NHS Research Ethics Committee Research Articles

#2283 Vitamin D metabolism in end stage kidney failure: people receiving haemodialysis can still synthesise 1,25-dihydroxyvitamin D

Abstract Background and Aims A large proportion of haemodialysed patients remain vitamin D deficient, contributing to the development, and severity, of chronic kidney disease-mineral bone disorder (CKD-MBD). This study aimed to investigate the effect of vitamin D (cholecalciferol) supplementation on serum levels of 25-hydroxyvitamin D3, 1,25-dihydroxyvitamin D3 and 24,25-dihydroxyvitamin D3 in a group of people receiving haemodialysis. Method Eighty-one haemodialysis patients (dialysis vintage ≥1 month) with low serum total 25(OH)D consented to participate. 40,000IU cholecalciferol was given weekly for 12-weeks followed by a maintenance dose of 20,000IU fortnightly (administered by dialysis nursing staff as part of routine care). Patients remained on active vitamin D (1,25(OH)2D3 and analogues) as part of routine care (clinician prescribed for management of calcium and PTH). Baseline and 12-month data were compared using related-samples Wilcoxon signed rank test (Table 1). NHS research ethics committee approval was received. Results Complete data were available and analysed for 55 patients. 1,25(OH)2D3 levels were low at baseline (48.3pmol/L, IQR 35.9-57.9pmol/L) despite 44 of 55 patients (80%) being prescribed an active vitamin D analogue (normal range 60-120pmol/L). Cholecalciferol supplementation normalised both serum 25(OH)D3 and 1,25(OH)2D3 and significantly increased 24,25(OH)2D3 (Table 1). Conclusion Synthesis of 1,25(OH)2D3 is maintained (in kidney failure) but is substrate dependent, and low serum 25(OH)D was evident at baseline. 1,25(OH)2D3 deficiency is therefore partly a consequence of 25(OH)D deficiency, rather than solely due to elevated FGF23 and reduced renal 1α-hydroxylase activity (which is shown to be present in kidney failure). Cholecalciferol supplementation increases the inactive substrate 25(OH)D3 rather than directly increasing 1,25(OH)2D3. Increases in 25(OH)D3 and 24,25(OH)2D3 are disproportionate to 1,25(OH)2D3 increases, demonstrating the known tight regulation of 1,25(OH)2D3 synthesis and secretion (in response to calcium and parathyroid hormone). Conventional oral vitamin D supplementation may provide a cheap and safe strategy for the management of vitamin D homeostasis in chronic kidney disease.

Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN

IntroductionIndividuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in...

NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease

IntroductionIncidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have...

Allergy recording in clinical systems: comparing general practice and hospital records

Abstract Introduction Healthcare organisations may have different clinical and administrative electronic systems, meaning there may be gaps in how important information about a patient’s care is communicated effectively between organisations.1 Our current hospital discharge summary does not include a record of patients’ allergies and sensitivities despite this being one of the national standards.2 Furthermore, the electronic transfer of allergy/intolerance data must be classed as machine-readable through coded entries using SNOMED CT or dm+d terminology.3 We wanted to determine whether allergy/sensitivity records in primary and secondary care are transferred accurately and if our hospital discharge summaries should be amended to include allergy information for improved flow of data. Aim To record and compare the number of allergies/sensitivities matched on both the hospital electronic prescribing system (EPS, CareFlow Medicines Management) and a GP practice system (SystmOne), and to determine whether inconsistencies within allergy recording between primary and secondary care are significant, and if there is scope to add allergy recording to eDischarges. Methods A random sample of 150 patients registered with a GP practice who had been admitted to hospital and had undergone recent medicines reconciliations (during 2022/23) and had at least one allergy recorded on the hospital EPS was analysed. Allergy entries (medication or class of medication or other) were collated and analysed using Microsoft Excel. As this project falls under the definition of a service evaluation, according to UK NHS Research Ethics Committees, formal ethical approval was not required. This project was registered on the hospital’s clinical audit database. Results The 150 patients (61% female, mean age 63 years, range 1-97) recorded a total of 350 allergy entries in the hospital EPS system and 294 entries in primary care SystmOne. Only 71 (47%) patients had matching records across both systems. Fifty-two (35%) patients had one or more allergies not recorded on SystmOne compared to EPS, whereas only 16 (11%) patients had one or more allergies not recorded on EPS compared to SystmOne. A total of 11 (7%) patients had one or more inconsistencies across both systems. There were significant issues with how medication names were recorded e.g. generic/brand name for the same medicine. The majority of inconsistencies in records were related to penicillin allergies. Discussion/Conclusion Whilst a small-scale study only, we observed that allergy data is often not transferred accurately between primary and secondary care, resulting in unmatched records and discrepancies, particularly in transfer from secondary to primary care. This limits the potential of computerised decision support systems to help alert clinicians to the risk of further reactions. This problem may be due to a lack of allergy information on the current hospital eDischarge summaries; hence any new allergies identified through medicines reconciliation completed during the admission, or reactions to newly prescribed drugs in hospital, are not transferred. One patient safety improvement would be improved interoperability such that allergies on EPS are included on hospital eDischarge summaries in accordance with PRSB Standards.2 Ideally, this information should be coded in a suitable format to ensure effective transfer onto SystmOne.

A Service Evaluation of the Implementation of E-sign for Homecare Prescriptions in Secondary Care

Abstract Introduction Homecare Medicine Services allow patients with chronic conditions, reliant on specialist medicines prescribed by secondary care, to manage their symptoms at home rather than requiring regular attendance to a hospital for treatment1. The Royal Cornwall Hospital NHS Trust (RCHT) manages over 3000 patients on homecare services across a range of specialties. Traditional homecare processes required prescriptions to be printed on paper at the hospital, signed by hand by a prescriber and then securely couriered to the homecare provider for processing. The secondary care Electronic Prescription Service (EPS) is coming but in the interim a solution was commissioned by the National Homecare Medicines Committee to improve processes, reduce administrative burden, and improve the timeliness of prescriptions for direct patient benefit. The product selected was E-sign (E-Sign (UK) Ltd) which allows prescriptions, as PDF files, to be signed with an advanced electronic signature and tracked through a managed workflow compliant with applicable legislation2. Working collaboratively with Sciensus we introduced E-sign in March 2022. In the last year we have processed approximately 3500 prescriptions via this process. We sought to evaluate E-sign prior to wider adoption within the Trust. Aim To evaluate the acceptability, benefits or drawbacks of the new E-sign process for prescribers and patients. Methods In January 2022 (pre- implementation) we audited 100 homecare prescriptions recording the time between prescribing on our electronic prescribing system (ePMA) and collection by the Sciensus courier. Post-implementation data was gathered by comparing the time of prescribing on ePMA and time of release to Sciensus on the E-sign workflow for 142 prescriptions in May 2023. Data was analysed in Microsoft Excel and a T-test was used to test significance. A short survey was sent to all prescriber and pharmacist users of the E-sign system (12) to evaluate the speed, flexibility and ease of use of the system. As this project falls under the definition of a service evaluation, according to UK NHS Research Ethics Committees, formal ethical approval was not required, it was registered with the Trust’s clinical audit database. Results There was a statistically significant (p < 0.05) decrease in the average time taken for prescription transmission, from 200 hours pre-implementation to 25 hours post-implementation. All respondents to the survey (N=8) agreed it was easier to use than the manual system and would recommend it to colleagues. Most (75%) felt the system was faster and more flexible than the paper system. 50% believed it improved the service to patients. All respondents would recommend the system to their colleagues. Discussion/Conclusion The E-sign system has brought benefits to prescribers and ultimately patients. Prescriptions are now transferred significantly more quickly to homecare providers, and the risk of lost prescriptions is removed. E-sign has allowed for service transformation; we now have prescribers who work entirely remotely using E-sign. Future developments will include collaborating with additional homecare providers, including a new patient workflow, and migrating to EPS when available. Study limitations were due to the sample size of prescribers available for survey.

A cross-sectional study of hospital pharmacists communicating medication changes at discharge

Abstract Introduction Medication discrepancies can happen at transitions of care and there are recognised problems with the content of discharge letters.1 We introduced a discharge medication reconciliation process that was shown to improve the quality of medication information in discharge summaries.2 This involves pharmacists recording any changes to patient’s medication in the electronic prescribing system during the inpatient stay and summarising these changes on discharge in a discharge medication reconciliation (DMR) note. Though this is part of routine clinical pharmacy practice we have not directly quantified these notes in comparison to standards for the clinical structure and content of patient records,3 nor have we examined which medication classes are commented upon by our pharmacists. Aim To characterise the type of medication changes that pharmacists describe and the classes of medication that warrants such attention. Methods A retrospective study of a purposive sample of 100 patient episodes where a DMR note was recorded at a 750-bed teaching district general hospital in England. We classified the text of the DMR note using the four categories (added, amended, on hold, and discontinued) in the eDischarge Summary Standard,3 plus four further categories. The actual medication named was categorised according to the main BNF therapeutic chapters. Data were collated and analysed using Microsoft Excel. As this project falls under the definition of a service evaluation, according to UK NHS Research Ethics Committees, formal ethical approval was not required. This project was registered on the hospital’s clinical audit database. Results Data were extracted for 100 discharges from early 2023. The mean age was 70 years (range 12 to 96), and 40% were male. In total, 352 medicines were named in the DMR notes with 184 (52%) recorded as added, 41 (12%) amended, 32 (9%) on hold, and 42 (12%) discontinued. For 32 (9%) instances the DMR note specifically referred to continuation of medication; in 12 (3%) instances to monitoring required; and 22 (6%) instances fell into other category. For 33 (33%) of episodes there was a note indicating that no changes had been made to other pre-admission medication during the hospital stay. Of the medication attracting a DMR note, the main chapters were cardiovascular 162 (46%), gastrointestinal 45 (13%), central nervous system 40 (11%), and 28 (8%) each for infection and for blood and nutrition. Discussion/Conclusion For this sample of patients who undergo a DMR process, the pharmacy team clarified medication changes at a mean rate of 3.5 changes per patient. Addition of medication was the most common event. The most frequent class of medication attracting a DMR note may be a reflection of the cardiovascular morbidities of patients as well as perceived adverse effects as 27/32 ‘on hold’ notes were for cardiovascular medication. Limitations of this study include the patient sample being collected in one hospital, hence results may not be generalizable. There was no attempt to ascertain if the DMR notes added value to primary care medicines reconciliation process.

“I wasn’t interested until I actually had that consultation”: Exploring the acceptability of a community pharmacy-based hypertension visualisation intervention

Abstract Introduction Hypertension affects around 30% of the UK population and is the leading modifiable cause of cardiovascular disease1. Despite available evidence-based treatments, nonadherence to antihypertensive medication is prevalent. Health psychology theory suggests that beliefs about a condition and its treatment influence health-related behaviours such as medication adherence through the formation of ‘illness representations’, a lay perception of the health threat. Accurate illness representations and an increased belief in the necessity for medication are associated with greater medication adherence2. Visualisation of the internal process of an illness has been shown to support the accuracy of illness representations3. ViSTA-BP (Visualisation to Support Treatment Adherence for High Blood Pressure) is a digital intervention used within a healthcare consultation, enabling individuals to visualise and conceptualise hypertension and the resulting changes to the circulatory system using real-time animations. The purpose is to support medication adherence through the improved understanding of hypertension and increased perception of medication necessity. Aim To explore the acceptability of a community pharmacy-based hypertension visualisation intervention (ViSTA-BP) with community pharmacists and patients. Methods Acceptability of ViSTA-BP was investigated in a community pharmacy setting in South Wales by conducting semi-structured qualitative interviews with pharmacists and patients. Ethical approval was granted by NHS Research Ethics Committee Wales (REC) 5 (20/WA/0280) and Cardiff Metropolitan University Ethics Committee (PGR-3806). Template analysis, a form of qualitative thematic analysis, was used to guide data interpretation. The Theoretical Framework of Acceptability (TFA) provided a lens through which to investigate acceptability, considering affective attitude towards the intervention burden, intervention coherence, ethicality, opportunity costs, perceived effectiveness and self-efficacy. Patients were purposely selected, incorporating a range of locations, adherence and treatment beliefs, thus minimising bias. Results Interviews were conducted with fifteen patients and eight pharmacists who provided feedback. Both groups demonstrated a positive attitude towards ViSTA-BP. Patients were both interested in and reassured by the intervention. They showed good intervention coherence, articulating an increased understanding of hypertension and suggesting patient groups that could benefit from ViSTA-BP. Pharmacists felt ViSTA-BP illustrated the necessity for medication, demonstrating that hypertension could be managed effectively. Patients and pharmacists were positive about ViSTA-BP’s potential for effectiveness. Patients felt it provided context for their understanding of hypertension and could prompt action. Pharmacists liked the visual elements, with ViSTA-BP providing a useful addition to their consultation ‘toolkit’. Patients felt that ViSTA-BP fits well within a community pharmacy setting. Intervention accessibility and facilitator knowledge were key; patients found the intervention duration acceptable. Pharmacists felt that ViSTA-BP fits within their current practice. However, the evolving role of the community pharmacy workforce and time pressures from competing workloads created uncertainty regarding the future feasibility of ViSTA-BP within this setting. Discussion/Conclusion Both patients and pharmacists were positive about ViSTA-BP, acknowledging the potential effectiveness of the personalised interactive visual to engage the viewer and conceptualise hypertension through visual-based communication. However, pharmacists’ perceptions of future roles supported by the community pharmacy contractual framework in Wales and staff time constraints provide potential barriers to future implementation.

Evaluation of simvastatin and CYP3A4-inhibitor interactions in an inpatient population

Abstract Introduction The maximum recommended dose for simvastatin in conjunction with the CYP3A4 inhibitors amiodarone, amlodipine, diltiazem, or verapamil is 20 mg/day.1 Studies have reported on the extent of potentially harmful simvastatin interactions which can increase the risk of myopathy.2 A project in a local primary care setting had identified that 42 (14%) of 305 patients prescribed simvastatin and one of these CYP3A4 inhibitors were receiving the unlicensed dose of simvastatin 40mg. We wanted to investigate if there were similar concerns for hospital inpatients. Aim The aim of this evaluation was to ascertain whether patients were prescribed simvastatin 40mg with one of the named interacting drugs during their hospital admission and whether any action was taken for patients on such a combination. Methods A search was undertaken of patients prescribed simvastatin 40mg with amiodarone, amlodipine, diltiazem, or verapamil using the electronic prescribing system (EPS) (Careflow Medicines Management) between January to October 2022. Relevant data were extracted from the EPS and discharge summaries were searched for any additional information, in particular for any notes made by the prescriber or pharmacy team that they had recognised and acted on this combination. Data were collated and analysed using Microsoft Excel. As this project falls under the definition of a service evaluation, according to UK NHS Research Ethics Committees, formal ethical approval was not required. This project was registered on the hospital’s clinical audit database. Results Fifty-six patients (mean age 78, range 59-94, 50% female) were prescribed a combination of interest during their admission. A further 13 who died in hospital were excluded. Thirty (54%) patients were admitted on this combination. Simvastatin 40mg appeared with amlodipine in 77% (n=43) of instances, diltiazem in 11% (n=6), amiodarone in 11% (n=6), and verapamil in 1% (n=1). Thirty-one (55%) of 56 patients were discharged on this combination, and 6 had no discharge information. Of the 19 (34%) not discharged on the combination, six were due to proactive pharmacy intervention, whilst remaining instances were due to other clinical reasons. Discussion/Conclusion We observed a possible lack of knowledge of these potentially hazardous interactions with some inpatients commenced on the combination, and just over half of the cohort discharged on such a combination. Such in-hospital prescribing of interacting drugs and lack of pharmacy team clinical check could be due to unawareness of the MHRA alert. Though our EPS has the functionality of triggering alerts to notify prescribers of interactions, only level 4 warnings are flagged and the interactions we examined, as a level 3 warning, remain suppressed and not easily visible to the prescriber. Our results will be shared with hospital and primary care pharmacy teams, as this is an area of prescribing that the Care Quality Commission may review when inspecting general practices.3 This evaluation will be repeated. Recognised limitations of this single centre, retrospective study include: we did not look at interactions between simvastatin and other medicines, nor interactions with other statins; we did not investigate whether these patients were suffering from muscle-related adverse events.

Surveillance reports to identify duplicate anticoagulant prescribing

Abstract Introduction A number of patients admitted to hospital on direct oral anticoagulants (DOACs) are often switched to low molecular weight heparin (LMWH) for a limited period of time as part of their clinical management. Electronic prescribing systems (EPMA) allow DOACs to be suspended temporarily and then re-started when clinically indicated. However the system does not generate an alert when DOACs are re-started, leading to unintentional co-prescribing of LMWH which could lead to severe patient harm.1,2 Aim To determine whether anticoagulation surveillance reports reduce the number of inappropriate duplicate anticoagulation prescriptions. Methods A retrospective review of duplicate anticoagulation errors was carried out between September 2017 and March 2022 across the 3 main Royal Cornwall hospital sites. Data on all anticoagulant administrations and the administration time was collected from EPMA via Crystal Reporting pre and post intervention with each period covering 831 days. Data was analysed using Excel. As part of the intervention, surveillance reports were set up in December 2019 to identify patients who were prescribed both LMWHs and DOACs. Reports were generated twice a day, 7 days a week and reviewed for patients who were prescribed both LMWHs and DOACs. The ward pharmacists were then alerted of co-prescribing to complete the necessary interventions. As this project falls under the definition of a service evaluation, according to UK NHS Research Ethics Committees, formal ethical approval was not required. This project was registered on the hospital’s clinical audit database. Results 948,036 doses of LMWH and DOACs were administered (September 2017 to March 2022) with 817 duplicate prescribing identified, a 0.09% error rate. The longest time on duplicate therapy was dramatically reduced pre and post intervention from 322 hrs to 36 hrs with mean number of hours reduced from 14.03 to 8.07. The number of patients receiving more than two doses of co-prescribed LMWH and DOAC before the error was rectified, also reduced from 56 (pre-intervention) to 30 (post-intervention). Likewise, the average duration of more than 2 doses of co-prescription reduced from 48.3 to 18.7 hours before the error was corrected. Discussion/Conclusion Some limitations of the study are that staffing is more limited on weekends which may have prevented pharmacists actioning these alerts over weekends. Data will only include anticoagulants prescribed on EPMA so excludes some infusions such as unfractionated heparin. Timestamps associated with administrations on EPMA are user-entered so may not be exact to the time given. Although EPMA generates an alert when patients on DOACs are prescribed LMWHs, it does not provide a similar alert when suspended DOACs are re-started. EPMA providers are planning to develop alerts to correct this. In the interim we have shown that surveillance reports capture co-prescribing of DOACs and LMWH at an earlier stage preventing potential serious patient harm. It also allows for pharmacists to educate prescribers on risks of anticoagulation co-prescribing. This report is now routine practice, including additional monitoring - patients on warfarin, fondaparinux, LMWH prescribed twice daily and INR levels. We will re-evaluate to include new parameters.

LOCAL AND SYSTEMIC MEDIATORS OF SKELETAL MUSCLE WASTING IN HUMANS FOLLOWING ACUTE TRAUMA

AbstractIntroductionSkeletal muscle wasting is an important clinical issue following acute traumatic injury, and can delay recovery and cause permanent functional disability particularly in the elderly. However, the fundamental mechanisms involved in trauma-induced muscle wasting remain poorly defined and therapeutic interventions are limited.ObjectivesTo characterise local and systemic mediators of skeletal muscle wasting in elderly patients following acute trauma.MethodsExperiments were approved by a local NHS Research Ethics Committee and all participants provided written informed consent. Vastus lateralis biopsies and serum samples were taken from human male and female patients shortly after acute trauma injury in lower limbs (n=6; mean age 78.7±4.4 y) and compared to age-matched controls (n=6; mean age 72.6±6.3 y). Atrogenes and upstream regulators (MuRF1; MAFbx; IL6, TNFα, PGC-1α) mRNA expression was assessed in muscle samples via RT-qPCR. Serum profiling of inflammatory markers (e.g. IL6, TNFα, IL1β) was further performed via multiplex assays. To determine whether systemic factors induced by trauma directly affect muscle phenotype, differentiated primary human myotubes were treated in vitro with serum from controls or trauma patients (pooled; n=3 each) in the final 24 hours of differentiation. Cells were then fixed, stained for myogenin and imaged to determine minimum ferret diameter. Statistical significance was determined at P<0.05.ResultsThere was an increase in skeletal muscle mRNA expression for E3 ligase MAFbx and inflammatory cytokine IL-6 (4.6 and 21.5-fold respectively; P<0.05) in trauma patients compared to controls. Expression of myogenic determination factor MyoD and regulator of mitochondrial biogenesis PGC-1α was lower in muscle of trauma patients vs controls (0.5 and 0.39-fold respectively; P<0.05). In serum, trauma patients showed increased concentrations of circulating pro-inflammatory cytokines IL-6 (14.5 vs. 0.3 pg/ml; P<0.05) and IL-16 (182.7 vs. 85.2 pg/ml; P<0.05) compared to controls. Primary myotube experiments revealed serum from trauma patients induced atrophy (32% decrease in diameter) compared to control serum-treated cells (P<0.001).ConclusionSkeletal muscle from patients following acute trauma injury showed greater expression of atrophy and inflammatory markers. Trauma patient serum exhibited higher circulating pro-inflammatory cytokine concentrations. Primary human myotubes treated with serum from trauma patients showed significant atrophy compared to healthy serum-treated controls. We speculate a mechanism(s) acting via circulating factors may contribute to skeletal muscle pathology following acute trauma.Declaration of Interest(b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project.

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol

IntroductionA digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being....

O008 The impact of home-based exercise prehabilitation on skeletal muscle mitochondrial function in patients awaiting curative surgery for cancer

Abstract Introduction Cancer cachexia is associated with poor surgical outcomes, including increased length of stay, morbidity and mortality. Cachexia is a complex multi-faceted pathological process consistently associated with energy imbalance via hypermetabolism. Beyond this, pre-clinical animal models suggest mitochondrial dysfunction to be an important component of cachexia, although this is unconfirmed in humans. This study aimed to investigate the mitochondrial function of pre-surgical cancer patients, and the impact of exercise prehabilitation on this. Methods This study was approved by an NHS research ethics committee (IRAS: 275264). Male patients awaiting surgery with curative intent for colorectal and prostate cancer were eligible, with healthy volunteers recruited for comparison. Muscle biopsies of vastus lateralis were taken before and after 4-weeks home-based exercise (3x/wk). Mitochondrial oxidative phosphorylation (OXPHOS) was analysed using high-resolution respirometry (Oroboros Instruments). Results Eleven cancer patients and 6 healthy volunteers were recruited. Cancer patients had significantly lower maximal coupled (44.49pmol/(s*mg) vs. 74.81pmol/(s*mg), p=0.004) and uncoupled (55.82pmol/(s*mg) vs. 100.00pmol/(s*mg), p<0.001) OXPHOS capacity compared to healthy controls. Exercise training significantly increased maximal coupled (44.10pmol/(s*mg) vs. 54.64pmol/(s*mg), p=0.045) and uncoupled (56.20pmol/(s*mg) vs. 71.96pmol/(s*mg), p=0.001) OXPHOS capacity in this cancer cohort. Conclusion Declines in mitochondrial function appear to play a role in cancer cachexia. Short-term exercise training, in keeping with target timeframes for surgery (i.e., <31-days from decision-to-treat), appears to attenuate these declines. Further work is needed to determine if declines in mitochondrial function are causative or reactive, and to identify optimal exercise regimes to mitigate these declines.

'Real-life' benefit of hearing preservation cochlear implantation in the paediatric population: a single-site case–control study

IntroductionCochlear implantation with hearing preservation (HPCI) has allowed a cochlear implant (CI) electrode to be implanted while trying to preserve residual acoustic low-frequency hearing. The concept arises from the importance...

Risk reduction intervention for raised blood pressure (REVERSE): protocol for a mixed-methods feasibility study

IntroductionAround 40% of adults have pre-hypertension (blood pressure between 120–139/80–89), meaning they are at increased risk of developing hypertension and other cardiovascular disease-related conditions. There are limited studies on the...

Changing from face-to-face to virtual meetings due to the COVID-19 pandemic: protocol for a mixed-methods study exploring the impact on cancer multidisciplinary team (MDT) meetings

IntroductionIn the UK, the National Cancer Plan (2000) requires every cancer patient’s care to be reviewed by a multidisciplinary team (MDT). Since the introduction of these guidelines, MDTs have faced...

Patients’ perspectives of the skills and competencies of therapy radiographers/radiation therapists (TRs/RTTs) in the UK, Portugal and Malta; a qualitative study from the SAFE Europe project

IntroductionThe role of the Therapy Radiographer/Radiation Therapist (TR/RTT) is to provide radiotherapy to patients with a cancer diagnosis. This includes, not only administration of treatment, but also management of side-effects and provision of support/care. Despite this role being consistent throughout Europe, there is currently no standardisation of education for TRs/RTTs. The SAFE EUROPE project aims to standardize TR/RTT education to enable ‘safe and free exchange’ of TRs/RTTs across Europe. Consequently, this study aims to explore patients' perspectives regarding the current skills and competencies of TRs/RTTs. MethodsFrom May 2021 to February 2022, semi-structured interviews were conducted with patients who had recently received radiotherapy in the UK, Malta and Portugal. Ethical approval for this study was granted by the NHS Research Ethics Committee with additional local approvals obtained. ResultsForty-eight participants from the UK (n = 18), Portugal (n = 19), and Malta (n = 11) completed interviews. Participants described high satisfaction with TRs'/RTTs’ competence and skills in all three countries. The main theme arising from the analysis was the importance of trust building with TRs/RTTs. Six factors were identified as influencing levels of trust: communication; side-effect management; team consistency; relational skills; patient dignity; and competence. A small number of patients reported feeling rushed and not having their physical and emotional needs met by TRs/RTTs. ConclusionThis multicentre study demonstrated that patients perceive TRs/RTTs in the UK, Malta and Portugal as highly competent and skilled. Practical recommendations are provided to address identified deficits in practice, which can be addressed through adaptation of TR/RTT education/training and clinical practice. Implications for practiceRecommendations arising from this study are important to ensure that TRs/RTTs have transferable skills that provide consistently high quality care to patients throughout Europe.

Getting through the NHS Research Ethics Committee (REC) review

‘Psychologists value the dignity and worth of all persons, with sensitivity to the dynamics of perceived authority or influence over persons and peoples and with particular regard to people’s rights’ (Code of Ethics and Conduct, 2018, p.5).

1195 EFFECTIVENESS OF A NEW PROACTIVE MULTIDISCIPLINARY CARE SERVICE FOR OLDER PEOPLE WITH FRAILTY: A NON-RANDOMISED CONTROLLED TRIAL

Abstract Introduction Integrated care potentially improves health outcomes for older people with frailty. We aimed to assess the effectiveness of a new, proactive, multidisciplinary care service in improving the wellbeing and quality-of-life of older people with frailty. Methods A community-based non-randomised controlled trial. Participants (≥65 years, electronic Frailty Index ≥0.36) received either this new integrated care service plus usual care, or usual care alone. Data collection was at 3 time points: baseline, 2-4 weeks, and 10-14 weeks; the primary outcome was patient well-being at 2-4 weeks, measured using the Integrated Patient Outcome scale, IPOS. The secondary outcome was quality-of-life, measured using EQ-5D. Wellbeing and quality-of-life at 10-14 weeks were measured to test safety and duration of effect. Data was analysed with STATA v17. Results 199 intervention and 54 control participants were recruited. At baseline, participants were similar in age/gender/body mass index/ethnicity/living status. At 2-4 weeks, the intervention group had improved well-being (median IPOS reduction 5, versus control group increase 2, p<0.001) and improved quality of life (median EQ-5D index values increase 0.12, versus control 0.00, p<0.001); these were clinically significant. After adjusting for age, gender and living status, intervention group had an average total IPOS score reduction of 6.34 (95% CI: -9.01: -4.26, p<0.05). Propensity score matching analysis based on functional status/deprivation score showed similar results (reduction in IPOS score in intervention group 7.88 (95% CI: -12.80: -2.96, p<0.001). At 10-14 weeks, the intervention group sustained well-being improvement (median IPOS score reduction 4, versus control increase 2, p<0.001) and improved quality of life (median EQ-5D index values increase 0.06, versus control -0.01, p<0.001). Conclusion This new integrated care service improves the overall wellbeing and quality of life of older people with frailty at 2-4 weeks; improvement was sustained at 3 months. Ethics Approval: IRAS-250981 and NHS Research Ethics Committee 18/YH/0470.

Beliefs, behaviour, and blood pressure: preliminary analysis from a pharmacy-based hypertension visualisation intervention to support medication adherence

Abstract Introduction Hypertension is the leading preventable risk factor for cardiovascular disease, with an estimated prevalence of 31% worldwide1. Antihypertensive medication reduces both blood pressure (BP) and cardiovascular risk; however, approximately 50% of patients become nonadherent to antihypertensives within a year of treatment initiation2. Nonadherence can be considered as either intentional or unintentional. Research suggests that rather than being a solely passive process, illness beliefs and treatment perceptions may influence nonintentional nonadherence3, highlighting the importance of considering patients’ beliefs when supporting adherence. The use of visuals is one method to aid understanding of complex health information and influence treatment beliefs. Aim To investigate the feasibility and acceptability of a community pharmacy-based visualisation intervention (ViSTA-BP) and explore the preliminary effect on patients’ perceptions of hypertension, medication adherence and blood pressure. Methods ViSTA-BP is a digital intervention that allows users, through real-time animations, to visualise both the condition that is hypertension and how blood pressure affects the circulatory system. The purpose of ViSTA-BP was to improve patients’ understanding of hypertension, increase perceived necessity of treatment and ultimately support medication adherence. A mixed-methods pre-post design pilot study was conducted. NHS Research Ethics Committee Wales Rec 5 (reference 20/WA/0280) and Cardiff Metropolitan University (reference PGR-3806) granted ethical approval. The intervention was consultation-based and researcher-facilitated. Outcomes were recorded at baseline, immediately post-intervention, and at three-months. Validated questionnaires were used to measure illness and treatment beliefs (Brief Illness Perception Questionnaire (B-IPQ)/Beliefs about Medicines Questionnaire (BMQ)), adherence captured using self-report measures (Medicines Adherence Rating Scale (MARS-5)/recent adherence questionnaire) and medication dispensing/collection data. BP was measured at baseline and 3-month follow-up. Semi-structured interviews with patients and pharmacists explored intervention acceptability. Results Pharmacists recruited 69 patients with hypertension across five community pharmacies (CP) in South Wales; 54 attended the three-month follow-up. The ease of participant recruitment and high retention rates demonstrated the feasibility of delivering ViSTA-BP in this setting. ViSTA-BP content and the CP location were acceptable to patients and pharmacists. Time to deliver the intervention was a concern for pharmacists but not patients. There was no statistically significant change in adherence outcomes at three-month follow-up; however, the median scores for both self-report questionnaires were maximal at baseline. Changes were seen in illness belief scores, with a significant improvement in total B-IPQ score over time (p=0.04). Significant changes in B-IPQ treatment control (p=0.01), illness coherence (p<0.001) and BMQ Necessity subscale scores (p=0.003) were reported at all time-points. There was a statistically significant improvement in both systolic (SBP) (p<0.01) and diastolic BP (DBP) (p=0.03) three-months post-intervention. At baseline, 31% of participants had SBP at or below the UK target; however, at three-month follow-up, 59% were at or below the UK target. Discussion/Conclusion ViSTA-BP was considered a feasible researcher-facilitated intervention in this CP setting. Improvements seen in blood pressure control, patients’ understanding of hypertension, and perceptions of utility and necessity of treatment highlight the potential for the ViSTA-BP intervention to help reduce cardiovascular risk in the future. While preliminary analysis shows promise, further adequately powered research studies are necessary to evaluate future ViSTA-BP impact.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. 90146150 (28/03/2019).