This is a descriptive report that is based on health care professionals’ experiences of involving patients as research partners in an ongoing clinical study. We compare our results to those of a previous clinical study that did not involve patients as research partners. The GRIPP-2 reporting guideline [12] was used to report these experiences.
Previous clinical study without PPI
In a previous study from our department at Odense University Hospital, the use of PET/CT was compared with the standard breast cancer recurrence examination program of computed tomography (CT) scan and bone scintigraphy (NCT01552655) [13]. In this study, 100 women with previous breast cancer underwent CT, bone scintigraphy, and PET/CT, where the PET/CT set-up required two scans per day for the enrolled patients. Patients underwent a biopsy if advanced breast cancer was suspected. We found that PET/CT had higher accuracy than CT and bone scintigraphy, and it was thus implemented as the standard examination for breast cancer recurrence at our institution. No patient representatives were involved in the research team of this study.
Current clinical study with PPI
The current study is a large, ongoing collaborative study of breast cancer patients at Odense University Hospital that was initiated in September 2017 (NCT03358589). The data on patient recruitment and retention that are reported here were from November 2019, i.e. 26 months after study initiation. At that time, the study was expected to comprise 260 women with suspected advanced breast cancer.
The study population is similar to that of the previous study (i.e. women with suspected metastatic spread from breast cancer), the only difference being that women with primary breast cancer with high risk of metastatic spread at the time of diagnosis were excluded from the previous study.
In the current study, women had no further scan if no metastases were detected on PET/CT, but all patients were asked to have a blood test for genomic mutations. This meant that the participator information material was quite complex due to the risk of incidental findings in the genome. If bone metastases were detected on PET/CT, the patient proceeded to whole-body MRI scan. If advanced breast cancer was suspected at PET/CT, the patient underwent a biopsy from a metastatic lesion to enable exact diagnosis and appropriate choice of treatment.
Advanced breast cancer is an incurable disease with a need for life-long medical treatment, e.g. chemotherapy. Women with biopsy-verified advanced breast cancer proceeded to the response monitoring stage of the study, where the treatment effect was evaluated every 3 months using standard CT and blinded PET/CT for research purposes.
Patients as research partners
We invited previous breast cancer patients who were members of the Danish Breast Cancer Patient Organization to be partners in our research team. The Danish Breast Cancer Patient Organization is a large and established group of volunteers who have all previously had breast cancer. Two women responded within one week; their role in the organization was to arrange patient information meetings on patient-relevant subjects and to serve as patient consultants. Both women were involved in research councils at Odense University Hospital and in other breast cancer committees in Denmark. We considered these patients to have the physical and psychological resources to participate in our research group, and both women were invited as partners.
These patient representatives were not provided with any training but were paid an acknowledgment fee that covered their transport expenses according to Danish standards. Both patients have contributed to the present manuscript. Throughout the study, ad hoc meetings were arranged in a smaller group consisting of two researchers (MV and MGH) and the two patient representatives (MLR and SG). These meetings were held at the Department of Nuclear Medicine at Odense University Hospital, and the timing and agendas are shown in Fig. 1.
Specific tasks for the patients in the PPI process were established before meeting the patient representatives. These tasks included: development of participator information material and written consent forms, active involvement in funding activities, interpretation of interim analysis, and dissemination of research results.
Development of written participator information material
Before the first meeting in April 2017, the study protocol and written participator information material were approved by the Danish Ethics Committee after small changes had been made (e.g. a study flowchart was requested). This written material was sent to the patient representatives for oral feedback; hence, no written material was expected from the patients. Further revision of the written material was arranged by e-mail, and it received final approval from the Danish Ethics Committee in June 2017.
Involvement in funding activities
In 2017, the University of Southern Denmark, Odense University Hospital, and the local television arranged a funding contest to improve the public’s knowledge about health care research. The citizens of Funen were invited to vote for what they believed to be the best research project, and the winning project was awarded 1 million DKK. Our patient representatives participated in the contest through television interviews and publicity to promote the clinical study they were involved in.
Interpretation of interim analysis
An interim analysis of the response monitoring stage of the study was performed during November–December 2018. The patient representatives were invited to the meeting where the results from the interim analysis were presented so that they could hear the in-depth explanations of the results and could discuss whether to proceed in the clinical study with or without the blinded PET/CT. The patient representatives were invited to present their opinions and participate in the decision-making.
Dissemination of research results
The research group planned the dissemination of study results in patient-friendly language for the participating patients as well as for popular science media. The patient representatives had a central role in these activities.
Outcome measures: patient recruitment and retention
The success rate for patient recruitment (i.e. expected patient recruitment compared to the actual patient recruitment) in the ongoing study with PPI was related to that of the previous study without PPI. For the ongoing study, patient recruitment rates were available at ClinicalTrials.gov [14] and will be published elsewhere in a later phase of the study. For the previous study, data on expected patient recruitment were obtained from the study protocol available at the Department of Nuclear Medicine at Odense University Hospital, while data on observed patient recruitment were obtained from the final publication [13].
For the ongoing study, patient retention was assessed 26 months after study initiation. After excluding patients who had left the study due to disease-related issues (e.g. death, comorbidity, side effects), we determined the percentage of patients who continued to attend the regular 3-month follow-up scans. Data on patient retention were not available for the previous study.
We qualitatively observed and described the researchers’ attitudes towards PPI during the current study. Not all members of the larger research team participated in the preparation of this manuscript, so we describe here both our own experiences and those observed amongst other members of the research team. The impact of PPI on patient-relevant ethical issues, funding activities, and the dissemination strategy was also observed during the current study.