The Patient Engagement Quality Guidance

A practical guide to planning, developing and assessing the quality of patient engagement activities and projects.

Download the medicines development version
Download the Medtech version

Co-developed

The tool was co-developed with a large community of stakeholders (more than 100 people from 51 organisations), representing patient associations, industry, academics, researchers and external experts.

Simple

Who can use the tool? Simple. All stakeholders working on patient engagement projects (for example, patient advocates, clinical investigators, researchers, or sponsors).

Suitable for all projects

You can use it for a patient engagement project that takes place at any point along the medicine and medical device development and can be applied to health and social research.

Seven Patient Engagement
Quality Criteria

The guidance introduces seven quality criteria to assess patient engagement practices. These have been consolidated from published PE frameworks and co-developed further by PFMD Contributors.

There are two versions or scenarios of the PE Quality Guidance Tool – scenario 1 will help you in planning a patient engagement project, and scenario 2 will help you assess your ongoing or completed project.

Download

What’s coming next

The Patient Engagement Quality Guidance has been integrated with Synapse – your digital tool for patient engagement. If you want to first learn more about this tool access the Patient Engagement Training in Practice.

Explore synapse

Who developed this tool

The “Patient Engagement Management Suite” is brought to you by the PFMD partnership.

Continuity and sustainability

This refers to the smooth progression of the project, as well as efforts to maintain an ongoing relationship with stakeholders. Consideration should be given for the role of stakeholders beyond a single project. When starting the project, consider including in your project plan the actions needed for maintaining the expected flow of the project from beginning to end.

Create a plan to nurture relationships with your partners and stakeholders involved during the project, and when needed and requested, beyond the project as well. For all stakeholders, successful planning and personal and organisational resilience should be anticipated.

Transparency in communication and documentation

This refers to the establishment of a communications plan and ongoing project documentation1 that can be shared with stakeholders. Communication among stakeholders must be open, honest and complete. In addition, adequate up-to-date documentation must facilitate communication with all stakeholders throughout the project.

Consider proactively and openly sharing progress updates throughout the project externally. In addition, communicating outcomes of the project to all stakeholders and how their contribution was of value to the success of the project is critical.

Capacity and capability for engagement

This refers to (1) capacity as having relevant and dedicated resources from all stakeholders (for example, providing a dedicated point of contact by the sponsor and having allocated sufficient time by all stakeholders to allow genuine engagement); and (2) capabilities for all stakeholders to enable meaningful engagement (for example, the level of knowledge, expertise and training stakeholders might need to deliver PE activities throughout the project).

Consider supporting stakeholders to build the required capacity and capabilities for this project in different forms of training both with sponsor organisations and with each stakeholder (for example, helping to understand the context, processes, relevant terminology etc.). Both capacity and capability building are intended to facilitate participation and lower barriers to collaborate. Stakeholders can be given access to learning resources and given dedicated support (if needed). Capability needs may vary depending on the project needs, but also e.g. personal circumstances of PE representatives.

Roles and responsibilities

This refers to the need for clearly agreed, and ideally co-created roles and responsibilities, in writing, addressing that all aspects of project needs will be established upfront and revisited regularly.

Representativeness of stakeholders

This refers to the mix of people you involve, which should reflect the needs of the project, and the interests of those who may benefit from project outputs (for example, target population). Consider diversity in expertise, experience, demographics, and other relevant criteria for inclusion.

When selecting PE stakeholders, patients, attention will be given to awareness of the diversity required to achieve visible representative voice.

Respect and accessibility

This refers to (1) respecting each other, and respectful interactions within the project to be established among partners, and (2) openness to and inclusion of individuals and communities (to the project) without discrimination. Considerations to ensure good conditions to implement the project should be made from the beginning.

For example:

  • simplification of wording
  • budget and payment considerations
  • cultural adaptations to procedures
  • practicalities such as meeting timing, location and format
  • accessibility of project materials
  • written co-developed rules of conduct

 

Accessibility to participate may be facilitated by enabling multiple ways to involve stakeholders who could benefit from and/ or contribute to the project. For example, patients with cognitive impairment might need more time to go through project material, or need printed versions rather than electronic documents or PDFs for easier reading.

Shared purpose

This refers to the project’s aims and outcomes that all stakeholders taking part should agree on before starting the project. Consider putting in place processes to help facilitate discussions between all stakeholders to identify each other’s values, expectations and objectives, and review and discuss priorities in the planning of the project.

It can be valuable to enable stakeholders to exchange views openly to understand the scope and objectives of the project, acknowledging that some of their objectives may differ. All parties concerned should also have a shared written description of the common goals of the project.