Jane Blyth, BN (Hons), RGN, DN, RN, ISMPP CMPPTM, Complete HealthVizion*, Glasgow, UK; Mary Gaskarth, MA (Hons), PhD, ISMPP CMPP™, CMC AFFINITY*, Macclesfield, UK; Andrea Plant, BSc (Hons), PhD, ISMPP CMPPTM, Caudex*, Oxford, UK; Kathryn Woods, BSc (Hons), PhD, ISMPP CMPPTM, Complete HealthVizion*, Macclesfield, UK
*Complete HealthVizion, CMC AFFINITY, and Caudex are divisions of McCann Health Medical Communications, which is part of the McCann Health network.
| Patients have the most to gain from the research and development of medicines. Their perspective on the development of new treatments is critical and should be valued alongside that of the investigator and sponsor. The pharmaceutical industry is taking action to ensure patient engagement is more than a token gesture; but when it comes to data access and communication, patients are still waiting for their seat at the table. Medical communication professionals have an important role in encouraging and facilitating the communication of medical research to non-specialist audiences. |
Improving patient involvement in communication of published data – the logical next step in patient-centricity
The pharmaceutical industry is increasingly aware of how much can be learned about a disease and the unmet needs in treatment and care from the perspective of the patient. Many pharmaceutical companies are now partnering with patient organizations, charities, and advocacy groups to increase disease awareness and education for the community as a whole and to better understand what the industry needs to achieve in order to improve patients’ lives. But how much does this partnership really shape drug development activities? Research conducted by Geissler et al suggests that patients can and should have meaningful involvement in all aspects of medicine development – study design and planning, research conduct and operations, data dissemination and communication, and post-approval activity.1 For patients to be able to contribute in this way, it is important that they are valued as a priority audience for the findings of major clinical trials and all other stages of research. This gap needs to be addressed in order to be truly patient-centric.
| The responsibility for communicating with patients should not lie with patient groups and charities. Data owners need to recognize the value of communicating biomedical research in a patient-friendly format. As publication planning professionals, there is the potential to make a difference and ensure data owners meet this critical responsibility by advocating that the latest peer-reviewed research is accessible to all. |
Patient access to published research – changing content style is just the start…
Patients have ready access to a plethora of medical content online, but how easy is it for them to find peer-reviewed, published research without journalistic interpretation or social media opinion? Even for open-access journal content, is the journal article format itself a barrier to gaining information, not only for patients and caregivers but also for time-poor specialists and other healthcare providers? Publishers have increased the visibility of published research by providing open-access options and alternative content formats, such as video abstracts, alongside articles, and some journals are now requesting submission of plain-language summaries (PLS) in order to communicate research to the important non-specialist audiences. However, recent research from Narayanan et al, presented at the 2018 Annual Meeting of ISMPP, showed that very few journals are publishing PLS and that many of the PLS they reviewed still used technical language that patients may find difficult to comprehend.2 The poor availability of PLS is surprising given that many patients are seeking out medical information, as was demonstrated in surveys conducted by Pushparajah et al, who found that most patients agreed that health-related information should be made available to them in an accessible and easily understandable format. Most of the physicians surveyed rated PLS as valuable (46%) or neutral (46%).3 In addition, the patients surveyed noted a preference for using general internet searches or patient organization websites over medical journals for disease-related information.3 Thus, having a PLS available only on a journal website is no guarantee that the information will reach its intended audience.
The European Union (EU) Clinical Trials Regulation of 2014 requires sponsors to provide summary results of clinical trials in a format understandable to laypeople.4 Trial summaries are expected to become mandatory in 2019, once the necessary EU database becomes available. Lay summaries of clinical trials are not the same as PLS, but this development could help all parties to become more familiar and comfortable with providing and accessing PLS for peer-reviewed publications. However, this development also raises the question of where to host PLS. Cochrane have led the way in terms of accessibility, by making PLS available for all of their reviews via the searchable Cochrane Database of Systematic Reviews. Many publishers have moved to start including PLS in their journals: for example, all ADIS journals will accept a PLS submitted by the authors, such as this example from Rheumatology and Therapy; and Elsevier are supporting the provision of PLS for selected papers, hosted on the homepages of several of their journals, including the Journal of Hepatology and Epilepsy & Behavior Case Reports. For all publishers, it is reasonable that they will want to retain control of content published in their journals, but hosting PLS on external platforms does not necessarily mean loss of control. For example, The BMJ is partnering with KUDOS to allow authors to provide a PLS developed according to a structured template, which, upon acceptance of the paper, is hosted on the KUDOS site, but can also be shared by the authors via social media, academic sharing sites, email, and professional networks.
So, what can be done to improve access to published research? How far has the use of PLS progressed at the start of 2019, and what can be done differently now to make a positive difference for patients tomorrow?
At the 2019 European Meeting of ISMPP, several PLS research studies were presented, sparking lively debate around the posters, at associated roundtables, and within the parallel session on “Innovations in Data Publishing.” The work of FitzGibbon et al highlighted the problem of a lack of consistency between biomedical journals in how PLS are referred to, journal requirements, and where PLS are located. Such inconsistency does little to help intended audiences find and use PLS.5 Another study presented at the European Meeting demonstrated that the value of PLS can go beyond journal articles. The study by Chari et al found the American Society of Clinical Oncology (ASCO) to be an engaged partner when they investigated the feasibility of working with patients to create PLS for scientific congress abstracts.6 Importantly, all developed PLS were accessed during the ASCO congress. Furthermore, the authors concluded that patient involvement added substantial value to the PLS development process.
One of the major barriers to patients engaging with published research is the level of technical language used in journal articles – the shorter length and less technically focused content of a PLS can help to tackle this issue. Martínez Silvagnoli et al investigated PLS format preferences among different patient groups and found that infographic-style summaries were preferred. When choosing between text-only PLS formats, patients from the specific therapy area groups preferred medium-complexity versions with a reading age of 14–17 years.7 One of the great benefits of PLS is the opportunity for publishers to provide content that is not constrained by the structure limitations of a journal article, so it would be counterintuitive to suggest PLS should follow a set structure. However, there are some key points to consider when writing PLS:
- Use short sentences and short words – avoid complex grammatical structures
- Avoid jargon, but use technical words when needed
- Use accessible, conversational language and the active voice
- Filter out unnecessary detail and start with the take-home message
- Bring content to life with analogies and examples
- Use tools in Word (Flesch reading ease and Flesch-Kincaid Grade level) to assess readability of text
- Format – use left aligned rather than justified text, use bold for key points, use headers, use bullets sparingly, add visuals where possible, and use graphs and figures with consideration
- Consider involving patients in writing or reviewing the PLS to ensure they are appropriate for the audience
All parties, including authors, sponsors, and publishers, have a role in making PLS engaging as well as easy to find and freely accessible (see Figure 1 below).
Figure 1. How to develop and deliver successful PLS
What are the next steps to support the advancement of PLS?
Why are more journals not embracing PLS as a way to disseminate the latest research to a wider audience? If the healthcare community is truly invested in engaging and valuing the patient voice, why are PLS not required for more articles – even for all articles? Journal editors themselves may be grappling with the dilemma of whether it is a core element of their mission to communicate to non-specialist audiences. One issue is concern within the pharmaceutical industry that by describing findings using more accessible language than the scientific vernacular typical of primary research articles, PLS may be perceived as being promotional. Perceived duplicate publication is another challenge. However, if PLS summarize but do not generalize findings, are peer-reviewed alongside all other elements of an article, and are published within that article or on a recognized third-party platform that clearly cites and links to the original article, the issues of perceived promotion and duplicate publication should be surmountable. Research authors are used to writing to communicate with their peers but are often inexperienced in writing in the very different style needed to engage broader lay audiences. Authors may also be reluctant because, in embracing plain language, they may feel they are relinquishing power and knowledge. As specialists in distilling complex data into accurate, engaging communications, publication professionals are ideally placed to advise and support investigators and the pharmaceutical industry on these important areas when developing PLS.
PLS have a central role to play in opening up the latest scientific research to wider audiences. They may even prove a useful tool in moderating media inflation of research findings and the battle against fake news. Isn’t it time for patients to be fully embraced as an equal audience and partner in communicating medical research? And shouldn’t the healthcare community stop looking for reasons not to move ahead with PLS?
Acknowledgments
The authors would like to thank Rhiannon Meaden, BSc (Hons), PhD (Complete HealthVizion), and Ray Magee, BSc (Hons), PhD (CMC CONNECT) for conceptual contributions to the article. Complete HealthVizion and CMC CONNECT are divisions of McCann Health Medical Communications, which is part of the McCann Health network.
References
- Geissler J et al. Improving patient involvement in medicines research and development: a practical roadmap. Ther Innov Regul Sci 2017;51:612–619
- Narayanan R et al. Patient lay summaries in biomedical journals: what and how much is currently available? Presentation at the 14th Annual Meeting of ISMPP, 2018, National Harbor, MD, USA
- Pushparajah DS et al. Value of developing plain language summaries of scientific and clinical articles: a survey of patients and physicians. Ther Innov Regul Sci 2018;52:474–481
- Regulation on clinical trials on medicinal products for human use. 16 April 2014. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf. Accessed April 1, 2019
- FitzGibbon H et al. Where are biomedical research plain-language summaries (PLS)? Poster presentation at the 2019 European Meeting of ISMPP, London, UK
- Chari D et al. Developing plain language summaries of scientific congress abstracts – with patients, for patients: a feasibility study. Poster presentation at the 2019 European Meeting of ISMPP, London, UK
- Martínez Silvagnoli L et al. Evaluation of plain-language summaries (PLS): optimising readability and format. Presentation at the 2019 European Meeting of ISMPP, London, UK