ENTRUST-PE: An Integrated Framework for Trustworthy Pain Evidence. White Paper.

The personal, social and economic burden of chronic pain is enormous. Yet patients with chronic pain, clinicians and the public are often poorly served by an evidence architecture that contains multiple structural weaknesses which reduce confidence in treatment practice. Weaknesses include incomplete research governance, a lack of diversity and inclusivity, inadequate stakeholder engagement, poor methodological rigour and incomplete reporting, a lack of data accessibility and transparency, and a failure to communicate findings with appropriate balance. These issues span pre-clinical research, clinical trials, systematic reviews and impact on the development of clinical guidance and practice. Research misconduct and inauthentic data present a further critical risk. These problems are not unique to research in pain but, combined, they increase bias and uncertainty in research, waste resources, drive the provision of low-value care, increase research and healthcare costs and impede the discovery of potentially more effective interventions, all of which negatively impact people living with pain.This White Paper summarises the discussions and recommendations of the ENhancing TRUSTworthiness in Pain Evidence (ENTRUST-PE) network project, which received funding from the European Commission in 2023 (ERA-NET NEURON Consortium). An international and interdisciplinary group from the pain research community met on multiple occasions with the objective of developing a novel integrated framework for enhancing and facilitating the trustworthiness of evidence for pain. The resulting framework conceptualises trustworthy research as being underpinned by 7 core values: 1. Integrity and Governance, 2. Equity Diversity and Inclusivity, 3. Patient and Public Involvement and Engagement, 4. Methodological Rigour, 5. Openness and Transparency, 6. Balanced Communication, and 7. Data Authenticity. We propose that each of these core values should drive universal actions and behaviours in researchers and stakeholders across all roles and stages of the research process. In this paper we summarise the challenges addressed by each core value, make recommendations for each key stakeholder group in the research ecosystem in order to enhance the trustworthiness of pain research and present the case for systems-level change.