Willgoss Tom, Escontrias Omar A, Scrafton Carole, Oehrlein Elisabeth, Livingstone Victoria, Chaplin Fiona C, Benivento Maddalena, Chapman Hayley, Brooke Nicholas
Patient Centered Outcomes Research, Roche, Hexagon Place, Falcon Way, Welwyn Garden City, UK.
Escontrías, National Health Council, 1730 M St. NW, Suite 650, Washington, DC, 20036, USA.
Res Involv Engagem. 2023 Oct 12;9(1):92. doi: 10.1186/s40900-023-00503-9.
Putting patients' needs and priorities at the forefront of healthcare initiatives and medical product development is critical to achieve outcomes that matter most to patients. This relies on the integration of early, meaningful patient engagement (PE) to learn what is important to patients, and collection of representative patient experience data (PXD). The increased number of PE/PXD efforts across global regulatory, health technology assessment, and healthcare systems is an important step forward to deliver improved health outcomes for patients. However, these initiatives are fragmented and lack integration, which is necessary to maximize efforts and reduce burden on patients. To overcome these challenges, the Global Patient Experience Data Navigator has been co-created by Patient Focused Medicines Development to provide practical resources that can facilitate and optimize PXD generation, collection, analysis, and dissemination for patient benefit and aims to be applicable across all therapeutic areas for all stakeholders.
Co-creation of the Navigator took place through an iterative process of validation and formalization driven by a diverse, multi-stakeholder working group with individuals who have varying knowledge/experience in PE/PXD.
A series of workshops took place to conduct a gap analysis, develop a taxonomy model, and integrate existing frameworks. The collective insights led to the development of the Navigator consisting of four specific tools in the form of downloadable templates, which can be used to: (1) prioritize outcomes that matter most to patients and their caregivers; (2) select appropriate measurement methods for these outcomes; (3) identify when and why PXD is used throughout the product development cycle for each stakeholder; (4) identify when and why PXD is used throughout the healthcare process for each stakeholder. A public consultation was carried out to collect user feedback before the Navigator was made publicly available in December 2022.
To our knowledge, the Global Patient Experience Data Navigator is the only publicly available toolkit developed with a multi-stakeholder and disease-agnostic approach providing taxonomically grouped resources to optimize the collection and collation of PXD for patient benefit. Future work will aim to further engage patients by adding a PE dimension to the Navigator.
将患者需求和优先事项置于医疗保健举措及医疗产品开发的前沿，对于实现对患者最为重要的结果至关重要。这依赖于早期、有意义的患者参与（PE）的整合，以了解对患者重要的事项，并收集具有代表性的患者体验数据（PXD）。全球监管、卫生技术评估和医疗保健系统中患者参与/患者体验数据工作的增加，是朝着为患者提供改善的健康结果迈出的重要一步。然而，这些举措分散且缺乏整合，而整合对于最大限度地发挥作用和减轻患者负担是必要的。为克服这些挑战，患者聚焦药物研发共同创建了全球患者体验数据导航器，以提供实用资源，促进和优化患者体验数据的生成、收集、分析和传播，以造福患者，并旨在适用于所有治疗领域的所有利益相关者。
导航器的共同创建通过一个由多元化、多利益相关者工作组驱动的迭代验证和形式化过程进行，该工作组的成员在患者参与/患者体验数据方面具有不同的知识/经验。
举办了一系列研讨会，进行差距分析、开发分类模型并整合现有框架。这些集体见解促成了导航器的开发，导航器由四个特定工具组成，形式为可下载模板，可用于：（1）确定对患者及其护理人员最重要的结果的优先级；（2）为这些结果选择合适的测量方法；（3）确定每个利益相关者在整个产品开发周期中何时以及为何使用患者体验数据；（4）确定每个利益相关者在整个医疗过程中何时以及为何使用患者体验数据。在2022年12月导航器公开可用之前，进行了一次公众咨询以收集用户反馈。
据我们所知，全球患者体验数据导航器是唯一一个采用多利益相关者和疾病无关方法开发的公开可用工具包，提供分类分组资源以优化患者体验数据的收集和整理，造福患者。未来的工作将旨在通过在导航器中增加患者参与维度来进一步让患者参与进来。
