Dr Stuart Faulkner, Oxford University, reports on the first joint workshop of PARADIGM Work Packages 1 & 2
On Oct 11th 2018, at UCB headquarters in Anderlecht, Brussels, PARADIGM WP1 and WP2 held their first joint workshop, ‘Translating Inputs into outputs’. This marked a pivotal point in the development timelines of both work packages that facilitated detailed sharing of progress, alignment of key joint timelines and process, and discussion of how we can continue to develop together, for the greater good of the consortium.
It was attended by 25 people from WP1 and WP2 with key multi-stakeholder representation from other WPs and included representatives from the European Patients’ Forum (EPF), European Organisation for Rare Diseases Association (EURORDIS), Alzheimer Europe (AE), Fundació Sant Joan de Déu Research Foundation (FSJD), European Aids Treatment Group (EATG), and Health Technology Assessment (HTA) bodies.
The morning session focused on WP1 – Assessment of needs, preferences and expectations for PE. It shed light on the outputs of the impressive WP1 survey and the key learnings from the focus groups undertaken with young people (FSJD) and elderly (AE) and the upcoming HTA meeting.
It emerged that there remain large gaps in current impressions vs expectations of PE at specific decision-making points. Patient groups most commonly reported being prepared for PE but needing extra help. Continued challenges for effective PE related to delays in PE activities due to bureaucratic processes, a lack of openness, and poor communication between stakeholders. Involvement of patients in decision making was still not universal and the process can be very complex; it is not only to what extent patients are engaged in decision making, but also the indirect influence they have on decision making.
One of the most discussed mechanisms to improve systematic patient engagement was ‘Metrics to measure outcomes and impact’. However, this is challenging, in particular to HTA bodies as they have few or no standardised methods to measure PE outcomes or success.
The complementary feedback from the focus groups raised additional important considerations for the development of consortium outputs. For example, young people’s experience is not the same as their parents’. Similarly, dementia patients’ voices must be involved directly. Language, timing and accessibility of the PE activity for these populations needs careful consideration, along with a single point of contact within the organisation undertaking PE. Discussion centred on ensuring the right balance of training vs practicalities of time and resource commitment – this should be matched with timely feedback to patients as to the ‘fruits of their labour’.
The morning session concluded with an energetic breakout session where participants critically assessed the three draft Delphi questionnaires which will be used to create the final WP1 output – the consensus-based minimum criteria for effective PE.
With energy levels topped up (and with a large dose of caffeine), the afternoon session took stock of the morning’s discussions and focused on WP2, Assessing existing practices and processes. It reviewed the database of existing practices and process. In the continued ethos of PARADIGM we are building upon databases, knowledge and tools that already exist in initiatives such as the European Patients Academy (EUPATI) and Patient Focused Medicines Development (PFMD).
Work package 2 called on other consortium and PARADIGM International Liaison Group (PILG) members to assist in identifying further examples of practices and processes in areas where there are few – such as early dialogues, young people, older people and their carers, and those in countries outside of central Europe.
An open and organic afternoon session considered feedback from all participants on the first iteration of the tool to measure GAPs in PE – what some of the GAPs in PE are and how we might measure them.
The workshop was timely and enlightening and provided both WPs with a transparent and constructive environment to gather feedback from all stakeholders on how each deliverable can be refined and improved.
November WP1 begins the three rounds of the Delphi process covering the three decision-making points (research priority setting, early dialogues with HTA and regulators, and clinical trial design). Work package 2 is now expanding the database of existing practices and processes and developing further iterations of the tool – with input and learnings from other initiatives and other work packages – in preparation for a busy analysis phase early in 2019.
So much can be achieved through bringing such a varied and knowledgeable group of people together – there are always (pleasant) surprises, fascinating insights, and friendships developed – all for the greater good of progressing PE for everyone, by everyone.