In a recent interview in The Publication Plan, patient advocate and patient research partner, Simon Stones, shared his thoughts on how to involve patients in medical publishing. Following on from Simon’s insightful interview, we now hear about patient involvement in medical publishing from the perspective of Dawn Lobban, Senior Scientific Lead at Alligent Europe, Envision Pharma.

In your experience, how often are patients involved with medical publications and what does their role most commonly look like?

“Recognition of the value of patient engagement throughout the drug development lifecycle to ensure effective and relevant medications is growing. Within medical publications, patients can and are providing valuable input at a number of key stages including:

• Publication planning: As members of a publication steering committee, to ensure that patients are a considered audience in the plan. We are currently working with publication professionals and patient advocacy staff from industry to implement this important innovation in publications.
• Publication generation: As contributors or authors to ensure that publications are relevant and reflect the lived experience. We, and others, have presented and published research with patient co-authors. Notably, patient authors can and should help with journal selection; they are likely to be strong advocates for open-access journals offering timely review and innovative ways to extend the reach of published research. They may be less likely to pursue unrealistic target journals and thus, could potentially reduce resubmission delays and costs.
• Publication reviewers: As part of the journal review process, to identify relevant research. As highlighted below, The BMJ has been involving patients as peer reviewers for many years.
• Publication optimisation and distribution: To broaden the audience of medical publications, for instance through the review of plain language summaries and subsequent online sharing. We have involved patient peer reviewers to help prepare hundreds of plain language summaries to date and their feedback has been critical to the sensitivity, relevance, and readability of these documents. We have also shown how proactive patients can be in sharing plain language summaries of publications via social media (eg, via Twitter), which reinforces just how interested patients can be in raising awareness of, and sharing, the latest research.

In reality, patient input into any of these stages is still relatively low. However, interest in improving this situation is increasing, with the conversation progressing from the ‘why’ to the ‘how’. In particular, we are seeing more patients involved in the generation and review of publication plain language summaries for which they are one of a number of potential audiences. This increase is facilitated by the development of evidence-based, co-created, and free guidance for plain language summaries, which highlights the importance of patient review.”

Is there an area of medical publishing in which the patient voice is particularly lacking? What can be done to rectify this?

“As patients are increasingly involved in the design of clinical trials, the potential for some of them to go on and fulfil International Committee of Medical Journal Editors (ICJME) authorship criteria is also increasing. How often such patient representatives are actually even considered to be authors on trial-related publications is not clear. We hope that such invitations will be made more proactively and frequently in the years ahead. The ICMJE has explicitly stated that the public has a legitimate interest in journal content and has no objections to patient authorship.

Further work is needed to ensure that, where relevant, patients are given the opportunity to author publications. A recent systematic review of patient involvement in publications, co-authored with patients, identified that patient involvement brings benefits to:

• Publications (eg, real-world relevance, broader dissemination)
• Patient authors (eg, respected for input, new skills)
• Non-patient authors (eg, access to new funding, new research topics).

However, for this to happen key stakeholders need to work together to consider the patient as a potential author from the outset, ensuring that they, and their co-authors, fully understand their role and the value that the patient voice can bring. With a number of key influencers encouraging patient authorship, including the Patient-Centered Outcomes Research Institute (PCORI), Patient Focused Medicines Development (PFMD) and medical journals such as The BMJ, this is likely to become more commonplace for relevant publications. Another major, but addressable, gap for patient involvement is in authoring ‘reporting guideline’ publications (such as the Consolidated Standards of Reporting Trials [CONSORT], the Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA], and the Strengthening the Reporting of Observational Studies in Epidemiology [STROBE]). We have shown that patients (and publication professionals) have largely been excluded from these authorship groups.”

Is it difficult to identify patient authors? What is the best way to go about doing this and what can medical publications professionals do to support and encourage the involvement of patient authors?

“To facilitate patient authorship, a potential opportunity needs to be identified at an early stage and key stakeholders need to collaborate to ensure appropriate patient selection, training and contribution.”

“To facilitate patient authorship, a potential opportunity needs to be identified at an early stage and key stakeholders need to collaborate to ensure appropriate patient selection, training and contribution. Potential patient authors may include patient advocates involved in optimising a clinical trial design, or patient experts with a research question. Whatever their background, they need to have the capacity and capability to author the publication.

Based on our systematic review on how to enhance the benefits and reduce the risks associated with patient authorship, medical publication professions can facilitate patient authorship in a number of ways, including:

• Raising the question at an early stage to ensure potential patient authorship is considered at the outset to enable all ICJME criteria to be subsequently fulfilled.
• Ensuring patient authors understand their role and responsibilities as an author.
• Engaging patients as authors according to demonstrated best practice.
• Being aware of available guidance for optimal patient engagement, while remaining open and keen to learn from every opportunity for patient interaction.
• Encouraging the development of ‘companion publications’ to original publications with patient authors. These companion publications would follow the Guidance for Reporting Involvement of Patients and the Public (GRIPP)2 reporting guidelines and document how patients were involved as authors and the effects of patient authorship.”

How commonly do journals include a patient review in addition to traditional peer reviews as part of their editorial processes? How can this shape the final published article?

“Establishment of patient review of medical publications, alongside the traditional peer review, aims to provide broader insights into the impact of living with illness.”

“Since the introduction of patient editors over 20 years ago, The BMJ has led the way in patient engagement in publishing. Establishment of patient review of medical publications, alongside the traditional peer review, aims to provide broader insights into the impact of living with illness. Given the increased relevance of the content and the access to broader communities provided by patient reviewers, other journals are now also embracing similar models and including patient reviewers as part of their editorial processes.”

Do you feel that more should be done by any other group (for example, industry, researchers, journals, or patients themselves) to increase the extent to which patients are involved in medical publications?

“Collectively, we all need to ensure that as our experience of patient engagement in medical publication grows, we commit to assessing and publishing relevant data.”

“Patient involvement in medical publications is associated with a number of potential benefits, but further work is needed by all key stakeholders to demonstrate exactly what these benefits are and to ensure that best practice guidance facilitates them:

• Industry colleagues need to be open to change, address internal barriers, educate colleagues, and adapt current standard operating procedures to embrace patient engagement in medical publications.
• Publishers need to agree and implement best practices to provide some clarity and consistency to assist the reader.
  • Plain language summaries should be optimised in terms of format and length based on best practice, location, and online searchability e.g. through PubMed.
  • Patient authors should be easily identifiable and the use of patient reviewers should be increased.
• Publishers and editors can also follow the lead of The BMJ, which requires authors to include a ‘Patient and Public Involvement Statement’ in their research publications. A number of journals have now implemented this transparency initiative, including BMJ Open, BJOG, Research Involvement and Engagement, and several leading titles in The BMJ’s portfolio of specialist journals.
• Medical publication professionals need to embrace patients as key authors, providing guidance, practical assistance and training as needed, to enable them to fulfil their important role.
• Finally, patients themselves with an interest in being involved in medical publications need to ensure that they are fully aware of the implications, undergo necessary training and commit the time needed to provide valuable input.

Collectively, we all need to ensure that as our experience of patient engagement in medical publication grows, we commit to assessing and publishing relevant data. Only by growing the current body of evidence will we be able to clearly demonstrate the value that patient input can bring to medical publications.”

Do you expect the next version of the Good Publication Practice (GPP) Guidelines to include recommendations on patient involvement? What would you like to see included in the guidelines regarding involving patients?

“Given the growth in interest and execution of patient engagement activities across the drug development lifecycle, it is vital that the patient voice, with its important insights, is not lost from the resulting medical publications.

With a Steering Committee already established, revisions to the GPP guidelines are already underway. Given the amount of interest already demonstrated (via #GPP4 on Twitter) regarding the role of the patient, my hope and expectation is that GPP4 will indeed provide further guidance on the optimal engagement of patients in all aspects of medical publications.

I would encourage everyone with an interest to contribute to this conversation with an open-mind and genuine excitement regarding the opportunity to work with patients to advance medical publications in order to facilitate shared decision-making.”

Dawn Lobban is Senior Scientific Lead at Alligent Europe, Envision Pharma. You can contact Dawn via dawn.lobban@envisionpharmagroup.com.

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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd

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