Skip to main content

Table 3 Detailed overview of research PPI-activities, output and outcome

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

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
  1. a Participants: Ad hoc sub-group within the advisory group
  2. b Participants: PI and a patient representative