Reconvening once again in Washington, DC, the 19th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) took place from 24-26 April with the theme ‘Patients First’.

With a record-breaking 720 participants, the meeting theme explored the role of patients and patient advocates as collaborators in medical research and medical communications. Thought-provoking and engaging keynote addresses, oral presentations, interactive sessions, and roundtables addressed these topics, plus other issues relevant to medical publications and communications professionals.

A summary of the morning sessions from the second day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

 You can also read our summaries from Day 1 , the afternoon of Day 2, and Day 3. 

Summaries of the morning of Day 2

Tom Drake (Global Outcomes Group, Inc.) welcomed attendees to Day 2 of the meeting, which opened with a keynote address.

Keynote: Four crises in science and communication

KEY TAKEAWAYS

• Crises exist in science and communication but alternative research funding models, a culture of openness, the use of simple language, and artificial intelligence all provide grounds for optimism.

How well is science working? How can doctors and other medical professionals communicate more clearly with their patients and the public? How do we make sense of artificial intelligence (AI)? These were some of the topics explored by Derek Thompson (The Atlantic and Plain English with Derek Thompson podcast).

Crisis 1: The meta science question: what if we had no idea how well science is working?

Although the National Institutes of Health and National Science Foundation provide US $50 billion in funding every year, the time-consuming application process and infamously slow decisions have several negative consequences. Scientists report that they spend 20–40% of their time on grant applications rather than on science itself. This time commitment, together with the centralisation of funding, may promote conservatism and discourage much needed experimentation. Thompson suggested that initiatives such as Fast Grants, set up in response to the COVID-19 pandemic to provide rapid funding for research, could help to get interesting scientific ideas off the ground.

Crisis 2: The patient involvement question: how much feedback from patients and the public is really useful?

Thompson stated that more public conversation around science does not automatically create more wisdom: it also creates more scrutiny, debate, and conspiracy. Thompson cited high vaccine hesitancy in the US during the COVID-19 pandemic, despite the country’s key role in advancing mRNA technology. He noted that “scientists don’t get to choose the way their work is discussed; they don’t pick the terms for debate”. Although there is no alternative to openness and honesty in science, Thompson believes we need to be clear about the costs of openness but not be afraid of it.

Crisis 3: The clarity question: how can doctors and other medical professionals communicate more clearly with their patients and the public?

Thompson recommended that in this climate of openness, scientists and science communicators speak plainly and honestly to combat conspiracy. Complicated language and jargon may offer writers and speakers the illusion of sophistication but can instead make them appear less intelligent or as if they are overcompensating. Thompson asserted that using short words to express complicated truths without losing nuance is challenging, but it is our job.

Thompson recommended that in this climate of openness, scientists and science communicators speak plainly and honestly to combat conspiracy.

Crisis 4: The AI question

The final crisis Thompson highlighted relates to how we make sense of the “extraordinarily strange and wondrous and dangerous and thrilling and nerve-wracking” developments in AI. We may be entering an age in which flawed papers written by AI are difficult for peer reviewers to catch, but Thompson noted we should remain optimistic as there is great potential in generative AI tools for scientific communicators. Indeed, Thompson shared some impressive examples where ChatGPT explained new or complicated ideas using familiar metaphors: a valuable strategy for effective communication.

ChatGPT and BardAI: the dawn of generative AI in medical communications

KEY TAKEAWAYS

• Generative AI has the potential to be a useful tool in medical communications, particularly in creating plain language summaries. Transparency, validation, and proper acknowledgement are crucial.

For the second session of the day, Richard Davis (ApotheCom) led an engaging discussion on the potential role of generative AI in the medical communications sphere, with Josh Nicholson (scite.ai), Angela Cochran (American Society of Clinical Oncology [ASCO]), Joanne Walker (Becaris Publishing), and the day’s keynote speaker composing the panel.

AI as a tool for PLS

The panel discussed the challenges of distilling complex ideas into plain language and the potential power and pitfalls of AI tools in creating plain language summaries (PLS). Exact prompts must be used to achieve the right output, and ‘testing’ AI through providing more complex prompts may help to achieve the desired output. The more complex the prompt, the more parameters the AI tool has to work with, although Thompson emphasised that AI tools should be considered a smart research assistant rather than a guide. Walker suggested publishers should give authors guidance on prompts for AI tools to help develop good quality PLS, aiming to level the playing field. Cochran noted the need to ask the right questions when interacting with AI tools, voicing concerns that we may be inadequately prepared to interact with these tools at this moment in time.

Publishers should give authors guidance on prompts for AI tools to help develop good quality PLS.

How close is the answer AI gives you to the published research?

Thompson noted that sandwiching (combining a good prompt with back-end research) can help distinguish the useful parts of AI outputs. He also suggested that ChatGPT can help to frame questions, which may be useful when discussing a researcher’s work in an unfamiliar therapy area. Another strength of AI tools is that they are good at mapping one body of knowledge with another. Thompson shared the example of asking an AI tool to summarise complex information so that it could be understood by a 12-year-old.

These tools are here, and people are using them, so how do we use them transparently?

The panellists discussed the transparency of using AI tools in medical communications. Walker noted that, at this time, publishers generally agree that AI tools cannot be authors, but if they are used, they must be acknowledged. Publishers need to advise authors on how to use AI tools appropriately. Cochran acknowledged that at ASCO there is enthusiasm for using AI tools, particularly among authors whose first language is not English. The use of AI tools may also remove barriers for fatigued clinicians, allowing them to focus on clinical practice. Conversely, there are concerns that AI-generated content is not original, the systems need to be validated, and there is a need to evaluate whether the information can be trusted. In terms of disclosing AI use in a manuscript, Cochran emphasised the need for transparency and suggested disclosing:

• the AI tool used and the version
• information about what the AI tool was trained on
• the prompts used
• any potential sources of bias.

Guidelines ought to be developed to ensure transparency; however, Cochran noted that this can be challenging given the speed of change. Cochran was adamant that AI tools should never be used for opinion pieces or editorials, as publishers expect these to be original commentary from contributors. She also provided a worrisome example of a peer reviewer using ChatGPT. The use of AI was identified when the references suggested for inclusion in the manuscript were found to be invalid, AI-generated references. Walker provided a further example where she had experimented with ChatGPT to select peer reviewers for a manuscript, but the names provided were all AI generated.

The panel discussed several areas where AI tools could be beneficial:

• reducing time spent on grant applications
• generating hypotheses
• supporting with initial scans of the literature
• summarising research in a particular therapy area quickly and effectively.

Despite the potential benefits, the panel emphasised the limitation that much of the published literature currently sits behind paywalls, limiting the data sources AI tools can be trained on.

Q&A session

Some interesting points also arose during the Q&A following the session:

• When providing commentary, AI tools could help challenge strongly held author perspectives, encouraging them to recognise and evaluate the perspectives of others. They could also be used to help overcome writer’s block and generate ideas.
• There is already a need to validate the quality of information we access in journal articles; however, these issues will be accelerated and accentuated with the use of AI. Systems to fact check and verify information must be built to counter misinformation.
• Prompt engineering will be critical to improve the accuracy of AI-generated content.

Member research oral presentations

KEY TAKEAWAYS

• A study of 313 healthcare professionals (HCPs) found they spent little time reading medical publications. Omnichannel approaches—with video particularly effective—are key to reaching HCPs.
• Patient-experience publications bring significant value to health technology assessments and are increasingly common, but patient authorship on these publications is shockingly low.
• Real world data are not effectively reaching clinical audiences. Medical communications professionals should leverage audio and visual tools to improve dissemination.

Moderating, Amy Calamari (Gilead) explained that this year’s meeting saw a record-breaking 85 abstract submissions, and that the 3 chosen for presentation during this session were selected based on originality and their potential to improve practice.

What do doctors really do on the internet?

Gary Burd (IPG Health Medical Communications) presented a study investigating how 313 US healthcare professionals (HCPs) accessed medical information online over a 4-week period, using a passive digital tracking tool with full consent. Most of the HCPs were neurologists with an average of 25 years in practice.

The HCPs often had multiple windows/tabs open simultaneously on their devices, leading to 29 hours’ recorded daily activity on average. Of this, an average of 4 hours 39 minutes was spent on medical content and 24 hours 6 minutes was spent on everything else. HCPs spent minimal time on medical publications, averaging 12 minutes per day, with 1 minute 38 seconds per engagement. Burd suggested HCPs are merely reading abstracts to determine relevance. HCPs spent more time on pharma websites, although they typically did not navigate beyond the homepage and may have been accessing prescribing or safety information. YouTube was the most active platform, with oncologists and some neurologists watching long-form videos.

HCPs spent minimal time on medical publications, averaging 12 minutes per day, with 1 minute 38 seconds per engagement.

Burd concluded that HCPs typically engage with medical publications infrequently, with findings suggesting that medical communications professionals should consider utilising specific platforms to engage with HCPs, for example, YouTube to target oncologists and neurologists and social media for primary care physicians. To best engage with HCPs, an omnichannel approach is key.

Do patient-experience publications have authors with patient experience?

Dawn Lobban (Envision Pharma Group) presented the results of a study that looked to quantify patient-experience publications and patient authorship, compare accessibility of publications with and without patient authorship, and evaluate the alignment of patient authorship with health technology assessment (HTA) patient involvement values.

Lobban defined patients as “people living with health conditions, caregivers, families, patient advocates, and advocacy organisations” and explained the purpose of patient-experience publications was to capture patient perspectives, hear the patient voice, and understand patients’ needs and priorities, rather than report results from clinical studies. As such, patients should be involved at every stage of study design, planning, analysis, and publication. Lobban noted the many guidelines around patient involvement in HTA, and that studies should adhere to the core values of relevance, fairness, equity, legitimacy, and capacity building.

For this study, PubMed was searched to identify publications between 1 January 1900 and 31 December 2022. Patient-experience publications were identified through search terms such as “patient journey”, “patient perspectives”, and “patient experience”, and patient authorship was established using search terms typical of patient author bylines. The study identified a doubling of patient-experience publications in the last 5 years, expected given the increased interest in patient involvement. Shockingly, less than 1% of patient-experience publications had a patient author; those that did were typically in mental health. While patient authorship is increasing, this is from a very low baseline. Publications with a patient author were significantly more likely to be open access or include a PLS, although few did.

The study identified a doubling of patient experience publications in the last 5 years…Shockingly, less than 1% of patient-experience publications had a patient author.

In terms of alignment with HTA values, the group agreed that patient authorship does reflect the values of HTA assessment:

• Relevance: input from patients provides insights that cannot be gained from HCPs’ interpretation of what it is like to live with a condition.
• Fairness: when patients have been involved in designing and planning a study, they have the right to be able to co-author the research.
• Equity: it is important to consider including diverse patient voices in research and look at equity issues around the distribution of healthcare.
• Legitimacy: including the patient voice adds credibility to decision making.
• Building capacity: patients are keen to be involved in research, so it is a natural progression to include them as authors with a voice in the scientific literature.

Lobban concluded that patient-experience publications rarely include patient authors, although this is increasing. As medical communications professionals, we should think about who our audience is and how we can improve accessibility for non-specialist authors.

Is real world evidence reaching clinicians? A target audience analysis of publications and congress presentations

Matthew Clasen (Syneos Health) began his presentation defining real world evidence (RWE) as the body of evidence generated from various sources of real world, not clinical trial, data. RWE can complement registrational trial data and lead to a richer body of evidence to inform decision making, with FDA guidance for industry highlighting its importance.

The study Clasen presented aimed to determine the primary target audience for RWE journal articles and congress presentations. Real-world data (RWD) publications from 2008–2022 in Embase were analysed to determine the target audience for RWE in the top 10 congresses and journals, RWD sources in clinical publications over time, and RWD publications in the top 10 clinical journals by impact factor.

Around 41,000 RWE publications were identified, including 22,000 journal articles and 13,000 congress presentations. Clasen highlighted the increasing volume of RWE publications over the past 15 years, with the majority published in the last 5 years. Across the top 10 congresses, only 39% of the 5,116 RWD congress abstracts reached a clinical audience (rather than healthcare policy decision makers, public health professionals and pharmacoepidemiologists). Similarly, across the top 10 journals, only 23% of the 2,677 RWD journal articles reached a clinical audience. RWD sources have evolved over time, with a growing proportion of registry and health insurance claims data being used in RWE journal articles in recent years. RWD was found to be largely absent from  clinical journals with the highest impact factor.

Clasen concluded that clinicians are not receiving RWE through publications. Barriers must be identified and removed to realise the full potential of RWD, such as:

• lack of familiarity with RWE/RWD, its role, and application to clinical practice
• inadequate knowledge of RWD methodology
• perceived importance of registrational trial data compared with RWD
• that RWD are evolving, requiring clinicians to keep up with trends.

Effective communication can help mitigate these barriers. As medical communications professionals, we should look to leverage the use of talking papers, infographics, graphical abstracts, and video abstracts to extend the communication of RWD to more clinicians.

Clinicians are not receiving RWE through publications; barriers must be identified and removed to realise the full potential of RWD.

GPP and me

KEY TAKEAWAYS

• Following the 2022 release of the latest Good Publication Practice guidelines, patient authorship and reimbursement remain key topics of discussion.

In this engaging interactive session, Lisa DeTora (Hofstra University), Faith DiBiasi (AstraZeneca), Eline Hanekamp (Excerpta Medica), Dikran Toroser (Merck), and Laura Dormer (Becaris Publishing) discussed the implementation of the Good Publication Practice  (GPP) 2022 guidelines. After a brief overview of the guidelines, results of a survey developed by the GPP authors were presented. Most respondents reported they were either fully aligned with GPP 2022 or expected to fully adopt the guidance within the next 6–12 months. The inclusion of patients, either in publication planning or as authors, was highlighted most frequently as the part of the guidelines still being investigated by organisations. Topics of particular interest identified through open-ended survey questions were discussed for the remainder of the session.

GPP beyond Europe and the US

The panel highlighted that there was strong representation from the Asia–Pacific region on the GPP steering committee and that a Chinese translation of GPP 2022 is now available. A Japanese translation is also in development.

Compliance

The panel emphasised that GPP is guidance rather than regulation or law. The extent to which legal and compliance teams will incorporate GPP will largely depend on each organisation’s structure and risk tolerance.

Payments and reimbursement

The panel advised that payment of patient authors is still a grey area and is complicated by regional differences. It was noted that HCPs can receive payment for consultancy roles rather than directly for authorship, and that these same rules will also apply to patients. Transparent reporting is important: guidance on the need to disclose relevant financial payments should be provided in advance.

Payment of patient authors is still a grey area and is complicated by regional differences… Transparent reporting is important: guidance on the need to disclose relevant financial payments should be provided in advance.

Social media

The panel noted that social media compliance is not part of the role of the publication professional; however, guidance on social media use is being updated regularly, and it can be difficult to navigate complex rules that may differ across regions and therapy areas.

Authorship

Author non-responsiveness is an issue affecting publication professionals, and the panel provided some guidance on managing this, including setting expectations at the outset, the importance of clear communication, and potentially seeking support from the author’s administrative team.

The importance of patient authors is increasingly recognised, and patients are often enthusiastic and passionate about becoming authors. To best involve patient authors, the panel advised planning well in advance and seeking support from patient advisory groups, which can be identified through sources like diseaseinfosearch.org. The panel also highlighted several sessions from Day 1 about the role of patients as authors. During the Q&A following the session, the panel discussed the potential conflict of interest if a patient receiving study treatment also acted as an author, concluding that trial participation (as well as other contributions, such as to study design) should be disclosed, but this does not preclude authorship.

AI

The panel recommended caution when using AI in medical publishing. They highlighted the World Association of Medical Editors recent recommendations that chatbots should not be included as authors and that authors must be transparent about chatbot use. Putting company proprietary information into an AI tool can also pose a compliance issue, and how AI can be harnessed as a useful and trustworthy tool remains up for debate.

Enhancing engagement

Many publishers are keen to discuss how to improve engagement with authors and pharmaceutical companies, but time and space is needed to do this effectively. Setting a good example for enhanced engagement is key, and demonstrating the benefits will encourage others to follow.

GPP and patients: guiding patient partnerships in publications

KEY TAKEAWAYS

• The Good Publication Practice 2022 guidelines have a strong patient focus: this session shared experiences of patients adding value to the publications process and recommendations for working with patient authors.

The next session continued the focus on GPP 2022, with Lobban introducing the session by highlighting that the recommendations in this iteration of the guidelines have been transformative with regards to patient involvement in medical publications. However, a live poll demonstrated that most attendees had not yet partnered with patients in publications, indicating that more needs to be done to make this a reality. Case studies describing how patients can add value to the publications process were then presented.

Patient Publications Collaborative Board

Catherine Skobe (Pfizer) described the Patient Publications Collaborative Board that Pfizer has established in order to develop long-term relationships with patient advocates and to ensure that patients are actively engaged throughout the publication process. Achievements so far include:

• development of patient materials in plain language, including an infographic in the welcome kit
• successfully voicing the case for open access publications at Pfizer
• giving presentations at external meetings in 2022, such as Patient as Partners Europe and the DIA Medical Affairs and Scientific Communications Forum.

A 3-year plan has also been developed, with objectives including raising awareness of the board, establishing a database of current and potential patient authors, and involving patients in the vendor evaluation process. Skobe concluded by acknowledging that setting up similar initiatives may be challenging for smaller companies with fewer resources than Pfizer, but hosting a webinar with patients is one simple option for introducing patient collaborations to an organisation.

Practical considerations for working with patient authors

Dakota Fisher-Vance (BioCryst Pharmaceuticals), who has personal experience as a patient author, then looked at practical considerations for engaging patients as authors. Fisher-Vance highlighted that not all patients are the same in terms of their expertise and knowledge, but they can collectively bring a wide range of experiences and perspectives to the publication process. Although patient authors must meet the International Committee of Medical Journal Editors (ICMJE) authorship criteria, this can occur through multiple avenues, such as helping to design patient-centric studies and identifying and prioritising the parts of a publication that are relevant to patients.

Next, Fisher-Vance highlighted some sources for identifying potential patient authors, such as:

• in-house patient initiatives
• patient advocacy groups and patient networks
• patient engagement vendors
• patient authorship searches
• social media
• conferences, webinars, and meetings
• word of mouth recommendations.

Fisher-Vance noted it is important to be aware that patient authors require a unique approach, taking various factors into account, including:

• respect for varied levels of expertise and scientific literacy
• training in the peer review process
• flexibility of working
• appropriate compensation.

Not all patients are the same in terms of their expertise and knowledge, but they can collectively bring a wide range of experiences and perspectives to the publication process.

Developing PLS

The GPP guidelines and publications community all acknowledge the need for high-quality PLS to increase understanding and knowledge, reduce misinformation, communicate research, and drive inclusivity, empowerment, and trust among the broader HCP and lay communities. Indeed, a live poll during the session showed most of the audience had been involved in developing PLS for journal articles and congresses, as well as standalone PLS. However, companies need to establish consistent processes to simplify PLS development and ensure that the content is relevant to the audience. With this objective in mind, Sonia Schweers (Bristol Myers Squibb) concluded the session looking at how their company has implemented PLS standards. Initially, PLS were developed as and when a journal or congress allowed them, but there were no set templates or procedures, and legal approval was given case-by-case. A pilot PLS implementation phase was conducted to establish uniform processes, with key steps including:

• identifying the target audience, which could potentially include payors, time-poor specialists or generalists, allied HCPs, and patients and carers
• determining which publication should have a PLS
• finding the right agency partner
• developing an enduring implementation package with annotated templates and checklists to ensure consistency
• partnering with expert patient panel reviewers to gain feedback on how easy the PLS was to read.

“What’s in a name?” The power of language and terminology

KEY TAKEAWAYS

• Using common language is key for effective communication with patients and caregivers.

This session, focusing on the power of words, was introduced by Sarah Griffiths (Oxford PharmaGenesis) and kicked off with an audience poll on communication with patients. Many attendees were comfortable or very comfortable speaking with or about patients (61%) but almost never engaged with patients to inform content (93%). Over half (57%) were very unaware or unaware of best practices to optimise diversity and inclusion in patient interactions and materials, and 73% had not considered behavioural change approaches and techniques to optimise patient information. Griffiths highlighted that the Shakespeare quote “What’s in a name? That which we call a rose by any other name would smell as sweet” can be interpreted to mean that names and terminology do not matter. The reality is that they do matter when speaking with patients: the language used when engaging with—and even talking about—patients is crucial, and acronyms and complex terminology can present barriers. Griffiths shared a landscape analysis demonstrating the inconsistent terminology used in patient materials, concluding that there is a need to think about clear, consistent communication that is appropriate for the end user.

The power of language

Sally Dews (Pfizer UK) continued the session, reiterating that confusion about health information and scientific jargon is a worldwide problem. For example, 43% of UK adults do not understand what dose of paracetamol to give their child because of confusing labels and 9 out of 10 US adults struggle to understand and use health information when it is filled with unfamiliar or complex terms. Considering the language used in medical communications is a small but important step towards better communication between industry, academia, HCPs, and patients/carers. Dews emphasised the need to encourage patients to get involved and to treat patients as equal and valued partners.

The need to stop using acronyms and technical language, and produce glossaries, was confirmed by a patient co-authorship group created by Pfizer. Rachel Daley (The Positivitree), a member of the co-authorship group, shared her experiences with advocacy that began when her son was diagnosed with a rare cancer. Daley spoke about her activities, including co-authoring a paper with Pfizer authors about patient involvement in research. Her main message was that patients often feel completely overwhelmed by the terminology used in published papers, so the first step towards involvement has to be standardising the terminology and using plain language. Different modes of communication may also be needed, and the importance of enrolling in training and implementing co-development practices was emphasised. Daley highlighted that language is a powerful tool for promoting diversity, equality, and inclusion to achieve meaningful patient involvement in research.

Language is a powerful tool for promoting diversity, equality, and inclusion to achieve meaningful patient involvement in research.

The patient experience is not one size fits all

Lee Wulund (AstraZeneca) then discussed the need to consider how pharmaceutical team working practices and structures may unconsciously bias the materials produced by a ‘global’ team, limiting the impact, reach, and generalisability of insights. Language and terminology are one dimension, but location and organisational diversity also have an effect. When considering the target patient audience, you must analyse what assumptions you are making, what you are requiring of the patients you work with, and whether the patients you work with are representative of the global patient population.

Wulund expanded on 4 considerations around diversity and inclusion:

• Language: it may be necessary to translate lexica and materials, and to work with local markets to understand their needs instead of assuming that preferences and insights in English-speaking countries are applicable globally.
• Terminology: person-first language should be used, reductive or dehumanising terms avoided, and accuracy maintained, with patients/advocacy groups asked about preferences. Consideration should also be given to perceived dominance in word order.
• Location and culture: differences in treatment pathways and experiences due to location and cultural norms should be considered.
• Audience demographics: characteristics such as age, sex, gender, and socioeconomic status should also be considered.

Wulund also urged medical communicators to think about the accessibility of patient materials, considering visual differences, attention span, and education level when presenting data. The format used to share information is important and should depend on what the intended audience needs and how they engage with information – for example, is a PDF the best format if it will be accessed on a mobile phone? Would video summaries or podcasts be better? Lastly, the platform used to share information must be considered in terms of discoverability, availability of access (eg, due to firewalls in certain countries), and file sizes.

Behavioural change to empower patients

Petrina Stevens (AstraZeneca) began the final part of this session by discussing how blind spots can be uncovered using a behavioural change approach. Considering the drivers and barriers linked to patient behaviour can improve understanding of the patient journey, ensuring the right information goes to the right patient at the right time. AstraZeneca have developed a framework for consistent assessment of patient behaviour, to explore psychological and physical capabilities to understand their own disease and self-care, and identify what social, physical, and cultural barriers exist. Understanding people’s thoughts, plans, desires, and habits in this way can also help facilitate successful content co-creation with patients. The hope is that understanding patients’ needs and desires, in conjunction with demographics, can help to empower patients in their journey.

Three behavioural assessment steps were suggested:

1. Identify what you wish to learn about patient behaviour.
2. Identify insights relevant to the behavioural objective.
3. Apply appropriate behaviour models to address the insights.

Stevens explained that understanding behavioural drivers supports solutions and language that activate and positively impact patients’ future health behaviour. AstraZeneca are applying behavioural change techniques across patient interventions.

Marie Eckerd (AstraZeneca) followed, noting what we say to patients can often be confusing and needs to be decoded, so using a common language lexicon is important. Eckerd noted that we want to make patient engagement attainable, rather than introducing barriers through confusing language. Common language is the backbone of an environment in which patients can be better informed and empowered to understand their disease and potential treatments. Understanding the patient environment and how patients search for information is also essential.

Eckerd then shared an example from AstraZeneca. After finding that the lexicon remained too complex, even after years working with patients, a cross-functional project was conducted to produce a searchable tool to help patients decode language in several disease areas. The tool was reviewed and improved by patients and included terms like ‘therapy’ rather than ‘intervention’ and ‘changes medications cause within the body’ instead of ‘pharmacodynamics’. Eckerd framed this as a first step in breaking the language barrier. Co-created common language reference tools can help improve patient understanding of complex information, as well as consistency.

Several interesting points were also raised in the Q&A that followed:

• Medical professionals should not be afraid of keeping it simple, and caregivers, patients, and advocates should not be afraid to ask HCPs to use simple language.
• Good, publicly accessible health literacy glossaries are available, but using AI tools may also be useful.
• Careful partnering with internal medical colleagues may be necessary to avoid complications with regulatory functions, in terms of approval of simplified language.

“What patients want matters, and what we say matters to patients.”
– Marie Eckerd

Why not also read the summaries of Day 1 , the afternoon of Day 2, and Day 3 of the meeting?

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Written as part of a Media Partnership between ISMPP and The Publication Plan, by Aspire Scientific, a proudly independent medical writing and communications agency led by experienced and dedicated industry experts.

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The 2023 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 24–25 January. The first in-person European Meeting since 2020, themed ‘Fueling Creativity’, saw a record 360 delegates in attendance.

A summary of the second day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

A summary of the first day of the meeting can be found here.

Summaries of Day 2

Day 2 opened with parallel sessions, with attendees each having the opportunity to select 2 sessions to attend.

Parallel session: A balancing act: creativity and industry compliance

KEY TAKEAWAY

• Creative solutions that aim to improve data accessibility, transparency, and patient engagement come with risks, but are achievable with rigorous risk assessment.

In this parallel session, Geraldine Drevon (GSK), Christine Vanderlinden (GSK), Catherine Skobe (Pfizer), Veronica Porkess (UCB), and Jonas Lind Hansen (Novo Nordisk) explored the balance between industry regulations and creativity that must be navigated to address evolving needs for scientific dissemination.

Independent platforms
The first part of the panel discussion focused on scientific dissemination on independent (ie non-industry-sponsored) platforms, such as figshare. Vanderlinden was tasked with identifying risks: lack of control over who can access the data and how the materials are used, the potential for varied quality of data posted on such sites, and how companies should compliantly decide which data are (and are not) uploaded. Despite these risks, Skobe shared a case study demonstrating how Pfizer has successfully developed a process to use figshare to publish manuscript plain language summaries (PLS), ensuring all content is peer reviewed and can be linked to the journal article using a digital object identifier (DOI). After a successful pilot, they plan to expand the process for other uses, such as enhanced publication content, further supplementary information, and eventually as a green open access repository.

Industry-sponsored platforms
The next topic in the session was use of industry-owned platforms. While some risks are similar to those for independent platforms, Porkess discussed further potential issues related to copyright and balancing access versus promotion of data (eg if someone scans a poster QR code, is it appropriate for users to be able to access other posters from that link?). Hansen provided some guidance on these platforms from a legal perspective, advising that the perception of company-owned websites being promotional is false – if content is objective and meets the same criteria as other publications (including in terms of copyright), then such sites are a viable solution for sharing enhanced content, if journals and congresses do not offer the possibility. Hansen emphasised the need to involve legal and compliance teams throughout the process, not just at the end. A case study from Novo Nordisk showed the process of building a freely accessible scientific exchange platform (Science Hub) to address the varied communication preferences of today’s healthcare professionals (HCPs). Novo Nordisk use the platform to house manuscripts or links to manuscripts, publication extenders, congress presentations, and medical education materials, which are all rigorously assessed for compliance before being uploaded.

The perception of company-owned websites being promotional is false – if content is objective and meets the same criteria as other publications…then such sites are a viable solution for sharing enhanced content.

Industry involvement with patients
Finally, the panel discussed the involvement of patients in scientific publications. Vanderlinden explained how to mitigate potential risks associated with patient authors for industry-sponsored manuscripts, including:

• the importance of careful assessment of why patients should be involved (it may not make sense for every publication)
• involving patients from the evidence generation step onwards, rather than when considering publication
• preparing patients to help them provide meaningful feedback on publications.

As raised in the fireside chat session on Day 1, payment of patient authors remains a challenging topic in the industry, with varied processes and policies at different pharmaceutical companies. A final case study from UCB showcased a successful partnership with patients to develop a manuscript on the lived experience with a disease. The protocol was designed in collaboration with a patient council, analysis of key themes was patient-led, and patients were included as authors of both a poster and a peer reviewed manuscript, in accordance with International Committee of Medical Journal Editors (ICMJE) criteria.

The Q&A session following the panel discussion raised some interesting points, including:

• the importance of developing industry guidelines for digital platforms and partnering with patients, to help improve uptake by risk-adverse companies
• the concept of a ‘professional patient’ who may work with multiple pharmaceutical companies (and therefore may be considered more objective), but may create challenges for appropriate payment
• criteria for selecting appropriate publications for patient authorship remain to be defined, with suggestions including active participation in study design, or a topic such as quality of life.

Parallel session: Connecting the dots – turning information into insights

KEY TAKEAWAYS

• Insights are the combination of information and context, and need to be actionable (aligned with strategic goals) and managed in an ongoing process.

Belinda Dean (3 Stories High) moderated this session, which focused on how insights gathered from external stakeholders can be used to inform strategic planning.

Kicking off the presentations, Sharon Suntag (IQVIA) explained that while information can be gathered from multiple sources, adding context is what provides the insight. Suntag summarised the ‘cycle of insights’:

• Interrogating data sources: these are unrefined facts.
• Assessing the information: what is happening?
• Forming the insights: adding context.
• Producing an actionable insight: what to do.

Suntag highlighted that strategic goals need to be considered when moving through this process. Suntag also highlighted that data lakes might contain information that is:

• structured – available in a table format that is defined and searchable and has been developed for a specific purpose
• unstructured – qualitative data, website content, presentations, medical data such as lab reports, or imaging.

Suntag emphasised that it is important to use the most appropriate data when developing questions to drive insight generation, and that different data sources are needed to ask questions of different key stakeholders.

Laura McGovern (Nucleus Global) then provided an agency perspective on a schematic approach to insights-driven medical planning. McGovern discussed a  project which captured cross-functional insights based on a small data lake. Initially, insights were collated and evaluated against the medical objectives. McGovern highlighted that the quality of different sources needs to be carefully weighed – for example, social media may be fraught with fraudulent posts. Using a digital dashboard can optimise the efficiency of collecting insights at this stage. Once insights were gathered, a cross-functional workshop was held to align on priority actionable insights. A core group then worked to build an action plan (including timeframes and roles and responsibilities). The plan was then implemented, and its success evaluated through the collection of metrics. McGovern noted that the process of insights-driven medical planning is circular, with additional insights gathered and the plan amended as needed.

The final speaker in this session was Clare Baker (Idorsia). Baker shared that the insights-driven medical communications planning process at Idorsia begins with medical objectives and involves alignment of questions and listening priorities across countries and regions. The process was framed as follows:

• Insight gathering: insights are gathered from medical science liaisons (MSLs) using Customer Relationship Management platforms, medical information requests, and ad boards.
• Insight analysis: this ongoing process includes manual activities and artificial intelligence (AI) approaches, such as Microsoft Power BI.
• Insight reporting: at Idorsia, this is manually led by the Medical Operations function to identify insights that can inform product and communications strategies.
• Insight actioning: determined by cross-functional review.

Baker explained that cross-functional collaboration and sharing feedback are key to the success of insights-driven medical communications planning. Partnerships with agencies can also help with implementing insights within strategic and communications plans.

Cross-functional collaboration and sharing feedback are key to the success of insights-driven medical communications planning.

Parallel session: Publications without borders: harmonising local and global planning

KEY TAKEAWAYS

• Understanding local needs and priorities will help global publication leads to integrate local publications into the global plan; open communication is key to achieving this.

Maria Haughton (AstraZeneca) chaired this session, and also presented slides on behalf of Michael Sheldon (GSK) who was unable to attend. Tom Grant (UCB) and Anisha Mehra (Ferring Pharmaceuticals) completed the panel, sharing perspectives on challenges and best practices for developing publication plans that integrate global and local priorities. Despite the differences in company sizes, common themes emerged.

The panel all acknowledged the importance of local publications to augment the global plan. Different countries may have different medical priorities and products may have different launch times; local publications can target these specific needs. However, local teams often face resource and time challenges. Small teams are often responsible for multiple products and therapy areas, and often, publications are at the bottom of a very long priority list. Local teams might also be siloed from global, and not aware of processes. High staff turnover at a local level also means that existing knowledge on process is lost, which can translate to challenges for global publications leads, eg last minute requests, ‘surprise’ publications, and the risk of non-compliant publications when processes are not followed.

The panel (and the audience during the Q&A) had some practical recommendations to ensure best practice for local engagement in publication planning. Collaboration was key –a regular call with local teams is a very simple way to keep global informed about local priorities and plans and vice versa. Further, engaging with local teams in a meaningful way is important. This could be through involvement in publication planning workshops. Regular training should be carried out, with the use of case studies to illustrate the benefits of publication planning, as well as the development of clear processes and standard operating procedures (SOPs). The local point of view can also go beyond medical priorities and may impact how publications are delivered – for example, when considering whether local or global agencies should be employed, it is important to consider the preference of the local teams. The recommendations all came back to one core issue: open (and two-way) communication. Engaging with local needs and priorities will help global publication leads integrate local publications into the global plan in a meaningful way, that is beneficial for all.

The recommendations all came back to one core issue: open (and two-way) communication. Engaging with local needs and priorities will help global publication leads integrate local publications into the global plan in a meaningful way, that is beneficial for all.

Parallel session: Guided poster tour

Attendees also had the opportunity to attend a guided poster tour, which visited 4 posters:

• Accessibility of scientific information for non-English speakers: using browser-based tools to translate plain language summaries (PLS) and abstracts.
• Ghosts in the machine: retracted articles still haunt the literature.
• Diversity in medical publications: a cross-sectional evaluation of COVID-19 vaccine research.
• Evaluating the publication of randomised controlled trials in inflammatory bowel disease by trial outcome and journal attributes.

Once upon a time… Effective storytelling in an age of omnichannel communication

KEY TAKEAWAY

• Providing a clear, succinct, and aligned narrative using a variety of formats, across different channels and to a broad, cross-functional audience requires advanced planning but is a vital component of effective scientific storytelling.

Chaired by Caroline Halford (Springer Healthcare), the ever-growing role of omnichannel communication for effective storytelling was discussed in this plenary session. Despite great changes in communication methods over the past 20 years, succinct and engaging content that maintains scientific integrity continues to underpin effective communication across multiple types of media. Omnichannel communication is a vital component of this: a holistic method to share preferred content in preferred formats, that takes into account the readers’ perspective and delivers what they want to read.

The new normal: bitesize information needs

Nathalie van Havre (European Hematology Association) kicked off the session with a staggering statistic: since 1950, medical knowledge doubling time has decreased from 50 years to just 73 days. Efficient communication needs to adapt, harnessing different methods of learning.

Van Havre noted that microlearning is a simple and cost-effective addition to an educational strategy. Delivering scientifically sound information in a variety of formats, microlearning keeps learner fatigue at bay. At EHA, microlearning is used to deliver key topics of interest to an audience that spans 100 countries, through initiatives such as ‘Learning Mondays’, ‘Thinking Thursday’, and more in-depth case studies. Describing some key elements of a successful microlearning piece, van Havre highlighted the importance of interactivity, linking out to relevant sources, using a mixture of words and pictures, and encouraging a transferable, systematic thinking process.

Creative storytelling across communications

Fiona Thomas (KPMG) explained that storytelling doesn’t just happen at a single point in time. A great story is one that is retold over and over, and stories must align, complement, and build on one another across the various formats of communication. In scientific storytelling, a clear and aligned narrative needs advance planning and must be developed with a broad audience in mind.

Thomas also noted that a scientific story should be complete regardless of the journey the consumer has taken. She shared some key takeaways:

• Content and clarity are key.
• Profile your learners, not HCP type.
• Scientific storytelling is a relay: build the story and plan for the unexpected.

In scientific storytelling, a clear and aligned narrative needs advance planning and must be developed with a broad audience in mind.

Getting attention in the digital age

In the final presentation of the session, James Dathan (AstraZeneca) challenged the standardised processes in scientific storytelling. Using posters as an example, the format of scientific communication has changed little, despite user feedback showing a clear preference for infographic presentation of data. The use of omnichannel communication, including QR codes, allows readers to choose whether to delve more deeply, and even virtually connect with presenting authors, allowing posters to highlight the main results and conclusions. Dathan noted that in an age of digital adoption, front and centre information is no longer necessary, and innovation should be the motivator for change. Concluding, Dathan underscored the need for collaborative co-creation of scientific stories that embrace omnichannel communication.

The Q&A session also raised some interesting points:

• Collaborative co-creation of digital content is key to managing risk and understanding how to use social media compliantly.
• While we need to consider the different time zones of our audience, the latest data suggest Tuesday and Thursday mornings are good for sharing digital content. Releasing the same type of content on the same day provides consistency.
• Catering for different learning or HCP types isn’t sophisticated enough. We need to combine different formats and modalities to support different learning styles, while also considering different demographics and digital competence.

Member research oral presentations

AI for the development of clinical trial lay summaries: are we ready to replace writers with machines?

KEY TAKEAWAY

• Improvements are needed before AI can take over from writers in developing clinical trial lay summaries.

In the first of the three presentations in this session, David McMinn (Lay Summaries Ltd) shared findings from research into whether automatic text summarisation using natural language processing can accurately generate lay summaries. A literature search was performed to identify existing AI models, which were performance tested. The two best performing models were then fine-tuned and re-tested. McMinn found that the selected models were able to accurately produce certain sections of the lay summary, namely the title, background information, objective, and generic content but struggled with the results, adverse events, flow, and complex trial designs. The performance of AI models may be improved in the future with more powerful computers, larger data sets, enhanced metrics, and targeted text extraction. McMinn concluded that while AI does show promise, improvements are needed before writers can be replaced by machines.

Are conference presentations accessible? Insights from an online survey to improve equity

KEY TAKEAWAY

• Less visual clutter on posters and providing slides ahead of talks would improve the accessibility of conference presentations.

James Wells (CMC Connect) presented results from a 23-question online survey, which was designed to establish accessibility requirements and preferred methods of receiving information among conference attendees with diverse needs. Of 493 respondents, 57% reported at least one accessibility need or disability, most frequently processing, sensory, hearing, or visual needs. Respondents preferred posters with less text, considering it easier to gain information from the #BetterPoster design than infographic examples or traditional text-heavy posters. When asked how posters could be improved, recommendations included:

• less visual clutter (71%)
• bigger text (48%)
• bigger figures (43%)
• plain language (42%)
• audio summary via a QR code (32%).

Respondents felt it was easiest to gain information from talks with traditionally formatted slides containing text (with or without images), compared with TED-style talks with limited slides, slides with little text, or panel discussions with no slides. Recommendations to improve the accessibility of talks included:

• providing slides ahead of the talk (66%)
• recording a video of the talk for attendees to watch afterwards (60%)
• more verbal explanations of images (50%)
• bigger images (48%)
• less text on slides (45%)
• live closed captions (34%).

Respondents also provided recommendations for conference spaces, which included ensuring that there is sufficient seating (including in poster halls), ensuring sufficient space for wheelchair access, providing quiet spaces, improving acoustics/microphone use, and providing quality virtual options.

Respondents felt it was easiest to gain information from talks with traditionally formatted slides containing text (with or without images)…Recommendations to improve the accessibility of talks included providing slides ahead of the talk.

Adverse event reporting in industry sponsored primary clinical trial articles

KEY TAKEAWAY

• A substantial proportion of industry-sponsored clinical trials articles use vague, general phrases to report adverse events.

In the final presentation of the session, Susan Wieting (Takeda) discussed the results of a study performed to assess how well the recommendation from Medical Publishing Insights and Practices (MPIP) to avoid overly general descriptions of adverse events (AEs) is followed in industry-sponsored clinical trial publications. A MEDLINE search was performed to identify abstracts of industry-sponsored peer reviewed articles (from the top 10 pharmaceutical companies by 2021 revenue) published in 2016–2022, that included one of the following phrases:

• safe and well tolerated
• AEs seen were minor and generally well tolerated
• no unexpected AE
• or a similar phrase.

In total, 103 articles were identified: 13 articles contained the phrase “safe and well tolerated” and 92 contained a similar phrase to those specified. Of these 92 articles, 49 used the phrase “well tolerated” and 24 included “generally well tolerated”. When assessed by year, the use of vague phrases had not reduced over time. Wieting noted that vague phrases are not informative, and highlighted the opportunity for the industry to consistently report specific AEs, which would increase the clarity and robustness of data.

Keynote: Global economic and policy influences on the pharmaceutical industry

KEY TAKEAWAY

• Low–middle income countries are leading the way in healthcare innovations for an ageing population.

The Day 2 keynote presentation was given by Mark Chataway (Hyderus/Baird’s Communicant Management Consultants Ltd), who laid out the extent of the global challenges facing healthcare and what these might mean for medical communications.

An ageing global population

Chataway set the scene by charting the enormous changes in life expectancy seen over the last decade and forecast over the years ahead. In short, the world is getting older. Chataway outlined that life expectancy is generally higher in countries with greater levels of healthcare spending. He made the case that the additional cost can be offset to some degree by the spending patterns of older people, who will spend money rather than save it, thus giving back to the economy. This is augmented even further if ‘retired’ people also work part time, although Chataway noted that retirement ages haven’t yet kept pace with increased life expectancy.

What does this mean for medical communications?

• Even more attention to measures such as quality-adjusted life years and disability-adjusted life years
• increased focus on productivity gains and health-care resource utilisation associated with treatments
• a need for better patient education on the quality of life possible in older age.

Health spending and system innovations

Another global trend Chataway highlighted was the decrease in extreme poverty. Despite this, health spending in low–middle income countries has not kept pace with increases in life expectancy. There are signs this is starting to change, as health sovereignty becomes more important in some regions and emerging economies look to invest in health technology. Examples include:

• the G20’s focus on digital health innovations and solutions
• the increased prevalence of innovative healthcare networks in some middle-income countries (eg in South Africa, nurse-led clinics refer through to leading institutions)
• innovations capitalising on efficiencies of scale, as previously reported for heart surgery in India.

What does this mean for medical communications?

• Some medical specialties are changing or even disappearing.
• Publication professionals will need to support HCPs and researchers who are new to publishing.

As health sovereignty becomes more important in some regions and emerging economies look to invest in health technology…publication professionals will need to support HCPs and researchers who are new to publishing.

Personalised medicine

Chataway closed by noting the expansion of personalised medicine and related infrastructure, such as the large national health records database currently being established in India.

What does this mean for medical communications?

• Registries and databases will become accessible to researchers in areas where cost may have been prohibitive until now.
• Conversely, some of the largest new databases may place restrictions on what can be published.

GPP and me

KEY TAKEAWAY

• GPP 2022 serves as expanded guidance to medical publications professionals and continues to evolve, yet authorship remains contentious and questions remain around the use of social media and AI.

The final panel discussion session looked at how GPP 2022, published in August 2022, has changed working practices for medical publications professionals. Moderated by Eleanor Raynsford (Ipsen), panellists were Laura Dormer (Becaris Publishing), Eline Hanekamp (Excerpta Medica), Fiona Plunkett (Articulate Science), and Vanderlinden. All panellists were GPP 2022 steering committee members and authors.

Ahead of the meeting, a questionnaire circulated via the ISMPP community forum and LinkedIn received 29 responses, with 59% reporting that the updates to GPP had affected their day-to-day activities. 75% of respondents still had questions about GPP 2022, aligning with three main topics: authorship, reimbursement, and patient involvement. These topics formed the basis of the panel discussion. The panel noted that the survey results were as expected, stating that “GPP 2022 is not a revolution.  It is an evolution, providing supplementary material to give everyday guidance.”

Authorship

GPP 2022 expanded guidance on authorship in line with ICMJE recommendations, including removing limits on the number of authors. The panel discussed that authorship should be considered on a case-by-case basis, and not subject to arbitrary limits. The panel noted that a steering committee should be established well in advance of publication initiation. The steering committee is then best placed to discuss any queries and concerns arising during publication development.

Authorship should be considered on a case-by-case basis, and not subject to arbitrary limits…The ISMPP Authorship Algorithm tool can help to determine author contributions to ICMJE criteria #1.

The ISMPP Authorship Algorithm tool can help to determine author contributions to ICMJE criteria #1 (substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work). Where large numbers of potential authors are involved, it is unlikely that all can contribute substantially to publication development. Assigning a study or working group would capture all individuals involved – these contributions are also indexed, for example on PubMed. Where appropriate, contributions should also be acknowledged and captured on indexing sites. The panel also discussed the case of individuals becoming unavailable during publication development, eg through parental leave or a new job. In this case, their role as author must be reassessed using the ICMJE criteria. A discussion should be held in advance of any known leave (ideally with the steering committee) on whether the individual will be able to fulfil their role. Sensitivities should be considered for leavers, for example those moving to competitors. Acknowledgement or contributorship may be suitable alternatives.

A case study was shared by Helen Chambers (Costello Medical), who noted that GPP 2022 had helped enforce good practice when discussing publication development processes with clients. Key to this was the guidance that all authors should be engaged prior to project initiation. Chambers reflected that ultimately, early author input drives a smoother process.

Reimbursement

GPP 2022 provides further details for reimbursement of HCPs and patients, the latter being a hot topic of discussion in other sessions. The panel noted that it is transparent, legitimate, and appropriate that a provider of services or a patient should receive payment for their contribution and still qualify as an author, as long as a full disclosure is incorporated. While authors cannot be paid for their name being listed as an author, it is possible to reimburse their time for contributing their expertise: patients should not be excluded as authors for receiving reimbursement for their services. However, company reimbursement policies for patient authors vary.

Tamzin Gristwood (Oxford Pharmagenesis) shared a case study where GPP 2022 provided clearer rationale around naming medical writers on review articles. Gristwood noted that if appropriate, the writer can be an author and also receive payment (through their professional medical writing role) in terms of time spent developing the article.

It is possible to reimburse [patient’s] time for contributing their expertise: patients should not be excluded as authors for receiving reimbursement for their services.

Patient involvement

GPP 2022 also provided guidance on working with patients, to ensure patient expertise is respected and assistance provided (if required) to help them reach their full potential for contributing as an author. GPP 2022 has increased the confidence of both agencies and pharmaceutical companies working with patients, providing guidance on how best to involve patients in the publications process. Importantly, patient author involvement must be meaningful and valid rather than a tick-box exercise, with early engagement ensuring that patient authors can be involved throughout the publication process. Patient authors and patient reviewer feedback are both invaluable, and provide a different perspective from that of HCPs.

Outstanding queries

Several areas of outstanding queries were also raised during the session.

In terms of patient involvement:

• Although the development of PLS is becoming more common, is this medium providing patients with a voice if their involvement is limited?
• Should journals question a lack of patient authors, and should they be looking to update their guidance on authorship?
• Authors are generally required to provide details such as qualification, affiliation, and contact details. While a ‘traditional’ author can provide their work credentials, there is no clear guidance for patient authors.

In terms of social media:

• There is clearly a need for guidance on social media, but GPP is not best placed to provide that guidance. Guidance would be best coming from a legislator or regulator.
• Should authors work with publishers, so that journals share publications on social media?

In terms of AI:

• While no information about the role of AI in publications was given in GPP, it was noted that the World Association of Medical Editors (WAME) and Nature both recently shared information that may serve as a useful reference point.

Poster awards, exhibitor raffles, and closing remarks

Rob Matheis (ISMPP President & CEO) and Raynsford closed proceedings, thanking the abstract review committee and poster presenters. This year’s poster prize winners were congratulated:

• Most reflective of meeting theme: Why did it go viral? An informatics-based case study of exaggerated language in news and social media – Hollie Rawlings, Tomas Rees, Lubaina Koti, Avishek Pal, and Andrew Liew.
• Best original research: Does publishing on medRxiv affect a manuscript’s outreach? – Pedro Caldas Custodio de Campos Silva, Christian Matheou, Alex Marshall, and Shilpa Khobragad.
• Most innovative digital poster format or enhancement: Ghosts in the machine: retracted articles still haunt the literature – Stephen Craig and Andy Shepherd.

Why not also read our summary of Day 1 of the meeting?

The Publication Plan also looks forward to bringing you more insightful and thought-provoking coverage from the forthcoming 19th Annual Meeting of ISMPP, due to take place on 24–26 April 2023 in Washington, DC.

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Written as part of a Media Partnership between ISMPP and The Publication Plan by Aspire Scientific, an independent medical writing agency led by experienced editorial team members and supported by MSc- and/or PhD-educated writers.

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Many of those working within the medical communications industry will be familiar with the Good Publication Practice (GPP) guidelines, which were recently updated with the publication of GPP 2022. The guidelines provide recommendations on how to follow ethical and transparent practices when publishing company-sponsored biomedical research. GPP 2022 is the fourth version of the guidelines, which were previously updated in 2015 with the release of GPP3. The Publication Plan spoke to Lisa DeTora, Associate Professor at Hofstra University and lead author of GPP 2022, to find out how the guidelines were developed and to gain her insights on some of the new topics covered.

Could you explain why the time was right to update the guidelines and briefly summarise the key topics introduced in the new version?

“Although I was not part of the decision-making process that determined a new GPP iteration was needed, my understanding is that several new areas were identified that required some guidance—notably enhanced content and patient involvement in publications.

We concentrated on stating the goals of GPP in positive terms. Unlike the GPP3 team, who had to contend with negative coverage of publication planning in the press, we were able to define good practice without having to address negative accusations or practices. As such, GPP3 indirectly reflects on some media preoccupations with bad practices, including ghostwriting, and how to prevent them, whereas our team was able to concentrate on defining what we as a profession already do well and to present additional best practices that have emerged since 2015.

The scope of GPP 2022 expanded beyond clinical trial publications to cover all scientific areas. We moved away from mainly considering Consolidated Standards of Reporting Trials (CONSORT)-specific papers and acknowledge that the International Committee of Medical Journal Editors (ICMJE) authorship criteria are not universally used, even though they are an appropriate default if no other authorship guidelines are specified.

We broke down the various processes in publication planning in a supplement that walks the reader through steering committees, publication planning, authorship determination, publication working groups, and the publication process. In each of these areas, we included new information as needed on working with patients, working in alliances, social media, enhanced content, and plain language summaries (PLS). These sections are intended to be usable for day-to-day work, for training teams, and for orienting newcomers to the profession.

“We included new information as needed on working with patients, working in alliances, social media, enhanced content, and plain language summaries.”

We also added information about the leadership potential of publication professionals in developing policies and standard operating procedures (SOPs), and training teams.

Inclusivity was also an important new theme: we considered this in terms of demographic criteria, job roles, patients, and including investigators from various regions on author bylines.”

GPP 2022 was developed with input from pharma, medical communication agencies, journal editors, publishers, and academics, and underwent substantial review with over 150 invited expert and International Society for Medical Publication Professionals (ISMPP) member reviewers providing feedback. Could you briefly describe the development process?

“The original vision for this GPP iteration was to update GPP3 and then to add any new sections that might be needed. However, as the steering committee members began to develop the new content and updates, it became clear that we could produce a much more usable document. I was nominated to produce the full draft in part because I had some ideas about how I would organise what is now the supplement, and how those sections could be used for training and to introduce practices to investigators, students, and others. It was a little daunting because I had not envisioned being asked to take on a decision-making role for this work. Luckily, the steering committee was very supportive and positive.

In terms of the process, the steering committee began by identifying GPP3 content that required an update and new content that needed to be added. We reviewed all the content together, then I organised a new draft. The steering committee commented, and a consolidated document was then shared with a panel of 38 experts selected by the steering committee in consultation with ISMPP’s leadership. We consulted with ISMPP because we wanted to include expert reviewers who lead publications teams at pharmaceutical companies.

Fiona Plunkett (Articulate Science), Dan Bridges (Inizio Medical), and I then reviewed the 38 sets of expert comments. I consolidated the comments that we felt were feasible to include, then the steering committee commented, and the resulting document was sent for a review by ISMPP volunteers, who had been identified through an open call. Volunteer reviewers were asked to solicit feedback within their groups or companies and return consolidated comments via a portal set up by ISMPP. The steering committee members divided up the comments for preliminary review, but I read all of the comments and Dikran Toroser (Merck) read most of them as well, before I consolidated the document.

We accepted every comment that we could. I felt strongly that we needed to make sure stakeholders felt heard. As expected, though, some of the comments conflicted and then we deferred to the original steering committee views. The majority of the comments that we could not address were highly specific to a particular working setting or were editorial in nature. For instance, there were suggestions about minimum and maximum numbers of authors or steering committee members; the rationale for each of the suggestions was sound in a specific context but didn’t always apply in other scenarios. We also listened to feedback in person at the ISMPP Annual Meeting and in our day-to-day working relationships.

There was only one substantive difference of opinion regarding what to include in GPP 2022, and that was resolved by deferring to regulatory frameworks. In all other cases, we were able to develop text that would accommodate a range of acceptable approaches. For instance, we do recommend steering committees if teams need advice about scientific strategy or journal selection; however, it is not always feasible to have a separate steering committee and publication working group.”

How did you ensure that the guidelines represented balanced views and experiences of a diverse group of stakeholders, and that all voices were heard?

“We tried to keep GPP 2022 as neutral and high-level as possible, and to emphasise the idea that inclusivity should be considered in all areas of publication planning and development. The steering committee itself is diverse and we also solicited feedback from a diverse group of expert stakeholders. In addition, we accepted every comment that was feasible to address from the volunteer review.

One thing to keep in mind about listening to diverse voices is that a high-level document like GPP 2022 is not the correct place to establish what counts as diversity and inclusion in practice for every working setting. All we can do is to indicate that best practice in research and publication includes attention to diversity, equity, and inclusion at all stages. Attention also needs to be paid to inclusivity and diversity during study design, for instance, but that may be outside the remit of many publication teams. We can look to the ICMJE Recommendations for a model: they indicate that author lists should reflect representation from all regions (and countries, if feasible, I believe) in which a study was performed. I personally feel that we all need to keep thinking and continuously evaluate how we are doing in terms of diversity and inclusion and in listening to various stakeholders. We can employ “Lean” or Six Sigma practices that emphasise continuous evaluation, for instance.

Of course, there is more work to be done. It’s impossible in a high-level document like GPP 2022 to fully capture methods for building trust and working relationships with patients and patient advocate groups, or to account for regional representation in multiregional clinical trials or other kinds of studies. It’s also difficult to mandate how and when to include patients, given the wide range of study and publication types we consider. The best we could do for this initial mention of patient participation in GPP is to emphasise that patients should be included as appropriate—for instance in publications of clinical trial results in chronic conditions and/or rare diseases—and as equal partners. Patients should be treated as experts in living with conditions, whose expertise warrants respect, and authorship, if they contribute substantively to a publication. However, patients are autonomous beings and should therefore be included in the decision-making process and allowed to opt in or out of specific roles as they see fit. The idea is to foster inclusivity and not to create additional requirements that might impede publication.

“Patients are autonomous beings and should therefore be included in the decision-making process and allowed to opt in or out of specific roles as they see fit. The idea is to foster inclusivity and not to create additional requirements that might impede publication.”

Another sticky issue is including investigators from various regions on author bylines. There has been a past pattern of not including investigators from certain regions on the main author byline of a publication, but adding names for regional conferences. The current ICMJE Recommendations indicate that the main author byline should reflect all of the regions in which the research was conducted. GPP 2022 supports this position as well: if authorship reflects the full breadth and scope of participation in multiregional clinical trials, then there is no need to manage additions for conferences.”

The guidelines note that patients and patient advocates may author publications or be involved in publication planning. What do you think are the key benefits of patient involvement?

“In my opinion, the key benefit of patient involvement in publications about rare or chronic conditions is that only patients really understand the lived experience of having those conditions. Patients are the only true experts regarding these experiences and are the only group of people who can contextualise scientific outcomes in terms of patient experience. Understanding patient experiences is also vital for anticipating compliance issues, untoward outcomes, or even what kinds of outcome measures could be used to assess certain kinds of adverse effects. Patient input is essential for fully understanding patient reported outcomes, not only in terms of interpretation but also for designing the measures in the first place.

In clinical study settings for acute illnesses or vaccines, patient or participant involvement may still be important and should be strongly considered. It may not be necessary to have a patient on every publication, but patient steering committees may offer important advice to publications teams, review manuscripts, and provide guidance on the best way to represent study findings in plain language. As I said earlier, GPP can’t mandate the exact practice for every situation; however, there should be some mechanism to solicit patient or participant input on relevant publications, even if the patients and participants opt not to engage with the publication process.

Another important benefit to patient involvement in publications is holding the biomedical research community accountable for communicating their findings clearly, accurately, and completely. It is all too easy for researchers to become used to interacting only with other experts, and rely on readers to fill in the blanks of logic or data interpretation. The need to communicate with patients can help experts keep in mind that many different groups of people rely on their research, and to be thorough and complete in presenting analysis and interpretation of results.”

Were any challenges or obstacles identified that may need to be overcome for patients to more frequently author publications?

“In my view there is a difference between including patient voices in the publication process and trying to expand patient authorship of publications. I really think that patients need to be making the decisions about how they would like to be involved in the publication process and whether they would like to expand their presence as authors. For instance, we need to think about the burdens of authorship—which can be difficult and time consuming—and what it’s fair to ask patients to do. We also need to consider what patients want to do. There are potential questions of medical confidentiality to consider, for instance. However, these are my opinions, and the opinions that are truly needed are those of patients who might want to author or provide different kinds of feedback on publications. We should also consider the value of patients as peer reviewers of publications and PLS.

In terms of GPP 2022, we did not delve deeply into these questions because we took the stance that patients should be included as equal stakeholders at all stages of the publication process, where appropriate, which leaves the decision-making to those specific teams and those patients. In general, I believe that it is important that patients take the lead in setting the terms of these discussions. The most important thing to remember, again in my opinion, is that if patients are involved, they should be treated as co-equal partners with investigators and other publication stakeholders.”

GPP 2022 endorses the inclusion of enhanced content with publications, including PLS. Could you explain why PLS are considered so important and briefly outline the key recommendations on when and how they should be developed? 

“Enhanced content utilises different forms of media, often visual media, to make publications more accessible to various expert and nonexpert audiences. For instance, supplemental tables might be included to allow meta-analytical work, or a 1-minute video could explain the key points of a clinical study to help researchers decide whether or not to read a paper in detail. In paediatric trial settings, enhanced content in comic book or infographic form can also be really useful for conveying information. Such visual formats can also be beneficial in settings where literacy is an issue, or if there is a need to communicate with speakers of minoritised languages.

GPP 2022 recommends that a PLS accompany every publication of clinical trial data that follows the CONSORT guidance—which basically means every primary publication. Of course, a PLS might be helpful for every publication, but it is especially critical to communicate clearly about clinical trials of products currently being used in medical practice.

“For me, the most important function of a PLS is that it forces the authoring group to state plainly what they think the main impact of their publication is.”

For me, the most important function of a PLS is that it forces the authoring group to state plainly what they think the main impact of their publication is. It can be easy to fall into ‘expert speak’ and assume that all readers will be able to navigate technical jargon and fill in any gaps in logic. However, PLS have many audiences, from patients to medical students to experts or healthcare professionals who speak English as a foreign language. The PLS format requires a clearer statement of the work’s importance.

There are many ways (and times) to develop a PLS. The simplest PLS is an abstract form that restates the study design and outcomes in plain language. Developing infographics or comics or video can be more expensive and time-consuming. Teams should consider carefully which audiences they are serving and how important it is to convey which information to those audiences. One recommendation I have is to look at recent statements on PLS by publishers and editors. Journal requirements will help guide teams regarding the time needed to develop a PLS to accompany a publication.”

The importance of inclusivity is highlighted in GPP 2022. Could you describe the aspects of inclusivity considered by the guidelines and share some examples of how those working within medical communications might be able to encourage inclusivity in publications?

“GPP 2022 recommends inclusivity of many sorts—from demographic characteristics to job roles, to countries and regions, to patients. One basic recommendation is that diversity, equity, and inclusion must be considered when assembling teams, steering committees, and working groups.

“One basic recommendation is that diversity, equity, and inclusion must be considered when assembling teams, steering committees, and working groups.”

This includes diversity in terms of race, ethnicity, and gender as well as scientific roles. Treating patients as co-equal partners is another form of inclusivity we recommend, as is including investigators from various regions on author bylines. Obviously, the best place to start thinking about inclusivity is at study design stage—but publication professionals should still consult with subject matter experts and data owners to identify diverse teams even if they enter the picture after study design is established.

In general, it’s easy to try to be inclusive but difficult to adjust team culture to accommodate differences and be truly equitable. For instance, including regional investigators may require adjusting timelines and being tolerant of multi-language working situations. I’ve worked on teams where we accepted comments in all languages spoken by the co-authors and then produced the drafts in English. It’s also important to recognise that in some cultures, opinions must be requested more than once. It may also be necessary to adjust meeting times to include partners around the globe. Patients and investigators are also people who have jobs and other responsibilities, which may mean that timelines need some adjustment in order to be truly inclusive.”

The development of GPP 2022 took place during the COVID-19 pandemic. Did any challenges faced by the medical publications community during this time, or changes such as the rise in popularity of preprints, impact any of the recommendations?

“We were somewhat delayed from our initial timeline because many people working within the industry became a lot busier. And those, like me, in academic roles had a lot of added logistical pressures. I asked to include a statement about publication ethics during public health emergencies in GPP 2022, which was received as rather non-controversial by the rest of the authors, given the circumstances. We did have some discussion of preprints, but it was actually quite easy to come to a consensus about our recommendation because we were well aligned around the idea that preprints have a specific function, but should not be used to circumvent the peer review process.”

Were there any topics included in GPP 2022 that proved particularly controversial or difficult to reach consensus on?

“We were quite well aligned at a high level on almost every issue. The logistics or granular details at times are not entirely aligned, but that is a circumstance out of any individual person’s control. It is a strength of the group, in fact, that we are not all working in precisely the same way.

The one thing I’m comfortable saying about any ‘lively debate’ among the team members was that it always seemed to arise out of what turned out to be authentic legal and regulatory differences. In other words, we did not really disagree ultimately, but we were coming together from different positions and/or working within different frameworks. For instance, social media posting doesn’t fall under ‘safe harbour’ protections for industry partners, and caution is warranted when developing a standalone PLS if any information is off-label. This meant that certain ‘common sense’ approaches would not work in all situations. We therefore recommend evaluation of legal and regulatory requirements on an ongoing basis, as well as consulting with legal and other experts.

Another interesting conversation was how to manage situations in which legal or other constraints were not the same for all stakeholders. For instance, compensating investigators to be on a steering committee might be a legally reportable transfer of value, which would not be the case for patients who are not healthcare providers. Similarly, social media posting about publications can have very different implications depending on who is posting and the relationship of the publication to label indications or accepted treatment guidelines. We tried to offer advice that took all of these considerations into account, but individual publications professionals will still have to manage day-to-day situations.”

How have the guidelines been received so far? Have you received any initial feedback as to how they will be incorporated and used?  

“My impression is that they’re being adopted as feasible. There are some changes, and many publication teams still work primarily with clinical trial publications, which means that some of the new information does not apply. We received 0% negative feedback during the reviews, which was very gratifying after putting in so many hours.

A few people have been fairly clear in wanting very specific guidance to be included. One instance is specific limits on the number of steering committee members or authors: these make sense in certain situations but not others. My personal feeling is that GPP 2022 presents high level principles and that experts within specific working settings should be making decisions about what makes sense for that setting, in terms of applying those principles.”

“My personal feeling is that GPP 2022 presents high level principles and that experts within specific working settings should be making decisions about what makes sense for that setting, in terms of applying those principles.”

Would you like to see greater involvement of any stakeholders, such as patients, in the development of future GPP guidelines?

“My personal feeling is that we really need a patient-led document on publications that outlines what patients would like to see, similar to the article written by Hesp et al on applying GPP3 in the Asia–Pacific region, taking GPP3 principles and translating them to the regional context.

It would also be nice to see work from stakeholders in low- and middle- income countries that outlines their views on publications, inclusivity, and good practice.

“It would also be nice to see work from stakeholders in low- and middle- income countries that outlines their views on publications, inclusivity, and good practice.”

I’d also like to see what experts in various scientific and medical specialties might recommend to their members.”

What do you predict is next for GPP? Which topics may need to be covered in future iterations of the guidelines as the publications landscape evolves?

“I sincerely hope this iteration lasts for several years. The next steps I foresee are answering any FAQs and identifying areas that need attention. For instance, there seems to be some question about how many steering committees to have. GPP 2022 covers several possibilities and I think day-to-day experts, of whom there are many, should share their experiences. As a next step, I also see various groups commenting on how they apply GPP principles in various working contexts. It would be especially helpful, for instance, to hear more from people working in low- and middle-income countries about the needs for training or support to enable inclusion in steering committees and authoring teams. As noted, I also believe that we need to hear more from patients—there are some publications on how to form a patient steering committee, for instance, but there seems to be a space for more work, such as how to help patients participate in peer review.

We anticipated that artificial intelligence and other technological advances will impact publications and that journals will enhance their policies on preprints. These should not affect the main principles of GPP, though, I would hope.”

 Lisa DeTora is Associate Professor at Hofstra University. You can contact Lisa at lisa.m.detora@hofstra.edu or on LinkedIn.

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