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Meeting report: summary of sessions 3 and 4 of the 10th EMWA symposium

The 10th European Medical Writers Association (EMWA) symposium, entitled ‘Communicating with the public – what has the COVID-19 pandemic taught us?’ took place on 5 May. The symposium explored this topic through presentations and panel discussions, focusing on insights relevant to medical writers and communicators.

A summary of sessions 3 and 4 of the symposium is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.

You can also read our summaries of sessions 1 and 2.

Session 3

Why the public needs medical writers


KEY TAKEAWAYS
  • Accurate and accessible scientific information, that is co-created alongside patients, empowers patients to better manage their own health and advocate much-needed clinical research.

The afternoon sessions were kicked off with patient advocate Mitchell Silva’s presentation on why the public needs medical writers. During Silva’s PhD, in which he studied predictors of COPD and asthma flare-ups, he was diagnosed with a long-term lung condition. Despite his knowledge of and connection with experts in the field, Silva found difficulty in accessing the right information and navigating misinformation, particularly with regard to clinical trials.

Despite his knowledge of and connection with experts in the field, Silva found difficulty in accessing the right information and navigating misinformation, particularly with regard to clinical trials.

Silva quickly recognised that he, as a well-versed scientist facing challenges, would not be alone in experiencing these difficulties and wanted to empower patients to take part in clinical trials, and even become advocates of them.

When patients are empowered, they are enabled to participate in shared decision-making, better manage their own health and further empower themselves. Not only has patient empowerment been shown to improve patient outcomes, like quality of life, but also clinical outcomes.

Silva underscored the importance of medical writers in patient empowerment, highlighting the utmost need for accurate yet accessible scientific information. Different types of support and personalised communication are required at various junctures along the patient journey, from information about diagnosis to clinical trials, and writers must be cautious not to make assumptions about patients’ health literacy, which is highly heterogenous.

Silva went on to talk about several approaches that have been taken to empower patients in the clinical trial space, including trial result summaries, enabling patients to monitor trials to which they have given their time and an App to track symptoms, set SMART goals and provide useful information. Patient expert centres were also mentioned, which have been developed with patient associations, to help educate patient experts and facilitate their input into clinical trials.

Silva concluded by describing medical writers as partners of patients: co-creating information with patients to optimise outcomes and form part of the solution to empower patients.

Silva concluded by describing medical writers as partners of patients: co-creating information with patients to optimise outcomes and form part of the solution to empower patients.

How even the regulators can get it wrong – the strange story of aducanumab


KEY TAKEAWAYS
  • Throughout a drug’s lifecycle, transparency, openness, and patient engagement are crucial elements to supporting patients’ choice and access to treatment whilst upholding the responsibility to protect their safety.

Through his capacities as a physician, writer and medical ethics & health policy expert, Jason Karlawish has cultivated an appreciation for the importance of information production and transparency in medical research.

As a physician caring for patients with Alzheimer’s disease, Karlawish long anticipated the arrival of a safe and effective treatment. In 2021, the US Food and Drug Administration (FDA) gave accelerated approval of Biogen’s aducanumab, an anti-β-amyloid antibody reported to reduce Alzheimer’s disease-associated amyloid. The ability of the drug to reduce β-amyloid was used as a surrogate of its clinical benefit to patients, yet the clinical benefit of β-amyloid reduction in Alzheimer’s patients remains contentious amongst experts in the field. Proponents of the FDA’s decision thought it had fulfilled its mission to give patients with serious and life-threatening diseases, choice and access to treatment. Yet opponents believed the FDA had failed to protect patients from drugs that require more data to fully establish their efficacy and safety.  Indeed, the FDA’s peripheral and central nervous system advisory committee unanimously, with one abstention, voted against aducanumab.

The initial FDA label indicated aducanumab in the treatment of Alzheimer’s disease, a label that Karlawish described as very broad and suggestive of a drug that is safe and efficacious in a large number of patients at all stages of cognitive development. The label has since been revised to align with Biogen’s late-stage trials in patients with mild cognitive impairment or mild dementia. Despite this change, the US Centers for Medicare and Medicaid Services (CMS) has recently confirmed it will limit aducanumab coverage to clinical trials only since ‘there is currently not enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare’.

The outcomes of meetings between Biogen and the FDA as well as ‘listening sessions’ with selected patients have been kept out of the public domain as were, until recently, aducanumab clinical trial data, explained Karlawish. These elements, alongside the initial broad label were described as failures of information production. The process behind the drug’s approval lacked transparency; Karlawish called for more openness with clinical data, engagement with patient groups throughout a drug’s lifecycle and informative labels that, where necessary, bear a clear statement of what accelerated approval means.

Karlawish called for more openness with clinical data, engagement with patient groups throughout a drug’s lifecycle and informative labels.

Introducing the MRCT Center clinical research glossary


KEY TAKEAWAYS
  • The MCRT Center clinical research glossary is a resource for patients, medical writers, and participants of clinical trials that provides a plain-language definition of commonly used terms and aids informed diagnosis in clinical trials.

Representing the Multiregional Clinical Trials (MRCT) Center, Art Gertel introduced the MRCT Center clinical research glossary: a resource for patients, caregivers, medical writers, and participants of clinical trials comprising a plain-language glossary of terms that they are likely to encounter. There are currently very few resources that use plain language, and even fewer have involved patients or participants in their development; the aim of the glossary, therefore, was to fulfil this unmet need and to help patients and participants make an informed decision before taking part in a clinical trial.

There are currently very few resources that use plain language, and even fewer have involved patients or participants in their development; the aim of the glossary, therefore, was to fulfil this unmet need and to help patients and participants make an informed decision before taking part in a clinical trial.

The MRCT Center initiated the pilot project to develop the collaborative, consensus-driven glossary in 2002. The glossary was co-created with patients to be understood by the general public and accepted by industry and academic stakeholders across the clinical research ecosystem. Health literacy principles were used to produce the glossary of selected terms; these principles mandate:

  • plain language
  • fewer ideas in a single definition
  • fewer idioms and jargon
  • removal of additional, non-essential information work with few syllables
  • active voice
  • shortened sentences.

Feedback on the definitions was collected over 6 months using an agile process and broad audience. The terms were reviewed based on their:

  • clarity
  • accuracy
  • consistency with regulatory definitions
  • plain language
  • understandability to patients/participants
  • concordance with other authority definitions
  • use across different contexts.

The glossary also includes links to further information, pronunciation guides, related terms as well as schematics and secondary information to provide context for more complicated terms and explain what they might mean in different scenarios.

Gertel concluded the talk by outlining expansion efforts of the project, which includes additional review by representatives of diverse communities with an international perspective and urged the audience to commit to using common definitions to aid clarity and transparency in scientific research.

Gertel urged the audience to commit to using common definitions to aid clarity and transparency in scientific research.

Later in the day, during the panel discussion, Gertel again stressed the importance of terminology: some terms are charged and have potentially negative connotations, and might cause offence. It is important to consider the potential perceptions of terms like clinical trial versus study, or subject versus participant versus patient versus volunteer. While originally conflated, ‘blinded’ and ‘masked’ now tend to refer to how assignments are hidden from clinicians, trial participants, or sponsors, and how a product is packaged so that the contents are concealed, respectively. However, it may be preferable to consistently use ‘masked’ rather than ‘blinded’ in some contexts, such as for ocular diseases, to avoid giving participants false expectations or impressions of risks that should not be implied.

Gertel noted that authoritative sources such as regulators and standards organisations were used as the starting point for the development of the Clinical Data Interchange Standards Consortium (CDISC) glossary. Definitions were either incorporated as written or modified (with attribution), or drawn up based on the expertise and experience of team members if available information did not seem appropriate. For the MRCT plain language glossary discussed above, many team members were previously involved in the CDISC glossary, so had already processed definitions from these sources and brought these to the table.

In terms of ensuring the use of inclusive and plain language in the MRCT glossary, Gertel noted that some of the participants in the exercise were ‘test subjects’ whose role was to evaluate whether definitions made sense. Gertel noted that they always tried to use inclusive language, for example “I would like” rather than “one would like”, to help increase engagement. Personalising and humanising material means that people are more likely to engage with the resource.

Communicating science and medicine to the public through literature


KEY TAKEAWAYS
  • Convincing an audience that they care and are interested in a topic, then distilling the information to an appropriate level is fundamental to successfully engaging different types of audiences.

The final talk of the session included a ‘fireside chat’ with Mike Lemonick, freelance science journalist and Princeton University lecturer, whose career has involved communicating with a range of audiences. Lemonick was inspired to become a science journalist by his father, a physicist, whose particle physics pitch was able to captivate any audience.

When asked which challenges exist when communicating with different audiences, Lemonick described his process as unconscious. When speaking with an audience, Lemonick gauges their reactions to distil his message to a level he perceives they are capable of understanding.  Unconscious code switching is an important part of communicating appropriately with an audience and is guided by a sense and knowledge of who they are.

Unconscious code switching is an important part of communicating appropriately with an audience and is guided by a sense and knowledge of who they are.

Whilst reaction gauging isn’t possible when writing scientific communications, Lemonick believes that he has absorbed sufficient knowledge of non-scientific audiences to have developed a subconscious sense of how to accurately deliver a message without going into too much scientific detail.

Lemonick described some of the key aspects of successful engagement with different audiences; first and foremost is convincing them that they are interested in the subject matter. Whilst there is no premium on convincing peers to read scientific material, since they are likely to be motivated to keep up to date with their field, popular journalism requires writers to persuade readers to take interest in topics they were previously unaware of, or indifferent to. Lemonick noted that anecdotes can be helpful in appealing to an audience and encouraging them to care, referring to the author Oliver Sacks, who has very successfully used this technique to deliver his message to the reader. Such a method is often employed in popular journalism, using anecdotes as an introduction to segue into the underlying science. Lemonick also touched on the importance of respecting where an audience is coming from and identifying with this viewpoint; not implying that readers are unknowledgeable makes them more receptive to the message we, as writers, have to deliver.

Session 4

Safety communication for the general public – how do we determine and then communicate benefit/risk?


KEY TAKEAWAYS
  • Different stakeholders make benefit/risk assessments from different perspectives: considering how patients make benefit/risk judgements can help to ensure that drug development delivers products that meet the end users’ needs.
  • Clear, precise, and unbiased communication of benefits and risks by pharmaceutical companies and medical writers is crucial to deliver the information stakeholders need for their own decision-making.

The final session of the symposium saw Professor Lawrence Liberti (Temple University School of Pharmacy) share his experiences and insights into conducting and then communicating benefit/risk assessments.

Assessing benefit/risk

Liberti noted that, to some extent, most of us balance benefits and risks in decision-making every day, but we don’t always think about how we do this. For example, when we are presented with information about a potentially dangerous substance, we have to determine whether it is relevant to us, what level of exposure would be dangerous, and what alternatives we might have, in order to consider whether the benefits outweigh the risks. We also have to ask ourselves whether we have enough information to make the decision.

Throughout the process of drug development, and after a drug becomes available to patients, evidence and experience are continuously accumulating. The degree of uncertainty about the benefits and risks decreases over time; equally, after a lot of patient experience has been gained, ‘unknown-unknowns’, or risks that could not have reasonably been predicted, may start to be identified. Liberti illustrated how the understanding of benefits and risks can evolve over time with an adapted cartoon from The New Yorker, in which a healthcare professional (HCP) says to a patient: “You should start taking the pills now, before we discover that they are harmful or don’t make any difference.” Liberti emphasised that safety or effectiveness may differ from expectations: the benefit/risk profile involves a continuum of learning.

Safety or effectiveness may differ from expectations: the benefit/risk profile involves a continuum of learning.

Benefit/risk assessments use regulatory science to identify evidence available to reduce uncertainty, facilitate technical or value judgements, and improve decision-making processes across the product development lifecycle. This should enable regulatory decisions that are better informed, more meaningful, and better communicated, which in turn, should allow stakeholders including payers, patients, and caregivers to make their own benefit/risk assessments and decide on the best approach or option for their situation. We must consider how best to provide the information required by these stakeholders to inform their assessments.

Liberti mentioned a range of terminology used in benefit/risk assessment, for example describing benefits as ‘favourable effects’ and risks as ‘unfavourable effects’. In all cases, consideration must be given to the level of uncertainty, which can arise from variation, sources of bias, and limitations of datasets. The probability of uncertainties may be applied to benefits and harms to give ‘benefit optimisation’ and ‘risks’.

During drug development, there is a continuum of trade-offs between benefits and risks. The benefit/risk balance is likely to influence decision-making about regulatory submissions:

Level of benefit
Low High
Level of risk Low Product may not be submitted or approved Ideal product
High Product likely to be rejected Product benefit/risk profile may be suitable in certain special cases, eg cancer

 

 

Furthermore, the types of assessment differ throughout the product lifecycle, as perspectives vary between stakeholders:

  • Regulatory agencies ask whether the drug does more good than harm in a defined group of patients, by examining the efficacy and safety profile at the population level.
  • Payers ask what the value of the drug is, based on its efficacy and safety.
  • Prescribers ask how the drug performs relative to other interventions, examining relative effectiveness and safety.
  • Patients ask what the value of the drug is to them: are they willing to take the risk and able to pay for the treatment?

It can be difficult to know how different stakeholders make benefit/risk decisions, and there is a need to improve the transparency of these processes. A vast range of techniques may be used in benefit/risk assessment: approaches may be classified as descriptive frameworks, quantitative frameworks, threshold indices, health indices, trade-off indices, estimation techniques, or utility survey techniques. In all cases, science provides the data to inform benefit/risk analyses, but it does not provide the answers: judgements, influenced by biases and perceptions, are always required. Regulators make judgements on benefit/risk at the population level, while HCPs and patients must translate the population information to the individual patient level.

Science provides the data to inform benefit/risk analyses, but it does not provide the answers: judgements, influenced by biases and perceptions, are always required.

Uncertainties and perceptions of benefit, expectations, hope, trust, risk, anxiety/fear, credibility, and doubt all play into how individuals make benefit/risk judgements.

Liberti noted that the importance of considering benefit/risk assessments made by patients, as the end users, is increasingly recognised through patient-focused drug development. Considering patient perceptions in the drug development process and throughout the lifecycle can help ensure that interventions meet patient needs. In recent years, there have been efforts to integrate patient preferences into medicine development, such as the Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) research project, funded by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Guidance is also available from the FDA regarding how to integrate patient-reported outcomes (PROs) into benefit/risk assessment during drug development – such guidance is important to encourage consistency with bringing the patient voice into benefit/risk assessment. Valuable projects, such as the Parent Project Muscular Dystrophy, have also shed light on the outcomes that are most important to patients and their caregivers. Such initiatives can be particularly useful in rare diseases, helping to ensure that benefit/risk assessment during drug development focuses on factors that would reflect true improvements from the patient perspective.

Communicating benefit/risk

In the second part of his talk, Liberti discussed how best to communicate benefit/risk information. He noted that sometimes a picture is worth 10,000 words, so visual displays can be particularly valuable. The IMI Pharmacoepidemiological Research on Outcomes of Therapeutics in a European Consortium (PROTECT) project has evaluated different possibilities for visually representing benefit/risk data, ranging from the familiar bar chart to scatterplots, surface plots, area graphs, and Tornado diagrams. The IMI advocates increasing graphical presentation of data, for audiences including regulators, HCPs, and patients. Liberti gave two examples of patient-friendly communications:

  • smiley/sad faces to illustrate positive/negative outcomes
  • illustrations to convey potential benefits/risks.

For the latter example, Liberti emphasised that not all visualisations need to communicate quantitative data.

Liberti emphasised that not all visualisations need to communicate quantitative data.

Liberti noted that the pharmaceutical industry, and medical writers in particular, have a crucial role in communicating benefits and risks. These should be communicated explicitly, with benefits usually extending from the analysis of efficacy endpoints and risks drawn from assessment of data gathered across all development phases. Liberti shared some recommendations:

  • Summarising key benefits and risks side by side, on the same page, can aid comprehension.
  • Consistent formatting, such as always presenting data for the drug on the left and for the placebo on the right, facilitates pattern recognition and aids understanding.
  • Statistics should be used consistently throughout communications.
  • Communications, and terminology used, should be tailored to the audience.
  • Communications should be clear: ideas should not be left open to (mis)interpretation.

Liberti noted that the benefit/risk balance drives the entire drug development and assessment process. He recommended setting the stage for understanding the benefit/risk profile early on in drug development, by preparing mock package inserts or summary of product characteristics, which should then be periodically verified against actual data. Liberti recommended that when developing communications, you should always think of the endgame: is the information understandable by and useful to the patient?

When developing communications, you should always think of the endgame: is the information understandable by and useful to the patient?

Liberti shared some examples of clear communication in the context of COVID-19 vaccines, such as benefits and risks outlined by the Centers for Disease Control and Prevention, and information from Duke Health and the Australian Academy of Science designed to guide patients to conduct their own benefit/risk assessment. He noted that these examples were clearly laid out, but lacked illustrations of the benefits/risk balance that could facilitate interpretation. Liberti also shared some recommendations for communicating benefit/risk with the public, drawing on a recent article about COVID-19 vaccines:

  • communicate frequently about the process and outcomes
  • make values explicit
  • use clear, accurate, actionable messages
  • diversify communication channels and platforms
  • identify and address misinformation
  • prioritise key groups for communication
  • use credible spokespeople
  • sustain trust
  • use data to inform action
  • monitor and evaluate.

Liberti stressed the importance of information being delivered from credible sources and of evaluating the impact of communications.

Liberti shared perspectives on different types of communications from the pharmaceutical industry to patients:

  • Direct-to-consumer communications (particularly in the US context) present challenges for pharmaceutical companies, who must ensure that quantitative efficacy or risk information is communicated in an accurate and understandable way. FDA guidance provides an indication of the type of information best included, and suggests strategies for communicating quantitative data effectively, such as presenting probabilities in terms of absolute frequencies, percentages, and relative frequencies, and using easy-to-understand visual aids to illustrate risk information.
  • FDA guidance on medication guides details the information that should be included to inform patient decision-making. Liberti noted that the bulleted formatting of these package inserts can make the information easily accessible and understandable.
  • Clinical study plain language summaries must also include clear benefit/risk information for patients to read when considering joining a study.

Liberti emphasised that it is critical to align communications with the level of patient knowledge, and to ensure readability. The value of gaining insights from real users, through sharing materials with patients and obtaining their feedback, should not be overlooked.

The value of gaining insights from real users, through sharing materials with patients and obtaining their feedback, should not be overlooked.

Medical writers must be mindful not to overstate benefits, or minimise or disregard risks. Expected benefit/risk issues based on known class effects should be addressed upfront, before tailoring communications to benefits/risks raised in specific studies for the product concerned. Information on benefits and risks should be presented in a clear, precise, dispassionate, and unbiased manner so that stakeholders can make benefit/risk judgements for themselves.

Information on benefits and risks should be presented in a clear, precise, dispassionate, and unbiased manner so that stakeholders can make benefit/risk judgements for themselves.

In closing, Liberti emphasised the importance of the writer in communicating benefits and risks within a pharmaceutical company, to regulators, to patients, and to other stakeholders.

Panel discussion


KEY TAKEAWAYS
  • HCPs remain key channels for the delivery and interpretation of information to patients, although clear communication of critical messages directly to patients can also be valuable.
  • More could be done to understand how the public comprehends and retains health information; at the individual level, patient navigators could increasingly help meet patient needs for tailored information.

Following Liberti’s informative talk, he was joined by Lemonick, Silva, and Gertel for a panel discussion. Some key topics covered are summarised below.

Is there enough trust in pharmaceutical companies for patients to accept educational materials provided directly, such as on company websites?

Silva noted that much of the educational information out there has been generated by industry, but if this is not disseminated via channels accessed by patients, they may not see it. He recommended that if you want information to be seen as trustworthy and accepted by patients, then primary or specialist physicians and nurses may be the key channels for delivery. It is important to consider which HCPs have the time and opportunity to communicate the information to the patient, or to plant the seed for patients to go on to access more information themselves. Some patients use and benefit from information provided to them directly: these patients may be a minority, but this depends on the therapy area and patient population.

If you want information to be seen as trustworthy and accepted by patients, then primary or specialist physicians and nurses may be the key channels for delivery.

Liberti added that particularly over the past 5 years, we have learned that people may not have the expertise in critical thinking to be able to balance and contextualise health information. Everyone also has biases which influence the information they retain. We need to think about the critical messages that can be clearly conveyed directly to patients, alongside the key role of the ‘learned intermediary’ HCPs in interpreting information for patients and providing advice. Liberti noted that patients with specific or rare diseases are often very well informed, and are one step ahead of non-specialist clinicians in many cases, bringing information to HCPs involved in their care. For more general health information, Liberti highlighted the importance of HCPs as well as trust in regulators.

 We need to think about the critical messages that can be clearly conveyed directly to patients, alongside the key role of the ‘learned intermediary’ HCPs in interpreting information for patients and providing advice.

Is there a way to measure how effective medical communications to the public are?

Lemonick kicked off the discussion on this topic, noting that there probably are ways to measure the effectiveness of communications, but distressingly, this is not done in journalism. Particularly in the US, journalists are in the business of informing rather than educating, meaning that there is no testing to see whether you have effectively transmitted information that people understand and retain. While people are more likely to read health-related stories than, for example, those about black holes, journalistic pieces need to be intriguing and exciting to gain readership. However, despite accuracy of statistics and quotes, stories can give readers a false impression if context is lacking – for example, pieces about cures for cancer that do not state that the research was conducted only in mice.

Liberti added that surveys conducted during the COVID-19 pandemic have shed new light on the public’s interpretation and retention of health information, or misinformation disseminated via social media. Dishearteningly, the information best retained may be misinformation, rather than information that is trustworthy, replicable, and reliable. In the future, improved metrics for understanding the type of benefit/risk information best understood by patients would be valuable. Already, we have an understanding that large volumes of information can cloud people’s ability to make benefit/risk judgements.

Silva noted that when it comes to the treatment of individual patients, there is room for assessing knowledge and then delivering relevant information directly. The rise of patient navigator programmes could help to facilitate this assessment and information provision for individual patient trajectories.

Should medical writers be more involved with patient advocacy groups to help improve the quality of communications?

Silva explained that it can be very valuable to talk to and form partnerships with patient advocacy groups to improve information dissemination. He noted that there are different types of patient advocacy group, so interactions may require different skillsets, but learnings can always be gained and taken forward to future projects.

What is your top tip for medical writers preparing communications for the public?

Finally, the panellists shared their perspectives:

  • Test what you have written with your target audience in a structured way.
  • Evaluate what a non-expert takes away from the piece.
  • Storytelling can be an effective mechanism to guide the audience towards comprehension of results.

Summary and conclusions

Lisa Chamberlain James (Trilogy Writing and Consulting) closed the symposium by thanking her co-hosts, the programme committee, and all involved in running the symposium, as well as the eminent speakers for their informative talks.

Why not also read our summaries of sessions 1 and 2?

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Written as part of a Media Partnership between EMWA and The Publication Plan.

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