Self-help materials for smoking relapse prevention: a process evaluation of the SHARPISH randomized controlled trial.

Background: UK Stop Smoking Services are effective at assisting smokers to quit. However, smoking relapse rates are high, representing a significant public health problem. No effective interventions are currently available. This embedded qualitative process evaluation, within a randomized controlled trial of a self-help smoking relapse prevention intervention, aimed to understand patient perspectives in explaining the null trial finding, and to make recommendations for intervention development. Methods: The intervention was a British version of the 'Forever Free' self-help booklets (SHARPISH-ISRCTN 36980856). The qualitative evaluation purposefully sampled 43 interview participants, triangulated with the views of 10 participants and 12 health professionals in focus groups. Data were thematically analysed. Results: Analysis revealed important variation in individual engagement with the self-help booklets. Variation was interpreted by the meta-themes of 'motivation for cessation', and 'positioning on information provision', interacting with the theme of 'mechanisms for information provision'. Conclusions: Targeting self-help information towards those most motivated to engage may be beneficial, considering the social and cultural realities of individual's lives. Individual preferences for the mechanisms of information delivery should be appraised when designing future interventions. Long-term personalized follow-up may be a simple step in improving smoking relapse rates.

Differences in Longer-Term Smoking Abstinence After Treatment by Specialist or Nonspecialist Advisors: Secondary Analysis of Data From a Relapse Prevention Trial.

INTRODUCTION: Smokers receiving support in specialist centers tend to have a higher short-term quit rate, compared with those receiving support in other settings from professionals for whom smoking cessation is only a part of their work. We investigated the difference in longer-term abstinence after short-term smoking cessation treatment from specialist and nonspecialist smoking cessation services. METHODS: We conducted a secondary analysis of data from a randomized controlled trial of self-help booklets for the prevention of smoking relapse. The trial included 1088 short-term quitters from specialist stop smoking clinics and 316 from nonspecialist cessation services (such as general practice, pharmacies, and health trainer services). The difference in prolonged smoking abstinence from months 4 to 12 between specialist and nonspecialist services was compared. Multivariable logistic regression analyses were conducted to investigate the association between continuous smoking abstinence and the type of smoking cessation services, adjusted for possible confounding factors (including demographic, socioeconomic, and smoking history variables). RESULTS: The proportion of continuous abstinence from 4 to 12 months was higher in short-term quitters from specialist services compared with those from nonspecialist services (39% vs. 32%; P = .023). After adjusting for a range of participant characteristics and smoking variables, the specialist service was significantly associated with a higher rate of longer-term smoking abstinence (odds ratio: 1.48, 95% CI = 1.09% to 2.00%; P = .011). CONCLUSIONS: People who receive support to stop smoking from a specialist appear to be at lower risk of relapse than those receiving support from a nonspecialist advisor.

Estimating the burden of minor ailment consultations in general practices and emergency departments through retrospective review of routine data in North East Scotland.

BACKGROUND: Minor ailment attendances in general practices and emergency departments (EDs) place significant burden on health care resources. OBJECTIVES: To estimate the prevalence and type of minor ailment consultations for adults in general practice and ED that could be managed in a community pharmacy. METHODS: Retrospective review of routine data from general practices (n = 2) and one ED in North East Scotland. Two independent consensus panels assessed each consultation summary to determine whether it represented a minor ailment. Outcomes included prevalence of consultations for minor ailments in general practice and ED and frequency of different minor ailment type that could be managed in community pharmacies. RESULTS: In total, of the 494 general practice and 550 ED consultations assessed, 13.2% [95% confidence interval (CI): 18.6-25.9%] and 5.3% (95% CI: 4.0-8.0%), respectively, were categorized as minor ailments suitable for management in community pharmacies. Consensus among panel members was moderate for general practice consultations, but fair to poor for ED consultations. Agreement between uni- and multi-disciplinary panels was good. Applied to national data, these estimates would equate to ~18 million general practice and 6500000 ED consultations that could be redirected to community pharmacy, equating to ~£1.1 billion in resources. CONCLUSION: Minor ailment consultations still present a major burden on higher cost settings. Effective strategies are needed to raise awareness among patients and health professionals regarding conditions that can be managed effectively in pharmacies and to change patient health-seeking behaviour for such conditions.

Patients' perceptions of physical activity before and after joint replacement: a systematic review with meta-ethnographic analysis.

BACKGROUND: It has been perceived that people following total hip arthroplasty (THA) or total knee arthroplasty (TKA) have the capability, with reduced pain, to increase their levels of physical activity. OBJECTIVES: To determine the attitudes and perceptions of people awaiting or having undergone THA or TKA to physical activity post-arthroplasty and to identify potential facilitators or barriers to engage in active living and physical activity pursuits. METHODS: Systematic review of published and unpublished databases was undertaken from their inception to November 2014. Studies exploring the attitudes and perceptions of people awaiting or having undergone THA or TKA to physical activity post-arthroplasty were included. Data were analysed through a meta-ethnography approach. RESULTS: From 528 citations, 13 papers were eligible, sampling 282 people post-THA or TKA. The literature was judged moderate to high quality. Following THA and TKA, people either wished to return to their pre-pathology level of physical activity or simply be able to engage in less physically demanding activities that are meaningful to them and their lifestyles. Barriers to engaging in higher levels of physical activity were largely related to limited information, which culminated in fear surrounding 'doing the right thing' both for individual's recovery and the longevity of the joint replacement. CONCLUSIONS: While many people post-THA or TKA wish to return to pre-pathological physical activity status, there is limited interest in actually undertaking greater levels of physical activity post-arthroplasty either for pleasure or health gains. Improvement in education and awareness of this may be key drivers to improve habitualisation of physical activity post-arthroplasty. TRIAL REGISTRATION NUMBER: CRD42014014995.

Exploring the Concepts of Abstinence and Recovery Through the Experiences of Long-Term Opiate Substitution Clients.

BACKGROUND: This study aimed to explore the client experience of long-term opiate substitution treatment (OST). METHODS: A qualitative grounded theory study set in a U.K. rural community drug treatment service. RESULTS: Continuous OST enabled stability and a sense of "normality." Participants expressed relief at moving away from previous chaotic lifestyles and freedom from the persistent fear of opiate withdrawal. However, for some, being on a script made them feel withdrawn, lethargic, and unable to fully participate in mainstream society. Intrapersonal barriers (motivation and fear) were perceived as key barriers to abstinence. CONCLUSIONS: Participants experienced long-term OST as a transition between illicit drug use and recovery. Recovery was seen as a process rather than a fixed goal, confirming that there is a need for services to negotiate individualized recovery goals, spanning harm minimization and abstinence-oriented treatment approaches.

Leukotriene antagonists as first-line or add-on asthma-controller therapy.

BACKGROUND: Most randomized trials of treatment for asthma study highly selected patients under idealized conditions. METHODS: We conducted two parallel, multicenter, pragmatic trials to evaluate the real-world effectiveness of a leukotriene-receptor antagonist (LTRA) as compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta(2)-agonist (LABA) as add-on therapy in patients already receiving inhaled glucocorticoid therapy. Eligible primary care patients 12 to 80 years of age had impaired asthma-related quality of life (Mini Asthma Quality of Life Questionnaire [MiniAQLQ] score ≤6) or inadequate asthma control (Asthma Control Questionnaire [ACQ] score ≥1). We randomly assigned patients to 2 years of open-label therapy, under the care of their usual physician, with LTRA (148 patients) or an inhaled glucocorticoid (158 patients) in the first-line controller therapy trial and LTRA (170 patients) or LABA (182 patients) added to an inhaled glucocorticoid in the add-on therapy trial. RESULTS: Mean MiniAQLQ scores increased by 0.8 to 1.0 point over a period of 2 years in both trials. At 2 months, differences in the MiniAQLQ scores between the two treatment groups met our definition of equivalence (95% confidence interval [CI] for an adjusted mean difference, -0.3 to 0.3). At 2 years, mean MiniAQLQ scores approached equivalence, with an adjusted mean difference between treatment groups of -0.11 (95% CI, -0.35 to 0.13) in the first-line controller therapy trial and of -0.11 (95% CI, -0.32 to 0.11) in the add-on therapy trial. Exacerbation rates and ACQ scores did not differ significantly between the two groups. CONCLUSIONS: Study results at 2 months suggest that LTRA was equivalent to an inhaled glucocorticoid as first-line controller therapy and to LABA as add-on therapy for diverse primary care patients. Equivalence was not proved at 2 years. The interpretation of results of pragmatic research may be limited by the crossover between treatment groups and lack of a placebo group. (Funded by the National Coordinating Centre for Health Technology Assessment U.K. and others; Controlled Clinical Trials number, ISRCTN99132811.).

The experience of long-term opiate maintenance treatment and reported barriers to recovery: a qualitative systematic review.

BACKGROUND/AIM: To inform understanding of the experience of long-term opiate maintenance and identify barriers to recovery. METHODS: A qualitative systematic review. RESULTS: 14 studies in 17 papers, mainly from the USA (65%), met inclusion criteria, involving 1,088 participants. Studies focused on methadone prescribing. Participants reported stability; however, many disliked methadone. Barriers to full recovery were primarily 'inward focused'. CONCLUSION: This is the first review of qualitative literature on long-term maintenance, finding that universal service improvements could be made to address reported barriers to recovery, including involving ex-users as positive role models, and increasing access to psychological support. Treatment policies combining harm minimisation and abstinence-orientated approaches may best support individualised recovery.

A systematic review of barriers and enablers associated with uptake of influenza vaccine among care home staff.

Barriers and enablers to vaccination of care home (CH) staff should be identified in order to develop interventions to address them that increase uptake and protect residents. We aimed to synthesis the evidence describing the barriers and enablers that affect the influenza vaccination uptake of care home (CH) staff. METHOD: We searched PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, AMED, IBSS, SCOPUS to identify quantitative, qualitative or mixed-method studies. Data related to health or social care workers in CHs reported barriers or enablers were extracted and mapped to the Theoretical Domains Framework (TDF); the data within each domain were grouped and categorized into key factors affecting influenza vaccine uptake among CH staff. RESULTS: We screened 4025 studies; 42 studies met our inclusion criteria. Thirty-four (81 %) were surveys. Five theoretical domains were frequently reported as mediators of influenza vaccine uptake: Beliefs about consequences (32 studies), Environmental context and resources (30 studies), Emotions (26 studies), Social influences (25 studies), Knowledge (22 studies). The low acceptance rate of the influenza vaccine among CH staff can be attributed to multiple factors, including insufficient understanding of the vaccine, its efficacy, or misconceptions about the vaccine (knowledge), perceiving the vaccine as ineffective and unsafe (beliefs about consequences), fear of influenza vaccine and its side effects (emotions), and experiencing limited accessibility to the vaccine (environmental context and resources). CONCLUSION: Interventions aimed at increasing influenza vaccine uptake among CH staff should focus on addressing the barriers identified in this review. These interventions should include components such as enhancing knowledge by providing accurate information about vaccine benefits and safety, addressing negative beliefs by challenging misconceptions, managing concerns and fears through open communication, and improving accessibility to the vaccine through convenient on-site options. This review provides a foundation for the development of tailored Interventions to improve influenza vaccine uptake among CH staff.

Why the trial researcher matters: Day-to-day work viewed through the lens of normalization process theory.

Researchers working in the field, the places where research-relevant activity happens, are essential to recruitment and data collection in randomised controlled trials (RCTs). This study aimed to understand the nature of this often invisible work. Data were generated through an RCT of a pharmacist-led medication management service for older people in care homes. The study was conducted over three years and employed seven Research Associates (RA) working in Scotland, Northern Ireland, and England. Weekly research team meetings and Programme Management Group meetings naturally generated 129 sets of minutes. This documentary data was supplemented with two end-of-study RA debriefing meetings. Data were coded to sort the work being done in the field, then deductively explored through the lens of Normalization Process Theory to enable a greater understanding of the depth, breadth and complexity of work carried out by these trial delivery RAs. Results indicate RAs helped stakeholders and participants make sense of the research, they built relationships with participants to support retention, operationalised complex data collection procedures and reflected on their own work contexts to reach agreement on changes to trial procedures. The debrief discussions enabled RAs to explore and reflect on experiences from the field which had affected their day-to-day work. The learning from the challenges faced in facilitating care home research may be useful to inform future research team preparation for complex interventions. Scrutinising these data sources through the lens of NPT enabled us to identify RAs as linchpins in the successful conduct of a complex RCT study.

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial.

OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes. DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes. SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads. PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad. INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care. MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition. RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified. CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received. TRIAL REGISTRATION: ISRCTN 17847169.

Evaluation of the effectiveness of manual chest physiotherapy techniques on quality of life at six months post exacerbation of COPD (MATREX): a randomised controlled equivalence trial.

BACKGROUND: Manual chest physiotherapy (MCP) techniques involving chest percussion, vibration, and shaking have long been used in the treatment of respiratory conditions. However, methodological limitations in existing research have led to a state of clinical equipoise with respect to this treatment. Thus, for patients hospitalised with an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), clinical preference tends to dictate whether MCP is given to assist with sputum clearance. We standardised the delivery of MCP and assessed its effectiveness on disease-specific quality of life. METHODS: In this randomised, controlled trial powered for equivalence, 526 patients hospitalised with acute COPD exacerbation were enrolled from four centres in the UK. Patients were allocated to receive MCP plus advice on airway clearance or advice on chest clearance alone. The primary outcome was a COPD specific quality of life measure, the Saint Georges Respiratory Questionnaire (SGRQ) at six months post randomisation. Analyses were by intention to treat (ITT). This study was registered, ISRCTN13825248. RESULTS: All patients were included in the analyses, of which 372 (71%) provided evaluable data for the primary outcome. An effect size of 0·3 standard deviations in SGRQ score was specified as the threshold for superiority. The ITT analyses showed no significant difference in SGRQ for patients who did, or did not receive MCP (95% CI -0·14 to 0·19). CONCLUSIONS: These data do not lend support to the routine use of MCP in the management of acute exacerbation of COPD. However, this does not mean that MCP is of no therapeutic value to COPD patients in specific circumstances.

Development and feasibility testing of an evidence-based training programme for pharmacist independent prescribers responsible for the medicines-related activities within care homes.

INTRODUCTION: The UK pharmacists with independent prescribing rights (pharmacist independent prescribers [PIPs]) are authorised to prescribe within their areas of competence. To enable PIPs to provide pharmaceutical care to residents in care homes and assume responsibility for medicines management, a process for development and assessment of competence is required. The aim of this research was to develop a training and accreditation process (training programme) to enable PIPs to operate safely and effectively within care homes. METHODS: Located in England, Scotland and Northern Ireland across four sites and based on a systematic review, it consisted of four phases: (1) initial stakeholder engagement, (2) uni-professional focus groups and interviews, (3) expert panel consensus and (4) feasibility testing. Four PIPs were trained each to provide pharmaceutical care to 10 care home residents. An expert panel synthesised the evidence at each stage to develop each iteration of the training programme. Content analysis was used throughout. RESULTS: Differences in baseline knowledge of PIPs required inclusion of a Personal Development Framework and the provision of a mentor. Face-to-face training focussed on managing medicines for a complex older person, minimising prescribing costs and supporting people without capacity. Provision of time to understand local context and develop relationships with care homes and general practitioners was identified as a central requirement. PIPs were assessed for competency via viva. Feasibility testing demonstrated that the derived training programme was acceptable, practical and effective. DISCUSSION: The model seemed to work, but due to small numbers, larger-scale testing of the training programme is now required.

Systematic review and narrative synthesis of pharmacist provided medicines optimisation services in care homes for older people to inform the development of a generic training or accreditation process.

OBJECTIVES: To develop a training programme to enable pharmacists with prescribing rights to assume responsibility for the provision of pharmaceutical care within care homes, a systematic review and narrative synthesis was undertaken to identify reported approaches to training pharmacists and use this literature to identify potential knowledge requirements. METHODS: A PROSPERO-registered systematic review was performed using key search terms for care homes, pharmacist, education, training and pharmaceutical care. Papers reporting primary research focussed on care of the older person within the care home setting were included. No restrictions were placed on methodology. Two researchers independently reviewed titles, abstracts and papers. Agreement on inclusion was reached through consensus. Data on titles, training and activities undertaken were extracted and knowledge requirements identified. Findings were synthesised and reported narratively. KEY FINDINGS: Fifty-nine papers were included, most of which were uncontrolled service evaluations. Four papers reported an accreditation process for the pharmacist. Thirteen papers reported providing tools or specific training on a single topic to pharmacists. The main clinical and therapeutic areas of activity (requiring codified knowledge) were dementia, pain, antipsychotic and cardiovascular medication. Provision of pharmaceutical care, effective multidisciplinary working and care home staff training represented the main areas of practical knowledge. CONCLUSIONS: Information regarding training and accreditation processes for care home pharmacists is limited. This study provides insight into potential codified and practical knowledge requirements for pharmacists assuming responsibility for the provision of pharmaceutical care within care homes. Further work involving stakeholders is required to identify the cultural knowledge requirements and to develop a training and accreditation process.

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study.

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: 1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. 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. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. 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.

Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study.

BACKGROUND: Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within each care home. and shown that a pharmacist independent prescriber service is feasible in this context. AIMS AND OBJECTIVES: To conduct a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of a pharmacist-independent prescribing service in care homes compared to usual general practitioner (GP)-led care. OBJECTIVES: To perform a definitive randomised controlled trial (RCT) with an internal pilot to determine the intervention's effectiveness and cost-effectiveness and enable modelling beyond the end of the trial. METHODS: This protocol is for a cluster RCT with a 3-month internal pilot to confirm that recruitment is achievable, and there are no safety concerns. The unit of randomisation is a triad comprising a pharmacist-independent prescriber (PIP) based in a GP practice with sufficient registered patients resident in one or more care homes to allow recruitment of an average of 20 participants. In the intervention group, the PIP will, in collaboration with the GP: assume responsibility for prescribing and managing residents' medicines including medication review and pharmaceutical care planning; support systematic ordering and administration in the care home, GP practice and supplying pharmacy; train care home and GP practice staff; communicate with GP practice, care home, supplying community pharmacy and study team. The intervention will last 6 months. The primary outcome will be resident falls at 6 months. Secondary outcomes include resident health-related quality of life, falls at 3 months, medication burden, medication appropriateness, mortality and hospitalisations. A full health economic analysis will be undertaken. The target sample size is 880 residents (440) in each arm) from 44 triads. This number is sufficient to detect a decrease in fall rate from 1.5 per individual to 1.178 (relative reduction of 21%) with 80% power and an ICC of 0.05 or less. DISCUSSION: Recruitment is on-going and the trial should complete in early 2020. The trial results will have implications for the future management of residents in care homes and the ongoing implementation of independent pharmacist prescribing. TRIAL REGISTRATION: ISRCTN, ID: 17847169. Registered on 15 December 2017.

Administration of aspirin tablets using a novel gel-based swallowing aid: an open-label randomised controlled cross-over trial.

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<0.05). DISCUSSION: We cannot assume that uncoated aspirin administration with and without gel is bioequivalent. Administration with gel resulted in reduced salicylate levels and therefore increased platelet function. Further research is required to determine the exact reason for this result. The results bring into question current processes for providing marketing authorisation for medical devices which are designed to aid swallowing.

The Care Home Independent Prescribing Pharmacist Study (CHIPPS)-a non-randomised feasibility study of independent pharmacist prescribing in care homes.

BACKGROUND: Residents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification. METHODS: Mixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3 months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (≥ 65 years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident's quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants' views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed. RESULTS: Across the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84 years; 61% (24) were female), and 38 participants remained at 3 months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5 L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload. CONCLUSION: Implementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.

Relapse to smoking and health-related quality of life: Secondary analysis of data from a study of smoking relapse prevention.

BACKGROUND: Previous studies have shown that smoking and smoking cessation may be associated with health-related quality of life (HRQoL). In this study, we compared changes in HRQoL in people who maintained abstinence with people who had relapsed to smoking. METHODS: This was a secondary analysis of data from a trial of a relapse prevention intervention in 1,407 short-term quitters. The European Quality of Life -5 Dimensions (EQ-5D) measured HRQoL at baseline, 3 and 12 months. Smoking outcome was continuous abstinence from 2 to 12 months, and 7-day smoking at 3 and 12 months. We used nonparametric test for differences in EQ-5D utility scores, and chi-square test for dichotomised response to each of the five EQ-5D dimensions. Multivariable regression analyses were conducted to evaluate associations between smoking relapse and HRQoL or anxiety/depression problems. RESULTS: The mean EQ-5D tariff score was 0.8252 at baseline. People who maintained abstinence experienced a statistically non-significant increase in the EQ-5D score (mean change 0.0015, P = 0.88), while returning to smoking was associated with a statistically significant decrease in the EQ-5D score (mean change -0.0270, P = 0.004). After adjusting for multiple baseline characteristics, the utility change during baseline and 12 months was statistically significantly associated with continuous abstinence, with a difference of 0.0288 (95% CI: 0.0006 to 0.0571, P = 0.045) between relapsers and continuous quitters. The only difference in quality of life dimensions between those who relapsed and those who maintained abstinence was in the proportion of participants with anxiety/depression problems at 12 months (30% vs. 22%, P = 0.001). Smoking relapse was associated with a simultaneous increase in anxiety/depression problems. CONCLUSIONS: People who achieve short-term smoking abstinence but subsequently relapse to smoking have a reduced quality of life, which appears mostly due to worsening of symptoms of anxiety and depression. Further research is required to more fully understand the relationship between smoking and health-related quality of life, and to develop cessation interventions by taking into account the impact of anxiety or depression on smoking.

It's not what you do it's the way that it's measured: quality assessment of minor ailment management in community pharmacies.

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.

Postpartum smoking relapse--a thematic synthesis of qualitative studies.

BACKGROUND AND AIMS: Many women quit smoking during pregnancy, but relapse after the baby is born. To understand why and identify ways of preventing this, this study reviewed the qualitative literature on women's experience of postpartum smoking relapse. METHODS: A systematic review of qualitative studies and process evaluations of trials. We undertook a thematic synthesis of published qualitative data. RESULTS: We screened 1336 papers. Twenty-two papers reporting on 16 studies were included, reporting on the views of 1031 postpartum women. Factors affecting relapse and barriers and facilitators to relapse prevention were identified around the key themes of beliefs, social influences, motivation, physiological factors and identity. Women's beliefs about smoking as a means of coping with stress and the need for social support, especially from a partner, emerged as important. Extrinsic motivation to quit during the pregnancy (for the health of the fetus) appeared to be a factor in prompting relapse after the baby was born. During the immediate postpartum period women believed that physiological changes influence cigarette cravings. The stress of caring for a newborn, sleeplessness and adjusting to a new mothering identity were also reported to be important. CONCLUSIONS: Among women who quit smoking during pregnancy, those who relapse postpartum talk commonly about no longer needing to protect the baby and the effects of stress. Partner support and a sense of changed identity are cited as factors preventing relapse.