Factors influencing public health engagement in alcohol licensing in England and Scotland including legal and structural differences: comparative interview analysis.

Background: Greater availability of alcohol is associated with higher consumption and harms. The legal systems, by which premises are licensed to sell alcohol in England and Scotland, differ in several ways. The 'Exploring the impact of alcohol licensing in England and Scotland' study measured public health team activity regarding alcohol licensing from 2012 to 2019 and identified seven differences between England and Scotland in the timing and type of activities undertaken. Objectives: To qualitatively describe the seven previously identified differences between Scotland and England in public health approaches to alcohol licensing, and to examine, from the perspective of public health professionals, what factors may explain these differences. Methods: Ninety-four interviews were conducted with 52 professionals from 14 English and 6 Scottish public health teams selected for diversity who had been actively engaging with alcohol licensing. Interviews focused primarily on the nature of their engagement (n = 66) and their rationale for the approaches taken (n = 28). Interview data were analysed thematically using NVivo. Findings were constructed by discussion across the research team, to describe and explain the differences in practice found. Findings: Diverse legal, practical and other factors appeared to explain the seven differences. (1) Earlier engagement in licensing by Scottish public health teams in 2012-3 may have arisen from differences in the timing of legislative changes giving public health a statutory role and support from Alcohol Focus Scotland. (2) Public Health England provided significant support from 2014 in England, contributing to an increase in activity from that point. (3) Renewals of statements of licensing policy were required more frequently in Scotland and at the same time for all Licensing Boards, probably explaining greater focus on policy in Scotland. (4) Organisational structures in Scotland, with public health stakeholders spread across several organisations, likely explained greater involvement of senior leaders there. (5) Without a public health objective for licensing, English public health teams felt less confident about making objections to licence applications without other stakeholders such as the police, and instead commonly negotiated conditions on licences with applicants. In contrast, Scottish public health teams felt any direct contact with applicants was inappropriate due to conflicts of interest. (6) With the public health objective in Scotland, public health teams there were more active in making independent objections to licence applications. Further in Scotland, licensing committee meetings are held to consider all new applications regardless of whether objections have been submitted; unlike in England where there was a greater incentive to resolve objections, because then a meeting was not required. (7) Finally, Scottish public health teams involved the public more in licensing process, partly because of statutory licensing forums there. Conclusions: The alcohol premises licensing systems in England and Scotland differ in important ways including and beyond the lack of a public health objective for licensing in England. These and other differences, including support of national and local bodies, have shaped opportunities for, and the nature of, public health engagement. Further research could examine the relative success of the approaches taken by public health teams and how temporary increases in availability are handled in the two licensing systems. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Reseacrh programme as award number 15/129/11.

When alcohol becomes more widely available, harms tend to increase. In England and Scotland, this availability is controlled by local councils. They 'licence' shops, bars and other venues to allow them to sell alcohol. Local health teams, including doctors, often advise councils on licensing. In earlier work, we found seven differences in what Scottish and English health teams do on licensing. In this study, we explore these seven differences and why they came about. To do this, we interviewed 94 professionals working in public health across both countries. Scottish health teams got involved in licensing earlier than in England. This was partly because of when certain laws changed. Also, they were helped earlier by national organisations that try to reduce harm from alcohol. Scottish teams were more involved in local policies on licensing. This was probably because these policies changed more often in the Scottish system. Scottish teams involved the public more. This was partly because Scottish councils must set up 'local licensing forums'. Scottish teams also objected more often to licence applications. They generally felt that they could be more actively involved, because of a law in Scotland that says licensing must protect public health. This law does not apply in England. In England, health teams were more likely to talk to businesses that wanted licences. They were less likely to try to block applications. When they agreed changes to applications with businesses instead of objecting, fewer formal licensing meetings were needed. This was not the case in Scotland. Also, Scottish teams did not feel it was okay for them to talk to businesses. In summary, there are important differences in licensing law between Scotland and England. These matter for how health teams in the two countries engage with local councils, businesses and the public on licensing matters.

Public health engagement in alcohol licensing in England and Scotland: the ExILEnS mixed-method, natural experiment evaluation.

Background: International systematic reviews suggest an association between alcohol availability and increased alcohol-related harms. Alcohol availability is regulated through separate locally administered licensing systems in England and Scotland, in which local public health teams have a statutory role. The system in Scotland includes a public health objective for licensing. Public health teams engage to varying degrees in licensing matters but no previous study has sought to objectively characterise and measure their activity, examine their effectiveness, or compare practices between Scotland and England. Aim: To critically assess the impact and mechanisms of impact of public health team engagement in alcohol premises licensing on alcohol-related harms in England and Scotland. Methods: We recruited 39 diverse public health teams in England (n = 27) and Scotland (n = 12). Public health teams more active in licensing were recruited first and then matched to lower-activity public health teams. Using structured interviews (n = 66), documentation analysis, and expert consultation, we developed and applied the Public Health Engagement In Alcohol Licensing (PHIAL) measure to quantify six-monthly activity levels from 2012 to 2019. Time series of PHIAL scores, and health and crime outcomes for each area, were analysed using multivariable negative binomial mixed-effects models to assess correlations between outcome and exposure, with 18-month average PHIAL score as the primary exposure metric. In-depth interviews (n = 53) and a workshop (n = 10) explored public health team approaches and potential mechanisms of impact of alcohol availability interventions with public health team members and licensing stakeholders (local authority licensing officers, managers and lawyers/clerks, police staff with a licensing remit, local elected representatives). Findings: Nineteen public health team activity types were assessed in six categories: (1) staffing; (2) reviewing and (3) responding to licence applications; (4) data usage; (5) influencing licensing stakeholders/policy; and (6) public involvement. Usage and intensity of activities and overall approaches varied within and between areas over time, including between Scotland and England. The latter variation could be explained by legal, structural and philosophical differences, including Scotland's public health objective. This objective was felt to legitimise public health considerations and the use of public health data within licensing. Quantitative analysis showed no clear evidence of association between level of public health team activity and the health or crime outcomes examined, using the primary exposure or other metrics (neither change in, nor cumulative, PHIAL scores). Qualitative data suggested that public health team input was valued by many licensing stakeholders, and that alcohol availability may lead to harms by affecting the accessibility, visibility and norms of alcohol consumption, but that the licensing systems have limited power to act in the interests of public health. Conclusions: This study provides no evidence that public health team engagement in local licensing matters was associated with measurable downstream reductions in crime or health harms, in the short term, or over a 7-year follow-up period. The extensive qualitative data suggest that public health team engagement is valued and appears to be slowly reorienting the licensing system to better address health (and other) harms, especially in Scotland, but this will take time. A rise in home drinking, alcohol deliveries, and the inherent inability of the licensing system to reduce - or in the case of online sales, to contain - availability, may explain the null findings and will continue to limit the potential of these licensing systems to address alcohol-related harms. Future work: Further analysis could consider the relative success of different public health team approaches in terms of changing alcohol availability and retailing. A key gap relates to the nature and impact of online availability on alcohol consumption, harms and inequalities, alongside development and study of relevant policy options. A national approach to licensing data and oversight would greatly facilitate future studies and public health input to licensing. Limitations: Our interview data and therefore PHIAL scores may be limited by recall bias where documentary evidence of public health activity was not available, and by possible variability in grading of such activity, though steps were taken to minimise both. The analyses would have benefited from additional data on licensing policies and environmental changes that might have affected availability or harms in the study areas. Study registration: The study was registered with the Research Registry (researchregistry6162) on 26 October 2020. The study protocol was published in BMC Medical Research Methodology on 6 November 2018. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number 15/129/11.

Research finds that when alcohol is more easily available, because more places sell alcohol or have longer opening hours, people tend to drink more and harms tend to increase. In England and Scotland, 'Licensing Committees' in local governments have power over which venues are given a licence to sell alcohol legally. They make decisions based on local policy and on licensing goals set out in law. Licensing laws are slightly different in both nations, and health representatives are often involved in trying to influence local licensing decisions and policies, to reduce alcohol-related harms. We aimed to find out what public health teams have done to influence alcohol licensing and whether their actions have affected alcohol-related harms. We recruited 39 public health teams (Scotland: 12; England: 27) and measured how active they were on licensing matters. We gathered detailed information (from interviews and papers) about their actions from 2012 to 2019, and asked them and others involved in licensing (including police, and local authority licensing teams and lawyers) about how their efforts might make a difference to harms. We gathered local data on alcohol-related health harms and crimes during 2009­19. We analysed whether any changes in these harms were related to the level of public health team activity, and explored differences between Scotland and England. Public health teams across Scotland and England took varied approaches to engaging in alcohol licensing, and their work was often welcomed by others working in the licensing system. However, we found no clear relationship between the level of licensing-related activity that public health teams engaged in and the levels of alcohol-related health harms or crime. This may be because their actions make only a modest difference to licensing decisions, or because it may take longer than the study period for them to have a sizeable impact. Reducing alcohol-related harms through licensing may require strengthening national licensing laws and the powers of public health teams, including by addressing online sales and home deliveries.

Measuring How Public Health Stakeholders Seek to Influence Alcohol Premises Licensing in England and Scotland: The Public Health Engagement In Alcohol Licensing (PHIAL) Measure.

OBJECTIVE: In the United Kingdom, some public health teams (PHTs) routinely engage with local alcohol premises licensing systems, through which licenses to sell alcohol are granted. We aimed to categorize PHT efforts and to develop and apply a measure of their efforts over time. METHOD: Preliminary categories of PHT activity were developed based on prior literature and were used to guide data collection with PHTs in 39 local government areas (27 in England; 12 in Scotland), sampled purposively. Relevant activity from April 2012 to March 2019 was identified through structured interviews (N = 62), documentation analysis, and follow-up checks, and a grading system was developed. The measure was refined based on expert consultation and used to grade relevant PHT activity for the 39 areas in 6-month periods. RESULTS: The Public Health engagement In Alcohol Licensing (PHIAL) Measure includes 19 activities in six categories: (a) staffing; (b) reviewing license applications; (c) responding to license applications; (d) data usage; (e) influencing licensing stakeholders or policy; and (f) public involvement. PHIAL scores for each area demonstrate fluctuation in type and level of activity between and within areas over time. Participating PHTs in Scotland were more active on average, particularly on senior leadership, policy development, and working with the public. In England, activity to influence license applications before decision was more common, and a clear increase in activity is apparent from 2014 onward. CONCLUSIONS: The novel PHIAL Measure successfully assessed diverse and fluctuating PHT engagement in alcohol licensing systems over time and will have practice, policy, and research applications.

Impact of public health team engagement in alcohol licensing on health and crime outcomes in England and Scotland: A comparative timeseries study between 2012 and 2019.

Background: Public health teams (PHTs) in England and Scotland engage to varying degrees in local alcohol licensing systems to try to reduce alcohol-related harms. No previous quantitative evidence is available on the effectiveness of this engagement. We aimed to quantify the effects of PHT engagement in alcohol licensing on selected health and crime outcomes. Methods: 39 PHTs in England (n = 27) and Scotland (n = 12) were recruited (of 40 contacted) for diversity in licensing engagement level and region, with higher activity areas matched to lower activity areas. Each PHT's engagement in licensing for each 6 month period from April 2012 to March 2019 was quantified using a new measure (PHIAL) developed using structured interviews, documentary analyses, and expert consultation. Outcomes examined were ambulance callouts, alcohol-related hospital admissions, alcohol-related and alcohol-specific mortality and violent, sexual and public order offences. Timeseries were analysed using multivariable negative binomial mixed-effects models. Correlations were assessed between each outcome and 18-month average PHIAL score (primary metric), cumulative PHIAL scores and change in PHIAL scores. Additionally, 6-month lagged correlations were also assessed. Findings: There was no clear evidence of any associations between the primary exposure metric and the public health or crime outcomes examined, nor between cumulative PHIAL scores or change in PHIAL score and any outcomes. There were no significant associations in England or Scotland when analysed separately or between outcomes and lagged exposure metrics. Interpretation: There is no clear evidence that allocating PHT resources to engaging in alcohol licensing is associated with downstream reductions in alcohol-related health harms or crimes, in the short term or over a seven year follow-up period. Such engagement likely has benefits in shaping the licensing system to take account of health issues longer term, but as current systems cannot reduce alcohol availability or contain online sales, their potential benefits are somewhat constrained. Funding: The ExILEnS project is funded by the NIHR Public Health Research Programme (project number 15/129/11). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Exploring the impact of public health teams on alcohol premises licensing in England and Scotland (ExILEnS): procotol for a mixed methods natural experiment evaluation.

BACKGROUND: Recent regulatory changes in the system by which premises are licensed to sell alcohol, have given health representatives a formal role in the process in England and Scotland. The degree to which local public health teams engage with this process varies by locality in both nations, which have different licensing regimes. This study aims to critically assess the impact on alcohol-related harms - and mechanisms - of public health stakeholders' engagement in alcohol premises licensing from 2012 to 2018, comparing local areas with differing types and intensities of engagement, and examining practice in Scotland and England. METHODS: The study will recruit 20 local authority areas where public health stakeholders have actively engaged with the alcohol premises licensing system (the 'intervention') and match them to a group of 20 lower activity areas using genetic matching. Four work packages are included: (1) Structured interviews and documentary analysis will examine the type and level of intervention activity from 2012 to 2018, creating a novel composite measure of the intensity of such activity and will assess the local licensing system and potential confounding activities over the same period. In-depth interviews with public health, licensing, police and others will explore perceived mechanisms of change, acceptability, and impact. (2) Using longitudinal growth models and time series analyses, the study will evaluate the impact of high and low levels of activity on alcohol-related harms using routine data from baseline 2009 to 2018. (3) Intervention costs, estimated National Health Service cost savings and health gains will be evaluated using the Sheffield Alcohol Policy Model to estimate impact on alcohol consumption and health inequalities. (4) The study will engage public health teams to create a new theory of change for public health involvement in the licensing process using our data. We will share findings with local, national and international stakeholders. DISCUSSION: This interdisciplinary study examines, for the first time, whether and how public health stakeholders' involvement in alcohol licensing impacts on alcohol harms. Using mixed methods and drawing on complex systems thinking, it will make an important contribution to an expanding literature evaluating interventions not suited to traditional epidemiological research.

Clinical, microbiological, and immunological characteristics in HIV-infected subjects at risk for disseminated Mycobacterium avium complex disease: an AACTG study.

The clinical, microbiologic, and immunologic parameters in HIV-infected subjects first presenting with disseminated Mycobacterium avium complex (DMAC) were determined. Four HIV-positive groups not yet on DMAC treatment were enrolled: 19 subjects with CD4 lymphocyte counts < or =50/microl thought to have DMAC on clinical grounds; 18 subjects newly found to have a positive blood culture for MAC; 25 asymptomatic controls (CD4 cell counts < or =50); and 25 asymptomatic controls (CD4 counts 100-250/microl). Outcome measures include comparisons between groups for clinical characteristics; results of cultures from blood, marrow, and gastrointestinal and respiratory tracts; immunological markers from staining of marrow and flow cytometry of circulating lymphocytes; and cytokine production of PBMCs. Only 21% of the 19 patients entered on suspicion of having DMAC grew MAC from blood or marrow. Neither clinical presentation nor laboratory tests differentiated those culture-positive from those culture-negative patients. However, prior PCP or multiple other opportunistic infections were more common in the DMAC group. MAC was isolated from 82% of marrow and 50% of blood specimens from the DMAC group. Respiratory or gastrointestinal colonization was present in 36% of DMAC subjects, but only 5% of non-DMAC subjects with CD4 counts <50 cells/microl. CD8+ cells were more frequent in bone marrow, and CD4 cells recognizing MAC antigen were more frequent in blood from DMAC subjects vs. controls. Results suggest an early stage of tissue dissemination preceding persistent bacteremia, and mucosal entry without persistence of colonization. MAC-specific T cell responses apparently develop and persist during DMAC, but are dysfunctional or too infrequent to prevent persistence.

Daily low-dose subcutaneous interleukin-2 added to single- or dual-nucleoside therapy in HIV infection does not protect against CD4+ T-cell decline or improve other indices of immune function: results of a randomized controlled clinical trial (ACTG 248).

CONTEXT: Approaches to preserve or enhance immune function in HIV-1 infection are needed. OBJECTIVES: To examine the ability of daily low-dose interleukin-2 (IL-2) in combination with antiretroviral therapy to preserve circulating CD4+ T-cell counts, the clinical safety and tolerability of this treatment, and safety with respect to changes in plasma HIV-1 RNA levels. DESIGN: Twenty-four-week, phase 2, multicenter, randomized, open-label trial conducted at 12 AIDS Clinical Trials Units between September 1995 and May 1997. PARTICIPANTS: A total of 115 HIV-infected persons with screening CD4+ T-cell counts between 300 and 700 cells/mm who were on stable single- or dual-nucleoside therapy for at least 2 months, 11% of whom were also on a protease inhibitor at study entry. INTERVENTIONS: Patients were randomly assigned to receive IL-2 at a dose of 1 million IU subcutaneously once daily plus continued anti-retroviral therapy (ART + IL-2, n = 57) vs. continued ART alone (ART alone, n = 58). IL-2 dose reductions were made for objective or subjective toxicities. All subjects randomly assigned to the IL-2 arm who interrupted ART were also required to discontinue IL-2 for the same period. MAIN OUTCOME MEASURES: The primary endpoint was a decrease in CD4 T-cell count from baseline; the safety analysis was based on change in plasma HIV RNA by bDNA; and clinical safety and tolerability were analyzed by standard clinical criteria. RESULTS: Of the patients with a baseline CD4 T-cell count recorded, 15 (27%) of 55 patients randomly assigned to ART alone had a drop of > or =25% in their CD4 T-cell count and 23 (41%) of 56 patients randomly assigned to ART + IL-2 had a drop of > or =25% in their CD4 T-cell count at some time over the 24 weeks of the study. This difference was not statistically significant. There was a statistically significant greater variance in CD4 T-cell counts in the IL-2-treated group. More patients in the IL-2 group had at least a 25% increase in CD4 T-cell counts over baseline (34 vs. 13%, P = 0.007). A comparison of grade 3 or worse toxicity showed no differences between the arms, but IL-2 was associated with significantly more grade 2 or worse general body symptoms, primarily discomfort and fatigue. There was no significant difference between the groups with regard to changes in plasma HIV RNA, lymphocyte proliferation, natural killer cell activity, skin test responses to recall antigens, or antibody responses to immunization. Plasma markers of immune activation all increased significantly in IL-2 recipients. CONCLUSIONS: In patients with baseline CD4 T-cell counts > or =300 cells/mm primarily treated with single- or dual-nucleoside ART, subcutaneously administered IL-2 at a dose of 1 million IU daily for up to 24 weeks had low toxicity but showed no consistent benefit in preventing decline in CD4 T-cell counts and minimal evidence of immunologic improvement vs. continued ART alone.

A prospective, randomized trial examining the efficacy and safety of clarithromycin in combination with ethambutol, rifabutin, or both for the treatment of disseminated Mycobacterium avium complex disease in persons with acquired immunodeficiency syndrome.

This multicenter, randomized, open-label phase 3 clinical trial compared the safety and efficacy of 3 clarithromycin-containing combination regimens for the treatment of disseminated Mycobacterium avium complex (MAC) disease in persons with acquired immunodeficiency syndrome. A total of 160 eligible patients with bacteremic MAC disease were randomized to receive clarithromycin with either ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks of treatment, the proportion of subjects with a complete microbiologic response was not statistically significantly different among treatment arms: the proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R group (P=.454). The proportion of patients with complete or partial responses who experienced a relapse while receiving C+R (24%) was significantly higher than that of patients receiving C+E+R (6%; P=.027) and marginally higher than that of patients receiving C+E (7%; P=.057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).

A multi-investigator/institutional DNA bank for AIDS-related human genetic studies: AACTG Protocol A5128.

BACKGROUND: An understanding of the relationships among allelic variability and clinical outcomes will be critical if HIV-infected patients are to benefit from the explosion in knowledge in human genomics. Human DNA banks must allow future analyses while addressing confidentiality, ethical, and regulatory issues. METHOD: A multidisciplinary group of clinical investigators, ethicists, data managers, regulatory specialists, and community representatives developed Adult AIDS Clinical Trials Group (AACTG) Protocol A5128. Participants in past or present AACTG clinical trials may contribute DNA. Extraction from whole blood is performed at a central laboratory, where participants' unique identifiers are replaced by randomly assigned identifiers prior to DNA storage. To identify genotype-phenotype relationships, genetic assay results can be temporarily linked to clinical trials data. RESULTS: Institutional review boards in 21 states and Puerto Rico have approved Protocol A5128, and accrual is ongoing. Of the first 4,247 enrollees, 82% are male, 56% are white, 26% are African American, and 15% are Hispanic. Because participants may participate in multiple AACTG protocols, these represent 11,424 cases in 324 different AACTG studies and substudies, with at least 100 participants from 24 different studies. Studies exploring specific genotype-phenotype relationships are underway. CONCLUSION: The AACTG DNA bank will be an important resource for genomic discovery relevant to HIV therapy.