Charmayne Mary Lee Hughes, Andrew Jeffers, Arun Sethuraman, Michael Klum, Milly Tan, Valerie Tan
{"title":"The detection and prediction of surgical site infections using multi-modal sensors and machine learning: Results in an animal model.","authors":"Charmayne Mary Lee Hughes, Andrew Jeffers, Arun Sethuraman, Michael Klum, Milly Tan, Valerie Tan","doi":"10.3389/fmedt.2023.1111859","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1111859","url":null,"abstract":"<p><strong>Introduction: </strong>Surgical Site Infection (SSI) is a common healthcare-associated infection that imposes a considerable clinical and economic burden on healthcare systems. Advances in wearable sensors and digital technologies have unlocked the potential for the early detection and diagnosis of SSI, which can help reduce this healthcare burden and lower SSI-associated mortality rates.</p><p><strong>Methods: </strong>In this study, we evaluated the ability of a multi-modal bio-signal system to predict current and developing superficial incisional infection in a porcine model infected with Methicillin Susceptible Staphylococcus Aureus (MSSA) using a bagged, stacked, and balanced ensemble logistic regression machine learning model.</p><p><strong>Results: </strong>Results demonstrated that the expression levels of individual biomarkers (i.e., peri-wound tissue oxygen saturation, temperature, and bioimpedance) differed between non-infected and infected wounds across the study period, with cross-correlation analysis indicating that a change in bio-signal expression occurred 24 to 31 hours before this change was reflected by clinical wound scoring methods employed by trained veterinarians. Moreover, the multi-modal ensemble model indicated acceptable discriminability to detect the presence of a current superficial incisional SSI (AUC = 0.77), to predict an SSI 24 hours in advance of veterinarian-based SSI diagnosis (AUC = 0.80), and to predict an SSI 48 hours in advance of veterinarian-based SSI diagnosis (AUC = 0.74).</p><p><strong>Discussion: </strong>In sum, the results of the current study indicate that non-invasive multi-modal sensor and signal analysis systems have the potential to detect and predict superficial incisional SSIs in porcine subjects under experimental conditions.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1111859"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10150061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9762482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jason P Kirkness, Jonathan Dusting, Nina Eikelis, Piraveen Pirakalathanan, John DeMarco, Stephen L Shiao, Andreas Fouras
{"title":"Association of x-ray velocimetry (XV) ventilation analysis compared to spirometry.","authors":"Jason P Kirkness, Jonathan Dusting, Nina Eikelis, Piraveen Pirakalathanan, John DeMarco, Stephen L Shiao, Andreas Fouras","doi":"10.3389/fmedt.2023.1148310","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1148310","url":null,"abstract":"<p><strong>Introduction: </strong>X-ray Velocimetry (XV) ventilation analysis is a 4-dimensional imaging-based method for quantifying regional ventilation, aiding in the assessment of lung function. We examined the performance characteristics of XV ventilation analysis by examining correlation to spirometry and measurement repeatability.</p><p><strong>Methods: </strong>XV analysis was assessed in 27 patients receiving thoracic radiotherapy for non-lung cancer malignancies. Measurements were obtained pre-treatment and at 4 and 12-months post-treatment. XV metrics such as ventilation defect percent (VDP) and regional ventilation heterogeneity (VH) were compared to spirometry at each time point, using correlation analysis. Repeatability was assessed between multiple runs of the analysis algorithm, as well as between multiple breaths in the same patient. Change in VH and VDP in a case series over 12 months was used to determine effect size and estimate sample sizes for future studies.</p><p><strong>Results: </strong>VDP and VH were found to significantly correlate with FEV<sub>1</sub> and FEV<sub>1</sub>/FVC (range: -0.36 to -0.57; <i>p </i>< 0.05). Repeatability tests demonstrated that VDP and VH had less than 2% variability within runs and less than 8% change in metrics between breaths. Three cases were used to illustrate the advantage of XV over spirometry, where XV indicated a change in lung function that was either undetectable or delayed in detection by spirometry. Case A demonstrated an improvement in XV metrics over time despite stable spirometric values. Case B demonstrated a decline in XV metrics as early as 4-months, although spirometric values did not change until 12-months. Case C demonstrated a decline in XV metrics at 12 months post-treatment while spirometric values remained normal throughout the study. Based on the effect sizes in each case, sample sizes ranging from 10 to 38 patients would provide 90% power for future studies aiming to detect similar changes.</p><p><strong>Conclusions: </strong>The performance and safety of XV analysis make it ideal for both clinical and research applications across most lung indications. Our results support continued research and provide a basis for powering future studies using XV as an endpoint to examine lung health and determine therapeutic efficacy.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1148310"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10335741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9807142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Human-centred health-care environments: a new framework for biophilic design.","authors":"Bekir Huseyin Tekin, Rosa Urbano Gutiérrez","doi":"10.3389/fmedt.2023.1219897","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1219897","url":null,"abstract":"<p><p>Increasing research corroborates that the qualities of the setting in which a patient receives healthcare positively influence health outcomes. Therefore, it has become progressively important to review the concept of therapeutic environments, as places where patients are treated with the most advanced medicine and technology, but also support their users in psychological, emotional and social terms. This quest for the optimal healing environment brings to the forefront the need to include other parameters in our design briefs, where the application of biophilic design proves to be paramount, as exposure to nature is associated with multiple health benefits. However, current biophilic design frameworks fail to provide efficient guidance, as their design recommendations don't differentiate the level of value of each design parameter for each building programme and context. Our position is that a biophilic design framework can only be efficient if it is adapted to specific building functions and is geographically and culturally contextualized. This study assessed the application of biophilic design in therapeutic environments for cancer patients in the UK, and provided a revised conceptual framework that can more efficiently guide designers and policies in future interventions. This framework was informed by synthesised analyses from healthcare environments on the user's experiences, and primary data obtained from semi-structured interviews with architects and managers, which was then benchmarked against scientific data about the impact of biophilic design on humans. This comprehensive approach helped to identify and rank those biophilic design parameters that appear the most critical for promoting and supporting health and wellbeing in cancer healthcare settings and provided an up-to-date compilation of crucial design actions to enact the necessary change in future research and design practice.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1219897"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10408300/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10345228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Adaptability in healthcare buildings: a perspective through Joseph Bracops Hospital.","authors":"Giulia Scialpi, Joost Declercq","doi":"10.3389/fmedt.2023.1199581","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1199581","url":null,"abstract":"<p><p>The healthcare sector has to face changes happening fast and often in an unpredictable way, such as epidemiological trends, the advancements of medical technology and processes or evolving social and economic needs. This results in a frequent need for infrastructures' retrofitting, with an increasing focus on the environmental impact of buildings, which have one of the highest embodied carbon footprints per square meter in the construction sector. As result, interest in healthcare buildings' adaptability is growing among researchers and practitioners. After an introduction on the research topic, a focus on the definition of adaptability and the existing assessment models is provided to address the following research question: to what extent are adaptability models effective to evaluate and orient the design of healthcare buildings? A quite varied use of the term adaptability has been found in the literature, as well as a new research trend aiming to establish a link with circularity. Moreover, most of the assessment models do not have a focus and have never been tested on the healthcare sector. An approach to circular and adaptable design is presented through the case study of the Joseph Bracops Hospital (Belgium), which has been submitted for evaluation by the Reversible Building Design protocol developed by Dr. Durmisevic. The evaluation highlights some of the current barriers in the design of adaptable healthcare facilities. Insights for future research are provided to encourage data-collection about the service life of healthcare buildings, so to understand if the adaptability of these infrastructures should be mainly monofuntional or transfunctional.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1199581"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9872751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alicia D Henn, Taci Pereira, Joshua Hunsberger, Kunal Mitra, Zohreh Izadifar, Sita Somara, Lisa Lindström, Thomas Forest Farb-Horch, Jake Boy, George F Muschler, Steven R Bauer, Randy Yerden
{"title":"Cytocentric measurement for regenerative medicine.","authors":"Alicia D Henn, Taci Pereira, Joshua Hunsberger, Kunal Mitra, Zohreh Izadifar, Sita Somara, Lisa Lindström, Thomas Forest Farb-Horch, Jake Boy, George F Muschler, Steven R Bauer, Randy Yerden","doi":"10.3389/fmedt.2023.1154653","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1154653","url":null,"abstract":"<p><p>Any Regenerative Medicine (RM) business requires reliably predictable cell and tissue products. Regulatory agencies expect control and documentation. However, laboratory tissue production is currently not predictable or well-controlled. Before conditions can be controlled to meet the needs of cells and tissues in culture for RM, we have to know what those needs are and be able to quantify them. Therefore, identification and measurement of critical cell quality attributes at a cellular or pericellular level is essential to generating reproducible cell and tissue products. Here, we identify some of the critical cell and process parameters for cell and tissue products as well as technologies available for sensing them. We also discuss available and needed technologies for monitoring both 2D and 3D cultures to manufacture reliable cell and tissue products for clinical and non-clinical use. As any industry matures, it improves and standardizes the quality of its products. Cytocentric measurement of cell and tissue quality attributes are needed for RM.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1154653"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10172495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9470360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Editorial: Artificial intelligence: applications in clinical medicine.","authors":"Joshua Levy, Emilio Madrigal, Louis Vaickus","doi":"10.3389/fmedt.2023.1206969","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1206969","url":null,"abstract":"","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1206969"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10289260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9707630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrea Mantovani, Claudia Leopaldi, Cassandra Maria Nighswander, Rossella Di Bidino
{"title":"Access and reimbursement pathways for digital health solutions and <i>in vitro</i> diagnostic devices: Current scenario and challenges.","authors":"Andrea Mantovani, Claudia Leopaldi, Cassandra Maria Nighswander, Rossella Di Bidino","doi":"10.3389/fmedt.2023.1101476","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1101476","url":null,"abstract":"<p><strong>Objectives: </strong>Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based <i>in vitro</i> diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.</p><p><strong>Methods: </strong>We investigated the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs. The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The analysis was limited to the US, European countries (Germany, France, and UK), and Australia due to maturity in digital health product adoption and regulatory processes, and recent regulations related to IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs.</p><p><strong>Results: </strong>Many countries regulate DTx as medical devices or software integrated with a medical device, and some have a more specific pathway than others. Australia has more specific regulations classifying software used in IVD. Some EU countries are adopting similar processes to the Digital Health Applications (DiGA) under Germany's Digitale-Versorgung Gesetz (DVG) law, which deems DTx eligible for reimbursement during the fast access pathway. France is working on a fast-track system to make DTx available to patients and reimbursable by the public system. The US retains some coverage through private insurance, federal and state programs like Medicaid and Veterans Affairs, and out-of-pocket spending. The updated Medical Devices Regulation (MDR) and <i>In Vitro</i> Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated.</p><p><strong>Conclusion: </strong>The outlook for DTx and IVDs is changing as they are becoming more technologically advanced, and some countries are adapting their device classifications depending on specific features. Our analysis showed the complexity of the issue demonstrating how fragmented are regulatory systems for DTx and IVDs. Differences emerged in terms of definitions, terminology, requested evidence, payment approaches and the overall reimbursement landscape. The complexity is expected to have a direct impact on the commercialization of and access to DTx and IVDs. In this scenario, willingness to pay of different stakeholders is a key theme.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1101476"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986593/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9082480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Igor Barjaktarevic, Glen Meyerowitz, Onike Williams, I Obi Emeruwa, Nir Hoftman
{"title":"Proof-of-concept study of compartmentalized lung ventilation using system for asymmetric flow regulation (SAFR).","authors":"Igor Barjaktarevic, Glen Meyerowitz, Onike Williams, I Obi Emeruwa, Nir Hoftman","doi":"10.3389/fmedt.2023.1121674","DOIUrl":"https://doi.org/10.3389/fmedt.2023.1121674","url":null,"abstract":"<p><p>Asymmetrical distribution of acute lung injury in mechanically ventilated patients can result in a heterogeneity of gas distribution between different regions, potentially worsening ventilation-perfusion matching. Furthermore, overdistension of healthier, more compliant lung regions can lead to barotrauma and limit the effect of increased PEEP on lung recruitment. We propose a System for Asymmetric Flow Regulation (SAFR) which, combined with a novel double lumen endobronchial tube (DLT) may offer individualized lung ventilation to the left and right lungs, better matching each lung's mechanics and pathophysiology. In this preclinical experimental model, the performance of SAFR on gas distribution in a two-lung simulation system was tested. Our results indicate that SAFR may be a technically feasible and potentially clinically useful although further research is warranted.</p>","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"5 ","pages":"1121674"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10101564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9317631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}