Jaboyedoff Manon, Rakic Milenko, Bachmann Sara, Berger Christoph, Diezi Manuel, Fuchs Oliver, Frey Urs, Gervaix Alain, Glücksberg Amalia Stefani, Grotzer Michael, Heininger Ulrich, Kahlert Christian R, Kaiser Daniela, Kopp Matthias V, Lauener Roger, Neuhaus Thomas J, Paioni Paolo, Posfay-Barbe Klara, Ramelli Gian Paolo, Simeoni Umberto, Simonetti Giacomo, Sokollik Christiane, Spycher Ben D, Kuehni Claudia E
Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
Service of Pediatrics, Department Women-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Swiss Med Wkly. 2021 Dec 21;151:w30069. doi: 10.4414/smw.2021.w30069. eCollection 2021 Dec 20.
Improvement of paediatric healthcare is hampered by inefficient processes for generating new evidence. Clinical research often requires extra encounters with patients, is costly, takes place in an artificial situation with a biased selection of patients, and entails long delays until new evidence is implemented into health care. Electronic health records (EHR) contain detailed information on real patients and cover the entirety of patients. However, the use of EHR for research is limited because they are not standardised between hospitals. This leads to disproportionate amounts of work for extracting data of interest and frequently data are incomplete and of poor quality.
SwissPedData aims to lay the foundation for a paediatric learning health system in Switzerland by facilitating EHR-based research. In this project, we aimed to assess the way routine clinical data are currently recorded in large paediatric clinics in Switzerland and to develop a national EHR-based set of common data elements (CDEs) that covers all processes of routine paediatric care in hospitals.
A taskforce of paediatricians from large Swiss children's hospitals reviewed the current status of routine data documentation in paediatric clinical care and the extent of digitalisation. We then used a modified Delphi method to reach a broad consensus on a national EHR-based set of CDEs.
All Swiss children's hospitals use EHR to document some or all aspects of care. One hundred and nineteen paediatricians, representing eight hospitals and all paediatric subspecialties, participated in an extended Delphi process to create SwissPedData. The group agreed on a national set of CDEs that comprises a main module with general paediatric data and sub-modules relevant to paediatric subspecialties. The data dictionary includes 336 CDEs: 76 in the main module on general paediatrics and between 11 and 59 CDEs per subspecialty module. Among these, 266 were classified as mandatory, 52 as recommended and 18 as optional.
SwissPedData is a set of CDEs for information to be collected in EHR of Swiss children's hospitals. It covers all care processes including clinical and paraclinical assessment, diagnosis, treatment, disposition and care site. All participating hospitals agreed to implement SwissPedData in their clinical routine and clinic information systems. This will pave the way for a national paediatric learning health system in Switzerland that enables fast and efficient answers to urgent clinical questions by facilitating high-quality nationwide retrospective and prospective observational studies and recruitment of patients for nested prospective studies and clinical trials.
新证据生成过程效率低下阻碍了儿科医疗保健的改善。临床研究通常需要与患者进行额外接触，成本高昂，在患者选择有偏差的人为环境中进行，并且在新证据应用于医疗保健之前会有很长的延迟。电子健康记录（EHR）包含真实患者的详细信息且涵盖所有患者。然而，EHR在研究中的应用受到限制，因为不同医院之间它们未标准化。这导致提取感兴趣数据的工作量不成比例，并且数据经常不完整且质量差。
SwissPedData旨在通过促进基于EHR的研究为瑞士的儿科学习健康系统奠定基础。在这个项目中，我们旨在评估瑞士大型儿科诊所目前记录常规临床数据的方式，并开发一套基于全国EHR的通用数据元素（CDE），涵盖医院常规儿科护理的所有流程。
来自瑞士大型儿童医院的儿科医生组成的特别工作组审查了儿科临床护理中常规数据记录的现状以及数字化程度。然后我们使用改进的德尔菲法就一套基于全国EHR的CDE达成广泛共识。
所有瑞士儿童医院都使用EHR记录部分或全部护理方面。代表八家医院和所有儿科亚专业的119名儿科医生参与了创建SwissPedData的扩展德尔菲过程。该小组就一套全国性的CDE达成一致，其中包括一个包含儿科一般数据的主模块和与儿科亚专业相关的子模块。数据字典包括336个CDE：儿科一般主模块中有76个，每个亚专业模块中有11至59个CDE。其中，2个66被列为强制性，52个为推荐性，18个为可选性。
SwissPedData是一套用于在瑞士儿童医院的EHR中收集信息的CDE。它涵盖所有护理流程，包括临床和辅助临床评估、诊断、治疗、处置和护理地点。所有参与医院都同意在其临床常规和诊所信息系统中实施SwissPedData。这将为瑞士的全国性儿科学习健康系统铺平道路，通过促进高质量的全国性回顾性和前瞻性观察性研究以及为嵌套前瞻性研究和临床试验招募患者，能够快速有效地回答紧急临床问题。
