PARES

Patient-centered development of appropriate forms of communication of scientific results to participants in clinical trials.

Background

In the context of clinical studies, the involvement of study participants is usually limited to making themselves available for the observation of disease symptoms or for the application of experimental forms of therapy. Study participants rarely receive information about the resulting findings. Most

participants express the desire for information about the scientific study results already in the initial interview. It is therefore highly relevant to establish a mutually fruitful exchange between researchers and study participants in the procedures for conducting clinical studies in the future.

Research question and objectives

In the present project, forms of scientific communication in layman's language are to be evaluated in a joint exchange between patients and researchers. For the project, a consortium was formed in advance, which includes participants of ongoing projects of the AG Clinical Neuroimmunology, members of the study team and representatives of patient organizations (DMSG). In this consortium, a survey for study participants of completed studies of our study outpatient clinic was created. With this survey we would like to find out which aspects/results of the respective studies are of interest to the patients/participants. What would patients like to be informed about after completion of the study? In what form would patients like to have such an exchange? We would like to achieve that the task of study participants is not limited to working for the

science, but rather in terms of active participation and the citizen science approach in research processes. The aim is to strengthen the health literacy of the population by disseminating scientific results in lay language.

Method
This is a one-time survey link that will be emailed to participants and will take approximately 10-15 minutes to complete. The online survey will solicit their input on their motivation for study participation, research questions relevant to them, perceived effort/benefit ratio of study participation, interest in sharing study results, and open-ended questions within their most recent study participation. Participants also have the option of discussing their information further in a personal interview.

Current status

First consortium meeting took place on 16.06.2023 (result: survey was created)
Selection of study participants has been made
Approval of the ethics application is pending
Technical implementation and study database is currently being designed together with IT

Next steps

After a positive ethics vote, the consent form and study information will be sent to the selected eligible participants
After the consent forms are returned, the survey link is sent to the participants.
Analysis of the survey results
Creation of study-specific, patient-relevant content for 5-10 completed studies
Draft a document on the basic content structure for the provision of scientific results in layman understandable language for future projects

Institutions

Charité Universitätsmedizin Berlin
Neuroscience Clinical Research Center NCRC
AG Klinische Neuroimmunologie

Project lead: PD Dr. med. Tanja Schmitz-Hübsch und Dr. med. Eva-Maria Dorsch