scholarly journals Pilot trial and process evaluation of a multilevel smoking prevention intervention in further education settings

2017 ◽  
Vol 5 (8) ◽  
pp. 1-82 ◽  
Author(s):  
Adam Fletcher ◽  
Micky Willmott ◽  
Rebecca Langford ◽  
James White ◽  
Ria Poole ◽  
...  

Background Preventing smoking uptake among young people is a public health priority. Further education (FE) settings provide access to the majority of 16- to 18-year-olds, but few evaluations of smoking prevention interventions have been reported in this context to date. Objectives To evaluate the feasibility and acceptability of implementing and trialling a new multilevel smoking prevention intervention in FE settings. Design Pilot cluster randomised controlled trial and process evaluation. Setting Six UK FE institutions. Participants FE students aged 16–18 years. Intervention ‘The Filter FE’ intervention. Staff working on Action on Smoking and Health Wales’ ‘The Filter’ youth project applied existing staff training, social media and youth work resources in three intervention settings, compared with three control sites with usual practice. The intervention aimed to prevent smoking uptake by restricting the sale of tobacco to under-18s in local shops, implementing tobacco-free campus policies, training FE staff to deliver smoke-free messages, publicising The Filter youth project’s online advice and support services, and providing educational youth work activities. Main outcome measures (1) The primary outcome assessed was the feasibility and acceptability of delivering and trialling the intervention. (2) Qualitative process data were analysed to explore student, staff and intervention team experiences of implementing and trialling the intervention. (3) Primary, secondary and intermediate (process) outcomes and economic evaluation methods were piloted. Data sources New students at participating FE settings were surveyed in September 2014 and followed up in September 2015. Qualitative process data were collected via interviews with FE college managers (n = 5) and the intervention team (n = 6); focus groups with students (n = 11) and staff (n = 5); and observations of intervention settings. Other data sources were semistructured observations of intervention delivery, intervention team records, ‘mystery shopper’ audits of local shops and college policy documents. Results The intervention was not delivered as planned at any of the three intervention settings, with no implementation of some community- and college-level components, and low fidelity of the social media component across sites. Staff training reached 28 staff and youth work activities were attended by 190 students across the three sites (< 10% of all eligible staff and students), with low levels of acceptability reported. Implementation was limited by various factors, such as uncertainty about the value of smoking prevention activities in FE colleges, intervention management weaknesses and high turnover of intervention staff. It was feasible to recruit, randomise and retain FE settings. Prevalence of weekly smoking at baseline was 20.6% and was 17.2% at follow-up, with low levels of missing data for all pilot outcomes. Limitations Only 17% of eligible students participated in baseline and follow-up surveys; the representativeness of student and staff focus groups is uncertain. Conclusions In this study, FE settings were not a supportive environment for smoking prevention activities because of their non-interventionist institutional cultures promoting personal responsibility. Weaknesses in intervention management and staff turnover also limited implementation. Managers accept randomisation but methodological work is required to improve student recruitment and retention rates if trials are to be conducted in FE settings. Trial registration Current Controlled Trials ISRCTN19563136. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 5, No. 8. See the NIHR Journals Library website for further project information. It was also funded by the Big Lottery Fund.

2017 ◽  
Vol 5 (7) ◽  
pp. 1-98 ◽  
Author(s):  
James White ◽  
Jemma Hawkins ◽  
Kim Madden ◽  
Aimee Grant ◽  
Vanessa Er ◽  
...  

BackgroundIllicit drug use increases the risk of poor physical and mental health. There are few effective drug prevention interventions.ObjectiveTo assess the acceptability of implementing and trialling two school-based peer-led drug prevention interventions.DesignStage 1 – adapt ASSIST, an effective peer-led smoking prevention intervention to deliver information from the UK national drug education website [see www.talktofrank.com (accessed 29 August 2017)]. Stage 2 – deliver the two interventions, ASSIST + FRANK (+FRANK) and FRANK friends, examine implementation and refine content. Stage 3 – four-arm pilot cluster randomised control trial (cRCT) of +FRANK, FRANK friends, ASSIST and usual practice, including a process evaluation and an economic assessment.SettingFourteen secondary schools (two in stage 2) in South Wales, UK.ParticipantsUK Year 8 students aged 12–13 years at baseline.Interventions+FRANK is a UK informal peer-led smoking prevention intervention provided in Year 8 followed by a drug prevention adjunct provided in Year 9. FRANK friends is a standalone informal peer-led drug prevention intervention provided in Year 9. These interventions are designed to prevent illicit drug use through training influential students to disseminate information on the risks associated with drugs and minimising harms using content from www.talktofrank.com. Training is provided off site and follow-up visits are made in school.OutcomesStage 1 – +FRANK and FRANK friends intervention manuals and resources. Stage 2 – information on the acceptability and fidelity of delivery of the interventions for refining manuals and resources. Stage 3 – (a) acceptability of the interventions according to prespecified criteria; (b) qualitative data from students, staff, parents and intervention teams on implementation and receipt of the interventions; (c) comparison of the interventions; and (d) recruitment and retention rates, completeness of primary, secondary and intermediate outcome measures and estimation of costs.Results+FRANK and FRANK friends were developed with stakeholders [young people, teachers (school management team and other roles), parents, ASSIST trainers, drug agency staff and a public health commissioner] over an 18-month period. In the stage 2 delivery of +FRANK, 12 out of the 14 peer supporters attended the in-person follow-ups but only one completed the electronic follow-ups. In the pilot cRCT, 12 schools were recruited, randomised and retained. The student response rate at the 18-month follow-up was 93% (1460/1567 students). Over 80% of peer supporters invited were trained and reported conversations on drug use and contact with trainers. +FRANK was perceived less positively than FRANK friends. The prevalence of lifetime illicit drug use was 4.1% at baseline and 11.6% at follow-up, with low numbers of missing data for all outcomes. The estimated cost per school was £1942 for +FRANK and £3041 for FRANK friends. All progression criteria were met.ConclusionsBoth interventions were acceptable to students, teachers and parents, but FRANK friends was preferred to +FRANK. A limitation of the study was that qualitative data were collected on a self-selecting sample. Future work recommendations include progression to a Phase III effectiveness trial of FRANK friends.Trial registrationCurrent Controlled Trials ISRCTN14415936.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 5, No. 7. See the NIHR Journals Library website for further project information. The work was undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer). Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK CRC, is gratefully acknowledged.


2021 ◽  
Vol 9 (9) ◽  
pp. 1-116
Author(s):  
Esther MF van Sluijs ◽  
Helen E Brown ◽  
Emma Coombes ◽  
Claire Hughes ◽  
Andrew P Jones ◽  
...  

Background Family-based physical activity promotion presents a promising avenue for promoting whole-family physical activity, but high-quality research is lacking. Objectives To assess the feasibility, acceptability and preliminary effectiveness of FRESH (Families Reporting Every Step to Health), a child-led online family-based physical activity intervention; and to identify effective and resource-efficient family recruitment strategies. Design The project consisted of (1) a randomised feasibility trial, (2) a randomised controlled pilot trial and (3) a systematic review and Delphi study. Setting Norfolk/Suffolk counties, UK. Participants Families, recruited from schools, workplaces and community settings, were eligible to participate if one child aged 7–11 years and one adult responsible for their care provided written consent; all family members could participate. Interventions The FRESH intervention, guided by self-determination theory, targeted whole families and was delivered via an online platform. All family members received pedometers and were given website access to select family step challenges to ‘travel’ to target cities around the world, log steps, and track progress as they virtually globetrotted. Families were randomised to FRESH intervention, pedometer-only or control arm. Main outcome measures Physical (e.g. blood pressure), psychosocial (e.g. family functioning) and behavioural (e.g. device-measured family physical activity) measures were collected at baseline and at 8- and 52-week follow-up. A mixed-methods process evaluation assessed the acceptability of the intervention and evaluation. Data sources review Systematic search of four databases (Cochrane Library, PubMed, PsycINFO and SCOPUS). Review methods Articles were screened in duplicate, and data extraction was fully checked. Academic experts participated in the three-round Delphi study. Data were combined to identify effective and resource-efficient family recruitment strategies. Inclusion criteria Included generally healthy school-aged children and at least one adult; intervention attempted to change physical activity, sedentary behaviour, screen use, diet, or prevent overweight/obesity in multiple family members; presented relevant measure of effect in children and adults. Results The feasibility study (12 families, 32 participants; 100% retention at 8 weeks) demonstrated the feasibility and acceptability of FRESH, but highlighted that adaptations were required. Of 41 families recruited in the pilot study (149 participants), 98% and 88% were retained at the 8-week and 52-week follow-up, respectively. More children in the FRESH arm self-reported doing more family physical activity, and they thought that FRESH was fun. There were no notable between-group differences in children’s outcomes. Change in moderate to vigorous physical activity at 8 weeks favoured FRESH intervention adults [vs. control: 9.4 minutes/week (95% confidence interval 0.4 to 18.4) vs. pedometer only: 15.3 (95% confidence interval 6.0 to 24.5)], and was stronger in fathers, but this was not maintained. In 49 included studies, apart from recruitment settings and strategies used (reported in 84% and 73% of the studies, respectively), recruitment details were scarce. School-based recruitment was predominant. The Delphi study identified a wide range of recruitment settings and strategies. Limitations Recruitment was the main limitation of the FRESH studies; generalisability of the proposed recruitment strategies may be limited. Conclusions This study has demonstrated the feasibility and acceptability of the FRESH intervention. However, we failed to recruit the target sample size and were unable to demonstrate a signal of effectiveness. Future research should employ a multifaceted recruitment approach. Future work Further refinements to intervention delivery and recruitment methods should be investigated. Study registration Current Controlled Trials ISRCTN12789422 and PROSPERO CRD42019140042. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Z Zins

Abstract The overarching objective of CONSTANCES is to constitute a research infrastructure based on a large population-based cohort to serve as a versatile, high quality and efficient platform for population health research. Constances is designed as a representative sample of 200,000 adults aged 18-69 at inception living in different regions of France. CONSTANCES, which is accessible to the national and international research community, enables the conduct of valid and well-powered studies in a wide range of scientific domains. For each participant, it combines detailed data collection at baseline, englobing lifestyle, environmental, social, and medical history information, with medical examinations, neuropsychological testing with the added advantage of linkage with two major national administrative data bases (SNDS and CNAV). Further, CONSTANCES collects information about changing lifestyles, environments, health behaviors and health conditions on a prospective ongoing basis. A biobank of blood and urine samples is in the process of being constituted. As of April 2018, 85 nested projects designed by French and international teams in many areas of biomedical and public health research were initiated. Constances participates in several French and international consortiums. We established relationships with public health institutions and industrial companies. In the next years, we plan to continue longitudinal follow-up CONSTANCES along the same lines by extending the follow-up of the cohort and by developing innovative new themes prioritizing the strengthening of certain “niches” where CONSTANCES can have international leadership.


2021 ◽  
Vol 9 (12) ◽  
pp. 1-138
Author(s):  
Judi Kidger ◽  
Rhiannon Evans ◽  
Sarah Bell ◽  
Harriet Fisher ◽  
Nicholas Turner ◽  
...  

Background Health and Safety Executive data show that teachers are at heightened risk of mental health difficulties, yet few studies have attempted to address this. Poor teacher mental health may impact on the quality of support provided to young people, who also report increased mental health difficulties themselves. Objective To test the effectiveness of an intervention aiming to improve secondary school teachers’ well-being through mental health support and training. Design A cluster randomised controlled trial with embedded process and economic evaluations. Setting Twenty-five mainstream, non-fee-paying secondary schools in the south-west of England and South Wales, stratified by geographical area and free school meal entitlement, randomly allocated to intervention or control groups following collection of baseline measures (n = 12, intervention; n = 13, control) between May and July 2016. Participants All teachers in the study schools at any data collection. All students in year 8 (baseline) and year 10 (final follow-up). Intervention Each intervention school received three elements: (1) a 1-day mental health first aid for schools and colleges training session delivered to 8% of all teachers; (2) a 1-hour mental health session delivered to all teachers; and (3) 8% of staff trained in the 2-day standard mental health first aid training course set up a confidential peer support service for colleagues. Control schools continued with usual practice. Main outcome measures The primary outcome was teacher well-being (using the Warwick–Edinburgh Mental Wellbeing Scale). Secondary outcomes were teacher depression, absence and presenteeism, and student well-being, mental health difficulties, attendance and attainment. Follow-up was at 12 and 24 months. Data were analysed using intention-to-treat mixed-effects repeated-measures models. Economic evaluation A cost–consequence analysis to compare the incremental cost of the intervention against the outcomes measured in the main analysis. Process evaluation A mixed-methods study (i.e. qualitative focus groups and interviews, quantitative surveys, checklists and logs) to examine intervention implementation, activation of the mechanisms of change outlined in the logic model, intervention acceptability and the wider context. Results All 25 schools remained in the study. A total of 1722 teachers were included in the primary analysis. We found no difference in mean teacher well-being between study arms over the course of follow-up (adjusted mean difference –0.90, 95% confidence interval –2.07 to 0.27). There was also no difference in any of the secondary outcomes (p-values 0.203–0.964 in the fully adjusted models). The average cost of the intervention was £9103 (range £5378.97–12,026.73) per intervention school, with the average cost to Welsh schools being higher because of a different delivery model. The training components were delivered with high fidelity, although target dosage was sometimes missed. The peer support service was delivered with variable fidelity, and reported usage by teachers was low (5.9–6.1%). The intervention had high acceptability, but participants reported low support from senior leadership, and minimal impact on school culture. Limitations Participants and the study team were unblinded, self-report for the main outcome measures and inaccurate measurement of peer support service usage. Conclusions The Wellbeing in Secondary Education (WISE) intervention was not effective at improving teacher or student well-being, or reducing mental health difficulties, possibly because of contextual barriers preventing it becoming embedded in school life. Future work Identification of ways in which to achieve system-level change and sustained support from senior leaders is important for future school-based mental health interventions. Trial registration Current Controlled Trials ISRCTN95909211. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 12. See the NIHR Journals Library website for further project information. Intervention costs were met by Public Health Wales, Public Health England and Bristol City Council.


2015 ◽  
Vol 3 (15) ◽  
pp. 1-188 ◽  
Author(s):  
Jeremy Segrott ◽  
Heather Rothwell ◽  
Gillian Hewitt ◽  
Rebecca Playle ◽  
Chao Huang ◽  
...  

BackgroundInvolvement of parents/carers may increase the effectiveness of primary school-based alcohol-misuse prevention projects. However, few interventions have been designed for pre-adolescent children, or specifically involve parents/carers. The Kids, Adults Together (KAT) programme in primary schools aimed to reduce alcohol misuse through such an approach.ObjectiveTo determine the value and feasibility of conducting an effectiveness trial of KAT.DesignParallel-group cluster randomised exploratory trial with an embedded process evaluation. Schools were the unit of randomisation.SettingPrimary schools (n = 9) in south Wales, UK.ParticipantsPupils in Year 5/6 (aged 9–11 years) and their parents/carers; school staff.InterventionThe Kids, Adults Together programme consisted of (1) classwork addressing the effects of alcohol; (2) a family event for children and parents/carers; and (3) a ‘goody bag’ containing fun items, including a digital versatile disc (DVD) for families to watch together. The intervention comprised KAT plus existing alcohol-related activities and lessons. Control-group schools continued with existing alcohol-related lessons and activities.Main outcome measuresKey outcomes related to the progression criteria for a potential future effectiveness trial. These included the acceptability, participation equity, feasibility and implementation of KAT; the recruitment and retention of research participants; and the acceptability and feasibility of research processes, including data collection methods and outcome measures.ResultsNine schools (free school meal entitlement ranging from 1% to 37.2%) participated. Two of five intervention schools withdrew but all four control schools were retained, and these seven schools facilitated all research data collections. Programme acceptability and participation rates were high in all three intervention schools (parent/carer participation rates ranged from 45.1% to 65.7%), although implementation quality varied. At baseline, approximately 75% of eligible children (n = 418) provided data, of whom 257 also provided data at follow-up. Only 27 parents/carers (estimated response rate 6.5%) completed interviews. Most children were willing to complete questionnaires but measures were not appropriate for this age group. Measures of alcohol consumption produced inconsistent responses. Intermediate outcomes on family communication showed no evidence of intervention effectiveness.ConclusionsIn the three schools that received the KAT intervention, it was found to be acceptable to schools and pupils and there were good levels of participation from parents/carers from across a range of socioeconomic groups. However, two intervention schools withdrew from the trial. Findings from intermediate outcomes on family communication did not support programme theory. In addition, the study highlighted challenges in identifying suitable outcome measures for children aged 9–11 years and the feasibility of long-term follow-up via secondary schools.Future workIt would not be appropriate to proceed to an effectiveness trial of KAT. There are doubts/uncertainties about the potential effects of KAT; suitability of measures; the large number of schools which would be required for an effectiveness trial of KAT, and the cost of this; feasibility of follow-up in secondary schools; and programme implementation and theory. There is a need to develop and validate measures for children aged 9–11 years; to test the feasibility of follow-up data collection methods in secondary schools; and to further consider sample size requirements and feasibility.Trial registrationCurrent Controlled Trials ISRCTN80672127.FundingThe exploratory trial of this project was funded by the National Institute for Health Research Public Health Research programme and the process evaluation was funded by the Economic and Social Research Council. The work was undertaken with the support of The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. This project will be published in full inPublic Health Research; Vol. 3, No. 15. See the NIHR Journals Library website for further project information.


2015 ◽  
Vol 3 (4) ◽  
pp. 1-60 ◽  
Author(s):  
Suzanne Audrey ◽  
Sunita Procter ◽  
Ashley Cooper ◽  
Nanette Mutrie ◽  
William Hollingworth ◽  
...  

BackgroundPhysical inactivity increases the risk of many chronic diseases, including coronary heart disease, type 2 diabetes, obesity and some cancers. Increasing physical activity levels, particularly among the most sedentary, is an important aim of current public health policy in the UK. An opportunity for working adults to increase physical activity levels may be through walking during the daily commute.ObjectivesTo build on existing knowledge and resources to develop an employer-led scheme to increase walking to work; to test the feasibility of implementing and evaluating the intervention; and to explore other requirements of a full-scale trial.DesignFeasibility study incorporating phase 1 resource review, focus groups with employees and interviews with employers in three workplaces (one small, one medium and one large); and phase 2 exploratory cluster randomised controlled trial (RCT) including process and economic evaluations.SettingWorkplaces (eight small, five medium and four large) in Bristol.ParticipantsOne hundred and eighty-seven employees (89 male and 98 female) at baseline.InterventionsWalk to Work promoters were recruited and trained about the health, social, economic and environmental benefits of walking to work and how to identify and promote safe walking routes for employees. They were given resource packs based on nine key behaviour change techniques. The role of the Walk to Work promoter was to encourage participating employees in their workplace to walk to work; to help to identify walking routes; to encourage goal setting; and to provide additional encouragement through four contacts over the following 10 weeks (face to face, e-mail or telephone, as appropriate).Main outcome measuresRecruitment and retention rates; sample size calculation and estimation of the intracluster correlation coefficient (ICC); acceptability of the intervention and evaluation methods; and estimation of costs.ResultsWorkplace and employee recruitment appeared to be restricted by the initial requirement to identify employees living within 2 miles of the workplace. Once recruited, no workplace withdrew from the study between baseline and 1-year follow-up. It proved feasible to recruit and train workplace Walk to Work promoters. The response rate was 132 (71%) at 1-year follow-up. Although the study was not powered to measure effectiveness, accelerometer data suggest that overall physical activity and moderate to vigorous physical activity (MVPA) were higher in the intervention arm than in the control arm at 1-year follow-up. The ICC was estimated at 0.12 (95% confidence interval 0.00 to 0.30). Based on an average cluster size of eight, an ICC of 0.15 and attrition of 25%, a total sample size of 678 would have 80% power with 5% significance to detect a 15% increase in mean MVPA. The average cost of the intervention was estimated at £441 per workplace. Activity levels were similar in the intervention and control arms at baseline.ConclusionsThe intervention and evaluation were feasible, and acceptable to participants. There was sufficient evidence of promise to justify a full-scale trial incorporating lessons learned during the feasibility study. Future work: an application is being submitted for a follow-on full-scale cluster RCT.Trial registrationCurrent Controlled Trials ISRCTN72882329.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 4. See the NIHR Journals Library website for further project information. The work was undertaken with the support of The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged.


2021 ◽  
Author(s):  
Neville Calleja ◽  
Neetu Abad ◽  
AbdelHalim AbdAllah ◽  
Naglaa Ahmed ◽  
Dolores Albarracin ◽  
...  

BACKGROUND An infodemic is an overflow of information of varying quality that surges across digital and physical environments during an acute public health event. It leads to confusion, risk-taking and behaviors that can harm health and lead to erosion of trust in health authorities and public health responses. The global scale and high stakes of the emergency have made responding to the infodemic related to the COVID-19 pandemic particularly urgent. Building on diverse research disciplines and expanding the discipline of infodemiology, more evidence-based interventions are needed to design infodemic management interventions and tools, and implement them by health emergency responders. OBJECTIVE WHO organised the first global infodemiology conference, entirely online during June-July 2020, and a follow up August-October 2020, to review current multidisciplinary evidence, interventions and practices that can be applied to the COVID-19 infodemic response. This resulted in a public health research agenda for managing infodemics. METHODS As part of the conference, a structured expert judgement synthesis method was used to formulate a public health research agenda. One hundred and ten participants represented diverse scientific disciplines, from over 35 countries and global public health implementing partners. The conference used a laddered discussion sprint methodology by rotating participant teams, and a follow-up managed process to assemble a research agenda based on the discussion and structured expert feedback. This resulted in a five-work-stream frame of the research agenda for infodemic management and 166 suggested research questions. The participants then ranked the questions for feasibility and expected public health impact. The expert consensus was summarised in a public health research agenda which included a list of priority research questions. RESULTS The public health research agenda for infodemic management has five work-streams: (i) measuring and continuously monitoring the impact of infodemics during health emergencies; (ii) detecting signals and understanding the spread and risk of infodemics; (iii) responding aThe public health research agenda for infodemic management has five work-streams: (i) measuring and continuously monitoring the impact of infodemics during health emergencies; (ii) detecting signals and understanding the spread and risk of infodemics; (iii) responding and deploying interventions that mitigate and protect against infodemics and their harmful effects; (iv) evaluating infodemic interventions and strengthening the resilience of individuals and communities to infodemics; and (v) promoting the development, adaptation and application of interventions and toolkits for infodemic management. Each work-stream identified research questions and highlights 49 high priority research questions.nd deploying interventions that mitigate and protect against infodemics and their harmful effects; (iv) evaluating infodemic interventions and strengthening the resilience of individuals and communities to infodemics; and (v) promoting the development, adaptation and application of interventions and toolkits for infodemic management. Each work-stream identified research questions and highlights 49 high priority research questions. CONCLUSIONS Public health authorities need to develop, validate, implement and adapt tools and interventions for managing infodemics in acute public health events in ways that are appropriate for their countries and contexts. For that to be possible, infodemiology provides a scientific foundation. This research agenda proposes a structured framework for targeted investment for the scientific community, policymakers, implementing organizations and other stakeholders to consider.


2015 ◽  
Vol 3 (10) ◽  
pp. 1-152 ◽  
Author(s):  
Simon C Moore ◽  
Mohammed Fasihul Alam ◽  
David Cohen ◽  
Kerenza Hood ◽  
Chao Huang ◽  
...  

BackgroundViolence in and around premises licensed for the on-site sale and consumption of alcohol continues to burden the NHS with assault-related injuries.Trial designA randomised controlled trial with licensed premises as the unit of allocation, with additional process and cost-effectiveness evaluations.MethodsPremises were eligible (n = 837) if they were licensed for on-site sale and consumption of alcohol, were within 1 of the 22 local authorities (LAs) in Wales and had previously experienced violence. Data were analysed using Andersen–Gill recurrent event models in an intention-to-treat analysis. An embedded process evaluation examined intervention implementation, reach, fidelity, dose and receipt. An economic evaluation compared costs of the intervention with benefits.InterventionPremises were randomised to receive a violence-reduction intervention, Safety Management in Licensed Environments (SMILE), which was delivered by an environmental health practitioner (EHP; the agent). SMILE consisted of an initial risk audit to identify known risks of violence, a follow-up audit scheduled to enforce change for premises in which serious risks had been identified, structured advice from EHPs on how risks could be addressed in premises and online materials that provided educational videos and related material.ObjectiveTo develop intervention materials that are acceptable and consistent with EHPs’ statutory remit; to determine the effectiveness of the SMILE intervention in reducing violence; to determine reach, fidelity, dose and receipt of the intervention; and to consider intervention cost-effectiveness.OutcomeDifference in police-recorded violence between intervention and control premises over a 455-day follow-up period.RandomisationA minimum sample size of 274 licensed premises per arm was required, rounded up to 300 and randomly selected from the eligible population. Licensed premises were randomly assigned by computer to intervention and control arms in a 1 : 1 ratio. Optimal allocation was used, stratified by LA. Premises opening hours, volume of previous violence and LA EHP capacity were used to balance the randomisation. Premises were dropped from the study if they were closed at the time of audit.ResultsSMILE was delivered with high levels of reach and fidelity but similar levels of dose to all premises, regardless of risk level. Intervention premises (n = 208) showed an increase in police-recorded violence compared with control premises (n = 245), although results are underpowered. An initial risk audit was less effective than normal practice (hazard ratio = 1.34, 95% confidence interval 1.20 to 1.51) and not cost-effective. Almost all eligible intervention premises (98.6%) received the initial risk audit; nearly 40% of intervention practices should have received follow-up visits but fewer than 10% received one. The intervention was acceptable to EHPs and to some premises staff, but less so for smaller independent premises.ConclusionsSMILE was associated with an increase in police-recorded violence in intervention premises, compared with control premises. A lack of follow-up enforcement visits suggests implementation failure for what was seen as a key mechanism of action. There are also concerns as to the robustness of police data for targeting and assessing outcome effectiveness, while intervention premises may have received greater attention from statutory agencies and, therefore, the identification of more violence than control premises. Although SMILE had high reach and was feasible and acceptable to EHPs, it was found to be ineffective and associated with increased levels of violence, compared with normal practice and it requires additional work to promote the implementation of follow-up enforcement visits. Future work will aim to better understand the role of intervention dose on outcomes and seek more objective measures of violence for use in similar trials.Trial registrationCurrent Controlled Trials ISRCTN78924818.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 10. See the NIHR Journals Library website for further project information.


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