Objectives: 
Patient engagement (PE) in medicines R&D needs a cultural change supported by measures that can demonstrate the ‘return on engagement’ of patients; we reviewed the literature on the evaluation of PE to inform a draft framework for evaluating patient engagement at 3 points in medicines development.
Methods: 
We did a literature review, using search terms including ‘Patient, Public, Engagement, Involvement, Framework, Impact, Indicator, Measure, Outcome’. Data describing outcomes and impacts of patient engagement and any monitoring or evaluation criteria were extracted and thematically analysed.
Results: 
1305 records were retrieved; from these 91 publications were included for data extraction after exclusion of duplicates and screening for relevance by two researchers. A few documents describe metrics in terms of numerical output but most used qualitative methods to evaluate PE practices and describe outcomes in subjective terms. Some publications use mixed methods.
The literature demonstrates valuable insights into PE processes outcomes and impacts, but few describe the relationship between input, output, outcomes and impact.  Most studies focus on the benefits of PE on research; the value across all stakeholder groups is missing. In addition, limited attention is given to the context and mechanisms that influence outcomes and impact. 
We present a summary of the benefits, costs and challenges and some indicators for measurement extracted from the literature we reviewed.
Conclusion: 
To embed PE in the development of medicines at the key decision making points of priority setting, clinical trial design and HTA approval, better measurement and articulation of the benefits to the output of the research and development process are needed.  
This study has mapped the outcomes and impact of PE in medicines development. On the basis of this review PARADIGM is developing and testing an evaluation framework that describes the relationship between input, outcomes, impact and value in relation to the context and mechanisms of PE for all stakeholders in medicines development.

Monitoring and Evaluating Patient Engagement in Medicines Development:  How literature informed a draft evaluation framework.

DIA Europe 2019

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.