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Editorial: Where to from here: Advancing patient and public involvement in health technology assessment (HTA) following the COVID-19 pandemic. 社论:从这里开始:在COVID-19大流行之后,促进患者和公众参与卫生技术评估(HTA)。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1168278
Janet L Wale, Marie-Pascale Pomey
COPYRIGHT © 2023 Wale and Pomey. This is an openaccess article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
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引用次数: 0
Editorial: New trends in biomimetic tissue and organ modelling. 编辑:仿生组织和器官建模的新趋势。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1182828
Camilla Luni, Anna Urciuolo, Jeremy Micah Crook, Carmine Gentile
COPYRIGHT © 2023 Luni, Urciuolo, Crook and Gentile. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
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引用次数: 0
Editorial: Highlights in diagnostic and therapeutic devices 2021/22. 社论:2021/22年度诊断和治疗设备的亮点。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1119558
Yangzhi Zhu, Mohammod Abdul Motin, Qingyu Cui
COPYRIGHT © 2023 Zhu, Motin and Cui. This is an openaccess article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
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引用次数: 0
A descriptive study of the clinical impacts on COVID-19 survivors using telemonitoring (The TeleCOVID Study). 使用远程监护对COVID-19幸存者临床影响的描述性研究(TeleCOVID研究)。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1126258
Josephine Sau Fan Chow, Annamarie D'Souza, Megan Ford, Sonia Marshall, Susana San Miguel, Ahilan Parameswaran, Mark Parsons, Jacqueline Ramirez, Rumbidzai Teramayi, Nutan Maurya

Background: There is increasing evidence that COVID-19 survivors are at increased risk of experiencing a wide range of cardiovascular complications post infection; however, there are no validated models or clear guidelines for remotely monitoring the cardiac health of COVID-19 survivors.

Objective: This study aims to test a virtual, in-home healthcare monitoring model of care for detection of clinical symptoms and impacts on COVID-19 survivors. It also aims to demonstrate system usability and feasibility.

Methods: This open label, prospective, descriptive study was conducted in South Western Sydney. Included in the study were patients admitted to the hospital with the diagnosis of COVID-19 between June 2021 and November 2021. Eligible participants after consent were provided with a pulse oximeter to measure oxygen saturation and a S-Patch EX to monitor their electrocardiogram (ECG) for a duration of 3 months. Data was transmitted in real-time to a mobile phone via Bluetooth technology and results were sent to the study team via a cloud-based platform. All the data was reviewed in a timely manner by the investigator team, for post COVID-19 related symptoms, such as reduction in oxygen saturation and arrhythmia.

Outcome measure: This study was designed for feasibility in real clinical setting implementation, enabling the study team to develop and utilise a virtual, in-home healthcare monitoring model of care to detect post COVID-19 clinical symptoms and impacts on COVID-19 survivors.

Results: During the study period, 23 patients provided consent for participation. Out of which 19 patients commenced monitoring. Sixteen patients with 81 (73.6%) valid tests were included in the analysis and amongst them seven patients were detected by artificial intelligence to have cardiac arrhythmias but not clinically symptomatic. The patients with arrhythmias had a higher occurrence of supraventricular ectopy, and most of them took at least 2 tests before detection. Notably, patients with arrhythmia had significantly more tests than those without [t-test, t (13) = 2.29, p < 0.05].

Conclusions: Preliminary observations have identified cardiac arrhythmias on prolonged cardiac monitoring in 7 out of the first 16 participants who completed their 3 months follow-up. This has allowed early escalation to their treating doctors for further investigations and early interventions.

背景:越来越多的证据表明,COVID-19幸存者在感染后出现各种心血管并发症的风险增加;然而,目前还没有经过验证的模型或明确的指南来远程监测COVID-19幸存者的心脏健康。目的:本研究旨在测试一种用于检测COVID-19幸存者临床症状及其影响的虚拟家庭医疗保健监测模型。验证系统的可用性和可行性。方法:这项开放标签、前瞻性、描述性研究在悉尼西南部进行。该研究包括2021年6月至2021年11月期间因诊断为COVID-19而入院的患者。在同意后,为符合条件的参与者提供脉搏血氧仪来测量氧饱和度,并提供S-Patch EX来监测他们的心电图(ECG),持续3个月。数据通过蓝牙技术实时传输到手机上,结果通过云平台发送给研究小组。研究小组及时审查了所有数据,以了解COVID-19后相关症状,如血氧饱和度降低和心律失常。结果测量:本研究旨在考虑在真实临床环境中实施的可行性,使研究团队能够开发和利用虚拟的家庭医疗保健监测模型来检测COVID-19后临床症状和对COVID-19幸存者的影响。结果:研究期间,有23例患者同意参与。其中19例患者开始监测。16例患者81例(73.6%)有效试验纳入分析,其中7例患者经人工智能检测为心律失常,但无临床症状。心律失常患者室上异位发生率较高,且多数患者在检测前至少做过2次检查。值得注意的是,有心律失常的患者比没有心律失常的患者进行了更多的检查[t检验,t (13) = 2.29, p]。结论:初步观察发现,在完成3个月随访的前16名参与者中,有7人在长时间心脏监测中发现心律失常。这使得他们的治疗医生能够及早了解情况,进行进一步调查和早期干预。
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引用次数: 0
Digital technologies and healthcare architects' wellbeing in the National Health Service Estate of England during the pandemic. 大流行期间英格兰国家卫生服务庄园的数字技术和医疗保健建筑师的福祉。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1212734
Evangelia Chrysikou, Eleni Papadonikolaki, Eleftheria Savvopoulou, Eleni Tsiantou, Christian Alexander Klinke

Introduction: UK Built Environment is currently undergoing a digital transformation, as is happening in the National Health Service (NHS) of England. In this paper, the focus was on the intersection of the two sectors and specifically the potential digital transformation of the NHS Estate. The NHS has developed a strategy for its workforce, to improve staff health and wellbeing, and support equality, diversity, inclusion and the development of existing staff. Digital technologies (DTs) can relate to all Estates and Facilities Management priorities, as it cross-cuts all proposed actions. As opposed to most studies on the wellbeing of blue-collar workers, this article focuses on white-collar workers, specifically architects working in the NHS, especially since NHS at this stage is developing two important policies: the New Hospital Programme and the Workforce Action Plan. Therefore, it is important for the NHS to look at the digital transformation strategy in the prism of the other two. As architecture traditionally has low job satisfaction, it negatively impacts wellbeing. This study argues that this might have been accentuated during the pandemic for the architects working in the NHS and dealing with the added pressure from three new major tasks: adjusting the infrastructure capacity to fight Covid-19; and creating the infrastructure for the testing and vaccination programs. DTs in architecture potentially affect job satisfaction in terms of creativity, autonomy, time pressure, organisational commitment, and so on.

Methodology: The methodology comprises a literature review and a pilot of interviews with healthcare architects/designers working in the NHS or on NHS-related projects. The research context is informed by the COVID-19 crisis that brought healthcare architecture to the frontline of the pandemic, with NHS architects creating new wards and vaccination centers, while private healthcare architects designed new hospitals.

Results: In the niche area of healthcare architecture, architects were in their busiest year. Yet, the DTs available to them then could only support limited tasks and did not link well to operational data.

Discussion: To explore how DTs transform the wellbeing of healthcare architects, understanding wellbeing in healthcare architecture in light of digital transformation is crucial for creating the necessary leadership for the sector to grow.

简介:英国建筑环境目前正在经历数字化转型,正如英格兰国家卫生服务体系(NHS)所发生的那样。在本文中,重点是两个部门的交集,特别是NHS遗产的潜在数字化转型。国民保健制度为其员工制定了一项战略,以改善员工的健康和福利,并支持平等、多样性、包容性和现有员工的发展。数码科技可涉及所有屋苑及设施管理的优先事项,因为它涉及所有拟议的行动。与大多数关于蓝领工人福利的研究相反,本文侧重于白领工人,特别是在NHS工作的建筑师,特别是因为NHS在这个阶段正在制定两项重要政策:新医院方案和劳动力行动计划。因此,NHS在其他两个棱镜中看待数字化转型战略是很重要的。由于传统上建筑业的工作满意度较低,它对幸福感产生了负面影响。这项研究认为,对于在NHS工作的建筑师来说,在大流行期间,这种情况可能会加剧,他们需要应对三项新的主要任务带来的额外压力:调整基础设施能力以对抗Covid-19;为测试和疫苗接种项目建立基础设施。架构师在创造性、自主性、时间压力、组织承诺等方面潜在地影响工作满意度。方法:该方法包括文献综述和对在NHS或NHS相关项目中工作的医疗保健建筑师/设计师的访谈试点。研究背景是COVID-19危机,该危机将医疗保健建筑带到大流行的前线,NHS建筑师创建了新的病房和疫苗接种中心,而私人医疗保健建筑师设计了新的医院。结果:在医疗保健建筑细分领域,建筑师处于最忙碌的一年。然而,当时提供给他们的数据传输工具只能支持有限的任务,并且不能很好地连接到业务数据。讨论:为了探索DTs如何改变医疗保健架构师的福祉,根据数字化转型了解医疗保健架构的福祉对于为该行业的发展创造必要的领导力至关重要。
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引用次数: 0
The trajectory for software-based medical devices. 基于软件的医疗设备的发展轨迹。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1195929
Dinesh Kumar
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引用次数: 0
Novel and efficient method for the reconstruction of adenoviruses through isothermal assembly and its potential applications. 等温组装重建腺病毒的新方法及其应用前景。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1095198
Ke Wen, Matthew D Resch, Ryan Mazboudi, Hannah Mulhall Maasz, Jose M Galarza

Adenovirus based vectors are useful tools for vaccine development, gene therapy, and oncolytic virotherapy. Here we describe a novel approach for the genetic engineering of any portion of the adenovirus genome and the reconstruction of either fully replication competent or defective virions. This innovative strategy is rapid, effective and suitable for the manipulation of the entire genome broadening the spectrum of potential applications for the adenovirus system. Our strategy involved insertion of restriction enzyme recognition sequences absent in the native virus into the termini of the adenovirus genome in order to facilitate recovery. These restriction enzyme sites, together with the two inverted terminal repeats and packaging sequences, were synthesized and then subcloned into the pBR322 vector. The remaining internal portion of the adenovirus genome was separated and amplified via PCR into six segments, of which groups of two were joined together by PCR and then subcloned into pBR322 plasmids. During the PCR reaction, an overlap of 30-40 bp was added to the termini of the adjacent fragments, allowing for the subsequent isothermal assembly and correct orientation of all fragments. This approach allows for the genetic modification of each genomic fragment according to the specific research goals, (e.g., deletion, substitution, addition, etc.) To recreate the entire viral genome, the four engineered fragments (each comprised of two adenovirus genomic sections) as well as the pBR322 backbone, were reassembled into a single construct utilizing an isothermal assembly reaction. Finally, the reassembled plasmid containing the entire genome was linearized and transfected into HEK293 cells to recover the complete reconstructed adenoviral vector. Using this approach, we have successfully generated two recombinant reporter adenoviruses, one of human adenovirus serotype 14 and another of serotype 55. The E3 region was replaced by the reporter genes (GFP and Luciferase) to visualize and track the recovery process. Subsequent infection of A549 cells with these reconstructed adenovirus vectors demonstrated that they were replication competent. This method shortens the viral reconstruction process because the one-step isothermal assembly requires less than 4 days, and recombinant adenovirus recovery occurs within 10 days. This new method allows for single or multiple genetic modifications within any portion of the viral genome and can be used to construct or manipulate any adenovirus whose complete genome sequence is known.

腺病毒载体是疫苗开发、基因治疗和溶瘤病毒治疗的有用工具。在这里,我们描述了一种新的方法,用于腺病毒基因组的任何部分的基因工程和完全复制或有缺陷的病毒粒子的重建。这种创新的策略是快速、有效和适用于整个基因组的操作,拓宽了腺病毒系统的潜在应用范围。我们的策略包括将原生病毒中缺失的限制性内切酶识别序列插入腺病毒基因组的末端,以促进恢复。这些限制性内切酶位点与两个末端重复序列和包装序列一起合成,然后亚克隆到pBR322载体中。将腺病毒基因组的剩余内部部分分离并通过PCR扩增成6个片段,其中2个片段通过PCR连接在一起,然后亚克隆到pBR322质粒中。在PCR反应中,在相邻片段的末端添加了30-40 bp的重叠,允许随后的等温组装和所有片段的正确定向。这种方法允许根据特定的研究目标对每个基因组片段进行遗传修饰,(例如,删除,替换,添加等)为了重建整个病毒基因组,利用等温组装反应将四个工程片段(每个片段由两个腺病毒基因组部分组成)以及pBR322主干重新组装成一个结构体。最后,将重组的含全基因组的质粒线性化,转染到HEK293细胞中,恢复完整的重组腺病毒载体。利用这种方法,我们成功地生成了两种重组报告腺病毒,一种是人腺病毒血清型14,另一种是血清型55。E3区域被报告基因(GFP和荧光素酶)取代,以可视化和跟踪恢复过程。随后用这些重建的腺病毒载体感染A549细胞,表明它们具有复制能力。该方法缩短了病毒重建过程,一步等温组装需要不到4天,重组腺病毒在10天内恢复。这种新方法允许在病毒基因组的任何部分进行单次或多次遗传修饰,并可用于构建或操纵任何已知完整基因组序列的腺病毒。
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引用次数: 2
Editorial: Data-driven technologies for future healthcare systems. 社论:未来医疗保健系统的数据驱动技术。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1183687
Md Anisur Rahman, Alireza Moayedikia, Uffe Kock Wiil
COPYRIGHT © 2023 Rahman, Moayedikia and Wiil. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
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引用次数: 0
Assessment of a novel continuous cleaning device using metatranscriptomics in diverse hospital environments. 在不同的医院环境中使用超转录组学评估一种新型连续清洁装置。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1015507
Justin R Wright, Truc T Ly, Karen B Cromwell, Colin J Brislawn, Jeremy R Chen See, Samantha Lc Anderson, Jordan Pellegrino, Logan Peachey, Christine Y Walls, Charise M Lloyd, Olcay Y Jones, Matthew W Lawrence, Jessica A Bess, Arthur C Wall, Alexander J Shope, Regina Lamendella

Introduction: Despite routine implementation of cleaning and disinfection practices in clinical healthcare settings, high-touch environmental surfaces and contaminated equipment often serve as reservoirs for the transmission of pathogens associated with healthcare-associated infections (HAIs).

Methods: The current study involved the analysis of high-touch surface swabs using a metatranscriptomic sequencing workflow (CSI-Dx™) to assess the efficacy of cleanSURFACES® technology in decreasing microbial burden by limiting re-contamination. This is a non-human single center study conducted in the Emergency Department (ED) and on an inpatient Oncology Ward of Walter Reed National Military Medical Center that have followed hygienic practices during the COVID-19 pandemic environment.

Results: Although there was no difference in observed microbial richness (two-tailed Wilcoxon test with Holm correction, P > 0.05), beta diversity findings identified shifts in microbial community structure between surfaces from baseline and post-intervention timepoints (Day 1, Day 7, Day 14, and Day 28). Biomarker and regression analyses identified significant reductions in annotated transcripts for various clinically relevant microorganisms' post-intervention, coagulase-negative staphylococci and Malassezia restricta, at ED and Oncology ward, respectively. Additionally, post-intervention samples predominantly consisted of Proteobacteria and to a lesser extent skin commensals and endogenous environmental microorganisms in both departments.

Discussion: Findings support the value of cleanSURFACES®, when coupled with routine disinfection practices, to effectively impact on the composition of active microbial communities found on high-touch surfaces in two different patient care areas of the hospital (one outpatient and one inpatient) with unique demands and patient-centered practices.

简介:尽管在临床卫生保健环境中常规实施清洁和消毒措施,但高接触环境表面和受污染的设备往往成为与卫生保健相关感染(HAIs)相关的病原体传播的水库。方法:目前的研究涉及使用超转录组测序工作流程(CSI-Dx™)对高接触表面拭子进行分析,以评估cleanSURFACES®技术通过限制再污染来减少微生物负担的功效。这是一项在沃尔特里德国家军事医疗中心急诊科(ED)和住院肿瘤病房进行的非人类单中心研究,在COVID-19大流行环境中遵循卫生规范。结果:虽然观察到的微生物丰富度没有差异(双尾Wilcoxon检验与Holm校正,P > 0.05),但β多样性发现发现,从基线和干预后时间点(第1天、第7天、第14天和第28天),表面之间的微生物群落结构发生了变化。生物标志物和回归分析发现,在急诊科和肿瘤科,各种临床相关微生物的干预后,凝固酶阴性葡萄球菌和限制马拉色菌的注释转录物分别显著减少。此外,干预后的样本主要由变形菌属组成,在较小程度上由皮肤共生菌和内源性环境微生物组成。讨论:研究结果支持cleanSURFACES®的价值,当与常规消毒实践相结合时,可以有效影响医院两个不同患者护理区域(一个门诊区和一个住院区)高接触表面上活性微生物群落的组成,这些区域具有独特的需求和以患者为中心的实践。
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引用次数: 0
Migration of endothelial cells on the surface of anodized Ni-Ti stent strut. 阳极氧化镍钛支架支架表面内皮细胞的迁移。
Pub Date : 2023-01-01 DOI: 10.3389/fmedt.2023.1149594
Zi Wang, Naofumi Ohtsu, Kasumi Tate, Yukiko Kojima, Hanif Saifurrahman, Makoto Ohta

Background: Stent is widely regarded as the main treatment for curing cardiovascular diseases such as stenosis. Previous research has revealed that the damage of endothelial cells (EC), i.e., the components of endothelium, during stent implantation, could lead to severe complications, such as restenosis. To prevent restenosis, enhancements have been made to surface biocompatibility to accelerate the stent endothelialization process. Anodization on the Ni-Ti is a simple and efficient surface modification method to improve the biocompatibility of the Ni-Ti stent surfaces by enhancing the surface hydrophilicity, leading to an increase in the EC activities. The EC activity is known to be affected by the blood flow. Flow change by stent structure may result in EC dysfunctions, thereby leading to restenosis. It is thus essential to investigate the EC activities resulting from the anodization on the Ni-Ti surface under flow conditions.

Objective: To study the influence of the endothelialization process on the Ni-Ti stent surface through anodization. The EC attachment and morphology on the anodized stent strut were observed under both with and without the flow conditions.

Method: A parallel plate flow chamber was designed to generate a constant wall shear stress (WSS) to study the flow effect on the EC behavior. The hydrophilicity of the Ni-Ti stent strut surface was enhanced by a TiO2 layer fabricated via anodization. The EC distribution on the surface of the anodized nitinol stent strut was observed after 24 h of static (without flow) and flow exposure (with flow) experiment.

Results: Under the static condition, the EC density on the surface of the anodized Ni-Ti stent strut was higher compared with the control. Under the flow condition, the enhancement of the EC density on the surface of the stent strut with anodization was reduced. The EC demonstrates a long and thin spindle-shaped morphology under the flow condition.

Conclusion: Unlike the static condition, the EC is demonstrating a long and thin morphology in response to the flow under the flow condition. By improving the surface hydrophilicity, the anodization could enhance the EC migration onto the strut surface, and subsequently, accelerate the Ni-Ti stent endothelialization process. The improvement of the surface hydrophilicity is lower under the flow conditions when compared with the static conditions.

背景:支架被广泛认为是治疗狭窄等心血管疾病的主要治疗方法。先前的研究表明,在支架植入过程中内皮细胞(EC)即内皮成分的损伤可导致严重的并发症,如再狭窄。为了防止再狭窄,已经对表面生物相容性进行了增强,以加速支架内皮化过程。在Ni-Ti表面进行阳极氧化处理是一种简单有效的表面改性方法,通过增强Ni-Ti支架表面的亲水性,提高其EC活性,从而提高支架表面的生物相容性。众所周知,EC的活性受血流的影响。支架结构引起的血流改变可导致EC功能障碍,从而导致再狭窄。因此,研究流动条件下Ni-Ti表面阳极氧化产生的EC活性是必要的。目的:研究内皮化过程对镍钛支架表面阳极氧化的影响。在有流动和无流动条件下,观察了阳极氧化支架支架上EC的附着和形貌。方法:设计平行板流室,产生恒壁剪应力(WSS),研究流动对EC行为的影响。通过阳极氧化制备的TiO2层增强了Ni-Ti支架支撑表面的亲水性。通过静态(无流动)和流动暴露(有流动)24 h的实验,观察氧化镍钛合金支架支撑表面EC的分布。结果:在静态条件下,阳极氧化镍钛支架支架表面EC密度高于对照组。在流动条件下,阳极氧化对支架支撑表面EC密度的增强作用减弱。在流动条件下,EC呈现出细长的纺锤形形貌。结论:与静态条件不同,在流动条件下,EC对流动的响应呈现出细长的形态。通过改善表面亲水性,阳极氧化可以促进EC向支架表面的迁移,从而加速Ni-Ti支架的内皮化过程。与静态条件相比,流动条件下的表面亲水性提高幅度较小。
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引用次数: 0
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