Patients' and researchers' experiences with a patient board for a clinical trial on urinary tract infections

Imke Schilling; Heike Behrens; Jutta Bleidorn; Ildikó Gágyor; Claudia Hugenschmidt; Hannah Jilani; Guido Schmiemann; Ansgar Gerhardus

doi:10.1186/s40900-019-0172-0

Patients' and researchers' experiences with a patient board for a clinical trial on urinary tract infections

Res Involv Engagem. 2019 Nov 28:5:38. doi: 10.1186/s40900-019-0172-0. eCollection 2019.

Authors

Imke Schilling^{1

2}, Heike Behrens¹, Jutta Bleidorn^{3

4}, Ildikó Gágyor^{5

6}, Claudia Hugenschmidt¹, Hannah Jilani^{1

2}, Guido Schmiemann^{1

2

4}, Ansgar Gerhardus^{1

2}

Affiliations

¹ 1Department for Health Services Research, Institute of Public Health and Nursing Research, University of Bremen, Grazer Straße 4, 28359 Bremen, Germany.
² 2Health Sciences Bremen, University of Bremen, 28359 Bremen, Germany.
³ 3Institute of General Practice, Jena University Hospital, Bachstr. 18, 07743 Jena, Germany.
⁴ 4Institute of General Practice, Medical School Hannover, Carl-Neuberg-Str. 1, 30635 Hannover, Germany.
⁵ 5Institute of General Practice, Würzburg University Hospital, Joseph-Schneider-Str.2/D7, 97080 Würzburg, Germany.
⁶ 6Institute of General Practice, Göttingen University Hospital, Humboldtallee 38, 37070 Göttingen, Germany.

Abstract

Background: Patient and public involvement (PPI) has become an essential part of the design, conduct, and dissemination of research. While researchers who employed PPI mainly report on the positive aspects, in practice PPI is still an exception in clinical trials in Germany. There are specific challenges in the process of involvement that can jeopardize the conduct of involvement. The aim of our study was to analyze the experience of patients and researchers with PPI in a clinical trial in Germany, so we could learn more about potential challenges and how they could be addressed.

Methods: We established a patient board for a randomized controlled trial on urinary tract infections, where patients and researchers regularly met to discuss relevant aspects of the trial. Minutes were taken for each meeting and the moderator also noted her observations in a postscript. After four meetings, we conducted two focus groups, one each with the patients and researchers. We analyzed and categorized the minutes, postscripts, and focus group transcripts using thematic qualitative text analysis.

Results: Patients and researchers felt comfortable with the composition of the patient board and its' atmosphere. In terms of challenges, patients and researchers needed time to get familiar with PPI. Both parties saw a need for training in PPI but differed in their views on the relevant topics. Patients wished to learn more about their role and tasks within the board at the onset of the PPI. They also preferred to meet more frequently and get more intensely involved in the trial. In contrast, researchers perceived that they were already highly involved. They further felt that the involvement was of benefit to them, the trial and future research. Patients described benefits for themselves, but also wondered if their involvement had had an impact on the trial.

Conclusions: To facilitate effective PPI, resources, adequate structures, and training are needed. Patients and researchers need to agree on their respective roles, training needs, and the mode of cooperation right at the beginning. The parties involved should continuously reflect on the actual benefits of PPI, describe them explicitly and make them transparent for all.

Keywords: Challenges; Clinical trial; Experiences; PPI; Patient and public involvement; Patient board; Patient engagement; Qualitative research.