Frameworks of Health Outcomes for Performance Specifications in Laboratory Medicine

BACKGROUND: Clinical laboratory measurements provide essential results for prediction, screening, diagnosing, treating, monitoring, and prognosis of patients. To ensure patient safety, laboratory professionals must define appropriate analytical requirements for each measurand, including measurement uncertainty, selectivity, traceability, and robustness. Performance specifications should ensure that laboratory measurement results provide valuable information to support medical decisions, which then lead to improved patient outcomes. CONTENT: To facilitate discussions and studies of performance specifications based on outcomes, here we review generic frameworks for health outcomes in healthcare evaluations. Seven frameworks are presented in chronological order, starting from the World Health Organization definition of health. Most frameworks distinguish between physical, mental, and social health and emphasize functional health: a person's ability to conduct the physical, mental, and social activities that are necessary or meaningful in daily life, given their health conditions and context. We then explore the links between laboratory testing and these health outcomes. These are indirect: in most cases testing affects health outcomes through downstream clinical actions, guided by test results. SUMMARY: Most frameworks of outcomes in healthcare evaluations distinguish between physical, mental, and social health. Because of the indirect link between testing and outcomes, developing recommendations based on effects on outcomes is challenging. Nevertheless, explicitly specifying the respective pathways from testing to potential health outcomes through downstream actions will provide the necessary context for such discussions.