Patient publication steering committees

A patient publication steering committee brings patients into decisions about publication priorities before writing begins. Its framework defines membership, governance and working documents, while medical writers help members develop and carry out a patient-led publication plan.

Purpose and publication priorities

A patient publication steering committee plans and oversees timely, ethical development of high-quality publications on disease burden and the patient journey, as identified by patients. ^{1, 2} Patient involvement encompasses people living with or affected by disease, including caregivers and family members. ³ A patient-led publication plan should complement a traditional publication plan. ⁴

Patient-led plans may differ in three respects. ⁴

• Topics: patients are best placed to identify topics important to their real-world care; their priorities may differ from healthcare professionals', and publications addressing those priorities should help shared decision-making.
• Author candidates: patient leaders' networks may identify people with relevant skills and expertise, widening the author pool to include patients whose voices need not be represented by healthcare professionals; patient-author training courses were being developed in 2020.
• Dissemination: patients' experience of conferences and journals may help identify suitable outlets, and less attachment to journal impact factors may allow innovation; patients and the public have advocated for plain language summaries and increased awareness of publications and summaries through patient communities and social media.

^{4, 5}

UCB Pharma's interest in a committee was driven by five factors. ^{5, 4}

• Belief in the value of patients' perspectives for presentations and publications.
• GPP3's recommendation of publication steering committees for industry-sponsored research.
• Increasing advocacy by patient experts and advocates for involvement in publication planning.
• A systematic review of patient authorship reinforcing involvement before publication writing begins.
• Benefits of early, non-tokenistic patient involvement in other advisory groups, such as trial steering committees.

^{5, 4}

A framework developed before the first meeting

UCB Pharma developed a committee framework between October 2019 and May 2020, following this sequence. ⁶

Period	Activity
October 2019	Review literature to confirm that the committee would be an innovation in industry publication practice.
November 2019–February 2020	Collaborate with internal patient engagement and advocacy, publications, compliance and medical functions, and external expert patients, patient advocates and publication professionals, including medical writers.
November 2019–April 2020	Co-create governance documents and measure readability, reading speed and speaking speed.
May 2020	Obtain endorsement from key internal stakeholders.

^{6, 7}

The framework was based on UCB Pharma's publications standard operating procedure, aligned with GPP3. ⁸ Its compliance considerations included the following. ^{8, 7, 9}

• Pre-specified, fair and robust selection criteria for patient representatives.
• A written charter clearly defining members' roles and responsibilities.
• Transparent, justifiable inclusion of clearly identified, non-product-specific publications in a strategic publication plan.

^{7, 9}

Patient experts and medical writers experienced in plain language and patient involvement in publications co-created seven draft documents for the first meeting. ⁹

1. A plain language guide to the confidentiality agreement.
2. A plain language guide to the author agreement.
3. The committee charter.
4. The committee invitation.
5. A publication process overview.
6. A patient author candidate matrix.
7. A plain language summary of GPP3.

⁹

For legal reasons, the confidentiality and author agreements themselves were unchanged; the accompanying guides were considered more suitable for patients. ⁹ The other five documents followed plain language principles, met readability targets and were considered suitable for patients. ⁹

Membership and the planned pilot

By December 2020, preparation for the first committee meeting was complete and a pilot was planned for 2021 in one therapeutic area, using UCB Pharma's existing patient engagement principles. ^{8, 10} The completed and planned steps were as follows. ^{9, 10}

Step	Status in December 2020
Consult the internal and external stakeholders needed to support, approve and implement the committee.	Completed
Establish membership selection criteria.	Completed
Develop a draft charter, with patient review, defining roles and responsibilities.	Completed
Develop draft operational documents, with patient review, including a publication process schematic and plain language documents.	Completed
Identify a suitable therapeutic area for the pilot.	Completed
Hold the first committee meeting to finalise co-creation of governance and operational documents.	Planned
Develop the first publication plan, identifying topics, timelines, target conferences and journals, and resource requirements.	Planned

^{9, 10}

Qualifying members of an existing patient council would be invited, and council members would select the committee using pre-specified criteria such as recognised disease-area patient expertise, knowledge of the patient community, spoken and written English fluency, interest, availability and willingness to participate. ¹⁰ The first meeting would cover roles and responsibilities and formally review the draft documents, which would be finalised using members' input. ¹⁰

Medical writing support

Medical writers helped generate compliance documents and plain language guides and documents for the first meeting. ⁴ The following three perspectives identify possible support throughout the committee's work. ¹¹

Perspective	Possible medical writing support
Industry sponsor	Prepare documents to gain internal support and approval, including from compliance; contribute to a framework that guides committees consistently across the company; contribute to the first meeting with an overview of GPP3 and stepwise publication planning and development; assist development and execution of the strategic publication plan.
Patient advocate	Gather and summarise community feedback with patient leaders to inform committee development and implementation; identify documents needing plain language versions; help co-create documentation; identify suitable committee candidates with patient leaders; identify novel dissemination methods for wider and targeted audiences; address members' training needs and knowledge gaps.
Medical writer	Be the contact for members' and patient authors' GPP3 questions, perhaps through recurring check-ins; help develop and execute the publication plan ethically, compliantly and effectively; summarise scientific publishing practices; explain publication-planning, presentation and publication steps and timelines; explain publishing terminology and abbreviations, including abstract, encore, congress, manuscript, journal, conflicts-of-interest disclosure, GPP3, ICMJE, impact factor, open access and peer review; explain journal and congress selection; guide compliant nomination and selection of patient authors; explain authorship roles and responsibilities, for example with the plain language guide to GPP3, including whether a candidate accepts their name appearing and the time commitment; explain co-authors and their research roles where necessary; establish preferred feedback methods in writing, by phone or by email and allow additional time or flexibility; turn author feedback into publications; suggest success metrics; volunteer to adapt tools and processes for future committees.

¹¹