ABSTRACT
BACKGROUND: By August 2022, CoronaVirus Disease-2019 (COVID-19) had caused 600 million illnesses and 6.5 million fatalities globally. A massive vaccination program is being implemented worldwide to suppress this condition. Several works of literature stated that mRNA COVID-19 vaccination, specifically with the mRNA-1273 vaccine, is followed by clear evidence of the COVID arm effects associated with this vaccine. OBJECTIVE: To analyze the latest evidence of COVID arm as a common effect of mRNA-1273 vaccination with the ultimate goal of improving vaccine counseling to help healthcare professionals and reassure patients. METHODS: A comprehensive search was performed on topics that assess the COVID arm as a cutaneous manifestation following mRNA-1273 vaccination from inception up until July 2022. RESULTS: Eighteen studies with a total of 1129 participants after the first and second dose of mRNA-1273 vaccination reported that most participants had COVID arm following the first dose administration. The characteristics of the patients were a mean age of 43.8 years old, and females represented ≥ 50% in most studies, with a mean onset of 6.9 days after the first dose administration. Symptoms resolved within seven days following the treatment and were harmless. CONCLUSIONS: This study found that the COVID arm condition is most common following the first mRNA-1273 vaccination in the female and middle-aged group. The correlation between demographic variables and COVID arm risk elucidates that the reaction is a type IV allergic skin reaction.
Subject(s)
COVID-19 , Hypersensitivity, Delayed , Skin Diseases , Middle Aged , Humans , Female , Adult , 2019-nCoV Vaccine mRNA-1273 , Arm , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Vaccination/adverse effectsABSTRACT
This paper provides an overview of the usability engineering process and relevant standards informing the development of medical devices, together with adaptations to accommodate situations such as global pandemics where use of traditional face-to-face methods is restricted. To highlight some of those adaptations, a case study of a project developing a novel electronic rehabilitation device is referenced, which commenced in November 2020 amidst the COVID-19 pandemic. The Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) project, led by Sheffield Teaching Hospitals NHS Foundation Trust (STH), aimed to design, manufacture and trial an intervention for use to treat upper arm spasticity after stroke. Presented is an outline and discussion of the challenges experienced in developing the SHAPES health technology intended for at-home use by stroke survivors and in implementing usability engineering approaches. Also highlighted, are the benefits that arose, which can offer easier involvement of vulnerable users and add flexibility in the ways that user feedback is sought. Challenges included: restricted travel; access to usual prototyping facilities; social distancing; infection prevention and control; availability of components; and changing work pressures and demands. Whereas benefits include: less travel; less time commitment; and greater scope for participants with restricted mobility to participate in the process. The paper advocates a more flexible approach to usability engineering and outlines the onward path for development and trialling of the SHAPES technology.
Subject(s)
COVID-19 , Stroke Rehabilitation , Stroke , Arm , Humans , Pandemics , Stroke/therapyABSTRACT
BACKGROUND: Since 2019, all over the world is still suffering from managing never-experienced pandemic era of coronavirus-2019 (COVID-19). Prompt development and administration of vaccines contributed lowering severity of the disease, but adverse events related to vaccination were also reported. Exact association between each adverse conditions and vaccination or COVID-19 infection are being investigated. CASE DESCRIPTION: A 44-year-old Asian male developed right upper arm diffuse swelling 4 days after receiving the third dose of messenger ribonucleic acid (mRNA)-1273 COVID-19 vaccine in his left deltoid muscle. He was previously healthy, but has history of COVID-19 infection 4 months before the third dose vaccination. Venous duplex ultrasound revealed acute thrombosis in the right cephalic arch, axillary vein, and subclavian vein. There were no abnormal laboratory test results. After 3 months of anticoagulation therapy, arm vein thrombosis was completely resolved upon follow-up duplex ultrasonography. CONCLUSIONS: Although, positive COVID-19 polymerase chain reaction (PCR) history might be associated with potential cause of this unusual arm vein thrombosis, we postulate that a possible cause may be secondary to his third dose of mRNA-1273 vaccine given the onset and no prior medical comorbidities. Since the previous studies was mostly done based on mRNA vaccines of other manufacturers rather than Moderna, exact thrombosis mechanism of this case was not established yet. Contralateral arm vein thrombosis is unique to report, and future comprehensive studies are needed.
Subject(s)
COVID-19 , Thrombosis , Venous Thrombosis , Male , Humans , Adult , 2019-nCoV Vaccine mRNA-1273 , COVID-19 Vaccines/adverse effects , Arm , COVID-19/prevention & control , Venous Thrombosis/etiology , Venous Thrombosis/drug therapy , Thrombosis/etiology , Vaccination/adverse effects , RNA, MessengerABSTRACT
The two clinico-pathological patterns are 'Sweet-like syndrome' and 'Multiple COVID-Arm'. 'Sweet-like syndrome' presents clinically as erythematous and oedematous papules or plaques, sometimes developing vesiculation or bullae. Histology shows classical Sweet syndrome with a diffuse dermal neutrophilic infiltrate, or an infiltrate of histiocyte-like immature myeloid cells consistent with a histiocytoid Sweet syndrome. 'Multiple COVID-arm' is characterized by multiple large inflammatory plaques with histological analyses showing a perivascular and interstitial inflammatory infiltrate with eosinophils.
Subject(s)
COVID-19 , Sweet Syndrome , Arm/pathology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Histiocytes/pathology , Humans , Sweet Syndrome/diagnosis , Sweet Syndrome/etiology , Sweet Syndrome/pathologySubject(s)
COVID-19 , Thrombophlebitis , Arm , COVID-19 Vaccines/adverse effects , Humans , Thrombophlebitis/etiologyABSTRACT
BACKGROUND: Encouraging upper limb use and increasing intensity of practice in rehabilitation are two important goals for optimizing upper limb recovery post stroke. Feedback from novel wearable sensors may influence practice behaviour to promote achieving these goals. A wearable sensor can potentially be used in conjunction with a virtually monitored home program for greater patient convenience, or due to restrictions that preclude in-person visits, such as COVID-19. This trial aims to (1) determine the efficacy of a virtual behaviour change program that relies on feedback from a custom wearable sensor to increase use and function of the upper limb post stroke; and (2) explore the experiences and perceptions of using a program coupled with wearable sensors to increase arm use from the perspective of people with stroke. METHODS: This mixed-methods study will utilize a prospective controlled trial with random allocation to immediate or 3-week delayed entry to determine the efficacy of a 3-week behaviour change program with a nested qualitative description study. The intervention, the Virtual Arm Boot Camp (V-ABC) features feedback from a wearable device, which is intended to increase upper limb use post stroke, as well as 6 virtual sessions with a therapist. Sixty-four adults within 1-year post stroke onset will be recruited from seven rehabilitation centres. All outcomes will be collected virtually. The primary outcome measure is upper limb use measured by grasp counts over 3 days from the wearable sensor (TENZR) after the 3-week intervention. Secondary outcomes include upper limb function (Arm Capacity and Movement Test) and self-reported function (Hand Function and Strength subscale from the Stroke Impact Scale). Outcome data will be collected at baseline, post-intervention and at 2 months retention. The qualitative component will explore the experiences and acceptability of using a home program with a wearable sensor for increasing arm use from the point of view of individuals with stroke. Semi-structured interviews will be conducted with participants after they have experienced the intervention. Qualitative data will be analysed using content analysis. DISCUSSION: This study will provide novel information regarding the efficacy and acceptability of virtually delivered programs to improve upper extremity recovery, and the use of wearable sensors to assist with behaviour change. TRIAL REGISTRATION: ClinicalTrials.gov NCT04232163 . January 18, 2020.
Subject(s)
COVID-19 , Stroke Rehabilitation , Adult , Arm , Hand Strength , Humans , Prospective Studies , Randomized Controlled Trials as Topic , Recovery of Function , SARS-CoV-2 , Treatment Outcome , Upper ExtremityABSTRACT
The term "COVID arm" has been coined to describe a harmless delayed hypersensitivity reaction occurring approximately a week after administration of the novel SARS-CoV-2 mRNA vaccine. It appears as a red, warm, pruritic, indurated, or swollen area in the vicinity of the vaccine site. These reactions, especially if accompanied by systemic symptoms, have been mistaken for cellulitis. We report 3 cases of COVID arm, 2 of which were mistaken for cellulitis. Distinguishing features of COVID arm from cellulitis include pruritus as a common finding, occurrence approximately a week after vaccination, a lack of progression of symptoms, rapid response to topical steroids, and/or spontaneous resolution usually over 4 to 5 days.Practice Points:⢠Patients receiving SARS-CoV-2 vaccines may experience delayed hypersensitivity reactions characterized by erythema, swelling, and itching occurring near the vaccination site (COVID arm), approximately a week after vaccination.⢠Clinicians can distinguish SARS-CoV-2 vaccine reactions from cellulitis by the time of onset (approximately a week vs 5 days), by the lack of progression of symptoms, and resolution over 4 to 5 days.⢠Severe cases of COVID arm may be treated with topical steroids.
Subject(s)
COVID-19 , Hypersensitivity, Delayed , Vaccines , Arm , COVID-19 Vaccines , Cellulitis/chemically induced , Cellulitis/diagnosis , Diagnostic Errors , Humans , Hypersensitivity, Delayed/chemically induced , Hypersensitivity, Delayed/diagnosis , SARS-CoV-2ABSTRACT
The study analyzes whether the COVID-19 pandemic affects the incidence of arm, forearm, and hip fractures. Additionally, the change in the overall cost of those fractures treatment was estimated. During the COVID-19 pandemic, the incidence of arm, forearm, and hip fractures and the cost of fracture management are decreased. INTRODUCTION: Purposes of the study were to analyze if COVID-19 pandemic influences the incidence of arm, forearm, and hip osteoporotic fractures and to estimate the changes in costs of their management. METHODS: Data on arm, forearm, and hip fracture incidence were collected for inhabitants aged over 50 years in the district of Tarnowskie Góry and the city of Piekary Slaskie, South Poland, in the early stage of COVID-19 pandemic (77 days, from March 16th to May 31st 2020). These results were compared with the number of fractures noted in years 2015-2019 in the same period of the year. The ratio of analyzed fractures per 100,000 inhabitants was calculated. RESULTS: The recorded numbers of fractures of arm, forearm, and hip were 13, 43, and 29, respectively. The respective mean number for fractures reported in corresponding period in 2015-2019 years was 23.6, 52, and 33. The year fracture incidence calculated per 100,000 inhabitants decreased by 45.8%, 18.4%, and 13.4%, respectively. The estimated numbers of avoided fractures extrapolated for the whole country for arm, forearm, and hip were 1722, 1548, and 947, respectively. The total number of avoided fractures was 4217. The expected nationwide cost reduction for the arm, forearm, and hip fracture management was estimated at 568,260, 332,820, and 1,628,840, respectively. The total cost reduction was 2,529,920 over the period of observation. CONCLUSION: During COVID-19 pandemic, a decrease of arm, forearm, and hip fracture incidence was observed which may result in decrease of total costs for Polish healthcare system.
Subject(s)
COVID-19 , Hip Fractures , Osteoporotic Fractures , Aged , Arm , Forearm , Hip Fractures/epidemiology , Humans , Incidence , Middle Aged , Osteoporotic Fractures/epidemiology , Pandemics , SARS-CoV-2ABSTRACT
SIGNIFICANCE: The estimation of tissue oxygenation is vital in the diagnosis and therapeutic evaluation of a huge assortment of diseases. The hyperspectral (HS) imaging system is a rising innovation that can be utilized to build a highly sensitive, non-invasive, and tissue hemoglobin immersion map. OBJECTIVE: As a result of the urgent need to design and implement early detection devices and applications for the COVID-19 pandemic, we propose building a non-invasive custom optical imaging system to assist with phlebotomy and vascular approach to survey the reliability of blood oxygen saturation (SpO2) levels recovered from spectral images. MATERIALS AND METHODS: HS images were gathered from 15 healthy subjects without previous medical history complications and with an average age range of 20 to 38 years, who were undergoing phlebotomy. The forearm was vigorously illuminated utilizing an HS camera with polychromatic source light of spectrum range (400â¼980 nm). Spectroscopic reflectance images were caught by a focal plane exhibit for the region of interest (ROI). Then the custom algorithm comprising normalization and moving average filtering for noise removal was applied, followed by K-mean clustering for image segmentation to visualize and highlight the arteries and the veins in the investigated forearm. RESULTS: The investigations show that after normalization of the recorded signal from the HS camera of the participating subjects it was noticed that at wavelength of 460 nm the oxygenated arteries had a stronger signal than the de-oxygenated veins, and at a wavelength of 750 nm the de-oxygenated veins had a stronger signal than the oxygenated arteries. Thus, the ideal wavelength to reveal the oxygenated arteries was 460 nm, and the ideal wavelength to reveal the de-oxygenated veins was 750 nm. CONCLUSIONS: HSI is a prospective technique to assist with phlebotomy and non-contact oxygen saturation approach. Additionally, it may permit future surgical or pharmacological intercessions that titrate or limit ischemic injury continuously.
Subject(s)
Arm/blood supply , Hyperspectral Imaging/methods , Oxygen/blood , Phlebotomy/methods , Adult , COVID-19/epidemiology , Female , Humans , Male , Prospective Studies , Reproducibility of Results , SARS-CoV-2 , Young AdultABSTRACT
Novel COVID-19 continues to intrigue medical professionals with its varied presentations. Though it affects the respiratory tract primarily, thrombogenesis has been the Achilles' heel. A 44-year-old man diagnosed with COVID-19 presented with upper limb pain at a local hospital and was found to have thrombosis of the right axillary artery. Despite a successful embolectomy at the local hospital, there was re-occlusion of the axillary artery and the limb became ischaemic. He was referred to our institution by which time the limb became gangrenous above the elbow and had to be amputated. Extensive sloughing of the nerves was also seen in the local area. Hypercoagulability presenting with various manifestations is common in COVID-19 and needs early anticoagulation. We present this asymptomatic patient who lost a limb to this COVID-19 sequelae.
Subject(s)
Amputation, Surgical , Arm/surgery , Axillary Artery , COVID-19/complications , Gangrene/surgery , Ischemia/surgery , Thrombosis/complications , Adult , Arm/blood supply , Arm/pathology , Axillary Artery/surgery , Embolectomy , Gangrene/etiology , Gangrene/pathology , Humans , Ischemia/etiology , Ischemia/pathology , Male , Recurrence , SARS-CoV-2 , Thrombosis/surgerySubject(s)
COVID-19/complications , COVID-19/physiopathology , Intracranial Thrombosis/diagnosis , Venous Thromboembolism/diagnosis , Anticoagulants/therapeutic use , Arm/blood supply , Female , Humans , Intracranial Thrombosis/drug therapy , Intracranial Thrombosis/etiology , Middle Aged , Platelet Aggregation Inhibitors/therapeutic use , Prognosis , Regional Blood Flow , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiologySubject(s)
Arm/blood supply , Coronavirus Infections/complications , Pneumonia, Viral/complications , Ultrasonography, Doppler/methods , Venous Thrombosis/diagnostic imaging , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Arm/diagnostic imaging , Aspirin/administration & dosage , Aspirin/therapeutic use , Betacoronavirus , COVID-19 , Coronavirus Infections/diagnosis , Edema/etiology , Enoxaparin/administration & dosage , Enoxaparin/therapeutic use , Humans , Jugular Veins/diagnostic imaging , Male , Middle Aged , Pandemics , Pneumonia, Viral/diagnosis , SARS-CoV-2 , Treatment Outcome , Venous Thrombosis/drug therapyABSTRACT
BACKGROUND: Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. METHODS AND FINDINGS: A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. CONCLUSIONS: Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230). TRIAL REGISTRATION: The trial is registered at ISRCTN, trial number ISRCTN30393230.