The integration of patient-reported outcomes (PROs) into healthcare systems is shaping the future of clinical decision-making and research. The Patient-Centred Outcomes Research Project in the Medical Informatics Initiative (PCOR-MII) in Germany is focused on embedding patient perspectives into national medical data infrastructures. By leveraging an established digital framework, the initiative aims to improve diagnostics, treatment monitoring and health outcome assessments. A recent article published in the Journal of Healthcare Informatics Research explores the structured approach of PCOR-MII, its integration into national data-sharing networks and its application in three key medical areas: anorexia nervosa, persistent somatic symptoms and kidney transplantation.
Structuring Patient-Centred Outcomes in Healthcare
PCOR-MII employs a construct-oriented methodology to integrate PROs into electronic health records (EHRs) while addressing interoperability challenges. A key feature of this approach is the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR)-based National Core Dataset, which enables PRO data to be recorded and used effectively across multiple healthcare settings. This structure ensures that patient-reported data is standardised, comparable and applicable to both clinical and research needs. The initiative also focuses on real-time data accessibility, enhancing the ability to predict risks, monitor treatment adherence and assess long-term outcomes.
By incorporating PROs in a systematic manner, PCOR-MII aims to improve both clinical decision-making and patient engagement. Patients benefit from self-monitoring tools, allowing them to track their health status and communicate their experiences more effectively. Clinicians, in turn, can access patient-reported data to support personalised treatment plans. Furthermore, the integration of PROs into national healthcare databases facilitates evidence-based policymaking by providing a structured source of patient-centred data.
Integration into the National Medical Informatics Initiative
PCOR-MII is embedded within Germany’s Medical Informatics Initiative (MII), a national platform that includes all 35 academic medical centres and affiliated hospitals. Within this system, Data Integration Centres (DICs) serve as hubs for combining clinical and patient-reported data. These centres ensure that PROs are collected, processed and accessible for use in individual patient management and large-scale research studies.
To improve interoperability, PCOR-MII incorporates a PROM (Patient-Reported Outcome Measure) module within the MII framework. This module supports the integration of patient data from clinical trials, electronic records and mobile health applications. A federated data-sharing model allows healthcare institutions to securely exchange PRO data while maintaining compliance with data protection standards.
PCOR-MII also prioritises user-friendly digital solutions, such as mobile apps and web platforms, which facilitate PRO collection. Patients can track their health status, report symptoms and communicate with healthcare professionals while researchers gain access to structured datasets for longitudinal studies. These tools contribute to a more streamlined and patient-centred digital healthcare system.
Clinical Applications
PCOR-MII applies its structured approach across three distinct patient groups, each illustrating different ways in which PROs can be used.
1. Anorexia Nervosa: Risk Prediction
This application explores how patient-reported psychological and physiological data can help predict disease relapse. As anorexia nervosa has one of the highest mortality rates among psychiatric disorders, identifying early risk factors is critical. PCOR-MII enables continuous health monitoring using digital tools, allowing clinicians to track changes in weight, emotional well-being and behavioural patterns over time. By collecting PROs at different stages of treatment, the initiative aims to refine personalised intervention strategies to help prevent relapse.
2. Persistent Somatic Symptoms: Outcome Assessment
Persistent somatic symptoms (PSS), including chronic pain, fatigue and other recurring physical symptoms, can present challenges in diagnosis and treatment. These conditions often involve subjective symptoms that are difficult to assess using standard medical tests. PCOR-MII’s structured PRO collection provides a long-term view of symptom progression, helping to establish more accurate diagnoses and guide treatment adjustments. By integrating patient-reported data into clinical workflows, the initiative supports long-term outcome tracking and informed decision-making.
3. Kidney Transplantation: Monitoring Adherence and Health Status
Post-transplant care depends on adherence to treatment plans and early detection of potential complications. PCOR-MII introduces a patient-centred monitoring system to track medication adherence, mental well-being and overall health status. Through digital health tools, transplant recipients can regularly submit self-reported health data, allowing clinicians to detect potential issues such as signs of organ rejection or medication side effects. This process supports timely interventions and improved long-term transplant outcomes.
PCOR-MII represents a structured approach to patient-centred healthcare, integrating PROs into national medical infrastructures. By harmonising PRO data with clinical records, the initiative supports risk prediction, treatment monitoring and patient engagement. The structured implementation across multiple disease areas demonstrates its potential for broader healthcare applications. As the initiative continues to evolve, it may serve as a model for incorporating patient perspectives into digital health ecosystems, contributing to more comprehensive and responsive medical care.
Source: Journal of Healthcare Informatics Research
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