Patients Active in Research and Dialogues for an Improved Generation
WP1 – Defining stakeholders’ preferences, needs and expectations
This report describes the work that was done as part of PARADIGM’s work package 1 (WP1), which aimed to identify and define stakeholders’ preferences, needs and expectations in patient engagement (PE) through an online survey and focus group consultations that were conducted in 2018. The objectives of this work were two-fold: firstly to prioritise those needs and expectations identified, and secondly, with the help of topic experts, turn those prioritised needs into a set of criteria for a good PE activity.
The Delphi methodology was used as the main tool to reach these objectives. Three expert panel groups were formed to match the three decision-making points Paradigm project focuses on [setting research priorities (SRP), the design of clinical trials (DCT) and early dialogues with Health Technology Assessment (HTA) bodies and regulators (ED)]. Each expert group went through two online survey rounds, and a subsequent meeting in Brussels where experts (who completed both online rounds) discussed to reach consensus on the final criteria to assess PE practices. The format, procedure and methodology of all three meetings were identical. Each group produced a set of weighted criteria and categories for their dedicated decisionmaking point. The weights allocated represent the relative importance of the criteria in the set to assess PE practices.
The outcomes of the three Delphi groups showed some similarities. Some convergence can be seen at the level of themes as aims and objectives, and selecting the right target population to engage with scored as top criteria, and sustainability which scored the lowest in two Delphi groups (SRP and DCT), while the third Delphi group (ED) dropped sustainability in its final meeting. Some criteria were debated more than others due to differences in interpretations of the terminology. Additionally, some bias in interpretation could have also come due to the EU and US perspective. These results will be used in other PARADIGM work packages (i.e. WP2) in order to co-create questions for the gap analysis tool. In addition, the authors propose a way the results of the Delphi could be operationalized as a tool to assess PE practices in each of the three specific decision-making points to determine whether they meet the expectations for a good PE practice.