Patient and Stakeholder Engagement (PSE)
Would you like to actively involve patients and probands as partners in your NCRC study or clinical research project? If so, you will find detailed information and possible approaches on the following page.
For further information please contact:
Dr. Juliet Roudini
Research Fellow – Patient & Stakeholder Engagement
Dr. Claudia Blum
Public Relations | Quality Management
Understanding Patient and Stakeholder Engagement (PSE)
PSE is a collaborative and inclusive approach that brings together researchers, patient organizations, and individuals affected by medical conditions to jointly plan, design, conduct, evaluate, and communicate research. A consortium of multiple stakeholders defined PSE as follows:
“The active, meaningful, and collaborative interaction between patients and researchers across all stages of the research process, where research decision-making is guided by patients’ contributions as partners, recognizing their specific experiences, values, and expertise” (Harrington et al., 2020).
PSE has the potential to improve the quality and relevance of studies for patients, which can foster a successful translation into practice. Early patient engagement leads to more impactful outcomes and patient-oriented studies.
PSE is a development process. The step-by-step model (Wright et al, 2015) shows that there are different levels of participation depending on the requirements of the project and the target group. The aim is to reach the highest possible level of participation. In many cases, however, only preliminary stages of participation can (initially) be realized.
The journey toward PSE need not immediately aim for the highest level; rather, it begins with smaller projects. This incremental approach allows familiarity and step-by-step acclimatization to PSE principles.
Figure1: Stages of participation according to Wright et al. (2015, S. 142) https://www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0033-1347268.pdf
Increasingly, the patient is considered crucial for successful initiatives within healthcare institutions, as there is a growing expectation for patients and the public to be engaged in various research aspects (Hoddinott et al., 2018; Jørgensen et al., 2020; NIHR INVOLVE, 2018). Active patient engagement in trials and studies not only enhances their effectiveness but also ensures meaningful benefits for the engaged communities (Fergusson et al., 2018): This approach provides multiple benefits, including improved relevance, study design, recruitment, dissemination, transparency, acceptance and translation, along with empowering patients. By involving patients and stakeholders, researchers can expect more impactful and relevant outcomes, novel perspectives from the patient's point of view, new research ideas, and an expanded professional network. Engaging patients also enhances motivation, communication strategies, public support for research, and the potential for stronger funding applications (Coulter & Ellins, 2007; Forsythe et al., 2019; Oliver et al., 2014; Staniszewska et al., 2017).
- Phases of a clinical research project
Figure 2: Phases of a clinical research project
- Examples and methods for patient engagement
When submitting a research proposal, particularly one that seeks to engage or involve patients, several factors and questions should be taken into account to ensure meaningful and effective participation. Below are some considerations and potential questions related to engaging or involving patients in a research proposal:
What specific roles will patients play in the research? What are the goals of patient engagement in this study?What methods will be used to engage with patients?
How often will interactions with patients occur, and in what format?
Before finalizing your research proposal, consult the specific guidelines and criteria of the funding body to ensure that you address their requirements for patient engagement comprehensively. Given the specific nature of each grant and funding organization, always tailor your proposal to match their expectations and guidelines.
DFG Proposal Preparation Instructions: https://www.dfg.de/formulare/17_03/17_03_en.pdf Förderbekanntmachung Versorgungsforschung: https://innovationsfonds.g-ba.de/foerderbekanntmachungen/foerderbekanntmachung-versorgungsforschung-zum-themenspezifischen-bereich.45
- Payments for Time: Compensation for patients' contributions (hourly/daily rates).
- Travel and Subsistence: Cover transport, meals, and potential overnight stays.
- Training: Costs for courses or trainers, materials, and venues.
- Support and Facilitation: Fees for interpreters, facilitators, or specialized equipment.
- Administrative Costs: Printing, mailing, phone/video conferencing subscriptions.
- Meeting Costs: Venue hire, equipment, and refreshments.
- Childcare or Care for Dependents: Costs for childcare services or care for dependents.
- Insurance: Potential additional premiums or policy adjustments.
- Feedback and Dissemination: Printing and distribution of results.
- Contingency: 5-10% of the total budget for unforeseen costs.
For precise budgeting, refer to guidelines and consult with finance professionals based on your specific project needs.
You can find stakeholders and patients for your research project by contacting:
- Patient Organizations
Connect with self-help and advocacy groups.
- Hospitals and Clinics
Partner with health professionals.
Use notice boards for outreach.
- Social Media
Share on platforms like Facebook, Twitter.
Engage on health forums and blogs.
- Academic Institutions
Collaborate with research departments.
Reach out through student organizations.'
- Community Outreach
Host workshops at community centers.
Advertise in local newspapers.
- Online Patient Communities
Engage on sites like PatientsLikeMe.
Use online surveys for feedback.
Attend relevant conferences.
Use word of mouth through networks.
- Collaborate with Researchers
Connect with those who've previously involved patients.
Ensure respect and privacy when reaching out to potential participants.
Which methods can I use? What do I have to consider during the evaluation?
- Interviews, Focus Groups, and Observations:
- Qualitative Research Guidelines Project: Open-Ended Questions
- American Evaluation Association: Protecting Confidentiality
- Surveys and Metrics:
- Combining Qualitative and Quantitative:
- Stay objective and unbiased.
- Ensure patient confidentiality.
- Set clear evaluation objectives.
- Obtain patient consent for evaluations.
- Use multiple methods (triangulation) for comprehensive insights.
- Always be culturally and ethically sensitive.
Choose evaluation methods based on your specific research goals and ensure clear communication with involved patients.
- Early Engagement: Include patients from the research's initial stages.
- Clear Communication: Use simple language; avoid jargon.
- Diverse Representation: Ensure varied patient backgrounds.
- Ongoing Training: Equip patients with knowledge about research.
- Feedback Mechanism: Regularly gather and act on patient feedback.
- Value Contributions: Respect patients' time; consider compensation.
- Transparency: Share research findings openly.
- Cultural Sensitivity: Respect cultural and linguistic differences.
- Ethical Adherence: Prioritize patient welfare and confidentiality.
- Continuous Evaluation: Refine the process based on feedback.
By adhering to these practices, research becomes more patient-centric and effective.
Links to Best Practice examples:
These sources provide foundational knowledge on patient engagment in research:
- INVOLVE is a UK-based initiative that supports public involvement in the National Health Service (NHS), public health, and social care research. Website
- PCORI is a US organization that funds research to provide better evidence for healthcare decisions. Website