Involvement of patients in the research process.

Healthcare research emphasises involvement of patients in the research process, recognizing that this can enhance the relevance, quality, and implementation of research. This article highlights the need for more systematic planning to successfully involve patients in research projects and provides guidance on key aspects that researchers should consider in the planning of involving patients in research. The article accentuates the importance of establishing clear frameworks and guidelines to promote transparency and facilitate implementation.

Recommendations for successful involvement of patient partners in complex intervention research: a collaborative learning process.

BACKGROUND: Patient and public involvement in health-related research is a new discipline in Denmark. In 2021, a national conference titled 'Patient and Public Involvement in Complex Intervention Research' provided a forum for discussion between patient partners, researchers and clinicians on involving patients as partners in complex intervention research. METHODS: We aimed to describe specific challenges to and initiatives for patient partner involvement in order to develop recommendations for creating successful partnerships in complex intervention research. Through a collaborative learning process, 140 researchers identified the most important challenges for them in patient partner involvement and potential initiatives to improve such involvement. At a subsequent workshop, four patient partners identified the challenges and initiatives from their perspective as patient partners. They also gave feedback on the challenges and initiatives suggested by the researchers and helped shape three recommendations for practice. Three of the patient partners were involved in writing this paper. RESULTS: The five most important challenges identified by researchers were time, recruitment, ethics, power and inequality. Between four and seven initiatives to overcome these challenges were suggested. The three most important challenges identified by patient partners were communication, when you get information that is hard to handle and recruitment. They suggested three to four initiatives for improvement. Patient partners confirmed the importance of all the researcher identified challenges when presented with them, they also provided additional comments on the researchers' initiatives. This led to the formation of recommendations for involving patient partners. CONCLUSIONS: A collaborative learning process was shown to be a suitable method for patient partner involvement. Consistency was seen between the challenges and initiatives identified by researchers and patient partners. Based on these observations, three recommendations were developed: (1) create specific programmes that aim to involve all kind of patients (including but limited to vulnerable patients) as patient partners, (2) produce ethical guidelines for the involvement of patient partners, and (3) develop a national strategy for patient partner involvement. To build on these recommendations, a joint workshop with both researchers and patient partners is needed.

Involving patients in complex intervention research is new in Denmark, so there is a need to work out how to do it properly. In 2021, a national conference about this was arranged. There, two workshops were held with 70 complex intervention researchers in each. In the workshops, challenges and steps needed to bring patient partners into complex intervention research were identified. Later, a similar workshop was organized with four patient partners. Their views were similar to what was concluded at the earlier workshops. All challenges and steps to overcome these were discussed between patients and researchers at the last workshop. This resulted in the development of three recommendations to successfully involve patient partners into complex intervention research: (1) create programmes to involve patients who might otherwise be missed as patient partners, (2) produce ethical guidelines for involving patient partners in complex intervention research, and (3) develop a national plan for involving in patient partners.

Supporting Families with Breast Cancer: Insights from the Danish Nurse-Led Program "The Children's Tour" for Families with Parental Cancer.

PURPOSE: This study explores how a Danish nurse-led program designed to provide support to families where mothers are affected by breast cancer is experienced by the women attending the program and the nurses organizing it. Their experiences provide insights into the program's impact and potential areas of improvement and inform future interventions targeting the well-being of this specific population. DATA SOURCES: The study involved data collected through qualitative research. An observational study of the intervention was conducted to inform the development of an interview guide for semistructured individual interviews and a focus group interview. Five women with breast cancer and children aged 5 to 16 years were interviewed, and four nurses involved in the nurse-led program took part in the focus group interview. Data were audio recorded, transcribed verbatim, and thematically analyzed. CONCLUSION: Families participating in the nurse-led program reported it helpful in many ways. Three themes emerged from the analysis of the interviews: 1) "How to talk about parental cancer with school-aged children," 2) "Setting up the room," and 3) "Exchanging imagination for reality." Getting familiar with the treatment room and nurses, playing with hospital gear (syringes, bandages, and the treatment chair), and watching a movie together indicate that the visit to the ward is important and cannot be entirely replaced by digital solutions. With the need for support and limited resources at the hospital, it is pivotal to identify the families most in need. IMPLICATIONS FOR NURSING PRACTICE: Women with breast cancer parenting adolescent children need family-based care based at the hospital. Further research is needed to refine the program to cover the concerns of the whole family, including fathers and grandparents, and to apply the program to other families with parental cancer of other types.

Developing and testing guidance to support researchers engaging patient partners in health-related research.

BACKGROUND: Although interest in Patient and Public Involvement in health-related research is growing, there seems to be a lack of guidance supporting researchers in deciding on methods and levels for Patient and Public Involvement in health-related research throughout the research process. Furthermore, the numerous definitions, methods, and frameworks make it challenging for researchers new to this field to decide on the most appropriate approach for their project. METHODS: This study aimed to develop and test guidance for researchers deciding on approaches, levels, and methods for engaging patient partners in health-related research. A group of 11 researchers in Patient and Public Involvement in health-related research participated in six workshops to develop the guidance. The feasibility and acceptability of the guidance were tested in a survey of 14 researchers using the System Usability Scale plus two elaborative questions. The guidance was also tested by five PhD students engaging patient partners in their projects. RESULTS: The guidance developed consisted of two resources: Resource I outlined five international approaches to Patient and Public Involvement in health-related research, and Resource II described the different levels and methods for engaging patient partners in research. The System Usability Scale score (at the 50th percentile) was 80, indicating excellent usability. Qualitative data showed that the two resources supported reflections regarding different approaches, levels, and methods. CONCLUSION: The researchers found the guidance to be supportive of their reflective thinking about engaging patient partners in their research. The testing provided knowledge about when and how to use the guidance but also raised questions about the usefulness of the guidance in communications with patients.

More and more patients are taking part in research as patient partners. However, researchers have little guidance on how to bring patient partners into research studies and at what levels. There are many ways to do this. It can be hard to choose the way most appropriate for a specific project, especially for newer researchers. We (11 researchers at different career levels) developed guidance through six workshops to help new researchers choosing the way to engage patient partners most appropriate for their project. The guidance resulted in two different resources. Resource I gives five international approaches for bringing patient partners into research. Resource II describes methods for engaging patient partners at different levels. Fourteen researchers and five PhD students tested the guidance and scored how usable it is. It had excellent usability. The two resources did help researchers to decide on the best ways to engage patient partners in research. We now need to test how the guidance can be used to talk to patients about taking part in specific research projects.

Effect of patient-reported outcomes as a dialogue-based tool in cancer consultations on patient self-management and health-related quality of life: a clinical, controlled trial.

BACKGROUND: With increased survival among patients with metastatic melanoma and limited time with health care providers, patients are expected to assume a more active role in managing their treatment and care. Activated patients have the knowledge, skills, and confidence to make effective solutions to self-manage health. The use of patient-reported outcomes (PRO) could have the potential to enhance patient activation. However, PRO-based interventions that facilitate an activation in patients with metastatic melanoma are lacking and warranted. MATERIAL AND METHODS: In this prospective non-randomized controlled, clinical trial, patients with metastatic melanoma were assigned to either the intervention (systematic feedback and discussion of PRO during consultation) given at one hospital or the control group (treatment as usual) if they received treatment from two other hospitals in Denmark. The primary outcome was the patient activation measure (PAM), which reflects self-management. Secondary outcomes were health-related quality of life (HRQoL), self-efficacy, and Patient-Physician interaction. Outcomes were measured at baseline, and after 3, 6, and 12 months. The analysis of the effect from baseline to 12 months employed mixed-effects modeling. RESULTS: Between 2017 and 2019, patients were allocated to either the intervention group (n = 137) or the control group (n = 142). We found no significant difference in the course of patient activation between the two groups over time. The course of HRQoL was statistically significantly improved by the intervention compared to the control group. Especially, females in the intervention group performed better than males. The other secondary outcomes were not improved by the intervention. CONCLUSION: The intervention did not improve knowledge, skills, and confidence for self-management for patients with metastatic melanoma. Neither did it improve coping self-efficacy nor perceived efficacy in Patient-Physician interaction. However, the results suggest that the intervention can have a significant impact on HRQoL and in particular social and emotional well-being among the females.

The impact of patient involvement in research: a case study of the planning, conduct and dissemination of a clinical, controlled trial.

BACKGROUND: The interest in patient and public involvement (PPI) in health research is increasing. However, the experience and knowledge of PPI throughout the entire research process and especially in the analysis are limited. We explored ways to embrace the perspectives of patients in a research process, and the impact and challenges our collaboration has had on patients, researchers, and the research outcomes. METHODS: This is an explorative single case study of a Danish, clinical, controlled intervention trial and a nested intervention fidelity study included herein. Five patient representatives with metastatic melanoma were part of designing, undertaking and disseminating the trial where the effect of using patient-reported outcome (PRO)-measures as a dialogue tool in the patient-physician consultation was tested. In the fidelity study, audio-recorded consultations were analyzed after training in the Verona Coding Definitions of Emotional Sequences (VR-CoDES). Results were jointly disseminated at an international scientific conference. The outcomes, impact, and challenges were explored through a workshop. RESULTS: In the design phase, we selected PRO-measures and validated the dialogue tool. The information sheet was adjusted according to the patients' suggestions. The analysis of the fidelity study showed that patients and researchers had a high consensus on the coding of emotional cues and concerns. The patients contributed with a new vocabulary and perspective on the dialogue, and they validated the results. PPI caused considerations related to emotional (sadness/sorrow and existential thoughts), administrative (e.g. arranging meetings, balancing work and small talk) and intellectual (e.g. avoiding information harm, continuing activities despite the death of patients) investments. A limitation of the study was the lack of use of a solid evaluation tool to determine the impact of PPI. CONCLUSION: PPI throughout the process and co-creation in the analysis was feasible and beneficial. The case is unique in the degree of workable details, sustainability, and transparency. Moreover, the co-creation provides ideas of ways to operationalize PPI. An evaluation workshop revealed considerations about emotional, administrative and intellectual investments - best described as tacit, yet important 'work'. This knowledge and experience can be applied to other studies where patients are partners in the research. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03163433, registration date: 8th May 2017.

The development of PROmunication: a training-tool for clinicians using patient-reported outcomes to promote patient-centred communication in clinical cancer settings.

BACKGROUND: The value of using real-time patient-reported outcome (PRO) measures in cancer communication has gained attention both in the clinic and in research. Despite this, no internationally accepted guidelines or training programs for clinicians on how to engage in patient-centred communication based on PROs exist. Lack of training may complicate implementation and systematic use of PROs in the clinic. We aimed to develop a short and feasible manual and training session in PRO-based dialogue rooted in patient-centred communication, coined PROmunication. METHODS: PROmunication was implemented in two studies using PROs in different clinical cancer settings. We interviewed clinicians twice during the development phase. First, adopting a clinical perspective, they provided ideas for content, length and structure of the training session and the manual. Second, they approved the draft of the manual with minor adjustments on how to document clinician-patient communication. The final version of the PROmunication tool was built on clinicians' input, theory on patient-centred communication, a literature review, and didactic considerations. RESULTS: The one-page manual gave clinicians a brief and clear overview of how to prepare for, undergo and document a PRO-based consultation. Illustrations and verbal phrases were offered to operationalize and facilitate patient-centred communication. The training session included elements like evidence-based knowledge about the rationale, benefits and challenges of using PROs and comprised theory, experimental training and instructions for the use of the manual in clinical practice. Ad hoc training and feedback in the clinic followed the training session. CONCLUSIONS: This paper presents the development of a short, theory-driven manual and training session intended to support and engage clinicians in PRO-based dialogue leading to patient-centred communication. Further testing of the tool is necessary and adjustments may be required if the PROmunication tool should be applied in other clinical settings were patients are seen regularly. An evaluation of the tool is planned to be performed in future studies. Training in PROmunication may further systematic and consistent use of PRO data in the consultation, leading to patient-centred consultations and increased patient involvement.