LAGOS: learning health systems and how they can integrate with patient care.

PROBLEM: Learning health systems (LHS) are an underexplored concept. How LHS will operate in clinical practice is not well understood. This paper investigates the relationships between LHS, clinical care process specifications (CCPS) and the established levels of medical practice to enable LHS integration into daily healthcare practice. METHODS: Concept analysis and thematic analysis were used to develop an LHS characterisation. Pathway theory was used to create a framework by relating LHS, CCPS, health information systems and the levels of medical practice. A case study approach evaluates the framework in an established health informatics project. RESULTS: Five concepts were identified and used to define the LHS learning cycle. A framework was developed with five pathways, each having three levels of practice specificity spanning population to precision medicine. The framework was evaluated through application to case studies not previously understood to be LHS. DISCUSSION: Clinicians show limited understanding of LHS, increasing resistance and limiting adoption and integration into care routine. Evaluation of the presented framework demonstrates that its use enables: (1) correct analysis and characterisation of LHS; (2) alignment and integration into the healthcare conceptual setting; (3) identification of the degree and level of patient application; and (4) impact on the overall healthcare system. CONCLUSION: This paper contributes a theoretical framework for analysis, characterisation and use of LHS. The framework allows clinicians and informaticians to correctly identify, characterise and integrate LHS within their daily routine. The overall contribution improves understanding, practice and evaluation of the LHS application in healthcare