Professor Karen L. Woolley. Envision Pharma Group, Australia; University of Queensland, Brisbane, Australia; University of the Sunshine Coast, Maroochydore, Australia.
Professor Beverley Yamamoto. Osaka University, Osaka, Japan; Hereditary Angioedema Japan (Registered NPO), Hyogo, Japan; Hereditary Angioedema International (Registered NPO/Charity), Fairfax City, VA, USA. Patient author.
Richard Stephens. Consumer Forum, National Cancer Research Institute, London, UK; Research Involvement and Engagement, London, UK. Patient author.
Dr Dawn Lobban. Envision Pharma Group, Wilmslow, UK.
Hiroko Ebina. Envision Pharma Group, Tokyo, Japan.
Dr Lauri Arnstein. Envision Pharma Group, London, UK.
This is the first article in a two-part series on patient authorship. The second article will be posted in late May 2020.
There are two types of medical publication professionals in this world…
Patient authorship belief graphic by Envision Pharma Group, 2020; CC BY 4.0.
As a medical communication professional, you will need to decide what YOU believe when it comes to patient authorship. What is your position on it right now? Like other ISMPP members, you may have questions about patient authorship. This is not surprising – patient authorship is an innovation in publications, especially for publications of company-sponsored research.
The purpose of our article, co-authored by patients and medical communication professionals, is to provide answers to key questions about patient authorship. Where possible, we share practical examples from our real-world experience of being patient authors or working with patient authors. We disclose upfront that we are advocates for patient authorship and recognize that patient authors are most likely to be expert patients (eg, leaders in the patient community).
We present this article in two parts:
- In Part A, we highlight factors driving patient authorship and answer Question 1: “What are the potential benefits for industry sponsors that encourage patient authorship and the potential risks for those that do not?”
- In Part B, we provide practical tips as we answer Question 2: “How can patient authors meet the first ICMJE [International Committee of Medical Journal Editors] criterion?” and Question 3: “What challenges might patients face when becoming authors and how could medical communication professionals help address these challenges?”
Even if you have not worked with patient authors directly, it is important to recognize that patient authorship is a reality. Patients have already authored peer-reviewed publications in:
- General medical journals (eg, https://pubmed.ncbi.nlm.nih.gov/27919865/)
- Specialist medical journals (eg, https://pubmed.ncbi.nlm.nih.gov/28289895/)
- Industry-focused journals (eg, https://pubmed.ncbi.nlm.nih.gov/26539338/; includes co-authors from Pfizer, Novartis, UCB Pharma, GlaxoSmithKline, Merck)
- Patient-focused journals (eg, https://pubmed.ncbi.nlm.nih.gov/29152330/)
- Non-English-language journals (eg, https://pubmed.ncbi.nlm.nih.gov/31501361/).
Further, in our continually evolving publication environment, patient authorship is expected to increase (see Table 1 below). If you don’t prepare for patient authorship now, you risk being left behind.
Table 1. Factors driving an increase in patient authorship
|Encouragement or requirement by major funders to involve patients as authors and research partners (eg, Patient-Centered Outcomes Research Institute, USA; National Institute of Health Research, UK; National Health and Medical Research Council, Australia; Agency for Medical Research and Development, Japan).|
|Encouragement of patient authorship by peer-reviewed journals embracing patient involvement in research (eg, The BMJ, Research Involvement and Engagement).|
|No objections to legitimate patient authorship, with appropriate disclosures, by the International Committee of Medical Journal Editors (ICMJE; http://peterbates.org.uk/wp-content/uploads/2017/04/how_to_involve_the_public_as_co-authors.pdf).|
|The availability of evidence-based recommendations on how to maximize the benefits and minimize the risks of patient authorship (Arnstein L et al. Research Involvement and Engagement. 2020; In Press; Arnstein L et al. Current Medical Research and Opinion. 2019. https://www.tandfonline.com/doi/full/10.1080/03007995.2019.1587943).|
|The development of training courses for patients on how to author publications (eg, modules for the 2020 Workgroup of European Cancer Patient Advocacy Networks [WECAN] Academy co-developed by PatVocates, Envision Pharma Group, and a Patient Editorial Board https://wecanadvocate.eu/?fbclid=IwAR2XzaEUPJj7g_5nAt_5h9rfqtqEW1Ymk5fgVlilXVo-GfhwegRwQrhyLog).|
|Involvement of patients in Trial Steering Committees leading to consideration of authorship on trial-related publications (eg, patients are members of Trial Steering Committees on approximately 20% of academic cancer research studies in the UK; R. Stephens, personal communication).|
|Facilitation of patient-led research leading to patient-authored publications (eg, https://plrh.org/about-us/; https://blogs.bmj.com/bmj/2019/11/12/trisha-greenhalgh-towards-an-institute-for-patient-led-research/).|
|Industry innovators establishing global processes for Patient Publication Steering Committees and for involving patients as authors (abstract accepted for DIA Annual Meeting 2020).|
What are the potential benefits for industry sponsors that encourage patient authorship and the potential risks for those that do not?
Non-industry sponsors (eg, from academia, government, not-for-profit sectors) have led the way in encouraging the innovation of patient authorship. Among industry sponsors, the “early adopters” are publishing papers with patient authors and benefitting from doing so (see Table 2 below). As with any innovation, however, there will be “laggards.” Sponsors that do not encourage patient authorship will face risks (see Table 2 below).
Table 2. Potential impact for sponsors that do or do not encourage patient authorship
|Factor||Potential benefits to sponsors that DO encourage patient authorship||Potential risks to sponsors that DO NOT encourage patient authorship|
|1. Impact on publication plans and medical plans||Increased confidence that publication and medical plans will address topics that have real-world relevance.||In an era of shared decision-making and patient-oriented research, publication and medical plans will increasingly need to address topics of real-world relevance to healthcare professionals and patients. Sponsors that fail to consider including patients as authors risk developing publications that are less relevant to an increasingly large and important global audience.|
|Justification of priorities in publication and medical plans based on input from patient authors (eg, secondary outcomes, post-hoc analyses, unmet needs for future research).||Lost opportunities to co-author publications with patients that contribute to important debates and discussions in the peer-reviewed literature. Patients will continue to author publications and pursue important real-world research with other sponsors, non-industry sponsors, or on their own (ie, the hesitant or laggard sponsor will be left out of this research and publication pathway).|
|Clarification of areas of disconnect between patient and healthcare professionals, which can then be identified in publications and addressed in medical plans.||The failure of publications to reach patient communities. These communities can be strong advocates for published research with healthcare professionals, regulators, and reimbursement authorities.|
|Faster, better, and easier preparation of plain language summaries of publications.||Late entry into patient authorship could have a negative effect on patient involvement in upstream activities (eg, contributing to Trial and Publication Steering Committees).|
|Increased awareness of the publication via patient communities and social media (patient authors are likely to become champions for the integrity and value of the work, as well as strong advocates for publishing in open-access journals).|
|Patient-led support for evidence-based, appropriate use of medicines (especially new medicines) based on patient-authored publications of clinical trial and real-world publications.|
|2. Relationships with patient communities and other stakeholders||Potential to enhance the level of trust between patients, researchers, and industry.||Public criticism from patient communities. Patients are working with and seeing sponsors encouraging patient authorship. Patient communities may question or publicly criticize those sponsors that exclude them from publications. Attitudes that “patients can’t be authors” or “publications are not for patients” can be out of step with the current views of many other key stakeholders. Further, these attitudes may raise concerns about equity. For example, if both a clinician and a patient advocate were not involved in the study design, but could still be considered for authorship, is it fair to be more accepting of involving the clinician as an author, but not the patient advocate?|
|Positive recognition of a sponsor’s leadership in patient authorship by patient communities and other stakeholders with a keen interest in patient involvement in research (eg, funders, regulators, journal editors, publishers, reimbursement authorities).|
|Patient authors could extend their relationships with sponsors to add unique value to other areas of the business (eg, peer review of grant submissions and investigator-sponsored research proposals).|
|3. Sponsor reputation||Tangible demonstration of how patients, researchers, and industry sponsors can work together, ethically and effectively.||Late entry into patient authorship could lead to an inefficient and inferior experience for patient authors with that sponsor compared to other sponsors. Early adopters have worked with patient authors to develop streamlined processes.|
|Tangible demonstration of patient-focused innovation that can be shared across and beyond the sponsor’s organization.||Other areas of the sponsor’s company (eg, clinical research, market access) that may have embraced patient involvement could be negatively impacted (ie, hesitancy or refusal to support patient authorship or the negative experience of patient authors could cause other patients to reject that sponsor as a “partner of choice”). This could undermine highly visible areas of the business (eg, hindering trial recruitment and retention leading to delays and additional costs).|
|Damage to the sponsor’s brand as an innovator when the sponsor is unable or unwilling to embrace patient authorship.|
|Perception of tokenism. Taglines or branding that indicate the company is patient-focused could be seen as tokenistic when sponsors refuse to partner with patients or do so only when forced to (eg, to keep up with the competition).|
To conclude Part A of this two-part article, we encourage ISMPP members and the broader publication community (including patients and the public!) to consider their position on patient authorship. Are you a believer? Are you open to change? In Part A, we have stressed that patient authorship is already happening and identified factors that will contribute to its increase. We have also described the potential benefits to sponsors that encourage patient authorship and the potential risks to sponsors that don’t.
As ISMPP members gain experience with patient authorship, it will be important to share practical insights on how to involve patients as authors, ethically and effectively. As medical communication professionals, we should be able to help optimize the patient authorship experience for patient and non-patient authors. In Part B, we will focus on sharing practical insights from our experience of working as or with patient authors.
 We use a broad definition of patient, ie, people living with or affected by a condition (can include family, caregivers).