Determining the ‘value’ of patient engagement

“What is in it for me?” A question often asked by people involved in patient engagement practices. Evaluating whether engagement adds value for different stakeholder groups can be an effective tool to further support patient engagement. The PARADIGM project is a European public-private partnership that is developing ways to ensure that patients are meaningfully involved in medicines development. One of the aims of the project is to develop metrics to measure the “return on engagement”. To contribute to this system innovation, the PARADIGM workstream co-led by MSD and the Athena Institute (VU Amsterdam) aims to enrich good quality engagement practices with process indicators that can be used to monitor and evaluate whether the ongoing process of developing a new medicine leads to valuable outcomes for all stakeholders involved. This includes patient representatives or patient partners, Health Technology Assessment (HTA) organisations and industry. It will deliver a coherent and flexible framework that can be used as a toolbox. This implies that the framework can be used by participants in a wide variety of engagement practices, like patient engagement in protocol development, in agenda setting or in approval or reimbursement procedures of new medicines. At the end of the 30-month project, the monitoring and evaluation framework can be used as a toolbox to open the floor for full dialogue, containing helpful evaluation tools for everyone involved. This undertaking has not been done before and addresses the need for a consensus-based monitoring and evaluation framework. Current scientific and non-scientific literature suggests several indicators to measure the value of patient engagement, but these are scattered over decision points and do not always link up to clear outcomes. Furthermore, less is published on methods to actually measure the value of patient engagement, and validated tools for evaluating impact are not available. The explicit goal of our work is to create this framework in a co-construction process with all relevant stakeholders, where PARADIGM partners and others are invited to discuss whether the most relevant endpoints are included and how the framework can be as practical as possible. We are applying the Reflexive Monitoring in Action (RMA) approach, an integrated methodology to encourage learning within multi-actor groups or networks as well as institutional change, in order to not only build a framework but work on successful implementation by co-developing it with the future end-users. In the first six months of PARADIGM, we worked on a literature review to gain insights on existing tools, indicators and the like, leading to a preliminary framework that conceptualizes the (observable) outcomes and impact for medicines development across the lifecycle. Furthermore, we explored what constitutes value of patient engagement for all parties involved, and how this can be measured; what are appropriate and feasible indicators, what is the return on engagement? In parallel, we started to collect examples of patient engagement practices from within and outside the PARADIGM consortium. We concluded these efforts by organising a workshop, kindly hosted by the Association of the British Pharmaceutical Industry (ABPI) in London, where participants provided valuable input on how to best present and categorise the results of the literature review and how we should approach which examples of existing patient engagement practices. We are now embarking on, first, the retrospective analysis of examples of patient engagement practices based on the preliminary framework together with the respective partners. We will apply, test and refine the framework by evaluating the examples. Second, we will apply the improved framework to prospective cases and use it to help the stakeholders enhance the value and impact of the engagement. This will lead us to produce two distinct, but interrelated products for all parties: 1) a tailor-made advice on how valuable impact can be reached in their own context 2) an accompanying evaluation framework that can be used by everyone who wants to enrich good quality engagement practices and improve the value and impact for all involved. We strongly believe that the co-creation of this actionable framework will greatly support the cultural shift that is needed to move the needle towards greater patient engagement in medicines R&D