Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018 [0.03%]
2001年至2018年获得美国食品药品监督管理局市场准入批准的高风险新型治疗设备制造商之间的市场竞争分析
Vinay K Rathi,James L Johnston,Sanket Dhruva et al.
Vinay K Rathi et al.
Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators [0.03%]
一种关于独特设备识别符实施和使用的现实世界证据研究：与NESTcc健康系统网络合作者的混合方法研究
Sanket S Dhruva,Jennifer L Ridgeway,Joseph S Ross et al.
Sanket S Dhruva et al.
Objectives: To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world eviden...
Computer-assisted simulated workplace-based assessment in surgery: application of the universal framework of intraoperative performance within a mixed-reality simulation [0.03%]
计算机辅助的手术工作场所考核模拟：在混合现实模拟中运用手术过程表现的通用框架
Philipp Stefan,Michael Pfandler,Aljoscha Kullmann et al.
Philipp Stefan et al.
Objectives: Workplace-based assessment (WBA) is a key requirement of competency-based medical education in postgraduate surgical education. Although simulated workplace-based assessment (SWBA) has been proposed to complem...
Exploring procedure duration and risk for serious adverse events during congenital cardiac catheterization [0.03%]
先天性心脏导管手术的持续时间和严重不良事件的风险探究
Mary J Yeh,Elizabeth Lydon,Kimberlee Gauvreau et al.
Mary J Yeh et al.
Objectives: While procedure length is considered an important metric for cardiothoracic surgical procedures, the relationship between procedure length and adverse events (AEs) in congenital cardiac catheterizations has li...
Integration of a personalised mobile health (mHealth) application into the care of patients with brain tumours: proof-of-concept study (IDEAL stage 1) [0.03%]
个性化移动医疗(mHealth)应用程序在脑肿瘤患者护理中的整合：概念验证研究（IDEAL第一阶段）
Andrew Gvozdanovic,Felix Jozsa,Naomi Fersht et al.
Andrew Gvozdanovic et al.
Objectives: Brain tumours lead to significant morbidity including a neurocognitive, physical and psychological burden of disease. The extent to which they impact the multiple domains of health is difficult to capture lead...
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks [0.03%]
通过协调登记网络推动医疗器械的真实世界证据发展
Art Sedrakyan,Danica Marinac-Dabic,Bruce Campbell et al.
Art Sedrakyan et al.
Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid...
Development of a coordinated registry network for pelvic organ prolapse technologies [0.03%]
骨盆器官脱垂技术的协同登记网络的发展
Courtney E Baird,Bilal Chughtai,Catherine S Bradley et al.
Courtney E Baird et al.
Objectives: The accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse...
Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN) [0.03%]
肥胖设备协调登记网络(CRN)的最小核心数据结构开发
Cynthia Long,James E Tcheng,Danica Marinac-Dabic et al.
Cynthia Long et al.
Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose ...
Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network [0.03%]
利用协调登记网络建立急性缺血性卒中干预装置评估基础(DAISI)
Hartley LeRoy,Laura Elisabeth Gressler,David S Liebeskind et al.
Hartley LeRoy et al.
Orthopedic Coordinated Registry Network (Ortho-CRN): advanced infrastructure for real-world evidence generation [0.03%]
骨科协作注册网络（Ortho-CRN）：生成真实世界证据的高级基础设施
Laura Elisabeth Gressler,Vincent Devlin,Mary Jung et al.
Laura Elisabeth Gressler et al.