Over two days last month (17-18 January, 2017), around 250 delegates and exhibitors attended the 2017 European meeting of the International Society for Medical Publication Professionals (ISMPP) in London. The agenda was centred around the evolving role of publication professionals in a multi-stakeholder environment and included a keynote address, lively panel discussions, smaller roundtable case-study reports and interactive parallel sessions. The Publication Plan has posted summaries of the plenary presentations from the meeting for those of you that could not attend, as well as acting as a timely reminder of the highlights for those that did. A summary of the second day of the meeting is provided below. A summary of the first day of the meeting can be found here.

Day 2: Wednesday 18th January 2017

Extending the reach of publications: pitfalls, challenges and how we can improved

In this first session on the second day of ISMPP, an experienced faculty comprising Gavin Sharrock (John Wiley & Sons), Paul Lane (Envision Pharma Group) and Jürgen Wiehn (Shire International GmbH) provided an overview of how medical publishing has shifted from being print-only to now encompass a range of multi-channel approaches, and how developing publications has changed to keep pace.

Gavin Sharrock opened the session by giving the publisher’s perspective on the importance of understanding how different healthcare professionals access and ‘consume’ publications and related content. Publishers and journals recognise that different end user groups (such as cardiologists versus GPs) behave differently and, by using metrics and survey results, they can segment users into different personas. These personas encompass factors such as age, sex, career stage, qualifications, and, importantly consumption behaviours (e.g. time of day they search for content, search preferences, content preferences, how they evaluate the quality of content, social media use). Gavin concluded that content ‘strategy’ depends on the end user group and highlighted that engagement with a publication can be increased by converting the content into an appropriate, targeted format.

The next presentation by Paul Lane covered some of the key issues to consider when planning manuscripts and abstracts, and how to ‘extend’ their reach. Recognising that social media is an important vehicle to drive and change behaviours, many journals now offer multimedia and social networking options, e.g. podcasts, video summaries, tweets. It was noted that most social media happens within the first month of an online publication, and on this point, Sysomos, Crimson Hexagon, greenleaf, Altmetric, Plum Analytics were mentioned by Paul Lane as available tools to help measure this impact. Congresses too have a greater virtual reach, with many having an online poster platform and a Twitter presence, while QR codes on posters offer delegates another way to access content. However, the increased availability and accessibility of online content can also pose risks, e.g. posting documents on sites such as SlideShare or figshare can compromise full publication in some journals, while a Twitter quote (now requested by some journals during submission) is considered pre-approval promotion by some pharma company guidelines. Paul concluded by asking whether publication professionals should now be referred to as ‘multi-channel professionals’?

Jürgen Wiehn finished the session by focusing on challenges he experienced with two types of projects that extended the reach of publications: (1) developing video abstracts to accompany the publication of papers in journals, and (2) QR codes on congress posters. Key considerations and obstacles related to the video abstracts were the lack of internal guidance and regulations within the organisation, the duration of the video (any journal time limits must be adhered to), and the cost of filming and editing a video. Regarding QR codes, Jürgen stated the numbers of people accessing posters this way has declined over the past few years, perhaps because many congresses now have online platforms from which posters can be obtained.

Patient-reported outcomes (PROs) and patient engagement: what are the opportunities and key considerations for publications development?

Reflecting the current interest in PROs and patient engagement, in this session Richard White and Julie Beeso (both from Oxford PharmaGenesis) provided an overview of and helpful advice related to developing publications on these topics. Richard began by giving a definition of PROs, their relationship with ‘hard’ outcomes, and the various steps involved in developing a PRO, along with an explanation of the associated jargon. All stages of PRO development represent a publication opportunity, and to support such publications, guidance documents are available (e.g. from the EQUATOR Network, including the CONSORT PRO extension), while specialist journals exist for the publication of the more technical aspects of PRO development. Key take-home messages when drafting a PRO publication are to communicate what the results mean for the patient. Reporting the data with respect to the minimal clinically important difference (MCID) is a recommended approach to help achieve this.

Julie continued the session by first outlining the concept of health literacy, stating that if you want most of the general public to understand a piece of writing, the text should be written at the level of a 9–11 year old. For writing for patients, the advice was to use simple language, short sentences, simple numeric information (e.g. 3 out of 10 people rather than 30%), a large font with lots of white space, bold lowercase for emphasis, left alignment of text, and only include pictures that directly relate to the text. The readability of text can be checked using formulae such as the Simple Measure of Gobbledygook (SMOG), with a score of <12 considered ideal for patients. Suggestions for improving patient engagement and understanding of medical publications included: publish open access, provide patient (lay) summaries, include secondary analysis of key patient populations, use clear and intuitive graphics, and to consider having patients as co-authors. Julie concluded that thanking patients for their contributions within a publication was a recommended best practice.

Population-based registries

The population-based registries parallel session, opened by Dr Margaret Haugh (MediCom Consult), focused on the usefulness of such registries in three different healthcare settings: vaccines, cancer and rare diseases. Dr Myint Tin Htar (Pfizer-France) described how data from national registries in Europe were used to assess the impact of new pneumococcal conjugate vaccines in the ‘real-life’ setting. It was noted that population-based registries allow assessment of the holistic, society-wide benefits of vaccination programs (in this case, on the incidence of pneumococcal meningitis and other invasive pneumococcal diseases in the general population).

Dr Claudia Allemani, Senior Lecturer in Cancer Epidemiology at the London School of Hygiene & Tropical Medicine, reviewed the large number of population-based cancer registries now established globally (such as SEER). As well as measuring cancer incidence, such registries permit surveillance of cancer survival, thereby providing an indicator of the effectiveness of different healthcare systems and informing policies on cancer control.

In contrast to cancer registries, which are largely public-funded, registries that collect data on rare diseases are often led by industry. Dr Chris Rains (Shire) discussed some of the challenges faced by groups running these registries, including the possible inadvertent identification of patients in relating publications, and competition for patients between similar registries. Despite such challenges, rare disease registries can provide invaluable novel information on patient characteristics and treatment effects, as described in the approximately 50 published manuscripts from the Fabry Outcome Survey, a global registry of patients with Fabry disease, a genetic lysosomal storage disorder.

Publication planning and management at smaller pharmaceutical/ biotechnology companies

This session was led by Åsa Lommelé (Alexion Pharma GmbH) and Susan Scott (Scott Pharma Solutions, formerly at Ipsen), who both have experience of working in pharmaceutical companies with fewer than 4,500 employees. During the session, the speakers outlined the differences in managing publications within a small company versus a large pharmaceutical company, which included:

• Publications are in the spotlight in a small company, and attract major interest internally and from investors.
• The publication development processes can be less developed compared with a large company, but are nevertheless generally aligned with Good Publication Practice.
• Internal education of ethical guidelines is required at all levels, including explanation of the current environment and risks, and the need for removal of any commercial influence.
• In a small company, publications managers are particularly accountable for their actions due to the small numbers of staff. There is a need for publication managers to be flexible and innovative, but at the same time transparent, ethical and consistent.
• Priorities can shift rapidly in a small company, meaning that staff need to be adaptable to change.
• Publications managers in small companies need to constantly demonstrate the value/benefits of the publication management team and medical writers.
• Small companies tend to be less bureaucratic, with fewer review and approval steps, which can lead to more expeditious development of publications.
• Compared with a large company, it is easier to create high-achieving, motivated teams.
• External medical writers are an extension of the internal team in small companies.
• Small/medium medical writing agencies are considered the best partners, being more aligned with the priorities of a small pharma company.

Keynote address: finding the truth in evidence that matters

At the 2017 meeting, the keynote address was given by Carl Heneghan, who is a Professor of Evidence-Based Medicine at the Department of Primary Care Health Sciences at the University of Oxford, Director of the Centre for Evidence-­Based Medicine, a fellow of Kellogg College and a General Practitioner. He is also a founder of the alltrials campaign.

The presentation began with a quote from Doug Altman from the EQUATOR Group and Oxford Clinical Trials Research Unit: “We need less research, better research, and research for the right reasons.”. In this respect, Professor Heneghan elaborated that only a small proportion of the clinical trials that are conducted each year report findings that successfully lead to a change in clinical practice. The reasons why clinical trial outcomes fail to translate into benefits for patients is illustrated in the table below:

Reasons why clinical trial outcomes fail to translate into benefits for patients	Further details
Design badly chosen	Surrogate Composite Subjective Complex scales Lack of relevance to patients and decision makers
Methods badly collected	Missing data Poorly specified
Publication selectively reported	Publication bias Reporting bias Under-reporting of adverse events Switched outcomes
Interpretation inappropriately interpreted	Relative measures Spin Multiplicity Core outcome sets

Professor Heneghan chose to focus on two of the biggest reasons for why many trials are flawed and do not lead the changes in clinical practice: (1) the choice of outcomes studied, and (2) the impact of bias/selective reporting.

Choice of outcomes studied

Several issues were outlined relating to the choice of outcomes studied in a clinical trial, including:

• Surrogate outcomes are often selected (e.g. cholesterol levels) rather than the main disease outcome (e.g. mortality)
• Optimal, appropriate or validated outcomes are often not measured, and these can have a lack of relevance to patients and decision makers
• Composite outcomes can be chosen, which are often complex, confusing for clinicians and often not validated
• The choice of the study population chosen for analysis can impact on the effect size (e.g. use of intent-to-treat)
• PROs are increasingly being studied, but are often not fully validated or optimised

Impact of bias and selective reporting

The problems relating to bias and selective reporting were discussed. Tamiflu was used as an example of how under-reporting of clinical trials can skew the evidence base and lead to inaccurate decisions and conclusions amongst decision makers and clinicians. Professor Heneghan explained that around 60% of clinical trial data relating to Tamiflu were not initially published. Based on the evidence available at that time, countries stock-piled significant quantities of the drug for managing influenza epidemics. However, once the complete evidence was made available by the manufacturers, it became clear that the actual evidence did not fully support the effectiveness of the drug, and the clinical decisions that had been made.

Switched outcomes were also discussed as a major problem that distorts the evidence used to make real-world clinical decisions. Pre-specified outcomes are often left unreported, while outcomes that were not pre-specified are reported, without being declared as novel. Professor Heneghan described the COMPare project, which is tracking switched outcomes in clinical trials. Between October 2015 and January 2016, the COMPare team systematically checked every trial published in the top five medical journals (NEJM, JAMA, The Lancet, Annals of Internal Medicine, BMJ), to see if they misreported their findings. Overall, 67 trials were checked. Of these, 9 were perfect. However, in the remaining studies, 354 outcomes were not reported and 357 new outcomes were silently added. On average, each trial reported just 58.2% of its specified outcomes. And on average, each trial silently added 5.3 new outcomes. More information on this initiative, including further details on the COMPare findings, can be found here.

In summing up, Professor Heneghan stated that while all the issues he covered are a major problem in clinical research, the biggest single growing problem today is the fabrication of data. This is a particularly significant issue occurring in emerging countries, such as China

Professor Heneghan closed by inviting attendees to attend the Evidence Live conference, which is a forum where the issues he outlined are discussed in much greater detail, and where participants strive to fix the issues associated with current research. The meeting will be held on June 21-22, 2017 in Oxford, UK.

Following the keynote address, and after a successful 2 days in London the 2017 European meeting of ISMPP drew to a close. The sessions were well attended and full of interesting and thought provoking content.

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By Aspire Scientific, a boutique medical writing and publication planning agency led by professionals with at least a decade of medical writing experience and supported by PhD-educated writers and academics at the forefront of their specialist fields.