Objective: Healthcare decision-makers recognise the value of Patient Experience Data (PED) (such as Patient Reported Outcomes, Patient Preferences), but challenges impede its implementation in practice. This qualitative study aims to identify stakeholders’ insights on these challenges and policy ways forward.
Methods: Semi-structured interviews (n=38) were conducted with stakeholders from healthcare industry, academia, non-profit organisations, regulatory authorities, Health Technology Assessment (HTA) bodies, and patient organisations. Interview transcripts were analysed thematically using the framework method.
Results: Several barriers impeding the integration of PED in healthcare decision-making and policy ways forward were identified. A first hurdle highlighted by all stakeholders was the absence of clear European policy frameworks and guidance concerning the collection and utilisation of PED in healthcare decision-making, particularly concerning the design and implementation of patient preference studies. Stakeholders and especially industry stakeholders stressed the need for standardised requirements and quality criteria to govern PED collection and evaluation. Secondly, transparency and understanding of how PED is assessed and utilised within clinical trials, regulatory, HTA, and payer decision-making processes was found to be missing. Stakeholders called for increased transparency through the implementation of standardised assessment guidelines and publicly available assessment criteria to enhance clarity and consistency. Thirdly, there was a perceived lack of validated methodologies and tools for collecting high-quality PED, such as robust Patient-Reported Outcome Measures (PROMs) and fit-for-purpose patient preference studies. Stakeholders and particularly the regulatory stakeholder group advocated for more research to establish validated PED collection and analysis methods to ensure reliability and relevance. Lastly, diverging opinions emerged among stakeholders concerning who should initiate particular actions. While industry stakeholders advocated for regulatory guidelines to facilitate systematic PED implementation, regulators preferred gaining more practical experience before drafting such guidelines. To reconcile these differences, stakeholders unanimously emphasised the importance of fostering collaboration and open dialogue among all stakeholders. Developing a comprehensive policy strategy that clearly delineates expectations and responsibilities for each stakeholder group was seen as an important way forward.
Conclusion: This study revealed the critical policy barriers that challenge the effective and systematic implementation of PED in healthcare decision-making and identified practical ways forward. While stakeholders shared certain priorities such as the need for transparency and concrete guidance, their opinions differed regarding others. The diversity of perspectives among stakeholders underscored the complexity of these challenges and the need for multi-stakeholder dialogue. Suggested policy actions encompass the development of clear policy frameworks, the establishment of validated and standardised methodologies and tools, an increased emphasis on transparency, and fostering collaborative policy strategies outlining expectations and responsibilities. Fostering critical and constructive reflections on the proposed policy ways forward identified in this study will be important to address current challenges that hamper the systematic implementation of PED, thereby paving the way for the collective goal of improving patient-centred healthcare decision-making that truly meets patients’ needs and preferences.

**Objective**: Healthcare decision-makers recognise the value of Patient Experience Data (PED) (such as Patient Reported Outcomes, Patient Preferences), but challenges impede its implementation in practice. This qualitative study aims to identify stakeholders’ insights on these challenges and policy ways forward.
**Methods**: Semi-structured interviews (n=38) were conducted with stakeholders from healthcare industry, academia, non-profit organisations, regulatory authorities, Health Technology Assessment (HTA) bodies, and patient organisations. Interview transcripts were analysed thematically using the framework method.
**Results**: Several barriers impeding the integration of PED in healthcare decision-making and policy ways forward were identified. A first hurdle highlighted by all stakeholders was the absence of clear European policy frameworks and guidance concerning the collection and utilisation of PED in healthcare decision-making, particularly concerning the design and implementation of patient preference studies. Stakeholders and especially industry stakeholders stressed the need for standardised requirements and quality criteria to govern PED collection and evaluation. Secondly, transparency and understanding of how PED is assessed and utilised within clinical trials, regulatory, HTA, and payer decision-making processes was** **found to be missing. Stakeholders called for increased transparency through the implementation of standardised assessment guidelines and publicly available assessment criteria to enhance clarity and consistency. Thirdly, there was a perceived lack of validated methodologies and tools for collecting high-quality PED, such as robust Patient-Reported Outcome Measures (PROMs) and fit-for-purpose patient preference studies. Stakeholders and particularly the regulatory stakeholder group advocated for more research to establish validated PED collection and analysis methods to ensure reliability and relevance. Lastly, diverging opinions emerged among stakeholders concerning who should initiate particular actions. While industry stakeholders advocated for regulatory guidelines to facilitate systematic PED implementation, regulators preferred gaining more practical experience before drafting such guidelines. To reconcile these differences, stakeholders unanimously emphasised the importance of fostering collaboration and open dialogue among all stakeholders. Developing a comprehensive policy strategy that clearly delineates expectations and responsibilities for each stakeholder group was seen as an important way forward.
**Conclusion**: This study revealed the critical policy barriers that challenge the effective and systematic implementation of PED in healthcare decision-making and identified practical ways forward. While stakeholders shared certain priorities such as the need for transparency and concrete guidance, their opinions differed regarding others. The diversity of perspectives among stakeholders underscored the complexity of these challenges and the need for multi-stakeholder dialogue. Suggested policy actions encompass the development of clear policy frameworks, the establishment of validated and standardised methodologies and tools, an increased emphasis on transparency, and fostering collaborative policy strategies outlining expectations and responsibilities. Fostering critical and constructive reflections on the proposed policy ways forward identified in this study will be important to address current challenges that hamper the systematic implementation of PED, thereby paving the way for the collective goal of improving patient-centred healthcare decision-making that truly meets patients’ needs and preferences.

Advancing Patient Experience Data in Healthcare Decision-Making: Multi-stakeholders’ insights on policy ways forward

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