Dr Stuart Faulkner and Dr Teresa Finlay,  University of Oxford

The aim of the PARADIGM project is to enable structured, effective, meaningful, ethical, innovative, and sustainable patient engagement (PE) that demonstrates the ‘return on the engagement’ for all stakeholders. PARADIGM’s partners are convinced of the importance of PE and are committed to working to improve its impact, value and sustainability across medicines research and development (R&D). At this midway point, it is worth reflecting on other views pertaining to PE in order to keep sight of why we are committed to this project and how we can maintain an inclusive approach as the tools we are developing begin to take shape.

One such reminder that caught our attention is from well-known patient activist (PA), Jennifer Johannesen who levelled a powerful critique of institutionalised PE to the Cochrane Colloquium on December 2018. Johannesen differentiates between patient activists, those who drive change in health research and healthcare from their ‘grassroots’ and engaged patients who work with researchers and health service providers according to set agendas. Those agendas are largely informed by policy and she argues against institutionalised PE rather than that which originates from patients directly.

“I think that programmatic, institution-sponsored patient engagement needs to end – because it allows institutions to monopolise dialogue and constrain the topics that can be discussed. It should end because it turns patients into enthusiastic participants in institutional agendas that may work against their interests. It should end because when implemented mindlessly across the board it interferes with how research is conducted. It should end because there is plenty of literature to suggest it is not what it seems, that calls into question whether the patient engagement enterprise is actually serving patients.” (Johannesen 2018)

This could leave us between a rock and a hard place, or in danger of throwing the PE or the PA babies out with the proverbial bathwater. If we consider that PARADIGM is a large public-private partnership project with numerous stakeholders and agendas, partly funded by the European Commission, the argument that PE is being monopolised by institutions seems obvious. We are working on PE at three decision-making points in medicines R&D; again, her arguments that the topic for discussion is constrained by the project or that patient participants are being sucked in by an institutional agenda, could seem to stack up. Equally, patient activism is challenging in the context of a large, policy-driven, multi-stakeholder public-private partnership project.

Patient engagement, whatever the setting, whoever the stakeholders, is challenging. To undertake it meaningfully, effectively and sustainably is difficult and complex. Numerous factors need to be taken into account (including individual, professional and organisational cultures and processes, legal and compliance requirements, codes of conduct, ethical principles, human and financial resources); organisational contexts and processes all affect outcomes. So it is perhaps unsurprising that PE can be seen as becoming an institutional routine rather than serving patients by co-producing health research or service development in partnership with them and their representatives.

Johanneson suggests:

  1. i) PE is being sterilised and made formulaic as funders increasingly require that PE be designed, undertaken and reported on in research that is contingent on funding. She warns against undermining valid, reliable or rigorous research for the sake of demonstrating PE to funders.
  2. ii) PE can be selective, that is, we seek the patient input we want rather than welcoming diversity and broad representation.

iii) PE is being incorporated into a daily routine rather than shifting culture(s) and processes for meaningful, effective patient-centred engagement that is central to co-production of health services and research.

We in PARADIGM would propose that;

  1. i) Meaningful, ethical and sustainable PE in medicines R&D is PARADIGM’s central aim. Incorporating the needs, expectations and agendas of all stakeholders, to co-create outputs with patients (and other stakeholders) throughout ensures that our outputs will be useful and fit for purpose, and not simply a ‘tick box’ exercise.
  2. ii) PARADIGM’s research methods are robust, evidence-based and co-produced with all the project’s stakeholders including patients and their representatives from vulnerable groups including young people, people with dementia and their carers. This makes for lively debate as different views, agendas and contextual influences become evident but it also provides opportunities for listening, sharing and new understandings.

iii) Our public-private partnership and the multi-stakeholder design of PARADIGM ensures that the work we are doing to incorporate meaningful PE in medicines R&D is co-produced. All stakeholders make equal contributions to understanding what is required for meaningful PE and how to best to achieve that whatever their priorities. Our work includes co-producing evidence-based tools and frameworks which support the business case for PE thus addressing industry’s agenda as well as patients’. Our partners PFMD and EUPATI are providing platforms for PARADIGM’s legacy outputs to ensure that they are accessible, fit-for-purpose, and can evolve as required in the future.

As the second Patient Engagement Open Forum approaches on 18th and 19th September, we have the opportunity to consider our progress to date within the wider landscape of PE. Accordingly, we have written this blog post not because we wish to rebut Jennifer’s remarks or bask in what she describes as “righteousness” in relation to PARADIGM’s successes to date. Rather, we have done so to reflect on her assertions and be mindful that within the constraints of a large, organisationally-generated project such as PARADIGM, we need to keep listening, be reflexive, continually review how we work together and keep learning how to improve our PE practices so that collectively we can fulfil our promise to make effective PE in medicines R&D sustainable in future.

accessed 20/06/2019