Der KKS-Prüferkurs als Qualifizierungsmaßnahme hausärztlicher Praxen zur Teilnahme an klinischer Forschung: eine qualitative Studie mit Teilnehmenden aus dem Forschungspraxennetz SaxoForN

Background

With the aim of increasingly integrating research into outpatient care and ensuring its quality, the Dresden/Frankfurt am Main General Practice Research Network (SaxoForN, information at www.saxoforn.de) has been qualifying GP practice teams for research in outpatient care since the beginning of 2021. SaxoForN offers four qualification modules for this purpose, including the course for members of the investigator group in accordance with the German Medicines Act (AMG, investigator course) in order to be trained for participation in clinical trials and to be introduced to the principles of good clinical practice (GCP) so that they can work together on research projects. This course is implemented in SaxoForN through cooperation with the Coordination Centre for Clinical Studies Dresden (KKS-Dresden) (KKS examiner course). An evaluation was to be conducted to examine how well the qualification concept works for general practitioners (GPs) and medical assistants (MFAs) in the research practice network and how they perceive the KKS examiner course.

Methods

The evaluation of the PPS examiner course for GP practice teams was planned for September 2021 using a qualitative design. The research interests focused on the participants’ subjective experiences and opinions. Due to the potential vagueness and complexity of the remembered course experiences, a qualitative study design was chosen to enable a differentiated and explorative analysis of these impressions. For the survey, telephone-based, guided interviews with 11 narrative-generating, open questions were agreed upon by a team of several researchers being familiar with qualitative methods from the social and health care sciences. The interviews were analyzed using Mayring’s qualitative content analysis. The methodology was documented according to the COREQ checklist.

Results

A total of eight participants of the KKS examiner course were interviewed in October 2021 (n = 8, interview duration 15–20 min). The focus was on three central topics: (1) the quality of the content of the PPS examiner course, (2) the framework conditions in terms of time management and implementation, and (3) the suitability of the course for clinical trials and GP practices. In particular, the organization and interactive design of the KKS examiner courses were rated positively. However, the need for improvement was identified with regard to the accuracy of the training for GP practice teams: above all, the participants felt that the adaptation to the GP setting through instructions for the concrete implementation of studies in GP practices was lacking.

Conclusion

The integration of the KKS examiner course into the SaxoForN research practice network has worked well to cover the necessary GCP basics in the outpatient setting. However, there is a need for further development in the practical implementation of the qualification content. In the future, this need is to be met through intensive collaboration between SaxoForN and the KKS as well as accompanying workshops with tools for implementation in GP practices.