Abstract：
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.
摘要：
新的健康技术正在不断发展。然而,它们对健康的影响和对卫生系统的影响并不总是很清楚。面对这种情况,在过去的45年里，卫生技术评估（HTA）在与医疗保健系统中技术实施有关的决策过程中发挥了重要作用。根据CoreModel®EUnetHTA，“完整的HTA”应涵盖九个领域：健康问题和当前技术使用，描述和技术特征，安全,临床有效性，成本和经济评价，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，该方法是基于证据的，并使用流行病学数据，系统评价，以收集有关干预措施和比较者的临床疗效和安全性以及组织和经济模型的最佳证据。一个例外是伦理分析，使用基于价值的方法。虽然在新生儿重症监护病房（NICU）有高度先进的技术环境，HTA尚未在该领域广泛用于确定诊断和治疗程序的“价值”。NICU中使用的诊断工具的一个例子是近红外光谱(NIRS)，一种能够实时监测危重新生儿外周组织状况的非侵入性装置。这种诊断工具的可用性可以改善对新生儿临床情况的最合适治疗的选择。NIRS的预期好处激发了对完整HTA的需求。结论:HTA在新生儿重症监护中的应用还很少,但它可能是确定该领域使用的技术的“值”的适当工具。临床试验和HTA的实施可能有助于对新生儿重症监护新技术进行循证评估。这可以促进将最佳健康技术快速引入临床实践。已知内容：•健康技术评估（HTA）在与医疗保健系统中技术的实施有关的决策过程中发挥了重要作用•HTA中道德的中心地位已经众所周知。事实上,道德在HTA中无处不在，和价值判断渗透到所有级别的HTA新功能：•HTA在新生儿重症监护中仍然很少使用，但它可能是确定该领域使用的技术的“价值”的适当工具•临床试验和HTA的实施可能有助于对新生儿重症监护新技术进行基于证据的评估，并将最佳和道德上可接受的健康技术引入临床实践。
