Vita-Salute San Raffaele University, Milan, Italy.
IRCCS Istituto Ortopedico Galeazzi, Via Cristina Belgioioso 173, 20157, Milan, Italy.
Radiol Med. 2024 Jul;129(7):1076-1085. doi: 10.1007/s11547-024-01832-9. Epub 2024 Jun 10.
Health technology assessment (HTA) is a systematic process used to evaluate the properties and effects of healthcare technologies within their intended use context. This paper describes the adoption of HTA process to assess the adoption of the EOSedge™ system in clinical practice.
The EOSedge™ system is a digital radiography system that delivers whole-body, high-quality 2D/3D biplanar images covering the complete set of musculoskeletal and orthopedic exams. Full HTA model was chosen using the EUnetHTA Core Model version 3.0. The HTA Core Model organizes the information into nine domains. Information was researched and obtained by consulting the manufacturers' user manuals, scientific literature, and institutional sites for regulatory aspects.
All nine domains of the EUnetHTA Core Model helped conduct the HTA of the EOSedge, including (1) description and technical characteristics of the technology; (2) health problem and current clinical practice; (3) safety; (4) clinical effectiveness; (5) organizational aspects; (6) economic evaluation; (7) impact on the patient; (8) ethical aspects; and (9) legal aspects.
EOS technologies may be a viable alternative to conventional radiographs. EOSedge has the same intended use and similar indications for use, technological characteristics, and operation principles as the EOS System and provides significant dose reduction factors for whole spine imaging compared to the EOS System without compromising image quality. Regarding the impact of EOS imaging on patient outcomes, most studies aim to establish technical ability without evaluating their ability to improve patient outcomes; thus, more studies on this aspect are warranted.
卫生技术评估(HTA)是一种系统的过程,用于评估医疗技术在其预期使用环境中的特性和效果。本文描述了采用 HTA 过程来评估 EOSedge™系统在临床实践中的采用情况。
EOSedge™系统是一种数字射线照相系统,可提供全身高质量的 2D/3D 双平面图像,涵盖完整的肌肉骨骼和矫形检查。选择了完整的 HTA 模型,使用的是 EUnetHTA 核心模型版本 3.0。HTA 核心模型将信息组织成九个领域。通过查阅制造商的用户手册、科学文献和机构网站的监管方面,研究和获取了信息。
EUnetHTA 核心模型的所有九个领域都有助于进行 EOSedge 的 HTA,包括:(1)技术的描述和技术特征;(2)健康问题和当前临床实践;(3)安全性;(4)临床效果;(5)组织方面;(6)经济评估;(7)对患者的影响;(8)伦理方面;和(9)法律方面。
EOS 技术可能是传统射线照相的可行替代方案。EOSedge 的预期用途和使用适应症、技术特征和操作原理与 EOS 系统相同,与 EOS 系统相比,可为整个脊柱成像提供显著的剂量减少因素,而不会影响图像质量。关于 EOS 成像对患者结果的影响,大多数研究旨在建立技术能力,而不评估其改善患者结果的能力;因此,需要更多的研究。