Pub Date : 2024-07-17DOI: 10.3389/fmedt.2024.1397561
M. Aldrich, John C. Rasmussen, R. Karni, C. Fife, Frank Aviles, K. A. Eckert, M. M. Melin
Automated manual lymphatic drainage therapy (AMLDT) is available for home use in the form of a pneumatic mat of 16 pressurized air channels that inflate and deflate to mimic the stretch and release action of manual lymphatic drainage therapy. Four cases (a patient with complex regional pain syndrome and lymphedema, a healthy patient, a breast cancer survivor with chronic pain, and a patient with a history of abdominal surgery) underwent near-infrared fluorescence lymphatic imaging (NIRFLI) with AMLDT to evaluate the effect of AMLDT on lymphatic pumping and pain.Each patient received 32–36 injections of 25 μg indocyanine green (ICG) on the anterior and posterior sides of their body and underwent 1 h of NIRFLI to assess the drainage of ICG laden lymph toward regional nodal basins at baseline. Each patient lay supine on the mat for 1 h of AMLDT with NIRFLI to assess lymphatic flow during treatment. A final NIFRFLI assessment was done 30–60 min posttreatment with the patient in the supine and prone position. Patients reported baseline and posttreatment pain using the Visual Analogue Scale. An imager analyzed NIRFLI images using ImageJ (US National Institutes of Health). Using time stamps of the first and last images to determine time lapsed and the number of pulses observed in a timeframe, pulsing frequency (pulses/min) was obtained to assess lymphatic function.All 4 cases completed the NIRFLI and AMLDT without complications; all 3 patients with baseline pain reported reduced pain posttreatment. AMLDT appeared to alter lymphatic contractility, with both increased and decreased pulsing frequencies observed, including in nonaffected limbs. Pulsing frequencies were very heterogeneous among patients and varied within anatomic regions of the same patient.This proof-of-concept study suggests that AMLDT may impact lymphatic contractility. Further research on its effect on lymphatic function is warranted.
{"title":"Case Report: The effect of automated manual lymphatic drainage therapy on lymphatic contractility in 4 distinct cases","authors":"M. Aldrich, John C. Rasmussen, R. Karni, C. Fife, Frank Aviles, K. A. Eckert, M. M. Melin","doi":"10.3389/fmedt.2024.1397561","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1397561","url":null,"abstract":"Automated manual lymphatic drainage therapy (AMLDT) is available for home use in the form of a pneumatic mat of 16 pressurized air channels that inflate and deflate to mimic the stretch and release action of manual lymphatic drainage therapy. Four cases (a patient with complex regional pain syndrome and lymphedema, a healthy patient, a breast cancer survivor with chronic pain, and a patient with a history of abdominal surgery) underwent near-infrared fluorescence lymphatic imaging (NIRFLI) with AMLDT to evaluate the effect of AMLDT on lymphatic pumping and pain.Each patient received 32–36 injections of 25 μg indocyanine green (ICG) on the anterior and posterior sides of their body and underwent 1 h of NIRFLI to assess the drainage of ICG laden lymph toward regional nodal basins at baseline. Each patient lay supine on the mat for 1 h of AMLDT with NIRFLI to assess lymphatic flow during treatment. A final NIFRFLI assessment was done 30–60 min posttreatment with the patient in the supine and prone position. Patients reported baseline and posttreatment pain using the Visual Analogue Scale. An imager analyzed NIRFLI images using ImageJ (US National Institutes of Health). Using time stamps of the first and last images to determine time lapsed and the number of pulses observed in a timeframe, pulsing frequency (pulses/min) was obtained to assess lymphatic function.All 4 cases completed the NIRFLI and AMLDT without complications; all 3 patients with baseline pain reported reduced pain posttreatment. AMLDT appeared to alter lymphatic contractility, with both increased and decreased pulsing frequencies observed, including in nonaffected limbs. Pulsing frequencies were very heterogeneous among patients and varied within anatomic regions of the same patient.This proof-of-concept study suggests that AMLDT may impact lymphatic contractility. Further research on its effect on lymphatic function is warranted.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":" 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141829489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-12DOI: 10.3389/fmedt.2024.1407409
Rega H. Kasim, T. Chillon, Anna Maria Eleftheriadou, Eddy Rijntjes, W. Minich, Stefan Zechmann, L. Schomburg
Ghrelin is an orexigenic peptide that becomes post-translationally modified. Natural autoantibodies to ghrelin (ghrelin-aAb) have been described in healthy subjects, in eating disorders and rheumatic diseases, with potential clinical relevance. Despite these important reports, the data base on the prevalence and physiological role is small and technical approaches for assessing ghrelin-aAb are few, encouraging respective research for improving knowledge on the potential endocrine significance.A novel immunoprecipitation assay was generated based on a fusion protein of human ghrelin with a reporter gene. Assay quality was verified with commercial antibodies. Assay characteristics and matrix effects were determined, including stability of natural ghrelin-aAb to freezing, signal linearity in dilution experiments, and comparison of different matrices. Three groups of serum samples were analyzed for ghrelin-aAb, comprising commercial sera from healthy subjects and patients with type 1 or type 2 diabetes mellitus.The newly generated ghrelin-aAb assay proved sensitive, robust and reliable over a broad concentration range. Results from serum and plasma differed slightly. The signals from serum remained stable towards freezing and thawing, and in dilution experiments. Applying a mathematical criterion for outliers (P75 + 1.5-times IQR), an average prevalence of 11%–12% of positive samples was identified in the different human cohorts, with no significant sex-or disease-related difference.A novel diagnostic autoantibody assay detected ghrelin-aAb with a similar prevalence in diabetic patients and controls, suggesting that autoimmunity to ghrelin plays little role in diabetes mellitus, but may be of relevance in other diseases where ghrelin signaling is essential.
{"title":"Detection of natural autoimmunity to ghrelin in diabetes mellitus","authors":"Rega H. Kasim, T. Chillon, Anna Maria Eleftheriadou, Eddy Rijntjes, W. Minich, Stefan Zechmann, L. Schomburg","doi":"10.3389/fmedt.2024.1407409","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1407409","url":null,"abstract":"Ghrelin is an orexigenic peptide that becomes post-translationally modified. Natural autoantibodies to ghrelin (ghrelin-aAb) have been described in healthy subjects, in eating disorders and rheumatic diseases, with potential clinical relevance. Despite these important reports, the data base on the prevalence and physiological role is small and technical approaches for assessing ghrelin-aAb are few, encouraging respective research for improving knowledge on the potential endocrine significance.A novel immunoprecipitation assay was generated based on a fusion protein of human ghrelin with a reporter gene. Assay quality was verified with commercial antibodies. Assay characteristics and matrix effects were determined, including stability of natural ghrelin-aAb to freezing, signal linearity in dilution experiments, and comparison of different matrices. Three groups of serum samples were analyzed for ghrelin-aAb, comprising commercial sera from healthy subjects and patients with type 1 or type 2 diabetes mellitus.The newly generated ghrelin-aAb assay proved sensitive, robust and reliable over a broad concentration range. Results from serum and plasma differed slightly. The signals from serum remained stable towards freezing and thawing, and in dilution experiments. Applying a mathematical criterion for outliers (P75 + 1.5-times IQR), an average prevalence of 11%–12% of positive samples was identified in the different human cohorts, with no significant sex-or disease-related difference.A novel diagnostic autoantibody assay detected ghrelin-aAb with a similar prevalence in diabetic patients and controls, suggesting that autoimmunity to ghrelin plays little role in diabetes mellitus, but may be of relevance in other diseases where ghrelin signaling is essential.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"82 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141655735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.
{"title":"Ensuring safety and efficacy in combination products: regulatory challenges and best practices","authors":"Deepak Kumar Gupta, Akhilesh Tiwari, Yashraj Yadav, Pranay Soni, Megha Joshi","doi":"10.3389/fmedt.2024.1377443","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1377443","url":null,"abstract":"Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"27 25","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141660644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-05DOI: 10.3389/fmedt.2024.1287851
A. Thevenon, F. Derache, O. Faucoz, K. Zuj, D. Chaput, P. Arbeille
With current technology, ultrasound imaging in remote conditions, such as the International Space Station, is performed with vocal guidance or using a teleoperated echograph controlled by an expert. Both methods require real-time communications between the novice operator and expert to locate the probe over the appropriate acoustic windows (AW). The current study presents the development and testing of a new augmented reality software (Echo-QR) that would allow novice operators (with no medical imaging background) to correctly locate the ultrasound probe over the AW of interest without expert assistance.On the first day of the study, the positions of the probe over the AWs were identified for each organ by an expert sonographer and saved in the Echo-QR software. On the second day, the novices independently performed the ultrasound investigation using the Echo-QR software to correctly position the probe over each organ’s AW.Using the Echo-QR software, novice operators found the AW in 73 (92%) of the 79 organs. The 2D images acquired by the novices “2D direct image” were acceptable for medical evaluation in 41% of the cases. However, when the “2D direct image” did not show the entire organ, a 3D capture of the volume below the probe was also performed, which allowed for the extraction of the appropriate 2D image “2D/3D image” for medical evaluation in 85% of the cases.Therefore, in the absence of real-time communication between an isolated participant and an expert sonographer, novel software (Echo-QR) and automated 3D volume capture can be used to obtain images usable for ultrasound diagnostics.
{"title":"Augmented reality-based software (Echo-QR) for guiding the echographic probe toward the acoustic window: a pilot study","authors":"A. Thevenon, F. Derache, O. Faucoz, K. Zuj, D. Chaput, P. Arbeille","doi":"10.3389/fmedt.2024.1287851","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1287851","url":null,"abstract":"With current technology, ultrasound imaging in remote conditions, such as the International Space Station, is performed with vocal guidance or using a teleoperated echograph controlled by an expert. Both methods require real-time communications between the novice operator and expert to locate the probe over the appropriate acoustic windows (AW). The current study presents the development and testing of a new augmented reality software (Echo-QR) that would allow novice operators (with no medical imaging background) to correctly locate the ultrasound probe over the AW of interest without expert assistance.On the first day of the study, the positions of the probe over the AWs were identified for each organ by an expert sonographer and saved in the Echo-QR software. On the second day, the novices independently performed the ultrasound investigation using the Echo-QR software to correctly position the probe over each organ’s AW.Using the Echo-QR software, novice operators found the AW in 73 (92%) of the 79 organs. The 2D images acquired by the novices “2D direct image” were acceptable for medical evaluation in 41% of the cases. However, when the “2D direct image” did not show the entire organ, a 3D capture of the volume below the probe was also performed, which allowed for the extraction of the appropriate 2D image “2D/3D image” for medical evaluation in 85% of the cases.Therefore, in the absence of real-time communication between an isolated participant and an expert sonographer, novel software (Echo-QR) and automated 3D volume capture can be used to obtain images usable for ultrasound diagnostics.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"110 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141674213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-14DOI: 10.3389/fmedt.2024.1358956
Anthony Raphael Gatt, Patricia Vella Bonanno, Raymond Zammit
The regulation and use of herbal medicines is a topic of debate due to concerns about their quality, safety, and efficacy. EU Directive 2004/24/EC on Herbal Medicinal Products was a significant step towards establishing a regulatory framework for herbal medicinal products in the EU, and bridging the gap between conventional and herbal medicines. This Directive allows herbal medicinal products to be marketed in the EU through full marketing authorisation, well-established use, and traditional use of herbal medicinal products. The framework relies on the correlation between the therapeutic claims of herbal medicine and the scientific evidence backing them up: the greater the claims made regarding medicinal benefits, the more evidence is required to substantiate its efficacy and safety. This regulatory framework acknowledges and incorporates traditional knowledge when evaluating herbal medicines, showcasing a balanced approach that values cultural traditions while mandating monographs for traditional herbal medicinal products. Excluding herbal medicines completely limits access to affordable treatment, particularly when they serve as the only alternative for some, and protects consumer autonomy. This EU framework could therefore serve as a practical guidance for the use and regulation of herbal medicines, even outside the EU. In conclusion, it is argued that the same moral imagination and courage shown by regulators in the case of herbal medicines could perhaps be used in the regulatory frameworks of other healthcare products.
{"title":"Ethical considerations in the regulation and use of herbal medicines in the European Union","authors":"Anthony Raphael Gatt, Patricia Vella Bonanno, Raymond Zammit","doi":"10.3389/fmedt.2024.1358956","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1358956","url":null,"abstract":"The regulation and use of herbal medicines is a topic of debate due to concerns about their quality, safety, and efficacy. EU Directive 2004/24/EC on Herbal Medicinal Products was a significant step towards establishing a regulatory framework for herbal medicinal products in the EU, and bridging the gap between conventional and herbal medicines. This Directive allows herbal medicinal products to be marketed in the EU through full marketing authorisation, well-established use, and traditional use of herbal medicinal products. The framework relies on the correlation between the therapeutic claims of herbal medicine and the scientific evidence backing them up: the greater the claims made regarding medicinal benefits, the more evidence is required to substantiate its efficacy and safety. This regulatory framework acknowledges and incorporates traditional knowledge when evaluating herbal medicines, showcasing a balanced approach that values cultural traditions while mandating monographs for traditional herbal medicinal products. Excluding herbal medicines completely limits access to affordable treatment, particularly when they serve as the only alternative for some, and protects consumer autonomy. This EU framework could therefore serve as a practical guidance for the use and regulation of herbal medicines, even outside the EU. In conclusion, it is argued that the same moral imagination and courage shown by regulators in the case of herbal medicines could perhaps be used in the regulatory frameworks of other healthcare products.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"49 42","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141339232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-10DOI: 10.3389/fmedt.2024.1388113
Taiwo Oreoluwa Ajayi, M. Poka, B. Witika
Preformulation investigations into the development of drug formulations, encompassing considerations related to the structure of the drug, excipients, composition, and physical attributes are crucial. This phase is pivotal in ensuring the ultimate success of nanoemulsion development. The objective of this study was to evaluate and define the properties of bedaquiline (BDQ) and the necessary excipients for the formulation of self-emulsifying BDQ-loaded nanoemulsions. To determine the saturation solubility of BDQ in various oils, an in-house validated HPLC method was used. Fourier transform infrared spectroscopy was utilised to identify and evaluate the compatibility between BDQ and the selected excipients. The water titration method was used to construct phase diagrams to identify the type of structure that resulted following emulsification and to characterise the behaviour of mixtures along dilution paths. The solubility studies revealed that BDQ exhibited the highest solubility in olive oil, with a solubility of 3.45 ± 0.041 mg/ml. The design space led to the formation of emulsions categorised as Winsor products. Importantly, the FTIR data indicated the absence of any potential interactions between BDQ and the chosen excipients. The preformulation studies were successful and facilitated the selection of compatible and suitable excipients for the formulation of BDQ-loaded nanoemulsions.
{"title":"Development of bedaquiline nanoemulsions intended for paediatric multidrug-resistant tuberculosis: excipient selection and preformulation studies","authors":"Taiwo Oreoluwa Ajayi, M. Poka, B. Witika","doi":"10.3389/fmedt.2024.1388113","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1388113","url":null,"abstract":"Preformulation investigations into the development of drug formulations, encompassing considerations related to the structure of the drug, excipients, composition, and physical attributes are crucial. This phase is pivotal in ensuring the ultimate success of nanoemulsion development. The objective of this study was to evaluate and define the properties of bedaquiline (BDQ) and the necessary excipients for the formulation of self-emulsifying BDQ-loaded nanoemulsions. To determine the saturation solubility of BDQ in various oils, an in-house validated HPLC method was used. Fourier transform infrared spectroscopy was utilised to identify and evaluate the compatibility between BDQ and the selected excipients. The water titration method was used to construct phase diagrams to identify the type of structure that resulted following emulsification and to characterise the behaviour of mixtures along dilution paths. The solubility studies revealed that BDQ exhibited the highest solubility in olive oil, with a solubility of 3.45 ± 0.041 mg/ml. The design space led to the formation of emulsions categorised as Winsor products. Importantly, the FTIR data indicated the absence of any potential interactions between BDQ and the chosen excipients. The preformulation studies were successful and facilitated the selection of compatible and suitable excipients for the formulation of BDQ-loaded nanoemulsions.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"104 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141362131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-26DOI: 10.3389/fmedt.2024.1362688
Noel Victor Amador-Legon, Marlen Perez-Diaz
A Computer-Assisted Detection (CAD) System for classification into malignant-benign classes using CT images is proposed.Two methods that use the fractal dimension (FD) as a measure of the lung nodule contour irregularities (Box counting and Power spectrum) were implemented. The LIDC-IDRI database was used for this study. Of these, 100 slices belonging to 100 patients were analyzed with both methods.The performance between both methods was similar with an accuracy higher than 90%. Little overlap was obtained between FD ranges for the different malignancy grades with both methods, being slightly better in Power spectrum. Box counting had one more false positive than Power spectrum.Both methods are able to establish a boundary between the high and low malignancy degree. To further validate these results and enhance the performance of the CAD system, additional studies will be necessary.
{"title":"Use of fractals in determining the malignancy degree of lung nodules","authors":"Noel Victor Amador-Legon, Marlen Perez-Diaz","doi":"10.3389/fmedt.2024.1362688","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1362688","url":null,"abstract":"A Computer-Assisted Detection (CAD) System for classification into malignant-benign classes using CT images is proposed.Two methods that use the fractal dimension (FD) as a measure of the lung nodule contour irregularities (Box counting and Power spectrum) were implemented. The LIDC-IDRI database was used for this study. Of these, 100 slices belonging to 100 patients were analyzed with both methods.The performance between both methods was similar with an accuracy higher than 90%. Little overlap was obtained between FD ranges for the different malignancy grades with both methods, being slightly better in Power spectrum. Box counting had one more false positive than Power spectrum.Both methods are able to establish a boundary between the high and low malignancy degree. To further validate these results and enhance the performance of the CAD system, additional studies will be necessary.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"122 51","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140378636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-25DOI: 10.3389/fmedt.2024.1200400
J. Kirby, Katherine Kim, Marko Zivkovic, Siwei Wang, Vishvas Garg, Akash Danavar, Chao Li, Naijun Chen, Amit Garg
Hidradenitis suppurativa (HS) is a chronic inflammatory follicular skin condition that is associated with significant psychosocial and economic burden and a diminished quality of life and work productivity. Accurate diagnosis of HS is challenging due to its unknown etiology, which can lead to underdiagnosis or misdiagnosis that results in increased patient and healthcare system burden. We applied machine learning (ML) to a medical and pharmacy claims database using data from 2000 through 2018 to develop a novel model to better understand HS underdiagnosis on a healthcare system level. The primary results demonstrated that high-performing models for predicting HS diagnosis can be constructed using claims data, with an area under the curve (AUC) of 81%–82% observed among the top-performing models. The results of the models developed in this study could be input into the development of an impact of inaction model that determines the cost implications of HS diagnosis and treatment delay to the healthcare system.
{"title":"Uncovering the burden of hidradenitis suppurativa misdiagnosis and underdiagnosis: a machine learning approach","authors":"J. Kirby, Katherine Kim, Marko Zivkovic, Siwei Wang, Vishvas Garg, Akash Danavar, Chao Li, Naijun Chen, Amit Garg","doi":"10.3389/fmedt.2024.1200400","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1200400","url":null,"abstract":"Hidradenitis suppurativa (HS) is a chronic inflammatory follicular skin condition that is associated with significant psychosocial and economic burden and a diminished quality of life and work productivity. Accurate diagnosis of HS is challenging due to its unknown etiology, which can lead to underdiagnosis or misdiagnosis that results in increased patient and healthcare system burden. We applied machine learning (ML) to a medical and pharmacy claims database using data from 2000 through 2018 to develop a novel model to better understand HS underdiagnosis on a healthcare system level. The primary results demonstrated that high-performing models for predicting HS diagnosis can be constructed using claims data, with an area under the curve (AUC) of 81%–82% observed among the top-performing models. The results of the models developed in this study could be input into the development of an impact of inaction model that determines the cost implications of HS diagnosis and treatment delay to the healthcare system.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"114 22","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140381312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-22DOI: 10.3389/fmedt.2024.1320762
Aura Kullmann, Farida Akberali, Jaime J. Van Gompel, Robert A. McGovern, W. R. Marsh, Debra Kridner, Camilo A. Diaz-Botia, Michael C. Park
Stereoelectroencephalography (sEEG) is a minimally invasive procedure that uses depth electrodes stereotactically implanted into brain structures to map the origin and propagation of seizures in epileptic patients. Implantation accuracy of sEEG electrodes plays a critical role in the safety and efficacy of the procedure. This study used human cadaver heads, simulating clinical practice, to evaluate (1) neurosurgeon's ability to implant a new thin-film polyimide sEEG electrode according to the instructions for use (IFU), and (2) implantation accuracy.Four neurosurgeons (users) implanted 24 sEEG electrodes into two cadaver heads with the aid of the ROSA robotic system. Usability was evaluated using a questionnaire that assessed completion of all procedure steps per IFU and user errors. For implantation accuracy evaluation, planned electrode trajectories were compared with post-implantation trajectories after fusion of pre- and postoperative computer tomography (CT) images. Implantation accuracy was quantified using the Euclidean distance for entry point error (EPE) and target point error (TPE).All sEEG electrodes were successfully placed following the IFU without user errors, and post-implant survey of users showed favorable handling characteristics. The EPE was 1.28 ± 0.86 mm and TPE was 1.61 ± 0.89 mm. Long trajectories (>50 mm) had significantly larger EPEs and TPEs than short trajectories (<50 mm), and no differences were found between orthogonal and oblique trajectories. Accuracies were similar or superior to those reported in the literature when using similar experimental conditions, and in the same range as those reported in patients.The results demonstrate that newly developed polyimide sEEG electrodes can be implanted as accurately as similar devices in the marker without user errors when following the IFU in a simulated clinical environment. The human cadaver ex-vivo test system provided a realistic test system, owing to the size, anatomy and similarity of tissue composition to that of the live human brain.
{"title":"Implantation accuracy of novel polyimide stereotactic electroencephalographic depth electrodes—a human cadaveric study","authors":"Aura Kullmann, Farida Akberali, Jaime J. Van Gompel, Robert A. McGovern, W. R. Marsh, Debra Kridner, Camilo A. Diaz-Botia, Michael C. Park","doi":"10.3389/fmedt.2024.1320762","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1320762","url":null,"abstract":"Stereoelectroencephalography (sEEG) is a minimally invasive procedure that uses depth electrodes stereotactically implanted into brain structures to map the origin and propagation of seizures in epileptic patients. Implantation accuracy of sEEG electrodes plays a critical role in the safety and efficacy of the procedure. This study used human cadaver heads, simulating clinical practice, to evaluate (1) neurosurgeon's ability to implant a new thin-film polyimide sEEG electrode according to the instructions for use (IFU), and (2) implantation accuracy.Four neurosurgeons (users) implanted 24 sEEG electrodes into two cadaver heads with the aid of the ROSA robotic system. Usability was evaluated using a questionnaire that assessed completion of all procedure steps per IFU and user errors. For implantation accuracy evaluation, planned electrode trajectories were compared with post-implantation trajectories after fusion of pre- and postoperative computer tomography (CT) images. Implantation accuracy was quantified using the Euclidean distance for entry point error (EPE) and target point error (TPE).All sEEG electrodes were successfully placed following the IFU without user errors, and post-implant survey of users showed favorable handling characteristics. The EPE was 1.28 ± 0.86 mm and TPE was 1.61 ± 0.89 mm. Long trajectories (>50 mm) had significantly larger EPEs and TPEs than short trajectories (<50 mm), and no differences were found between orthogonal and oblique trajectories. Accuracies were similar or superior to those reported in the literature when using similar experimental conditions, and in the same range as those reported in patients.The results demonstrate that newly developed polyimide sEEG electrodes can be implanted as accurately as similar devices in the marker without user errors when following the IFU in a simulated clinical environment. The human cadaver ex-vivo test system provided a realistic test system, owing to the size, anatomy and similarity of tissue composition to that of the live human brain.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139958015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.3389/fmedt.2024.1320810
Jon-Emile S. Kenny
The left ventricular outflow tract velocity time integral (LVOT VTI) is commonly used in the intensive care unit as a measure of stroke volume (SV) and how the SV changes in response to an intervention; therefore, the LVOT VTI is used to guide intravenous fluid management. Various peripheral Doppler surrogates are proposed to infer the LVOT VTI (e.g., measures from the common carotid artery). A recently-described, novel method of insonation has an excellent ability to detect change in the LVOT VTI. This approach raises important facets of Doppler flow and insonation error, as well as the general principles at play when using a peripheral artery to infer changes from the left ventricle. Relating the VTI of a peripheral artery to the LVOT VTI was recently described mathematically and may help clinicians think about the Doppler relationship between central and peripheral flow.
{"title":"The left ventricular outflow tract and carotid artery velocity time integrals","authors":"Jon-Emile S. Kenny","doi":"10.3389/fmedt.2024.1320810","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1320810","url":null,"abstract":"The left ventricular outflow tract velocity time integral (LVOT VTI) is commonly used in the intensive care unit as a measure of stroke volume (SV) and how the SV changes in response to an intervention; therefore, the LVOT VTI is used to guide intravenous fluid management. Various peripheral Doppler surrogates are proposed to infer the LVOT VTI (e.g., measures from the common carotid artery). A recently-described, novel method of insonation has an excellent ability to detect change in the LVOT VTI. This approach raises important facets of Doppler flow and insonation error, as well as the general principles at play when using a peripheral artery to infer changes from the left ventricle. Relating the VTI of a peripheral artery to the LVOT VTI was recently described mathematically and may help clinicians think about the Doppler relationship between central and peripheral flow.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"70 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139601882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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