Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

BACKGROUND: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown. METHODS: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study. CONCLUSION: The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04276441.

How to advise women on the safe use of medicines while breastfeeding

Medicines use plays an important role in women's decisions to start or continue breastfeeding. Some may stop breastfeeding or the medicine to avoid combining the two, as they feel very strongly about tainting their milk when breastfeeding[10]. Women deserve to be involved in discussions on compatibility, using evidence-based resources presented in a manner in which they can understand. There is a presumption by some healthcare professionals, mothers, families and wider society that formula has benefits over breast milk with a trace of medication in, or that adverse events are likely and serious if this breast milk is consumed. In addition, there is a reticence from healthcare professionals to use professional judgement and go outside the licence application for medicines. This leaves the mother with a dilemma: to interrupt or stop breastfeeding to take the medication, or to delay medication - with chronic diseases, the latter is rarely an acceptable option. In January 2021, the MHRA launched the Safer Medicines Consortium, owing to the "need for reliable and consistent information about medicines used before or during pregnancy and breastfeeding for women and the healthcare professionals who advise them". The vision of the consortium is that "all women will have access to accurate and accessible information to make informed decisions with their healthcare professional about taking medicines before or during pregnancy or breastfeeding"[44]. As experts in medicines, pharmacists should share evidence-based information with the mother and support her in making a decision that is right for her and her baby, as outlined above. Copyright © 2021 Pharmaceutical Press. All rights reserved.

Guillain-Barre Syndrome and Parsonage-Turner Syndrome Following COVID-19 Viral Vector Vaccination

Case Diagnosis: Patient is a 63-year-old male with Guillain-Barre Syndrome and Parsonage-Turner Syndrome following COVID-19 Vaccination Case Description or Program Description: Eight days after receiving a viral vector COVID-19 vaccination, the patient developed low back and left thigh pain with severe right shoulder pain developing the following day. He denied recent viral illnesses, gastrointestinal symptoms, or prior right shoulder pain. Pain, weakness, and sensory changes gradually involved all four extremities. He was hospitalized and Guillain-Barre Syndrome (GBS) was confirmed by lumbar puncture. He tested negative for Campylobacter jejuni. Cervical and lumbar spine MRIs showed mild degenerative changes without stenosis or neuroforaminal impingement. Right shoulder MRI showed no abnormality. He responded to a 5-day course of IVIG. His extremity pain gradually resolved but right shoulder weakness remained. Electrodiagnostic testing six months after symptom onset showed evidence of GBS in recovery. Right shoulder girdle muscles were not tested during the first EMG. After stays at an LTAC and SNF, the patient was admitted to IPR. While at IPR, he reported debilitating right shoulder weakness and limited ROM. On exam, significant atrophy of the right deltoid, infraspinatus, and supraspinatus muscles was observed. A repeat electrodiagnostic study showed evidence of a right Parsonage-Turner syndrome (PTS) in addition to the GBS in recovery. Setting(s): Inpatient Rehabilitation (IPR) Assessment/Results: Patient's presentation and EMG findings pointed to a concurrent occurrence of PTS and GBS after his COVID-19 vaccination. A right shoulder ultrasound-guided glenohumeral joint corticosteroid injection improved his shoulder ROM. The patient was discharged home with outpatient therapy after four weeks of IPR. Discussion (relevance): Rare instances of GBS and Parsonage-Turner Syndrome have been reported after a COVID-19 vaccination. This appears to be the first reported case where GBS and PTS have both occurred in a patient soon after receiving a COVID-19 vaccination. Conclusion(s): Concurrent PTS and GBS can develop after COVID-19 vaccine administration.

Improving household nutrition security and public health in the CARICOM: project overview

Objective: To provide an overview of the 'Improving Household Nutrition Security and Public Health in the CARICOM' (Food and Nutrition: FaN) project's objectives, design and methods, and summarize some of its core activities and achievements. Method(s): The three project countries were Jamaica, St. Kitts and Nevis, and St. Vincent and the Grenadines. To answer the research question, "What are the most effective, gendersensitive ways to improve food sovereignty, household food security, and nutrition in CARICOM states?", there were four objectives - two research objectives including scoping reviews and stakeholder engagement;and two objectives to design and assess interventions. The project was originally planned for execution January 2018 to January 2022. However, a 6-month no-cost extension was granted due to coronavirus disease 2019 (COVID-19)-related project delays. Result(s): Thirteen COVID-modified interventions were pursued under the categories schools, communities, and CARICOM supports and included revision of Primary and Secondary school curricula and development of school nutrition standards. Regional capacity was strengthened through community interventions, two Master of Public Health scholarships, and upgrading of lab equipment to test foods for fats, sodium, and sugar in Jamaica, among others. Dissemination was undertaken under the re-branded slogan and logo, "Food 4 Change Caribbean". The project website (www.food4changecaribbean.org) hosts reports and videos to ensure that resources can be accessed beyond the project time frame. Conclusion(s): Despite challenges precipitated by the COVID- 19 pandemic, including tabling of planned in-person activities, the project team was able to re-group and re-design interventions to accommodate the new reality.

Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic.

Pharmacovigilance plays a lifesaving role in the practice of medicine. In 2021, during the Coronavirus Infectious Disease 2019 (COVID-19) pandemic, Loyola University Chicago launched a graduate-level Pharmacovigilance Certificate Program (PV-CERT) and a pre-professional non-graduate Pharmacovigilance Certificate Course (EPEC-PV), to provide students a comprehensive and contemporary understanding of the principles and practices of pharmacovigilance. Formal training in pharmacovigilance through this course provided a structured understanding of how safety data are generated through clinical trials and from real-world evidence as well as the regulatory environment in which data are monitored and interpreted. Pharmacovigilance training is of critical importance, especially during the COVID-19 pandemic, during which several drugs were re-purposed for the management of various stages of COVID-19 without conventional safety data. Moreover, the safety of currently-used vaccines is of concern in some populations. Although anticoagulants and antithrombotic medications are crucial in the management of COVID-19, a clear pharmacovigilance program on their use in this indication is not established. As the century progresses, new diseases and infectious agents will require novel therapies for which the evaluation of benefits versus risks will be as essential as it has been for the current COVID-19 pandemic. As such, the Loyola course and accompanying programs on pharmacovigilance will play a key role in educating the next generation of professionals in pursuing careers in the development of therapies that ultimately improve patient outcomes while maintaining rigorous safety standards.

The use of orthopathway, decision support software, to reduce variation in practice, optimise patient care and reduce face-to-face appointments in trauma and orthopaedics

Introduction: Musculoskeletal problems account for 3.5million Emergency Department attendances annually. Front-line staff are under pressure, faced with complex decisions with limited supportive tools. Without adequate support there is greater variation in practice, poor patient outcomes, longer Emergency Department stays and unnecessary follow-up. OrthoPathway is a web application that enables the production of editable decision support pathways. We have published over 50 Consultant designed, locally approved, interactive pathways. Patient-facing staff can use these to follow national guidelines, by answering questions to establish appropriate treatments. Method: New and follow-up fracture clinic patients were audited over a one-week period. Clinic letters and clerking documents were analysed to identify the diagnosis and management plan. From information and radiographs available OrthoPathway was used to generate a management plan, used as the audit standard. Results: 78 new patients and 83 follow-up patients were seen in fracture clinic over a one-week period. Clinical pathways were available on OrthoPathway for 42% of new patients and 40% of follow-up patients. Variation in practice was seen in 42% of new patients and 59% of follow- up patients. The associated saving in appointments was 11 and 21 and in the new and follow-up patients, respectively. Conclusions: We have shown that OrthoPathway has the potential to reduce face-to-face appointments by 20%, with its current utilisation. Through the deployment of a full set of pathways we anticipated a reduction of greater than 40%, which is particularly pertinent given the current COVID-19 pandemic. This highlights the benefits of Consultant approved decision support pathways published on OrthoPathway.

Adapting to COVID-19 on construction sites: what are the lessons for long-term improvements in safety and worker effectiveness?

Purpose: Substantial changes were made on many UK construction projects in response to the COVID-19 pandemic. The purpose of this paper is to explore the unanticipated positive consequences of these and the scope for longer-term learning and developments within the sector. Design/methodology/approach: A qualitative approach was used, semi-structured interviews were conducted across six major project sites. Interviewees (n = 33) included site and senior managers, supply chain representatives and occupational safety and health (OSH) professionals. The interviews explored their experiences of working on site during the pandemic, the changes made to work practices and their perceived impacts of these changes. Findings: Improved planning and work sequencing were part of the revised process to make sites COVID-secure. This increased worker effectiveness and housekeeping/tidiness. The view on some sites was that this would improve OSH performance. The changes were perceived to be beneficial but may not be accepted by clients in the long term, as they could result in projects taking longer to complete. The ways in which COVID-19 risk has been communicated and perceived also provides longer-term lessons for the sector’s OSH management and training. Originality/value: Construction has adapted rapidly and effectively to new ways of working during the pandemic. This research captured in real time some of the changes made and presents an argument for embedding and adopting the changes to improve working arrangements and OSH within the construction sector. © 2021, Emerald Publishing Limited.

Empowering community voices: The influences of consumer race, disability, and poverty on public vocational rehabilitation service engagement

The public Vocational Rehabilitation (VR) program provides key services and supports to individuals with disabilities seeking to improve their employment, careers, and economic mobility. However, engagement in the VR program is not consistent across all populations, with a focus on those residing in historically underserved and marginalized low-income communities of color. The purpose of this study was to better understand the needs of current and former Black American VR consumers residing in a large urban area to inform current and future policy and practice needs within the state agency. While data was collected just prior to the COVID-19 pandemic, the views shared by participants regarding the stress and trauma of experiencing a chronic lack of resource and recommendations for improvements within the public VR program are perhaps even more relevant considering the disproportionate impact of the pandemic on this and similar communities. Recommendations for training and future research to enhance engagement, understanding, and better serve this population through the public VR program are offered. © 2021 National Rehabilitation Association. All rights reserved.

Outcomes and clinical characteristics of COVID-19 disease in the frail, elderly population of tayside

Introduction: With advancing age, frailty, multi-morbidity and need for care, elderly patients are some of the most vulnerable to Covid-19 disease. In NHS Tayside, a dedicated Covid-19 Medicine for the Elderly (MFE) Team was formed to care for patients identified as frail and likely to benefit from comprehensive geriatric assessment. Methods: All Covid-19 patients meeting frailty criteria1, cared for by the Covid-19 MFE Team were identified. Data on outcomes and clinical characteristics for all (140) patients admitted during the first pandemic wave (March-July 2020) was collected using electronic patient records and analysed. Results: Patients were predominantly male (58.6%). Ages ranged from 65-99 years, with 43.6% aged ≥85 years. 82.1% had one or more of cough, fever and anosmia on admission fitting Covid-19 case definition 2. Lymphopenia was present in 92.1%. Of note, 26.5% of patients had a normal or unchanged chest x-ray report, with only 10.2% showing bilateral peripheral infiltrates. 28-day mortality was 37.1% with Covid-19 Disease listed as primary cause of death in 90.4%. Conclusion(s): Entering further “waves” of infection, it is vital that we understand the clinical presentation and course of Covid-19 disease in elderly patients. Our data highlights that any Covid-19 symptom, even in isolation, should raise suspicion of disease. Chest xrays should not be used alone as a diagnostic tool.The presence of lymphopenia should raise suspicion of Covid-19 infection. In developing an understanding of how elderly patients with Covid-19 present, we can ensure early identification and initiation of appropriate infection control measures.

Characteristics of clinical trials evaluating cardiovascular therapies for Coronavirus Disease 2019 Registered on ClinicalTrials.gov: a cross sectional analysis.

Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. METHODS: ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. RESULTS: A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). CONCLUSIONS: A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.