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Meeting report: summary of day 2 of the 2019 ISMPP Annual Meeting

Annual banner featured image 1The 15th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in National Harbor on 15–17 April. A summary of the second day of the meeting is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did. The summary of day one of this meeting can be found here. The summary of day three of this meeting can be found here.

Day two of the meeting started with opening remarks by Jonathan Druhan (ISMPP Annual Program Committee and AstraZeneca), before a keynote address about health literacy, and how pharmaceutical companies should adapt to apply health literacy principles. Later talks covered topics including open access, data deposition, disclosures, patient authorship and preprints. Helpful tips on developing effective presentations and providing peer review responses were also shared.

Improving health literacy

The day began with a keynote address from Laurie Myers (Merck & Co), covering the challenges of poor health literacy in clinical trials. Readability (how appealing a document is to read) and the use of plain language (how easy it is to understand the content) promote health literacy. Health literacy is commonly defined as the “the degree to which an individual has the capacity to obtain, process and understand health information and services in order to make appropriate health decisions”. The roles of information providers, demands and complexities of the healthcare system, demands of the context, and cultural background, linguistic competency and cultural beliefs are increasingly acknowledged as factors influencing health literacy.

Health literacy is crucial, impacting a person’s ability to:

  • Access healthcare services
  • Use services appropriately
  • Adopt health-promoting behaviours
  • Manage chronic conditions
  • Navigate healthcare systems
  • Act on health-related news and information

Ultimately, studies indicate that poor health literacy is a stronger predictor of a person’s health than any demographic factor. Anyone can be affected by low health literacy, depending on the context, but certain populations in the US are at a higher risk of poor health literacy, including those aged over 65 years, individuals with low or no income, individuals who did not finish high school, individuals with Medicaid insurance, minority ethnic groups, and those without English as a first language.

Pharmaceutical companies communicate with patients in many ways, pre- and post-approval. Considering clinical trials, health literate information can improve study generalisability (by ensuring a wider demographic spread of volunteers), support adherence to the study protocol and help to generate valid study data. There is also a strong ethical rationale for considering health literacy, as improving participants’ understanding protects their safety and supports trial integrity. Health literacy embodies three ethical principles:

  • Justice – more eligible individuals can be included if they understand the research
  • Respect for persons – a commitment to a participant-researcher partnership and supporting autonomous decision-making can enable the inclusion of more eligible individuals
  • Beneficence – communications designed to minimise harms can lead to the inclusion of more eligible individuals

The external environment is driving data transparency and improved health literacy, including through:

  • Increased activity of patient advocates in clinical trials, expecting data transparency
  • Regulators and guidelines, including the FDA’s Patient Affairs Staff supporting patient engagement activities, the Revised Common Rule requiring research consent to be understandable, and the EU’s requirement for lay summaries to be available on a public database
  • The small (but growing) number of journals requiring plain language summaries

Myers emphasised the commitment that Merck has to health literacy, having supported health literacy training for 1000 people, including 700 in clinical research (delivered by Health Literacy Media). The training included commonly used medical jargon that should be avoided in materials aimed at patients, such as ‘adverse’, ‘adherence’ and ‘complication’. Helpfully, the Centers for Disease Control and Prevention (CDC)’s Health Literacy website includes a tool that provides plain language alternatives.

To apply health literacy principles, the target audience and their needs, interests and behaviours should be clearly identified. The purpose and objectives should be stated early on, and content limited to ‘need to know’ information. Materials should be focused on concrete actions, and written in plain language and a conversational style, at an appropriate reading level. Images should be representative, reflecting the age, gender, culture and ethnicities of the intended audience. If translation is required, this should be of high quality, interpreting the content.

In summary, health literacy matters for all of us – and is increasingly expected by patients, regulators and publishers. To help get you up to speed, the CDC’s Health Literacy website provides guidance on creating a health literacy plan, online courses, and many more resources, while you can find a health literacy checklist here.

Balancing act: open access and academic freedom

Setting the scene for this talk, ISMPP announced the release of their first ever society white paper, A multistakeholder discussion on open access and medical publishing, which is freely available online.

Britt Holbrook (New Jersey Institute of Technology and European Commission Expert Group on Open Science Indicators) then began his talk, examining the potentially competing interests of open access and academic freedom, given the ongoing debate surrounding the shift towards open access publishing under Plan S.

Holbrook asserted that open access is merely a means to achieve open science. Open science, however, implies democratisation of knowledge. Philosophically, this requires the balancing of ‘essential tensions’ including improvisation and conformity, or accountability and autonomy, within and between individuals. Meanwhile, academic freedom can be considered through two lenses. Negative freedom, freedom from, emphasises individual liberties. From this perspective, one opinion is that publishing in an open access journal, or not, should be up to the individual researcher, and thus open access mandates of any sort are unethical. On the other hand, positive freedom, freedom to, emphasises group liberty, recognising that open access mandates will allow researchers to maximise their impact and enable scientists and society to benefit from research.

Holbrook proposed that we should revalue academic freedom, moving from standard evaluation methods that rarely change and punish risk taking to instead encourage ‘academic flourishing’ where individuals take risks while seeking to meet new standards and exhibit originality. This paradigm might help to extend peer review in ways that democratise knowledge as established evaluation methods, including traditional peer review, are challenged. Holbrook closed by emphasising that Plan S comes into force on 1st January 2020, so we need to think about these issues sooner rather than later.

The Lancet preprint policy case study: challenges and insights

Next up, Rebecca Cooney (The Lancet) updated us on the Preprints with The Lancet trial, undertaken at the Lancet family of journals to establish the demand for and usefulness of preprints in the publication of medical research. The trial was run in collaboration with the freely accessible platform SSRN as part of First Look within the Medical Research Network (MedRN).

Preprints are sometimes described as manuscript drafts, non-peer-reviewed versions, discoverable and accessible but unpublished, research output, an alternative to ‘submitted’ or ‘under review’ on a CV, a document for which no copyright is transferred, or materials for personal or non-commercial use. However, preprints should be considered in the framework below:

What preprints are not

What preprints are

Peer reviewed (but can be under review) Well-developed manuscripts
Version of record Freely accessible
Editable Have a DOI and are citeable
Indexed in PubMed Central (limited to accepted, peer-reviewed author manuscript version) Mechanism for sharing ideas and an informal way of obtaining feedback

We should start thinking about preprints as another type of manuscript. Medical professionals should embrace preprints, to help establish priority, allow for immediate dissemination (which might increase exposure and interest from journals) and receive immediate feedback (which could improve reporting). Preprints might also help in meeting open access mandates and have no associated financial cost. However, challenges remain. Concerns about patient privacy and safety, alongside the myth of being ‘scooped’ and the consideration of preprints as prior publication by some journals, are limiting uptake in medical publishing. In addition, there are no standard mechanisms for disclosing competing interests or transparency guidelines specific to preprints at the current time.

The Lancet, a hybrid ‘legacy’ journal, launched their preprint pilot due to a desire to support author choice and interest in preprints, becoming an early adopter of preprints in the clinical research space. The journal was also interested in the potential for added value through peer review in the preprint forum. From June to December 2018, all Lancet family journals offered authors the choice to opt-in to the preprint pilot, free of charge but requiring the agreement of all co-authors. Practically, papers and metadata were classified by SSRN and checked by a Lancet editor.

The preprint experiment included only research papers (case reports were excluded due to confidentiality concerns). Submissions had to include four elements:

  • Funding source and declaration of interests
  • Clinical trial registration number (if applicable)
  • Prospective trial registration
  • Ethical approval (or a statement for why it should be exempt)

Surprisingly, around 30% of submissions that opted-in were rejected on these very basic criteria.

During the 27-week pilot, there were 2142 opt-ins (31% of all submitted research papers across the 16 Lancet family journals), with the percentage of opt-ins ranging from 22% for The Lancet to 48% for EBioMedicine. The majority (58%) of opt-ins were publicly-funded, while only 7% were commercially sponsored. Most opt-ins were observational studies (71%), while 20% were randomised controlled trials and 9% were systematic reviews or meta-analyses. Asia and Europe had the highest uptake of preprints (by region of corresponding author).

Overall, the uptake of preprints was relatively high across a range of research paper types and geographical regions, although the use of the commenting function has been low. Importantly, Preprints with The Lancet will continue, with increased efforts to educate authors about preprints, more checks to ensure author agreement, and management by an in-house Lancet editor. MedRN plans to expand their offering, with more journals involved and more de novo preprint submissions.

Working with PowerPoint as your co-presenter

Tim Collinson (Fishawack) moderated a talk full of top tips from Jude D’Souza (McCann Health Medical Communications) about how to make the most of PowerPoint to create engaging presentations. Seeing and hearing a presentation leads to higher retention rates (70%) than seeing (30%) or hearing (20%) alone. However, audiences prioritise information on the screen over that delivered verbally, so audiences will focus on the screen if too much of the presentation is shown on your slides. This distracts from the presenter – and also encourages speakers to read from their slides, further reducing audience engagement. Determining when you want the audience to focus on the slides versus the presenter should inform slide design: blanking the screen or showing slides with little explanation will mean that the audience will pivot to the presenter.

Considering the audience is key to developing slides. People want to be engaged, so a narrative and a good ‘hook’ should be developed to interest the audience. A hook could involve beginning with a conflict and then showing a resolution, starting with a question and suggesting the answer, or commencing with a problem and coming on to the solution.

The audience will have in-built prejudices that determine how receptive they are to your messages. This can be overcome by:

  • Evidence – showing the facts
  • Expertise – explaining what the facts mean
  • Emotion – showing why the audience should care

Emotion is extremely important, as it ensures that memories lock in more clearly, and improves later recall.

Key takeaways from the session were that slides should not be treated as a document – they are visual aids that should work with you. They should tell a story to engage the audience, adding emotion where possible. Finally, removing unnecessary content, using animations to guide attention and adding slides to break up ideas should not be feared, as these can all create more impactful presentations.

Member oral presentations

Attendees then listened to two oral presentations from ISMPP members, based on original research they had submitted to the meeting.

Systematic review and evidence-based recommendations for involving patients as publication authors

First up, Karen L. Woolley (Envision Pharma Group) discussed how to involve patients as authors, a concept supported by attendees of previous ISMPP meetings. Evidence-based recommendations have the potential to smooth the pathway from no patient authorship to ethical and effective patient authorship, removing the need for trial and error. A systematic review of the literature concerning patient authorship, which was conducted by Woolley and her team, found that the benefits outweighed the risks:

Risks

Benefits

Increased resources Meet funding requirements
Opportunity cost Save time and costs
Power dynamics Validate research need, relevance and value
Non-representative, tokenistic insights Novel and substantial contributions
Improved materials and processes
Improved reporting
Improved dissemination
Skill development (all authors)
Enhanced credibility and trust
Identify new research topics

The nine publications identified for this systematic review were drawn on to create evidence-based recommendations for before, during and after manuscript preparation. Key recommendations were:

  • Before: involve patients in publication planning to ensure that publications address relevant, important unmet needs; identify patient author candidates who are interested, have relevant expertise (e.g. lived experience) and can meet authorship criteria
  • During: recognise and respect diversity in the authorship team, understanding that patient authors can provide unique and useful input from lived experience rather than being expected to contribute like statisticians, clinicians or medical writers; consider data presentation at authorship meetings and in publications that could help non-specialists to understand and interpret findings
  • After: involve patients in the publication dissemination plan – they can raise awareness via patient advocacy groups, for example, and can contribute to plain language summaries

Ultimately, involving patients in publications is our choice, but patients are and will continue to publish without us. Evidence-based recommendations should be followed to minimise risks and maximise the benefits of involving patients as authors, for everyone. As one patient co-author put it, “Of course patients should be involved as co-authors of medical research papers. It’s our story you’re telling.”

Mapping the relationship between article publication and Wikipedia citations for pages related to a cohort of oral anticoagulants

Next, Michelle Kissner (Pfizer) discussed a study they had conducted investigating how new research is incorporated into Wikipedia articles. Wikipedia influences science and has been reported as a leading source of medical information, frequently used by HCPs. However, Wikipedia guidelines for medical articles prefer citation of secondary sources, particularly systematic reviews, textbooks or guidelines. This is contrary to how we are taught academically – and also in contrast to the papers we are encouraged to cite in academic publications – where primary evidence is considered key.

Taking oral anticoagulants as an example therapy area, Kissner and her co-authors evaluated the types of publications cited for five specific drugs in the corresponding Wikipedia entries. 43% of cited publications were narrative reviews, while 12% were systematic reviews or meta-analyses. The five drug pages had 565 editors, with 15 unique editors among the top five editors for each page: 60% of these editors were self-reported HCPs or individuals at hospitals. A key insight Kissnet et al found was that there were long delays between article publication to Wikipedia citation, with a median time of 20 months (range 0.03–89).

Overall, the study showed that Wikipedia’s guidance to cite secondary sources may be contributing to delays in information reaching articles, meaning that they may not be up-to-date. Furthermore, despite the use of reputable sources, the majority of content is edited by a small number of individuals, which may introduce bias.

Navigating data deposition requirements for publication

Sonia A. Schweers (Bristol-Myers Squibb) introduced this session, examining the evolving data sharing landscape. This has evolved from data sharing via therapeutic area platforms (2007) to the ICMJE Data Sharing Statement (2018) and current journal data deposition requirements. In 2014, the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing were released, mandating sharing of patient- and study-level data and protocols from relevant clinical trials. These guidelines outline processes for receiving, reviewing and fulfilling data sharing requests, and providing access to patient-level data while safeguarding patient privacy. An increasing number of journals require the deposition of patient-level data at the point of submission or publication, in repositories that may be controlled or open. Deposition in open repositories contrasts significantly from closed repositories or the data sharing model, in terms of the ability to review requests and implement contracts.

Mary Yianni (Taylor & Francis) then spoke from the journal perspective. The Center for Open Science released Transparency and Openness Promotion (TOP) Guidelines in 2015, created by journals, funders and societies to align scientific ideals for data sharing with practices, such as journal instructions for authors. Over 850 organisations have implemented TOP, and Taylor & Francis became a signatory in 2018. Yianni reminded us of several things to consider when depositing data, such as the FAIR principles, licensing and the plan for data preservation – as well as ensuring that authors are familiar with their chosen journal’s data sharing policies well in advance of submission.

Doreen Valentine (Bristol-Myers Squibb) then gave us the sponsor’s perspective. To protect and benefit patients, a balance must be struck between transparency and privacy. Transparency benefits patient advocacy, facilitates assessment of study reproducibility and enables population-level analysis, while the risks of compromised privacy must be mitigated and misuse of data prevented. Data use must be within the scope of the informed consent given. Valentine outlined three key areas to consider:

  • Ethical and risk considerations – Institutional Review Board approval, informed consent and human research protections; risk of re-identification; repository type (gated versus open access)
  • Intellectual property – investigational versus marketed drug; data ownership
  • Feasibility – possessing the data; know-how, in-house resources, cost, time, and repository requirements; de-identification (linked to the risk of re-identification)

In summary, developing a data-deposition process requires a collaborative approach, with each stage involving uncertainties. It requires planning on the part of authors, investigating journal requirements and repository options. Feasibility must be determined, within the parameters of legal constrains, and implementation requires data preparation, de-identification and quality control.

Art of writing effective response letters

Katherine L. Molnar-Kimber (Kimnar Group LLC) and Caroline Halford (Adis and Springer Healthcare Ltd) co-presented this session, providing some insights into how best to develop effective responses to journal peer reviewer comments.

The presenters began by clarifying that peer review takes a mean of 5 hours per manuscript and should be appreciated as a free consultation with subject matter experts. Reviewers follow publisher and journal guidelines, and the Committee on Publication Ethics (COPE) published updated Ethical Guidelines for Peer Reviewers in 2017.

Following peer review, five types of decision letter may be returned: acceptance as is, rejection, rejection with suggestion of submission to a speciality sister journal, resubmission with minor revisions, or resubmission with major revisions. Common reasons for rejection include competition in high impact journals, methodological flaws, insufficient novelty in results, results not supporting conclusions, vague or overstated conclusions, bias, plagiarism (including self-plagiarism) or failure to include important papers (particularly for review articles). Editors may be able to be flexible, but will be limited by factors including journal prestige, fatally flawed methodology or compliance issues, tone, and honesty about prior peer review. Disclosing prior review is always recommended, since it demonstrates transparency and honesty and may eliminate the need for a further complete peer review process. Copies of rejection comments from all previous journals should be included within a cover letter, with explanations of how comments were addressed or why certain comments were not.

If peer review is delayed, politeness counts! Bring the delay to the editor’s attention, provide suggestions of suitable peer reviewers in the field, and if the author has published in the journal before, indicate an understanding of the time commitment required for a thorough review. Additionally, perhaps offer to peer review another manuscript for the journal to help reduce any backlog, given the difficulty of finding reviewers.

In a response letter and document, you should always thank the editor and reviewers, maintain politeness and summarise changes according to the editor’s instructions. Requests for additional experiments should be thoroughly considered, particularly since several journals could reject the publication for the same reason. If adding the experiments is not possible, and they are not fundamental to the study’s aims or conclusions, draw comparisons between techniques, provide the rationale for not performing the experiment, and discuss the limitation and future possibilities. In the case of contradicting reviews, follow any guidance from the editor, and if possible, use a strategy to address both comments simultaneously, such as clarifying and shortening some text. Finally, you should reflect on whether any criticisms that may seem like personal attacks may be due to differences in study populations and provide clarification about the research rationale or study population as appropriate, drawing on the expertise and different perspectives of the authors.

Making a statement: author conflicts of interest and disclosures – opportunities for transparency vs obfuscation

Attendees reconvened for the final session of the day, examining the differences between conflicts of interest (COI) and disclosure statements and the surrounding guidance. Leslie Citrome (International Journal of Clinical Practice and Clinical Professor) opened the session, reminding us that ‘COIs’ in Good Publication Practice (GPP) 2 shifted to ‘disclosures’ in GPP3. This change was made since ‘COIs’ or ‘competing interests’ may imply actual (rather than perceived or potential) conflicts, and may inadvertently prevent full disclosure if considered too narrowly. In addition, in some cultures and locales, ‘COIs’ implies wrongdoing or corruption.

Richard Shader (Journal of Clinical Psychopharmacology, Clinical Therapeutics and Tufts University) defined a COI as existing “whenever one’s commitment to the integrity of a project is compromised by personal benefit, bias or beliefs”. Since such compromise may not always be obvious, full disclosure is preferable, allowing readers to draw their own conclusions about any apparent, perceived or inferred COIs. The obligation for transparency lies with authors, while the obligation for fair interpretation of disclosures falls on the reader and journal editors. We must trust authors to have integrity in providing full disclosure, just as we trust the integrity of their scientific content: journals do not have the capacity to investigate the completeness or accuracy of disclosures.

Lisa M. DeTora (Hofstra University) noted that not all potential biases are financial. They may be personal, intellectual, educational or cultural. Considering all of these intangible factors, and their interactions with more tangible sources of influence, is a challenge. The worst possible outcome of COI and disclosure processes is preventing intellectually invested and qualified individuals from participating in publications.

Finally, Gavin Sharrock (Wiley) looked to the future and to the journal’s role. Authors need to be held to a higher, consistent standard as self-declared COIs are often unreliable at best, and full disclosure is not without complications. Policing disclosure statements is extremely challenging for journals, but editors must act if suspected or confirmed inaccuracies are discovered, and the consequences of non-compliance should be clearly stated. The problem, and consequently the solution, does not solely lie with publication professionals.

The summary of day one of this meeting can be found here. The summary of day three of this meeting can be found here.

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Summary by Ryan Woodrow BSc, CMPP from Aspire Scientific

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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd


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