Patient and caregiver authorship

Patients and caregivers can be byline authors of peer-reviewed publications when they meet the authorship criteria that every author meets, and they bring to the work their lived experience of a disease or condition. Whether patient authorship works in practice turns on how the patient's role is shown without exposing their illness, how they are invited and how they are trained and supported through the publication.

Who counts as a patient author

Patient authorship is a relatively new phenomenon, part of the patient engagement movement, in which people with lived experience of a specific disease or condition are listed as byline authors of peer-reviewed publications. ^{1, 2, 3} The concept arose because of the substantial contributions that patient partners are starting to make to medical research and its dissemination. ² "Patient" here includes caregivers, family members and representatives of patient associations, and where the patient is a child the caregiver may be better placed to take the role. ^{4, 2} So "lived experience author" may be a more precise term than "patient author". ²

Another definition ties patient authorship to the criteria journal editors apply: it is when patients meet the criteria required to be listed as authors on a peer-reviewed publication, such as the International Committee of Medical Journal Editors' recommendations, with "patients" used in the European Patients Academy's broad sense of individual patients, carers, patient advocates, patient organisation representatives and patient experts. ⁵

Patient authors have played a meaningful role in producing a publication and sometimes in leading it. ⁶ Patient authorship is common where a publication describes patients' or caregivers' experiences, needs or expectations, or where a person with lived experience adds important perspective, as in rare diseases, where clinicians and researchers may have limited knowledge. ⁶ Patient authors of company-sponsored publications are often experienced patient advocates or leaders of patient organisations, and some are researchers or clinicians themselves, while others have little experience of medicine or publications. ⁷

What patient authors add

Patient and caregiver authors can help improve the relevance and reach of peer-reviewed publications, especially those that describe patients' experiences. ^{8, 1} Patient authors add value by validating the need for the research and its relevance and value and by increasing the credibility of and trust in its results. ⁴

Writers who provide publication services to patient authors, and who advocate involving patients in medicines development, hold that patient authors can help plan, generate and share publications, enhance their real-world relevance by identifying unmet needs and sharing insights from lived experience, and extend their reach by developing and disseminating plain language summaries. ^{9, 10, 11} With appropriate training, in the same writers' view, medical communicators are well placed to support and guide patient authors, and they can benefit from the personal and professional rewards of doing so. ^{10, 11} A systematic review of patient involvement in publications, coauthored with patients, identified benefits to three parties: to publications, such as real-world relevance and broader dissemination; to patient authors, such as respect for their input and new skills; and to nonpatient authors, such as access to new funding and new research topics. ¹² Patients can add important context, clarity and perspective to results through their lived experience, and they may be the only authors with firsthand knowledge of living with the disease around the clock; they can also facilitate broad and timely dissemination of relevant information and help identify and prioritise the unmet needs that future publication plans could address. ¹³ As one rare-disease patient advocate and patient author puts it, "Patient authors can help make publications relevant and readable. Change the input, enhance the output." ¹¹

Patient authors and the authorship criteria

All four ICMJE authorship criteria can be met by people with lived experience, and academic credentials are not required. ¹⁴ A substantial contribution need not cover every aspect of the research: for a patient or caregiver it could be bringing their perspective to interpreting and communicating the results, and partnering with patients or caregivers is encouraged for plain language summaries within publications and for stand-alone plain language summaries of publications. ¹⁴ Like other coauthors, patient partners need not write the manuscript but can contribute as critical reviewers of its content and writing. ¹⁴ The last two criteria, final approval and accountability, require only that patient partners are educated about what the criteria imply and that their agreement and compliance are ensured. ¹⁴ Based on existing guidelines, people with lived experience can, and in many cases should, be included as authors of peer-reviewed publications. ^{14, 15}

The 2022 update of Good Publication Practice validates the concept directly: "Patients and patient advocates may be included in publication planning and development, including as authors or contributors to publications, as appropriate to the topic or therapeutic area." ^{16, 17} It recommends the ICMJE authorship criteria for all authors, patients and caregivers included. ¹⁸ In 2024 the Guidance for Reporting Involvement of Patients and the Public, version 2 (GRIPP2), was the main guideline for patient engagement in research; it listed the items to include in publications involving patients or the public but gave no guidance on authorship. ^{16, 14}

Patient advocates can review or even co-author journal manuscripts, and patient authorship is consistent with the ICMJE recommendations; in July 2024 a special issue of the British Medical Journal was patient focused. ¹⁹ In spinal muscular atrophy, for example, a panel of experts that included patient organisations helped design a qualitative interview and survey study of the clinical meaningfulness of a pivotal trial's primary endpoint, and the patient experts are co-authors of the resulting publication. ^{20, 21}

Patient authorship should follow the established processes for authorship, such as meeting the criteria and submitting disclosures. ²² In one publication professional's view, the qualifying contribution need not be to the study design, and a patient could contribute through the analysis instead. ²³ In the same view, as involving patients in the design of trials becomes more common, a patient or patient advocate called upon to comment on a study protocol is building the credential to be an author. ²³ Not every journal applies the ICMJE criteria, and where a journal's criteria differ, that could affect whether a patient qualifies. ²³

Two cases from one publication team show patients qualifying. In analyses weighted toward real-world evidence, the patient authors had been involved in discussing the best endpoints for trials and took part in the discussion afterwards, so they qualified. ²⁴ In disability research, a body of clinical data mattered to a particular patient group, so the group was brought back in, retrospectively, to write a patient-focused summary of the whole set of trials for a journal interested in that perspective; its members qualified for authorship because they wrote the review and took part in deciding what was important from their own standpoint. ²⁴

The medical research community has nonetheless expressed doubt that people with lived experience can or should be byline authors of peer-reviewed publications. ⁴ In a survey of 112 editors-in-chief published in 2021, nearly a third considered patient authorship inappropriate, about one in six thought patients should have an academic affiliation, and about a third felt the ICMJE criteria should be revised to accommodate patient authors, some of them in the interest of protecting privacy or of defining responsibilities more clearly. ⁴

Education about patient authorship is another barrier to its adoption. ¹⁴ Patient and caregiver partners need to understand their responsibilities as byline authors, so that they can decide whether to accept and how their contribution should be stated. ¹⁴ Clinicians and other stakeholders need to know that patients and caregivers can be authors and can add value to a publication, which can help patient and caregiver authors feel accepted as part of the authoring team and better navigate its dynamics. ¹⁴ Detailed guidance on both is available in two publications. ¹⁴ As long as they meet the authorship requirements, patients and caregivers should be able to be byline authors, and work is still needed to encourage it in the medical research community and to agree how to identify authors with lived experience in a way that respects their privacy. ^{1, 25}

How common patient authorship is

In 2020 the prevalence of patient authorship was unknown and difficult to measure, but it was happening: patients had authored peer-reviewed publications in MEDLINE-listed general medical, specialist, industry-focused and patient-focused journals, including publications coauthored with employees of pharmaceutical companies such as Pfizer, Novartis, UCB Pharma, GSK and Merck. ^{26, 27, 10} Those precedent publications challenged the view, held by some industry employees, that "patients can't publish", and they were expected to help address compliance concerns about whether patients can meet the authorship criteria in publication guidelines and standard operating procedures. ²⁷ Patient authorship was expected to become more prevalent because influential funders such as the Patient-Centered Outcomes Research Institute, patient advocacy organisations such as Patient Focused Medicines Development, and journals such as The BMJ were encouraging it. ²⁷

By 2024 the number of peer-reviewed publications with patient authors was low but rapidly increasing, practices for including patient authors remained heterogeneous, and clear standards were lacking. ⁴ Partnering with patient authors is increasingly encouraged, by patient advocacy groups, healthcare professionals, medical journals, academic institutions, pharmaceutical companies, and regulatory and health technology assessment agencies. ^{4, 6} Publishers should encourage and facilitate the ethical involvement of patients and caregivers in medical publications. ^{18, 28} As patient authorship becomes more common, medical writers are more often asked to collaborate with and support patient authors, including on company-sponsored publications. ^{6, 29}

A rapid review searched Embase and MEDLINE on 20 June 2024 for peer-reviewed articles in English on the experiences, views and values of patients with rare diseases, and counted those with patients, caregivers or patient organisations as author affiliations. ^{8, 30} It identified 197 such articles, 13% of the 1494 articles on those experiences published from 2004 to 2024; their number had increased since the first in 2004, and their proportion increased steadily to 22% in 2021 but had fallen since. ^{31, 32} The commonest article types were qualitative study or survey (31%), consensus, guideline or recommendation (22%) and review (16%). ³² Of the authors identified as patients or caregivers, 95% were affiliated with rare disease associations, and the term "patient author" was the affiliation of only a single article. ^{32, 15} A consistent way of identifying patient and caregiver authors in databases is needed to understand their role and impact better. ³¹

Identifying patient authors without exposing them

A main issue limiting patient authorship is a lack of clarity about how a patient's or caregiver's role in preparing a publication should be shown: there is no systematic way of showing it, so finding publications with patient or caregiver authors is time-consuming and inexact. ¹⁵ In 2020 an efficient way to identify patient-authored publications was proposed for research on patient authorship: patient authors would list at least one of their affiliations as "Patient Author", which would let publishers submit tagged publications to PubMed and researchers retrieve them with an Advanced Search on that affiliation. ³³ The function had been tested and worked, though few publications were yet tagged, and its proposers were working with patient advocates and publishers to encourage the tagging. ³³

An affiliation of "patient author" or "patient/public author" has been proposed, but patients and caregivers may not want personal information about themselves or their family members made public. ¹⁵ Listing a patient advocacy group or association as the affiliation, as most patient and caregiver authors of the rare-disease articles in the rapid review did, may help keep their illness or condition confidential while giving them a respected affiliation, and authors who have both lived experience and an academic or professional affiliation may choose to make only the latter public. ¹⁵ An alternative to tagging individual authors could be a searchable field indicating simply that people with lived experience took part as authors. ¹⁵ Patient and caregiver authors should be made aware of what it means for identifying information such as their name, disease state and treatment history to be perpetually available on journal websites, indexing services and search engines, and some publishers may require them to complete consent forms for the use of that information. ²⁸

Preparing as a writer to work with patient authors

Writing for patients may be familiar territory for some medical communicators while working with patients as authors may not be, and patient authorship opens new opportunities for them to support and guide patient authors on publication norms, review processes and the roles and responsibilities of authorship. ¹³ Medical communicators need to gain knowledge of emerging patient authorship resources and guidelines and to develop an appreciation of what patient authors bring to publications. ¹³ Preparation starts with the writer, who should address any personal bias against patient authorship, such as the belief that patients cannot meet the authorship criteria; patient authors are here to stay, and medical communicators must adapt. ³⁴ The writer should also know how to find the patients who may be most suited to authorship. Patients' diversity must be respected, because in involving patients in medicines development, publications included, "one size does not fit all". ³⁴ In 2020 processes were emerging for identifying and selecting candidates, such as a patient author selection matrix built on prespecified, justifiable and transparent criteria. ³⁴ A "patient expert", with lived experience and an understanding of the key principles of research ethics and practice, may be the type of patient most likely to have the capacity and capability to author publications. ^{34, 35}

Patients range from noninformed "Dr knows best" patients through informed "information seekers" to informed and empowered "patient experts", and medical communicators may be most likely to work with patient authors who are informed and empowered. ^{34, 36} Two questions follow for a team: which patients may be most interested in authoring peer-reviewed publications, and whether they are represented on the authorship team and on any publication steering committee. ^{37, 36}

The rest of the preparation recommended in 2020 is this. ³⁴

• Engage patients as authors according to published best practice.
• Make sure patient authors know their rights and responsibilities as authors, for which a plain language summary of Good Publication Practice 3 was available.
• Evaluate the experience for patient and nonpatient authors, so that it keeps improving.
• Review and apply the evidence on maximising the benefits and reducing the risks of involving patients as authors.
• Use the GRIPP2 guidelines when reporting patient involvement in research, including patients as authors.
• Follow and contribute to the #GPP4 and #PatientAuthor discussions on Twitter, the first to help make sure the fourth edition of Good Publication Practice would address patient authorship, plain language summaries and publication steering committees, the second for examples of patient-authored publications.
• Complete AMWA's online patient authorship course for medical communicators.
• Help build the evidence base by publishing papers about the patient authorship experience.
• Be prepared for the enjoyment and pride of working with patients on publications that focus on their real-world needs.

^{34, 36}

The world's first patient coeditor of a MEDLINE-listed journal, the patient co-editor in chief of Research Involvement and Engagement, has called for such papers and puts the case as "Of course patients should be involved as co-authors of medical research papers. It's our story you're telling." ^{36, 38, 39, 10}

Inviting a patient author

An invitation to authorship can fail even when the patients have been involved from the start, as it did in one pharmaceutical company's Patient-involved Publications (PivoP) project. ^{40, 41} The project's vision is that including patient perspectives makes publications more relevant to the real world and supports shared treatment decisions between patients and physicians. ⁴¹

The case was the company's first collaboration with a patient advocacy group from study planning to publication, with NPO Breast Cancer Friendship Association Kirara, on a web-survey observational study, published in 2022, of adherence to adjuvant endocrine therapy in early breast cancer and of what demotivates or motivates patients to continue a treatment recommended for 5 to 10 years. ^{41, 42} The plan was to involve the group's patients in study planning and data interpretation and then to co-author the manuscript, its plain language summary and a congress abstract and presentation with the same patients. ^{43, 44} Three members did shape the protocol, the survey questionnaire and the data interpretation, but none of the three agreed to be an author; their reasons were not wanting to disclose their name, not having enough time to contribute, and believing others more qualified. ^{44, 45} One of them, none having authored a publication before, agreed to review the plain language summary and the congress abstract and presentation, pointed out medical jargon too difficult for the audience, and suggested better visual aids. ^{44, 45} The group valued being involved and being acknowledged in the publications, and recognised that the publications raised awareness of the importance of shared decision-making. ⁴⁴

The company traced the refusal to two mistakes of its own. ^{46, 47, 48} The first was the order of the conversation. ⁴⁷ Assuming that patients already involved in planning would want to co-author, and drawing on its practice with authors in general, the company focused more on explaining the authorship criteria and the publication rules than on discussing why reflecting patient perspectives mattered, why it wanted to co-create the publications and what it hoped to achieve. ⁴⁷ It also did not fully consider what would deter the patients from authorship: that a published name is a public announcement of an illness, or that physical and mental condition might not allow participation. ⁴⁷ The group's president observed in it a similar lack of communication to what sometimes happens between patients and physicians in clinical practice. ⁴⁷ The second was not separating two sets of expectations. ⁴⁸ For study planning the company wanted lived experience, without any need for motivation to take part in publication work, whereas authorship needed patients who understood publication activities, were willing to take part in them and would give input on behalf of the patient community. ⁴⁸ The company had not clarified these expectations before asking the group's president, who had been asked for patients of varied age and work status, to introduce candidates. ⁴⁸

The remedy reverses the order. First share the value of patient authorship, which is patients' insight into their disease that clinicians and companies may lack and which clarifies where patients and healthcare professionals disconnect, so that publications become more relevant and support shared decisions, and describe the author's role in concrete terms; only then explain the authorship criteria and rules. Discuss how participation could help the group's community and patients generally, communicate closely, leave enough time for explanation and questions, validate concerns, and keep in mind what candidates do and do not know about being an author. ⁴⁹ Clarify the expectations before asking, convey them, involve patients who can meet them, help them meet them since most patients have never co-authored a publication, and obtain their agreement before publication work starts. ⁵⁰ The company's expectations of a patient author, with what the company should do so that they can be met, are these. ⁵⁰

• Understand and accept the company's publication activities and recognise the value of patient authorship in the publication: communicate that value fully, give candidates enough time to decide, and answer their questions.
• Have enough knowledge, experience and understanding of the disease and of the general roles of publications: provide relevant information as needed, and answer questions.
• Understand the rules of authorship and publication guidelines: explain them in plain language, and answer questions.
• Be willing to share their own opinions to improve the publications: explain the research plan and data, and schedule meetings as appropriate on the publication content and the key points of the review.
• Be able to confirm independently that their opinions are reflected in the publications and to point out where they are not: notify them of review periods in advance, and answer their questions while they review drafts.
• Be able to secure the time to review publication drafts as scheduled.

⁵¹

Approaching a patient who already has the knowledge and experience, such as a patient advocacy group's president, may work better, because such a person is likely to understand why patient involvement in publications matters and to meet the expectations. The account rests on a limited number of the company's projects, so other challenges may not yet have been identified. ⁵²

Training and supporting patient authors

Patients and caregivers may contribute to the design and conduct of the research or sit on publication steering committees, but some patient authors are brought in only once writing starts, and in the worst cases they are added only to increase a publication's credibility, which is tokenism. ⁷ Patient authors are emotionally invested in advancing knowledge of a condition affecting them or someone they care for, so they want their perspective considered. ⁷ They may need additional time to understand complex information or to complete their work and resources to deal with physical challenges; they may lack knowledge of the publication process, author responsibilities, ethical issues and scientific or statistical issues; they may not know where to seek advice and support or how to collaborate with a professional medical writer; they may feel intimidated or not respected by experienced clinicians or researchers and not know how to navigate the power dynamics of the publication process; and they may have to deal with any existing relationship with a member of the authoring team, such as a physician who cares for them or their family member. ⁷ Feeling intimidated by or inferior to experienced clinicians and scientists on the team can leave patient authors not speaking up, not asking questions and generally overshadowed, and less experienced patient authors especially may find it hard to contribute their lived experience effectively. ^{53, 54, 29} Because their knowledge and experience vary, a writer should first meet them to determine their needs and the appropriate language. ⁷

For a patient author with little or no experience, training can start from a summary of the relevant parts of the ICMJE Recommendations, of which the part on the roles and responsibilities of authors, including the authorship criteria, matters most. ⁷ One recommendation is to insist as part of this training "that authorship is not token and that contributions are required by all authors". ⁷ Guidance on the publication process, also in the ICMJE Recommendations, should cover the steps in preparing and submitting a manuscript, how peer review works, how to deal with reviewers' comments, and how and why to complete conflicts of interest disclosures; it can help demystify the process, reinforce patient authors' understanding of authors' responsibilities and help them make sure their perspective is incorporated. ⁷ Patient authors should also be informed about Good Publication Practice, whose relevant aspects include the importance of reporting research in a complete, accurate, unbiased and timely manner, the requirement to give useful feedback at each stage of manuscript development, the privacy of patient information and the confidentiality of intellectual property. ⁷ A patient author, especially one who is not a researcher or clinician, can be helped to navigate the power dynamics of the authoring team by discussing who is on the team and their roles, the objective of the publication, who to turn to for help, how to communicate openly and clearly, the importance of lived experience and how to make sure it is incorporated, how to avoid and deal with conflict, best practices for editing, reviewing and commenting, and the role of professional medical writers, including the difference between ghost writing and professional medical writing and the value medical writers bring. ⁷ The recommended components of training for patient authors are these:

• Key guidelines: the ICMJE Recommendations and the Good Publication Practice guidelines.
• The structure and format of publications: the main sections and what belongs in each, other sections to complete such as acknowledgments, conflicts of interest and author contributions, formatting, and instructions for authors.
• The publication process: drafting and submitting a manuscript through drafts, quality checks and approvals, how the journal is selected, submission and how the journal makes its decisions, and peer review and how to respond to feedback.
• Roles and responsibilities: the authorship criteria, the patient author's role in the research and publication team, and expectations and responsibilities throughout the publication process, including timelines, reviews and providing feedback.
• The ethical responsibilities of authors: the confidentiality of intellectual property, protecting patient privacy, consent and data protection regulations, maintaining ethical standards in research and publishing, disclosing conflicts of interest and maintaining transparency, plagiarism, copyright, licensing and the sharing and reuse of published material, including articles they may be an author on, and author rights.
• Working with medical writers: the role and value of professional medical writers, why medical writers are not ghost writers, and how to collaborate effectively with one.
• How to balance personal experience with scientific data: incorporating personal experience and perspective into the manuscript, and balancing anecdotal evidence with scientific rigour.
• Communication skills: communicating with the team, for example through active listening, constructive feedback, effective questioning and email etiquette, navigating power dynamics, and commenting on and editing drafts.
• Project-specific training: the key medical and scientific terms of the research, and a basic understanding of the study design, its objectives and its statistics.
• Case studies: example publications in which patient and caregiver authors have taken part.

⁵⁵

All training, even for experienced authors, should be in plain language, which means words, grammar, structure and terminology that are easy to understand rather than dumbed-down content. ⁵⁴ For an experienced patient author it may mean avoiding complicated writing, and for a less experienced one explaining things in lay language, because an experienced author may be insulted by lay language and a less experienced one may not understand or be intimidated by technical language. ⁵⁴ A customised plain language glossary of technical terms may help a less experienced patient author. ⁵⁴ Even after training, patient authors may need continued support during the publication process. ⁵⁴ Patient authors may not feel comfortable asking questions in meetings of the full group, so a writer can be someone they turn to, spontaneously or in planned patient author meetings, can reassure them that their lived experience is valid and valuable and is the reason they were invited to be an author, and can work to make sure the authoring team understands the value of lived experience and respects the role of patient authors. ⁵⁴

A writer can mentor a patient author on the publication process, authorship responsibilities, technical terminology, study designs and statistics; advise them on dealing with strong personalities in the team, navigating difficult discussions, giving effective and constructive feedback on drafts and gaining the respect of expert clinicians and scientists; help them understand and contribute to discussions by paraphrasing discussion points in plain language and by intentionally asking them for input; ensure that their feedback and contributions are included during drafting and revision; and help resolve conflicts within the team. ⁵³ Training and support of this kind are meant to ensure that the patient author's perspective is respected and properly reflected in the publication. ²⁹

Training already available for patient authors includes the open-access online course "Patients in Publications" of the Workgroup of European Cancer Patient Advocacy Networks (WECAN), in four modules: introduction, publication planning, publication writing, and submission, peer review and beyond; the "Patient Authorship" website of Envision the Patient, with plain-language downloads on meeting the ICMJE criteria, an overview of the publications process, an infographic on the basics of conference and other abstracts, and disclosures; and the "Guidance for patient authors" website of Taylor & Francis, with basic information for patient authors. ⁵⁶

How patient authorship is changing publication practice

Because the pool of experienced patient authors was small and hard to find in 2020, publication processes would need to evolve to identify, train and mentor new ones. ²² Patient authorship might also enhance publication plans and processes by putting a stronger focus on three things: speed, since timely sharing of results is likely to matter much more to patient authors than a journal's impact factor and they can be strong advocates for reputable journals with fast turnaround; access, since they can be strong advocates for open-access journals so that paywalls do not impede dissemination; and plain language summaries of publications, which they can advocate to help nonspecialists understand recently published research and for which a free, evidence-based toolkit co-created with patient advocates, publishers, sponsors and plain language specialists was available. ²² Publishers appeared to be making plain language summaries of publications open access. ²²

In 2020 patient authorship was already changing research, technology, planning and training. ³³ It had prompted research, including a systematic review, into how to maximise its benefits and minimise its risks, which the "Patient Author" tagging would make easier. ³³ The most widely used publication management software had been updated with new metrics, so that sponsors could document and measure patient involvement in publications. ³³ Sponsors who saw the positive impact patient authors were having were looking to involve patients in planning publications, for example on publication steering committees. ³³ Patients were recognising that planning and writing publications requires certain skills and knowledge, new publication training courses were being developed for members of patient advocacy groups, and the first online patient authorship course for medical communicators was developed with AMWA's Knowledge Builder team. ³³ A growing number of journals, government agencies, pharmaceutical companies and other groups were changing their practices to facilitate patient involvement in publications. ¹³

In 2020 publication was joining study design, data and safety monitoring and needs assessment among the research activities in which the value of patients as advisers is increasingly recognised. ¹³ A broad and robust evidence base on patient authorship would help guide practice. ⁵⁷ Research on it might include bibliometric analyses of the number and type of publications with patient authors and how they change over time, real-world tests of the value of published recommendations, and a review of patient advocates' publications on the backlash that may follow when researchers leave patient authors off patient-relevant publications. ⁵⁷ Medical communicators may also be in a position to publish case studies with patient authors on what worked and what did not. ⁵⁷