
Introduction
Evidence relating to patients has always been at the heart of drug development; after all, every product to reach the market – even those which don’t – has relied on clinical trial data showing evidence of its safety and efficacy in patients. The whole industry is thus dependent on patients – and yet, they have historically been excluded from publication of the very evidence that wouldn’t exist without them. Wouldn’t you want a say in how data about you is communicated?
Indeed, it is perhaps surprising that the opportunity for patients to be involved in journal publications is a relatively recent evolution of the industry. It is an evolution which has allowed enrichment of the published literature, for example by provision of plain language summaries and inclusion of invaluable patient perspectives on clinical research (e.g., why a particular study is relevant to ‘real people’).[1] However, while the number of publications featuring patient co-authors is growing rapidly,[2] patient authorship still hugely lags behind other forms of including the patient voice in such papers, such as including data on patient-reported outcomes. So what can we as invested patient engagement professionals do to help patient authorship become more mainstream?
The case for patient authorship
Patient authorship is a natural extension of patient involvement in medicine development, the importance of which is widely acknowledged.[1] Patient involvement has been made a priority by regulatory bodies, and ethical frameworks and guidelines are in place to help the pharmaceutical industry partner effectively with patient communities. As a result, patient evidence is becoming increasingly woven into the fabric of medicine development, with the patient voice becoming ever more sought after and valued.
A 2020 systematic review outlined some of the benefits of patient involvement in publications, specifically: validation of research need, relevance and value; improved materials and processes; improved reporting and dissemination; enhanced credibility and trust; and development of new knowledge and skills for patients and other publications professionals.[1]
Furthermore, funders such as the Patient-Centered Outcomes Research Institute (PCORI) in the United States, the National Institute of Health Research (NIHR) in the UK, the National Health and Medical Research Council (NHMRC) in Australia, and the Japan Agency for Medical Research and Development (AMED) explicitly require or strongly encourage patient involvement in research and some proactively support patient authorship.[3]
Patient authorship is something to be supported, better understood and widely championed by anyone who genuinely believes in the importance of patient-focused drug development. However, it is still an area that requires careful navigation.
Navigating patient authorship
Some common barriers exist which prevent patient authorship from becoming accepted as a standard option in medical publications. The first hurdle is for patients to even qualify as an author in the first place. To do so, they need to meet the authorship criteria as set out by the International Committee of Medical Journal Editors (ICMJE).[4] Meeting these criteria can be tricky, particularly if an individual was not involved in the trial design.[5] However, the first ICMJE authorship criterion states that to be considered an author, an individual must:
“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)”.
This means that patients can be considered authors on a publication so long as they either a) use their lived experience to help develop or design a study, or b) analyse or interpret data from the patient perspective, including providing insight on how the study results might impact patients’ lives in the real world.
A 2021 literature review also found that it was difficult to find patient co-authored publications because of the many varied terms used to describe these contributors.[6] 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. ISPEPper Karen Woolley et al. found that between 2020 and 2022, however, the number of patient author affiliations had grown rapidly from 85 to 231 (also compare this with 2015, when just two were listed).[2] Nevertheless, the true number of patient-authored manuscripts is unknown because of the lack of standardised affiliations. Awareness of this issue is increasing, however, with researchers recently calling for the Guideline for Reporting Involvement of Patients and the Public (GRIPP2) reporting checklist to include a section to state whether the research included patient and public co-authors.[5]
A wide spectrum of opinion remains among publishers. While generally the value of patient authorships is increasingly recognized,[5] the breadth of opinion can be summarised as: ‘evolution’ (often the view of pioneers in the field who see it as a natural, gradual progression) vs ‘revolution’ (those who doubt patients’ suitability as authors).[2]
Indeed, a 2021 survey of 112 Editors-in-Chief found that 30.8% thought it was ‘not appropriate’ for patients to be authors or co-authors of journal articles.[7] Although in the minority, this sizeable portion suggested the industry had a way to go before embracing the concept of patient authorship.
Guidance and support
Inclusion on patient involvement in publications was seen in the Good Publications Practice guidelines in 2022, giving publication professionals much-needed, standardised advice and answers to common questions, such as whether patient involvement in publications can be compensated.
Industry and non-industry-funded training is also available for those wishing to become patient authors, with open access online courses offering modules for advocates who plan to publish their own research or become co-authors. Training such as this further helps to standardise patient authorship and may help to overcome any remaining fears that patients do not make ‘appropriate’ authors.
Our role at ISPEP
As the International Society for Patient Engagement Professionals (ISPEP), we share examples of best practice and don’t shy away from conversations with sceptical minds. When it comes to patient authored publications, we should highlight the benefits, explain how to overcome perceived barriers, and raise general awareness of these publications.
There are many individuals at ISPEP who are true experts in this area, with experience as patient authors themselves or as publishers. It is therefore incumbent on us to continue leading the way in the discussions around this topic and to openly champion and challenge across the wider industry. It is a task and a privilege we, as a collective, take seriously. There are specific actions we can take:
Understand and explain how patients can meet authorship criteria as this is one of the most common barriers. Sources of advice exist to help patients and co-authors work together effectively and navigate sensitive issues around authorship.[7] The available guidance needs to be proactively shared and highlighted by all.
Push for standardised affiliations for patient authors so these papers can be easily identified and lead to less confusion over who was involved. Standardised affiliations will also support research of these publications – essential if we are to develop further evidence-based guidance. We can help drive this by reaching and communicating a consensus on standard affiliation terms and encouraging patient authors to support their use.[2]
Patient authorship is an upwards trend, and it should be encouraged by all to further amplify the patient voice. After all, without patients, the crucial evidence required for drug development and approval simply wouldn't exist. So who better to help communicate it?
References
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).
Woolley, K.L., Stones, S.R., Stephens, R., Bharadia, T., Yamamoto, B., Geissler, J., Yang, B., Oliver, J., Boughey, A., Elliott, C., Dormer, L., Walker, J. and Lobban, D. (2024), Patient authorship of medical research publications: An evolution, revolution, and solution?. Learned Publishing, 37: e1607.
Oliver, J., Lobban, D., Dormer, L., Walker, J., Stephens, R., & Woolley, K. (2022). Hidden in plain sight? Identifying patient-authored publications. Research Involvement and Engagement, 8(1), 12.
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]
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/]
Richards, D. P., Birnie, K. A., Eubanks, K., Lane, T., Linkiewich, D., Singer, L., Stinson, J. N., & Begley, K. N. (2020). Guidance on authorship with and acknowledgement of patient partners in patient-oriented research. Research Involvement and Engagement, 6, 38.
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).
An additional barrier to patients and people with lived experience co-authoring papers is that Journals ask for ethical approval of involvement activities which is not needed. This adds an additional layer of complexity to the process, is time consuming and unnecessary.
The Shared Commitment to Public Involvement Partners (https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/putting-people-first-embedding-public-involvement-health-and-social-care-research/#commitment) are working together to try and address this