Divison of Neonatology, LMU University Children's Hospital, Dr. V. Hauner, Munich, Germany.
Divison of Neonatology, LMU University Children's Hospital, Dr. V. Hauner, Munich, Germany,
Neonatology. 2022;119(4):443-454. doi: 10.1159/000522318. Epub 2022 May 11.
Approximately, one in ten infants is born preterm or requires hospitalization at birth. These complications at birth have long-term consequences that can extend into childhood and adulthood. Timely detection of developmental delay through surveillance could enable tailored support for these babies and their families. However, the possibilities for follow-up are limited, especially in middle- and low-income countries, and the tools to do so are either not available or too expensive. A standardized and core set of outcomes for neonates, with feasible tools for evaluation and follow-up, could result in improving quality, enhance shared decision-making, and enable global benchmarking.
The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group, which was comprised of 14 health-care professionals (HCP) and 6 patient representatives in the field of neonatal care. An outcome set was developed using a three-round modified Delphi process, and it was endorsed through a patient representative-validation survey and an HCP survey.
A literature review revealed 1,076 articles and 26 registries which were screened for meaningful outcomes, patient-reported outcome measures, clinical measures, and case mix variables. This resulted in a neonatal set with 21 core outcomes covering three domains (physical, social, and mental functioning) and 14 tools to assess these outcomes at three timepoints.
This set can be implemented globally and it will allow comparison of outcomes across different settings and countries. The transparent consensus-driven development process which involved stakeholders and professionals from all over the world ensures global relevance.
大约十分之一的婴儿早产或需要在出生时住院。这些出生并发症会产生长期影响，甚至会延续到儿童期和成年期。通过监测及时发现发育迟缓，可以为这些婴儿及其家庭提供有针对性的支持。然而，特别是在中低收入国家，进行后续监测的可能性有限，而且相关工具要么不可用，要么过于昂贵。制定一套标准化的核心新生儿结局指标，并配以可行的评估和随访工具，将有助于提高质量、增强共同决策，并实现全球基准比较。
国际健康结果测量联合会（ICHOM）召集了一个由 14 名医疗保健专业人员（HCP）和 6 名新生儿护理领域的患者代表组成的国际工作组。采用三轮改良 Delphi 法制定了一套结局指标，并通过患者代表验证调查和 HCP 调查进行了认可。
文献综述筛选出 1076 篇文章和 26 项登记处，以确定有意义的结局、患者报告的结局测量、临床测量和病例组合变量。这产生了一个包含 21 个核心结局的新生儿结局指标集，涵盖三个领域（身体、社会和精神功能），并提供了 14 种工具来评估这三个时间点的结局。
该套结局指标可以在全球范围内实施，并允许在不同环境和国家之间比较结局。这个具有全球相关性的透明共识驱动的开发过程，涉及了来自世界各地的利益相关者和专业人员。
