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Background Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. Aims and Objectives To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation. Objectives To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. To explore the effects of individual intervention components on the primary outcomes. To investigate the mechanisms of impact. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff. Methods A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service. Discussion Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions. Trial registration ISRCTN17847169. Date registered: 15 December 2017.

Additional file 4. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Introduction To ease administration of medicines to people with dysphagia we developed and patented a gel formulation within which whole tablets could be inserted. The aim was to determine whether the gel would affect bioequivalence of uncoated aspirin tablet. Method A gel containing gelatin, hydroxypropylmethylcellulose, citric acid, potassium sorbate and water was developed to maintain structure on tablet insertion and increase saliva production to lubricate the swallow. In an open-label cross-over trial 12 healthy male volunteers were administered a 300 mg uncoated aspirin tablet with and without gel with a 7-day washout period. Blood salicylate levels, platelet activity and patient satisfaction were measured over 2 hours. Analysis was based on a random effects cross-over model. Results The estimated mean ratio (90% CI) of effect on salicylate levels when comparing administration with and without gel was 0.77 (90% CI 0.40 to 1.47) for amount absorbed and 0.76 (90% CI 0.44 to 1.31) and on total ASP-arachidonic acid platelet activity 1.16 (90% CI 0.88 to 1.53) and maximum ASP arachidonic platelet activity 0.98 (90% CI 0.79 to 1.22). These results are outside of the range allowable for the assumption of bioequivalence. Participants rated the taste of aspirin tablets significantly better when encapsulated in the gel (p

Service specification. (DOCX 21 kb)

Assessment of outcome measures based on data from Cochrane review [7] and experience of feasibility study. (DOCX 16 kb)

Recruitment strategies for GP and PIPs. (DOCX 14 kb)

Background: Effective management of minor ailments in community pharmacies could reduce the burden on alternative high-cost services (general practices, Emergency Departments). Evidence is needed regarding the appropriateness of management of these conditions in community pharmacies. Objective: To explore the appropriateness of minor ailment management in community pharmacies. Setting: Prospective, observational study of simulated patient (SP) visits to community pharmacies in Grampian (Scotland) and East Anglia (England). Method: Eighteen pharmacies (nine per centre) were recruited within a 25-mile radius of Aberdeen or Norwich. Consultations for four minor ailments were evaluated: back pain; vomiting/diarrhoea; sore throat; and eye discomfort. Each pharmacy received one SP visit per ailment (four visits/pharmacy; 72 visits total). Visits were audio-recorded and SPs completed a data collection form immediately after each visit. Primary Outcome Measure: Each SP consultation was assessed for appropriateness against product licence, practice guidelines and study-specific consensus standards developed by a multi-disciplinary consensus panel. Results: Evaluable data were available for 68/72 (94.4%) visits. Most (96%) visits resulted in the sale of a product; advice alone was the outcome of three visits. All product sales complied with the product licence, 52 (76%) visits complied with practice guidelines and seven visits achieved a ‘basic’ standard according to the consensus standard. Conclusion: Appropriateness of care varied according to the standard used. Pharmacy-specific quality standards are needed which are realistic and relevant to the pharmacy context and which reflect legal and clinical guidelines to promote the safe and effective management of minor ailments in this setting.

Introduction: More than 200,000 UK children aged 11–15 years start smoking each year and up to 50% of children who try smoking will become regular smokers within 2–3 years. Given the high personal, social and economic cost of smoking, intervening to prevent children and young people from beginning to smoke is an important public health goal. Whilst rates of smoking uptake have decreased significantly in recent years, the social gradient in young people taking up smoking remains marked, contributing to health inequalities. Methods: Using National Institute for Health Research (NIHR) Research Capability Funding (RCF) from a pooled fund contributed to by the Norfolk and Waveney Clinical Commissioning Groups, a team at the University of East Anglia undertook a comprehensive literature review and programme of public and patient involvement (PPI) in order to gather current evidence about the educational and psychosocial interventions that are effective in preventing smoking uptake, and improve understanding of current smoking prevention practice. The aim was both to provide evidence to inform commissioning decisions and to facilitate the development of an application for research funding for a trial of an intervention to support young people to choose not to start smoking. Results of review: The literature review identified a large number of educational and psychosocial interventions that have been found to be effective in reducing smoking uptake. Most of the identified interventions are universal, classroom-based interventions, designed to be delivered in mainstream schools. There is evidence that approaches to smoking prevention that combine elements designed to help young people refuse offers to smoke by improving general social competence, with elements aimed at increasing awareness of the social influences that promote smoking, may be most effective. However, it is important that smoking prevention interventions are tailored to the developmental stage of the age group targeted: interventions effective in one group may be ineffective, or even detrimental, in other populations. The ASSIST approach, involving training influential children to encourage their peers not to smoke, was the only approach identified with recent, UK evidence of both effectiveness and cost-effectiveness. Despite a clear rationale for targeting smoking prevention at high-risk groups, few interventions specifically targeting such groups have been trialled to-date. Results of PPI work: The PPI work carried out suggests that teaching in science lessons and/or Personal Social and Health education are the most common approaches to smoking prevention in Norfolk secondary schools. Providing information about the health threats of smoking was perceived by both teachers and pupils to be the most effective means of preventing smoking uptake. Given that research findings suggest that simply providing information about smoking is not the most effective means of preventing young people from taking up smoking, this may point to the need to provide schools with evidence-based information about optimum smoking prevention strategies. The use of peers to discourage smoking initiation was rarely reported as a currently used strategy in Norfolk, but most teachers and pupils responded that they believed this to be a good idea when specifically asked about this approach. Whilst all teachers and majority of pupils reported that their school had a policy in place in the event that pupils are found to be/suspected of smoking, fewer had a similar policy for pupils found to be/suspected of vaping (using e-cigarettes). Teachers reported awareness of school policies to also support smoking cessation where applicable (e.g. referral to specialist services), but pupils were generally unaware of such policies. Conclusions/recommendations: A range of evidence-based educational/psychosocial interventions for preventing uptake of smoking by young people are available, most of which are designed to be delivered within the school environment. The implementation of these interventions within schools has the potential to significantly reduce smoking prevalence, contributing to improvements in public health. However, it appears that many Norfolk schools may not be implementing these evidence-based interventions at present. Schools should be provided with information about the most effective strategies for preventing uptake of smoking by children and young people and encouraged to implement evidence-based smoking prevention initiatives. Equally, further research is needed to identify interventions that are effective in targeting groups of young people at high-risk of smoking uptake.

Aims: Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment. Design: A parallel-arm, pragmatic individually randomized controlled trial. Setting: Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics. Intervention: Participants in the experimental group (n = 703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n = 704) received a leaflet currently used in practice. Measurements: The primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self#x02010;reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables. Findings: There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75–1.16; P = 0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. Conclusions: In people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse.

The main characteristics of the included studies. (DOCX 86.4 kb)

Preoperative identification of smokers for smoking cessationâ a systematic literature reviewâ protocol.(DOCX 20.9 kb)

PRISMA 2009 Checklist. (DOC 63.5 kb)

Study selection flow diagram. (DOCX 27.8 kb)

List of excluded studies after full text examination.(DOCX 21.5 kb)