Table 1 The case of PPI in the research project

The advisory board

Before recruitment of PRPs, the six researchers (a cancer consultant, two clinical professors (one specialized in patient involvement), a professor in patient involvement, a health psychologist, a clinical nurse specialist, and a nurse Ph.D. student (principal investigator (PI)) agreed that the researchers had scientific responsibility, but the PRPs had the responsibility to bring forward the lived experience. Accordingly, the aim of the advisory board was to ensure quality, enable completion of the trial, and keep the intervention meaningful to patients and health care professionals. For the recruitment of PRPs, an open invitation was announced on the Facebook group site of the Danish melanoma network. The network has about 180 paying members and 890 members in their Facebook group. We assumed that patients who joined such an organization were likely to have the required skills and resources to contribute to an advisory board. We asked for patients who had experiences of living with metastatic melanoma and the treatment hereof within the last 5 years, and who believed they could express viewpoints and experiences to the researchers. Furthermore, patients should be able to communicate via email and to attend 6–12 meetings over a project period of 3 years. Four patients applied for the three positions. They were approached by email and telephone in order to align expectations. The three included patients represented a diverse range of experiences of living with metastatic cancer (from 2 months to 6 years) but a narrow age range (62, 65, and 65) and gender (only males). Due to the death of two patients within the first 1.5 years, two new patients were recruited through the same Facebook group. Two females (aged 52 and 49 with 1.5 years and 4 months of living with metastatic melanoma, respectively) joined the group after individual telephone contact, followed up by project information. One of the new members had a progression of her disease shortly after the telephone contact and never joined the following meetings.

The overall framework of activities

All meetings took place at the university hospital from February 2016 to November 2019 and had predefined agendas. In order to accommodate the participation of patients who were in the labour market, the meetings were mainly organized after normal working hours and lasted for 3 h. At least one meal was served at each meeting and a refund of PRPs’ travel expenses was offered.

Activities in the design and management phase

In this phase, information about the PRPs’ motivations for and expectations of joining the advisory board were gathered, and a clear division of tasks and responsibilities was discussed. The main activities were selecting of PRO measures and composing the patient information sheet. All meetings were planned and managed by the PI with a mixed level of engagement, alternating between consulting and collaboration in decision-making.

Activities in the analysis during the undertaking phase

We established an ad hoc sub-group consisting of four researchers and two PRPs, all interested in a qualitative analysis of how the PRO dialogue tool was used in practice. The two RPRs were the only ones left in the advisory board (due to death and progression of disease). The aim of the ad hoc sub-group was two-fold: 1) to determine pragmatic intervention fidelity by monitoring if PRO as a dialogue tool in the clinical trial was applied as intended, and 2) to investigate if patients would identify elements of perceived significance in the consultations, which the researchers alone would not notice. Audio-recorded consultations were collected and coded according to Verona Coding Definitions of Emotional Sequences (VR-CoDES) [24, 25]. The VR-CoDES can be used to analyze emotional communication in medical consultations. The focus is on patients’ emotional expressions, whether they are explicit (direct concerns) or indirect (cues), and the immediate response by the clinician [24,25,26]. Co-inventor and author of this coding system, Professor Arnstein Finset trained the ad hoc sub-group prior to the analysis and assisted the coding process. Applying the VR-CoDES rendered possible an analysis of PRO as a facilitator for further disclosure of emotions. In this phase, the level of engagement was co-creation, where all ad-hoc sub-group members contributed equally. Since the PRPs needed to meet the same requirements as the researchers, they were remunerated for their work on the analysis. To capture and evaluate the impact of PPI on PRPs, researchers and outcome, the ad hoc sub-group held an interactive evaluation workshop a couple of months after the coding in the analysis phase was finalized.

Activities in the dissemination phase

One patient representative and PI participated in an international conference with a poster and panel discussion on PPI and contributed to the preparation and execution of this paper. It is planned that the PRPs will be involved in the dissemination of the results of the clinical project.