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 first 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.

Read our summaries of the morning and afternoon sessions of Day 2, and Day 3.

Summaries of Day 1

Dan Bridges (Inizio Medical and Chair of the ISMPP Board of Trustees) opened the meeting by highlighting the progress made over the last decade in putting patients first. Bridges noted that many of the changes have been enforced by regulations, but that now was an opportunity to take charge by embracing patient involvement as an industry and learning from each other.

Keynote: Patients have AUTHORity

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KEY TAKEAWAYS

• Make sure information is powerful and clear.
• Collaboration is key: involve patients and advocacy groups in relevant publications.

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The Day 1 keynote was given by Sharon Terry (Genetic Alliance), who expressed her gratitude that patient engagement was at the heart of the conference. As a mother of two children diagnosed with genetic disorders, she expressed her familiarity with the obstacles that patients and their carers experience when receiving and assimilating a diagnosis, and then trying to get treatment so they can live with their disease. Terry expressed her frustration that there are thousands of rare diseases but only a small fraction with treatments available.

Information is locked behind paywalls

When Terry first sought information to help her understand her children’s disease, she found that access to information was often locked behind paywalls. After gaining access, she realised that misinformation was being perpetuated, often through credible journals. Outdated information was often left uncorrected and allowed to propagate. Terry observed that when journal articles are driven by scientific rivalries or establishing intellectual property, rather than communicating to patient audiences, even the savviest of patients can find it hard to cut through jargon to obtain information and draw their own conclusions. Becoming involved in publications was a vital step to becoming part of the conversation about her children’s condition.

When journal articles are driven by scientific rivalries or establishing intellectual property, rather than communicating to patient audiences, even the savviest of patients can find it hard to cut through jargon to obtain information.

Make sure information is powerful and clear

Although journals are key stakeholders when conveying information for patients, it is the authors’ job to ensure that information is powerful and clear. Medical publication professionals can be an important conduit between patients and the scientific community to support this process. Terry also expressed the need to articulate the value patients can bring to medical publications in terms of context, life experience, and communication style. She noted moves to improve patient involvement, with social and regulatory changes meaning patient involvement in trials and publications may be required. Patient-reported outcomes are becoming increasingly important to regulatory authorities; medical publication professionals can help create a platform for communicating these outcomes.

Journals can play a role in providing understandable and accessible information for patients

Terry provided several suggestions for how patient involvement could be improved in practice:

• Partnerships between patients, advocacy groups, authors, and journals can help make sure that information is up to date and communicated in a meaningful way to patients. Sites like diseaseinfosearch.org provide disease information and links to resources and support/advocacy groups.
• Plain language summaries (PLS), when written by experts and advocates, can be very helpful for rare disease groups.
• Practice guidelines are important for patients. It can take years for information to trickle down from professionals and societies. Updating guidelines and informing clinicians more quickly via publication in journals will help pass information on to patients more quickly.
• Dissemination – advocacy groups can help to disseminate content appropriately for patients.
• Social discourse – there is often a firewall between patients and journals/professional societies when it comes to social media. However, social media can be an important tool for conveying information. As such, advocacy groups may act as an intermediary for conveying information while maintaining standards for how information is communicated.

Patient involvement has evolved greatly over several decades, with many patients being eager to collaborate. A wealth of information is now readily available at patients’ fingertips and it is important for medical publications professionals to ensure that information is up to date, understandable, relatable, and grounded in lived experience.

A wealth of information is now readily available at the patients’ fingertips and it is important for medical publications professionals to ensure that information is up to date, understandable, relatable, and grounded in lived experience.

Patient Premiers: and the award goes to…

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KEY TAKEAWAYS

• Leading initiatives and resources are helping foster meaningful partnerships with patients in medical research and communications.

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The second session of the day reviewed the growing number of initiatives helping to create meaningful patient partnerships in medical research and communications, from different stakeholder perspectives. The faculty’s top 10 most inspiring and transformative initiatives were identified and ‘awards’ were given for the top 3.

The publisher perspective

Kelly Soldavin (Taylor and Francis Group) discussed the importance of making it easy for patients to interact with the publication process, whether as peer reviewers, advocates, or part of an editorial board. Soldavin discussed the 2021 OpenPharma recommendations for PLS, the first to provide industry consensus on best practices for developing PLS. The recommendations also established the importance of acknowledging patients as a key audience for medical publications. Secondly, Soldavin mentioned several PubMed enhancements, notably patient author tagging and the implementation of PLS indexing by Adis, making content more readily accessible to patients.

Soldavin chose the work of Trishna Bharadia, a multi award-winning health advocate and patient engagement consultant, as the winning initiative. Bharadia works with stakeholders including pharma, medical communications, publishers, patient associations, charities, clinicians, patients, and caregivers to amplify the patient voice, advocate for diversity, and encourage organisations to integrate patient perspectives in publications and health initiatives.

“Patients living with health conditions should have access to the latest research in a way that is understandable and meaningful, so that everyone is able to better understand their disease and the treatment pathways.”
–Trishna Bharadia

The pharmaceutical industry perspective

Avishek Pal (Novartis Oncology) noted that over the last 5 years, progress has been made towards inclusion, co-creation, and free information sharing with patients, but conceded that there is always the opportunity to do more. Pal chose 3 initiatives that he felt were the most innovative, creative, and impactful, and showed the pharmaceutical industry how to do things differently. The Patient Information Forum (PIF) Tick is a quality mark for healthcare information, helping patients find trusted health information and avoid misinformation, while the UK not-for-profit Patient Focused Medicines Development (PFMD) ‘How to…’ guides for patient engagement are a one-of-a-kind, unified, practical roadmap on how to develop patient-focused plain language materials that have been used extensively since their launch.

Pal’s chosen winner was publisher Future Science Group for the development of plain language summaries of publications (PLSPs), to extend the reach of scientific information to a wider audience. Each PLSP is published as a peer-reviewed, standalone article in Future Science Group journals with its own digital object identifier (DOI) so that it is citable, indexed on databases, and easily discoverable.

The patient perspective

Health consultant and patient advocate Patrick Gee (iAdvocate, Inc.) discussed his role in working as a BMJ patient partner from both an authorship and peer review perspective. Through his work with the Kidney Health Initiative, Gee also works with the US Food and Drug Administration (FDA): he noted the FDA is collaborative and eager to work with patients to discuss their needs and how they manage their conditions.

The 19^th Annual Meeting of ISMPP, with its ‘patients first’ focus, was Gee’s winning initiative: he highlighted the importance of having publishers, patients, and industry collaborating together in one room. Gee acknowledged his journey from being a patient to pupil to published author, and emphasised the importance of being able to share his insights as a patient with researchers, industry experts, care partners, and other patients to encourage them to share their voice.

The medical communications perspective

Jason Gardner (3 Stories High) explained how patients should be integral to planning, conducting, and reporting studies, noting that industry could learn from charities and not-for-profit organisations that have been leading the way. Gardner praised the PLS Publication Toolkit, co-developed by patients, publishers, and pharmaceutical industry representatives in 2018, and acknowledged Pfizer’s patient advocacy and engagement initiatives, describing Pfizer as a trailblazer in the areas of PLS, patient authorship, and collaboration.

For his winning initiative, Gardner selected the GPP 2022 Guidelines, a ‘gamechanger’ for providing clarity, consensus, a strong framework for communicating information, and emphasising the central role of patients as contributors.

Bringing the patient voice into clinical research – patient participation on study steering committees, protocols, and publications

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KEY TAKEAWAYS

• To build long-term engagement, patients should be involved at every stage of clinical research and communications.

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The third session was a vibrant discussion on bringing the patient voice into clinical research. Donald Nelinson (Sanofi) introduced the session, noting that medical publications professionals must now wear two hats – one as a medical publications professional, the second as a patient – to explore why and how engaging and optimising the patient voice across the spectrum of clinical research and communications is important. Nelinson highlighted the current disconnect in clinical research, based on a discussion with a terminally ill patient who explained that study participants rarely know what happens to the study or the impact of the study findings, and it is easy for patients to get lost in the process. This emphasises the need to involve patients in both the design and communication of clinical trials.

Why include patients?

Charlotte Singh (Sanofi) polled the audience, showing that few of the attendees were actively engaging and including patients as part of the protocol development process or on study steering committees, although a greater number were engaging patients as authors or contributors. Very few attendees were engaging patients across all 3 areas. Singh explained how this highlighted the need for better education: if people do not know what to do or how to do it, it can lead to ‘analysis paralysis’ and they never get started. Singh thought this was particularly relevant given the regulatory environment of clinical trials, where consultation with compliance teams is necessary before process changes can be implemented.

Singh made several points about involving patients in clinical trials:

• Patients need to know what is in it for them.
• They need information beyond just ‘informed consent’ and the numbers.
• They need to know why they should undertake the risk, if they do not get to find out about the impact or the results of the study.
• Patients want to be actively involved in conversations, not just ‘pushed along’ and told to sign forms, and they should be asked if they want to be involved.

Singh explained that if patients are involved in a trial, then it is necessary to provide access, flexibility, feasibility, good timing, and logistics. This is particularly important when you are working with patients who have chronic diseases.

If patients are involved in a trial, then it is necessary to provide access, flexibility, feasibility, good timing, and logistics. This is particularly important when you are working with patients who have chronic diseases.

How can we best engage patients?

Amrita Bhowmick (Health Union) looked at what motivates patients to get involved: the primary motivator being to get better, with helping others a secondary motivation. Currently, patients do not feel like they have a place at the table, so it is critical to help them feel comfortable with their expertise. Bhowmick noted it is important to differentiate between patient leaders and patients who are typically enrolled in trials. Patient leaders are generally more visible on social media/blogs, familiar with the language and scientific information, comfortable engaging with experts, and typically the easiest patient group to work with. Patient leaders can play the role of translator or conduit between the scientific population and the wider patient group, using their own health journey, or the journey of a loved one, to raise awareness, share knowledge, and help others. Patient leaders also typically have high health literacy and can effectively connect with and educate other patients.

In contrast, patients who are typically enrolled in trials often have limited experience with the healthcare publishing landscape and health literacy. However, they do have tacit knowledge that is incredibly valuable and can inform researchers about language barriers, and the burdens and day-to-day challenges of a disease. Bhowmick provided the example that some people do not join trials simply because they cannot afford the parking. In this respect, patients, rather than patient leaders, are better placed to provide this level of insight.

At what stage in the development process should patient engagement be considered?

Bhowmick explained that it is important to involve patients at every stage of the development process. The later patients are involved, the harder it is to build engagement. Bhowmick highlighted 4 key areas for patient involvement:

1. Study communications: before the study starts, patients can provide feedback on whether consent forms make sense. At study completion, patients can support with PLS and the dissemination of study results.
2. Design: patients can identify clinical outcomes that are meaningful and relevant to them. Studies should be designed to capture these outcomes accurately.
3. Logistics: patients can provide insights as to barriers and burdens that may prevent study participation and adherence. It is important to proactively offer support throughout the process – patients may not want to ask for support, but will often accept it if it is offered.
4. Recruitment: social media can be used to access patients across the world. Patients want to hear from peers, so study recruiters should consider utilising patient leaders and advocacy groups.

Bhowmick also noted the importance of capturing ongoing patient feedback, through observational research, leveraging social media, or more traditional methods such as focus groups. Patients should also be asked what their goals and expectations are for the study.

What does ‘good’ patient engagement look like?

It is critically important to put guard rails in place to prevent bias as much as possible. Moreover, the patient voice should be integrated from design to execution, and right through to evaluation and reporting. Nelinson provided several examples of good patient engagement in the research process:

• The NIH/National Cancer Institute has an existing feedback loop so that the patient advocate steering committee can provide feedback after trial analysis on what made sense and what could be improved.
• The LITE study is a comparative effectiveness study in psoriasis, guided by a committee comprised of dermatology experts, patients living with psoriasis, and leaders in health care insurance.
• Accellacare’s The Patient Voice is a group of nearly 400 current, past, and potential Accellacare study participants, together with patients of partner healthcare institutions who have opted in to provide patient insights on initiatives such as study proposals, messaging development, and study recruitment and retention.
• The American Heart Association (AHA) Lay Stakeholder initiative has mandated that patients are involved in steering committees for AHA-funded studies.
• The University College of Dublin Patient Voice in Cancer Research is an initiative to engage patients with cancer, researchers, patient advocates, families, carers, healthcare professionals (HCPs), and policymakers in discussions and decision-making processes to positively impact cancer research and patient outcomes.

Beyond reporting trial results on ClinicalTrials.gov, what does good publication look like?

Nelinson identified several important factors for patient-centric publication practices:

• Engage ordinary (‘rank and file’) passionate patients as authors.
• Develop a PLS, infographic, or video abstract.
• Use multimedia patient author publications to provide a level of insight that HCPs do not have. These can also act as tools that clinicians can use in their interactions with patients.
• Create digital materials with patient leaders/advocates discussing the study with 2 HCPs (for example, roundtable discussions).

Nelinson concluded with a case study of a dry eye disease study that examined patient-reported outcomes. Unsurprisingly, a disparity was found between how HCPs assessed patient status and how patients assessed their own status. Nelinson noted several areas where the study could have been improved, notably by including a patient author, identifying outcomes that were relevant and meaningful to the patient, and providing graphical abstracts to extend the value of the publication.

[There were] several areas where the study could have been improved, notably by including a patient author, identifying outcomes that were relevant and meaningful to the patient and providing graphical abstracts to extend the value of the publication.

Roundtables

Attendees had the opportunity to take part in roundtables covering the following topics:

• Patient perspective research – ensuring inclusion and diversity in patient participation
• How can we measure value in patient engagement?
• Patient privacy in precision and modern medicine
• Diversity in decentralised trial design and reporting
• Incorporating patient voice in healthcare research to improve quality of care and outcomes: stakeholder perspectives
• What makes a patient author?
• Are you engaging the patient throughout the publication planning and development process? Why not?
• Facilitating information needs by optimising omnichannel and use of artificial intelligence
• Innovating to improve sustainability in medical communications
• To meet or to Zoom, that is the question. How HCP engagement is evolving
• Gap analyses: holistic approach to understanding audience needs
• Leveraging actionable insights for effective medical communication strategies
• Authorship challenges & solutions: using the ISMPP Authorship Algorithm tool
• How artificial intelligence (AI) can increase accessibility and compliance of medical publications: generating plain language summaries
• Best practices for working with freelance medical writers in publications
• The people and process of peer review: a peek behind the curtain
• Meaningful metrics
• Newer professionals, open topics

Following the roundtables, attendees had the opportunity to attend parallel sessions.

Working with patient advocacy groups: what does the future hold?

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KEY TAKEAWAYS

• Working with patient advocacy groups is crucial to ensure patient-centric healthcare and drug development.

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In this parallel session, David Gibson (ApotheCom), Corinne Scripps (Center for Information and Study on Clinical Research Participation), and Chrissy Stanojev (Inizio Medical) focused on the evolving relationship between pharmaceutical/biotechnology companies, medical communications agencies, and patient advocacy groups.

How can patients contribute to medical communications?

There is growing awareness of the importance of patient contributions at multiple touchpoints across the drug development process. In the context of medical communications, patients have begun to contribute to a range of deliverables, including patient and caregiver surveys, PLS and voice of the patient reports. However, from discussions with patient groups, it is clear that there are many challenges associated with building successful relationships between patients, pharmaceutical companies and medical communications agencies. For example:

• Patients often feel that engagement happens too late and can be little more than a box-ticking exercise.
• Projects are often restricted to PLS.
• Patients need to be engaged from the outset to support patient-focused drug development.
• Patient groups are keen to publish, but may struggle to generate data, may lack resources and expertise, and can find the cost of working with medical communications agencies to be prohibitive.
• Patients can find it difficult to access information.

There is a need to develop methods for evaluating the effectiveness of patient-focused initiatives.

The patient voice is more important than ever, and we need to listen and respond.

The need for digital dexterity

Looking to the future, we find ourselves in a world where analytics and innovation are of critical importance. As the amount of data in the world continues to expand, there has been an evolution in decision-making, with a switch from empirical to data-driven approaches. Digital dexterity, defined as using emerging technologies for better business outcomes, may enable us to make the most of the vast amount of data that is now available, and help to address some of the challenges associated with working with patients and patient groups.

Digital tools in healthcare

The session continued with a proof-of-concept real world example of how digital tools can be used to meet patient needs. Strategies to Embrace Living with Lupus Fearlessly (SELF), a free online management programme, was developed addressing some of the unmet needs associated with patient advocacy:

• Earlier engagement: the patient voice combined with input from HCPs was intrinsic to the design.
• Patient-centric approach: education modules can be personalised based on patient responses to questions on their current needs and symptoms. In addition, push notifications enable patients to engage on multiple digital screens at various times throughout the day.
• Generating data and evaluating effectiveness: Google Analytics and website engagement data allowed further optimisation of the SELF programme based on patient behaviours.

In addition to SELF, the Lupus Foundation of America has set up Research Accelerated by You (RAY), a lupus data platform that collects self-reported patient data to help researchers accelerate the development of new treatments and improve disease outcomes.

The session ended with a Q&A, in which several key points arose:

• It is important to engage all patients, not just those who are computer-literate.
• Patients require regular feedback from digital tools to facilitate a trusting relationship.
• Tools need to be designed to support an enduring relationship between patients and the tool.
• The use of digital tools by patients has increased substantially in recent years. Engagement needs to be maintained by ensuring relevance, transparency, quality, and user-friendliness.
• Transparency is essential with regards to funding.

Digital dexterity may enable us to make the most of the vast amount of data that is now available, and to address some of the challenges associated with working with patients and patient groups.

Guided poster tour: it’s all about data

There were a total of 71 posters presented at the meeting, with abstracts published in Current Medical Research and Opinion. The guided poster tour called out 4 posters covering the theme of data availability and accessibility (presenting authors show in bold):

• Accessibility of scientific information for non-English speakers: using browser-based tools to translate PLS and abstracts – Presented by Ana Bozas on behalf of: Claire Beeby, Victoria Tomlinson, Eleanor Raynsford, and Charles Pollitt.
• Preprints for clinical trials: their acceptability and progress to peer-reviewed journals – Himabindu Gutha, Jyotsana Dixit, Ubedul Hoda, Madhavi Patil, and Vatsal Shah.
• Improving patient lives: using open repositories to disseminate non-traditional research outputs – Rushi Dave and Dan Valen.
• Understanding patients’ preferences for receiving health communications and information about clinical trials – Dalia Majumdar, Diane Webb, Stephanie Parsons, Liza Selwan-Lewis, Trisha Rettig, Emily Chastain, Winifred Obanor, Rob Birnberg, and Amy Kuang.

Amplifying the voices of patients and their caregivers

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KEY TAKEAWAYS

• Seeing their experiences reflected in the literature validates and empowers patients and caregivers.

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In this parallel session, Leslie Moody (Lumanity), Valerie Leishman (Lumanity), Scott Campbell (Takeda), Caren Suesserman (patient advocate/consultant, Exon 20 Group), and Joseph Marzella (Lumanity) discussed the importance of patient and caregiver experiences. The session focused on how to utilise and disseminate insights obtained from patients and caregivers.

Industry perspective

Campbell described Takeda’s patient journey work that began with surveying patients to gain qualitative and quantitative information to understand their needs and experiences with therapy for different cancers. The results were disseminated through congress posters and a paid patient-directed supplement in Cure. Although the goal was to gain insights to inform planning at Takeda, they soon realised that there was value in using the insights to inform the wider community, and that allowing patients to connect with other stakeholders and peers could enrich understanding of patients’ experiences, particularly for those with rare conditions. Patient organisations were convened to share the insights.

Key points for engaging in patient studies include:

• Involve a team for the work, including a patient advocate/advocacy group, writer, advisory board/HCP, and study coordinator.
• Plan how you will utilise the insights from the start.
• Immerse yourself in what the patients have to say.
• Identify suitable participants for the study and plan for a lengthy recruitment period.
• Plan back from the publication deadline.
• Determine target congresses and journals that accept patient studies and that reach the intended audience.

Patient/caregiver perspective

Suesserman provided the caregiver’s perspective, confirming that informed patients are driving their own journeys nowadays. The more information they have, the better they can educate their doctors and participate in treatment decisions. She highlighted that active patient groups motivate industry to recognise that patients matter too, and identify when more research is needed. Suesserman felt it important to recognise that rare cancers can be isolating and that there is strength in community. Indeed, describing her own journey as a caregiver for her husband, Suesserman explained how useful they found the Exon 20 Group. The group also highlighted possible clinical trials and the efficacy of first-line treatments that could buy time before entering trials. Knowledge is power: everyone benefits from better-informed patients.

Suesserman emphasised that seeing published patient research makes patients feel that they are not alone and are not ignored; it validates and empowers them, especially in a difficult-to-treat environment. It is important to note that patients want peer reviewed, credible information alongside anecdotal information, so that they speak the same language as their HCPs.

Concluding, the panel noted how advocacy groups/forums play a crucial role in amplifying the patient voice:

• Allowing patients to interact with each other and gain different insights.
• Helping to compile lists of possible clinical trials that patients can participate in.
• Enabling patients and patient advocates to work with industry to create digestible plain language materials that resonate with patients, including innovative technologies, infographics, and post-congress summaries.
• Working with patients to find out what they want to know and how they want to access and process the information.
• Providing QR codes to spread relevant information to HCPs and patients.

The more information patients have, the better they can educate their doctors and participate in treatment decisions.

The power of collaboration: how to engage effectively with health economics and outcomes research (HEOR) partners

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KEY TAKEAWAYS

• Collaborators involved in developing HEOR communications have different expertise and varied understanding of the writing and publication process.
• Use the Responsible, Accountable, Consulted, Informed (RACI) framework and effective teamwork to successfully cross the finish line.

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Catherine Mirvis (OPEN Health), Beth Lesher (OPEN Health), and Caitlyn Solem (GSK) delivered this parallel session, using a case scenario of writing and submitting a HEOR manuscript to illustrate the challenges and possible solutions arising during the process. The hypothetical scenario included a publications lead, 2 HEOR scientists, a medical writer, and an external clinical specialist (a physician), each with differing levels of experience and understanding of the writing/publications process. Noting the primary objectives for HEOR are to establish value and market access for a drug (compared to establishing efficacy, safety, and support for drug approval for clinical research), the panel discussed common publication pitfalls, including breakdowns in communication and different concerns and expectations through various stages of the process.

The following solutions were identified to ensure effective collaboration:

• Have a kick-off meeting to discuss team roles and expectations, build consensus and trust, clarify housekeeping tasks including timelines and periods of unavailability, share information/data, identify key messages and target audience, and select the target journal.
• Keep an open mind and teach each other to bridge gaps in understanding.
• Play to team strengths.
• Use the RACI framework to clarify responsibilities and accountabilities of the team players:
  • Responsible (task-oriented)
  • Accountable (outcome-oriented)
  • Consulted (input based on expertise)
  • Informed (keep in the loop).
• Keep communicating at every stage, including providing updated versions of relevant documents.
• Stay aware of external events (eg if publication is needed pre-launch).
• Do a timely submission dry run to anticipate expected journal requirements.
• Decide on add-ons/extenders (eg visual abstract) early in the process.
• Acknowledge the frustrations encountered in the process and the desire to just get the publication out into the world.

HEOR-trained medical writers can support both publications professionals and HEOR experts, and help bridge gaps between groups.

Why not also read the summaries of the morning and afternoon sessions of Day 2, and Day 3?

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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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