Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital.

Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).

The Study of 'Preparation Guidelines' Towards Phetchabun Government Officers and Health Massage Establishments

The purpose of research was to study practices, barriers, and solutions of Phetchabun health massage establishments under COVID-19 situation. Non-participant observation, informal interview, in-depth interview, and participation observation were carried out respectively. Purposive sampling was used with 15 health consumer protection officers in charge;11 district level, 2 provincial level, 2 regional level as well as each representative of 11 districts. Results after implementation of "Preparation Guidelines for Health Spa, Health Massage, and Beauty Massage to Promote Health Tourism During COVID-19 Pandemic" were categorized into two sections. Firstly, the practices, barriers, and solutions of government officer performances included preparation for reopening, monitoring of the provider practices, and performance report. Secondly, the provider operations consisted of doing "Self-Assessment of Health Establishment", logging-in webpage before reopening, and practices for clients included screening and report of patients under investigation, establishment monitor, service, and establishment cleaning. In summary, the preparation guidelines were purposed to reopen their business with numerous contents and messages written by official language, it caused establishment providers and practitioners difficultly understood when applying. LINE Application and making calls were easy and accessible methods for their communication to reach current data and to ensure exact information. Various encouragements and having compliments were also considerable to form trust and confidence among them, they also raised their proud.Copyright © 2023, World Informations Syndicate. All rights reserved.

Severe Prps1 Deficiency and Response to S-Adenosylmethionine and Nicotinamide Riboside Supplementation

Background: PRPS1 deficiency spectrum is an X-linked condition caused by pathogenic variants in PRPS1, which encodes for the PRPP enzyme involved in the purine synthesis pathway, among other metabolic pathways. Severely affected individuals, also known as Arts syndrome, have congenital sensorineural hearing loss, optic atrophy, developmental delays, ataxia, hypotonia, and recurrent infections. Infections often precipitate worsening of symptoms and many individuals pass away in childhood. Mildly to moderately affected individuals can have isolated hearing loss, also known as DFNX1, or hearing loss with later onset ataxia and optic neuropathy concerns, also known as CMTX5. Given the importance of PRPP in the role of purine synthesis as well as other cellular processes, including formation of NAD(P), supplementation of these pathways is a logical approach for these patients. 2 Arts syndrome patients were previously supplemented with S-adenosylmethionine, starting in mid-childhood, with improvement in infection severity and frequency, as well as stabilization of other symptoms. Recently another Arts syndrome patient was supplemented with S-adenosylmethionine and nicotinamide riboside, starting in early childhood, with improvement in infection frequency and developmental gains. Here we present a now 23 month old male patient with severe PRPS1 deficiency spectrum symptoms, who was started on S-adenosylmethionine and nicotinamide riboside supplementation. Result(s): This is a 23 month old male with developmental delay, retinal dystrophy, congenital bilateral sensorineural hearing loss, and hypotonia with a PRPS1 c.383A > T / p.Asp128Val likely pathogenic variant. He does not have a history of recurrent infections, however family reports relative isolation due to the Covid-19 pandemic. He sat unsupported at 10 months, crawled at 14 months, pulled to stand at 18 months, and is nonverbal. His uric acid testing was in the low range of normal. He had normal purine testing with low normal xanthine and hypoxanthine levels. At 19 months the patient started 20 mg/kg/d S-adenosylmethionine supplementation. At 20 months this was increased to 40 mg/kg/d S-adenosylmethionine and he started on 30 mg/kg/d nicotinamide riboside supplementation. Parents reported subjective improvement in strength and endurance with supplementation. He made significant developmental gains including walking with a walker. He had done well with occasional upper respiratory infections without regression in skills, worsening hypotonia, or increased respiratory needs. Unfortunately, very recently he had a cardiac arrest secondary to respiratory failure from rhinovirus/enterovirus and H. influzenzae pneumonia, for which he remains hospitalized at this time. Conclusion(s): This is the 4th reported patient with severe PRPS1 deficiency treated with S-adenosylmethionine supplementation and the 2nd reported patient treated with nicotinamide riboside supplementation. Both supplements have a limited side effect profile and have a biochemical basis for consideration in PRPS1 deficiency. He initially did well on supplementation with improvements in strength and endurance, as well as developmental gains, however his current trajectory remains to be seen. Unfortunately, NAD/NADP, ADP/ATP, and similar markers were unavailable to us and we plan to continue clinical monitoring on supplementation. Further studies are needed to evaluate the effectiveness of S-adenosylmethionine and nicotinamide riboside supplementation in these patients.Copyright © 2023

Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic

As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal pCO2 (ETCO2) and bedside pulse oximetry to measure oxygen saturation (SpO2), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed ETCO2, SpO2, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing CO2 retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. © 2023, The Institution of Engineers (India).

Multidisciplinary management of a quickly growing pediatric atypical Spitz nevus, mimicking melanoma, during the COVID-19 pandemic

Spitzoid melanoma is very rare tumour in the pediatric population, with clinical and non-uniform behaviour, different from adult melanoma [1]. It can be difficult to differentiate an atypical Spitz nevus from a Spitzoid melanoma, resulting in diagnostic problems. In addition, in our clinical case, the COVID-19pandemiccaused significant delays both in the diagnosis and in the surgical treatment of our patient. We present the clinical case of a 4-year-old child suffering from a localized polypoid cutaneous neoformation on the dorsum of the left hand, which started immediately before the lockdown and steadily increased during the COVID-19 pandemic. After a general clinical framing, the child underwent an excisional biopsy at our Department of Plastic and Reconstructive Surgery, at the Policlinico of Foggia. Subsequently, two independent anatomic pathology groups examined the specimen. Definitive diagnosis was made only after careful genetic analysis in combination with supporting histological and immunohistochemical examinations. This clinical case shows how during the pandemic we have been facing advanced forms of tumours, compared to the previous period and highlight show an interdisciplinary and multicenter collaboration allowed a quick diagnosis of certainty, demonstrating the utility of molecular pathology as a fundamental aid in clinical/surgical practice. © 2022 The Authors

Un Possibile Effetto Avverso Della Vaccinazione Anti Sars-Cov-2

Background: SARS CoV-2 vaccines, which demonstrated a high efficacy and a beneficial safety profile, could also represent a trigger factor for immune-mediated disease. We report a case of severe anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis following the mRNA vaccine for COVID-19, diagnosed de novo in February 2022 in a Nephrology Unit of Southern Italy. Case Report: A 21-year-old man of Moroccan origin, with a history of bronchial asthma, entered the hospital for respiratory distress and low-grade fever, occurred few days after the first administration of the BNT162b2 vaccine. He was discharged with oral steroid and antibiotic therapy. One day after the second dose, he entered the hospital again due to worsening of respiratory symptoms, fever, edema and papulo-erythematous/purpuric lesions on limbs and trunk. He underwent routine blood tests with these findings: hypereosinophilia (6.63x103cell/muL), increased creatinine (2.1 mg/dl), proteinuria (6 g/24h) and microhematuria (>1.0 mg/dL). Further laboratory tests showed increased levels of total IgE (6474 IU/ mL, normal value <100 IU/mL) and Eosinophilic Cationic Protein (109 mug/L, normal value <13 mug/L). Autoantibodies anti Myeloperoxidase (Anti-MPO) were positive with high levels (740 CU/mL, cut-off value <20 CU/mL). Additional instrumental examinations and renal biopsy confirmed the diagnosis of ANCA-associated vasculitis. The patient was treated with metilprednisolone (3 boluses of 1g/ day), then prednisone (1mg/kg/day) and 2 boluses of Rituximab (375mg/m2). After two months, the follow-up exams revealed normal serum creatinine level (0.8 mg/dl), reduction of proteinuria (3 g/24h), negative anti-MPO and complete remission of the respiratory status. Conclusion(s): Among the complications of anti COVID-19 vaccines, several cases of de novo or relapsed ANCAassociated vasculitis were recently reported. We described a new case, onset in a younger man than previous studies. Even though the relationship between COVID-19 vaccination and development of autoimmune disease has only been suggested, an appropriate laboratory approach, in support of clinical surveillance for immunological complications, should be helpful to diagnosis, monitoring and clarification of possible physiopathologic connection.

A SPECTRUM OF CAUSES OF MOLECULAR INJURY IS DETECTED BY DONOR-DERIVED CELL-FREE DNA AFTER LUNG TRANSPLANT: PRELIMINARY EXPERIENCE

SESSION TITLE: Lung Transplantation: New Issues in 2022 SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: Donor-derived cell-free DNA (dd-cfDNA) is a promising plasma analyte for surveillance of rejection and lung transplant (LT) injury. Herein we report our preliminary real-world experiences in concert with standard of practice (SOP) assessments. METHODS: We performed a prospective, cross-sectional, cohort study of a clinically available dd-cfDNA test (the Prospera™ test, Natera, Inc.) combined with SOP clinical assessments − spirometry, fiberoptic bronchoscopy (FOB), donor-specific HLA antibodies (DSA). Single LT dd-cfDNA results were corrected (2X) for lung mass before analysis. Clinical-pathologic cohorts were assigned based on ISHLT guidelines for acute cellular rejection (ACR), uncomplicated chronic lung allograft dysfunction (U-CLAD), and either CoVid-19 or Non-CoVid-19 allograft infection. We also compared median dd-cfDNA fractions between patients experiencing allograft dysfunction (AD) (defined by ΔFEV1≥ -10%) vs stability (STA) and stratified by DSA status. Groups were analyzed by Mann-Whitney (p<0.05) and data expressed as median with 25-75% interquartile range (IQR). RESULTS: A total of 54 plasma samples from 42 unique LT recipients (Single=6, Double=36) were collected at Spectrum Health between November 2021 and February 2022. Primary diagnoses included chronic obstructive pulmonary disease (n=7), interstitial lung disease (n=31), CoVid-19 related ARDS (n=2), CF (n=1) and PAH (n=1). Matching histopathology was available for 68% of dd-cfDNA samples. dd-cfDNA fraction trended 2-fold higher in patient with ACR (1.59%, IQR: 0.09-3.57;n=3) and U-CLAD (1.88%, IQR: 0.88-3.32;n=4) than STA (0.86%, IQR: 0.21-1.62;n=14) patients. Patients with CoVid-19 had significantly higher dd-cfDNA fraction (6.91%, IQR: 2.41-9.77;n=4) than both STA (p=0.035) and NON-CoVid-19 infection cohorts (p=0.049). Although no antibody-mediated rejection (AMR) events were observed, dd-cfDNA fraction was significantly elevated in DSA(+) patients (2.75%, IQR: 1.72-6.25;n=8, class I (4) and II (4)) vs DSA(-) (1.035%, 0.04-1.64;n=46) cohorts (p=0.011). A trend was noted with elevated dd-cfDNA with AD (1.58%, IQR: 0.74-3.62;n=17) vs AS (1.05%, 0.66-1.79;n=37) (p=0.29). CONCLUSIONS: Our preliminary experience is consistent with prior studies, suggesting elevated dd-cfDNA fraction during LT allograft rejection and specific types of infection, in particular, CoVid-19. Of interest, dd-cfDNA detected potential occult molecular injury associated with anti-HLA DSA. CLINICAL IMPLICATIONS: dd-cfDNA fraction assessment after LT represents a valuable clinical tool for clinical surveillance of organ transplant health. DISCLOSURES: Employee relationship with Veracyte, Inc Please note: 2 years by Sangeeta Bhorade, value=Salary Removed 04/03/2022 by Sangeeta Bhorade Employee relationship with Natera Inc Please note: 2/22/22- present Added 04/03/2022 by Sangeeta Bhorade, value=Salary Employee relationship with Natera Please note: 05/2021-present Added 04/04/2022 by Kathryn Crabtree, value=Salary research relationship with United Therapeutics Please note: 2016- ongoing by Reda Girgis, value=Grant/Research research relationship with Pfizer Please note: 2014-2020 by Reda Girgis, value=Grant/Research Speaker/Speaker's Bureau relationship with Boehringher Ingelheim Please note: 2016-ongoing by Reda Girgis, value=Honoraria Speaker/Speaker's Bureau relationship with Genentech Please note: 2016-ongoing by Reda Girgis, value=Honoraria no disclosure on file for Cameron Lawson;No relevant relationships by Edward Murphy Employee relationship with Natera, Inc. Please note: 2020- present by David Ross, value=Salary

NHS GRAMPIAN REVIEW OF NEW GUIDANCE FOR VARICEAL SCREENING

Introduction Covid-19 pandemic caused significant disruption to elective endoscopy services nationally. This paved way to endoscopy minimised management pathways for patients with liver cirrhosis. Standard pathway pre-COVID19 was as set out in Baveno VI consensus guidelines and involved variceal screening endoscopy for all patients with clinically significant portal hypertension. We adopted the new pathway as suggested by the national clinical forum, endorsed by the Scottish Government, which proposes the use of Carvedilol in patients with clinically significant portal hypertension and endoscopy reserved for patients who are intolerant of carvedilol or have contraindications to beta-blocker use. The rationale behind new guidance is the improvement in survival with Carvedilol and its efficacy in reducing hepatic venous pressure gradient and preventing decompensation. The recent Baveno VII consensus also suggests patients established on Carvedilol therapy do not need endoscopy as it is unlikely to change clinical management. We aim to assess the impact of applying the new guidance on the variceal screening/surveillance endoscopy waiting list. Methods 243 patients were identified on our variceal endoscopy waiting list who were due an endoscopy between 2019 and 2024. Patients on variceal banding programme have been excluded from this analysis. Data collected included their Childs Pugh score, fibroscan score, medications, platelet count and previous endoscopy results if applicable. Patients were then categorised into three groups. 1. Clinical monitoring of blood tests and fibroscan yearly without endoscopy 2. Carvedilol therapy indicated 3. To continue with endoscopic screening. Results 26/243 (10.6%) patients were removed from the waiting list with plan for yearly monitoring. 10/243 (4%) patients were to continue with endoscopic screening due to Carvedilol intolerance. 207 patients met the criteria to commence Carvedilol without the need for endoscopy. Therefore, 207/233 (88%) patients could be removed from the waiting list by applying the new guidance. This would free up approximately 29 endoscopy lists which can be utilised to address other areas within gastroenterology and hepatology service with longer waiting times. Conclusions The impact on variceal endoscopy waiting times by adopting the new guidance is significant. It provides opportunity to utilise the resources more effectively. From patient's perspective, endoscopy is an invasive procedure and anxiety provoking to some patients resulting in failure to attend endoscopy appointments. As the requirement for endoscopy is considerably low, the new guidance may be more acceptable to patients who prefer to avoid endoscopy. Patient compliance and tolerance to Carvedilol will be recorded prospectively to assess the overall impact on the service.

Evidence of Ischemic Stroke in Pediatric Patient with Post-COVID-19 Syndrome

Objective: Stroke has been reported to be a potential neurological complication of COVID-19 infection in adults, however, only a few reports have been made in the pediatric population. We describe a case of a 12-year-old female with post-COVID-19 syndrome who was found to have an ischemic stroke on MRI as well as positive for lupus anticoagulant. Background: COVID-19 has been documented to potentiate a prothrombotic and proinflammatory state. It is postulated this occurs via endothelial cell disruption and clotting cascade activation. However, cases have reported the presence of prothrombotic antibodies in patients with COVID-19 infections. The persistent presence of these antibodies has important clinical implications, including an increased thrombotic risk. Design/Methods: Chart review Results: A 12-year-old female with history of migraines presented to the neurology clinic for increased frequency and severity of headaches. Patient reported to have COVID-19 infection one year prior with symptoms of fatigue, arthralgias, sore throat, and headaches. Following infection, patient had resolution of most symptoms but continued having increased headaches and difficulty concentrating. Headaches have been occurring multiple times per week, lasting hours to days, and are associated with nausea, vomiting, and photophobia. Patient has no focal neurological deficits. Brain MRI showed small focal encephalomalacia with surrounding gliosis and volume loss in the anterior right basal ganglia and adjacent external capsule consistent with a small chronic infarct. On thrombophilia work-up patient was positive for lupus anticoagulant and had a heterozygous MTHFR variant. Patient was started on baby aspirin and her headaches have been controlled with prophylactic co-enzyme Q-10 and naproxen. Conclusions: Due to the known prothrombotic risk of COVID-19 infections, there should be a high index of suspicion for stroke symptoms among pediatric patients with COVID-19. Improved clinical surveillance and increased screening for prothrombotic antibodies could ensure better outcomes, including timely treatment and prevention of complications.

REMOTE SIM: RECONFIGURING EDUCATION TO MEDICAL OFFICERS WITH TELE-ENABLED SIMULATION

Background: Public health restrictions during the COVID-19 pandemic create a need to restructure education delivery to health professionals. Simulation is a fundamental education mode for teams and individuals.1 An Australian scoping review published by Heffernan and colleagues in 2021 suggests the remote delivery of simulation may be both feasible and effective for participants and facilitators.2 The education unit of a tertiary hospital in Perth, Western Australia, sought to develop a method to deliver remote tele-simulation using existing local resources. There are similarly equipped units across Australasia with dedicated simulation suites that could benefit from the REMOTE Sim framework. Aim: The aim of the project was to develop a tele-simulation method that preserved the benefits of simulation education for medical staff when inperson delivery was not possible. A secondary objective was to leverage existing simulation suite infrastructure to enhance the tele-simulation format. Method: Authors reviewed an existing, locally evaluated, in-person simulation program designed to improve multidisciplinary collaboration in recognising and responding to ward-based acute clinical deterioration. By applying principles from established simulation frameworks, authors adapted in-person delivery to a tele-simulation format. Key frameworks included advocacy-inquiry, tag-team, and stop-and-go simulation.3-5 Results: The existing in-person simulation programme divided participants into two groups. One group participated as responders to a simulated scenario, while the other observed via a live audio-visual feed. Observers viewed live audio and video of the simulation, as well the simulated patient's clinical monitoring. In REMOTE Sim, this existing audio-visual feed is shared via video conferencing software. This enables remote participants to observe the simulated patient room and clinical monitoring in real time. Faculty members are located in the simulation suite and participants connect via video conferencing individually in their own environment. Faculty comprises of four or more members allocated to the roles of simulation director, manikin operator, confederate first responder, confederate second responder and so on. Participants are divided into two groups, and undertake a pre-brief that includes an overview of the format and video-conferencing etiquette. During scenarios participants are asked to direct confederate faculty to perform tasks at intervals guided by the simulation director. For example, when the first responder enters the room, group one would be asked by the simulation director to provide direction. Participants might identify the patient is speaking but in respiratory distress, and direct the relevant faculty member to apply 15L of oxygen via a non-rebreather mask. At the next interval, group two would be asked to provide direction to confederate faculty. This maintains the engagement of both groups of participants, using principles of stop-and-go and tag-team simulation.3,4 During these intervals learning points can also be discussed. Following each scenario a simulation debrief is performed with all participants via video-conference. Conclusion: The adapted tele-simulation format described aims to maintain the beneficial use of simulation suite infrastructure when in-person delivery is not possible. Validation of the format is developing, with particular focus on the impact of technology on participant engagement, critical thinking, psychological safety, and learning and reflection during the simulation and debrief.

Virtual cardiac rehabilitation during the COVID-19 pandemic: a tertiary site experience

Background: The COVID-19 pandemic resulted in the abrupt suspension of centre-based cardiac rehabilitation (CR). Multidisciplinary virtual CR (VCR) with the use of digital, telephone, and video communication was implemented for continued care access. Exercise therapy was delivered through synchronous video-supervised sessions, pre-recorded sessions, and self-directed physical activity. Purpose: To describe patient characteristics, completion rates, and safety outcomes in a real-world VCR population. Methods: Prospective observational study of a tertiary academic CR program. VCR was implemented at pandemic onset (March 2020). Patients who were enrolled in, and either completed or dropped out, during the study period were included. Completers were defined as completing 6 months of virtual enrolment and an exit assessment. Risk was defined by the AACPVR 2020 risk categorization. Adverse cardiovascular events were defined as a patient-initiated event requiring medical assessment and stratified as exercise or non-exercise related. Continuous variables are presented as means and SD or medians and IQR. Student's t-test was used for between group comparisons. Categorical variables are presented as n (%) and compared using the χ2 test or Fischer's exact test. A p-value <0.05 was considered significant. Results: Between March 13th, 2020, and August 31st, 2021, 222 [mean age 61.8 years (SD, 12.6) 77% male], were enrolled and discharged from the VCR program (Table 1). There were 160 completers and 62 non-completers (completion rate 72%). Among the non-completers 26 attended the MD intake assessment only. The remaining 36 completed a median of 85 days (IQR 25-197). This cohort included 21 (9%) high-risk and 35 (16%) moderate risk patients. Those at moderate risk were more likely to be non-completers and those at low risk were more likely to be completers (Table 1). Two exercise and 17 non-exercise adverse events were observed (median clinical surveillance 217 days [IQR 205-240]) (Table 2). Exercise related adverse events included neurally mediated syncope during a synchronous video exercise session in a low risk patient. This was responded to as per centre developed virtual safety protocols. A second syncope related to heart block occurred in a moderate risk patient during independent physical activity and required permanent pacemaker insertion. Both patients completed the program. Three non-exercise adverse cardiac events resulted in cessation of participation included one death and two heart failure hospitalizations (Table 2). One stroke and 13 emergency department visits for cardiac symptoms occurred in completers. Conclusion: Real world VCR is feasible, including in those at moderate to high risk. Modest completion rates and a low exercise related adverse event rate were observed. Synchronous video exercise sessions with video monitoring and safety protocols may improve response to adverse exercise related events. (Table Presented).

A Generic Blockchain-Based Remote Clinical Monitoring Framework Through Wearable Devices to Mitigate the COVID-19 Pandemic

At present, the novel coronavirus is posing a bigger threat to the whole human race. However, adopting emerging technologies like the Internet of Things, artificial intelligence, blockchain technology, and machine learning helps in a greater deal to handle the pandemic effectively. The virus has cost many human lives, and one primary reason could be neglecting the symptoms. The earlier identification of the disease will help in providing immediate medical support. Wearable devices are effective in identifying the coronavirus disease, i.e., COVID-19 cases than the traditional methods. They help in improved tracking and management of the disease. This paper intends to present a framework where the wearable devices associated with the Internet of Things (IoT) collect information from individuals and store it either in a cloud server or to a local fog computing node. Furthermore, the implementation of a decentralized storage system to collect, analyze, and preserve the gathered data among the healthcare professionals is also included in the system. The system takes advantage of blockchain systems to automate smart contracts. The goal of this research is to see how wearable gadgets might help combat COVID-19’s effects by providing efficient methods for identification, monitoring, and collaboration in remote patient monitoring. © 2022, The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

COVID-19 PANDEMIC IMPACT on HIV PrEP PROGRAM ENGAGEMENT in BRITISH COLUMBIA

Background: In March 2020, British Columbia (BC) declared a COVID-19-related public health emergency. Measures to limit SARS-CoV-2 transmission impacted social behaviors and disrupted healthcare access. We examined client engagement in BC's province-wide, publicly-funded HIV PrEP program before and during the COVID-19 pandemic. Methods: Using de-identified data from BC's provincial PrEP Program, we describe client engagement in the 15 months pre-(Jan 2019-Mar 2020) and during (Apr 2020-Jun 2021) the pandemic, summarized by 3-month periods. Fisher's exact, Wilcoxon rank sum test, and GEE models were used to compare median number of PrEP clients (total and new) and the proportion with PrEP dispensing and HIV testing in pre-vs during pandemic periods. We also compared these outcomes in the Apr-Jun quarter of 2019 (pre-) vs 2020 (early) and 2021 (late) pandemic. Results: A total of 7300 clients engaged with the PrEP program during the 30-month study period, with median (Q1-Q3) age 33 (27-42) years, 98% cis-male, 1% trans-female, 98% gay-bisexual-MSM (gbMSM). The median (Q1-Q3) quarterly active PrEP clients increased from 4366 (4019-4677) pre-pandemic to 4754 (4683-4784) during-pandemic (p<0.001) following program expansion late 2019, but the median (Q1-Q3) number of new clients declined from 545 (504-566) to 319 (318-320;p=0.033) and the proportion of clients with HIV testing fell from 87% (87-88%) to 82% (77-82%;p<0.001). PrEP engagement in relation to the pandemic timeline (Figure) showed a transient, early pandemic drop in new initiations and medication dispensing followed by rebound. As a proportion of all active clients, new PrEP clients in the Apr-Jun quarter dropped from 14% in 2019 to 4% in 2020 (p<0.001) and remained lower at 8% in 2021 (p<0.001). A transient decrease in the proportion of new enrolees from sexual health clinics was also observed: 54% in 2019 to 44% in 2020 (p=0.017) with rebound to 55% in 2021 (p=0.784). Similarly, clients with PrEP dispensed in this quarter fell from 75% in 2019 to 56% in 2020 (p<0.001) with partial rebound to 68% in 2021 (p<0.001). HIV testing in PrEP clients fell from 87% in 2019 to 82% in 2020 (p<0.001) and remained lower at 84% in 2021 (p<0.001). Conclusion: BC PrEP program engagement declined early in the COVID-19 pandemic, with partial rebound coinciding with the easing of public health restrictions. Ongoing clinical monitoring for PrEP remains key. Continued evaluation will facilitate understanding the pandemic impact on HIV prevention programming.

Evaluating The Use Of Iot For Healthcare Providers In Treating Elderly NCD Patients In Malaysia

Noncommunicable Diseases (NCDs) are one of the major health challenges, which has caused global concern due to their magnitude and high social cost. Industry 4.0 will significantly bring in IoT in the healthcare sector in an age of great growth in connected devices (up to 100 billion by 2030). The COVID-19 pandemic further accentuates the importance of using IoT in healthcare settings for both the providers and NCD patients due to controlled movements and enforced self-isolation throughout the world including Malaysia. In this regard, the improvement of “connected devices” has had a remarkable effect upon the entire healthcare sector and has been noticeably appreciated in “remote clinical monitoring”, “chronic disease management”, “preventive care”, and “assisted living” for senior NCD patients. This study intends to interpret the significance of IoT in connection with wearable technologies and digital healthcare. The study discusses several benefits of IoT like reducing cost, rising profits for the healthcare service providers in Malaysia, a higher level of success and productivity, and precision of “health monitoring and treatment systems”. The insights of this study will help the elderly NCD patients’ community and healthcare providers to recognise the significance of IoT Enabled Health Monitoring and Assistive Systems due to their significant contribution to improving healthcare in the country in the long run.

The new outpatient model indwelling pleural catheter(IPC) insertion pathway success in NBH

Introduction/Aim: NBH is a new hospital with a public/private partnership without an established pleural disease management pathway for malignant effusion. A new outpatient model of management of IPC was established in January 2021 and we aim to assess the success of the new outpatient model indwelling pleural catheter(IPC) insertion pathway. Methods: The NBH outpatient pleural service started in Jan 2021. Initial IPC's insertions were carried on the ward with overnight hospital stay to educate the nursing staff and establish the outpatient pathways. Alternatively, for outpatients, insertions were performed in the procedure room and discharged following two-hour of clinical monitoring and a Chest X-Ray. Drainage bottles were funded either by the private health funds or arrangement with the hospital for public patients. The drainage in the community was carried out by Northern Sydney North Home Nursing Service with follow up the day after the procedure. All patients had threetimes a week drainage to start with followed by review at four weeks at the pleural clinic and decided on need for talc pleurodesis. If auto-pleurodesis was achieved the IPC was removed. Results: Between January - September 2021, 14 IPC inserted in our service ( Service was suspended for 3 months during COVID lock down period ). Nine patients had autopleurodeses by 4 weeks and IPC removed. Two died whilst the IPC is in-situ. Two had ongoing effusion past 4 weeks and it was changed to symptomatic drainage. Two patients had talc insertion via the IPC. Two had IPC after surgical (VATS) pleurodesis. None of the patients returned to the hospital following insertion of IPC for a pleural effusion related issue. No infections were reported. One accidental dislodgement of the IPC reported. Ward nursing staff had an education session 30mins after the first 3 insertions and refresher anytime an insertion is performed in the ward. Procedure room nurses were educated by the advance trainee. Over 80% patients were privately insured. Conclusion: The new outpatient model of IPC insertion in a new hospital with a public/private model was successful with auto-pleurodesis rate at high level and infection rates were low. The model was successful as majority of patients were privately insured and the hospital had to bear a minimal cost. The Northern Sydney North Home Nursing Service was vital to the success of the programme.

NEUROLOGICAL REHABILITATION DURING THE COVID-19 PANDEMIC: WHAT CHANGES AND WHAT HAVE WE LEARNT

The COVID19 pandemic posed unprecedented challenges towards the delivery of neuro-rehabilitation services across the globe. A nation-wide lockdown made the accessibility to neuro-rehab facilities especially difficult for people with disabilities. Since there was not much data available on practices of neuro rehab during the COVID-19 pandemic, a cross sectional observational study was conducted to evaluate the changes in neuro rehabilitation practices in India during this pandemic using an online survey. The pandemic affected the people with disabilities in not merely the physical domains but also social effects, participation restriction and psychological effects and yet majority of both hospital and home-based physiotherapists reported a decrease in referrals and number of therapy sessions provided to the patients. Tele-rehabilitation has emerged as a new model of rehabilitation for delivery of neuro rehabilitation. It offers an alternate way of facilitating communication between the rehab professional and the patient. This includes strategies like low cost virtual reality gaming for rehab in children, mobile based rehab, etc. However, the shift to telerehab provides a tremendous learning opportunity and a huge scope for innovation in improving its accessibility to the community, especially in LMICs. Majority of both Hospital and Home-based Physiotherapists reported a decrease in referrals and number of therapy sessions provided to the patients. Despite evidence on the need for physiotherapy for respiratory care, most respondents did not implement the same. No protocols/guidelines for therapy delivery were implemented or used by our sample of respondents. This paper highlights the needs under three main categories, (1) Development and implementation of suitable clinical-practice-guidelines, clinical-monitoring systems for Neurological Physiotherapy, (2) incorporation of evidence-based respiratory care as part of neurological physiotherapy especially during such pandemics, (3) changes in policies at government and private sectors for inclusion and appropriate implementation of neurophysiotherapy along with public awareness programmes on the need for continued physiotherapy.

Multicenter Evaluation of Superinfection Occurrence and Impact on Clinical Outcomes in Patients with COVID-19

Background. The coronavirus disease 2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread globally throughout late 2019. During this pandemic, concern for bacterial and fungal superinfections has been present during the treatment of these patients. Methods. Hospitalized, adult patients with laboratory confirmed and symptomatic COVID-19 disease admitted between March 12, 2020 and May 31, 2020 were eligible for inclusion in this study. Data was obtained from electronic medical records and the hospital system's clinical surveillance program including demographics, comorbidities, hospitalization dates, laboratory values, mechanical ventilation, positive blood and respiratory cultures, treatment administration for COVID-19 as defined by the system's fluid treatment algorithm, and discharge disposition. Outcomes of this analysis include overall bacterial and fungal superinfection occurrence rate within 28 days of admission, patient characteristics that correlate with a higher risk of a superinfection, and the effect on 28-day mortality. Results. A total of 404 patients were included in the study analyses of which 56 (13.9%) had a documented superinfection within 28-days from admission. The most common superinfection organisms observed were Staphylococcus spp. (36.9%), Candida spp. (16.7%), and Klebsiella spp. (13.1%). Mortality was significantly higher in patients with superinfections (12.1% vs 5.8%, p < 0.001). To best assess characteristics that place patients at a higher risk of superinfection, a backwards, stepwise, multivariable logistic regression was performed. Black ethnicity, chronic kidney disease, intensive care unit (ICU) upon admission, lymphocytopenia, and receipt of tocilizumab were found to more likely have a superinfection within 28-days from admission. Comparison and analysis of baseline characteristics in patients with or without superinfection present. Day-28 mortality comparison in patients with or without superinfection. Mortality was observed in 7/58 patients with a superinfection versus 20/346 patients without superinfection present (p < 0.001). Multivariable analysis results for increased superinfection risk. All baseline characteristics with univariate analysis resulting in a p value of < 0.2 were included in the backwards, stepwise logistic regression model. Conclusion. In conclusion, our retrospective cohort study reports a superinfection rate of 13.9%. Presence of a superinfection significantly increases the likelihood of mortality within 28-days from admission. Characteristics that have a significant correlation to increased risk of superinfections include Black ethnicity, chronic kidney disease, ICU upon admission, and receipt of tocilizumab.

The oral anticoagulant therapy clinical management during pandemia: the solution found by the fcsa 123 hemostasis and thrombosis center in savona

Background: The emergency caused by the Covid-19 pandemic has forced the reformulation of the operating methods of the Health System, turning the spotlight on the need for greater interaction between hospital and territory. This aspect is even more evident in patients needing for a more strict followup as those under antithrombotic therapy (TAO), making clear the essential usefulness of digital tools and of new organizative models. Objectives: Minimize the risks for adverse events in patients on oral anticoagulant therapy with vitamin K inhibitor drugs (AVK) or direct oral anticoagulants (DOAC), maintaining an optimal level of clinical / consulting support, allowing accurate monitoring of compliance and managing both hemorrhagic and thrombotic emergencies remotely, in order to reduce access to the Emergency Room (when possible) and to hospital facilities. Methods: The patients in charge at the Thrombosis Center of the San Paolo Hospital in Savona (FCSA 123) are in total 781: 66% diagnosed with atrial fibrillation (FA), 20% for the presence of mechanical or biological valve prostheses and 14% for thrombotic pathologies such as deep vein thrombosis (DV) and pulmonary embolisms (EP). 560 patients are in DOAC, while 221 patients in AVK. During the pandemic, a dedicated mobile telephone number was activated (twelve hours/day from 8 am to 8 pm) equipped with an instant messaging application service. Each patient was asked for an email address and signed consent to the computerized management of TAO therapy and forwarding of health documents. Results: In order to monitor the expected results, the following indicators were evaluated: number of incoming phone calls;number of treatment plans issued for DOAC;time in range for patients in AVK;number of complications recorded in the period under review (April 2020 -April 2021). The results obtained are respectively: about 9000 phone calls received;560 treatment plans released;time in range from patients in AVK (TTR) 74%;22 adverse events including two major hemorrhages. Conclusions: The new organization, based on digital support of clinical monitoring, has received high appreciation from patients and consequently a greater compliance with the therapy protocol. This management model has allowed an effective control both of the number and severity of adverse events, while the reduction of outpatient access has allowed to drastically reduce the infectious risk. In addition, e-mailing of reports and treatment plans allowed an optimization of human resources.