The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2).

BACKGROUND: SARS-CoV-2 has ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters preceding an adverse event. Wearable sensors can measure vital signs continuously and remotely, outside of hospital facilities, recognising early clinical deterioration. We aim to determine the feasibility & acceptability of remote monitoring systems for quarantined individuals in a hotel suspected of COVID-19. METHODS: A pilot, proof-of-concept, feasibility trial was conducted in engineered hotels near London airports (May-June 2020). Individuals arriving to London with mild suspected COVID-19 symptoms requiring quarantine, as recommended by Public Health England, or healthcare professionals with COVID-19 symptoms unable to isolate at home were eligible. The SensiumVitals™ patch, measuring temperature, heart & respiratory rates, was applied on arrival for the duration of their stay. Alerts were generated when pre-established thresholds were breeched; trained nursing staff could consequently intervene. RESULTS: Fourteen individuals (M = 7, F = 7) were recruited; the mean age was 34.9 (SD 11) years. Mean length of stay was 3 (SD 1.8) days. In total, 10 vital alerts were generated across 4 participants, resulting in telephone contact, reassurance, or adjustment of the sensor. No individuals required hospitalisation or virtual general practitioner review. DISCUSSION: This proof-of-concept trial demonstrated the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a pandemic at a hotel, acting as an extension to a healthcare trust. Benefits included reduced viral exposure to healthcare staff, with recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. CONCLUSION: Remote monitoring systems can be applied to hotels to deliver healthcare safely in individuals suspected of COVID-19. Further work is required to evaluate this model on a larger scale. TRIAL REGISTRATION: Clinical trials registration information: ClinicalTrials.gov Identifier: NCT04337489 (07/04/2020).

Key Stakeholder Barriers and Facilitators to Implementing Remote Monitoring Technologies: Protocol for a Mixed Methods Analysis.

BACKGROUND: The implementation of novel digital solutions within the National Health Service has historically been challenging. Since the start of the COVID-19 pandemic, there has been a greater push for digitization and for operating remote monitoring solutions. However, the implementation and widespread adoption of this type of innovation have been poorly studied. OBJECTIVE: We aim to investigate key stakeholder barriers and facilitators to implementing remote monitoring solutions to identify factors that could affect successful adoption. METHODS: A mixed methods approach will be implemented. Semistructured interviews will be conducted with high-level stakeholders from industry and academia and health care providers who have played an instrumental role in, and have prior experience with, implementing digital solutions, alongside the use of an adapted version of the Technology Acceptance Model questionnaire. RESULTS: Enrollment is currently underway, having started in February 2022. It is anticipated to end in July 2022, with data analysis scheduled to commence in August 2022. CONCLUSIONS: The results of our study may highlight key barriers and facilitators to implementing digital remote monitoring solutions, thereby allowing for improved widespread adoption within the National Health Service in the future. TRIAL REGISTRATION: ClinicalTrials.gov NCT05321004; https://clinicaltrials.gov/ct2/show/NCT05321004.

Outcomes of Vital Sign Monitoring of an Acute Surgical Cohort With Wearable Sensors and Digital Alerting Systems: A Pragmatically Designed Cohort Study and Propensity-Matched Analysis.

Background: The implementation and efficacy of wearable sensors and alerting systems in acute secondary care have been poorly described. Objectives: to pragmatically test one such system and its influence on clinical outcomes in an acute surgical cohort. Methods: In this pragmatically designed, pre-post implementation trial, participants admitted to the acute surgical unit at our institution were recruited. In the pre-implementation phase (September 2017 to May 2019), the SensiumVitals™ monitoring system, which continuously measures temperature, heart, and respiratory rates, was used for monitoring alongside usual care (intermittent monitoring in accordance with the National Early Warning Score 2 [NEWS 2] protocol) without alerts being generated. In the post-implementation phase (May 2019 to March 2020), alerts were generated when pre-established thresholds for vital parameters were breached, requiring acknowledgement from healthcare staff on provided mobile devices. Hospital length of stay, intensive care use, and 28-days mortality were measured. Balanced cohorts were created with 1:1 'optimal' propensity score logistic regression models. Results: The 1:1 matching method matched the post-implementation group (n = 141) with the same number of subjects from the pre-implementation group (n = 141). The median age of the entire cohort was 52 (range: 18-95) years and the median duration of wearing the sensor was 1.3 (interquartile range: 0.7-2.0) days. The median alert acknowledgement time was 111 (range: 1-2,146) minutes. There were no significant differences in critical care admission (planned or unplanned), hospital length of stay, or mortality. Conclusion: This study offered insight into the implementation of digital health technologies within our institution. Further work is required for optimisation of digital workflows, particularly given their more favourable acceptability in the post pandemic era. Clinical trials registration information: ClinicalTrials.gov Identifier: NCT04638738.

The diagnostic and triage accuracy of digital and online symptom checker tools: a systematic review.

Digital and online symptom checkers are an increasingly adopted class of health technologies that enable patients to input their symptoms and biodata to produce a set of likely diagnoses and associated triage advice. However, concerns regarding the accuracy and safety of these symptom checkers have been raised. This systematic review evaluates the accuracy of symptom checkers in providing diagnoses and appropriate triage advice. MEDLINE and Web of Science were searched for studies that used either real or simulated patients to evaluate online or digital symptom checkers. The primary outcomes were the diagnostic and triage accuracy of the symptom checkers. The QUADAS-2 tool was used to assess study quality. Of the 177 studies retrieved, 10 studies met the inclusion criteria. Researchers evaluated the accuracy of symptom checkers using a variety of medical conditions, including ophthalmological conditions, inflammatory arthritides and HIV. A total of 50% of the studies recruited real patients, while the remainder used simulated cases. The diagnostic accuracy of the primary diagnosis was low across included studies (range: 19-37.9%) and varied between individual symptom checkers, despite consistent symptom data input. Triage accuracy (range: 48.8-90.1%) was typically higher than diagnostic accuracy. Overall, the diagnostic and triage accuracy of symptom checkers are variable and of low accuracy. Given the increasing push towards adopting this class of technologies across numerous health systems, this study demonstrates that reliance upon symptom checkers could pose significant patient safety hazards. Large-scale primary studies, based upon real-world data, are warranted to demonstrate the adequate performance of these technologies in a manner that is non-inferior to current best practices. Moreover, an urgent assessment of how these systems are regulated and implemented is required.

Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: Protocol for a Real-World Prospective Study Evaluating Clinical Outcomes.

BACKGROUND: Advancements in wearable sensors have caused a resurgence in their use, particularly because their miniaturization offers ambulatory advantages while performing continuous vital sign monitoring. Digital alerts can be generated following early recognition of clinical deterioration through breaches of set parameter thresholds, permitting earlier intervention. However, a systematic real-world evaluation of these alerting systems has yet to be conducted, and their efficacy remains unknown. OBJECTIVE: The aim of this study is to implement wearable sensors and digital alerting systems in acute general wards to evaluate the resultant clinical outcomes. METHODS: Participants on acute general wards will be screened and recruited into a trial with a pre-post implementation design. In the preimplementation phase, the SensiumVitals monitoring system, which continuously measures temperature, heart, and respiratory rates, will be used for monitoring alongside usual care. In the postimplementation phase, alerts will be generated from the SensiumVitals system when pre-established thresholds for vital parameters have been crossed, requiring acknowledgement from health care staff; subsequent clinical outcomes will be analyzed. RESULTS: Enrolment is currently underway, having started in September 2017, and is anticipated to end shortly. Data analysis is expected to be completed in 2021. CONCLUSIONS: This study will offer insight into the implementation of digital health technologies within a health care trust and aims to describe the effectiveness of wearable sensors for ambulatory continuous monitoring and digital alerts on clinical outcomes in acute general ward settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04638738; https://clinicaltrials.gov/ct2/show/NCT04638738. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26240.

Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2).

BACKGROUND: The outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the World Health Organization (WHO), is a global health problem with ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters often preceding an adverse event. Wearable sensors can measure vital signs continuously (e.g. heart rate, respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration. METHODS: We describe the protocol for a pilot, proof-of-concept, observational study to be conducted in an engineered hotel near London airports, UK. The study is set to continue for the duration of the pandemic. Individuals arriving to London with mild symptoms suggestive of COVID-19 or returning from high-risk areas requiring quarantine, as recommended by the Public Health England, or healthcare professionals with symptoms suggestive of COVID-19 unable to isolate at home will be eligible for a wearable patch to be applied for the duration of their stay. Notifications will be generated should deterioration be detected through the sensor and displayed on a central monitoring hub viewed by nursing staff, allowing for trend deterioration to be noted. The primary objective is to determine the feasibility of remote monitoring systems in detecting clinical deterioration for quarantined individuals in a hotel. DISCUSSION: This trial should prove the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a healthcare trust. Potential benefits would include reducing infection risk of COVID-19 to healthcare staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. We hope our results can power future, robust randomised trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04337489 .

Rippling Associated with Pre-Pectoral Implant Based Breast Reconstruction: A New Grading System.

BACKGROUND: The incidence of breast cancer and immediate breast reconstruction is on the rise particularly in the US and Western Europe. Over the last decade, implant based breast reconstructions have gained popularity. The prepectoral breast reconstruction has emerged as a novel technique, minimally invasive, preserves the chest wall anatomy while restoring body image. However, implant rippling appears to be an adverse effect associated with this technique. METHODS: We have described a new grading system for rippling following prepectoral implant breast reconstruction and discussed its management. We then evaluated the new grading system in our practice. RESULTS: We looked at the first 50 consecutive patients who underwent prepectoral implant based breast reconstruction. In our experience, 45 patients (90%) had grade 1, 3 patients (6%) had grade 2, 1 patient (2%) had grade 3 and 1 patient (2%) had grade 4 rippling. The observed rippling was seen more often in patients with low BMI<20 and in those who had poor subcutaneous fat preoperatively (pinch test<2 cm). CONCLUSION: Prepectoral implant based breast reconstruction adds a whole new dimension to breast reconstruction. However rippling can be an undesired adverse effect associated with this technique and patients need to be informed.

Collapse in the elderly: rivastigmine-induced heart block and a literature review of the pharmacology of acetylcholinesterase inhibitors used in Alzheimer's disease.

Falls resulting in neck of femur fractures are common in the elderly. Often multiple comorbidities can make management and diagnosis of such a polyfactorial condition difficult, particularly with Alzheimer's dementia (AD). Indeed, poorly managed AD may contribute to falls. We present our management of an 87-year-old woman, on rivastigmine for AD, who presented with a collapse episode-attributed to rivastigmine-resulting in a neck of femur fracture. Furthermore, we perform a literature review of the pharmacology of acetylcholinesterase inhibitors and how their use in AD may contribute to bradyarrhythmias.

Management based on grading of animation deformity following implant-based subpectoral breast reconstruction.

Subpectoral breast reconstruction using implants and meshes have been used widely in Europe, the United States and the United Kingdom. Although this technique has several advantages, animation deformity is a well-documented problem. We propose a new grading system to classify breast animation in patients undergoing subpectoral implant based breast reconstruction. We also discuss different techniques to avoid and correct animation deformity.

Pre-operative axillary staging: should core biopsy be preferred to fine needle aspiration cytology?

OBJECTIVE: To determine the diagnostic accuracy of ultrasound guided fine needle aspiration (FNA) cytology and core needle biopsy (CNB) of axillary lymph nodes pre-operatively in newly diagnosed operable primary breast cancer. METHODS: An observational study for all patients who underwent pre-operative FNA cytology or CNB during September 2013-August 2014 was conducted at our institution (County Hospital, Stafford, UK). The accuracy of pre-operative axillary staging was compared to the post-operative histology. For this sensitivity, specificity, positive predictive value (PPV) and negative predictive values (NPV) were calculated. RESULTS: A total of 81 consecutive patients were evaluated by axillary ultrasound. Patients identified with potentially abnormal axillary lymph nodes underwent definitive surgery. Seven patients had positive cytology/histology who did not undergo definitive surgery and were excluded (N = 74) from the study. CNB had a sensitivity of 100% versus 72% (p = 0.006) for FNA cytology. Both had 100% specificity and PPV. The NPV of CNB was 100% versus 72% for FNA cytology. Among 35% of patients that underwent FNA cytology required repeat procedure versus 2.6% of patients who underwent CNB. 0/38 patients that had CNB required a second operation while 7/43 patients with negative FNA cytology had positive lymph nodes identified at sentinel lymph node biopsy (SLNB) requiring surgical re-intervention with axillary node clearance. CONCLUSION: CNB was superior to FNA cytology when interrogating the axilla. We recommend CNB to be adopted routinely in pre-operative axillary staging to reduce surgical re-intervention.

A Guide to Prepectoral Breast Reconstruction: A New Dimension to Implant-based Breast Reconstruction.

Acellular dermal matrix has revolutionized implant-based breast reconstruction. Breast reconstruction has evolved from the traditional submuscular to the new prepectoral implant based (also known as muscle-sparing) reconstruction. The new technique is emerging as a highly popular surgery owing to its more minimal approach. We conducted a narrative review to guide prepectoral breast reconstruction, highlighting the technique, the need for appropriate patient selection, and areas for further research. We show that prepectoral breast reconstruction is safe, feasible, and has excellent short-term outcomes (cosmesis and patient satisfaction). Its main advantages are that it avoids animation deformity, prevents shoulder dysfunction, and has a lower incidence of capsular contracture. Selection for the prepectoral technique is dependent on patient factors (eg, body mass index, lifestyle), breast size, flap assessment, and adjuvant radiotherapy. Whereas the initial short-term results are promising, long-term outcomes are yet to be reported and is an area that requires further research.

Double-edged sword of radiotherapy: a cause of secondary angiosarcoma after breast conservation therapy.

Angiosarcomas are rare and aggressive malignant tumours of vascular or endothelial origin that can originate in the breast. They can be classified as primary or secondary, with the latter most commonly due to postoperative radiotherapy as part of breast conservation therapy (wide local excision and adjuvant radiotherapy) for breast cancer. We report a case of postirradiation secondary angiosarcoma in a 56-year-old woman, alongside a review of the current literature, to inform clinicians of its clinical presentation and characteristics as a high index of clinical suspicion is required for an accurate diagnosis.

Breast lumps: a rare site for rheumatoid nodules.

Granulomatous mastitis (GM) of the breast is a rare benign inflammatory disease and its presentation closely mimics breast cancer. Its diagnosis is mainly based on histology and there is no consensus agreement regarding its management. We report a case of a 60-year-old woman presenting with a right breast lump associated with a history of rheumatoid arthritis and raised rheumatoid factor. Following triple assessment (history and examination, imaging and biopsy), GM was diagnosed and she was treated conservatively.

Marjolin's ulcer: a rare entity with a call for early diagnosis.

Marjolin's ulcer (MU) is an umbrella term covering squamous cell carcinoma (SCC), basal cell carcinoma and malignant melanoma that develop in chronic wounds, sinuses or scars. Cutaneous (non-MU) SCC is related to excessive sun-exposure, with Fitzpatrick skin types I and II being more susceptible. Radiation, genetic disorders (eg, Xeroderma pigmentosum) and immunosuppression, are other important risk factors often involved in the development of cutaneous malignancies and may also be involved in the development of MU. MU, first described by Jean-Nicholas Marjolin in 1828, is more aggressive than non-MU SCC, with a higher potential for early metastasis. A high index of suspicion and early histological diagnosis in chronic wounds and unstable scars with recent changes in characteristics offer the best prognosis with treatment. We present a case alongside a literature review contrasting the characteristics of MU and non-MU SCC, and suggest a management plan for early MU identification and prevention.

Feeling blue, going green and finding other attractive alternatives: a case of biphasic anaphylaxis to patent blue and a literature review of alternative sentinel node localisation methods.

Patent blue dye is used for sentinel lymph node localisation in order to stage the axilla in patients with breast cancer. Patent blue is one of the most common dyes used across the UK, however, the incidence of adverse effects seems to be increasing. This case highlights our experience of a biphasic anaphylactic reaction to patent blue dye, and we conduct a brief literature review of alternative and more novel methods to adequately visualise the lymphatics for sentinel lymph node biopsy.