IMPROVING PATIENT SAFETY THROUGH THE ESTABLISHMENT OF A PHARMACIST-LED BLOOD MONITORING CLINIC FOR JAK INHIBITORS IN RHEUMATOLOGY

BackgroundJanus kinase inhibitors drugs (JAKi) are novel small molecule medications known to cause abnormalities such as elevations in hepatic transaminases, decreases in neutrophil and lymphocyte counts and elevations in cholesterol and creatinine kinase. Blood monitoring is recommended and dose adjustments are advised if abnormalities arise. Recent warnings by the EMA and MHRA have highlighted the importance of monitoring these medications.Timely review and management of patients on JAKi drugs is difficult to maintain with increasing workload amongst the rheumatology team. A baseline audit (2020) demonstrated that hospital blood monitoring guidelines for JAKi drugs were not being followed. The rheumatology multidisciplinary team met and utilised Quality Improvement methodology including fish and driver diagrams to address this. This led to the creation of a pharmacist-led JAKi blood monitoring clinic.ObjectivesTo establish a pharmacist-led rheumatology blood monitoring clinic for the JAKi drug class in order to: increase patient safety with increased compliance to blood monitoring, save consultant/nurse time, improve communication with primary care on the frequency of blood testing required, increase patient understanding of the importance of blood monitoring with JAKi drugs, reinforce counselling advice such as risk of infections, shingles and thrombosis and promote medication adherence.MethodsThe clinic was established in March 2021. Patients commencing JAKi drugs are referred to the pharmacist-led clinic by the medical team. The pharmacist contacts the patient by phone following delivery of their medication. The patient is counselled on their new medication and dates for blood checks are agreed. A letter is sent to the patient and their GP providing this information. The patient is booked into virtual telephone appointments and bloods are monitored every month for the first 3 months and every 3 months thereafter. Any change or abnormality in blood results are flagged early in the patient's treatment and if necessary, discussed with the consultant. Adjustments are made to the patient's dose if appropriate.ResultsIn order to evaluate the benefit of the pharmacist clinic a re-audit of compliance with blood monitoring (March 2021- September 2022) was carried out alongside a patient satisfaction postal survey (August 2022).A total of 58 patients were sampled in the re-audit. The re-audit found an increase in compliance in blood monitoring since the introduction of the pharmacist clinic. 98% of patients had their full blood count performed at 3 months compared to 56% in audit 1 and 95% of patients had their lipid profile completed at 3 months compared to 15% in audit 1 (Table 1).A patient satisfaction survey (N=62, response rate 48%) found that 28 (93%) patients either agreed or strongly agreed that they were more aware of the importance of attending for regular blood monitoring when prescribed JAKi therapy as a result of the clinic.The pharmacy team made several significant interventions (self-graded Eadon grade 4 and 5). For example by improving medication adherence, detecting haematological abnormalities that required JAKi dose reduction, identifying patients suffering from infection requiring intervention including shingles and Covid-19.Table 1.Comparison of audit results pre (Audit 1) and post (Audit 2) clinic establishmentAudit 1 (N=48)Audit 2 (N=58)Number of patients with full blood count completed at weeks 4, 8 & 1227 (56%)57 (98%)Number of patients with lipid profile completed at week 127 (15%)55 (95%)Number of patients LFTs completed at weeks 4, 8 & 1226 (54%)54 (93%)ConclusionIntroduction of the pharmacist-led clinic has increased patient safety by ensuring compliance with blood monitoring as per hospital guidelines. The clinic has paved the way for improved communication with primary care teams and has provided patients with extra support during their first months on treatment with their JAKi. It has also expanded the role of the rheumatology pharmacy team and saved nursing and medical time.Acknowled ementsI wish to thank the SHSCT Rheumatology team for all their help, support and guidance with this project.Disclosure of InterestsNone Declared.

An Audit Showing the Successful Operation of a Nurse-Led Gout Clinic during the Covid-19 Pandemic

Background/Aims Research has shown nurse-led gout clinics provide better outcomes compared to usual care. This District General Hospital set up a pilot nurse-led gout clinic in autumn 2019. This aimed to improve patients' understanding of their condition, achieve better control of serum uric acid levels (SUA), reduce flares and prevent Emergency Department attendances. Methods A modified clinic protocol, closely modelled on BSR guidance was agreed within the department. With consultant supervision, one nurse specialist provided a mix of in-person and telephone appointments. Targets were set aiming for SUA <360mumol/L for most patients and <300mumol/L for those with erosive change or tophi. All patients were offered prophylaxis. Patients required a rheumatologist's diagnosis of gout or crystal confirmation for enrolment. Exclusion criteria were significant renal or hepatic derangement. Within 3 months of the service starting SARS-CoV-2 impacted the operation of healthcare worldwide and led to the closure of routine outpatient clinics in Northern Ireland. A decision was made to switch the gout clinic to run entirely by telephone. Blood testing was facilitated through primary care and phlebotomy hubs. Results Over a 19-month period, 78 patients were treated and audited through this clinic: 69 men and 9 women. Average age was 57, mean SUA 509 mumol/L at referral and 322 mumol/L on discharge. 69 patients received allopurinol and 9 received febuxostat. No patients required uricosuric drugs. All patients were offered and agreed to take prophylaxis with a majority (85.8%) remaining on it for 3-6 months. Patients required a mean of 3.38 appointments prior to discharge from the clinic. The mean dose of urate lowering therapy on discharge was 315.9mg allopurinol and 93.3mg febuxostat. 95% experienced >=2 flares during their enrolment in the clinic with no patients requiring Emergency Department attendance due to gout flare. Conclusion The nurse-led gout clinic was well received by patients and was effective as a telephone service during the pandemic when so many services were stood down. The clinic was able to continue to provide education, deliver effective reductions in uric acid as well as reduce incidence of flares and Emergency Department attendances. Lower doses of urate lowering therapy than expected were needed to achieve target. A small number of patients were discharged prior to enrolment for initial non-engagement which may have been exacerbated by the lack of face-to-face appointments. Our COVID-19 model did struggle with those patients needing an interpreter. In-person initial appointments have since been restarted;however, a greater proportion of reviews will continue to be offered by telephone given the unexpected success of the model. This audit showed that a nurse-led gout clinic can run successfully, even during a pandemic with a significant reliance on telephone consultations.

Trastuzumab deruxtecan (T-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic hormone receptor-negative (HR-), HER2-low breast cancer: updated results from BEGONIA, a phase 1b/2 study

Background: Patients with HR- advanced/metastatic breast cancer (a/mBC) with a low level of HER2 (immunohistochemistry [IHC] score 1+ or IHC 2+ and negative in situ hybridization [ISH]) have poor prognosis. Combining 1L chemotherapy with immune checkpoint inhibitors can modestly improve outcomes vs chemotherapy alone, but treatment benefit is largely seen in patients with PD-L1+ disease. BEGONIA (NCT03742102) is an ongoing 2-part, open-label platform study, evaluating safety and efficacy of D, an anti-PD-L1 antibody, combined with other novel therapies in 1L triple-negative a/mBC, including HR-, HER2-low disease. T-DXd is a trastuzumab-topoisomerase I inhibitor antibody-drug conjugate that improves survival in patients with previously treated HR-, HER2-low mBC (NCT03734029;Modi NEJM 2022). Here, we report updated results of the T-DXd + D combination from BEGONIA. Method(s): Patients with unresectable HR-, HER2-low (per local testing, IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) a/mBC were enrolled in the T-DXd + D arm. Patients eligible for 1L treatment, regardless of PD-L1 status, received intravenous T-DXd 5.4 mg/kg + D 1120 mg every 3 weeks until progression or unacceptable toxicity. PD-L1, assessed using the VENTANA PD-L1 (SP263) Assay, was defined as high if >= 5% of the tumor area was populated by PDL1-expressing tumor or immune cells. Primary endpoints were safety and tolerability. Secondary endpoints included investigator-assessed objective response rate (ORR;RECIST v1.1);progressionfree survival [PFS];and response duration. Patients included in the efficacy analysis had >= 2 ontreatment disease assessments, progressed, died, or withdrew from the study. Result(s): As of April 8, 2022, 56 patients received T-DXd + D (34 ongoing) and 46 were included in the efficacy analysis. Median (range) follow-up was 10.1 (0-22) months. Median age was 53.5 years, 71% had received prior treatment for early stage BC, and 64% had visceral metastases at baseline. Confirmed ORR was 26/46 (57% 95% CI, 41-71) and unconfirmed ORR was 33/54 (61% 95% CI, 47-74);1/46 patients (2%) had complete and 25/46 (54%) had partial responses. Confirmed response occurred irrespective of PD-L1 expression (PD-L1 high ORR, 5/7 [71%];PD-L1 low, 13/21 [62%];PD-L1 missing, 8/18 [44%]). Median duration of response was not reached;however, 64% of patients remained in response at 12 month follow-up and 73% had an ongoing response at data cutoff. Median PFS was 12.6 months (95% CI, 8-not reached). Adverse events (AEs) were consistent with the agents' known safety, with treatment-related AEs occurring in 49 patients (88%), any Grade 3/4 AEs in 18 patients (32%), and any serious AEs in 10 patients (18%). The most common all-Grade AEs were nausea (41 [73%]), fatigue (26 [46%]), and vomiting (17 [30%]). Adjudicated treatment-related interstitial lung disease/pneumonitis occurred for 5 patients (9%), which were mostly Grade 1 or 2 and 1 case of Grade 5 associated with COVID pneumonia. Seven patients (13%) and 21 patients (38%) had T-DXd dose reduction and dose delay, respectively;22 (39%) had D dose delay. Seven patients (13%) discontinued treatment due to AEs. Conclusion(s): For patients with HR-, HER2-low a/mBC, T-DXd in combination with D in the 1L setting shows manageable safety and promising efficacy including durable responses and an encouraging PFS. Although subgroups were small, responses were observed irrespective of PD-L1 expression. Analysis of additional translational data is ongoing. Funding(s): AstraZeneca/Daiichi Sankyo.

COVID-19 ethnic inequalities in mental health and multimorbidities: protocol for the COVEIMM study.

PURPOSE: The COVID-19 pandemic may have exacerbated ethnic health inequalities, particularly in people with multiple long-term health conditions, the interplay with mental health is unclear. This study investigates the impact of the pandemic on the association of ethnicity and multimorbidity with mortality/service use among adults, in people living with severe mental illnesses (SMI). METHODS: This study will utilise secondary mental healthcare records via the Clinical Record Interactive Search (CRIS) and nationally representative primary care records through the Clinical Practice Interactive Research Database (CPRD). Quasi-experimental designs will be employed to quantify the impact of COVID-19 on mental health service use and excess mortality by ethnicity, in people living with severe mental health conditions. Up to 50 qualitative interviews will also be conducted, co-produced with peer researchers; findings will be synthesised with quantitative insights to provide in-depth understanding of observed associations. RESULTS: 81,483 people in CRIS with schizophrenia spectrum, bipolar or affective disorder diagnoses, were alive from 1st January 2019. Psychiatric multimorbidities in the CRIS sample were comorbid somatoform disorders (30%), substance use disorders (14%) and personality disorders (12%). In CPRD, of 678,842 individuals with a prior probable diagnosis of COVID-19, 1.1% (N = 7493) had an SMI diagnosis. People in the SMI group were more likely to die (9% versus 2% in the non-SMI sample) and were more likely to have mental and physical multimorbidities. CONCLUSION: The effect of COVID-19 on people from minority ethnic backgrounds with SMI and multimorbidities remains under-studied. The present mixed methods study aims to address this gap.

Assessment of a Nursing and Pharmacy Collaborative Outpatient Parenteral Antimicrobial Therapy Management Program

Background. At our facility a collaborative team of nurse and pharmacist manage patients receiving outpatient parenteral antimicrobial therapy (OPAT). This project aims to characterize this collaboration and assess the effectiveness by reviewing interventions made by the nurse and pharmacist, and assessing patient outcomes such as OPAT or infection related hospital admissions or ED visits, infection clearance, and mortality. Methods. A retrospective cohort study was performed on patients started on OPAT between 1/1/19 and 12/31/20. This time period was split into three: Period 1 where the clinic only included the PharmD and they saw patients for in-person appointments, Period 2 where the clinic included both the OPAT RN and PharmD and the PharmD performed in-person appointments, and Period 3 where the clinic included both but due to COVID the in-person PharmD appointments were on hold. OPAT or infection related hospital admissions, ED visits, infection clearance, and death were compared for each period. Results. A total of 388 patients were included in the review. There were 158 (40.7%) and 148 (38.1%) OPAT-related phone calls from the PharmD and RN, respectively. The two most common reasons for both PharmD and RN phone calls were a medication stop order/confirmation, and weekly lab obtainment. The third most common reason for the PharmD was dose change, and for the RN it was patient education. During Periods 1 and 2 the PharmD had in-person appointments with 28.9% of patients. The overall OPAT/infection related hospital admission and ED visit rates were 7.7% and 5.4%, respectively. Periods 2 and 3, which utilized the combined efforts of RN and PharmD, had consistently lower hospital admissions related to OPAT/infection (46-50% vs 62% Period 1), and ED visits due to OPAT/infection (33-36% vs 47% for Period 1). Clearance of infection was high for all 3 periods (89-95%), and mean mortality was low (2.1%). Conclusion. Collaborative management allowed for the nurse and pharmacist to function as substitutes for each other without losing the specific focus of their specialties, with the RN performing more patient education, and the PharmD performing more medication dosing. The collaboration had positive effects on OPAT patient outcomes.

The Duluth International Airport aviation business cluster: The impact of COVID-19 and the CARES act

The COVID-19 pandemic struck the U.S. aviation sector in March 2020, reducing air passenger volumes by more than 50 percent versus March 2019. Airlines dramatically reduced available seat miles, leaving airports nearly vacant as the pandemic took hold. The Federal government responded with the Coronavirus Aid, Relief, and Economic Security (CARES) Act that provided aid and relief to airlines and airports. The Act generally achieved its intended purpose as a stopgap measure, but not all segments of the nation's aviation industry received immediate relief. Utilizing data from the Duluth Airport Authority, airport tenants, as well as governmental sources, this study examines the economic impact of the pandemic during 2020 on businesses in the Duluth, Minnesota, aviation business cluster and the efficacy of Title XII under Division B of the CARES Act in addressing the adverse effects of the pandemic on the Duluth aviation cluster. This paper does not make a judgment whether future relief packages should or should not be offered.

Necessity is the mother of invention - Value methodology in the age of pandemic

The onset of Covid-19 created widespread change in the daily lives, and in the way they conduct business, for people across the globe. This paper will explore the impact of the pandemic on the practice for a VM professional services company. We will explore the impacts of the pandemic and the shift to virtual VM studies;the challenges and opportunities;facilitative and technological changes that have been made;and an assessment of the effectiveness of these adaptations. Finally, we will offer our conclusions based on the lessons learned and the path forward for the practice of VM in the post-pandemic world. © SAVE Inter. 2021 Value Summit Proc. All rights reserved.

DeepSpatial'21: 2nd International Workshop on Deep Learning for Spatiotemporal Data, Applications, and Systems

With the advancement of GPS and remote sensing technologies and the pervasiveness of smartphones and mobile devices, large amounts of spatiotemporal data are being collected from various domains. Knowledge discovery from spatiotemporal data is crucial in broad societal applications. Examples range from mapping flooded areas on satellite imagery for disaster response to monitoring crop health for food security, from estimating travel time between locations on Google Maps to forecasting hotspots of diseases like Covid-19 in public health. The recent success in deep learning technologies in computer vision and natural language processing provides unique opportunities for spatiotemporal data mining (e.g., automatically extracting spatial contextual features without manual feature engineering) but also faces unique challenges (e.g., spatial autocorrelation, heterogeneity, multiple scales, and resolutions, the existence of domain knowledge and constraints). This workshop provides a premium platform for researchers from both academia and industry to exchange ideas on opportunities, challenges, and cutting-edge techniques of deep learning for spatiotemporal data. We hope to inspire novel ideas and visions through the workshop and facilitate the development of this emerging research area. © 2021 Owner/Author.

Insights from electronic health record data to improve mental health service delivery during the COVID-19 pandemic

BackgroundRemote consultation technology has been rapidly adopted due to the COVID-19 pandemic. However, some healthcare settings have faced barriers in implementation. We present a study to investigate changes in rates of remote consultation during the pandemic using a large electronic health record (EHR) dataset.MethodsThe Clinical Record Interactive Search tool (CRIS) was used to examine de-identified EHR data of people receiving mental healthcare in South London, UK. Data from around 37,500 patients were analysed for each week from 7th January 2019 and 20th September 2020 using linear regression and locally estimated scatterplot smoothing (LOESS) to investigate changes in the number of clinical contacts (in-person, remote or non-attended) with mental healthcare professionals and prescribing of antipsychotics and mood stabilisers. The data are presented in an interactive dashboard: http://rpatel.co.uk/TelepsychiatryDashboard.ResultsThe frequency of in-person contacts was substantially reduced following the onset of the pandemic (β coefficient: -5829.6 contacts, 95% CI -6919.5 to -4739.6, p<0.001), while the frequency of remote contacts increased significantly (β coefficient: 3338.5 contacts, 95% CI 3074.4 to 3602.7, p<0.001). Rates of remote consultation were lower in older adults than in working age adults, children and adolescents. Despite the increase in remote contact, antipsychotic and mood stabiliser prescribing remained at similar levels.ConclusionsThe COVID-19 pandemic has been associated with a marked increase in remote consultation, particularly among younger patients. However, there was no evidence that this has led to changes in prescribing. Further work is needed to support older patients in accessing remote mental healthcare.DisclosureAll authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: RS has received funding from Janssen, GSK and Takeda outside the submitted work. RP has received funding from Janssen, Induction Healthcare and H

A review of telephone consultations for head and neck cancer follow up: a patient satisfaction survey.

OBJECTIVE: To review patient satisfaction with the change in practice towards telephone consultations during and after the coronavirus disease 2019 pandemic for head and neck cancer follow up. METHOD: A retrospective analysis was conducted of head and neck cancer telephone appointments during a six-month period in a tertiary referral centre. RESULTS: Patients found the telephone consultations beneficial (98 per cent), with 30 per cent stating they were relieved to not have to attend hospital. Patients who travelled further, those with lower stage disease and patients with a greater interval from initial treatment were most satisfied with the telephone consultations. Sixty-eight per cent of patients stated they would be happy to have telephone consultations as part of their regular follow up after the pandemic. CONCLUSION: Patients found the telephone consultations beneficial and 30 per cent considered them preferable to face-to-face appointments. This study demonstrates that telephone consultations can be used as an adjunct to face-to-face appointments in an effort to reduce hospital attendances whilst maintaining close follow up.

Resilience in a time of contagion: Lessons from small businesses during the covid-19 pandemic

ABSTRACT The abrupt outbreak of the COVID-19 pandemic sent unprecedented shockwaves across the globe, creating an unparalleled crisis in terms of our health, severely impacting the way we live and work. Measures such as social distancing and travel restrictions, have disrupted production and supply chains, reinforcing a demand shock. In the midst of this pandemic, however, there are leaders of resilient firms that are effectively responding to these changing times. Using a multiple-case inductive enquiry, the paper analyses how leaders activate resilience in small businesses. Employing a process framework, which focuses on sequences of activities and their interrelations which we analyse to uncover how these leaders activated this resilience and explicitly integrated the literature of resilience with that of sensemaking. Resilience emerges when cognition and behaviour work in conjunction, with businesses adapting to combat the crisis. When it comes to global disruptive crises such as the COVID-19 pandemic, extant literature provides us with little guidance. The study not only makes a number of contributions to extant literatures but also provides valuable insights and tools to help leaders effectively navigate and respond to this crisis. By doing fast research in real time the paper provides novel and original insights MAD statement The impact of the corona virus, COVID-19, was swift and sudden on organizational life. For the majority of people, leaders and employees, the impact has been challenging and not in a good way. For a few leaders, however, the contagion proved to be a business opportunity rather than a disaster. In this paper we discuss how a handful of firms turned the crisis into good business, proving to be resilient and resourceful by bricolaging rapid responses to a radically changed situation from which good things flowed as positive responses, producing products that helped to deal with the virus. For example, production shifted from alcohol to hand sanitiser. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Guidelines for the management of diabetes services and patients during the COVID-19 pandemic.

The UK National Diabetes Inpatient COVID Response Group was formed at the end of March 2020 to support the provision of diabetes inpatient care during the COVID pandemic. It was formed in response to two emerging needs. First to ensure that basic diabetes services are secured and maintained at a time when there was a call for re-deployment to support the need for general medical expertise across secondary care services. The second was to provide simple safe diabetes guidelines for use by specialists and non-specialists treating inpatients with or suspected of COVID-19 infection. To date the group, comprising UK-based specialists in diabetes, pharmacy and psychology, have produced two sets of guidelines which will be continually revised as new evidence emerges. It is supported by Diabetes UK, the Association of British Clinical Diabetologists and NHS England.