With Plan S coming into effect earlier this year, there has been much discussion regarding the potential benefits and challenges associated with open access. It has been suggested that open access articles are available to a larger audience than those published behind paywalls, leading to increased visibility, readership and impact. Citations are often used to measure these factors. However, a number of studies have failed to reach a consensus on whether an open access citation advantage exists.

Dr Isabel Basson and colleagues aimed to address this question by applying three measures of citation advantage:

• normalised citation score (NCS) – indicates if an article received the expected number of citations and corrects for subject area and publication year
• citedness – whether articles were cited by individuals other than the authors within 2 years of publication
• most frequently cited – the percentage of publications in the most frequently cited 1%, 5% and 10% of articles in each subject area.

The study, published in Scientometrics, used open access labels in the Web of Science (WoS) metadata to identify open access articles published in journals listed in the Directory of Open Access Journals and compared measures of citation advantage with subscription journal articles. Limiting the articles to English-language only to avoid a potentially confounding effect of language, the authors identified over 3.6 million articles of which 87.3% were published in subscription journals and 12.7% were published open access. The proportion of open access versus subscription journal articles varied considerably with individual subject areas.

Basson and colleagues reported results for the three measures of citation advantage:

• NCS –a relationship between NCS and access status was found in 76 (30%) of the 250 WoS subject areas investigated. An open access citation advantage was only seen in one subject area; in the remaining 75 subject areas subscription journal articles showed a citation advantage.
• Citedness – a relationship between citedness and access status was seen in fewer than half of subject areas, only 4 of which showed an open access citation advantage.
• Most frequent cited – the citation advantage favoured subscription journal articles rather than open access journal articles in the majority of subject areas.

Across all measures of citation advantage, only six of the 250 subject areas in WoS were reported to experience an open access citation advantage compared with subscription journal articles.

This study was one of the first to use open access labels in the WoS metadata to investigate citation advantage with access status. Overall, the authors conclude that access status accounts for little of the variability in the number of citations an article receives and suggest that other factors need to be considered when explaining variation in citation.

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The COVID-19 pandemic has undoubtedly affected the medical communications industry, presenting unexpected challenges but also creating opportunities for change and innovation. Following his presentation at the 2021 European Meeting of the International Society for Medical Publication Professionals (ISMPP), The Publication Plan talked to Chris Brooks, Publication Lead at AstraZeneca, to learn more about the impact of the pandemic on medical publications and to find out how he sees his role evolving in the future.

 In your role as Publication Lead, you liaise with multiple parties, such as internal medics, authors, medical affairs teams, and agencies. Each of these groups will likely have different motivations and priorities. How do you manage to ensure that all of these stakeholders work together as a cohesive team?

“It’s most certainly a challenge, particularly when you’re new to a team or, as happens so often, colleagues in the various teams you work with are changing. Building relationships with each of the various groups is imperative; it really helps to get to know how they work and what exactly it is that they need or expect from you, as well as who you need to approach to get what you need for publications. Bringing these groups together for regular publication team meetings is one of the simplest ways of keeping everyone informed of plans and progress whilst also giving them a platform to provide input themselves. In addition, I think it’s important that the publications function is included in meetings hosted by other groups. There have been numerous occasions during these meetings where I have heard important snippets of information about studies, results, plans or strategic updates that impact publications. Attending meetings also allows me to provide publication updates or gain clarity on important topics.”

Building relationships with each of the various groups is imperative.

The COVID-19 pandemic has raised many challenges, leading to rapid adaptations across industries in response. In your experience, what have been the main impacts on the medical communications sector?

“I have two answers to this, purely based on the fact I have simultaneously worked on products both in and outside the COVID-19 space.

Firstly, with respect to COVID-19-specific activities, the pace of work has been incredible. I think everyone is abundantly aware of how quickly vaccines have been developed, tested, and approved, but what probably goes a little more unnoticed among the headlines is the fact that all of the other aspects have had to keep pace with the condensed clinical development timelines. Publications is just one tiny cog, and obviously an important one, in the enormous machine that develops a product and brings it to market. Just like everyone else in this effort, publications professionals have had to adapt to move at light speed. Publication timelines for developing and reviewing drafts have often been measured in hours rather than days, whilst timelines for developing manuscripts can be counted in days rather than weeks. These timelines have meant that the idea of submitting to a congress, something that has always been the norm, has been almost unthinkable for the delays it might cause to disseminating data.

The idea of submitting to a congress, something that has always been the norm, has been almost unthinkable for the delays it might cause to disseminating data.

The urgency required to share results has really brought preprints to the fore during the pandemic. For the most part, I think the use of preprints has been good, but it does come with challenges. They are an incredible resource for distributing important science in a rapid fashion, but we must remember that preprints have not undergone peer review when released.

Beyond COVID-19-related publications, I think the biggest impact of the pandemic has been the rise of the virtual congress. First and foremost, the societies organising the meetings have had to change their entire model, which is no small task, but the benefit is that a global audience can access the content so much more easily than they could before. For medical communications, it has presented its own fair share of challenges as we seek the best way to engage with a virtual audience across the many different platforms used by congresses.”

Have you faced any particular challenges or seen any positive outcomes or strategies emerge in response to the unprecedented situation caused by COVID-19?   

“The rapid shift to a virtual environment for congresses was an immediate challenge but I think it’s fair to say that we probably think of it as normal now. The level of innovation has been incredible and has shown what we can do when faced with a new challenge. It’s something that will have to continue to evolve because I think the virtual aspects of these congresses are here to stay.

The level of innovation has been incredible and has shown what we can do when faced with a new challenge.

With the speed at which COVID-19-related content has been delivered, I genuinely think we’ve learnt a lot about what is actually within the realm of possibility. However, this does come with the caveat that it’s not a pace that is sustainable over the long term.

By far and away the most significant positive impact I’ve experienced through the entire pandemic is an even keener awareness of the real, human impact of our work. What we’re doing – however small a part we play – is helping to improve and save lives every day, sometimes on a global scale.”

What we’re doing – however small a part we play – is helping to improve and save lives every day, sometimes on a global scale.

Over the last year, many medical congresses have taken place as virtual events allowing digital elements, while journals are increasingly offering enhanced digital features alongside articles. Which additional digital options do you think have the most value in ensuring that research has the widest reach and impact possible?

“From a congress perspective, it is hard to say as each one offers a vastly different package. There have been some great examples of infographic posters – some have downloadable content whereas others may have embedded video. There are so many possibilities now, depending on the congress. It’s difficult to say which option has the most value because each poster has its own story to tell, but the most basic option allowing the presenting author to record a presentation of their content for people to view on-demand is incredibly powerful – anything you can do on top of that is only going to add value.

Similarly, for journals, I think one of the simplest and most impactful things to offer is a short presentation of the results in some form of audio format.

For journals, I think one of the simplest and most impactful things to offer is a short presentation of the results in some form of audio format.

We know that there is so much competition for attention nowadays, so the option of being able to listen to an audio description of research findings offers a time-saving alternative for someone who would ordinarily have to sit down and read the full paper.”

For many authors, the journal impact factor continues to be a key consideration when selecting a target journal for their manuscript. What do you think are the most important aspects to look at when discussing journal options – is the impact factor a relevant metric?

 “It’s so hard to get away from it. I often joke that I’ve never attended a kick-off call where The Lancet, The Journal of the American Medical Association (JAMA) or The New England Journal of Medicine (NEJM) hasn’t been mentioned, but in reality it’s not far from the truth. You can never overlook these options – they are fantastic journals and there is a good reason that it’s difficult to publish in them, especially as the likes of NEJM are offering such fantastic digital add-ons to some of their publications right now.

That said, if you don’t have ground-breaking, pivotal phase 3 data that the big journals are going to be excited to get hold of, I really think there is a need to think a little more carefully. This is especially true if it’s a strategically important publication for which you want maximum exposure. Publication timelines can come into it as well; aiming too high can increase the time it takes for an article to get accepted as a single rejection can delay publication by weeks or months. Sometimes, the lower impact factor journals are the ones that offer more options for publication enhancements such as video abstracts, voiceovers, and podcasts that can help the article gain greater attention.

In all, I think it’s a delicate balance and one that needs open discussion and agreement with the author group from the outset.”

Open access publishing is actively promoted by some pharma companies, and others mandate that all research they fund is published open access. How important do you think open access publishing is and if there is not already a policy in place at AstraZeneca, is this something that you envision being implemented in the future? 

“I’m a big fan of open access publishing, having started out many years ago working for a publisher. It’s been fantastic seeing all of the publishers making COVID-19 publications open access to further research efforts globally and facilitate the spread of peer reviewed articles to stave off misinformation.

It’s been fantastic seeing all of the publishers making COVID-19 publications open access to further research efforts globally and facilitate the spread of peer reviewed articles to stave off misinformation.

Whilst open access publication is not mandated at AstraZeneca currently, I can envisage circumstances where such a policy might be introduced one day. At the same time, it would be fantastic to see this approach taken for all publications across pharma regardless of the sponsor.”

There have been calls for information to be made more accessible to patients, for example via plain language summaries. Do you feel that plain language summaries should be considered for publication alongside all research articles and how achievable would this be in practice?

“Absolutely yes! I’ve made a concerted effort on the publications I’ve worked on over the past year to develop some form of plain language summary.

I’ve made a concerted effort on the publications I’ve worked on over the past year to develop some form of plain language summary.

Within AstraZeneca, one of our core values is to put patients first, but in publications we don’t see patients which means it can be very easy to focus on the immediate deliverable. That makes it important for us to remember those who actually took the time to participate in the studies that provide our data, and are those who are ultimately going to be impacted by our outputs.

We also need to consider that we’re in an age where a patient can simply type a few words into a search engine to access a mass of information about their condition. Ultimately, patients are going to be consumers of our content so we need to be mindful of that. Plain language summaries are a quick win right now, but I think this is an area that will evolve rapidly over time in an effort to make sure that patients are well informed with accurate and reliable information, should they choose to access it.”

 Finally, how do you see the role of a Publication Lead evolving in the future?

 “I was on a panel discussion recently and one of the comments I heard on this subject was that the role is becoming more attuned to what could be described as a ‘Scientific Communications Specialist’. It’s a concept that resonated with me quite strongly, and I interpret it to mean that the Publications Lead will come to have a greater influence on how science is communicated beyond the development of strategy and execution of publications.

There are a number of other things that will come to the fore over time as well. Previously, I mentioned the increasing need to consider the patient in our work and that there is potential for growth in this area. I think we’re all aware that there are competing demands on the time and attention our audiences have available to read our content. As such, we need to think carefully about how we adapt what we deliver to meet their needs. Digital aspects of publications are going to become more important over time in an effort to garner attention and make it easier to connect and engage with our content, but there has to be a balance because the traditional publication is still central to delivering the science.”

Chris Brooks is Publication Lead at AstraZeneca.

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With predatory publishing continuing to escalate, there is a need to evaluate the extent to which it has infiltrated academic practice. In a recent analysis of Scopus, a leading scholarly database, researchers found that almost 3% of indexed studies had been published in potentially predatory journals.

As highlighted in a recent Nature news article, researchers searched Scopus for the names of “potential, possible or probable” predatory journals and publishers identified by Beall (2016). A total of 324 suspected predatory journals were identified; these titles published over 160,000 articles between 2015–2017, accounting for 2.8% of the studies indexed during this period.

Unfortunately, this isn’t an isolated problem — predatory journals have previously been found to be indexed on other databases such as PubMed. It is widely recognized that predatory publishing threatens research integrity, however defining “safelists” and “watchlists” isn’t easy and they are difficult to maintain as these journals constantly evolve their practices.

Although a spokesperson for Scopus told Nature that it has stopped indexing new content for 65% of flagged journals, old content remains. This means that their  citation counts still increase, and may continue to misinform important institutional decisions such as employee evaluation and funding. The authors of the analysis suggest that the current filters used to assess journals are proving ineffective against the more convincing predatory journals, and call for fact checking and upgraded selection criteria to address the issue.

They warn that “unless the selection criteria are upgraded and/or the bar for inclusion is raised significantly, fake scientific journals will keep creeping in the database”.

We look forward to seeing how scholarly databases adapt to this evolving threat.

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The  17^th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) was held virtually on 12–14 April 2021. The event attracted a record-breaking number of participants with over 650 delegates attending. The theme of this year’s meeting ‘Medical communications 2.0: Creating and embracing opportunities in a time of transformation’ covered the following key topics:

• risk communication and public trust
• equity, diversity and inclusion
• forward-thinking ways of communicating virtually and digitally.

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.

You can also read our summaries of Day 2 and Day 3 of the meeting.

Opening remarks & keynote: helping patients and healthcare professionals navigate medical misinformation

Todd Parker, ISMPP 2020-2021 Chair (MedThink SciCom), and Valérie Philippon, ISMPP 2020-2021 Chair-Elect (Takeda), welcomed delegates to this year’s virtual meeting and highlighted the meeting’s themes of trust; equity, diversity and inclusion; and looking to the future of medical communications. Parker and Philippon thanked the Program Committee for their work in creating a virtual congress in the midst of the COVID-19 pandemic, while acknowledging the challenges posed globally by the crisis, including in the field of medical publications. To this end, ISMPP have donated to ‘The Meetings Industry Fund’, which provides financial assistance to industry staff affected by the global pandemic. The speakers also commended all those in the medical publishing community who have helped disseminate and advance research into COVID-19.

This year’s virtual meeting comprised a varied program of keynotes, plenaries, debates, roundtables, real time poster Q&A sessions, and a wealth of on demand online programming. To kick things off, Parker introduced Brian Southwell (RTI International), who gave a keynote speech on ‘Combatting health misinformation and restoring public trust’.

Southwell outlined that, perhaps contrary to popular belief, misinformation is not a new phenomenon, although social media and the COVID-19 pandemic have exacerbated its reach and influence.

Southwell argued that society is inherently vulnerable to misinformation, for a number of reasons:

• bias towards acceptance
• misinformation is only detected post hoc and so the population is always exposed to it to a degree (in democracies)
• drive to form connections and share hopeful, ‘good news’
• proliferation of ‘bubbles’ in which the same information is repeatedly shared among the same people.

Importantly, addressing the problem requires a shift in mindset, from blaming those who believe and disseminate misinformation, to focusing on building trust and transparency. Southwell suggests four important approaches:

1. encourage compassion
2. embrace translation opportunities
3. learn about what people are encountering
4. empower and improve information seeking.

In short, find common ground, listen to what drove the individual to misinformation, then provide reliable information once trust has been built.

Southwell has been involved in a number of such initiatives, from workshops and a white paper, to translating science and expanding its reach through community radio. We are also now starting to see the beginnings of a body of academic literature on the subject.

Finally, Southwell offered practical tips for the medical publications community:

• Publication professionals: work with authors from an early stage to develop a plain language summary and/or visual abstract.
• Authors: consider what the ’30-second summary’ of your work would be from its outset.
• Publishers: provide publicly accessible platforms, such as podcasts or websites.

Unused vaccines can’t save lives – embracing an opportunity to overcome vaccination hesitancy in the midst of a global pandemic

In the first plenary session of the meeting, which was moderated by Eugene Tombler (CMC Connect), Heidi J Larson (London School of Hygiene & Tropical Medicine), Dan Carucci (McCann Health) and Jonathan Kennedy (Queen Mary University of London) discussed vaccine hesitancy and what the industry can do to educate and mitigate the barriers to vaccination.

As noted by Carucci: “The COVID pandemic is a historical moment, and at no other time has the public had a front row seat in vaccine development”

These unique circumstances have highlighted the importance of trust and transparency, as well as education. As the risk of severe illness from COVID-19 increases with age, the benefits of vaccination may be more obvious to older people than younger age groups. Changing the narrative to address the challenges that affect younger people, such as social and economic issues, may be instrumental in improving vaccine willingness in this age group. The population must be able to make informed decisions and realise it is only through a community vaccine effort that any sense of normality can return. When asked “How do you fight vaccine misinformation?”, the panellists agreed that scare tactics do not work. Instead, listening and empathy are required, while matching the anti-vax message on all fronts with the truth. The COVID-19 infodemic occurs across all platforms and this amplification of misinformation feeds into the distrust of doctors and governments that can arise from public health crises. There is a large gap between where the public is and where health authorities and pharma present their information.

Official sources need to be more engaging online, the narrative more enticing to read and the information easier to digest and understand.

Medical communications need to adapt and different strategies developed for each age group. One such initiative aimed at younger people is TeamHalo, a collaboration of scientists from around the world, who are using TikTok and Twitter to explain vaccine development and the critical role it has in ending the pandemic. Better communication will help build relationships, gain the public’s trust, and reduce vaccine hesitancy.

The public face of science – building trust

Building the public’s trust in science has always been important, but the COVID-19 pandemic has created additional urgency around this need as research is quickly churned out and consumed by the public.

Dave Andrews (Meridian HealthComms), Tom Grant (UCB Pharma), Catherine Skobe (Pfizer), and Guy Yeoman (Mallinckrodt) presented an insightful session focused on how the medical communications industry can build trust in science.

“Nothing in science has any value to society if it is not communicated, and scientists are beginning to learn their social obligations.” – Anne Roe, The Making of a Scientist (1953)

A focus on patient involvement at every stage of research – from disease area strategy to clinical trial design and publication development – is key. It is not uncommon to consider patient input at the later stages of research; for example, patient lay summaries have become increasingly popular as a way to ensure data are accessible by the public. However, patients can and should be involved at the earlier stages of research.

Additionally, it is important to involve patients with varied backgrounds and include everyone from ‘patient experts’ to lay patients and their carers. Insight can also be gleaned from patient organisations and online patient communities.

Other ways to encourage trust in scientific research include transparency-focused strategies such as robust data governance and ensuring open access to datasets.

A preprint pandemic: the evolving role of preprint servers in the COVID-19 era & preprint debate – to preprint or not?

Lisa Jolly (Parexel) and Tim Koder (OxfordPharmaGenesis) moderated this thought-provoking session, with panellists from medical publishing (Joanne Walker, Future Medicine), the pharmaceutical industry (Meghan Johnson-Watson, AstraZeneca and Janet Davies, UCB Pharma) and a preprint server provider (Richard Sever, Cold Spring Harbor Laboratory Press).

Ahead of talks from the various panellists, Jolly set the scene, highlighting the huge upsurge in the use of preprints during the COVID-19 pandemic. Jolly noted that this development was welcomed by the World Health Organization as a means of rapidly sharing new research findings on the coronavirus. Over the course of the session, the panel gave their perspectives on the role of preprints in medical publishing, both in terms of the effects of the COVID-19 pandemic and more widely across the field.

Up first, Walker gave the publishers’ perspective. The COVID-19 pandemic has massively impacted the publishing process, with increased submissions and a need for rapid publication without compromising standards. Since the start of the pandemic, STM members have provided free, immediate access to COVID-19-related publications and publishers have fast-tracked the peer review and publication of these articles. Over time, as the volume of publications and HCP workload have increased, there have been knock-on delays in the review and publication of non-COVID-19-related content. Walker proposed that preprints:

• generally align to STM’s response to COVID-19
• could form part of the overall publication process, alongside congress presentations and journal publications
• provide journals with insights into ongoing research.

However, Walker also raised concerns that the medical publishing industry is not yet ready to fully embrace preprints:

• Not all publishers have clear policies. Where these are in place, requirements vary between publishers.
• <10% preprints on the medical preprint server medRxiv have received comments.
• Rapid, open access, peer reviewed publication is already available.
• There is a need for industry guidance relating to preprint servers.

Next, Johnson-Watson put forward an industry perspective. COVID-19 has had wide-ranging effects on the presentation and publication of industry-sponsored research, from condensed timings for the preparation of posters and oral presentations at congresses to delays in author input and extended peer review times for manuscripts.

Johnson-Watson agreed that in the context of the pandemic, preprints have offered benefits by enabling the rapid dissemination and wide reach of COVID-19-related data. She argued though that, in general, preprints better lend themselves to the reporting of academic and preclinical data than to the reporting of industry-sponsored clinical trial data and that, on balance, the benefits do not outweigh the concerns in the case of clinical trial data. Among the concerns listed were:

• regulatory and compliance issues
• inconsistency in journal policies
• citability of preprints
• lack of clarity on industry’s role
• difficulties in monitoring and addressing comments for items such as off-label claims, or reporting of adverse events
• potential for data misinterpretation.

Finally, Sever made the case for preprint servers, giving his perspective on the successes of bioRxiv and medRxiv.

Around 14,000 COVID-19-related preprints have been released during the pandemic, on topics ranging from virus structure, to variants, to trials of potential treatments. By comparison, most (93%) papers on SARS were not published until after the pandemic. Alongside these achievements, COVID-19 has presented new challenges for preprint servers, with increased discussion of preprints in the wider media, and additional screening procedures added to bioRxiv for COVID-19-related preprints.

Sever stressed that preprints are not an alternative to peer review, rather they are a means to uncouple dissemination of research from its evaluation. Sever argued that the current model of undertaking peer review before publication does not fit with the digital age of publishing and leads to delays in dissemination of research, subsequent advances by other researchers, and ultimately to delays in patients receiving better care.

Sever hopes that servers such as bioRxiv and medRxiv can become a central part of the publications landscape, with a role in facilitating the discovery, discussion, reproducibility and certification of research. By decoupling dissemination and peer review Sever believes that peer review will undergo reform and become more innovative and inclusive, no longer reflecting the view of a small number of individuals at a specific point in time.

Jolly closed discussions with an overview of the recent American Medical Writers Association (AMWA)– European Medical Writers Association (EMWA)–ISMPP joint position statement on medical publications, preprints and peer review. The position statement suggests:

• citing preprints as personal communications
• clearly distinguishing preprints from peer-reviewed papers
• standardising screening procedures for preprints
• use of a comprehensive checklist by reviewers.

With the scene set, Davies and Sever debated ‘To preprint or not?’ The result was perhaps reflective of the challenging nature of the issue. In a post-debate poll ISMPP delegates were split, with 44% voting ‘yes’ and 56% voting ‘no’ to preprints.

44% of ISMPP delegates voted ‘yes’ and 56% voted ‘no’ to preprints

Roundtables

Attendees were able to attend 1 roundtable each day of the meeting. Roundtable topics were:

• social media in medical publications
• open access: making the future bright, making the future open
• encore presentations
• plain language summaries
• case studies in ethics and standards
• optimising virtual scientific exchange in a digitally fatigued world
• optimising team structure and function
• personalised medicine should begin with gender
• digital enhancements to maximise reach and engagement
• patient engagement
• speeding publication development
• simultaneous peer review: case study.

Future-proofing your organisation with digital transformation of medical communications

Todd Parker (MedThink SciCom) led a discussion on the digital transformation of the medical communications industry, which has been accelerated during the COVID-19 pandemic. This forward-looking session discussed the concept of digital transformation, and how to identify and apply a vision within an organisation.

What is digital transformation?

Leslie Rotz (MedThink SciCom) started the session by defining digital transformation:

• Digitisation: conversion of analogue/physical information to digital format.
• Digitalisation: use of digital technologies to enable or improve business models and processes.
• Digital transformation: process of using digital technologies to create new – or modify existing – business processes, culture, and customer experiences to meet changing business and market requirements.

As such, digital transformation is a coordinated change, with effort diffused through various structural and cultural aspects of a business.

Digital transformation is a coordinated change, with effort diffused through various structural and cultural aspects of a business.

Rotz stressed the importance of forward planning, by first defining the needs, establishing the vision (which involves collaboration with colleagues and leadership), developing a plan, before finally implementing the plan. Indeed, when embarking on a novel initiative, you are by definition the first to do it, so the engagement of all stakeholders such as Regulatory and Legal up-front is critical.

How has digital transformation been implemented during COVID-19?

Dheepa Chari (Pfizer Oncology) gave an industry publications perspective of implementing digital transformation during the last year. There were many drivers for transformation, such as information overload as the world moved online, changes in content consumption (eg devices), emerging audiences (eg patients), and new technology and platforms becoming available.

Chari described a paradigm shift in the digital journey, from a multichannel approach with fragmented communication lacking a single strategy, to an omnichannel approach with a centralised strategy and a 360 view of the physician/patient experience.

This resulted in increased consistency for the user, increased alignment with their needs, and appropriate targeting of the audience.

Looking ahead, Chari touched on the interest in using artificial intelligence (AI) to generate insights from activities. An example was using Natural Language Processing, which takes information from the literature, social media, congress activities, etc and gives actionable insights such as patterns, gap identification, landscape analyses, and even hypotheses. Other initiatives included enhancing the accessibility of content to align with audience needs, through for example, plain language summaries or promotion on social channels.

It was emphasised that digital transformation comes with challenges, and requires cross-functional training for optimal roll-out – upskilling across soft skills, technical skills, and latest technologies is essential for success.

Neil Adams (Karger Publishers) presented the publishers’ perspective. During the pandemic, publishers realised the need to communicate research:

• as quickly as possible
• with improved quality
• while managing increased quantity
• by transparent delivery
• in convenient formats
• for diverse audiences.

Digital solutions are now available for many aspects of the manuscript workflow, from journal selection (or assessment of alignment with journal requirements [eg through Penelope.ai]), submission (which may involve technology to help with language editing), and even manuscript peer review (eg the use of ‘select crowd review’ by Filestage). AI is also becoming an increasingly useful tool. For example, Artificial Intelligence Review Assistant (AIRA) is being trialled by Frontiers to assist in peer review, and Quertle can support literature searches.

Practical guidance

The panel encouraged the audience not to be afraid to fail, as these are novel initiatives that require optimisation. Small pilot studies are very useful for testing a novel project, and it is important to pause along the way to continually re-evaluate the needs and whether they are being addressed. Their practical guidance was to:

• Speak to internal and/or external stakeholders to define unmet needs and pain points.
• Determine the best approach for your organisation, and develop a supported rationale to obtain buy-in.
• Enhance focus through ruthless prioritisation (do one thing well).
• Identify 2 stakeholders as potential advocates, and partner with them throughout the journey.

Metrics, analytics and effective storyboarding

“Inevitably, if you work in publications, someone is going to ask you for metrics, it’s like death and taxes…” Dianne Barry (Vertex Pharmaceuticals)

Publication metrics requests are commonplace but can be time-consuming to address. Metrics reporting tools can save time and provide valuable insight, but require careful upfront consideration. Dianne Barry (Vertex Pharmaceuticals), Jason Villalobos (3vue) and Robert Wright (Sanofi) explored the practicalities and pitfalls of metrics reporting with custom analytics platforms in a panel discussion moderated by Elizabeth Crane (Envision Pharma Group).

Getting started

Important practical considerations for kicking off a metrics project were discussed:

• Establishing a thorough understanding of the end user and their true needs – a seemingly simple request for time from start-to-publish metrics could reveal a more complex desire to understand efficiency of publication processes.
• Getting comfortable with your raw data source and how it maps to your desired metrics, and identifying and addressing issues such as inconsistent data entry or missing fields.
• Establishing an effective collaboration with internal partners such as IT and external agencies, ensuring all are on the same page regarding scope and technical language.

A roadmap to success

The panel outlined an agile, iterative process for platform development, emphasising the importance of tackling such a large, complex project in small, clearly defined phases and allowing sufficient time for end-user testing to help drive further evolution – don’t try to run before you can walk! Appropriate data and project documentation combined with user training at roll-out is also key.

Looking to the future

Trends to watch out for include the impact of AI on the generation of reach metrics, use of metrics to assess resourcing, geoanalytics, and self-service options to meet different needs for different end users. Increased capability for assessing strategic alignment of tactics, both within publications and across the broader med affairs sphere, via use of data lakes and interconnected analytics was also discussed as an exciting possibility.

Patient engagement in a post-COVID world

Alex Morton (NucleusX Consulting) and Gerard Mortimer (Synaptik Digital) explored how COVID-19 has altered the patient engagement space, and what that means for the future.

It’s clear that COVID-19 has impacted every step of the patient journey, from screening to post-discharge care. Even treatment methods have evolved to include virtual elements. For example,  some 15 digital applications for mental health have been reviewed and approved by the UK National Health Service (NHS). The uptake of telehealth has skyrocketed, as has the adoption of virtual clinical trial technologies. In a study by ERT, 82% of clinical trial professionals reported adopting virtual trial technologies due to the pandemic, including:

• telemedicine
• electronic patient-reported outcomes
• wearables
• central nervous system assessments
• electronic diaries.

Mortimer predicts the benefits of this shift towards remote and virtual trials will ensure their longevity; not only do patients have improved access to virtual trials, they are also more likely to adhere to protocols, can be recruited more quickly, and are able to generate their own data in real time. These advantages are, however, counterbalanced by a lack of face-to-face support and reassurance.

Morton discussed the critical need for high-quality patient information. Never before has the majority of the public so closely followed and scrutinised the drug development process. Morton identified social media as a “primary battleground” where people take sides and share information, which includes a great deal of misinformation. He called for medical communications professionals to help “cut through the noise” by creating clear, evidence-based, and searchable information for patients in the right formats. Furthermore, both speakers highlighted the role pharma need to play in optimising patients’ online experience and in the “fight against misinformation”. Crucially, future patient communication strategies will need to consider those without the digital skills essential to daily life – recently reported to be 22% of people in the UK.

Morton noted that: “The pharmaceutical industry and drug development have been put under the microscope on a global scale.”

Public interest in pharma and healthcare is at an unprecedented high. This session suggested we capitalise on that interest; if patients have the information and tools they need, they can feel empowered and supported by pharma, rather than suspicious of it. Morton and Mortimer agreed that the future of patient engagement will involve a hybrid model, with many COVID-19-accelerated innovations here to stay.

Morton concluded: “Healthcare and pharma have done a lot of hard work in adapting to this situation. It’s now up to us to continue that work and keep improving patients’ lives, trying to innovate and improve solutions, and ensure patient engagement gets stronger and stronger.”

Tips for effective manuscript writing and feedback

This session, which was opened and chaired by Amy Foreman-Wykert (Amgen), focussed on the different stages of manuscript preparation. The 2 speakers, Lisa Humphries (Amgen) and Katherine Molnar-Kimber (Kimnar Group), provided key strategic tips on how to improve efficiency and productivity during manuscript development.

Planning and initiation

• Consider the desired impact of the publication, the audience and potential target journals.
• Establish the author list and key contacts.
• Set up an ideal timeline working backwards from the target date.
• Organise a project kick-off call to align on the content, roles and responsibilities, review processes, timelines and target journal.

Manuscript content

• Consult target journal and reporting guidelines early in development. Visit the Equator Network website to find the relevant reporting guidelines.
• Consult the target journal checklist for peer reviewers (if available).
• Initially develop a comprehensive outline including all sections required by the target journal, developing the results section first.
• Establish processes for formatting and styling, quality control, version control and reference management.
• Consider search engine optimisation to make your publication easier to find.

Author review

• Explain the evolution of tasks for reviewers at each stage of manuscript development.
• Provide guidance in the manuscript for the reviewers to help achieve actionable comments.
• Be solutions-focused: provide suggestions where appropriate.
• Inspect before replacing a word or phrase rather than using global replace.

Business Meeting, Financial Report

The outgoing Chair of the ISMPP Board of Trustees, Todd Parker (MedThink SciComm) opened this session with updates on the 5 prioritised areas of focus for the Board in 2020: education, expansion, evolution, extension, and efficiency. Parker highlighted the Education and Expansion task forces’ examination of the educational needs of ISMPP members, including the development of an Educational Needs Assessment survey designed to ensure that ISMPP’s educational initiatives are aligned with members’ requirements. He mentioned the recent news that ISMPP has assumed organisational leadership of Medical Publishing Insights & Practices (MPIP) and highlighted their useful Enhanced Publication Options Navigator (EPON) tool. Parker closed by noting that while there remain challenges ahead, there is a sense of hope for the future and ISMPP will be there to help navigate the ever-changing medical publications landscape.

Secondly, we heard from ISMPP Treasurer Courtney Leo (Pfizer). Leo outlined ISMPP’s finances over the past year, noting that despite the challenges of pivoting to virtual formats, all of the 2020 ISMPP meetings and the 2021 European Meeting were profitable. With increased virtual meeting attendance and Certified Medical Publication Professional (CMPP) recertifications, ISMPP maintains a healthy financial position with strong financial reserves and procedures.

ISMPP President and CEO Rob Matheis then gave the presidential address, referring to the recent update in the MAP Newsletter in which he discussed the successes of ISMPP members and the society in rising to the challenges presented by COVID-19. Matheis noted that:

• ISMPP is evolving on an organisational level to bolster administrative capabilities and maximise the ability to meet members’ needs, with new ISMPP Operations Project Manager and Director of Membership and Community roles being fulfilled by Wendy Hazard and Suzanne Fraga, respectively.
• ISMPP membership continues to grow year-on-year despite COVID-19, with a total of 1,818 members as of 31 March. Most members are from industry/agency backgrounds, with academia and Contract Research Organisations identified as key areas for membership growth.
• ISMPP are working to better address the specific needs of individual members, for example utilising member engagement tools (such as PropFuel) to help focus communications.
• The Educational Partnership between ISMPP and the University of Florida College of Pharmacy continues, and advocacy and outreach activities are growing globally.

Matheis also mentioned several ISMPP society and member initiatives:

• the recent AMWA-EMWA-ISMPP joint position statement on medical publications, preprints and peer review
• progress on the ISMPP Authorship Algorithm (discussed on day 3 of the meeting)
• the Good Publication Practices (GPP)4 guidance, which is progressing rapidly and should be submitted for publication by end of this summer
• future ISMPP meetings – the 2021 Asia Pacific Meeting of ISMPP (which will take place virtually in September) and ISMPP West, currently planned to take place live in Irvine, CA on 21–22 October.

Next up, Laura Carlson (Chair of the ISMPP Certification Board; Envision Pharma Group) gave an update on the CMPP programme. Carlson noted that there are nearly 1,500 CMPPs at present, with expansion seen into the Asia Pacific region and Europe. Aiming to meet the needs of CMPPs during COVID-19, online self-study opportunities have been significantly expanded. Notably, the CMPP credential has gone digital, making achievements easier to track and share, and a new and improved credit tracker has simplified the recertification process. The CMPP Mentor Program has also been launched to support those considering certification, with resource development ongoing. Finally, Carlson reminded us of the 1 August application deadline for the September CMPP exam.

Closing the session, Parker thanked departing Board members and introduced Valérie Philippon (Takeda) as the new Chair. Philippon noted that there are brighter days ahead and that she is excited to embark on the next year.

You can also read the summaries 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, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers.

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With thanks to our sponsor, Aspire Scientific Ltd

Traditionally, researchers have been told to be persuasive with their arguments and to “sell the science”, especially when communicating to non-scientific audiences. While this may work in terms of getting across key messages, omitting important information or presenting an unbalanced view of the data has the potential to damage trust in the research. In order to gain trust, scientists need to inform, not persuade, allowing individuals to make up their own minds. Michael Blastland and colleagues outline the key principles for communicating research to wider audiences that can help build trust and aid decision-making.

An important part of informing individuals on medical research, is conveying a fully balanced of view of the evidence. It is important to recognise that all individuals have some level of psychological biases and so true balance may be difficult to achieve. However, as medical communicators, these instincts must be challenged.

Another important component of medical communication is disclosing uncertainties about the research. Due to fears of confusion for non-scientific audiences, uncertainties have not always been adequately disclosed by the media. However, when investigating how to inform the public on the limitations of COVID-19 testing, the authors found that full disclosure of uncertainties (i.e. the possibility of a false negative test) did not affect trustworthiness of the data. Rather, the messaging helped to avoid false assurances gained from a negative test result. As such, the degree of uncertainty should always be part of core messages and margins of error or ranges should be reported rather than just exact numbers.

As explained by John Krebs who was chair of the UK Food Standards Agency during the BSE food crises in the 2000s: “I think you just have to go for a straightforward and honest way of communicating. People appreciate that.”

Another way that individuals assess the credibility of research is by the quality of the data. Notably, through their research, the authors found that the general public may notice the omission of key information on the quality of data and explain that:

“As scientists, we tend to underestimate the sophistication of our audiences’ sensitivity to cues of quality and how these affect trust.”

It is therefore vital when communicating to all audiences that key aspects regarding data quality, such as the size and source of the dataset, are conveyed so that individuals can gauge the relevance for themselves.

In a world where misinformation spreads rapidly on social media, there are concerns that presenting the complete picture of research together with uncertainties and complexities may give a foothold to false messages. However, pre-emptively warning individuals against attempts to sow doubt via misinformation (prebunking), is a powerful way to combat misunderstanding. For prebunking to work effectively, the concerns of the audience and any potential misunderstandings need careful consideration by the medical community before the spread of misinformation occurs.

Trust in clinical research is critical to allow patients, the general public or policy makers to make informed decisions based on the data. Always aiming to “sell the science” may damage trust in research and lead to behaviours that have a negative impact on health and society. It is therefore important that the broader medical community and the media consider the key principles for effective evidence communication for all audiences, and aim to transparently disclose all the relevant information on the research to facilitate evidence-based decision-making.

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Summary by  Josh Lilly PhD from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd

The European Medical Writers Association (EMWA) recently dedicated an issue of its quarterly publication, Medical Writing, on writing for patients. The issue includes ten articles focused on this theme, covering a wide range of topics from social media to publications.

With the events surrounding COVID-19, the importance of communicating medical information to the public has seemingly never been more important. In the foreword, Juan García Burgos and Paul Blake, writing on behalf of the European Medical Association, highlight the increasing importance of transparency and providing quality information to patients and the general public. They explain:

“If we fail to explain and connect with the EU citizens whom we serve, other less trustworthy sources may fill the gap with misinformation and inaccurate facts.”

Writing for patients is a diverse theme and requires many different skill sets. Below is a selection of the topics covered in this special issue.

Lay summaries for Phase I trials in healthy volunteers

Professional medical writers are likely becoming increasingly familiar with plain language summaries, though perhaps less so in the Phase I clinical trial setting. However, lay summaries are mandated by European Union Clinical Trials Regulation for all clinical trial phases. Clive Brown et al. describe a template developed to help medical writers to produce meaningful lay summaries of Phase I trials in healthy volunteers. The template aims to ensure that study designs and results are described in a consistent manner across different types of Phase I trials, addressing challenges such as ensuring that information is accessible and meaningful without oversimplification and managing the release of commercially sensitive information.

Promoting equity in understanding: a cross-organisational plain language glossary for clinical research

When developing plain language summaries, a key challenge is health literacy, which was found to be poor or inadequate in nearly half of respondents who took part in a European Health Literacy survey, across eight countries. With this in mind, a new global initiative is establishing a glossary of plain language terms used commonly in clinical research. Proposed benefits of a harmonised plain language clinical research glossary are:

• consistency
• accuracy
• efficiency
• ease of translation
• electronic interoperability
• transparency
• trustworthiness.

Establishing a patient publication steering committee (PPSC)

Increasingly patient involvement is occurring earlier in the publication life cycle. A recent innovation in industry publication practices is the development of a PPSC. Their purpose is to plan and oversee the timely and ethical development of high-quality publications on disease burden and the patient journey, as identified by patients themselves. Authors from UCB Pharma describe their plans to partner with patients to establish a PPSC, identifying the key roles, governance, and documentation required.

Based on their successful feasibility study, the authors think that establishing a PPSC “has the potential to change industry publication practices to enable early, compliant, and important partnerships with patients in the publication life cycle”.

We were excited to read this dedicated issue on an important theme in the medical communications industry.

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Summary by Robyn Foster PhD from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd

The development of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was a landmark step in enhancing the rigour of systematic review reporting and was widely endorsed by the scientific community. However, since its publication there have been many developments in the conduct of systematic reviews. These include new methods to synthesise and present findings, assess risk of bias, register review protocols, and share data, to name a few. Due to these advances, the updated PRISMA 2020 statement has been developed, which may prove to be another key milestone in improving the reporting of systematic reviews.

In the PRISMA 2020 statement, Page and colleagues present an updated 27-item manuscript checklist (with an accompanying explanation and elaboration document), an abstract checklist and a new study flow diagram. While there are a variety of changes from the 2009 publication, noteworthy new or updated recommendations within the PRISMA 2020 reporting items include:

• Full search strategies should be provided for all databases used (item #7).
• Details on how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process should be given (item #8).
• Authors should report how outcomes were defined, which results were sought, and methods for selecting a subset of results from included studies (item #10a).
• Details on study eligibility, preparation of data for synthesis, synthesising and displaying of results, possible causes of heterogeneity, and sensitivity analyses should be reported (item #13a–13f).
• Methods for, and results of, assessment of certainty (or confidence) should be reported in the body of evidence for an outcome (items #15 and #22).
• Authors should list citations of studies that met many but not all of the inclusion criteria (i.e. ‘near-misses’) and explain why they were excluded (item #16b).
• Authors should summarise the characteristics and risk of bias among studies, and present results of all syntheses, heterogeneity analyses, and sensitivity analyses (item #20a–20d).
• Amendments to information provided at registration or in the protocol should be described and explained (item #24a–24c).
• Authors should declare any competing interests (item #26).
• Authors should indicate whether data, analytic code and other materials used in the review are publicly available and where they can be found (item #27).

The PRISMA statement website will include helpful fillable templates of the new checklists to download and complete, and an editable template for each flow diagram. A web-based application that allows users to complete the checklist via a user-friendly interface is also currently under development and may facilitate reporting.

Overall, it is expected that implementation of the PRISMA 2020 statement will enhance the transparency, accuracy, and completeness of systematic review reporting, which should benefit the scientific community involved in developing systematic reviews. Importantly, improved reporting of systematic reviews may also have a downstream benefit for patients by facilitating evidence-based decision-making. It is therefore recommended that authors and writers fully utilise the PRIMSA 2020 statement and associated checklists when developing future systematic reviews. We also encourage journals to update their guidelines to include the completed checklist in their submission requirements for upcoming manuscripts.

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Summary by Josh Lilly PhD from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd

Social media has become a ubiquitous part of life in the 21^st century. In addition to popular platforms such as Twitter and Facebook, other research-oriented websites and apps (eg ResearchGate, Academia, and Mendeley) have increased in use.

Scientific researchers have begun to leverage these tools to further disseminate their research beyond the traditional peer-reviewed journal publication. In a recent article published in the Journal of Medical Internet Research, Prof Marco Bardus and colleagues conducted a systematic review to explore how social media affects the impact of health research.

The team identified 7 impact studies, which assessed the effect of social media on the dissemination of research, and 44 correlational studies, which assessed the relationship between Altmetrics and bibliometrics. While their analyses of the impact studies suggested that article views may have increased with social media activity, citations did not. The authors cautioned, though, that the social media interventions tested were too heterogenous to compare—with intervention duration and intensity ranging widely—making it difficult to draw conclusions.

Of the 44 correlational studies (most discussing Twitter and Mendeley), around half found a strong association between traditional citation-based and social media metrics. However, when limiting the analyses to just the 7 correlational studies of high methodological quality, the association was moderate or non-existent.

Despite their inconclusive findings, the authors recommend that  researchers continue to use social media to disseminate health research. The authors note that social media provides the opportunity to reach different, non-specialised readers, and advise researchers to adapt their work for specific target audiences. Sharing research in this way is likely to become increasingly important as publishers take steps to improve patient accessibility of journal articles and as the use of plain language summaries to share scientific content with the public continues to grow.

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Summary by Kristian Clausen MPH from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd

The 2021 European Meeting of ISMPP, held virtually on 26-27 January, will offer attendees the following:

• New Ways to Improve Communications & Publications
• Prepare for Changes in Our Profession & Practices
• Lessons Learned from Your Peers

REGISTER NOW!
Registration is Open Until 13 January 2021

 The meeting theme, Collaboration, Connectivity, and Change: A Holistic View of the Scientific Communications Environment in 2021, centres the two-day programme on:

Plenary Sessions that Explore Our Profession & Practices!

• Changing Times for the Publications and Scientific Communications Ecosystem: Addressing Challenges and Accelerating Innovation
• Communicating with a Lay Audience: Dubious Data and the Dangers of Miscommunication
• Needs, Expectations and the Future of Scientific Communications: What Do Our Key Stakeholders Really Think?
• How Professional Practices Are Evolving – And What Might Stick?

Parallel Sessions on Informatics and Data Visualisation, Real World Evidence, Patient Engagement

9 Roundtable Topics to Choose From – Talk to Your Peers!

Plus: 2 Keynote Speakers, Member Research, Exhibits, and More!

And: The Training Zone for New Publication Professionals, held virtually on 29 January! This popular training is limited to 30 participants, so BOOK EARLY!

VIEW the meeting programme and REGISTER TODAY!
Learn about ISMPP at: www.ismpp.org

Recent years have seen an encouraging increase in the representation of women in science, technology, engineering and mathematics (STEM) subjects, both in senior academic positions and leading the publication of scientific research. However, the disproportionate domestic care responsibilities of women continue to undermine the drive towards professional gender equality. The ongoing COVID-19 pandemic is exacerbating this, with women more likely than men to have to make career sacrifices to uphold caring responsibilities. An article in InsideHigherEd.com explores the latest data quantifying the adverse impact COVID-19 is having on women in science.

Dr Philippe Vincent-Lamarre and co-authors have quantified the COVID-19-related academic sacrifices of female scientists through an analysis of article submissions to preprint databases, published in Nature Index. The data are stark. As an example, female first-author submissions to medRxiv dropped from 36% in December 2019 to 20% in April 2020. In contrast, data from June and July 2020 show some normalisation of women’s submission rates back to the year average of around 31%. The authors note that male faculty are four times more likely to have a partner engaged in full domestic care than their female colleagues.

Kate Power, a research consultant who has published on the dramatic increase in women’s caring loads during the pandemic notes:

“There is a saying working mothers have: ‘You have to work like you don’t have children and parent like you don’t have a job.’ And that was before COVID-19.”

Journal-specific analyses, such as for JAMA Surgery, have also reported declines in first, last and corresponding author submissions by women compared with a year earlier, while submissions by men have increased. Across the myriad roles supporting academic publishing, including peer reviewers and invited contributors, journals have noted an increase in declined invitations or requests for deadline extensions for reasons related to the pandemic. One journal reported that the overwhelming majority of those specifically citing childcare responsibilities were women.

The concern is that, as well as exacerbating gender inequality, an under-representation of women in medical research publications risks excluding this important sector of society from contributing their interpretation and viewpoint on the data.

In terms of solutions, the call is very much for action from employers, academic institutions and funding agencies to develop processes that support women through this difficult period. Flexible working appears to be key, along with extending grant end dates for researchers and allowing for funding carryover into the next year. In short, a commitment to diversity and equality in scientific workplaces will require creative solutions that ensure women’s contributions are fairly recognised and they are not penalised for their responsibilities at home.

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Summary by Julianna Solomons PhD, CMPP from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd