Medical devices in allergy practice

Popov, Todor A.; Passalacqua, G.; González‐Díaz, Sandra Nora; Plavec, Davor; Braido, Fulvio; García-Abujeta, José Luis; DuBuske, L.M.; Rouadi, Philip W.; Morais‐Almeida, Mário; Бонини, С.; Cheng, Long; Ansotegui, Ignacio J.

doi:10.1016/j.waojou.2020.100466

Cited by 15 publications

(17 citation statements)

References 196 publications

(311 reference statements)

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“…LAS obtained is the average of three readings of SD1/SD2 taken at 7 am, 2 pm, and 10 pm to examine if there is any inherent hypersensitivity in the readings (i.e., data capturing by the algorithm). Hypersensitivity is not desired for any healthcare instrument as it may give an error at times [19]. Similar to HAM-A, LAS has been taken according to age group and gender.…”

Section: Methodsmentioning

confidence: 99%

Validating A Smartphone-Based Biomarker Tool Lyfas in Screening Anxiety Disorders

Chattopadhyay¹,

Das²,

Gaur³

2022

Preprint

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Lyfas is a smartphone-based biomedical application that captures the cardiovascular autonomic biomarkers (CVb), surrogating for mental health attributes. SD1/SD2 biomarker assesses the sympathovagal balance and is considered to be a potential indicator of Lyfas anxiety score (LAS). A total of 1837 males and 973 females took Lyfas (hypersensitivity-checked) and Hamilton Anxiety Rating Scale (HAM-A) self-scoring tests. LAS has been statistically validated by Linear regressions, one-way ANOVA, t-stat, correlations (r), and Bland Altman agreement assessment with respect to HAM-A. Sensitivity, specificity, precision, accuracy, Fscore, and Youden’s index (j-stat) are computed. Results show that (i) Lyfas is not a very hypersensitive instrument (mean-variance is 0.6). (ii) It can predict HAM-A with 94.7% accuracy (R2) and is a statistically significant model (p <0.05). (iii) LAS and HAM-A are positively correlated by 97%, the t-stat value of 5.38 for the population indicates that the two instruments have a significant mean difference. (iv) Bland Altman test showcases the overall agreement of 12.95% due to different modes and scales of measurements. (v) on average, LAS is 87.78% accurate, 86.82% precise, and its’ 65.2% j-stat value proves that Lyfas is a novel industry-standard smartphone biomarker application that can be used to accurately screen anxiety disorders.

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Section: Methodsmentioning

confidence: 99%

Validating A Smartphone-Based Biomarker Tool Lyfas in Screening Anxiety Disorders

Chattopadhyay¹,

Das²,

Gaur³

2022

Preprint

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“…Especially in Asian countries, surgical masks are used to prevent the spread of seasonal viruses such as influenza (19). In allergy practice, PPE together with nasal filters and "barrier" materials are the most common devices to avoid contact with allergens (20). PPE (associated with the use of gowns, shoe covers and protective goggles) are essential tools in the prevention of both occupational allergy in individuals who work with animals (e.g.…”

Section: -The Role Of Filtering Masks In Allergymentioning

confidence: 99%

COVID-19 lockdown, personal protective equipment, hyper-hygiene and allergy

Liccardi

Bilò

Milanese

et al. 2023

Eur Ann Allergy Clin Immunol

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At the beginning of SARS-CoV-2 pandemic, in the absence of "targeted" therapies, the national health authorities have introduced some measures aimed at reducing the spread of infection in the community [lockdown, social distancing, personal protective equipment (PPE), personal hygiene and disinfection of living environments]. All the containment measures have led to both positive and negative effects in patients with allergic diseases. We believe that further studies should be undertaken to investigate the possible correlations between SARS-CoV-2 infection and allergy, from a broader perspective. In particular, the risk factors for the development of undesirable effects should be investigated, especially in healthcare professionals forced to use PPE and sanitizing agents for a long time. However, since the COVID-19 pandemic probably will not be short-lived, the use of such protective aids will necessarily be widespread even in the general population. Therefore, further studies on the materials used for the production of PPE and sanitizing agents would be necessary to reduce their sensitizing and, in some cases, toxic potential.

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“…A medical device is defined as any device intended to be used for medical purposes. There are many items which fall within this definition and are used for disease management (Popov et al, 2020). In the European Union, botanical products sold as MDs are subjected to regulation by Directive 93/42/EEC and the more recent Regulation 2017/745/EC, which introduces the official term "medical devices made of substances" (MDMS) (Bilia et al, 2021), referring to natural substances composed of a large number of molecules, which act in synchrony, through a non-pharmacological mechanism of action, in a way, that is, best represented by the concept of a "system" (Bilia et al, 2021).…”

Section: Medical Devices Made Of Substancesmentioning

confidence: 99%

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Stagi

2022

Front. Drug Saf. Regul.

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Paediatricians are often called on to weigh up potential side effects and interferences associated with drug treatments. Ethical concerns often prevent clinical trials in children, meaning that specific data for the paediatric population can be lacking. This is true for pharmacological therapies and also natural remedies used as add-on therapy. Among natural health products are “medical devices made of substances” (MDMS) which have become increasingly important in the treatment of many disorders; the substances contained in MDMSs frequently consist of molecular structures present in a standardized preparation derived from a natural source which act as a “system.” The benefits of using MDMSs to treat paediatric conditions such as gastrointestinal disorders and obesity have been proven, although there remains a degree of uncertainty about the precise mechanism of action underlying their therapeutic effectiveness. This paper argues in favour of using MDSMs when there is scientific grounds to prove their efficacy.

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Medical devices in allergy practice

Cited by 15 publications

References 196 publications

Validating A Smartphone-Based Biomarker Tool Lyfas in Screening Anxiety Disorders

Validating A Smartphone-Based Biomarker Tool Lyfas in Screening Anxiety Disorders

COVID-19 lockdown, personal protective equipment, hyper-hygiene and allergy

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

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