One of the essential outputs from PARADIGM will be a set of recommended core capabilities that should underpin patient engagement in the defined priority areas within the medicines lifecycle.  These capabilities are composites of individual attributes; this includes knowledge, skills and attitudinal aspects of patient engagement that are context-bound. Additionally, organisational capabilities need to be considered such as processes, tools and systems.

Fundamental to this objective was the work towards the creation, during 2018, of a theoretical framework which would incorporate the definition of capabilities and alignment, where appropriate, with the PFMD patient engagement quality guidance. In the interest of ensuring dissemination of the competencies, an authoring group was formed and topics were defined; early this year, this group made recommendations on capabilities for patient engagement. 

In support of the creation of tools and templates, a mapping exercise also identified initiatives on patient engagement that may contain valuable material.   Elements such as guidelines, templates, forms, and proposals were assessed from 242 initiatives, with 77 initiatives selected for further analysis.

Looking ahead to 2019, the recommendations on core capabilities will be codified and then undergo a series of reviews. Workshops and other validation methods will be employed to gain insights from stakeholders.  The PARADIGM International Liaison Group, comprised of respected professionals who represent a varied group of patient engagement initiatives, will also contribute.

During the course of this year, a gap analysis will be conducted upon review of existing guidances and tools. This will provide substrate to update relevant aspects of existing guidances and/or to create new content for missing elements.

Within the project, tasks are distributed across a series of work groups in order to allow for reasonable workloads.  Therefore, it is essential to engage the consortium members and link and leverage the myriad efforts across the various workgroups.  This is imperative for the creation of robust recommendations for core capabilities.