Section of Hygiene, University Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Eur J Pediatr. 2024 Oct;183(10):4179-4184. doi: 10.1007/s00431-024-05620-5. Epub 2024 Aug 13.
New health technologies are constantly developing. However, their impacts on health and implications for health systems are not always clear. Faced with this situation, in the last 45 years, Health Technology Assessment (HTA) has taken an important role in the decision-making process related to the implementation of technologies in healthcare systems. According to the Core Model® EUnetHTA, a "full HTA" should cover nine domains: health problems and current use of technology, description and technical characteristics, safety, clinical effectiveness, costs and economic evaluation, ethical analysis, organizational aspects, patients and social aspects, legal aspects. In all domains of a HTA, the approach is evidence-based and uses epidemiological data, systematic reviews to gather the best level of proofs regarding clinical efficacy and safety of interventions and comparators and organizational and economic models. One exception is the ethical analysis, that uses value-based approach. Although in Neonatal Intensive Care Units (NICUs) there are highly advanced technological environments, HTA has not yet been widely used in this field for determining the "value" of the diagnostic and therapeutic procedures. An example of diagnostic tool used in NICUs is the near-infrared spectroscopy (NIRS), a noninvasive device that enables real-time monitoring of the condition of peripheral tissues in critically ill newborns. The availability of this diagnostic tool could improve the choice of the most appropriate treatment to the clinical situation of the newborn. The expected benefit of NIRS motivates the need of a full HTA. Conclusion: HTA is still little used in Neonatal Critical Care, but it may be the appropriate tool to determine the "value" of technologies used in this field. The implementation of clinical trials and HTA may help in an evidence-based evaluation of new technologies for the neonatal critical care. This could facilitate the rapid introduction of the best health technologies into clinical practice. What is Known: • Health Technology Assessment (HTA) has taken an important role in the decision-making process related to the implementation of technologies in healthcare systems • The centrality of ethics in HTA has been known. In fact, ethics is everywhere in HTA, and value judgments permeate all levels of HTA What is New: • HTA is still little used in Neonatal Critical Care, but it may be the appropriate tool to determine the "value" of technologies used in this field • The implementation of clinical trials and HTA may help in an evidence-based evaluation of new technologies for the neonatal critical care and in introduction of the best and ethically acceptable health technologies into clinical practice.
新的医疗技术不断发展。然而,它们对健康的影响以及对卫生系统的意义并不总是明确的。面对这种情况,在过去的 45 年中,卫生技术评估(Health Technology Assessment,HTA)在与医疗保健系统中技术实施相关的决策过程中发挥了重要作用。根据核心模型欧盟网 HT A,“全面 HTA”应涵盖九个领域:健康问题和现有技术的使用、描述和技术特点、安全性、临床有效性、成本和经济评估、伦理分析、组织方面、患者和社会方面、法律方面。在 HTA 的所有领域中,方法都是基于证据的,并使用流行病学数据、系统评价来收集关于干预措施和比较剂的临床疗效和安全性的最佳证据水平,以及组织和经济模型。一个例外是伦理分析,它使用基于价值的方法。尽管新生儿重症监护病房(NICU)中存在高度先进的技术环境,但 HTA 尚未在该领域广泛用于确定诊断和治疗程序的“价值”。在 NICU 中使用的诊断工具的一个例子是近红外光谱(Near-infrared spectroscopy,NIRS),这是一种非侵入性设备,可实时监测危重新生儿外周组织的状况。该诊断工具的可用性可以改善对新生儿临床情况最适宜治疗的选择。NIRS 的预期益处促使人们需要进行全面的 HTA。结论:HTA 在新生儿重症监护中应用较少,但它可能是确定该领域使用技术“价值”的适当工具。临床试验和 HTA 的实施可以帮助对新生儿重症监护的新技术进行基于证据的评估。这有助于将最佳卫生技术快速引入临床实践。已知的内容:• HTA 在与医疗保健系统中技术实施相关的决策过程中发挥了重要作用• 已经知道 HTA 的核心是伦理学。事实上,伦理学无处不在,价值判断渗透到 HTA 的各个层面。新的内容:• HTA 在新生儿重症监护中应用较少,但它可能是确定该领域使用技术“价值”的适当工具。• 临床试验和 HTA 的实施可以帮助对新生儿重症监护的新技术进行基于证据的评估,并有助于将最佳和符合伦理的卫生技术快速引入临床实践。