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Objectives To explore care home managers’ views and experiences of optimising medicines use for residents with dementia during the COVID-19 pandemic.Design, setting and participants A descriptive exploratory qualitative study using semistructured interviews (conducted via telephone or online videoconferencing platform), with care home managers across Northern Ireland, purposively sampled from care homes that provided care for residents with dementia. Care home managers were asked to describe their experiences of accessing primary healthcare services (such as those provided by general practitioners and community pharmacists), how medicines use by residents with dementia was affected by the pandemic, and what they had learnt from their experiences. Data were analysed using inductive thematic analysis.Results Fourteen interviews were conducted between January and July 2022. Four themes, ‘isolation’, ‘burden’, ‘disruption’ and ‘connection and communication’, were identified; isolation was a cross-cutting theme that permeated the other themes. Care home managers described feeling isolated from healthcare professionals, healthcare services and residents’ family members. This isolation placed additional burden on care home staff and residents with dementia by increasing staff workload and negatively affecting residents’ well-being. Participants reported that disruption to primary healthcare service provision, particularly services provided by general practices, had significant impact on residents with dementia. Participants described a lack of face-to-face contact with healthcare professionals, and medication reviews often ceased to take place. The connection and communication between key stakeholders were perceived to be important when optimising medicines for residents with dementia.Conclusions This study has highlighted the challenges and initial impact of the COVID-19 pandemic on medicines optimisation for care home residents with dementia, which was characterised by isolation. Further research is needed to determine the extent of the long-term impact of the COVID-19 pandemic on this resident population. In future public health crises, better communication is needed between healthcare professionals and care homes.

Abstract Background There is limited research examining the views of general practice pharmacists (GPPs) on their role and their impact in general practice. The aim of this study was to explore GPPs’ views regarding this role and its potential impact within general practice in Northern Ireland (NI). Methods A paper-based self-administered questionnaire was mailed to 319 general practices in NI in 2022, directed to the GPP who spent most time at the practice. A variety of closed and open questions were included in six sections. Responses to closed questions were analysed descriptively whilst open question responses were analysed using content analysis. To ascertain associations between variables (e.g. GPP prescribing status, working arrangements and aspects of collaboration with GPPs), Fisher’s exact test was employed with an a priori significance level of p 80%) showed positive attitudes towards collaboration with GPs and those who worked in multiple practices were more likely to agree with the Attitudes Towards Collaboration Instrument for pharmacists (ATCI-P) statements compared to those who worked in a single practice (p

Abstract Background Studies have shown that potentially inappropriate prescribing (PIP) is highly prevalent among people with dementia (PwD) and linked to negative outcomes, such as hospitalisation and mortality. However, there are limited data on prescribing appropriateness for PwD in Saudi Arabia. Therefore, we aimed to estimate the prevalence of PIP and investigate associations between PIP and other patient characteristics among PwD in an ambulatory care setting. Methods A cross-sectional, retrospective analysis was conducted at a tertiary hospital in Saudi Arabia. Patients who were ≥ 65 years old, had dementia, and visited ambulatory care clinics between 01/01/2019 and 31/12/2021 were included. Prescribing appropriateness was evaluated by applying the Screening Tool of Older Persons Potentially Inappropriate Prescriptions (STOPP) criteria. Descriptive analyses were used to describe the study population. Prevalence of PIP and the prevalence per each STOPP criterion were calculated as a percentage of all eligible patients. Logistic regression analysis was used to investigate associations between PIP, polypharmacy, age and sex; odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Analyses were conducted using SPSS v27. Results A total of 287 PwD were identified; 56.0% (n = 161) were female. The mean number of medications prescribed was 9.0 [standard deviation (SD) ± 4.2]. The prevalence of PIP was 61.0% (n = 175). Common instances of PIP were drugs prescribed beyond the recommended duration (n = 90, 31.4%), drugs prescribed without an evidence-based clinical indication (n = 78, 27.2%), proton pump inhibitors (PPIs) for > 8 weeks (n = 75, 26.0%), and acetylcholinesterase inhibitors with concurrent drugs that reduce heart rate (n = 60, 21.0%). Polypharmacy was observed in 82.6% (n = 237) of patients and was strongly associated with PIP (adjusted OR 24.1, 95% CI 9.0–64.5). Conclusions Findings have revealed a high prevalence of PIP among PwD in Saudi Arabia that is strongly associated with polypharmacy. Future research should aim to explore key stakeholders’ experiences and perspectives of medicines management to optimise medication use for this vulnerable patient population.

Abstract Background People with vision impairment encounter many difficulties when it comes to medicines use. However, evidence indicates that there are major gaps in pharmaceutical care service provision worldwide and limited research on interventions to optimise medication use for this patient population. The Theoretical Domains Framework (TDF) provides a method for theoretically understanding individuals’ behaviour and informing development of interventions. The aim of this research was to (a) identify the barriers and facilitators to the provision of medication dispensing and counselling services by pharmacists to patients with vision impairment, and (b) identify key TDF domains to be targeted in a future intervention. Methods Semi-structured interviews were conducted with pharmacists from different pharmacy practice settings/areas in Saudi Arabia. The 14-domain TDF was utilised as the theoretical lens through which pharmacists’ behaviours were examined. Interviews were conducted in Arabic or English, either face-to-face or over the telephone based on the participant’s preference. Following transcription, interviews conducted in Arabic were translated into English before analysis. Data analysis involved using the framework method and content analysis to identify important barriers and facilitators to the provision of dispensing and counselling services to those with vision impairment. Key TDF domains that could be targeted in a future intervention were then identified using a consensus-based approach. Results Twenty-six pharmacists were interviewed. Pharmacists’ experience in pharmacy practice ranged from two to 28 years. A range of barriers and facilitators were highlighted as important in providing services to those with vision impairment. Eight domains were identified as ‘key domains’ including: ‘Knowledge’, ‘Skills’, ‘Beliefs about capabilities’, ‘Goals’, ‘Memory, attention, and decision processes’, ‘Environmental context and resources’, ‘Social influences’, and ‘Behavioural regulation’. Conclusions Barriers and facilitators identified by pharmacists will inform the development of an intervention to ensure its applicability to everyday practice. Future research will focus on the process of developing the proposed intervention through targeting key TDF domains to improve medication dispensing and counselling by pharmacists to patients with vision impairment.

Background: Older patients experience challenges when taking polypharmacy. Studies have applied different interventions to improve adherence to polypharmacy. However, inconsistencies in outcomes have impeded the synthesis of evidence. To generate high-quality studies and selectively report outcomes, a Core Outcome Set (COS) is advocated. Objective(s): This study explored stakeholders' perspectives about the challenges older patients face when taking polypharmacy, strategies to overcome each challenge, and outcomes of importance that may contribute to COS development. Methods: Semi-structured interviews were undertaken with academics, healthcare professionals, and public participants. A series of open-ended questions investigated challenges with adherence to polypharmacy in older patients and strategies to overcome these challenges. A list of outcomes (n = 7) compiled from previous studies associated with adherence to polypharmacy was presented to participants for their views. Content analysis was conducted to identify key themes and outcomes proposed by participants. Results: Participants suggested 11 multidimensional healthcare system-related, medication-related, patient-related, and socioeconomic-related challenges and 16 educational and behavioural strategies associated with adherence to polypharmacy in older patients. Participants agreed with the importance of the seven outcomes presented and suggested a further six outcomes they deemed to be important for use in trials aimed at improving adherence to appropriate polypharmacy in older patients. Conclusions: Adherence to polypharmacy was deemed challenging, requiring supportive interventions. A list of 13 outcomes in the context of adherence to appropriate polypharmacy in older patients was identified to inform a future study that will develop a COS for clinical trials targeting interventions to improve adherence to appropriate polypharmacy in older patients.

Abstract Introduction There is concern about the use of anticholinergic medications in people living with dementia (PLWD). Such medicines may increase cognitive decline and may be associated with higher mortality in PLWD who take these medicines. The aim of this study was to analyse data from an online dementia discussion forum to explore the experiences and perspectives of PLWD and carers about the use of anticholinergic medicines in this population. Methods Following receipt of ethical approval, archived discussions (posts) from Dementia Talking Point, a fully public online forum for anyone affected by dementia, created and maintained by the Alzheimer's Society, were searched from the date of inception to January 2022 using a range of search terms including commonly used anticholinergic medicines. Posts, including any of the search terms, were assessed for relevance and analysed using inductive thematic analysis. Results Five hundred and fifty unique posts were analysed, all of which had been provided by carers, with no posts attributed to PLWD. The themes that encompassed carers' experiences were (1) motivators of prescribing, (2) perspectives on the process of prescribing and (3) the outcomes of prescribing. The dominant motivator of prescribing was the management of noncognitive symptoms, pre‐ and postdiagnosis of dementia. Carers' perspectives on the process of prescribing were informed by an assessment of the risk‐benefit of starting a medication and shared decision‐making between the carer and healthcare professional to a greater or lesser degree. The outcomes of prescribing were observing the effects of the medicines, which in turn influenced whether prescribing was reviewed and continued unchanged, continued but amended, reinitiated if the medicine had been previously stopped or discontinued (the process of deprescribing). Conclusion This study has provided unique insights into carers' experiences and perspectives about the use of anticholinergic medications in PLWD, highlighting how commonly these medications are prescribed for PLWD and carers' concerns about their use. There is a clear need for carers and PLWD to receive information about these medicines and healthcare professionals to consider how to optimise the use of these medicines to avoid adverse effects. Patient or Public Contribution This work was informed by findings from previous research studies focusing on optimising medicine use for people with dementia in primary care, in which interviews were conducted with PLWD, their carers and primary healthcare professionals. Although not strictly patient and public involvement, we utilised the feedback provided by key stakeholders to inform the research questions and aim/objectives of this study.

Abstract Background For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI). Methods This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT. Results Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two ‘Go’, three ‘Amend’). Conclusion Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. Trial registration ISRCTN, ISRCTN41009897 . Registered 19 November 2019. Clinicaltrials.gov, NCT04181879 . Registered 02 December 2019.

Abstract Background Although urinary tract infections (UTIs) are extremely common, isolation of causative uropathogens is not always routinely performed, with antibiotics frequently prescribed empirically. This study determined the susceptibility of urinary isolates from two Health and Social Care Trusts (HSCTs) in Northern Ireland to a range of antibiotics commonly used in the treatment of UTIs. Furthermore, we determined if detection of trimethoprim resistance genes (dfrA) could be used as a potential biomarker for rapid detection of phenotypic trimethoprim resistance in urinary pathogens and from urine without culture. Methods Susceptibility of E. coli and Klebsiella spp. isolates (n = 124) to trimethoprim, amoxicillin, ceftazidime, ciprofloxacin, co-amoxiclav and nitrofurantoin in addition to susceptibility of Proteus mirabilis (n = 61) and Staphylococcus saprophyticus (n = 17) to trimethoprim was determined by ETEST® and interpreted according to EUCAST breakpoints. PCR was used to detect dfrA genes in bacterial isolates (n = 202) and urine samples(n = 94). Results Resistance to trimethoprim was observed in 37/124 (29.8%) E. coli and Klebsiella spp. isolates with an MIC90 > 32 mg/L. DfrA genes were detected in 29/37 (78.4%) trimethoprim-resistant isolates. Detection of dfrA was highly sensitive (93.6%) and specific (91.4%) in predicting phenotypic trimethoprim resistance among E. coli and Klebsiella spp. isolates. The dfrA genes analysed were detected using a culture-independent PCR method in 16/94 (17%) urine samples. Phenotypic trimethoprim resistance was apparent in isolates cultured from 15/16 (94%) dfrA-positive urine samples. There was a significant association (P

Abstract Background Medicines management in care homes requires significant improvement. CHIPPS was a cluster randomised controlled trial to determine the effectiveness of integrating pharmacist independent prescribers into care homes to assume central responsibility for medicines management. This paper reports the parallel mixed-methods process evaluation. Method Intervention arm consisted of 25 triads: Care homes (staff and up to 24 residents), General Practitioner (GP) and Pharmacist Independent Prescriber (PIP). Data sources were pharmaceutical care plans (PCPs), pharmacist activity logs, online questionnaires and semi-structured interviews. Quantitative data were analysed descriptively. Qualitative data were analysed thematically. Results were mapped to the process evaluation objectives following the Medical Research Council framework. Results PCPs and activity logs were available from 22 PIPs. Questionnaires were returned by 16 PIPs, eight GPs, and two care home managers. Interviews were completed with 14 PIPs, eight GPs, nine care home managers, six care home staff, and one resident. All stakeholders reported some benefits from PIPs having responsibility for medicine management and identified no safety concerns. PIPs reported an increase in their knowledge and identified the value of having time to engage with care home staff and residents during reviews. The research paperwork was identified as least useful by many PIPs. PIPs conducted medication reviews on residents, recording 566 clinical interventions, many involving deprescribing; 93.8% of changes were sustained at 6 months. For 284 (50.2%) residents a medicine was stopped, and for a quarter of residents, changes involved a medicine linked to increased falls risk. Qualitative data indicated participants noted increased medication safety and improved resident quality of life. Contextual barriers to implementation were apparent in the few triads where PIP was not known previously to the GP and care home before the trial. In three triads, PIPs did not deliver the intervention. Conclusions The intervention was generally implemented as intended, and well-received by most stakeholders. Whilst there was widespread deprescribing, contextual factors effected opportunity for PIP engagement in care homes. Implementation was most effective when communication pathways between PIP and GP had been previously well-established. Trial registration The definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17847169 ).

Abstract Background The PolyPrime intervention is a theory-based intervention aimed at improving appropriate polypharmacy in older people (aged ≥65 years) in primary care. The intervention consists of an online video which demonstrates how general practitioners (GPs) can prescribe appropriate polypharmacy during a consultation with an older patient and a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. The aim of the process evaluation is to further examine the implementation of the PolyPrime intervention in primary care. This will involve investigating whether the PolyPrime intervention can be delivered as intended across two healthcare systems, how acceptable the intervention is to GPs, practice staff and patients, and to identify the intervention’s likely mechanisms of action. Methods The PolyPrime study is an external pilot cluster randomised controlled trial (cRCT) which aims to recruit 12 GP practices across Northern Ireland [NI] (n=6) and the six counties in the Republic of Ireland (ROI) that border NI (n=6). Practices have been randomised to intervention or usual care. An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention to GPs, practice staff and patients and potential mechanisms of action (i.e. what components of the intervention were perceived to be effective). Quantitative data will be collected from data collection forms completed by GPs and practice staff and a feedback questionnaire completed by patients from intervention arm practices, which will be analysed using descriptive statistics. Qualitative data will be collected through semi-structured interviews with GPs and practice staff and audio-recordings of medication review appointments from the intervention arm practices which will be transcribed and analysed using the framework method. Quantitative and qualitative data will be triangulated to provide an overall assessment of intervention fidelity, intervention acceptability, and mechanisms of action. Discussion This process evaluation will add to feasibility data from the pilot cRCT by providing evidence on the fidelity of implementing the intervention package across two healthcare systems, the acceptability of the intervention and potential mechanisms of action. Trial registration ClinicalTrials.gov ISRCTN41009897 . Registered on 19 November 2019. ClinicalTrials.gov NCT04181879 . Registered 02 December 2019.

Abstract Background Diverse outcomes reported in clinical trials of antimicrobial stewardship (AMS) interventions in care homes have hindered evidence synthesis. Our main objective was to develop a core outcome set (COS) for use in trials aimed at improving AMS in care homes. Methods A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study, was rated in a three-round international Delphi survey with 82 participants, using a nine-point Likert scale (from 1, unimportant, to 9, critical). This was followed by an online consensus exercise with 12 participants from Northern Ireland to finalise the COS content. Subsequently, a suitable outcome measurement instrument (OMI) was selected for each outcome in the COS by: identifying existing OMIs through a literature search and experts’ suggestions, assessing the quality of OMIs, and selecting one OMI for each core outcome via a two-round international Delphi survey with 59 participants. Results Of 14 outcomes initially presented, consensus was reached for inclusion of five outcomes in the COS after the three-round Delphi survey and the online consensus exercise, comprising the total number of antimicrobial courses prescribed, appropriateness of antimicrobial prescribing, days of therapy per 1000 resident-days, rate of antimicrobial resistance, and mortality related to infection. Of 17 potential OMIs identified, three were selected for the two-round Delphi exercise after the quality assessment. Consensus was reached for selection of two OMIs for the COS. Conclusion This COS is recommended to be used in clinical trials aimed at improving AMS in care homes.

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897 . Registered 19 November 2019. ClinicalTrials.gov, NCT04181879 . Registered 02 December 2019.

Abstract 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.

ABSTRACT: Introduction: Nonprescription sildenafil was introduced to the United Kingdom in 2018 as the first pharmacy service concerning sexual function, an important but often ignored factor for quality of life. Aim: This study aimed to evaluate pharmacists’ views on providing nonprescription sildenafil, their perceptions of the barriers and facilitators to provide this service and strategies to overcome potential barriers, using a theory-based approach. Methods: Community pharmacists were purposefully sampled in Northern Ireland, followed by snowball sampling. Face-to-face interviews were conducted between October 2019 and January 2020. The semi-structured interviews used a piloted topic guide based on the 14-domain Theoretical Domains Framework (TDF). All interviews were audio-recorded, transcribed verbatim and anonymized. Transcripts were analyzed deductively in NVivo 13, utilizing the TDF domains as coding categories. Within each domain, content analysis was utilized to identify barriers and facilitators. Main Outcome Measure: Barriers and facilitators within the TDF domains for pharmacists to provide nonprescription sildenafil. Results: Ten pharmacists were interviewed to reach data saturation. Eight pharmacists had experience with dispensing nonprescription sildenafil. They valued nonprescription sildenafil as an additional service (“Social/professional role and identity”). Training, concise product guidelines, and private consultation areas were important facilitators (“Environmental context and resources”). The service required trusting clients (“Optimism”), with concerns about abuse and men not visiting their GP. From experience gained, pharmacists became more confident dealing with difficult situations such as patients being vague about their medical history or alcoholism or mental problems as causes for erectile disfunction (ED) (“Skills” and “Beliefs about capabilities”). Pharmacists considered lifestyle and medication causes of ED important but preferred to focus on safe supply. In general, pharmacists were satisfied with the perceived professional recognition, using their clinical knowledge or helping patients resume sexual relationships (“Beliefs about consequences”). Conclusion: Pharmacists welcomed nonprescription sildenafil to enhance their role as easily accessible healthcare providers for patients.Gordijn R, Teichert M, Nicolai MPJ, et al. Learning From Consultations Conducted by Community Pharmacists in Northern Ireland for Nonprescription Sildenafil: A Qualitative Study Using the Theoretical Domains Framework. Sex Med 2021;9:100440.

Abstract Background People with dementia (PwD) face unique challenges with medicines management, yet little is known about these challenges from the perspectives of primary healthcare professionals, particularly general practitioners (GPs) and community pharmacists. Few medicines management interventions have been developed which are aimed at community-dwelling PwD. This study sought to develop an intervention to improve medicines management for PwD in primary care using a theory-informed approach. Methods Semi-structured interviews were conducted with GPs (n = 15) and community pharmacists (n = 15) to explore participants’ views and experiences of medicines management for PwD, and their perceptions of barriers and facilitators to successful medicines management for PwD. The 14-domain Theoretical Domains Framework was the underpinning theoretical guide, allowing key theoretical domains to be identified and mapped to behaviour change techniques (BCTs) which are considered the ‘active ingredients’ of an intervention. Draft interventions were developed to operationalise selected BCTs and were presented to GPs and community pharmacists during task groups. Final selection of an intervention for feasibility testing was guided by feedback provided during these task groups and through application of the APEASE (Affordability, Practicability, Effectiveness/cost-effectiveness, Acceptability, Side-effects/safety, Equity) criteria. Results Participants expressed a number of concerns about medicines management for PwD, particularly monitoring adherence to medication regimens and conducting medication review. Two draft interventions comprising selected BCTs (‘Modelling or demonstration of behaviour’; ‘Salience of consequences’; ‘Health consequences’; ‘Social and environmental consequences’; ‘Action planning’; Social support or encouragement’, ‘Self-monitoring of behaviour’) were developed, each targeting GPs and community pharmacists. Following the task groups and discussions within the research team, the community pharmacy-based intervention was selected for future feasibility testing. The intervention will target community pharmacists to conduct a medication review (incorporating an adherence check) with a PwD, delivered as an online video demonstrating key behaviours. The video will include feedback emphasising positive outcomes of performing the behaviours. Action planning and a quick reference guide will be used as complementary intervention components. Conclusions A community pharmacist-based intervention has been developed targeting medicines management for PwD in primary care using a systematic, theory-informed approach. Future work will determine the usability and acceptability of implementing this intervention in clinical practice.

Abstract 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.

Abstract Background Potentially inappropriate prescribing (PIP) is associated with negative health outcomes, including hospitalisation and mortality. Life and Living in Advanced Age: a Cohort Study in New Zealand (LiLACS NZ) is a longitudinal study of Māori (the indigenous population of New Zealand) and non-Māori octogenarians. Health disparities between indigenous and non-indigenous populations are prevalent internationally and engagement of indigenous populations in health research is necessary to understand and address these disparities. Using LiLACS NZ data, this study reports the association of PIP with hospitalisations and mortality prospectively over 36-months follow-up. Methods PIP, from pharmacist applied criteria, was reported as potentially inappropriate medicines (PIMs) and potential prescribing omissions (PPOs). The association between PIP and hospitalisations (all-cause, cardiovascular disease-specific and ambulatory-sensitive) and mortality was determined throughout a series of 12-month follow-ups using binary logistic (hospitalisations) and Cox (mortality) regression analysis, reported as odds ratios (ORs) and hazard ratios (HRs), respectively, and the corresponding confidence intervals (CIs). Results Full demographic data were obtained for 267 Māori and 404 non-Māori at baseline, 178 Māori and 332 non-Māori at 12-months, and 122 Māori and 281 non-Māori at 24-months. The prevalence of any PIP (i.e. ≥1 PIM and/or PPO) was 66, 75 and 72% for Māori at baseline, 12-months and 24-months, respectively. In non-Māori, the prevalence of any PIP was 62, 71 and 73% at baseline, 12-months and 24-months, respectively. At each time-point, there were more PPOs than PIMs; at baseline Māori were exposed to a significantly greater proportion of PPOs compared to non-Māori (p = 0.02). In Māori: PPOs were associated with a 1.5-fold increase in hospitalisations and mortality. In non-Māori, PIMs were associated with a double risk of mortality. Conclusions PIP was associated with an increased risk of hospitalisation and mortality in this cohort. Omissions appear more important for Māori in predicting hospitalisations, and PIMs were more important in non-Māori in predicting mortality. These results suggest understanding prescribing outcomes across and between population groups is needed and emphasises prescribing quality assessment is useful.

Abstract 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.

Background: The intervention Complexity Assessment Tool for Systematic Reviews (iCAT_SR) has been developed to facilitate detailed assessments of intervention complexity in systematic reviews. Worked examples of the tool’s application are needed to promote its use and refinement. The aim of this case study was to apply the iCAT_SR to a subset of 20 studies included in a Cochrane review of interventions aimed at improving appropriate polypharmacy in older people. Methods: Interventions were assessed independently by two authors using the six core iCAT_SR dimensions: (1) ‘Target organisational levels/categories’; (2) ‘Target behaviour/actions’; (3) ‘Active intervention components’; (4) ‘Degree of tailoring’; (5) ‘Level of skill required by intervention deliverers’; (6) ‘Level of skill required by intervention recipients’. Attempts were made to apply four optional dimensions: ‘Interaction between intervention components’; ‘Context/setting’; ‘Recipient/provider factors’; ‘Nature of causal pathway’. Inter-rater reliability was assessed using Cohen’s Kappa coefficient. Disagreements were resolved by consensus discussion. The findings are presented narratively. Results: Assessments involving the core iCAT_SR dimensions showed limited consistency in intervention complexity across included studies, even when categorised according to clinical setting. Interventions were delivered across various organisational levels and categories (i.e. healthcare professionals and patients) and typically comprised multiple components. Intermediate skill levels were required by those delivering and receiving the interventions across all studies. A lack of detail in study reports precluded application of the iCAT_SR’s optional dimensions. The inter-rater reliability was substantial (Cohen's Kappa = 0.75) Conclusions: This study describes the application of the iCAT_SR to studies included in a Cochrane systematic review. Future intervention studies need to ensure more detailed reporting of interventions, context and the causal pathways underlying intervention effects to allow a more holistic understanding of intervention complexity and facilitate replication in other settings. The experience gained has helped to refine the original guidance document relating to the application of iCAT_SR.

Abstract Background A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council’s complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection). Methods GPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients’ medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants’ feedback and clinical assessment findings. Results Four GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients’ clinical data. Conclusion The findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention’s effectiveness. Trial registration ISRCTN18176245

Abstract Background Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS). Methods A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7–9 and

Abstract Background It is advocated that interventions to improve clinical practice should be developed using a systematic approach and intervention development methods should be reported. However, previous interventions aimed at ensuring that older people receive appropriate polypharmacy have lacked details on their development. This study formed part of a multiphase research project which aimed to develop an intervention to improve appropriate polypharmacy in older people in primary care. Methods The target behaviours for the intervention were prescribing and dispensing of appropriate polypharmacy to older patients by general practitioners (GPs) and community pharmacists. Intervention development followed a systematic approach, including previous mapping of behaviour change techniques (BCTs) to key domains from the Theoretical Domains Framework that were perceived by GPs and pharmacists to influence the target behaviours. Draft interventions were developed to operationalise selected BCTs through team discussion. Selection of an intervention for feasibility testing was guided by a subset of the APEASE (Affordability, Practicability, Effectiveness/cost-effectiveness, Acceptability, Side-effects/safety, Equity) criteria. Results Three draft interventions comprising selected BCTs were developed, targeting patients, pharmacists and GPs, respectively. Following assessment of each intervention using a subset of the APEASE criteria (affordability, practicability, acceptability), the GP-targeted intervention was selected for feasibility testing. This intervention will involve a demonstration of the behaviour and will be delivered as an online video. The video demonstrating how GPs can prescribe appropriate polypharmacy during a typical consultation with an older patient will also demonstrate salience of consequences (feedback emphasising the positive outcomes of performing the behaviour). Action plans and prompts/cues will be used as complementary intervention components. The intervention is designed to facilitate the prescribing of appropriate polypharmacy in routine practice. Conclusion A GP-targeted intervention to improve appropriate polypharmacy in older people has been developed using a systematic approach. Intervention content has been specified using an established taxonomy of BCTs and selected to maximise feasibility. The results of a future feasibility study will help to determine if the theory-based intervention requires further refinement before progressing to a larger scale randomised evaluation.

Urinary tract infections (UTIs) are one of the most common infections in older people and are associated with increased morbidity and mortality. UTIs are also associated with increased risk of antimicrobial resistance (AR). This study examined changes in AR among older inpatients with a primary diagnosis of UTIs in the United States over an 8-year period and the impact of AR on clinical outcomes and hospital costs. Data were obtained from the longitudinal hospital HCUP-NIS database from 2009 to 2016 for inpatient episodes that involved those aged 65+ years. The ICD-9 and ICD-10 codes were used to identify episodes with a primary diagnosis of UTIs, comorbidities, AR status and age-adjusted Deyo-Charlson comorbidity index (ACCI) for the patient concerned. Weighted multivariable regression was used to examine the impact of AR on all-cause inpatient mortality, discharge destination, length of stay and hospital expenditures, adjusted for socio-demographic and clinical covariates. The proportion of admissions with AR increased, from 3.64% in 2009 to 6.88% in 2016 (p

BackgroundUrinary Tract Infections (UTIs) are common bacterial infections, second only to respiratory tract infections and particularly prevalent within primary care. Conventional detection of UTIs is culture, however, return of results can take between 24 and 72 hours. The introduction of a point of care (POC) test would allow for more timely identification of UTIs, facilitating improved, targeted treatment. This study aimed to obtain consensus on the criteria required for a POC UTI test, to meet patient need within primary care.MethodsCriteria for consideration were compiled by the research team. These criteria were validated through a two-round Delphi process, utilising an expert panel of healthcare professionals from across Europe and United States of America. Using web-based questionnaires, panellists recorded their level of agreement with each criterion based on a 5-point Likert Scale, with space for comments. Using median response, interquartile range and comments provided, criteria were accepted/rejected/revised depending on pre-agreed cut-off scores.ResultsThe first round questionnaire presented thirty-three criteria to the panel, of which 22 were accepted. Consensus was not achieved for the remaining 11 criteria. Following response review, one criterion was removed, while after revision, the remaining 10 criteria entered the second round. Of these, four were subsequently accepted, resulting in 26 criteria considered appropriate for a POC test to detect urinary infections.ConclusionThis study generated an approved set of criteria for a POC test to detect urinary infections. Criteria acceptance and comments provided by the healthcare professionals also supports the development of a multiplex point of care UTI test.

The oral contraceptive pill (OCP) remains the most popular form of prescription contraception in many countries, despite adherence difficulties for many. Uptake of long acting reversible contraceptives (LARCs), which are less reliant on user adherence, remains low. The aim of this study was to explore the experiences of, and attitudes towards, prescription contraception amongst samples of contraception users, general practitioners (GPs) and pharmacists.We conducted a qualitative study using semi-structured interviews with 18 contraception users, 18 GPs and 9 pharmacists. The study took place in Galway, Republic of Ireland between June and September 2014. Thematic analysis was used to analyse the data. Overall, contraception users were more familiar with the OCP, and all the women interviewed began their prescription contraception journey using this method. All participants identified episodes of poor adherence throughout the reproductive life course. The identified barriers for use of LARCs were lack of information, misconceptions, lack of access and high cost. In contrast, GPs believed that adherence to the OCP was good and stated they were more likely to prescribe the OCP than other methods, as they were most familiar with this option. Barriers to prescribing LARCSs were time, cost to practice, training and deskilling. Pharmacists also believed that adherence to the OCP was generally good and that their role was limited to dispensing medication and providing information when asked.There are contrasting perspectives between contraception service providers and contraceptive users. Training for healthcare providers is required to support informed contraceptive choice and adherence. It is necessary to address the practice barriers of cost and lack of time, to promote better communication around adherence issues and prescription contraception options. There is a need for more easily-accessible public health information to promote awareness on all methods of prescription contraception.