Patient involvement in clinical trial design has evolved to provide opportunity for patients to be involved in medical publications. This evolution has allowed medical publications to gain invaluable patient perspectives on clinical research, by involving patients as authors in the development of plain language summaries and other, more traditional types of research publications¹.

However, in comparison to patient involvement in other aspects of research, such as study design and recruitment, patient involvement in publications has lagged behind¹.

Some common questions exist, all of which reflect barriers in the way of establishing patient authorship as a standard option in medical publications. These questions include: Who can be a patient author? What impact will involving a patient author have on the publications process? Do any guidelines exist? Are all journals onboard?

This article will hopefully provide some answers.

Who can be a patient author?

Admittedly, there are hurdles to be overcome when involving a patient author. Patient authors need to fully understand the process and best practices. They need to understand the science behind the publication. But the first hurdle for patients is to even qualify as an author in the first place. In order to do so, they need to meet the authorship criteria as set out by ICMJE.  Meeting these criteria can be tricky, particularly if a patient author was not involved in the trial design.

The ICMJE state that to be considered and author, an individual must:

1. Provide a valuable contribution to the report (for example, use their experience as a patient to help design the study, or to help identify and describe the research findings that are most useful to patients)
2. Provide useful comments at each stage of writing the report
3. Read and approve the final version of the report
4. Be willing to take responsibility for the accuracy and integrity of the report and help to answer questions about the report²

The first criterion is often cited to be the biggest hurdle³. If patients are able to meet the first ICMJE criterion, however, it’s easier for them to meet the remaining three.

Patient authors will not always be independent individuals. A 2020 review of nine publications found patients were either patient and public involvement (PPI) group members, members of primary care research groups, individual patient advisors, patient advocacy group members, or patient research user group members¹. Where affiliations exist, these were listed but were not always explicitly stated.

Working with a patient author

Working with a patient author is likely to mean doing things slightly differently. The following tips might help¹:

• General process will be similar; however, identification of a suitable patient author may be time consuming
• Identify relevant publication and patient involvement guidelines that will be followed (such as GPP3)
• Additional briefing calls are useful, to make sure the patient author understands their role and responsibilities, and the background to the publications process, and their authorship agreement – particularly if the patient author hasn’t been involved in a publication before
• Take the time to explain to the patient author what they will need to do in order to meet the ICMJE authorship criteria
• Timelines will need to be more generous to allow for more regular briefings, check-ins, and the potential limitations on a patient author’s time due to managing their condition. Make sure the patient author knows this is expected and allowed for!
• Involve patient authors in early authorship meetings and Publication Steering Committees to allow them to contribute insights, ask questions and understand the trial data, and to build trust and rapport with their co-authors – this will help keep the following stages running more smoothly
• Provide plain language version of legal agreements, such as authorship agreements or confidentiality agreements
• Explain the roles of any agency-based medical writers involved, and appoint a designated contact person who can answer queries
• Be flexible in how patient authors can provide input (e.g. telephone, email, in person)

Are journals onboard?

Patient authors have published peer-reviewed work in many types of journals, from general to specialist titles. As with many innovations, there are early adopters and there are those slower to embrace the change. Not surprisingly, patient-focused journals have been quick to encourage patient authorship. Other journals to embrace and encourage patient authorship include the BMJ⁴, and some belonging to the BMC Springer, Wiley and Emerald groups¹.

However, a 2021 survey of 112 English-language medical journals’ Editors-in-Chief found that 30.8% thought it was ‘not appropriate’ for patients to be authors or co-authors on published biomedical research articles⁵. So, there is clearly still a way to go before all journals embrace patient authorship. To highlight the barriers still further, the same study found just 3.6% of journals have a policy in place that specifies how patients can be considered as authors.

As the article concludes, there is a need for “education and for consensus building within the biomedical community to establish processes that will facilitate equitable patient partners’ inclusion”⁵.

A 2021 literature review also found that it was difficult to find patient co-authored publications because of the many terms used to describe these contributors: patient, caregiver, consumer representative, patient partner, expert by experience, citizen researcher, or public contributor⁶. In 27% of articles, the review found that it was impossible or difficult to tell whether an author was a patient solely from the listed affiliation.

Conclusion

What all this tells us is that there is no standardised way in which patient authors are involved or cited in publications, and that journals all vary in how they report patient involvement. As the above review concluded, when patient and public-authored research becomes easier to find, its impact will be easier to measure⁶. At the moment, we’re still in somewhat murky waters.

Clearer guidelines are needed. GPP updates should address this in part; however, it is criteria such as ICMJE, which currently do not provide any recommendations for how patients should be involved as authors, that need to be changed to give clarity across the industry.

It is not necessary to wait for clearer guidelines, though. Patient authorship is achievable now, and it should be encouraged to help amplify the patient voice. Barriers do exist, but these can be overcome if, as an industry, we are prepared to adapt the way we work and bring the patient more centrally into how we deliver publications.

Read more about our work in Patient Engagement here 

Follow our Twitter for more insights and updates from the world of patient engagement

References

1. Arnstein, L., Wadsworth, A.C., Yamamoto, B.A. et al. Patient involvement in preparing health research peer-reviewed publications or results summaries: a systematic review and evidence-based recommendations. Res Involv Engagem 6, 34 (2020).
2. Defining the Role of Authors and Contributors. [Accessed online 29/09/21: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html]
3. Patient Authorship: Three Key Questions (& Answers!) for Medical Communication Professionals. 2020. [Accessed online 29/09/21: https://ismpp-newsletter.com/2020/05/26/patient-authorship-three-key-questions-answers-for-medical-communication-professionals-part-b/]
4. Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165.
5. Cobey, K.D., Monfaredi, Z., Poole, E. et al. Editors-in-chief perceptions of patients as (co) authors on publications and the acceptability of ICMJE authorship criteria: a cross-sectional survey. Res Involv Engagem 7, 39 (2021).
6. Ellis U, Kitchin V, Vis-Dunbar M. Identification and Reporting of Patient and Public Partner Authorship on Knowledge Syntheses: Rapid Review. J Particip Med. 2021 Jun 10;13(2):e27141.