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BACKGROUND 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. AIMS 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. METHODS 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. RESULTS 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. CONCLUSION 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.

Continuous improvement of health and healthcare system is hampered by inefficient processes of generating new evidence, particularly in the case of rare diseases and paediatrics. Currently, most evidence is generated through specific research projects, which typically require extra encounters with patients, are costly and entail long delays between the recognition of specific needs in ealthcare and the generation of necessary evidence to address those needs. The Swiss Personalised Health Network (SPHN) aims to improve the use of data obtained during routine healthcare encounters by harmonizing data across Switzerland and facilitating accessibility for research. The project “Harmonising the collection of health-related data and biospecimens in paediatric hospitals throughout Switzerland (SwissPedData)” was an infrastructure development project funded by the SPHN, which aimed to identify and describe available data on child health in Switzerland and to agree on a standardised core dataset for electronic health records across all paediatric teaching hospitals. Here, we describe the results of a two-day symposium that aimed to summarise what had been achieved in the SwissPedData project, to put it in an international context, and to discuss the next steps for a sustainable future. The target audience included clinicians and researchers who produce and use health-related data on children in Switzerland.

The steady increase in human life expectancy has been accompanied by a growing prevalence of patients with chronic diseases and multiple medical conditions, and the number of people in need of Palliative Care in Switzerland is expected to continue rising. Few people will die from a sudden death, whereas the majority will face an extended dying process, which will lead to a significant need for formal (e.g. hospital, retirement home) and informal care (e.g. family) throughout the course of a patient’s illness. At the same time, autonomy has emerged as a crucial principle in our modern societies. It plays a significant role in the many domains of our lives in which autonomous decision-making is promoted, and autonomy is particularly relevant for elderly patients. Therefore, different approaches on how to improve patients’ quality of life and promote their autonomy in clinical settings are increasingly important to discuss. The purpose of this PhD thesis is to integrate empirical and normative analyses using a qualitative and quantitative approach in order to promote respect of elderly patients’ autonomy. This PhD thesis consists of seven chapters (background, journal articles, and discussion). The background chapter (Chapter 1) introduces chronic diseases, demographic shift, clinical trials, autonomy, and Palliative Care. Chapter 1 also discusses the research objectives and the methodological approach. Each of the chapters 2-6 consists of a deep dive into one journal article. Chapter 2 analyses patients’ views regarding potential participation in clinical trials of synthetic biology. Our results indicate that information should be communicated with great accuracy and transparency to allay irrational fears of patients and minimize the risk that researchers present facts too optimistically in an effort to persuade patients to participate in the trials. Patients must be adequately informed in order to be able to autonomously decide whether or not to participate. Chapter 3 explores patients’ thoughts about the idea of participating in research ethics committees. If the patients were allowed to participate in the decision-making process, their autonomy would be more respected. Analysis of the interviews revealed a patients’ preference towards involvement in research ethics committees. The main motivation for the interviewed patients to participate was the improvement of therapeutic options in the future. Our study adds important knowledge about the idea of patients becoming research ethics committee members by exploring their perceptions of the prospective role. Chapter 4 focuses on different aspects of hope in the context of human health and well-being and explores the varieties of hope expressed by patients. Three concepts of hope emerged from the interviews: hope as certainty, hope as reflective uncertainty, and hope as self-therapy. Health professionals ought to be more aware of the three concepts of hope and their great potential as a coping strategy for patients. Hope seems to be genuinely beneficent for patients’ well-being in a therapeutic and in a research context. Chapter 5 analyses patients’ medical records to determine what is reported about burden and overburden and who seems to be mostly affected. Daily life situations reveal that the concept of autonomy is challenged when the two parties (e.g. patients and their families) have different interests, resources, and needs. Patients often felt burdened by their disease, financial problems, situation at home, and family members’ reactions to their disease. Families felt burdened by issues related to patients’ medical condition, providing home care, or financial and social aspects. Chapter 6 discusses different factors determining the application of advance care planning and advance directives. By enabling patients to determine their medical treatments in advance and make their preferences known, advance care planning promotes respect for patients’ autonomy. For most patients, a discussion about advance directives, values, and wishes was documented in the medical records. Of those patients, almost two-thirds engaged in advance care planning. Knowing patients’ preferences in advance is needed to base end-of-life decisions on the patients’ values and wishes. Chapter 7 provides a general discussion of the findings derived from the journal articles. More precisely, the discussion coalesces the empirical findings and discusses their ethical significance. Afterwards, limitations and implications for further research are discussed.