Search

Background: Indirect evidence suggests that using waiting list control designs in behavioural research may have unintended consequences. The aim of this study was to estimate the effects of a waiting list design on alcohol consumption among individuals who had looked online for help., Methods: A two-arm randomised controlled trial was employed. The intervention group was informed that they belonged to the intervention group and would receive immediate access to a digital alcohol intervention. The waiting list control group was informed that they belonged to the group that had to wait four weeks to be given access to the intervention and in the meantime, they would be given a summary of their drinking. However, both groups received immediate access to the same digital alcohol intervention; the experimental contrast was thus between being told to wait or not., Results: We randomised 3388 participants (intervention: 1692, waiting list: 1696). Data were available for 954 participants at 1-month follow-up. We found no strong evidence that alcohol consumption differed between groups, but the evidence pointed towards the intervention group reporting lowering weekly alcohol consumption compared to the waiting list control group (IRR = 0.95, 95 % CI = 0.83; 1.08, probability of effect = 78.8 %)., Conclusion: We found no strong evidence that being informed that access to an intervention would be delayed produced differential self-reported alcohol consumption compared to being informed that access would be immediate. We did find a difference in engagement with the intervention materials, indicating that the experimental manipulation was successful., Competing Interests: Declaration of Competing Interest MB owns a private company (Alexit AB) that maintains and distributes evidence-based lifestyle interventions to be used by the public and in health care settings. Alexit AB played no role in developing the intervention, study design, data analysis, data interpretation, or writing of this report. KUG, MH, JM declare no competing interests., (Copyright © 2024. Published by Elsevier B.V.)

Background: To evaluate the effects of booster and no booster versions of web-based alcohol Personalised Normative Feedback (PNF) and whether descriptive norms mediated and/or participant motivation moderated the effectiveness of the intervention in real world conditions (i.e. no financial incentives)., Methods: Pragmatic randomised controlled trial with 1-, 3-, and 6-month assessments. Brazilian college students reporting alcohol use in the last 12 months (N=931) were recruited from May/2020 to December/2022 and allocated to 1) No booster/single PNF(S-PNF); 2) Booster/multiple PNF(M-PNF); or 3) Assessment-only control. We applied Helmert coding [1: Any intervention (S-PNF or M-PNF) vs. Control; and 2: S-PNF vs. M-PNF]., Primary Outcomes: typical number of drinks/week and maximum number of drinks/week; secondary outcomes: drinking frequency and number of consequences. Three-months assessment was the primary interval. Descriptive norms were tested as mediator. Interest, importance, and readiness to change were examined as moderators., Results: Compared to control, any intervention did not influence primary outcomes at 3-months or 6-months, but did at 1-month, when reduced typical drinking (IRR:0.77, 95%CI:0.66;0.90) and maximum number of drinks (IRR:0.69, 95%CI:0.58;0.82). There was an intervention effect on the consequences at 3-months. No differences were observed between S-PNF and M-PNF. No mediation effects were found at 3-months. At 6-months, there was an indirect effect on typical drinking through norms at 3-months (b=-0.82, 95%CI:-2.03;-0.12) and effects on maximum drinks through norms at 1-month (b=-0.54, 95%CI:-1.65;-0.02). No support for moderation was found., Conclusions: Intervention reduced alcohol drinking at 1 month only and was not effective thereafter. Mechanisms of effect remain unclear., Competing Interests: Declaration of Competing Interest We have no conflicts of interest to disclose., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Digital alcohol interventions have been shown to exert effects in helping individuals reduce their drinking. However, little is known about the mechanisms which mediate such effects. The objective of this study was to estimate natural direct and indirect effects of a digital alcohol intervention., Methods: This secondary analysis of mediated effects used data from a randomised controlled trial which included individuals with unhealthy alcohol use with access to a mobile phone aged 18 years or older in Sweden. The comparator was basic alcohol and health information. The digital intervention was centrally designed around weekly monitoring of consumption followed by feedback and tools to support behaviour change. Mediated effects were estimated using measures from 1-, 2-, and 4-months post-randomisation. Primary outcomes were total weekly consumption (TWC) and frequency of heavy episodic drinking (HED). A counterfactual framework was used to estimate three hypothesised mediators: importance, knowledge of how to change (know-how), and confidence., Results: Between 25/04/2019 and 26/11/2020, 2129 participants were randomised. The intervention improved know-how and confidence, which in turn mediated the effects on TWC and HED at 2- and 4-months. Analyses with imputed data were not markedly different., Conclusions: A digital alcohol intervention was found to exert effects in reducing consumption by means of improving individuals' knowledge of how to reduce their consumption and confidence in their ability to reduce. The use of face-valid single item measures is a study limitation notwithstanding observed findings, as is attrition and lack of blinding of participants., Competing Interests: Declaration of Competing Interest MB owns a private company (Alexit AB) that maintains and distributes evidence-based lifestyle interventions to be used by the public and in health care settings. Alexit AB played no role in developing the intervention, study design, data analysis, data interpretation, or writing of this report. Services developed and maintained by Alexit AB were used for sending text messages and data collection. KÅ and JM declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Most public health research on the commercial determinants of health (CDOH) to date has focused on a narrow segment of commercial actors. These actors are generally the transnational corporations producing so-called unhealthy commodities such as tobacco, alcohol, and ultra-processed foods. Furthermore, as public health researchers, we often discuss the CDOH using sweeping terms such as private sector, industry, or business that lump together diverse entities whose only shared characteristic is their engagement in commerce. The absence of clear frameworks for differentiating among commercial entities, and for understanding how they might promote or harm health, hinders the governance of commercial interests in public health. Moving forward, it is necessary to develop a nuanced understanding of commercial entities that goes beyond this narrow focus, enabling the consideration of a fuller range of commercial entities and the features that characterise and distinguish them. In this paper, which is the second of three papers in a Series on commercial determinants of health, we develop a framework that enables meaningful distinctions among diverse commercial entities through consideration of their practices, portfolios, resources, organisation, and transparency. The framework that we develop permits fuller consideration of whether, how, and to what extent a commercial actor might influence health outcomes. We discuss possible applications for decision making about engagement; managing and mitigating conflicts of interest; investment and divestment; monitoring; and further research on the CDOH. Improved differentiation among commercial actors strengthens the capacity of practitioners, advocates, academics, regulators, and policy makers to make decisions about, to better understand, and to respond to the CDOH through research, engagement, disengagement, regulation, and strategic opposition., Competing Interests: Declaration of interests JL-N was supported by the Victorian Health Promotion Foundation. KL was supported by the Canadian Institutes of Health Research., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objective: To study reactions of control group participants allocated to two different presentations of basic health information in a digital alcohol intervention trial., Method: Control participants were randomised to wait with one of two different presentations of basic health information. Multiple choice questions and free-text comments assessed reactions, four months post randomisation. Effects of differential health information on responses were estimated, as were associations between responses, baseline characteristics and change in alcohol consumption., Result: Of 1066 control group participants, 572 (54%) responded to the questionnaire. Contrasting two different presentations of basic health information revealed no statistically significant differences. Responses revealed that 38% were interested sufficiently to look at the information while 42% felt frustration, irritation, or disappointment about having to wait. Approximately 55% responded that they decided to reduce their drinking whilst 17% stated that they continued to drink as usual, and 11% gave up on the idea of reducing their drinking. The two latter groups reported markedly higher alcohol consumption at follow-up in comparison to the former (probability of association >99.9%)., Conclusion: Being made to wait may invite negative research participation effects., Practice Implication: Comparator guidance should be updated to reflect the potentially negative consequences which are under researched., Competing Interests: Conflicts of interest MB owns a private company (Alexit AB) that maintains and distributes evidence-based lifestyle interventions to be used by the public and in health care settings. Alexit AB played no role in developing the intervention, study design, data analysis, data interpretation, or writing of this report. Services developed and maintained by Alexit AB were used for sending text messages and data collection. KUG and JM declare no competing interests., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Supply of alcohol to adolescents is associated with increased alcohol consumption and harms including alcohol use disorder (AUD). We aimed to identify: (1) trajectories of alcohol supply to adolescents; (2) sociodemographic characteristics associated with supply trajectory; (3) patterns of alcohol consumption by supply trajectory; and (4) supply trajectory associations with adverse alcohol outcomes., Methods: We used Australian longitudinal survey data (N = 1813) to model latent trajectories of parent and peer alcohol supply over five annual follow-ups (Waves 2-6; M age 13.9-17.8 years). Regression models assessed associations between supply trajectories and Wave 1 (M age =12.9 years) sociodemographic factors and associations between supply trajectories and Wave 7 (M age =18.8 years) alcohol outcomes., Results: We identified five alcohol supply classes: (1) minimal supply (n = 739, 40.8%); (2) early parent sips, late peer/parent whole drinks (n = 254, 14.0%); (3) late peer/parent whole drinks (n = 419, 23.1%); (4) early parent sips, mid peer/parent whole drinks (n = 293, 16.2%); (5) early peer/parent whole drinks (n = 108, 6.0%). Compared to minimal supply, the other classes were 2.7-12.9 times as likely to binge drink, 1.6-3.0 times as likely to experience alcohol-related harms, and 2.1-8.6 times as likely to report AUD symptoms at age 19., Conclusion: Earlier supply of whole drinks, particularly from peers, was associated with increased risk of early adulthood adverse alcohol outcomes. While minimal supply represented the lowest risk, supplying sips only in early-mid adolescence and delaying supply of whole drinks until late adolescence is likely to be less risky than earlier supply of whole drinks., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objective: This study (MEasurement Reactions In Trials) aimed to produce recommendations on how best to minimize bias from measurement reactivity (MR) in randomized controlled trials of interventions to improve health., Study Design and Setting: The MERIT study consisted of: (1) an updated systematic review that examined whether measuring participants had effects on participants' health-related behaviors, relative to no-measurement controls, and three rapid reviews to identify: (i) existing guidance on MR; (ii) existing systematic reviews of studies that have quantified the effects of measurement on behavioral or affective outcomes; and (iii) studies that have investigated the effects of objective measurements of behavior on health-related behavior; (2) a Delphi study to identify the scope of the recommendations; and (3) an expert workshop in October 2018 to discuss potential recommendations in groups., Results: Fourteen recommendations were produced by the expert group to: (1) identify whether bias is likely to be a problem for a trial; (2) decide whether to collect data about whether bias is likely to be a problem; (3) design trials to minimize the likelihood of this bias., Conclusion: These recommendations raise awareness of how and where taking measurements can produce bias in trials, and are thus helpful for trial design., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Community pharmacies have an increasingly prominent public health function. This includes addressing alcohol, but guidance on delivery of alcohol interventions in this setting is lacking. We have developed an intervention that integrates attention to alcohol within existing community pharmacy medicine review services. This paper examines the experiences of community pharmacists (CPs) in conducting a pilot trial of the intervention, including the acceptability of the trial patient recruitment procedures and the training and support provided by the research team., Method: The pilot trial was conducted in 10 community pharmacies in Yorkshire, England. One CP from each pharmacy was recruited via a multi-stage process to assess motivation, commitment and capacity to participate. Each CP attended a research training day and received on-going research support to conduct the trial. Semi-structured audio-recorded face-to-face interviews (lasting 40-105 min) were conducted with all the CPs at the end of the trial. Data were also available from three direct observations conducted during trial support visits. Data were analysed thematically., Results: The CPs were supportive of research in community pharmacy but had little direct experiences of research themselves. They valued the training and support provided, which had quickly identified areas where CPs were deviating from the study recruitment protocol. In some instances, the boundaries between research and practice became blurred with CPs making changes to their usual routines and interactions with patients to accommodate the research., Conclusions: The trial procedures were acceptable to CPs, in part because of the training and support provided. There are also identifiable areas where CPs' readiness for research could be enhanced to facilitate participation in future trials in this setting., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Participants in intervention studies are asked to take part in activities linked to the conduct of research, including signing consent forms and being assessed. If participants are affected by such activities through mechanisms by which the intervention is intended to work, then there is confounding. We examine how to account for research participation effects analytically., Study Design and Setting: Data from a trial of a brief alcohol intervention among Swedish university students is used to show how a proposed causal model can account for assessment effects., Results: The proposed model can account for research participation effects as long as researchers are willing to use existing data to make assumptions about causal influences, for instance on the magnitude of assessment effects. The model can incorporate several research processes which may introduce bias., Conclusions: As our knowledge grows about research participation effects, we may move away from asking if participants are affected by study design, toward rather asking by how much they are affected, by which activities and in which circumstances. The analytic perspective adopted here avoids assuming there are no research participation effects., (Copyright © 2021. Published by Elsevier Inc.)

Background: Parents frequently supply alcohol to their children, often only sips. We investigated whether supply of sips and whole drinks, from parents and other sources, are differentially associated with subsequent drinking outcomes., Methods: A cohort of 1910 adolescents (mean age 12.9yrs) were surveyed annually over seven years from 2010-11. We examined prospective, adjusted associations between the quantity of supply from parental and non-parental sources in the preceding 12 months and five outcomes in the subsequent year, over several consecutive years: binge drinking; alcohol-related harms; symptoms of alcohol abuse, dependence and alcohol use disorder (AUD)., Results: In early waves, most parental supply comprised sips, while supply of whole drinks increased in later waves. Among those not receiving alcohol from other sources, parental supply of sips was associated with increased odds of binge drinking (OR: 1.85; 99.5 % CI: 1.17-2.91) and alcohol-related harms (OR: 1.70; 99.5 % CI: 1.20-2.42), but not with reporting symptoms of alcohol abuse, dependence or AUD, compared with no supply. Relative to no supply, supply of sips from other sources was associated with increased odds of binge drinking (OR: 2.04; 99.5 % CI: 1.14-3.67) only. Compared with supply of sips, supply of whole drinks by parents or others had higher odds of binge drinking, alcohol-related harms, symptoms of dependence and of AUD. Secondary analysis demonstrated that supply of larger quantities was associated with an increased risk of all outcomes., Conclusion: Parental provision of sips is associated with increased risks and the supply of greater quantities was associated with an increasing risk of adverse outcomes., Clinical Trial Registration: ClinicalTrials.gov (NCT02280551)., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Medicines Use Reviews (MURs) and the New Medicine Service (NMS) are services delivered by UK community pharmacists to improve adherence, improve patient understanding of their medicines and reduce medicines wastage., Aim: In this scoping review we aim to identify, map and critically examine the nature of existing empirical evidence in peer reviewed journals relating to MUR and NMS consultations., Method: Systematic searches identified the available MUR and NMS empirical literature. We sought data on barriers and facilitators to conducting MUR or NMS consultations, the perceptions of pharmacists and patients, the conduct of consultations, and outcomes of consultations. Searches from 2005 (when MURs were introduced) to May 2018 were conducted in MEDLINE, PsycINFO, Embase and Scopus databases. Data were extracted into Excel for examination of study characteristics, participant characteristics, type of intervention/services delivered and key study quantitative and/or qualitative findings., Results: Forty-one papers from 37 studies met the inclusion criteria: 28 papers were of MURs, 10 of NMS and 3 for both services. Studies focused on the introduction and implementation of these services, with little attention to outcomes for patients; effectiveness was not evaluated beyond in a single NMS RCT. Observational data indicated that pharmacists and patients view MURs and the NMS positively, despite challenges implementing these services and apparent lack of communication between pharmacists and GPs. Consultations were reported to be short, typically 10-12 min, characterised by limited engagement with patients and their health problems. The extent and nature of advice on health behaviours during consultations or other content was rarely examined., Conclusion: The research literature on MURs and the NMS has developed slowly. There is much scope for further research attention to developing more patient-centred care., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: Nonresponse can bias prevalence estimates in population surveys. Effects of selective participation in behavior change intervention trials have been little studied. We tested hypotheses that trial participants who are hard to recruit are (1) more likely to be lost-to-follow-up and (2) less responsive to intervention., Study Design and Setting: We undertook a two-stage individual participant data meta-analysis of four alcohol intervention trials involving 9,251 university students in Australia, New Zealand, and Sweden, comparing participants who enrolled "late" (after the final invitation to participate) vs. "early" (before that). Outcomes were whether participants completed assessments at each trial's primary endpoint (late/early) and number of drinks consumed per week (intervention/control) among late enrolees vs. early enrolees., Results: Late enrolees were more likely to be lost-to-follow-up than early enrolees (OR 2.3, 95% CI: 1.7, 2.9). Intervention effect estimates were smaller for late vs. early enrolees, but not significantly so (RR = 0.93; 95% CI: 0.79, 1.08)., Conclusion: Greater effort to recruit trial participants was associated with higher attrition, but there was no clear evidence of bias in effect estimation. The possibility that intervention effect estimates do not generalize beyond a relatively compliant minority of trial participants may warrant further study., (Copyright © 2019. Published by Elsevier Inc.)

Background: This paper reports on a qualitative study which formed part of the intervention development phase of a five year research programme (Community pharmacy: Highlighting Alcohol use in Medication aPpointments; CHAMP-1)., Objectives: To better understand patient views on the appropriateness of alcohol as a subject for discussion in medication reviews in community pharmacy., Methods: Semi-structured interviews were conducted with a sample of 25 people eligible for medication reviews whose AUDIT-C screening scores identified them as likely risky drinkers. Transcripts were analysed using a modified framework method with a constructionist thematic analysis approach., Results: Most patients interviewed said they were open to the idea of a medication and alcohol linked discussion with a pharmacist if this was routine, well-conducted and confidential. Such a discussion was thought less personally relevant for those who viewed the proposed intervention through the prism of a particular set of ideas about the nature of alcohol problems, which distanced them from thinking about alcohol in terms of their everyday life and possible impacts on their health. Study findings attest to some of the sensitivities involved in discussion of alcohol, and the complexities inherent in helping people to talk about their own drinking, medicine use and health., Conclusions: Patients were open to the idea of discussing alcohol with community pharmacists in the context of a medicines review if this was sensitively done and the relevance was clear to them., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: There is a strong rationale for clinicians to identify risky drinking among young people given the harms caused by alcohol. This systematic review evaluates the quality of evidence in the validation literature on alcohol screening and assessment measures for young people under 25., Methods: Six electronic databases (MEDLINE; EMBASE; PsycINFO; SSCI; HMIC; ADAI) were searched in May 2016 for published and grey literature. Full-text reports published in English since 1980 were included if they aimed to validate an alcohol screening or assessment measure in comparison with a previously validated alcohol measure. Risk of bias was assessed in studies surpassing a priori quality thresholds for predictive validity, internal and test-retest reliability using COSMIN and QUADAS-2., Results: Thirty nine reports comprising 135 discrete validation studies were included. Summary estimates indicated that the screening instruments performed well - AUC 0.91 (95% CI: 0.88 to 0.93); sensitivity 0.98 (0.95 to 0.99); specificity 0.78 (0.74 to 0.82). Noting a paucity of validation evidence for existing assessment instruments, aggregated reliability estimates suggest a reliability of 0.81 (0.78 to 0.83) adjusted for 10 items. Risk of bias was high for both types of studies., Conclusions: The volume and quality of available evidence are superior for screening measures. It is recommended that clinicians use alcohol frequency or quantity items if asking a single question. If there is an opportunity to ask more questions either the 3-item AUDIT-C or the 10-item AUDIT are recommended. There is a need to develop new instruments to assess young people's alcohol-related problems., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: We tested the hypothesis that participants who know the behavioral focus of a study and are thus aware that a particular behavior is being studied will modify that behavior, independently of any possible effect of assessment, thereby dismantling a Hawthorne effect into two putative components., Study Design and Setting: We undertook a three-arm individually randomized trial online among students: group A (control) were told they were completing a lifestyle survey; group B were told the focus of the survey was alcohol consumption; and group C additionally answered 20 questions on their alcohol use and its consequences before answering the same lifestyle questions as Groups A and B. Nondrinkers were excluded, and all groups were aware they would be followed up after 1 month., Results: Outcome data were obtained for 4,583 of 5,478 trial participants (84% follow-up rate). There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks., Conclusions: There is no evidence that any form of Hawthorne effect exists in relation to self-reported alcohol consumption online among university students in usual research practice. Attention to study contexts is warranted for investigating research participation effects., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Most trials of electronic alcohol screening and brief intervention (e-SBI) have been conducted in young people. The aim of this study was to evaluate the effect of e-SBI in adults with hazardous or harmful drinking., Methods: This individually randomized, parallel, two-group, double-blind controlled trial was conducted in the outpatient department of a large public hospital in Australia. Consenting adults who scored 5-9 on the AUDIT-C (837/3225; 26%) were randomized in a 1:1 ratio by computer to screening alone (442/837; 53%) or to 10 min of assessment and personalized feedback on their alcohol consumption (comparisons with medical guidelines and age and sex-specific norms), peak blood alcohol concentration, expenditure on alcohol, and risk of alcohol dependence (395/837; 47%). The two primary outcomes, assessed six months after randomization, were the number of standard drinks (10 g ethanol) consumed by participants in the last seven days and their AUDIT score., Results: 693/837 (83%) and 635/837 (76%) participants were followed-up at 6 and 12 months, respectively. There was no statistically significant difference between the groups in the median number of standard drinks consumed in the last seven days (intervention: 12; control: 10.5; rate ratio, 1.12 [95% confidence interval, 0.96-1.31]; P = .17) or in their median AUDIT score (intervention: 7; control: 7; mean difference, 0.28 [-0.42 to 0.98]; P = .44)., Conclusion: These results do not support the implementation of an e-SBI program comprising personalized feedback and normative feedback for adults with hazardous or harmful drinking in the hospital outpatient setting., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: A large proportion of hospital outpatients are alcohol dependent (AD) but few are engaged in treatment for their drinking. Brief intervention, designed to raise patients' awareness of their drinking, might encourage uptake of referral to specialty treatment. We assessed the feasibility of conducting a randomized trial evaluating the effectiveness of electronic brief intervention on the uptake of specialty treatment in hospital outpatients with likely AD., Methods: This study was conducted in the outpatient department of a large public hospital in Newcastle, Australia. We randomly assigned adults who scored ≥10 on the AUDIT-C and were not currently receiving treatment for their drinking to electronic brief intervention (comprising an assessment of their drinking and personalized feedback) and referral (n = 59), or to referral alone (n = 64). We pre-specified two co-primary outcomes as the proportions of patients who (1) accepted and (2) attended a Drug and Alcohol outpatient clinic appointment. We interviewed 15 study participants to investigate why they had declined the appointment and what sort of help they might prefer to receive., Results: Ten patients (five in each group) accepted an appointment, and one patient (control) attended. Most interviewees' did not see their drinking as a problem or were confident they could manage it by themselves. Those who identified a preferred source of help expressed a preference for treatment by a GP., Conclusion: Uptake of specialty treatment in hospital outpatients with likely AD was low regardless of whether they received brief intervention. Accordingly, a large randomized trial does not appear to be feasible., (Copyright © 2017. Published by Elsevier B.V.)

Background: Although structured psychological treatments are recommended as first-line interventions for harmful drinking, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of Counselling for Alcohol Problems (CAP), a brief psychological treatment delivered by lay counsellors to patients with harmful drinking attending routine primary health-care settings., Methods: In this randomised controlled trial, we recruited male harmful drinkers defined by an Alcohol Use Disorders Identification Test (AUDIT) score of 12-19 who were aged 18-65 years from ten primary health centres in Goa, India. We excluded patients who needed emergency medical treatment or inpatient admission, who were unable to communicate clearly, and who were intoxicated at the time of screening. Participants were randomly allocated (1:1) by trained health assistants based at the primary health centres to enhanced usual care (EUC) alone or EUC combined with CAP, in randomly sized blocks of four to six, stratified by primary health centre, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC and those assessing outcomes were masked. Primary outcomes were remission (AUDIT score of <8) and mean daily alcohol consumed in the past 14 days, at 3 months. Secondary outcomes were the effect of drinking, disability score, days unable to work, suicide attempts, intimate partner violence, and resource use and costs of illness. Analyses were on an intention-to-treat basis. We used logistic regression analysis for remission and zero-inflated negative binomial regression analysis for alcohol consumption. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISCRTN registry, number ISRCTN76465238., Findings: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 377 participants (188 [50%] to the EUC plus CAP group and 190 [50%] to the EUC alone group [one of whom was subsequently excluded because of a protocol violation]), of whom 336 (89%) completed the 3 month primary outcome assessment (164 [87%] in the EUC plus CAP group and 172 [91%] in the EUC alone group). The proportion with remission (59 [36%] of 164 in the EUC plus CAP group vs 44 [26%] of 172 in the EUC alone group; adjusted prevalence ratio 1·50 [95% CI 1·09-2·07]; p=0·01) and the proportion abstinent in the past 14 days (68 [42%] vs 31 [18%]; adjusted odds ratio 3·00 [1·76-5·13]; p<0·0001) were significantly higher in the EUC plus CAP group than in the EUC alone group, but we noted no effect on mean daily alcohol consumed in the past 14 days among those who reported drinking in this period (37·0 g [SD 44·2] vs 31·0 g [27·8]; count ratio 1·08 [0·79-1·49]; p=0·62). We noted an effect on the percentage of days abstinent in the past 14 days (adjusted mean difference [AMD] 16·0% [8·1-24·1]; p<0·0001), but no effect on the percentage of days of heavy drinking (AMD -0·4% [-5·7 to 4·9]; p=0·88), the effect of drinking (Short Inventory of Problems score AMD-0·03 [-1·93 to 1·86]; p=0.97), disability score (WHO Disability Assessment Schedule score AMD 0·62 [-0·62 to 1·87]; p=0·32), days unable to work (no days unable to work adjusted odds ratio 1·02 [0·61-1·69]; p=0.95), suicide attempts (adjusted prevalence ratio 1·8 [-2·4 to 6·0]; p=0·25), and intimate partner violence (adjusted prevalence ratio 3·0 [-10·4 to 4·4]; p=0·57). The incremental cost per additional remission was $217 (95% CI 50-1073), with an 85% chance of being cost-effective in the study setting. We noted no significant difference in the number of serious adverse events between the two groups (six [4%] in the EUC plus CAP group vs 13 [8%] in the EUC alone group; p=0·11)., Interpretation: CAP delivered by lay counsellors plus EUC was better than EUC alone was for harmful drinkers in routine primary health-care settings, and might be cost-effective. CAP could be a key strategy to reduce the treatment gap for alcohol use disorders, one of the leading causes of the global burden among men worldwide., Funding: Wellcome Trust., (Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.)

Aims: This qualitative process study, nested within a randomised controlled trial evaluating community pharmacist brief alcohol intervention delivery, aims to explore participants' engagement with the trial, so as to identify whether research participation effects may explain why the brief intervention was not found to be effective., Method: Qualitative interviews were conducted with 24 randomly selected participants approximately one month after the end of the trial. Semi structured Interviews were conducted by telephone in which participants were asked to give a chronological account of their trial participation, leading to a discussion of possible impacts. These were digitally recorded, transcribed verbatim, and analysed using the Framework method., Results: A range of motivations for taking part in the trial were identified, including pharmacy visitors wanting to obtain an assessment of their drinking. Participants in both arms of the trial spoke of the potent effect that screening had on them. All participants were exposed to discussions about alcohol with empathic pharmacists and, as this is an integral intervention component, this constitutes contamination. Participants' pre-existing ideas about the nature of alcohol problems had an important bearing on how relevant they thought the intervention was to them., Conclusion: A detailed appreciation of participant engagement with the trial can provide a strong basis for interpretation of trial outcome data, and in this instance does help explain the null finding. Other findings also indicate the need for dedicated studies of public understanding of the nature of alcohol problems, and their implications for receptivity to brief interventions., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Few studies have examined the prevalence of unhealthy alcohol use in the hospital outpatient setting. Our aim was to estimate the prevalence of unhealthy alcohol use among patients attending a broad range of outpatient clinics at a large public hospital in Australia., Methods: Adult hospital outpatients were invited to complete the Alcohol Use Disorders Identification Test Consumption questions (AUDIT-C) using an iPad as part of a randomised trial testing the efficacy of alcohol electronic screening and brief intervention. Unhealthy alcohol use was defined as an AUDIT-C score ≥5 among men and ≥4 among women., Results: Sixty percent (3616/6070) of invited hospital outpatients consented, of whom 89% (3206/3616) provided information on their alcohol consumption (either reported they had not consumed any alcohol in the last 12 months or completed the AUDIT-C). The prevalence of unhealthy alcohol use was 34.7% (95% confidence interval [CI]: 33.0-36.3%). The prevalence among men aged 18-24 years, 25-39 years, 40-59 years and 60 years and older, was 74.4% (95% CI: 68.4-80.4%), 54.3% (95% CI: 48.7-59.8%), 44.1% (95% CI: 39.9-48.3%), and 27.0% (95% CI: 23.6-30.4%), respectively (43.1% overall; 95% CI: 40.8-45.5%). The prevalence among women aged 18-24 years, 25-39 years, 40-59 years, and 60 years and older, was 48.6% (95% CI: 39.2-58.1%), 36.9% (95% CI: 31.2-42.6%), 25.2% (95% CI: 21.5-29.0%) and 14.5% (95% CI: 11.7-17.3%), respectively (24.9% overall; 95% CI: 22.7-27.1%)., Conclusion: A large number of hospital outpatients who are not currently seeking treatment for their drinking could benefit from effective intervention in this setting., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

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., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

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., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

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., (Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The prevention of initiation of tobacco, alcohol and drug use is a major societal challenge, for which the existing research literature is generally disappointing. This study aimed to test the effectiveness of adaptation of Motivational Interviewing (MI) for universal prevention purposes, i.e. to prevent initiation of new substance use among non-users, and to reduce risks among existing users., Methods: Cluster randomised trial with 416 students aged 16-19 years old recruited in 12 London Further Education colleges without regard to substance use status. Individualised MI was compared with standard practice classroom-delivered Drug Awareness intervention, both delivered over the course of one lesson. Prevalence, initiation and cessation rates for the 3 target behaviours of cigarette smoking, alcohol consumption and cannabis use, along with reductions in use and harm indicators after both 3 and 12 months were assessed., Results: This adaptation of MI was not demonstrated to be effective in either intention-to-treat or sub-group analyses for any outcome. Unexpected lower levels of cannabis initiation and prevalence were found in the Drug Awareness control condition., Conclusions: This particular adaptation of MI is ineffective as a universal drug prevention intervention and does not merit further study., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Reactivity to assessment has attracted recent attention in the brief alcohol intervention literature. This systematic review sought to examine the nature of change in alcohol consumption over time in control groups in brief intervention studies. Primary studies were identified from existing reviews published in English language, peer-reviewed journals between 1995 and 2005. Change in alcohol consumption and selected study-level characteristics for each primary study were extracted. Consumption change data were pooled in random effects models and meta-regression was used to explore predictors of change. Eleven review papers reported the results of 44 individual studies. Twenty-six of these studies provided data suitable for quantitative study. Extreme heterogeneity was identified and the extent of observed reduction in consumption over time was greater in studies undertaken in Anglophone countries, with single gender study participants, and without special targeting by age. Heterogeneity was reduced but was still substantial in a sub-set of 15 general population studies undertaken in English language countries. The actual content of the control group procedure itself was not predictive of reduction in drinking, nor were a range of other candidate variables including setting, the exclusion of dependent drinkers, the collection of a biological sample at follow-up, and duration of study. Further investigations may yield novel insights into the nature of behaviour change with potential to inform brief interventions design.

Aims: To describe the sexual behaviour and related risk of a sample of dance drug users and compare this with data from the UK National Survey of Sexual Attitudes and Lifestyles 2000 survey., Methods: Cross-sectional purposive sampling using both self-completion postal and web-based questionnaires., Findings: This sample of dance drug users are more sexually active and have more concurrent partners than the general population. Rates of anal or vaginal sex within the last year without condom use are high and of concern (men 80 per cent; women 90 per cent). These dance drug users appear also to have higher lifetime prevalence of sexually transmitted infections than the general population and are also more likely to have ever attended a sexual health clinic., Conclusions: Clubbing and dance drug use, as part of a socially active lifestyle, is associated with elevated and pronounced sexual health risk. Future epidemiological studies of sexual health risk should incorporate investigation of both clubbing and recreational drug use in order to confirm the representativeness of these observations. Clubbers should be considered a target for dedicated sexual health promotion interventions, which may also be combined with interventions targeting drug and alcohol use.

Brief interventions are known to be effective in changing both substance use and other health-compromising behaviors. It is unknown whether they may have secondary effects on behaviors which are not specifically targeted. The literature on brief alcohol interventions was selected to explore this possibility, with a study focus on secondary impact on cigarette smoking. The CINAHL, EMBASE, MEDLINE and PSYCINFO bibliographic databases were searched for reviews of brief alcohol intervention studies published in English language, peer-reviewed journals between 1995 and 2005. Authors of primary studies identified in the reviews were contacted to ascertain whether or not their studies had collected cigarette smoking data and, if available, to obtain data. Random effect models were used to pool data for meta-analysis. Eleven review papers reported the results of 41 individual primary studies which were included in this systematic review. Fourteen of these studies collected cigarette smoking outcome data, of which 7 studies still had information available and provided these data for meta-analysis. There were no between-group differences in smoking cessation or reduction across these studies. High levels of smoking cessation were detected in both brief intervention and control groups with much heterogeneity between studies. Brief alcohol interventions do not also reduce cigarette smoking, and it appears unlikely that there exist other important secondary effects. The behavioral consequences of brief intervention study participation itself warrant further study.

Aims: To compare the psychometric performance of a range of existing alcohol measures when data are collected online with young people, and thereby to gain insights into the reliability and validity of this mode of data collection., Method: One hundred and sixty-seven U.K. resident young people aged 16-24 who had drunk alcohol within the past week participated in a cross-sectional psychometric study with a test-retest reliability component. Eight hazardous drinking measures were used: the alcohol use disorders identification test (AUDIT) summary instrument and dedicated assessments of consumption (timeline follow-back and diary-format recall of alcohol drunk in the last 7 days), dependence (Leeds dependence questionnaire and severity of dependence scale) and problems (Rutgers alcohol problem index, alcohol problems scale and academic role expectations and alcohol scale)., Results: Internal consistency and test-retest correlation statistics were generally satisfactory, providing evidence of reliability. Validation data obtained in principal components analyses, investigation of the correlation matrix and in a multiple regression model of total AUDIT score were also supportive of the online use of these measures. Evidence was weakest for the alcohol problems scale., Conclusions: A range of hazardous drinking measures exhibit sound psychometric properties when administered online. Further comparative study of the relationships between different measures is needed.

Objective: In-treatment and post-treatment outcomes were compared for three detoxification procedures (lofexidine+naloxone, lofexidine+placebo naloxone, and methadone). SAMPLE AND DESIGN: The sample was 137 opiate dependent in-patients. Detoxification treatments were 6-day lofexidine+naloxone (n=45), lofexidine+placebo naloxone (n=46), or 10-day methadone reduction (n=46). A cohort study design was used with double-blind random allocation to lofexidine+naloxone versus lofexidine+placebo. Patients who did not consent to, or who were excluded from randomisation received methadone., Results: Outcome differences between treatment groups at follow-up were generally associated with length of stay post-detoxification rather than detoxification procedure. Among patients who were not opiate abstinent throughout follow-up (n=85), those who received lofexidine+naloxone detoxification reported a longer interval to first heroin use, with an interaction between detoxification medication and subsequent retention in treatment also identified., Conclusions: Detoxification medication may influence medium-term opiate use outcomes via its effect upon retention in treatment.

Background: Rates of mortality due to cirrhosis of the liver are an important indicator of population levels of alcohol harm. Total recorded alcohol consumption in Britain doubled between 1960 and 2002, giving rise to a need to examine and assess cirrhosis mortality trends., Methods: Mortality rates were calculated for all ages and for specific age-groups (15-44 years and 45-64 years) for cirrhosis of the liver. Rates were directly age-standardised to the European standard population and compared with rates from 12 western European countries for the period 1955-2001., Findings: Cirrhosis mortality rates increased steeply in Britain during the 1990s. Between the periods 1987-1991, and 1997-2001, cirrhosis mortality in men in Scotland more than doubled (104% increase) and in England and Wales rose by over two-thirds (69%). Mortality in women increased by almost half (46% in Scotland and 44% in England and Wales). These relative increases are the steepest in western Europe, and contrast with the declines apparent in most other countries examined, particularly those of southern Europe. Cirrhosis mortality rates in Scotland are now one of the highest in western Europe, in 2002 being 45.2 per 100,000 in men and 19.9 in women., Interpretation: Current alcohol policies in Britain should be assessed by the extent to which they can successfully halt the adverse trends in liver cirrhosis mortality. The situation in Scotland warrants particular attention.