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Human factors integration with clinical investigations. 将人为因素与临床研究相结合。
Q3 Engineering Pub Date : 2023-11-01 Epub Date: 2024-06-10 DOI: 10.1080/03091902.2024.2355322
Charlie Irving, Ian Culverhouse

The human factors engineering (HFE) process supports the design and development of medical devices, especially novel devices requiring clinical investigation. The typical culmination of the HFE process prior to market approval is a human factors (HF) validation study, with specific requirements of participant, environment and task representation that carry a financial and temporal burden for medical device manufacturers. Whilst strongly recommended ahead of clinical investigations by regulators (and the authors), the prescribed methodology for HF validation studies required for pre-market approval may be excessive ahead of a clinical investigation during the development process. However, the stringent nature of HF validation studies will support effective clinical investigation design and minimise risks of poor clinical outcome or compliance. This paper provides recommendations in what to consider when determining what type of HF study to conduct ahead of each clinical investigation phase as well as insights into the symbiotic benefits of HFE and clinical investigations.

人因工程(HFE)流程支持医疗设备的设计和开发,尤其是需要进行临床研究的新型设备。在获得市场批准之前,人因工程流程的典型高潮是人因 (HF) 验证研究,该研究对参与者、环境和任务代表有具体要求,这给医疗设备制造商带来了经济和时间负担。虽然监管机构(和作者)强烈建议在临床研究之前进行高频验证研究,但上市前审批所需的高频验证研究的规定方法可能会在开发过程中的临床研究之前过多。不过,高频验证研究的严格性将有助于有效的临床研究设计,并将不良临床结果或合规性的风险降至最低。本文就确定在每个临床研究阶段之前进行哪种类型的高频研究时应考虑的事项提出了建议,并深入探讨了高频试验和临床研究的共生效益。
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引用次数: 0
Normal gastrointestinal temperature values measured through ingestible capsules technology: a systematic review. 通过可食用胶囊技术测量的正常胃肠道温度值:系统综述。
Q3 Engineering Pub Date : 2023-11-01 Epub Date: 2024-05-23 DOI: 10.1080/03091902.2024.2354793
William Martins Januário, Emille Rocha Bernardino de Almeida Prata, Antônio José Natali, Thales Nicolau Prímola-Gomes

Climate change has amplified the importance of continuous and precise body core temperature (Tcore) monitoring in the everyday life. In this context, assessing Tcore through ingestible capsules technology, i.e., gastrointestinal temperature (Tgastrointestinal), emerges as a good alternative to prevent heat-related illness. Therefore, we conducted a systematic review to point out values of normal Tgastrointestinal measured through ingestible capsules in healthy humans. The study followed PRISMA guidelines and searched the PubMed and Scielo databases from 1971 to 2023. Our search strategy included the descriptors ("gastrointestinal temperature") AND ("measurement"), and eligible studies had to be written in English and measured Tgastrointestinal using ingestible capsules or sensors in healthy adults aged 18-59 at rest. Two pairs of researchers independently reviewed titles and abstracts and identified 35 relevant articles out of 1,088 in the initial search. An average value of 37.13 °C with a standard deviation of 0.24 °C was observed, independently of the gender. The values measured ranged from 36.70 °C to 37.69 °C. In conclusion, this systematic review pointed out the mean value of 37.13 ± 0.24 °C measured by ingestible capsules as reference for resting Tgastrointestinal in healthy adult individuals.

气候变化凸显了在日常生活中持续、精确监测人体核心温度(Tcore)的重要性。在这种情况下,通过可摄入胶囊技术评估核心体温,即胃肠道体温(Tgastrointestinal),成为预防热相关疾病的一种良好替代方法。因此,我们进行了一项系统综述,以指出通过可食用胶囊测量健康人正常胃肠道温度的值。本研究遵循 PRISMA 指南,检索了 1971 年至 2023 年的 PubMed 和 Scielo 数据库。我们的搜索策略包括描述符("胃肠道温度")和("测量"),符合条件的研究必须以英语撰写,并在 18-59 岁的健康成年人中使用可食用胶囊或传感器测量休息时的胃肠道温度。两对研究人员独立审阅了标题和摘要,并从最初搜索的 1,088 篇文章中确定了 35 篇相关文章。观察到的平均值为 37.13 °C,标准偏差为 0.24 °C,与性别无关。测量值范围为 36.70 ℃ 至 37.69 ℃。总之,本系统综述指出,健康成年人的静息胃肠道温度参考值为 37.13 ± 0.24 °C,由可食用胶囊测量得出的平均值为 37.13 ± 0.24 °C。
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引用次数: 0
News and product update. 新闻和产品更新。
Q3 Engineering Pub Date : 2023-10-23 DOI: 10.1080/03091902.2023.2270855
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引用次数: 0
Apnoea detection using ECG signal based on machine learning classifiers and its performances. 基于机器学习分类器的心电图信号呼吸暂停检测及其性能。
Q3 Engineering Pub Date : 2023-10-01 Epub Date: 2024-04-16 DOI: 10.1080/03091902.2024.2336500
Rolant Gini J, Dhanalakshmi K

Sleep apnoea is a common disorder affecting sleep quality by obstructing the respiratory airway. This disorder can also be correlated to certain diseases like stroke, depression, neurocognitive disorder, non-communicable disease, etc. We implemented machine learning techniques for detecting sleep apnoea to make the diagnosis easier, feasible, convenient, and cost-effective. Electrocardiography signals are the main input used here to detect sleep apnoea. The considered ECG signal undergoes pre-processing to remove noise and other artefacts. Next to pre-processing, extraction of time and frequency domain features is carried out after finding out the R-R intervals from the pre-processed signal. The power spectral density is calculated by using the Welch method for extracting the frequency-domain features. The extracted features are fed to different machine learning classifiers like Support Vector Machine, Decision Tree, k-nearest Neighbour, and Random Forest, for detecting sleep apnoea and performances are analysed. The result shows that the K-NN classifier obtains the highest accuracy of 92.85% compared to other classifiers based on 10 extracted features. The result shows that the proposed method of signal processing and machine learning techniques can be reliable and a promising method for detecting sleep apnoea with a reduced number of features.

睡眠呼吸暂停是一种常见疾病,会阻塞呼吸道,影响睡眠质量。这种疾病还可能与某些疾病相关,如中风、抑郁症、神经认知障碍、非传染性疾病等。我们采用机器学习技术来检测睡眠呼吸暂停,使诊断更加简单、可行、方便和经济。心电图信号是检测睡眠呼吸暂停的主要输入信号。心电图信号需要经过预处理,以去除噪音和其他伪影。预处理之后,从预处理信号中找出 R-R 间期,然后提取时域和频域特征。在提取频域特征时,使用 Welch 方法计算功率谱密度。将提取的特征输入不同的机器学习分类器,如支持向量机、决策树、k-近邻和随机森林,以检测睡眠呼吸暂停,并分析其性能。结果显示,与其他基于 10 个提取特征的分类器相比,K-NN 分类器的准确率最高,达到 92.85%。结果表明,所提出的信号处理方法和机器学习技术可以在减少特征数量的情况下可靠地检测睡眠呼吸暂停,是一种很有前途的方法。
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引用次数: 0
Compact organ-tissue electrophoresis system (CORES). 紧凑型器官组织电泳系统(CORES)。
Q3 Engineering Pub Date : 2023-10-01 Epub Date: 2024-04-08 DOI: 10.1080/03091902.2024.2336497
Aysegul Gungor Aydin, Erdinc Sahin Conkur, Esat Adiguzel

Electrophoretic tissue clearing has been a commonly used laboratory method since the early twentieth century. Infrastructure for standard procedures has yet to be formed. In particular, control of the heat produced by electrophoresis, the voltage applied to the electrodes, the resistance, and the speed of liquid circulation create difficulty for researchers. We aimed to develop a compact organ electrophoresis system that enables the researcher to have easy, rapid, and inexpensive working opportunities. The system includes an electronic control unit, a liquid tank, a temperature control unit, and an electrophoresis chamber. The control unit software can keep the system stable by using information on temperature and circulation rate received through the sensors using the feedback principle. Corrosion and particle collection are reduced to a minimum as platinum wires are used for electrophoresis electrodes. A temperature control unit can heat and cool via a liquid tank base. The CORES is an all-in-one, easy-to-use solution for electrophoretic tissue clearing. It assures efficient, rapid, and consistent tissue clearing. The system was stable with 72 h of continuous operation. Patent applications and trial version studies for introducing the system to researchers are still in progress.

自二十世纪初以来,电泳组织清理一直是一种常用的实验室方法。标准程序的基础设施尚未形成。特别是对电泳产生的热量、施加在电极上的电压、电阻和液体循环速度的控制给研究人员造成了困难。我们的目标是开发一种结构紧凑的器官电泳系统,使研究人员能够获得简便、快速和廉价的工作机会。该系统包括一个电子控制单元、一个液体槽、一个温度控制单元和一个电泳槽。利用反馈原理,控制单元软件可通过传感器接收到的温度和循环速率信息保持系统稳定。由于电泳电极使用的是铂丝,因此可将腐蚀和微粒收集降到最低程度。温度控制装置可通过液槽底座进行加热和冷却。CORES 是一种一体化、易于使用的电泳组织清除解决方案。它能确保高效、快速、稳定地清除组织。该系统可连续稳定运行 72 小时。向研究人员介绍该系统的专利申请和试用版研究仍在进行中。
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引用次数: 0
Feasibility study of femur bone with continuum model. 利用连续模型对股骨头进行可行性研究。
Q3 Engineering Pub Date : 2023-10-01 Epub Date: 2024-04-16 DOI: 10.1080/03091902.2024.2336512
Kianoosh Abbassi, Maziar Janghorban, Farshad Javanmardi, Saleh Mobasseri

It is known that the geometric structures of bones are very complex. This has made researchers unable to model them with the continuum approach and suffice to model them with simulation or experimental tests. Undoubtedly, provide a simple and accurate continuum model for studying bones is always desirable. In this article, as the first serious endeavour, a suggested beam model is investigated to see whether it is suitable for modelling femur bones or not. If this model gives an acceptable answer, it can be a link to the continuum theories for beams. In other words, the approximated beam model can be formulated with continuum approach to study femur bone. For feasibility study of the approximated model for femur bones, both static and dynamic analysis of them are investigated and compared. It is found that in most cases for vibration analysis, the suggested model has acceptable results but in static analysis, the mean difference between the results is about 16%. This research is hoped to be the first serious step in this category.

众所周知,骨骼的几何结构非常复杂。这使得研究人员无法用连续方法对其进行建模,而只能通过模拟或实验测试对其进行建模。毫无疑问,为研究骨骼提供一个简单而精确的连续体模型一直是人们所期望的。在本文中,作为第一次认真的尝试,我们研究了一个建议的梁模型,看看它是否适合股骨头建模。如果该模型给出了可接受的答案,那么它就可以与梁的连续性理论联系起来。换句话说,近似梁模型可以用连续体方法来研究股骨头。为了研究股骨近似模型的可行性,我们对其进行了静态和动态分析,并进行了比较。结果发现,在振动分析的大多数情况下,所建议的模型具有可接受的结果,但在静态分析中,结果之间的平均差异约为 16%。希望这项研究能在这一领域迈出重要的第一步。
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引用次数: 0
News and product update. 新闻和产品更新。
Q3 Engineering Pub Date : 2023-08-31 DOI: 10.1080/03091902.2023.2243191
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引用次数: 0
Artificial intelligence and machine learning responses to COVID-19 related inquiries. 人工智能和机器学习对 COVID-19 相关询问的答复。
Q3 Engineering Pub Date : 2023-08-01 Epub Date: 2024-04-16 DOI: 10.1080/03091902.2024.2321846
Naser Zaeri

Researchers and scientists can use computational-based models to turn linked data into useful information, aiding in disease diagnosis, examination, and viral containment due to recent artificial intelligence and machine learning breakthroughs. In this paper, we extensively study the role of artificial intelligence and machine learning in delivering efficient responses to the COVID-19 pandemic almost four years after its start. In this regard, we examine a large number of critical studies conducted by various academic and research communities from multiple disciplines, as well as practical implementations of artificial intelligence algorithms that suggest potential solutions in investigating different COVID-19 decision-making scenarios. We identify numerous areas where artificial intelligence and machine learning can impact this context, including diagnosis (using chest X-ray imaging and CT imaging), severity, tracking, treatment, and the drug industry. Furthermore, we analyse the dilemma's limits, restrictions, and hazards.

最近,人工智能和机器学习取得了突破性进展,研究人员和科学家可以利用基于计算的模型将关联数据转化为有用信息,从而帮助疾病诊断、检查和病毒遏制。在本文中,我们广泛研究了人工智能和机器学习在 COVID-19 大流行开始近四年后的高效应对中发挥的作用。在这方面,我们研究了多个学科的学术和研究团体开展的大量重要研究,以及人工智能算法的实际应用,这些算法为调查不同的 COVID-19 决策场景提出了潜在的解决方案。我们确定了人工智能和机器学习可对这一背景产生影响的众多领域,包括诊断(使用胸部 X 光成像和 CT 成像)、严重程度、跟踪、治疗和制药业。此外,我们还分析了这一困境的局限性、限制和危害。
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引用次数: 0
Small-scale medical oxygen production unit using PSA technology: modeling and sensitivity analysis. 使用 PSA 技术的小型医用氧气生产装置:建模和敏感性分析。
Q3 Engineering Pub Date : 2023-08-01 Epub Date: 2024-04-16 DOI: 10.1080/03091902.2024.2331693
Lina Benkirane, Abdessamad Samid, Tarik Chafik

This study presents a solid approach for small-scale medical oxygen production unit using pressure swing adsorption (PSA) technology. The objective of this research is to develop a mathematical model and conduct a sensitivity analysis to optimise the design and operating parameters of the PSA system. Based on the simulation results, an optimal set of operational parameter values has been obtained for the PSA beds. The result shows that the binary system produced oxygen with a purity of 94%, at the adsorption pressure 1 bar and temperature of 308K. The findings demonstrate the effectiveness of the proposed small-scale PSA system for medical oxygen production, highlighting the impact of key parameters and emphasising the need for careful optimisation. The findings serve as a guide for the design and operation of small-scale PSA systems, enabling healthcare facilities to produce their own medical oxygen, thereby improving accessibility and addressing critical shortages during emergencies. Future research may explore the integration of large scale PSA units in hospitals in Morocco.

本研究提出了一种利用变压吸附(PSA)技术生产小型医用氧气的可靠方法。这项研究的目的是建立一个数学模型并进行敏感性分析,以优化 PSA 系统的设计和运行参数。根据模拟结果,得出了 PSA 床的一组最佳运行参数值。结果表明,在吸附压力为 1 巴、温度为 308K 的条件下,二元系统产生的氧气纯度为 94%。研究结果表明,拟议的小规模 PSA 系统在医用氧气生产方面非常有效,突出了关键参数的影响,并强调了仔细优化的必要性。这些研究结果为小型 PSA 系统的设计和运行提供了指导,使医疗机构能够生产自己的医用氧气,从而提高了可及性,并解决了紧急情况下的严重短缺问题。未来的研究可能会探索在摩洛哥的医院中整合大型 PSA 设备。
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引用次数: 0
Enhanced skin burn assessment through transfer learning: a novel framework for human tissue analysis. 通过迁移学习加强皮肤烧伤评估:人体组织分析的新框架。
Q3 Engineering Pub Date : 2023-07-01 Epub Date: 2024-03-22 DOI: 10.1080/03091902.2024.2327459
Madhur Nagrath, Ashutosh Kumar Sahu, Nancy Jangid, Meghna Sharma, Poonam Chaudhary

Visual inspection is the typical way for evaluating burns, due to the rising occurrence of burns globally, visual inspection may not be sufficient to detect skin burns because the severity of burns can vary and some burns may not be immediately apparent to the naked eye. Burns can have catastrophic and incapacitating effects and if they are not treated on time can cause scarring, organ failure, and even death. Burns are a prominent cause of considerable morbidity, but for a variety of reasons, traditional clinical approaches may struggle to effectively predict the severity of burn wounds at an early stage. Since computer-aided diagnosis is growing in popularity, our proposed study tackles the gap in artificial intelligence research, where machine learning has received a lot of attention but transfer learning has received less attention. In this paper, we describe a method that makes use of transfer learning to improve the performance of ML models, showcasing its usefulness in diverse applications. The transfer learning approach estimates the severity of skin burn damage using the image data of skin burns and uses the results to improve future methods. The DL technique consists of a basic CNN and seven distinct transfer learning model types. The photos are separated into those displaying first, second, and third-degree burns as well as those showing healthy skin using a fully connected feed-forward neural network. The results demonstrate that the accuracy of 93.87% for the basic CNN model which is significantly lower, with the VGG-16 model achieving the greatest accuracy at 97.43% and being followed by the DenseNet121 model at 96.66%. The proposed approach based on CNN and transfer learning techniques are tested on datasets from Kaggle 2022 and Maharashtra Institute of Technology open-school medical repository datasets that are clubbed together. The suggested CNN-based approach can assist healthcare professionals in promptly and precisely assessing burn damage, resulting in appropriate therapies and greatly minimising the detrimental effects of burn injuries.

肉眼检查是评估烧伤的典型方法,但由于全球烧伤发生率不断上升,肉眼检查可能不足以发现皮肤烧伤,因为烧伤的严重程度可能各不相同,有些烧伤肉眼可能无法立即察觉。烧伤可造成灾难性后果,使人丧失工作能力,如果不及时治疗,可导致疤痕、器官衰竭,甚至死亡。烧伤是相当高发病率的一个重要原因,但由于各种原因,传统的临床方法可能难以有效地在早期预测烧伤伤口的严重程度。由于计算机辅助诊断越来越受欢迎,我们提出的研究解决了人工智能研究中机器学习受到广泛关注,而迁移学习受到较少关注的空白。在本文中,我们介绍了一种利用迁移学习提高 ML 模型性能的方法,展示了它在各种应用中的实用性。迁移学习方法利用皮肤烧伤的图像数据估计皮肤烧伤的严重程度,并利用结果改进未来的方法。DL 技术由一个基本 CNN 和七个不同的迁移学习模型类型组成。使用全连接前馈神经网络将照片分为显示一级、二级和三级烧伤的照片以及显示健康皮肤的照片。结果表明,基本 CNN 模型的准确率为 93.87%,明显偏低,VGG-16 模型的准确率最高,达到 97.43%,其次是 DenseNet121 模型,为 96.66%。基于 CNN 和迁移学习技术的建议方法在 Kaggle 2022 数据集和马哈拉施特拉邦理工学院开放学校医学资料库数据集上进行了测试。所建议的基于 CNN 的方法可以帮助医护人员及时、准确地评估烧伤损伤,从而采取适当的治疗措施,并大大减少烧伤的不利影响。
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引用次数: 0
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Journal of Medical Engineering and Technology
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