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. Claudia Blum
Public Relations | Quality Management 
Email: claudia.blum@charite.de

The QUEST Center also supports researchers at Charité and BIH in planning and implementing patient engagement activities in their research projects by providing consultation services, trainings and funding measures.

Understanding Patient and Stakeholder Engagement (PSE)

Clinical research investigates the benefits, efficacy and safety of new therapies, health procedures and technologies. If this is conducted under experimental and controlled conditions, it is referred to as a clinical trial. Patients often have no influence on the planning and implementation of clinical trials, as they are usually only "passive" study participants.

A rethink has been conducted for some years now. Participative research approaches are becoming increasingly important, even among funders (e.g. BMBF). Patients, researchers, funders and self-help organizations consider it necessary or demand that the experiences, concerns and priorities of those affected be integrated into the planning and design of clinical research projects. (Source: University of Bremen Institute for Public Health and Nursing Research website)

The step-by-step model by 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 achieve the highest possible level of participation. In many cases, however, only preliminary stages of participation can be realized (initially). A step-by-step approach makes it possible to gain experience and familiarize oneself with the 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

The benefits of Patient and Stakeholder Engagement

The active and collaborative involvement of patients and stakeholders in a clinical research project can make a significant impact:

  • Consider new perspectives and experiences of patients
  • Recruit subjects and patients
  • Identify new/unusual issues
  • Increase the relevance of results (reality check)
  • Increase the innovation of projects
  • Strengthen the perspective of those affected (patient-relevant research)
  • Increase transparency and acceptance

Many funders, like the BMBF, now demand active patient involvement in clinical research projects.

Examples and methods for patient engagement in different study phases
  • Phases of a clinical research project

Figure 2: Phases of a clinical research project

 

  • Examples and methods for patient engagement 
Selection of methods - Advantages & Disadvantages
Plan your project and submitt a research proposal - what do I need to consider?

Active patient engagement may incur additional costs, which you must take into account when planning your research project. If patient participation is required by the funding provider, additional funding can also be applied for.

These can be....

  • Travel costs (transportation, hotel)
  • Reimbursement of costs (e.g. appropriate fixed rate or hourly fee)
  • Event costs (room rental, catering, technology, moderation, etc.)
  • Additional personnel costs for coordinating involvement
  • Training of the patients
  • Part-percentage of scientific staff

 

On this page you will find a detailed overview of the costs you should consider:

 

Detailed description in the research proposal - who, when, and how:

  • Persons/organizations (criteria, local/national)
  • Ways of recruitment
  • Time/ study phase
  • Tasks/ objectives
  • Methods (format, frequency, online/ presence)
  • Influence on decisions
  • The individual points must be justified.

Further information:
DFG proposal preparation instructions
Funding announcement for health services research

 

How do I find interested stakeholders & patients?

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.

  • Networking
    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.
Evaluation of patient involvement in research

Which methods can I use? What do I have to consider during the evaluation?

Qualitative Methods:

  1. Interviews, Focus Groups, and Observations:
  2. Open-ended Questions and Confidentiality:

Quantitative Methods:

  1. Surveys and Metrics:
  2. Representative Samples:

Mixed Methods:

  1. Combining Qualitative and Quantitative:
  2. Balancing and Integrating Findings:
  • 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.

 

Patient Involvement Best Practices
  • 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:

https://projekttraeger.dlr.de/media/gesundheit/GF/Forum-GF_Beispielsammlung-Patientenbeteiligung_03-2023.pdf,

https://www.bihealth.org/de/translation/innovationstreiber/quest-center/services/stakeholder-engagement/pse-projekte-an-der-charite

References

These sources provide foundational knowledge on patient engagment in research:

    1. INVOLVE: INVOLVE is a UK-based initiative that supports public involvement in the National Health Service (NHS), public health, and social care research. Website
    2. Patient-Centered Outcomes Research Institute (PCORI): PCORI is a US organization that funds research to provide better evidence for healthcare decisions. Website
    3. Carman, K.L., et al. (2013). "Patient and family engagement: a framework for understanding the elements and developing interventions and policies." Health Affairs, 32(2), 223-231. Link
    4. Shippee, N.D., et al. (2015). "Patient and service user engagement in research: a systematic review and synthesized framework." Health Expectations, 18(5), 1151-1166. Link
    5. Staniszewska, S., et al. (2018). "GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research." BMJ, 358, j3453. Link
    6. Holly Etchegary , Operationalizing a patient engagement plan for health research: Sharing a codesigned planning template from a national clinical trial, Wiley Journal. 2021 Link
    7. Patient Engagement Resource Centre Link
    8. Aktive Beteiligung von Patientinnen und Patienten in der Gesundheitsforschung – eine Heranführung für (klinisch) Forschende (2023) DOI: 10.5281/zenodo.7908077 Link

 

PSE projects by NCRC/NeuroCure researchers

  • Project: Development of a PROMIS Item Bank to Design Targeted Interventions in Psychosis: A Participatory Research
    Prof. Dr. med. Dr. phil. Andreas Heinz, Department of Psychiatry and Psychotherapy Campus Charité Mitte and NeuroCure Clinical Research Center NCRC

  • Project: Long-term monitoring of biomarkers for motor and non-motor symptoms in Parkinson's disease
    Dr. Feldmann, Lucia K. / Dr. Habets, Jeroen, Department of Neurology with Experimental Neurology
    Feldmann et al, 2023

  • Project: PARES - Patient-centered development of appropriate forms of communication of scientific results to participants in clinical trials
    PD Dr. med. Tanja Schmitz-Hübsch and Dr. med. Eva-Maria Dorsch, AG Klinische Neuroimmunologie / NCRC - Neuroscience Clinical Research Center
    https://www.nfdi4health.de/en/community-eng/citizen-science/pares.html
    https://neurocure.de/klinisches-zentrum/forschung-am-ncrc/laufende-studien/pares-studie.html
  • Establishing Patient-Centered Outcomes for MCT8 Deficiency: Stakeholder Engagement and Systematic Literature Review
    Wilpert NM, Tonduti D, Vaia Y, Krude H, Sarret C, Schuelke M. Link

  • The Charité MS Initiative
    In 2016, the Charité launched an initiative for patients with multiple sclerosis (MS). Its goal is to improve the quality of clinical MS trials and to increase patient relevance. Link

  • The Autism Research Cooperation
    The Autism Research Cooperation (AFK – Autismus-Forschungs-Kooperation) is an association of autistic people and autism scientists, mainly from the Humboldt University of Berlin. The aim is to research questions jointly that are relevant for adult autistic people. In the long term, the research results should contribute to improving the quality of life of people on the autism spectrum. Link