Hangsik Shin, Junyoung Park, Hyeon Seok Seok, Sang-Soo Kim
UNSTRUCTURED Photoplethysmogram is a biological signal with a high possibility of providing various hemodynamic information. Its measurement principle is simple and easy to implement. With the development of wireless communication technology, photoplethysmogram is increasingly used for the purpose of measuring the physiological state of an individual in a daily life beyond its use in a clinical environment. An example of this is that wearable devices such as smart watches and smartphones are increasingly providing healthcare services based on photoplethysmogram measurement. Despite increased spread and use of photoplethysmogram, it is not possible to specify the processing method of photoplethysmogram. Such method is considered a gold standard, including its pre-processing method. It is being studied in various ways by individual researchers. Unlike other reviews focusing on the measurement principle and clinical application of photoplethysmogram, this review examines existing research cases on photoplethysmogram about its generation mechanisms, measurement principles, clinical applications, noise definition, pre-processing techniques, feature detection techniques, and post-processing techniques for photoplethysmogram processing, especially from an engineering point of view. Furthermore, this review describes the flow of current signal processing techniques for photoplethysmogram and suggests future directions that photoplethysmogram processing research will be directed. In particular, this review looks at photoplethysmogram noise reduction technology using peak detection technology and signal quality assessment technology known to be important elements for the practical use of photoplethysmogram from a technical perspective.
{"title":"Photoplethysmogram analysis and applications: An Integrative Review (Preprint)","authors":"Hangsik Shin, Junyoung Park, Hyeon Seok Seok, Sang-Soo Kim","doi":"10.2196/preprints.25567","DOIUrl":"https://doi.org/10.2196/preprints.25567","url":null,"abstract":"\u0000 UNSTRUCTURED\u0000 Photoplethysmogram is a biological signal with a high possibility of providing various hemodynamic information. Its measurement principle is simple and easy to implement. With the development of wireless communication technology, photoplethysmogram is increasingly used for the purpose of measuring the physiological state of an individual in a daily life beyond its use in a clinical environment. An example of this is that wearable devices such as smart watches and smartphones are increasingly providing healthcare services based on photoplethysmogram measurement. Despite increased spread and use of photoplethysmogram, it is not possible to specify the processing method of photoplethysmogram. Such method is considered a gold standard, including its pre-processing method. It is being studied in various ways by individual researchers. Unlike other reviews focusing on the measurement principle and clinical application of photoplethysmogram, this review examines existing research cases on photoplethysmogram about its generation mechanisms, measurement principles, clinical applications, noise definition, pre-processing techniques, feature detection techniques, and post-processing techniques for photoplethysmogram processing, especially from an engineering point of view. Furthermore, this review describes the flow of current signal processing techniques for photoplethysmogram and suggests future directions that photoplethysmogram processing research will be directed. In particular, this review looks at photoplethysmogram noise reduction technology using peak detection technology and signal quality assessment technology known to be important elements for the practical use of photoplethysmogram from a technical perspective.\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44934808","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}
Limited attention has been given to the effectiveness of the platform swing walkway, which is a common way to improve gait pattern through activation of sensory stimuli (visual, auditory, vestibular, and somatosensory). The objective of this study was to determine the effect of a platform swing walkway on gait parameters in children with diplegic cerebral palsy (CP). A total of 30 children of both sexes (aged 6-8 years) with diplegic CP were enrolled in this study. They were randomly assigned into two groups of equal number: the control group (n=15) and the study group (n=15). The control group received the conventional physical therapy plan, whereas the study group received the same conventional physical therapy program in addition to gait training on a platform swing walkway. Temporal parameters during the gait cycle were collected using gait tracker video analysis, and the Growth Motor Function Measure Scale (GMFM-88) was used to assess standing and walking (Dimensions D and E) before and after the treatment program. A statistically significant improvement in both groups was noted when comparing the mean values of all measured variables before and after treatment (P≤.05). There were significant differences between the control and study groups with respect to all measured variables, which favored the study group when comparing the posttreatment outcomes (P≤.05). Results suggest that gait training on platform swing walkways can be included as an alternative therapeutic modality to enhance gait parameters and gross motor function in children with diplegic CP. ClinicalTrials.gov NTC04246658; https://clinicaltrials.gov/ct2/show/NTC04246658
{"title":"Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diplegic Cerebral Palsy: Randomized Controlled Trial","authors":"Hanaa Mohsen, Omnya Samy","doi":"10.2196/18232","DOIUrl":"https://doi.org/10.2196/18232","url":null,"abstract":"\u0000 \u0000 Limited attention has been given to the effectiveness of the platform swing walkway, which is a common way to improve gait pattern through activation of sensory stimuli (visual, auditory, vestibular, and somatosensory).\u0000 \u0000 \u0000 \u0000 The objective of this study was to determine the effect of a platform swing walkway on gait parameters in children with diplegic cerebral palsy (CP).\u0000 \u0000 \u0000 \u0000 A total of 30 children of both sexes (aged 6-8 years) with diplegic CP were enrolled in this study. They were randomly assigned into two groups of equal number: the control group (n=15) and the study group (n=15). The control group received the conventional physical therapy plan, whereas the study group received the same conventional physical therapy program in addition to gait training on a platform swing walkway. Temporal parameters during the gait cycle were collected using gait tracker video analysis, and the Growth Motor Function Measure Scale (GMFM-88) was used to assess standing and walking (Dimensions D and E) before and after the treatment program.\u0000 \u0000 \u0000 \u0000 A statistically significant improvement in both groups was noted when comparing the mean values of all measured variables before and after treatment (P≤.05). There were significant differences between the control and study groups with respect to all measured variables, which favored the study group when comparing the posttreatment outcomes (P≤.05).\u0000 \u0000 \u0000 \u0000 Results suggest that gait training on platform swing walkways can be included as an alternative therapeutic modality to enhance gait parameters and gross motor function in children with diplegic CP.\u0000 \u0000 \u0000 \u0000 ClinicalTrials.gov NTC04246658; https://clinicaltrials.gov/ct2/show/NTC04246658\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43308293","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}
Mreza Naeemabadi, Hesam Fazlali, Samira Najafi, B. Dinesen, John Hansen
Telerehabilitation programs are designed with the aim of improving the quality of services as well as overcoming existing limitations in terms of resource management and accessibility of services. This review will collect recent studies investigating telerehabilitation programs for patients with knee osteoarthritis while focusing on the technologies and services provided in the programs. The main objective of this review is to identify and discuss the modes of service delivery and technologies in telerehabilitation programs for patients with knee osteoarthritis. The gaps, strengths, and weaknesses of programs will be discussed individually. Studies published in English since 2000 were retrieved from the EMBASE, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Physiotherapy Evidence Database (PEDro), and PsycINFO databases. The search words “telerehabilitation,” “telehealth,” “telemedicine,” “teletherapy,” and “ehealth” were combined with “knee” and “rehabilitation” to generate a data set of studies for screening and review. The final group of studies reviewed here includes those that implemented teletreatment for patients for at least 2 weeks of rehabilitation. In total, 1198 studies were screened, and the full text of 154 studies was reviewed. Of these, 38 studies were included, and data were extracted accordingly. Four modes of telerehabilitation service delivery were identified: phone-based, video-based, sensor-based, and expert system–based telerehabilitation. The intervention services provided in the studies included information, training, communication, monitoring, and tracking. Video-based telerehabilitation programs were frequently used. Among the identified services, information and educational material were introduced in only one-quarter of the studies. Video-based telerehabilitation programs can be considered the best alternative solution to conventional treatment. This study shows that, in recent years, sensor-based solutions have also become more popular due to rapid developments in sensor technology. Nevertheless, communication and human-generated feedback remain as important as monitoring and intervention services.
远程康复计划旨在提高服务质量,并克服资源管理和服务可及性方面的现有限制。这篇综述将收集调查膝骨关节炎患者远程康复项目的最新研究,同时重点关注项目中提供的技术和服务。本综述的主要目的是确定和讨论膝骨关节炎患者远程康复计划中的服务提供模式和技术。项目的差距、优势和劣势将单独讨论。自2000年以来以英文发表的研究检索自EMBASE、Scopus、Web of Science、护理和相关健康文献累积索引(CINAHL)、PubMed、理疗证据数据库(PEDro)和PsycINFO数据库。将搜索词“远程康复”、“远程健康”、“远距离医疗”、“远距治疗”和“ehealth”与“膝盖”和“康复”相结合,生成一组用于筛查和审查的研究数据。这里回顾的最后一组研究包括那些对患者进行至少2周康复的远程治疗的研究。总共筛选了1198项研究,并对154项研究的全文进行了审查。其中包括38项研究,并相应地提取了数据。确定了四种远程康复服务提供模式:基于电话、基于视频、基于传感器和基于专家系统的远程康复。研究中提供的干预服务包括信息、培训、沟通、监测和跟踪。经常使用基于视频的远程康复计划。在确定的服务中,只有四分之一的研究介绍了信息和教育材料。基于视频的远程康复计划可以被认为是传统治疗的最佳替代方案。这项研究表明,近年来,由于传感器技术的快速发展,基于传感器的解决方案也变得更加流行。尽管如此,沟通和人为反馈仍然与监测和干预服务一样重要。
{"title":"Telerehabilitation for Patients With Knee Osteoarthritis: A Focused Review of Technologies and Teleservices","authors":"Mreza Naeemabadi, Hesam Fazlali, Samira Najafi, B. Dinesen, John Hansen","doi":"10.2196/16991","DOIUrl":"https://doi.org/10.2196/16991","url":null,"abstract":"\u0000 \u0000 Telerehabilitation programs are designed with the aim of improving the quality of services as well as overcoming existing limitations in terms of resource management and accessibility of services. This review will collect recent studies investigating telerehabilitation programs for patients with knee osteoarthritis while focusing on the technologies and services provided in the programs.\u0000 \u0000 \u0000 \u0000 The main objective of this review is to identify and discuss the modes of service delivery and technologies in telerehabilitation programs for patients with knee osteoarthritis. The gaps, strengths, and weaknesses of programs will be discussed individually.\u0000 \u0000 \u0000 \u0000 Studies published in English since 2000 were retrieved from the EMBASE, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Physiotherapy Evidence Database (PEDro), and PsycINFO databases. The search words “telerehabilitation,” “telehealth,” “telemedicine,” “teletherapy,” and “ehealth” were combined with “knee” and “rehabilitation” to generate a data set of studies for screening and review. The final group of studies reviewed here includes those that implemented teletreatment for patients for at least 2 weeks of rehabilitation.\u0000 \u0000 \u0000 \u0000 In total, 1198 studies were screened, and the full text of 154 studies was reviewed. Of these, 38 studies were included, and data were extracted accordingly. Four modes of telerehabilitation service delivery were identified: phone-based, video-based, sensor-based, and expert system–based telerehabilitation. The intervention services provided in the studies included information, training, communication, monitoring, and tracking. Video-based telerehabilitation programs were frequently used. Among the identified services, information and educational material were introduced in only one-quarter of the studies.\u0000 \u0000 \u0000 \u0000 Video-based telerehabilitation programs can be considered the best alternative solution to conventional treatment. This study shows that, in recent years, sensor-based solutions have also become more popular due to rapid developments in sensor technology. Nevertheless, communication and human-generated feedback remain as important as monitoring and intervention services.\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43999836","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}
Kenneth Okereafor, I. Ekong, Ini Okon Markson, Kingsley Enwere
Biometric systems use scanners to verify the identity of human beings by measuring the patterns of their behavioral or physiological characteristics. Some biometric systems are contactless and do not require direct touch to perform these measurements; others, such as fingerprint verification systems, require the user to make direct physical contact with the scanner for a specified duration for the biometric pattern of the user to be properly read and measured. This may increase the possibility of contamination with harmful microbial pathogens or of cross-contamination of food and water by subsequent users. Physical contact also increases the likelihood of inoculation of harmful microbial pathogens into the respiratory tract, thereby triggering infectious diseases. In this viewpoint, we establish the likelihood of infectious disease transmission through touch-based fingerprint biometric devices and discuss control measures to curb the spread of infectious diseases, including COVID-19.
{"title":"Fingerprint Biometric System Hygiene and the Risk of COVID-19 Transmission","authors":"Kenneth Okereafor, I. Ekong, Ini Okon Markson, Kingsley Enwere","doi":"10.2196/19623","DOIUrl":"https://doi.org/10.2196/19623","url":null,"abstract":"Biometric systems use scanners to verify the identity of human beings by measuring the patterns of their behavioral or physiological characteristics. Some biometric systems are contactless and do not require direct touch to perform these measurements; others, such as fingerprint verification systems, require the user to make direct physical contact with the scanner for a specified duration for the biometric pattern of the user to be properly read and measured. This may increase the possibility of contamination with harmful microbial pathogens or of cross-contamination of food and water by subsequent users. Physical contact also increases the likelihood of inoculation of harmful microbial pathogens into the respiratory tract, thereby triggering infectious diseases. In this viewpoint, we establish the likelihood of infectious disease transmission through touch-based fingerprint biometric devices and discuss control measures to curb the spread of infectious diseases, including COVID-19.","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48867392","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}
Rowena Williams, J. Lee, J. Muzaffar, T. Clutton-Brock, C. Coulson
Our aims were to determine the usability and practicality of the endoscope-i system, a novel mobile attachment for aural endoscopy. This incorporated assessing the ease of use of the endoscope-i for different professionals, and ultimately improving the system by receiving constructive feedback. Our objectives were to assess the ease of the endoscope-i system in conducting an aural examination and to assess its feasibility for integrating its use into clinical practice. We looked to assess its ease, effectiveness, and efficiency; to compare this to current practices with otoscopes; and to determine whether participants perceived the system to be able to produce an image of sufficient quality to make a clinical assessment. Finally, we wanted to assess the usefulness of the current training given for using the system, and we sought to gain feedback for the product from the differing specialists. A formative usability study of the endoscope-i system was conducted with 5 health care professionals. Each session lasted 40 minutes and involved audio/video consent, a hands-on session, a private semistructured interview, and an option to discuss the device with a company representative. All participants found the endoscope-i system easy to use. The image quality was perceived to be greater than that achieved by current otoscopes. The ability to record images and view them retrospectively was also seen as a positive. This study has not identified any significant issues relating to the design, functionality, or application of the endoscope-i. Participants perceived the system as superior to current options with a directly positive impact on their clinical practice.
{"title":"Usability and Practicality of a Novel Mobile Attachment for Aural Endoscopy (endoscope-i): Formative Usability Study","authors":"Rowena Williams, J. Lee, J. Muzaffar, T. Clutton-Brock, C. Coulson","doi":"10.2196/preprints.18850","DOIUrl":"https://doi.org/10.2196/preprints.18850","url":null,"abstract":"\u0000 \u0000 Our aims were to determine the usability and practicality of the endoscope-i system, a novel mobile attachment for aural endoscopy. This incorporated assessing the ease of use of the endoscope-i for different professionals, and ultimately improving the system by receiving constructive feedback.\u0000 \u0000 \u0000 \u0000 Our objectives were to assess the ease of the endoscope-i system in conducting an aural examination and to assess its feasibility for integrating its use into clinical practice. We looked to assess its ease, effectiveness, and efficiency; to compare this to current practices with otoscopes; and to determine whether participants perceived the system to be able to produce an image of sufficient quality to make a clinical assessment. Finally, we wanted to assess the usefulness of the current training given for using the system, and we sought to gain feedback for the product from the differing specialists.\u0000 \u0000 \u0000 \u0000 A formative usability study of the endoscope-i system was conducted with 5 health care professionals. Each session lasted 40 minutes and involved audio/video consent, a hands-on session, a private semistructured interview, and an option to discuss the device with a company representative.\u0000 \u0000 \u0000 \u0000 All participants found the endoscope-i system easy to use. The image quality was perceived to be greater than that achieved by current otoscopes. The ability to record images and view them retrospectively was also seen as a positive.\u0000 \u0000 \u0000 \u0000 This study has not identified any significant issues relating to the design, functionality, or application of the endoscope-i. Participants perceived the system as superior to current options with a directly positive impact on their clinical practice.\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46496345","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 : 2020-01-01Epub Date: 2019-11-19DOI: 10.2196/17106
Donna L Coffman, Xizhen Cai, Runze Li, Noelle R Leonard
Background: Ambulatory assessment of electrodermal activity (EDA) is an emerging technique for capturing individuals' autonomic responses to real-life events. There is currently little guidance available for processing and analyzing such data in an ambulatory setting.
Objective: This study aimed to describe and implement several methods for preprocessing and constructing features for use in modeling ambulatory EDA data, particularly for measuring stress.
Methods: We used data from a study examining the effects of stressful tasks on EDA of adolescent mothers (AMs). A biosensor band recorded EDA 4 times per second and was worn during an approximately 2-hour assessment that included a 10-min mother-child videotaped interaction. The initial processing included filtering noise and motion artifacts.
Results: We constructed the features of the EDA data, including the number of peaks and their amplitude as well as EDA reactivity, quantified as the rate at which AMs returned to baseline EDA following an EDA peak. Although the pattern of EDA varied substantially across individuals, various features of EDA may be computed for all individuals enabling within- and between-individual analyses and comparisons.
Conclusions: The algorithms we developed can be used to construct features for dry-electrode ambulatory EDA, which can be used by other researchers to study stress and anxiety.
{"title":"Challenges and Opportunities in Collecting and Modeling Ambulatory Electrodermal Activity Data.","authors":"Donna L Coffman, Xizhen Cai, Runze Li, Noelle R Leonard","doi":"10.2196/17106","DOIUrl":"https://doi.org/10.2196/17106","url":null,"abstract":"<p><strong>Background: </strong>Ambulatory assessment of electrodermal activity (EDA) is an emerging technique for capturing individuals' autonomic responses to real-life events. There is currently little guidance available for processing and analyzing such data in an ambulatory setting.</p><p><strong>Objective: </strong>This study aimed to describe and implement several methods for preprocessing and constructing features for use in modeling ambulatory EDA data, particularly for measuring stress.</p><p><strong>Methods: </strong>We used data from a study examining the effects of stressful tasks on EDA of adolescent mothers (AMs). A biosensor band recorded EDA 4 times per second and was worn during an approximately 2-hour assessment that included a 10-min mother-child videotaped interaction. The initial processing included filtering noise and motion artifacts.</p><p><strong>Results: </strong>We constructed the features of the EDA data, including the number of peaks and their amplitude as well as EDA reactivity, quantified as the rate at which AMs returned to baseline EDA following an EDA peak. Although the pattern of EDA varied substantially across individuals, various features of EDA may be computed for all individuals enabling within- and between-individual analyses and comparisons.</p><p><strong>Conclusions: </strong>The algorithms we developed can be used to construct features for dry-electrode ambulatory EDA, which can be used by other researchers to study stress and anxiety.</p>","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39712049","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}
Juan C Espinoza, Kathryn M. Cooper, Nadine Afari, P. Shah, S. Batchu, Y. Bar-Cohen
Pediatric medical devices cover a broad array of indications and risk profiles, and have helped to reduce disease burden and improve quality of life for numerous children. However, many of the devices used in pediatrics are not intended for or tested on children. Several barriers have been identified that pose difficulties in bringing pediatric medical devices to the market. These include a small market and small sample size; unique design considerations; regulatory complexities; lack of infrastructure for research, development, and evaluation; and low return on investment. In 2007, the Food and Drug Administration (FDA) created the Pediatric Device Consortia (PDC) Grants Program under the administration of the Office of Orphan Products Development. In 2018, the FDA awarded over US $30 million to five new PDCs. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is one of these PDCs and is centered at the Children’s Hospital Los Angeles. In February 2019, CTIP convened its primary stakeholders to discuss its priorities and activities for the new grant cycle. In this paper, we have presented a report of the summit proceedings to raise awareness and advocate for patients and pediatric medical device innovators as well as to inform the activities and priorities of other organizations and agencies engaged in pediatric medical device development.
{"title":"Innovation in Pediatric Medical Devices: Proceedings From The West Coast Consortium for Technology & Innovation in Pediatrics 2019 Annual Stakeholder Summit","authors":"Juan C Espinoza, Kathryn M. Cooper, Nadine Afari, P. Shah, S. Batchu, Y. Bar-Cohen","doi":"10.2196/preprints.17467","DOIUrl":"https://doi.org/10.2196/preprints.17467","url":null,"abstract":"Pediatric medical devices cover a broad array of indications and risk profiles, and have helped to reduce disease burden and improve quality of life for numerous children. However, many of the devices used in pediatrics are not intended for or tested on children. Several barriers have been identified that pose difficulties in bringing pediatric medical devices to the market. These include a small market and small sample size; unique design considerations; regulatory complexities; lack of infrastructure for research, development, and evaluation; and low return on investment. In 2007, the Food and Drug Administration (FDA) created the Pediatric Device Consortia (PDC) Grants Program under the administration of the Office of Orphan Products Development. In 2018, the FDA awarded over US $30 million to five new PDCs. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is one of these PDCs and is centered at the Children’s Hospital Los Angeles. In February 2019, CTIP convened its primary stakeholders to discuss its priorities and activities for the new grant cycle. In this paper, we have presented a report of the summit proceedings to raise awareness and advocate for patients and pediatric medical device innovators as well as to inform the activities and priorities of other organizations and agencies engaged in pediatric medical device development.","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42968809","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}
Immersive virtual reality (IVR) presents new possibilities for application in health care. Health care professionals can now immerse their patients in environments to achieve exposure to a specific scene or experience, evoke targeted emotional responses, inspire, or distract from an experience occurring in reality. This review aimed to identify patient-focused applications for head-mounted IVR for acute treatment of health conditions and determine the technical specifications of the systems used. A systematic review was conducted by searching medical and engineering peer-reviewed literature databases in 2018. The databases included PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Association for Computing Machinery, Institute of Electrical and Electronics Engineers, Scopus, and Web of Science. Search terms relating to health and IVR were used. To be included, studies had to investigate the effectiveness of IVR for acute treatment of a specific health condition. IVR was defined as a head-mounted platform that provides virtual and auditory immersion for the participant and includes a minimum of 3 degrees of orientation tracking. Once identified, data were extracted from articles and aggregated in a narrative review format. A total of 58 studies were conducted in 19 countries. The studies reported IVR use for 5 main clinical areas: neurological and development (n=10), pain reduction through distraction (n=20), exposure therapy for phobias (n=9), psychological applications (n=14), and others (n=5). Studies were primarily feasibility studies exploring systems and general user acceptance (n=29) and efficacy studies testing clinical effect (n=28). IVR has a promising future in health care, both in research and commercial realms. As many of the studies examined are still exploring the feasibility of IVR for acute treatment of health conditions, evidence for the effectiveness of IVR is still developing.
沉浸式虚拟现实(IVR)为医疗保健的应用提供了新的可能性。医疗保健专业人员现在可以让患者沉浸在环境中,以接触特定的场景或体验,唤起有针对性的情绪反应,激发或分散对现实中发生的体验的注意力。本综述旨在确定头戴式IVR在健康状况急性治疗中以患者为中心的应用,并确定所用系统的技术规范。2018年,通过检索医学和工程同行评审的文献数据库进行了系统综述。数据库包括PubMed、EMBASE、护理和相关健康文献累积索引、计算机协会、电气和电子工程师协会、Scopus和Web of Science。使用了与健康和IVR相关的搜索术语。为了纳入研究,必须调查IVR对特定健康状况的急性治疗的有效性。IVR被定义为一种头戴式平台,为参与者提供虚拟和听觉沉浸,并包括至少3度的定向跟踪。一旦确定,就从文章中提取数据,并以叙述性综述的形式汇总。共在19个国家进行了58项研究。研究报告了IVR在5个主要临床领域的应用:神经和发育(n=10)、通过分心减轻疼痛(n=20)、恐惧症暴露治疗(n=9)、心理应用(n=14)和其他(n=5)。研究主要是探索系统和一般用户接受度的可行性研究(n=29)和测试临床效果的疗效研究(n=28)。IVR在医疗保健领域有着广阔的前景,无论是在研究领域还是在商业领域。由于许多研究仍在探索IVR用于急性治疗健康状况的可行性,IVR有效性的证据仍在发展中。
{"title":"Immersive Virtual Reality in Health Care: Systematic Review of Technology and Disease States","authors":"Aaron J. Snoswell, C. Snoswell","doi":"10.2196/15025","DOIUrl":"https://doi.org/10.2196/15025","url":null,"abstract":"\u0000 \u0000 Immersive virtual reality (IVR) presents new possibilities for application in health care. Health care professionals can now immerse their patients in environments to achieve exposure to a specific scene or experience, evoke targeted emotional responses, inspire, or distract from an experience occurring in reality.\u0000 \u0000 \u0000 \u0000 This review aimed to identify patient-focused applications for head-mounted IVR for acute treatment of health conditions and determine the technical specifications of the systems used.\u0000 \u0000 \u0000 \u0000 A systematic review was conducted by searching medical and engineering peer-reviewed literature databases in 2018. The databases included PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Association for Computing Machinery, Institute of Electrical and Electronics Engineers, Scopus, and Web of Science. Search terms relating to health and IVR were used. To be included, studies had to investigate the effectiveness of IVR for acute treatment of a specific health condition. IVR was defined as a head-mounted platform that provides virtual and auditory immersion for the participant and includes a minimum of 3 degrees of orientation tracking. Once identified, data were extracted from articles and aggregated in a narrative review format.\u0000 \u0000 \u0000 \u0000 A total of 58 studies were conducted in 19 countries. The studies reported IVR use for 5 main clinical areas: neurological and development (n=10), pain reduction through distraction (n=20), exposure therapy for phobias (n=9), psychological applications (n=14), and others (n=5). Studies were primarily feasibility studies exploring systems and general user acceptance (n=29) and efficacy studies testing clinical effect (n=28).\u0000 \u0000 \u0000 \u0000 IVR has a promising future in health care, both in research and commercial realms. As many of the studies examined are still exploring the feasibility of IVR for acute treatment of health conditions, evidence for the effectiveness of IVR is still developing.\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43617143","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}
Ioannis Vourganas, V. Stanković, L. Stanković, A. Kerr
Stroke is increasingly one of the main causes of impairment and disability. Contextual and empirical evidence demonstrate that, mainly due to service delivery constraints, but also due to a move toward personalized health care in the comfort of patients’ homes, more stroke survivors undergo rehabilitation at home with minimal or no supervision. Due to this trend toward telerehabilitation, systems for stroke patient self-rehabilitation have become increasingly popular, with many solutions recently proposed based on technological advances in sensing, machine learning, and visualization. However, by targeting generic patient profiles, these systems often do not provide adequate rehabilitation service, as they are not tailored to specific patients’ needs. Our objective was to review state-of-the-art home rehabilitation systems and discuss their effectiveness from a patient-centric perspective. We aimed to analyze engagement enhancement of self-rehabilitation systems, as well as motivation, to identify the challenges in technology uptake. We performed a systematic literature search with 307,550 results. Then, through a narrative review, we selected 96 sources of existing home rehabilitation systems and we conducted a critical analysis. Based on the critical analysis, we formulated new criteria to be used when designing future solutions, addressing the need for increased patient involvement and individualism. We categorized the criteria based on (1) motivation, (2) acceptance, and (3) technological aspects affecting the incorporation of the technology in practice. We categorized all reviewed systems based on whether they successfully met each of the proposed criteria. The criteria we identified were nonintrusive, nonwearable, motivation and engagement enhancing, individualized, supporting daily activities, cost-effective, simple, and transferable. We also examined the motivation method, suitability for elderly patients, and intended use as supplementary criteria. Through the detailed literature review and comparative analysis, we found no system reported in the literature that addressed all the set criteria. Most systems successfully addressed a subset of the criteria, but none successfully addressed all set goals of the ideal self-rehabilitation system for home use. We identified a gap in the state-of-the-art in telerehabilitation and propose a set of criteria for a novel patient-centric system to enhance patient engagement and motivation and deliver better self-rehabilitation commitment.
{"title":"Factors That Contribute to the Use of Stroke Self-Rehabilitation Technologies: A Review","authors":"Ioannis Vourganas, V. Stanković, L. Stanković, A. Kerr","doi":"10.2196/13732","DOIUrl":"https://doi.org/10.2196/13732","url":null,"abstract":"\u0000 \u0000 Stroke is increasingly one of the main causes of impairment and disability. Contextual and empirical evidence demonstrate that, mainly due to service delivery constraints, but also due to a move toward personalized health care in the comfort of patients’ homes, more stroke survivors undergo rehabilitation at home with minimal or no supervision. Due to this trend toward telerehabilitation, systems for stroke patient self-rehabilitation have become increasingly popular, with many solutions recently proposed based on technological advances in sensing, machine learning, and visualization. However, by targeting generic patient profiles, these systems often do not provide adequate rehabilitation service, as they are not tailored to specific patients’ needs.\u0000 \u0000 \u0000 \u0000 Our objective was to review state-of-the-art home rehabilitation systems and discuss their effectiveness from a patient-centric perspective. We aimed to analyze engagement enhancement of self-rehabilitation systems, as well as motivation, to identify the challenges in technology uptake.\u0000 \u0000 \u0000 \u0000 We performed a systematic literature search with 307,550 results. Then, through a narrative review, we selected 96 sources of existing home rehabilitation systems and we conducted a critical analysis. Based on the critical analysis, we formulated new criteria to be used when designing future solutions, addressing the need for increased patient involvement and individualism. We categorized the criteria based on (1) motivation, (2) acceptance, and (3) technological aspects affecting the incorporation of the technology in practice. We categorized all reviewed systems based on whether they successfully met each of the proposed criteria.\u0000 \u0000 \u0000 \u0000 The criteria we identified were nonintrusive, nonwearable, motivation and engagement enhancing, individualized, supporting daily activities, cost-effective, simple, and transferable. We also examined the motivation method, suitability for elderly patients, and intended use as supplementary criteria. Through the detailed literature review and comparative analysis, we found no system reported in the literature that addressed all the set criteria. Most systems successfully addressed a subset of the criteria, but none successfully addressed all set goals of the ideal self-rehabilitation system for home use.\u0000 \u0000 \u0000 \u0000 We identified a gap in the state-of-the-art in telerehabilitation and propose a set of criteria for a novel patient-centric system to enhance patient engagement and motivation and deliver better self-rehabilitation commitment.\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46140088","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}
Medical device catheters that are used in minimally invasive interventional medical procedures all follow the same integrated design and use paradigm. The features and elements of any catheter device are combined in a single unitary construction. A modular approach to the design, construction, and use of these types of interventional catheters may provide significant advantages and benefits not available with an integrated design paradigm. This paper aimed to present the design of a modular catheter system and the findings from an initial veterinary use as a case study for the potential of modular catheter systems in general. A modular catheter system was designed using commercially available angioplasty balloon dilatation catheters as one module in the system and a custom designed scoring adapter as the other module. The scoring adapter incorporates wires to add scoring features to the angioplasty balloon catheter to improve the dilatation performance during a pulmonary valvuloplasty procedure. The scoring adapter also includes a novel attachment mechanism to couple the scoring adapter to any 0.035-inch guidewire–compatible angioplasty balloon catheter. The modular catheter system was successfully designed, manufactured, and used in an initial minimally invasive veterinary cardiovascular intervention to treat a case of canine subvalvular pulmonary stenosis. The scoring adapter and angioplasty balloon catheter were successfully combined tableside in the operating room at the time of the procedure and used to successfully dilate the subvalvular obstruction. The successful design and use of the presented modular catheter system demonstrates the feasibility and potential advantages of this type of paradigm to enable physicians to create interventional catheter devices at the time of a procedure guided by the procedural needs.
{"title":"Modular Catheter Systems in Minimally Invasive Interventional Medical Procedures: Case Study","authors":"B. Beach, B. Scansen","doi":"10.2196/14443","DOIUrl":"https://doi.org/10.2196/14443","url":null,"abstract":"\u0000 \u0000 Medical device catheters that are used in minimally invasive interventional medical procedures all follow the same integrated design and use paradigm. The features and elements of any catheter device are combined in a single unitary construction. A modular approach to the design, construction, and use of these types of interventional catheters may provide significant advantages and benefits not available with an integrated design paradigm.\u0000 \u0000 \u0000 \u0000 This paper aimed to present the design of a modular catheter system and the findings from an initial veterinary use as a case study for the potential of modular catheter systems in general.\u0000 \u0000 \u0000 \u0000 A modular catheter system was designed using commercially available angioplasty balloon dilatation catheters as one module in the system and a custom designed scoring adapter as the other module. The scoring adapter incorporates wires to add scoring features to the angioplasty balloon catheter to improve the dilatation performance during a pulmonary valvuloplasty procedure. The scoring adapter also includes a novel attachment mechanism to couple the scoring adapter to any 0.035-inch guidewire–compatible angioplasty balloon catheter.\u0000 \u0000 \u0000 \u0000 The modular catheter system was successfully designed, manufactured, and used in an initial minimally invasive veterinary cardiovascular intervention to treat a case of canine subvalvular pulmonary stenosis. The scoring adapter and angioplasty balloon catheter were successfully combined tableside in the operating room at the time of the procedure and used to successfully dilate the subvalvular obstruction.\u0000 \u0000 \u0000 \u0000 The successful design and use of the presented modular catheter system demonstrates the feasibility and potential advantages of this type of paradigm to enable physicians to create interventional catheter devices at the time of a procedure guided by the procedural needs.\u0000","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49511710","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}