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OBJECTIVE: The introduction of a new clinical pharmacist workforce via Primary Care Networks (PCNs) is a recent national policy development in the National Health Service in England. This study elicits the perspectives of people with responsibility for local implementation of this national policy package. Attention to local delivery is necessary to understand the contextual factors shaping the integration of the new clinical pharmacy workforce, and thus can be expected to influence future role development. DESIGN: A qualitative, interview study SETTING AND PARTICIPANTS: PCN Clinical Directors and senior pharmacists across 17 PCNs in England (n=28) ANALYSIS: Interviews were transcribed, coded and organised using the framework method. Thematic analysis and complex systems modelling were then undertaken iteratively to develop the themes. RESULTS: Findings were organised into two overarching themes: (1) local organisational innovations of a national policy under conditions of uncertainty; and (2) local multiprofessional decision-making on clinical pharmacy workforce integration and initial task assignment. Although a phased implementation of the PCN package was planned, the findings suggest that processes of PCN formation and clinical pharmacist workforce integration were closely intertwined, with underpinning decisions taking place under conditions of considerable uncertainty and workforce pressures. CONCLUSIONS: National policy decisions that required General Practitioners to form PCNs at the same time as they integrated a new workforce risked undermining the potential of both PCNs and the new workforce. PCNs require time and support to fully form and integrate clinical pharmacists if successful role development is to occur. Efforts to incentivise delivery of PCN pharmacy services in future must be responsive to local capacity.

BACKGROUND: Different forms of alcohol-related harm (e.g., hangovers, fighting) may confer differential risk of clinically relevant alcohol problems. We examine: (i) patterns of transition in experiencing alcohol-related harms across adolescence; (ii) whether factors in early adolescence predict transition patterns; and (iii) whether transition patterns predict later alcohol use disorder (AUD) symptoms. METHODS: We used a longitudinal Australian cohort (n = 1828) to model latent class transition patterns of alcohol-related harms across three timepoints (Mage = 13.9, 16.8, 18.8 years). Regression models assessed whether child, peer, and parent factors in early adolescence (Mage = 12.9) predicted harms transition patterns and whether these patterns predicted AUD symptoms in early adulthood (Mage = 19.8). RESULTS: Five transition patterns characterized most of the cohort (n ≈ 1609, 88.0%): (i) minimal harms (n ≈ 381, 20.8%); (ii) late physiological harms (n ≈ 702, 38.4%); (iii) early physiological harms (n ≈ 226, 12.4%); (iv) late all harms (n ≈ 131, 7.2%); and (v) gradual all harms (n ≈ 169, 9.2%). With late physiological harms as the reference, females had increased risk of experiencing early physiological harms (relative risk [RR]: 2.15; 99.5% CI: 1.19, 3.90). Late all harms (RR: 1.71; CI: 1.19, 2.47) and gradual all harms (RR: 1.84; CI: 1.37, 2.47) were each associated with increased odds of meeting criteria for AUD, even when patterns of alcohol consumption are considered. CONCLUSIONS: Adolescents display heterogeneous transition patterns across physiological and psychosocial alcohol-related harms. Females are at greater risk of experiencing early physiological harms. Experience of both physiological and psychosocial harms in late adolescence is an important and potentially modifiable precursor to clinically relevant alcohol problems in early adulthood.

BACKGROUND: Alcohol is challenging to discuss, and patients may be reluctant to disclose drinking partly because of concern about being judged. This report presents an overview of the development of a medications review intervention co-produced with the pharmacy profession and with patients, which breaks new ground by seeking to give appropriate attention to alcohol within these consultations. METHODS: This intervention was developed in a series of stages and refined through conceptual discussion, literature review, observational and interview studies, and consultations with advisory groups. In this study we reflect on this process, paying particular attention to the methods used, where lessons may inform innovations in other complex clinical consultations. RESULTS: Early work with patients and pharmacists infused the entire process with a heightened sense of the complexity of consultations in everyday practice, prompting careful deliberation on the implications for intervention development. This required the research team to be highly responsive to both co-production inputs and data gathered in formally conducted studies, and to be committed to working through the implications for intervention design. The intervention thus evolved significantly over time, with the greatest transformations resulting from patient and pharmacist co-design workshops in the second stage of the process, where pharmacists elaborated on the nature of the need for training in particular. The original research plans provided a helpful structure, and unanticipated issues for investigation emerged throughout the process. This underscored the need to engage dynamically with changing contexts and contents and to avoid rigid adherence to any early prescribed plan. CONCLUSIONS: Alcohol interventions are complex and require careful developmental research. This can be a messy enterprise, which can nonetheless shed new insights into the challenges involved in optimising interventions, and how to meet

In order to effectively evaluate complex interventions, there have been calls for the further integration of qualitative methods. Qualitative process studies of brief alcohol interventions and medicines reviews are notably lacking. This article provides a grounded example through the presentation of findings from an embedded qualitative process evaluation of a multi-site, pilot cluster RCT of a new intervention: the Medicines and Alcohol Consultation (MAC). MAC is designed to increase the capacity of community pharmacists (CPs) to conduct person-centred medicines reviews in which the subject of alcohol consumption is raised in connection with medications and associated health conditions. Participant-focused qualitative studies (interviews, observations, recorded consultations) sought to understand how CPs engaged with and implemented MAC in context. This article documents effects of the intervention on developing person-centred consultation practice and highlights how qualitative process studies can be used formatively to develop middle range programme theory and to optimise intervention design for testing in a definitive RCT.

BACKGROUND AND AIMS: Recent research suggests that parental supply of alcohol is associated with more risky drinking and alcohol-related harm among adolescents. However, the overall effect of parental supply throughout adolescence remains unclear, because parental supply of alcohol varies during adolescence. Due to the complexity of longitudinal data, standard analytical methods can be biased. This study examined the effect of parental supply of alcohol on alcohol-related outcomes in early adulthood using robust methods to minimize risk of bias. DESIGN: Prospective longitudinal cohort study. SETTING: Australia PARTICIPANTS: A cohort of school students (n = 1906) recruited in the first year of secondary school (average age 12.9 years) from Australian schools in 2010-11, interviewed annually for 7 years. MEASUREMENTS: The exposure variable was self-reported parental supply of alcohol (including sips/whole drinks) during 5 years of adolescence (waves 1-5). Outcome variables were self-reported binge drinking, alcohol-related harm and symptoms of alcohol use disorder, measured in the two waves after the exposure period (waves 6-7). To reduce risk of bias, we used targeted maximum likelihood estimation to assess the (counterfactual) effect of parental supply of alcohol in all five waves versus no supply on alcohol-related outcomes. FINDINGS: Parental supply of alcohol throughout adolescence saw greater risk of binge drinking [risk ratios (RR) = 1.53; 95% confidence interval (CI) = 1.27-1.84] and alcohol-related harms (RR = 1.44; 95% CI = 1.22-1.69) in the year following the exposure period compared with no supply in adolescence. Earlier initiation of parental supply also increased risk of binge drinking (RR = 1.10; 95% CI = 1.05-1.14), and any alcohol-related harm (RR = 1.09; 95% CI = 1.05-1.13) for each year earlier parental supply began compared with later (or no) initiation. CONCLUSIONS: Adolescents whose parents supply them with alcohol appear to have an increased ris

BACKGROUND: Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial. METHODS: This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates. RESULTS: 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreem

Community pharmacy faces ongoing challenges to its economic and social standing. A concern to legitimate professional status explains the attraction of public health. Interventions currently advocated by UK State-sponsored health care seek to reconcile the autonomous 'entrepreneurial' patient with market-driven solutions. Engaging critically with recent Foucauldian sociological work on pharmacy as a conduit for disciplinary power, we explore how professional ambiguity is exploited to 'manage' the subjectivities of community pharmacists. Locating our discussion in the observed empirical realities of pharmacy practice (the inclusion of alcohol and other 'healthy living' advice in the Medicines Use Review), we connect unresolved historical debates in community pharmacy with current ongoing (neoliberal) changes in policy and pharmacy business practices, drawing attention to the poor evidence base underpinning healthy living activities in community pharmacy. Our findings show how community pharmacists struggle to provide meaningful advice, valued by patients. Instead of enhancing professional status, 'add-on' public health roles created the risk of offering little more than an essentialised enactment of consumerist health care. Understanding how patients conceptualise drinking and 'healthy living' in relation to their long-term health, using more open discussions, including the negotiation (rather than provision) of information, could help community pharmacists challenge the current professional vulnerabilities they face.

Alcohol consumption has been linked to a wide range of social and health problems, and it is known that drinking among older age groups has been increasing. Relatively little qualitative research has examined how older drinkers make sense of their drinking practices, including how they seek to normalise their consumption when talking about it. This paper reports on a qualitative interview study with older drinkers (n = 25; aged 41-89), focusing on the various discursive strategies they use to rationalise their drinking. Discursive analysis of the interview transcripts highlights four key approaches used: strategic vagueness; reinforcing responsible restraint; self-serving comparisons; and downplaying drinking as mundane practice. Taken together, the efforts made to convey drinking in moderation suggest a concern among interviewees with being regarded as a good citizen, in control of their consumption and their lives generally. Some possible implications for health promotion, and ideas for further research, are discussed.

BACKGROUND: Alcohol use is a major contributor to the burden of disease, including long-term non-communicable diseases. Alcohol can also interact with and counter the effects of medications. This study addresses how people with long term conditions, who take multiple medications, experience and understand their alcohol use. The study objective is to explore how people conceptualise the risks posed to their own health from their concurrent alcohol and medicines use. METHODS AND FINDINGS: Semi-structured interviews were conducted with a sample of 24 people in the North of England taking medication for long term conditions who drank alcohol twice a week or more often. Transcripts were analysed using a modified framework method with a constructionist thematic analysis. Alcohol was consumed recreationally and to aid with symptoms of sleeplessness, stress and pain. Interviewees were concerned about the felt effects of concurrent alcohol and medicines use and sought ways to minimise the negative effects. Interviewees associated their own drinking with short-term reward, pleasure and relief. Risky drinking was located elsewhere, in the drinking of others. People made experiential, embodied sense of health harms and did not seem aware of, or convinced by, (or in some cases appeared resigned to) future harms to their own health from alcohol use. The study has limitations common to exploratory qualitative studies. CONCLUSIONS: Health risk communication should be better informed about how people with long-term health conditions perceive health outcomes over time, and how they adopt experience-based safety strategies in contexts in which alcohol consumption is heavily promoted and weakly regulated, whilst medicines adherence is expected. Supporting people to make active and informed connections between medicines, alcohol and potential personal health harms requires more than a one-way style of risk communication if it is to be perceived as opening up rather than restricting choi

INTRODUCTION AND AIMS: This paper reports on an exploratory ethnographic observation study which aimed to understand how alcohol fits into routine service provision in the New Medicine Service (NMS), Medication Use Reviews (MUR) and pharmacists' everyday practices in UK community pharmacies. DESIGN AND METHODS: Observations were undertaken in five community pharmacies featuring nine community pharmacists. This involved observation of 16 MURs and 15 NMS consultations and informal interviews with pharmacists as they conducted their work. Fieldnotes were subjected to a constructionist thematic analysis. RESULTS: Pharmacists were underprepared and unconfident in discussing alcohol in medicine consultations. Most pharmacists raised alcohol consumption in the MUR and NMS as part of a 'lifestyle check'. They reported that alcohol was difficult to raise, and to discuss and that people were reluctant to talk about their drinking. Their main concern was that raising the topic would alienate customers. DISCUSSION AND CONCLUSIONS: These findings raise questions regarding a range of issues about how pharmacists discuss alcohol in medicines consultations, why they lack a clear sense of purpose in doing so and therefore where alcohol fits into UK community pharmacy practice.

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.

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.

Background and Aims: Business corporations’ use of political donations to garner political influence is especially troubling in relation to products that damage human health. We sought to investigate patterns of donations to Australian political parties from tobacco, alcohol and gambling industry actors and the experiences of key informants. Design and Methods: We analysed public data on federal and state donations for 10 years to June 2015. We conducted 28 semi-structured interviews with current and former politicians, ex-political staffers and other key informants, concerning the role played by political donations of tobacco, alcohol and gambling companies in Australian politics. We examined temporal associations in donations data, and thematically analysed interviews. Results: Australian political parties declared donations of A$14 million (US$11 M) from tobacco ($1.9 M), alcohol ($7.7 M), gambling ($2.9 M) and supermarket ($1.7 M) entities, excluding donations below the $12 800 reporting threshold. Donations to the governing party increased substantially during debates about an alcohol tax and gambling law reform. Alcohol industry donations to major parties spiked ahead of elections. Interviewees identified the function of donations in terms of: (i) buying immediate influence; (ii) building long-term relationships; (iii) exploiting a flawed political system; and (iv) the need to look beyond donations, for example, to favour exchange; and the public's right to know about corporate influence on policy-makers. Discussion and Conclusions: The alcohol and gambling industries make substantial donations to influence particular decisions in the short term and build relationships over the long term. Banning corporate donations and publicly funding political parties warrant consideration to safeguard the integrity of public policy-making.

The case for policies to be based on evidence appeared to gain a major boost with the publication of the Brussels Declaration, apparently with support from many leading scientists and institutions. Yet, as we show in this analysis, there are major concerns about how it was developed and, in particular, the extensive involvement of tobacco and alcohol industry actors. We describe how its coverage of conflicts of interest and vested interests is consistent with the perspectives of these same actors. The process of developing the Declaration successfully involved science advisors, other senior officials in governments and politicians in its preparation. Despite this, the final Declaration fails to address the need for safeguards to protect the integrity of science or policy from corporate interests, including in relation to the tobacco industry. This undermines Article 5.3 of the Framework Convention on Tobacco Control which seeks to protect public health policies from interference by the tobacco companies. More broadly, the Declaration offers potential to serve as a vehicle for advancing the vested interests of corporate sectors in public policymaking and appears to have been regarded in this way by a range of organisations related to the alcohol industry. This exercise is now being extended to the continent of Africa, which is strategically important to both the tobacco and alcohol industries. It will be important to study carefully to what extent initiatives like this form part of the global political strategies of tobacco and alcohol industry actors.

BACKGROUND: Primary care is an important context for addressing health-related behaviours, and may provide a setting for identification of gambling problems. AIM: To indicate the extent of gambling problems among patients attending general practices, and explore settings or patient groups that experience heightened vulnerability. DESIGN AND SETTING: Cross-sectional study of patients attending 11 general practices in Bristol, South West England. METHOD: Adult patients (n = 1058) were recruited from waiting rooms of practices that were sampled on the basis of population characteristics. Patients completed anonymous questionnaires comprising measures of mental health problems (for example, depression) and addictive behaviours (for example, risky alcohol use). The Problem Gambling Severity Index (PGSI) measured gambling problems, along with a single-item measure of gambling problems among family members. Estimates of extent and variability according to practice and patient characteristics were produced. RESULTS: There were 0.9% of all patients exhibiting problem gambling (PGSI ≥5), and 4.3% reporting problems that were low to moderate in severity (PGSI 1-4). Around 7% of patients reported gambling problems among family members. Further analyses indicated that rates of any gambling problems (PGSI ≥1) were higher among males and young adults, and more tentatively, within a student healthcare setting. They were also elevated among patients exhibiting drug use, risky alcohol use, and depression. CONCLUSION: There is need for improved understanding of the burden of, and responses to, patients with gambling problems in general practices, and new strategies to increase identification to facilitate improved care and early intervention.

OBJECTIVE: To investigate reporting of alcohol consumption, we manipulated the contexts of questions in ways designed to induce social desirability bias. METHOD: We undertook a two-arm, parallel-group, individually randomized trial at an Australian public university. Students were recruited by email to a web-based "Research Project on Student Health Behavior." Respondents answered nine questions about their physical activity, diet, and smoking. They were unknowingly randomized to a group presented with either (A) three questions about their alcohol consumption or (B) seven questions about their alcohol dependence and problems (under a prominent header labeled "Alcohol Use Disorders Identification Test"), followed by the same three alcohol consumption questions from (A). RESULTS: A total of 3,594 students (mean age = 27, SD = 10) responded and were randomized: 1,778 to Group A and 1,816 to Group B. Outcome measures were the number of days they drank alcohol, the typical number of drinks they consumed per drinking day, and the number of days they consumed six or more drinks. The primary analysis included participants with any alcohol consumption in the preceding 4 weeks (1,304 in Group A; 1,340 in Group B) using between-group, two-tailed t tests. RESULTS: In Groups A and B, respectively, means (and SDs) of the number of days drinking were 5.89 (5.92) versus 6.06 (6.12), p = .49; typical number of drinks per drinking day: 4.02 (3.87) versus 3.82 (3.76), p = .17; and number of days consuming six or more drinks: 1.69 (2.94) versus 1.67 (3.25), p = .56. CONCLUSIONS: We could not reject the null hypothesis because earlier questions about alcohol dependence and problems showed no sign of biasing the respondents' subsequent reports of alcohol consumption. These data support the validity of university students' reporting of alcohol consumption in web-based studies.

Background Informed consent is the foundation of the ethical conduct of health research. Obtaining informed consent may unwittingly interfere with the data collected in research studies, particularly if they concern sensitive behaviours that participants are requested to report on. To address gaps in evidence on such research participation effects, we conducted a methodological experiment evaluating the impact of the informed consent procedure on participants’ reporting behaviour, specifically on their self-report of drinking behaviour as measured by Alcohol Use Disorder Identification Test (AUDIT). Methods A two arm double blinded randomised controlled trial was used. University students present in London student unions at the time of recruitment were contacted in two phases (an initial run-in phase followed by the main phase). Those providing positive responses to verbal questions: 1) “are you a student?”; 2) “do you drink alcohol?”; 3) “would you like to take part in a brief health survey, which will take around 5 minutes?” were recruited. Participants received one of the two envelopes by chance, with the sequence generated by an online random sequence generator. One contained the participant information sheet, informed consent form and the AUDIT questionnaire (the intervention group), while the other contained only the AUDIT questionnaire (the comparator group). The primary outcome was the mean AUDIT score, which ranges from 0 to 40. The secondary outcome was the proportion of participants in each group scoring 8 or more on the AUDIT, the threshold score for hazardous and harmful drinking warranting intervention. Results A total of 380 participants were successfully recruited, resulting in 190 participants in each group, of which 378 were included in the final analysis. There is no evidence of any statistically significant difference between groups in the primary outcome. A statistically significant difference in the secondary outcome was found in the run-in pha

The aim of this study was to investigate the Swedish population’s beliefs and attitudes on when it is appropriate to address patients’ alcohol in health care services and to identify the characteristics of those who are most supportive of this alcohol-preventive work. A cross-sectional study of 5981 nationally representative individuals (18-64. years) was done using confidential mail questionnaires. Alcohol consumption was assessed with AUDIT-C and respondents were classified into four levels of drinking status. Sociodemographic data were also collected. Thirty-four percent completely agreed that health care providers should routinely ask patients about their alcohol habits and 33% completely agreed that providers should ask but only if patients have consulted them with alcohol-related symptoms. There was limited support for a statement that alcohol conversations should be premised on the patient bringing up the issue and even less support for the notion that alcohol habits are people’s own business and not something that health care providers should address. Thirty-four percent believed that people did not answer honestly when asked about their alcohol habits in health care. There appears to be considerable support in the general population for alcohol prevention in Swedish health care services that involves questions being asked routinely about alcohol. This should be helpful in ongoing efforts to improve the implementation of alcohol screening and brief interventions in Sweden. Further studies on the views of hazardous and excessive drinkers appear particularly important. © 2012 Elsevier Ltd.

Background The concept of demand characteristics, which involves research participants being aware of what the researcher is investigating, is well known and widely used within psychology, particularly in laboratory-based studies. Studies of this phenomenon may make a useful contribution to broader consideration of the effects of taking part in research on participant behaviour. This systematic review seeks to summarise data from studies of the effects of demand characteristics on participant behaviours in non-laboratory settings. Methodology/Principal Findings Electronic databases were searched to identify eligible studies. These had to be purposely designed to evaluate possible effects of demand characteristics on at least one behavioural outcome under the autonomous control of the participants and use longitudinal study designs. Only 7 studies were included, 6 providing observational data and 1 experimental study, with 5 studies involving examination of possible effects on health behaviours. Although studies provided some evidence of effects of demand characteristics on participant behaviour, heterogeneous operationalisation of the construct, the limited number of studies and poor quality of study designs made synthesis and interpretation of study findings challenging. Conclusions/Significance Although widely accepted as important in psychology, there have been few dedicated studies of the effects of demand characteristics on research participant behaviours outside laboratory settings. This body of literature does not currently contribute to the wider study of research participation effects. A systematic review of data from laboratory-based studies is needed, as are high-quality primary studies in non-laboratory settings. We suggest that unqualified use of the term demand characteristics should be abandoned