Background Learning health care systems (LHSs) have the potential to transform health care. However, this transformation process faces significant challenges. Materials and methods Based on proposals and early examples of LHSs in the literature and conceptual analysis of the LHS mission, we provide four models with distinct organizational and ethical implications that may facilitate the transformation. Results An LHS could be developed in the following ways: by taking away practical impediments that prevent patients and professionals from engaging in scientific research (model 1: optimization LHS); by routinely analyzing observational data from electronic health records and other sources (model 2: comprehensive data LHS); by making clinical decisions based on the outcomes of the aforementioned data analyses and directly evaluating the outcomes in order to continuously improve decision‐making (model 3: real‐time LHS); or by embedding clinical trials into routine care delivery (model 4: full LHS). Conclusions Each model has different ethical implications for consent and oversight. Also, the four‐model approach shows that reorganizing a health care center into an LHS is not an all‐or‐nothing decision. Rather, it is a choice from a menu of possibilities. Instead of discussing the advantages and disadvantages of the LHS menu in its entirety, the medical community should focus on the designs and ethical aspects of each of the separate options.
As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change.
Background: Treatment choices for individual patients with an inborn bleeding disorder are increasingly challenging due to increasing options and rising costs for society.We have initiated an integrated interdisciplinary national research program. Objectives:The SYMPHONY consortium strives to orchestrate personalized treatment in patients with an inborn bleeding disorder, by unraveling the mechanisms behind interindividual variations of bleeding phenotype.
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