Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe

Objective

Medical devices (MDs) encompass a broad and heterogeneous range of technologies. While practices vary considerably across countries, MDs often find application in patient care with little or no evaluation of their effectiveness and safety following market approval. A recently proposed taxonomy of MDs considered devices from the viewpoint of Health Technology Assessment (HTA). The aim of the work presented here was to test its plausibility and applicability by considering real-world HTA practices.

正交试验优选益母阿胶膏的最佳工艺研究

目的优选益母阿胶膏生产的最佳提取工艺。方法以出膏率为指标,采用正交试验考察A加水量(倍)、B提取时间(h)、C提取次数(次)三个因素的影响,确定益母阿胶膏的最佳提取工艺。结果提取因素按影响大小依次是C提取次数>B提取时间>A加水量,最佳提取条件为:加12倍量水,提取1.5 h,提取2次。结论该制备工艺合理可行,可作为益母阿胶膏的最佳提取工艺。     

目标教学在前列腺超声诊断技术带教中的应用价值研究

目的探讨目标教学在前列腺超声诊断技术带教中的应用效果。方法选择2017年1月-2018年12月于我院进行前列腺超声诊断技术培训的影像学专业学生80例,根据入院时间先后顺序分为研究组与对照组,每组40例。对照组医学生采用常规教学法带教,研究组医学生采用目标教学法带教,比较两组带教效果。结果研究组医学生的超声诊断仪使用(94.12±2.73)分、超声扫查技巧(92.81±5.06)分、操作技能(90.83±5.11)分、超声图像表现掌握(91.96±3.67)分均高于对照组(P<0.05)。研究组医学生的总体满意度CEQ评分(8.22±0.24)分高于对照组的(5.25±0.30)分,两组比较差异具有统计学意义(P<0.05)。结论目标教学在前列腺超声诊断技术带教中的应用效果良好,可有效提高医学生的操作能力,提高医学生对带教模式的肯定度。     

饴糖的研究现状

饴糖,性温、味甘,为药食同源之品,应用较广泛,具有非常重要的研究价值。但是目前饴糖仍存在名称混淆及质量标准不完善等问题。通过查阅相关文献和《金匮要略》等专著,对饴糖的功效、在保健食品和药品中的应用、古今制法及相关质量标准进行综述,以期为饴糖的新发展、新应用提供理论依据。     

Powered off-road wheelchair for the transportation of tetraplegics along mountain trails

Purpose: For off-road mobility, some manual or power assisted devices were conceived to be self-driven by paraplegics while for tetraplegics non power-assisted devices were conceived. These devices require one or more conductors who are subjected to a high physical demand thus potentially creating: precarious safety condition for the user an elevated physical demand of conductors could reduce the care and the attention to give to the user; the time of the outdoor adventure experience of the user could be limited.

Methods: To address these issues, an innovative user-centered power assisted off-road wheelchair for the transportation of tetraplegics along mountain trails was developed. The device, structured like a trike, is driven by two healthy conductors; the user is placed in the middle of the frame. A movable seat provides for the transfer from the standard to the off-road wheelchair. An electrical motor, powered by a battery pack, provides for the actuation. All the design and prototype aspects, the control system and experimental tests are detailed.

Results: The prototype satisfies mechanical, safety and duration requirements. No physical demand while using the device and for the transfer of the user to the device was identified. Fun and engaging tests were carried out and all the participants were involved.

• Implications for Rehabilitation

• The device has the potential to enhance the quality of life of tetraplegics in terms of new life experiences.

• The device revealed the real possibility of a full recreational experience, an enhanced participation and a better social integration of tetraplegics.

     

Radiography Students' Learning of Plain X-Ray Examinations in Simulation Laboratory Exercises: An Ethnographic Research

IntroductionIn addition to lessons and clinical training, simulation-based learning has become more ubiquitous in radiography students' learning. Plain examinations are in the core of radiography, and studying how students learn them in simulation is therefore essential when considering students' professional development. The purpose of this study was to describe radiography students' learning to perform plain X-ray examinations in simulation laboratory exercises. The aim was to understand how the students learned.MethodsThe data were gathered by observing and interviewing 17 radiography students as they performed laboratory exercises of plain X-ray examinations before clinical training. Learning was understood according to social constructivism and was examined from the perspective of interpretive ethnography. Data were analyzed using the constant comparative method.ResultsIn simulation laboratory exercises, radiography students learned by model-based experimentation. Learning consisted of imaging bone and chest examinations of a manikin, evaluation of the images, and patient positioning and guidance among students. The learning method was collaborative learning. Three learning outcomes were found: simulation promoted theory-practice connection, simulation guided the students to follow instructions, and simulation strengthened collaboration between students. The factors supporting and impeding learning were the same: academic studies before the simulation and learning tasks. In addition, experimentation without teacher's supervision was an impeding factor for some students.ConclusionSimulation laboratory exercises with a manikin proved to be a useful learning method for radiography students in learning to perform plain X-ray examinations. The results indicated the need to pay attention to simulation pedagogy and students' academic skills.     

Discovery of [1,2,3]triazolo[4,5-d]pyrimidine derivatives as highly potent,selective, and cellularly active USP28 inhibitors

Ubiquitin specific peptidase 28 (USP28) is closely associated to the occurrence and development of various malignancies, and thus has been validated as a promising therapeutic target for cancer therapy. To date, only few USP28 inhibitors with moderate inhibitory activity have been reported, highly potent and selective USP28 inhibitors with new chemotypes remain to be discovered for pathologically investigating the roles of deubiquitinase. In this current study, we reported the synthesis and biological evaluation of new [1,2,3]triazolo[4,5-d]pyrimidine derivatives as potent USP28 inhibitors. Especially, compound 19 potently inhibited USP28 (IC₅₀ = 1.10 ± 0.02 μmol/L, K_d = 40 nmol/L), showing selectivity over USP7 and LSD1 (IC₅₀ > 100 μmol/L). Compound 19 was cellularly engaged to USP28 in gastric cancer cells. Compound 19 reversibly bound to USP28 and directly affected its protein levels, thus inhibiting the proliferation, cell cycle at S phase, and epithelial-mesenchymal transition (EMT) progression in gastric cancer cell lines. Docking studies were performed to rationalize the potency of compound 19. Collectively, compound 19 could serve as a new tool compound for the development of new USP28 inhibitors for exploring the roles of deubiquitinase in cancers.     

基于信息化的社区骨关节炎患者多学科管理模式构建及应用研究

背景 骨关节炎致残、致畸率高，可合并多种身心疾病，但早期症状不明显。当前社区骨关节炎的管理存在管治不协调、方法不健全、制度不完善等问题。 目的 构建并评价基于信息化的社区骨关节炎多学科管理模式，以促进对社区骨关节炎患者的管理，改善患者疾病预后。 方法 首先构建社区骨关节炎患者的多学科管理模式，包含基于危险因素分层的患者分级管理流程、多学科管理团队及其诊治分工，然后构建基于信息化的多学科管理流程，并完成信息软件开发。选取2019年7月至2020年7月在上海市定海、大桥社区卫生服务中心全科门诊，以及杨浦区中心医院骨科门诊就诊的膝骨关节炎患者80例为研究对象，采用随机数表法将其分为普通组和多学科组，各40例。普通组采用常规治疗模式，多学科组在此基础上进行基于信息化的多学科管理。分别于治疗前和治疗12周后评估两组患者的视觉模拟评分法（VAS）评分、西安大略麦克马斯特大学（WOMAC）骨关节炎指数、关节炎生活质量测量量表（AIMS2）评分、健康素养管理量表（HeLMS）评分、体质指数（BMI）。 结果 治疗前，多学科组和普通组膝骨关节炎患者的VAS评分、WOMAC骨关节炎指数、AIMS2评分、HeLMS评分、BMI比较，差异均无统计学意义（P>0.05）；治疗12周后，多学科组和普通组膝骨关节炎患者的VAS评分、WOMAC骨关节炎指数低于治疗前，AIMS2总分、HeLMS总分高于治疗前，差异有统计学意义（P<0.05）；治疗12周后，多学科组患者AIMS2总分、HeLMS总分高于普通组，VAS评分、WOMAC骨关节炎指数、BMI均低于普通组，差异有统计学意义（P<0.05）。 结论 对膝骨关节炎患者实施基于信息化的社区骨关节炎患者多学科管理模式，可有效减轻患者的关节疼痛和体质量，提高患者的日常生活能力和健康素养，改善患者的生活质量，延缓患者的病情进展。     

Methods for Early Assessment of the Societal Value of Health Technologies: A Scoping Review and Proposal for Classification

ObjectivesEarly assessments of health technologies help to better align and integrate their development and assessment. Such assessments can take many forms and serve different purposes, hampering users in their selection of the most appropriate method for a specific goal. The aim of this scoping review was to structure the large set of methods according to their specific goal.MethodsA scoping review was conducted using PubMed and reference lists of retrieved articles, to identify review studies with a methodological focus. From the included reviews, all individual methods were listed. Based on additional literature and examples, we extracted the specific goal of each method. All goals were clustered to derive a set of subclasses and methods were grouped into these subclasses.ResultsOf the 404 screened, 5 reviews were included, and 1 was added when searching reference lists. The reviews described 56 methods, of which 43 (77%) were included and classified as methods to (1) explore the nature and magnitude of the problem, (2) estimate the nature and magnitude of the expected (societal) value, (3) identify conditions for the potential value to materialize, and (4) help develop and design the type of research that is needed.ConclusionsThe wide range of methods for exploring the societal value of health technologies at an early stage of development can be subdivided into a limited number of classes, distinguishing methods according to their specific objective. This facilitates selection of appropriate methods, depending on the specific needs and aims.     

3D打印技术联合CBL教学法在骨科教学中的价值

目的对骨科临床教学中应用3D打印技术联合CBL教学法的临床实际应用价值进行研究分析。方法择取2018年4月—2019年4月间在我院骨科的实习生共80例作为研究对象,采用随机数字表法,将所有实习生分为观察组(40人)、对照组(40人);对照组应用常规教具联合CBL教学法,观察组应用3D打印技术联合CBL教学法,对比两组实习生的教学效果以及对教学活动的满意度。结果在理论知识以及临床操作方面,观察组实习同学成绩高于对照组(P<0.05);在对教学满意度方面,观察组实习同学高于对照组(P<0.05)。结论在骨科临床教学中,应用3D打印技术联合CBL教学法具有显著临床教学效果,学生的理论知识以及临床操作成绩更为优异,对教学满意度更高。