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 second article in a two-part series on patient authorship. The first article (Part A) was posted on May 13, 2020.
In Part A of our article, we highlighted factors driving patient authorship and answered 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 of our article, we answer the two remaining questions about patient authorship and share practical tips to help medical communication professionals work with patient authors, ethically and effectively.
|Question 2 |
How can patient authors meet the first ICMJE criterion?
In our experience, most questions about patient authors meeting the four ICMJE authorship criteria have focused on the first criterion: “substantial contributions to the conception or design of the work; OR the acquisition, analysis, or interpretation of data for the work.” Several of us have prepared an open-access plain language tool that highlights how each of the four criteria can be interpreted from the patient author perspective (https://figshare.com/articles/Plain_Language_Summary_of_Good_Publication_Practice_Guideline/11292047), but detail here a number of ways that patient authors can robustly meet the first criterion, including:
a) Helping to design the study and review the protocol based on their own lived experience or their understanding of patient issues (especially around recruitment and retention). When researchers involve patients early enough in the process, patients can:
- Suggest and/or validate research questions that have real-world relevance.
- Identify what matters most to patients to guide outcome selection (eg, quality of life and patient-reported outcome measures). Involving patients in outcome selection is becoming increasingly important for regulatory approval and reimbursement (https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical).
- Co-design or provide feedback on the trial protocol to help reduce amendments and minimize barriers to recruitment (eg, highlighting potentially unnecessary exclusion criteria that will reduce recruitment speed and generalizability) and retention (eg, allowing for cross-over, actively engaging with patients during the extension phase).
b) Acquisition of data. With access to broader patient communities and an understanding of their priorities, patients can be well positioned to collect and analyze data. We recently completed a research study in which a patient co-author played a key role in extracting and collating data (abstract accepted for the DIA Annual Meeting 2020).
c) Interpretation of data by identifying and describing the research findings that are most important to patients. For instance, patients can provide insight as to how these findings may affect patients’ daily lives. Patient authors can help differentiate between statistical significance and clinical importance.
If patients are given the opportunity to meet this first ICMJE authorship criteria, it may be easier for them to meet the remaining three ICMJE authorship criteria. Patients who have participated in early authorship meetings have recognized that they can offer insights, ask questions, raise issues, and identify future research topics that other authors may not. These real-life authorship exchanges can help both patient and non-patient authors understand why patient authors should have a seat “at the authorship table.” With their early involvement, patient authors can also find it quicker and easier to contribute to drafts (ie, they are already familiar with the study and the data). Early involvement can also provide patient authors with more time to gain trust in their co-authors’ contributions. This can help patient authors become more comfortable in approving the final version of the publication and in sharing the responsibility to address questions about the accuracy and integrity of the report.
The position taken by some people that patients can’t meet ICMJE authorship criteria may be harder to hold as more patients author publications and as more opportunities arise for patient-led research (eg, the Patient Led Research Hub with the Cambridge Clinical Trials Unit https://plrh.org/; explanatory patient-authored publication about the Hub here https://pubmed.ncbi.nlm.nih.gov/30002875/?from_term=patient-led+research&from_pos=1). Who is in a better position than patients to author publications based on patient-led research?
What challenges might patients face when becoming authors and how could medical communication professionals help address these challenges?
Like any innovation, challenges may arise with the adoption of patient authorship. Medical communication professionals are well placed to help address these challenges, given their expert knowledge of publication ethics and guidelines, as well as their practical experience of working with different types of authors (see Table 3 below).
Table 3. Patient authorship – examples of potential challenges and solutions
|Potential challenge faced by patient authors||Potential solution by medical communication professionals|
|1. Not being involved early enough in the research process to be considered for authorship||– Advocate for early patient involvement in Publication Steering Committees and volunteer to lead the pilot! Some patient members may be interested in, and able to author, subsequent publications.|
– Encourage company colleagues to involve patients early in medicines development (eg, Advisory Board for medical plan development; Trial Steering Committees); consideration for authorship can flow on from early involvement.
– Provide practical guidance on how to find POTENTIAL patient authors and contributors. A number of organizations have offered tips on how to find patients interested in partnering with researchers (eg, EUPATI: https://www.frontiersin.org/articles/10.3389/fmed.2018.00270/full; INVOLVE: https://www.invo.org.uk/posttyperesource/how-to-find-people-to-involve/). We also recommend the use of a patient author candidate matrix to ensure that justification of author candidates is documented in a transparent, systematic, and structured manner.
|2. Lack of confidence in contributing to a publication as an author||– Share examples of publications in which patients have contributed as authors (see Part A for examples of patient-authored publications; search #PatientAuthor on Twitter for more). These examples provide real-world reinforcement that patients are contributing as authors and demonstrate that journal editors and publishers have not rejected these patient-authored publications.|
– Discuss how patients can offer a unique and important perspective. For example, they may be the only authors who know what it is like to actually live with the condition and to navigate the healthcare system.
– Share publications that are starting to show the potential disconnect between patients and clinicians (eg, identifying which symptoms are most important, prioritizing research topics). If publications only provide the perspective of non-patients, important information may be missing.
|3. Lack of knowledge or experience of authorship (eg, author roles, rights, and responsibilities; the publications process; and likely time commitment)||– Recommend training courses (eg, those now being developed by patient advocates and medical communication professionals).|
– Fund ISMPP membership, encourage the use of ISMPP materials, and support the participation of patient presenters at ISMPP and other conferences. As ISMPP has reduced membership fees for some communities (eg, for students), it may be possible to consider reduced membership fees for patients.
– Invite patient authors to attend company training courses on publication planning and development.
|4. Difficulty in understanding written agreements (eg, Authorship Agreements, Confidentiality Agreements)||– Provide a plain language guide to the Good Publication Practice 3 (GPP3) guidelines (eg, https://figshare.com/articles/Plain_Language_ Summary_of_Good_Publication_Practice_Guideline/11292047).|
– Work with legal teams to convert “legalese” into plain language.
– As an interim measure, prepare plain language guides to complex written agreements.
|5. Concerns about co-author relationships (eg, being the “new” person on an authorship team)||– Initiate patient authorship projects with lead authors who understand that patients can offer unique and valuable input.|
– Organize a call/meeting with the lead author and patient author(s) before the all-author kick-off call to help build that critical relationship.
– Ensure the role of the patient author is clear to all co-authors (ie, providing unique and valuable input from the patient perspective; the patient’s expertise complements the expertise from the clinician, statistician, scientist, medical writer, etc.).
|6. Lack of confidence in being able to understand complex scientific and statistical concepts and data||– Reassure patient authors that other authors can struggle with these issues too!|
– As research becomes more specialized or interdisciplinary, authors need to work collaboratively and recognize their co-authors’ areas of expertise (eg, economist and statistician authors can bring unique expertise to clinical publications without being clinicians). A patient author may be the ONLY author that brings “lived experience” expertise to the authorship table. Note that this expertise is not restricted to clinical research publications. The value of patient involvement is also being recognized in nonclinical research (eg, research topic identification and prioritization, translational research).
– Have a pre-call with the patient author to review key points and data likely to be discussed; focus on how these may affect the patient author’s input.
– Explain that authors should be able to convey complex concepts in a way that non-specialists can understand. A patient author can challenge or confirm how well that goal is being met.
|7. Time constraints (eg, not having sufficient time to review documents)||– Explain that all authors can struggle with meeting review deadlines and that some deadlines are externally set (eg, abstract and conference presentation submission deadlines; theme issue deadlines).|
– Check with patient authors whether they have any upcoming times when they will be unable to work on the publication.
– Provide early notice of likely and actual deadlines.
– Try to build in some flexibility/contingency planning into project timelines.
|8. Not being familiar with financial issues related to authorship||– Be upfront with patient authors about any policies and practices related to paying authors (clarify the difference between paying for authorship and paying authors).|
– Discuss potential areas for payment (eg, data collection, training time) and reimbursement (eg, to attend author meetings).
– Ensure patient authors understand and agree to the need for full disclosure of financial payments (eg, review a “mock” ICMJE Disclosure Form; https://doi.org/10.6084/m9.figshare.12044004).
|9. Not being familiar with working with a professional medical writer (ie, thinking that authorship requires them to do all the writing work)||– Provide patient author with a plain language guide to the “typical” publication process, highlighting where a professional medical writer supports the authors and how.|
– Explain the difference between ghostwriting (unethical) and professional medical writing (ethical).
– Share evidence on the value that professional medical writers can bring (eg, as cited in GPP3 http://www.annals.org/article.aspx?doi=10.7326/M15-0288 and in the AMWA-EWMA-ISMPP Joint Position Statement on the Role of Professional Medical Writers https://www.ismpp.org/position-statements-and-guidances) and explain why some (but not all) authors choose to work with professional medical writers.
|10. Not being familiar with digital systems used to facilitate communication among authors||– Check how familiar patient authors are with the tools that you will use during the project (eg, Webex, teleconference, publication management/authoring software). It is prudent to assume (without being patronizing) that they may not be familiar with the tools you use every day.|
– Provide the patient author with a practice run on any system you intend to use during the project. If you don’t, you might be setting them up for failure on their first call.
In conclusion, it is clear that patient authorship is already happening. Nevertheless, we appreciate that patient authorship is still an innovation for some medical communication professionals, particularly for publications of company-sponsored research. As professionals, ISMPP members know they need to adapt as their industry evolves. Those who adapt quickly to this evolving “patient authorship” publication environment can help other stakeholders (eg, company colleagues, non-patient authors) adapt and can drive updates to publication policies and practices.
We hope our article provides ISMPP members with practical insights into how they can prepare for and support patient authorship. We encourage ISMPP members to review and contribute to examples of and ideas about patient authorship via Twitter (#patientauthor; #GPP4). As indicated in the graphic at the start of this article series, we know that some medical communication professionals have had doubts about patient authorship, but we believe doubters can become doers. They can join their peers who, when considering patient authorship, have already made the shift from “Oh really?” to “Yes, really!”