Table 3.
Detailed overview of research PPI-activities, output and outcome
| Aim | Activities | Output | Outcome |
|---|---|---|---|
| Design and managing phase | |||
| Meeting I. Length: 3 h, level of involvement: Consultation to Collaboration | |||
| - To clarify expectations and motivation for participation | - Individual sticky notes and subsequent sharing of expectations and motivations | - List of expectations and motivations for joining the advisory board | - The researchers used the contributions from the patient representatives to select PRO-measures for the dialogue tool. The chosen PRO-measures included health-related quality of life plus anxiety and depression. The final decision about PRO-measures was validated by the patient representatives in e-mail correspondence |
| - To inform patient representatives about the clinical study | - Assurance that the selected PRO-measures are sufficient to prioritize what is important for patients | ||
| - Dias show about the overall study purpose and design | |||
| - To choose PRO-measures for a dialogue tool | - Recommendation of PRO-measures on psychological issues in the dialogue tool | ||
| - Exposition of three PRO-measures selected prior to the meeting by the researchers as potential PRO-measures for the dialogue tool | |||
| - The relatives were considered, but to include them would be too wide-ranging. In the final dialogue tool, patients were encouraged to complete PRO together with relatives | |||
| - To choose PRO-measures for research | - Suggestion of PRO-measures for relatives because relatives play a major role for many patients in managing their disease | ||
| - The participants were asked to state their three most important issues to discuss | |||
| - Recommendation that completion of PRO-measures must be followed by a conversation | |||
| - Questionnaires designed according to an estimated max time consumption of 15 mins. | |||
| - Group work: | |||
| Completing the PRO-measures | - An IT solution for completion at home and at hospital | ||
| - Endorsement of an open-ended question on the most important issues to discuss in the consultation | |||
| Discussing PRO-measures’ suitability to address patients’ concerns | - “self-efficacy” and “health-related quality of life” were among domains in the final outcome “battery”, but the potential outcome was difficult to separate from the desired or important outcome | ||
| - Advice on length of the questionnaire: 15 mins for each completion is acceptable | |||
| Selecting PRO-measures | |||
| Discussing the length of the total dialogue tool | - Advice on completion: preferably at home in a comfortable environment but possible at hospital | ||
| Discussing completion time | |||
| - Suggestion about outcome measures: “self-efficacy” and “health-related quality of life” | |||
| - Exposition and discussion of relevant domains of PRO-measures for research | |||
| Meeting II. Length: 3 h, level of involvement: Consultation to Collaboration | |||
| - To complete a user-friendly patient information sheet | - Dias show about the decisions made since the last meeting | - Suggestion for a new title because the original was perceived as too long and not catchy | - The new title was used |
| - All suggested rewritings were implemented | |||
| - To brainstorm on a training manual for clinicians using PRO in the dialogue | - Information on a meeting for participants when results are available was included in the information sheet | ||
| - Group work: | - Sentence by sentence rewriting to shorten the text | ||
| Is the information sheet adequate? | |||
| - Rewriting of words that were incomprehensible in order to make it user-friendly | - The final version was sent out by e-mail and approved in the advisory board | ||
| All members received two draft versions before the meeting; one for the intervention group and one for the control group | |||
| Are the language and grammar easy to understand? | - Due to lack of time, the patient representatives were not further involved in the development of a training manual | ||
| - Advice to arrange and inform about a meeting to feed back results to participants as a “pay-back” for participation in the clinical trial | |||
| - Short presentation of ideas for a training manual on PRO for physicians | |||
| - Discussion about these ideas (due to lack of time, this was a brief discussion (5 min)) | - No specific ideas for the training manual besides the ideas presented by PI, but the involvement of clinicians was highlighted as an important next step | ||
| Pre-meeting III. Length: 1 h, level of involvement: Not applicable | |||
| - To introduce two new patient representatives | - Face-to-face meeting with one new patient representative | - Willingness to contribute as a patient representative | - Both new patient representatives were included in the advisory board |
| Inform about the clinical project, PPI, and responsibilities | |||
| - Telephone meeting with another patient representative | |||
| Meeting III. Length: 2 h, level of involvement: Consultation to Collaboration | |||
| - To welcome the new patient representatives | - Information about different methods for the intervention fidelity (e.g., interview, observation, audio recording) | - A joint decision to use audiotaped recordings of consultations | - Establishment of an ad-hoc sub group |
| - To inform about methods of monitoring, documenting and analyzing the way PRO is used in the consultation | - Willingness to engage as co-creators in the analysis process | - Contacted the founder of the coding system professor A. Finset in order to set up training and work schedule | |
| - Information on estimated process and time schedule for collecting and analyzing data | ○ Spend the additional time needed to engage in this work | - Signed contract about confidentiality and salary | |
| - To select an intervention fidelity study design | ○ Obtain training in a specific coding system | ||
| - Discussion and decision about method and level of PPI | |||
| ○ Code separately | |||
| ○ Meet for discussions | |||
| Undertaking phase | |||
| Traininga. Length: 7 h, level of involvement: Collaboration | |||
| - To learn how to code audiotaped consultations according to VR-CoDES | - Training in theory and method of the coding system | - The patient representatives engaged in the entire training session | - Knowledge to apply VR-CoDES to other transcripts on audiotaped consultations |
| - To decide how to map the use of PRO in the audiotaped consultations | - Practical exercise in coding exercise transcriptions | - Joint discussion and decision about how to code the use of PRO | - Practical experience of using the VR- CoDES |
| - Supervision by professor A. Finset | - Agreement of a plan for the mapping of the use of PRO in the consultation (six questions to address the use of PRO) | ||
| - Discussion on monitoring the use of PRO in consultations | |||
| Homework Ia. Length: 3–4 h, level of involvement: Co-creation | |||
| - To apply the VR-CoDES to transcripts of audiotaped consultations | - Individual coding (part I) of three consultations with audiotaped length of 11–26 min. Each (7–13 A4 pages each) | - Individual training and familiarity with the VR-CoDES | - The underlying basis for collaboration on the analysis |
| - To code the use of PRO | - Coding of all three audiotaped consultations | ||
| - Focus on PRO in the consultations | |||
| Consensus meeting Ia. Length: 3 h, level of involvement: Co-creation | |||
| - To compare and discuss the individual application of VR-CoDES | - Comparing our codes with each other’s and with the codes produced by A. Finset | - Expressions of being emotionally touched by the confrontations with fellow patients’ hard consultations | - Consensus on how to code |
| ○ We all agree on how to code a patient’s emotional concern or hint of concern, but the character of the hint or the response by the physician is more complicated to code, leading to varied views on why a patient hints various concerns and why physicians respond as they do | |||
| - To compare and discuss the use of PRO | Typical agreements and disagreements | - Emphasizing the importance of the patient-physician relationship in regard to the communication flow | - Consensus on the use of PRO |
| ○ The three most important issues to discuss are used as a starting point of the dialogue | |||
| Discussion about consensus | |||
| - Emphasizing the importance of the patient’s position in the course of a disease for the character of hints | ○ Difficult to tell if PRO symptoms and function are used | ||
| - Comparing our answers to the six questions to address the use of PRO | |||
| ○ Mainly, the physician initiates the dialogue | |||
| - Arguments on how a physician response can depend on how experienced a physician is | |||
| - Joint mapping of how PRO was referred to, initiated and used | |||
| Homework IIa. Length: 4–5 h, level of involvement: Co-creation | |||
| - To apply the VR-CoDES to transcripts of audiotaped consultations | - Individual coding (II) of three consultations with an audiotaped length of 14–60 min each (9–24 A4 pages each) | - Individual training and familiarity with the VR-CoDES | - The underlying basis for collaboration on the analysis |
| - To code the use of PRO | - Additional focus on the use of PRO in the consultations | ||
| - Coding of all three audiotaped consultations | |||
| Consensus meeting IIa. Length: 3 h, level of involvement: Co-creation | |||
| - To compare and discuss the individual application of VR-CoDES | - Comparing our codes to each other’s and to the codes produced by A. Finset | - One patient representative told about hearing information about prognosis that she had tried to avoid in relation to her own disease | - None of the patient representatives regret having been involved in the co-production |
| - To compare and discuss the use of PRO | Any typical agreements and disagreements | - The ad-hoc sub-group is more aligned in the codes than at last consensus meeting | |
| - One patient representative highlighted that a repeated question from a patient to a physician may not indicate an underlying concern, but might indicate an unacceptable physician response | - A new vocabulary and perspective to talk about the dialogue based on PRO in the consultation | ||
| - To discuss the impact of co-creation so far and going forward | - Comparing our answers to the six questions to address the use of PRO | - Validation of cues and concerns found (by patient representatives) | |
| - The dialogue tool was used as intended in all the audiotaped consultations | |||
| - The analysis revealed that the open-ended questions were the starting point of the dialogue, but we were unable to tell if the validated PRO-measurements were used during the consultations | |||
| - Recognition of the concerns and the questions in the audiotaped consultations | |||
| - Joint mapping of how PRO was referred to, initiated and used | |||
| Workshop on evaluation of the impact of PPIa. Length: 2½ hours, level of involvement: Co-creation | |||
| - To work out challenges in doing PPI in our case | - Discussions about engaging in this research project based on an interactive presentation software | - Guiding points for patient representatives and researchers in doing PPI, e.g.: | - Co-creation was feasible in the case |
| - To determine the impact of PPI on the patient representatives, the researchers and the outcome | - PPI was beneficial throughout the research process in order to incorporate the perspectives of patients with metastatic melanoma | ||
| ○ Clarify responsibility and expectations explicitly | - The validation of output and outcome assisted in a recognition of own contributions | ||
| - Gathering advice for other patients and researchers who engage in PPI in research | |||
| ○ Be aware of information harm | |||
| ○ Create room for trust and respect to unfold | |||
| - Validation of contributions and outcomes | |||
| ○ Be aware of expenses (time and money) | |||
| - Validation of the outputs and outcomes presented by PI. A few more were added | |||
| Disseminating phase | |||
| Meeting Ib. Length: 2½ hours, level of involvement: Co-creation | |||
| - To plan participation at an international conference on quality of life research (patient research partner scholarship obtained) | - Discussing different invitations to participate in session and panel discussions about patient engagement in research | - Joint decision to participate at one session as panelists and in one session as an active audience member | - Feedback to the session organizers about our decisions about participation |
| - Joint performances to demonstrate and display our cooperation in the research process | |||
| - To discuss the first draft of a poster made by PI | - Discussing the content, layout, and presentation of the poster | - Poster | - Poster finalized by PI included the input from the patient |
| ○ Layout is agreed upon as introduced by PI | |||
| ○ Content is agreed upon, but with the idea to outline considerations about PPI in research from both the researchers’ and patients’ perspectives | |||
| Tele-conference with organizers and panelistsb. Length: 1 h, level of involvement: Not applicable | |||
| - To receive an introduction about the session in which we were to become panelists | - Meeting the organizers and other panelists | - Initial preparation as panelists | - The initial preparation for the joint performance |
| - Discussing the format and questions for the panelists | |||
| Meeting IIb. Length: 2 h, level of involvement: Collaboration | |||
| - To finalize the preparation for the conference | - Discussing the questions for the panelists | - Final preparation for the conference and our performances | - Confidence in our performance |
| - Brainstorming answers for panel questions | - Check on practicalities, such as travel documents and the conference programme | ||
| - Discussing travel and conference programme | |||
| Participation at ISOQOL conference 2019b. Length: 4 days, level of involvement: Collaboration | |||
| - To present our work on PPI together | - Poster presentation on PPI in research | - Numerous responses to our presentations | - International acclaim for our work on PPI in cancer care |
| - To network with researchers and stakeholders interested in patient engagement | - Panel discussion on patient engagement in research | - International network | |
| - Informal dinner with Special Interest Group for Engagement | |||
| - Participating in sessions about PPI | |||
| Meeting IIIb. Length: 2 h, level of involvement: Collaboration | |||
| - To go over the paper based on a thorough, individual perusal | - Discussion of results and discussion paragraph | - One patient representative participated in publishing the present article | - Agreement between all authors |
| - To obtain consensus on the content | - Writing of layman summary | - Layman summary written by patient representative and PI | |
| - Review and approval of the article | |||
| Meeting IIIIb. Future planning, level of involvement: co-creation | |||
| - Feedback of results to clinicians is to be planned in detail | |||
| - Feedback of results to participants is to be planned in detail | |||
a Participants: Ad hoc sub-group within the advisory group
b Participants: PI and a patient representative