprise 31% of people in the 18-22 years age group, were the population. Research was conducted in 3 phases: (i) determination of the prevalence and risk factors for hazardous drinking, (ii) development of an intervention including assessments of its acceptability to the target population, and the feasibility of its implementation in a "real-world" setting, and (iii) a randomised controlled trial of the intervention. The prevalence of hazardous drinking was found to be very high in a sample of 1,480 students, with 60% of males and 58% of females typically exceeding recommended upper limits. Alcohol-related problems were also common. For example, 37% of males and 33% of females reported alcohol-related memory loss. In a cohort of 967 students, hazardous drinking was found to be highly persistent over time. Focus group studies conducted with students, suggested that practitioner-delivered brief intervention would be unacceptable to most hazardous drinkers. Many expressed concerns about being judged, and reservations about discussing their drinking with a health professional, unless the discussion was self-initiated. Focus groups suggested that a computerised approach to assessment and feedback might be more acceptable. Electronic Screening and Brief Intervention (ESBI) was developed and was found to be appealing to students and implementable at the Student Health Service. ESBI consists of a series of web pages including a screening questionnaire, an assessment, and personalised, motivational feedback. In a randomised, controlled trial, ESBI was found to produce significant reductions in hazardous drinking at 6 weeks and 6 months. The mean effect size of 0.37, falls within the range of estimates in meta-analytic reviews of practitioner-delivered BI. Given its efficacy, its acceptability, and the ease with which ESBI can be implemented, this approach has the potential to become a useful tool in the prevention of alcohol-related harm among young people

Research participation effects: a skeleton in the methodological cupboard.

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

Be aware of drinkaware

In 2006, Drinkaware was established as a charity in the United Kingdom following a memorandum of understanding between the Portman Group and various UK government agencies. This debate piece briefly reviews the international literature on industry social aspects organizations, examines the nature of Drinkaware\u27s activities and considers how the public health community should respond. Although the British addiction field and the wider public health community have distanced themselves from the Portman Group, they have not done so from Drinkaware, even though Drinkaware was devised by the Portman Group to serve industry interests. Both long-standing and more recent developments indicate very high levels of industry influence on British alcohol policy, and Drinkaware provides one mechanism of influence. We suggest that working with, and for, industry bodies such as Drinkaware helps disguise fundamental conflicts of interest and serves only to legitimize corporate efforts to promote partnership as a means of averting evidence-based alcohol policies. We invite vigorous debate on these internationally significant issues and propose that similar industry bodies should be carefully studied in other countries

Alcohol involvement in aggression between intimate partners in New Zealand: a national cross-sectional study

Objectives: To examine the role of alcohol at the time of aggressive incidents between intimate partners in the general population by gender, by estimating (1) prevalence and severity of aggression, and drinking at the time, (2) associations of drinking at the time of the aggression with reported severity, anger and fear, and (3) association of usual drinking patterns with partner aggression. Design: A national survey of 18-70-year-olds using an electoral roll sample obtained self-reported alcohol consumption, partner’s alcohol consumption and details of the most severe partner aggression by the respondent and towards the respondent in the past 2 years. The mean scores for associated severity, anger and fear were analysed by gender and alcohol involvement. Multinomial models estimated associations of drinking patterns with aggression to and from the respondent. Results: The response rate was 49% (n=1925). Men and women reported similar prevalence of victimisation and perpetration of aggression (11-15%). Alcohol was involved in more than 25% of incidents, and reported more by women than by men, particularly male-only drinking when the respondent was the victim. Women reported greater severity, anger and fear with victimisation than men, and drinking was associated with greater reported severity. Heavy episodic drinking by respondents was associated with a threefold increase in victimisation and doubling of perpetration of aggression involving alcohol. Heavy episodic drinking by either partner was also associated with drinking being involved in reported aggression. Conclusions: The experience of intimate-partner aggression in a cross-section of households differs by gender and the involvement of alcohol, and ‘counts’ of aggressive acts in a population-based survey do not reflect the reality of gender differences. Heavy episodic drinking patterns are associated with more aggression involving alcohol within relationships, and alcohol involvement is associated with increased severity

Effects of study design and allocation on self-reported alcohol consumption: randomized trial.

BACKGROUND: What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group. METHODS: Students from four universities (N = 72,903) were invited to participate in a 'research project on student drinking'. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A ('cohort') were informed their drinking would be assessed at baseline and again in one month. Group B ('control') were told the study was an intervention trial and they were in the control group. Group C ('intervention') were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed. RESULTS: In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, 'intervention' < 'control'). The 'cohort' and 'control' groups accessed the material to a similar extent (59% versus 57%) while the 'intervention' group were more likely to access it (78%) and to read it for longer (median 35 s (25th and 75th percentiles: 6, 97) versus medians of 7 s (0, 28) and 8 s (4, 42) for the 'cohort' and 'control' groups, respectively). CONCLUSIONS: Although the context given to the research participants significantly influenced access to the online information and reading time, this did not translate into any effect on drinking behaviour, for either hypothesis. This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000846022

"Using information to shape perception": tobacco industry documents study of the evolution of Corporate Affairs in the Miller Brewing Company

Background The Miller Brewing Company (MBC) was wholly owned by Phillip Morris (PM), between 1970 and 2002. Tobacco industry document studies identify alliances between the alcohol and tobacco industries to counter U.S. policies in the 1980s and 1990s. This investigation sought to study in-depth inter-relationships between MBC and PM, with a particular focus on alcohol policy issues. We used the Truth Tobacco Industry Documents library to trace the evolution of corporate affairs and related alcohol policy orientated functions within and between MBC and PM. Results MBC was structured and led by PM senior executives from soon after takeover in 1970. Corporate Affairs sought to influence public perceptions of alcohol to align them with business interests. Alcohol education was specifically designed to prevent the adoption of policies inimical to those interests (e.g., raising excise taxes). Strategic consideration of alcohol policy issues was integrated within company-wide thinking, which sought to apply lessons from tobacco to alcohol and vice versa. PM directly led key alcohol industry organisations nationally and globally, which have successfully delayed the adoption and implementation of known effective policy measures in the U.S. and worldwide. Conclusions PM has been a key architect of alcohol industry political strategies. This study builds on earlier work on alcohol companies in the tobacco documents, and offers historical data on how tobacco companies have used commercial involvements in other sectors to influence wider public health policy. We are only beginning to appreciate how multi-sectoral companies internally develop political strategies across product categories. Global health and national governmental policy-making needs to be better protected from business interests that fundamentally conflict with public health goals

Effects of study design and allocation on self-reported alcohol consumption: randomized trial

Abstract Background What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group. Methods Students from four universities (N = 72,903) were invited to participate in a ‘research project on student drinking’. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A (‘cohort’) were informed their drinking would be assessed at baseline and again in one month. Group B (‘control’) were told the study was an intervention trial and they were in the control group. Group C (‘intervention’) were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed. Results In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, ‘intervention’ < ‘control’). The ‘cohort’ and ‘control’ groups accessed the material to a similar extent (59% versus 57%) while the ‘intervention’ group were more likely to access it (78%) and to read it for longer (median 35 s (25th and 75th percentiles: 6, 97) versus medians of 7 s (0, 28) and 8 s (4, 42) for the ‘cohort’ and ‘control’ groups, respectively). Conclusions Although the context given to the research participants significantly influenced access to the online information and reading time, this did not translate into any effect on drinking behaviour, for either hypothesis. This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach. Trial registration Australian New Zealand Clinical Trials Registry ACTRN1261000084602

Effects of study design and allocation on participant behaviour-ESDA: study protocol for a randomized controlled trial

Background: What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. Methods/Design: A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. Discussion: The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation