Background
The use of patient-reported outcome measures (PROMs), including their electronic versions (ePROMs), is increasing in clinical practice and their value for individual patient care and health service delivery is becoming more widely recognized. However, their routine use remains limited due to the lack of structured and standardized systems for collecting and integrating this information into clinical workflows. Developing a sustainable system for ePROM data collection, requires addressing a range of organizational, technical and cultural challenges. The Health Outcome Observatory project (H2O) project aims to standardise and facilitate the concurrent collection of ePROs and clinical outcomes in routine clinical practice. This paper presents the 10-steps ePROM implementation framework to guide ePROM implementation in real-world clinical settings, based on project insights. The framework is primarily designed for implementation within individual clinical practices and hospital systems, while offering adaptable elements that can inform broader, population-level strategies.
Methodology
An implementation taskforce was formed within H2O, involving academic researchers with expertise in PRO measurement, digital and data specialists, Health Care Professionals (HCP), and ePROMs implementation specialists across four countries (Austria, Germany, Netherlands and Spain) and, representing the project’s three disease areas - diabetes, inflammatory bowel disease (IBD) and cancer. Data were iteratively collected from country teams and analysed thematically to identify common challenges, solutions and implementation elements. Internal validation was conducted through member checking with country teams, feedback from Patient Advisory Board (PAB) and expert triangulation within the taskforce.
Results
Ten core steps for successful ePROM implementation in clinical practice were derived. In addition, disease-specific and/or site-specific considerations such as clinical population, technology use, Information Technology (IT) literacy, demographic factors and engagement of patient and providers proves important. A significant challenge identified was establishing the required technological infrastructure and data flow needed for implementation.
Conclusions:
The ten steps derived provide a scalable framework that supports the integration of ePROMs into routine practice and fostering improvements in patient care by including the patient voice in a structured and useable manner. Additionally, the detailed analysis of challenges and solutions for successful ePROM implementation, based on the H2O initiative, strengthens our contribution to this field.
Gemma Galan, Preston Long, Yolima Cossio-Gil, Francesco Patalano, Kathryn Hamilton, Anouk S. Huberts, Anouk Neureiter di Torrero, Lisa R. Otto, Alizé A. Rogge, Liselotte Fierens, Rahim Lalji, Belle H. de Rooij, Ann-Kristin Porth, Carolina E. Watson, Alexandra Kautzky-Willer, Nadia C. W. Kamminga & Tanja Stamm
Disease Category:
Disease Name: N/A
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS methods research
- Advisory Groups
- Other
- Questionnaires were used to collect data from H2O country teams. Data were collected on current clinical practice and patient populations, local plans, and status of H2O data collection, lessons learned from PROM implementation, and unique implementation considerations for each country and disease area.
- Results from questionnaires were synthesised and used to inform preliminary model development by the H2O Core Group, achieved through use of thematic analysis. Internal validation of the model was undertaken to ensure diverse perspectives were incorporated, and included verification with country teams, involvement of a patient advisory board and feedback received from the Validation Group. After achieving agreement at this level, the ten steps were elaborated upon by selected experts within the H2O consortium. For each step, the Core Group nominated two consortium members with relevant expertise: one expert was responsible for drafting a detailed description of the step, while the other reviewed and provided feedback on the draft.