Table 2 Key learnings to optimize the approach

Elements that contributed to the overall success of the approach

Identify and involve patient partners from the project outset to ensure valuable input into defining the unmet need, designing, analyzing and publishing the data

Ensure objectives and project approach, including timelines, are agreed by all participants at the start of the project and ensure everyone understands the project objectives and process as well as their own roles and responsibilities within it

Involve company compliance teams from the outset and throughout the project to ensure the successful and smooth delivery of the project, including local teams for each patient where required

Agree on potential patient co-authors at the start of the project to ensure they can go on to fulfill ICJME authorship criteria, and to manage expectations of any non-author participants

Take time to explain the publication process to patient co-authors and provide plain language versions of explanatory materials where appropriate (e.g., authorship requirements, publication process, confidentiality forms)

Provide patient advocates with sufficient time to review documents and literature

Organize meetings at times to suit patient advocates, not to fit in with the schedules of researchers or industry attendees

Consider the optimal online platform for discussions and demonstrate functionality in advance

Gather feedback on both the positive and negative aspects of living with the condition to ensure a balanced portrayal of the lived experience

Design the workshop agendas to optimize input and allow an experienced facilitator to capture feedback from all attendees

Share the meeting output/summary with all the participants and ensure they review the final version of the paper

Design the analysis to limit researcher bias and ensure the data reflect the feedback from the patient advocates

Consider publication extenders, such as short videos, to enhance the article

Elements of the approach that could be improved

Consider all potential ethics board approvals at the outset of any qualitative data generation, as journal requirements may differ from local market research guidance

Provide simultaneous translation as needed during workshop discussions to ensure that all patient advocates can follow and input despite their native language

Divide workshop sessions into manageable time allocations for the patients involved. This analysis involved two half-day workshops, but running more sessions of shorter duration may be more appropriate for the patient advocates

Be realistic about the overall project timelines. Patient advocates are often managing their condition and are juggling other priorities

Consider an effective and compliant dissemination plan, working with the publishers, to optimize the reach of the published data to multiple audiences