OBJECTIVES: A systematic and practical guidance for patient engagement (PE) in medicines development has been identified as a priority by stakeholders. We co-created PE quality guidance (PEQG) incorporating quality criteria (PEQC) and implementation tools.

METHODS: Multi-stakeholder working groups (WGs) and task forces (TFs) were established for guidance co-creation. Published literature and existing frameworks were reviewed (2011-2016). SYNaPse (PE mapping and networking platform) was used to identify unpublished PE initiatives; initiative owners were invited to WGs/TFs. A preliminary PEQG tool (incorporating PEQC and standardised templates to allow systematic information capture for planned or ongoing/completed PE projects) was developed by TFs through an iterative process, using PE experience of participants and published material.

RESULTS: Seven WG/TF meetings were held (Nov 2016-June 2017) involving 76 participants, representing 51 organisations (including patient charities, academic researchers, funders, pharmaceutical companies). The PEQG tool was developed using published frameworks (n=6) and relevant publications (n=25) and incorporates 7 PEQC covering: [1] shared purpose; [2] respect/accessibility; [3] representativeness; [4] roles/responsibilities; [5] capacity/capability; [6] transparency; [7] continuity/sustainability. PEQG and templates were tested across WG organisations (Sept-Dec 2017), refined and released for public consultation (Dec 2017; 67 responses), and further refined and released (May 2018). We will present the PEQG tool and PEQC, public consultation results and good practice examples demonstrating each PEQC, and results from ongoing PEQG pilots.

CONCLUSIONS: The co-created PEQG tool can be used by multiple stakeholder groups and provides a practical guide to improve the quality of PE during planning and development of new projects or assess the quality and impact of ongoing/completed projects. The good practice examples provided will support PEQG implementation. We urge use of, and feedback on, the PEQG by diverse stakeholders to drive improvements in PE and allow continuous refinement of the tool.