Including the Patient Voice in Publication Planning and Development

Ideally, patients should be involved from the start and sit on advisory groups at very early-stage development. Incorporating patient voices early can help researchers identify priorities for research and design studies relevant to patients’ lived experience, including meaningful endpoints. The patient voice should be heard throughout the product life cycle, and that should include input regarding how to best communicate clinical trial and real-world evidence to patients. “That’s not the norm at present,” King said, but “that’s where we want to get to.” Involving patients in publication steering committees must also include the building of relationships with these patients and providing education on the role of publications, as well as thinking creatively about how to maximize the patient voice in committee meetings. Engaging with patients on publication steering committees can help the wider publication team and authors understand patients’ social reality, including their attitudes, beliefs and motivations. Patient perspectives can help the team plan manuscripts that center on patient voices. It can also lead the team to prioritize other types of publications relevant to patient communication. Publication Development: Patient Authorship and Review  Although patient authorship is important and demonstrably enriches articles, that does not mean their involvement is a requirement in every situation. “Patient involvement and authorships don’t need to be all or nothing. There can be a happy middle. You probably don’t need to include a patient author if you’re developing a manuscript looking at complete response rates for a new oncology product. But if that same study also included a patient-reported outcome measure, such as patient costs, losses in productivity or absenteeism, you may want to include a patient author if they meet authorship criteria.” Beth Lesher, Senior Director in Evidence & Access at OPEN Health Although we should continue to strive to include the patient as an author whenever appropriate, patient authorship requires both adherence to GPP guidance as it relates to authorship and a level of pragmatism within the professional publication community regarding realistic expectations for patient authors.1

1.  Substantial contributions to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work.
2.  Drafting the work or revising it critically for important intellectual content.
3.  Final approval of the version to be published.
4.  Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

There are ways to include the patient voice in different types of publications that move beyond traditional manuscripts. For example, including a patient perspective or commentary section alongside a publication allows the patient voice to be heard while also reaching a range of audiences. PLS are another method to facilitate the patient voice and present complex data in a way that a larger audience will better understand. Recognizing the importance of the patient voice, some congresses now allow submission of abstracts by all patient authors, which, if accepted, provides an opportunity for these patient authors to directly present a poster or oral presentation. Although these types of presentations are still novel and uptake is unclear, the fact that a growing number of publication options incorporate patient voices highlights the impetus for such publications. The number of options is likely to increase over time, offering ever more opportunities for patient involvement. It is also possible to adjust the nature of the manuscript itself to facilitate patient authorship. “One of the most exciting things I’ve worked on was a podcast manuscript that was a discussion between the patient and physician,” Imogen Allred, Senior Medical Writer at OPEN Health said. “The audio and manuscript — a transcription of the discussion, fully referenced with an abstract — were available on the journal website, and the podcast was shared via Spotify and Apple podcasts as well.” Such innovative approaches may eliminate some of the hurdles of traditional write-and-review publication development. Finally, when considering how we can involve patients in publication development, we must also ensure we understand how best to incorporate patient authors into reviews. As all authors are expected to read and review the manuscript to fulfill authorship criteria, you may need to alter your processes to effectively involve patient authors. Careful consideration of the questions we want to ask the patient will give us insights into how the data is meaningful to them. To facilitate the review and maximize efficiency, we recommend scheduling or spending time with patient authors to answer their questions and to maintain an open dialogue. It is especially important to understand how the patient author best prefers to engage in the review, because you may need to take special circumstances into consideration. For example, patients with limited vision may not be able to review work shared via email attachments or software programs. “In some cases, we’ve re-formatted documents so they work with screen readers. We’ve also made phone calls, read content to patients and asked them verbally for feedback,” Allred said. The publication team may need to build in extra time to facilitate patient involvement.