KEY TAKEAWAYS

• From January 2025, The BMJ is offering £50 or a 12-month online subscription to a BMJ journal for patients and members of the public who review an article.
• The BMJ hopes the policy will help to expand and diversify participation from its patient and public reviewers.

Patients, advocates, and public reviewers play an important role in the reporting of medical research by offering their lived experiences and perspectives. Starting from January 2025, The BMJ is complementing the 12-month BMJ online subscription given to all reviewers, adding £50 or a 12-month online subscription to any BMJ journal for patient and public reviewers.

The BMJ introduced patient and public reviews in 2014 and have accumulated over 2,600 patient and public reviews across various article types. These help to evaluate:

• the relevance and importance of research questions
• the appropriateness of outcome measures
• how patient and public involvement is reported.

The new BMJ policy aligns with National Institute for Health and Care Research (NIHR) guidelines on payments for public involvement in research and aims to:

• compensate the time and effort of patient and public reviewers
• expand and diversify patient reviewer participation.

Expanding representation in patient and public reviews

While The BMJ has over 1,000 engaged patient and public reviewers from over 20 countries, most reviews in the past decade were conducted by women based in the UK and US. The experiences of patient reviewers for The BMJ are positive, and their feedback has helped develop further guidance and training. Feedback from current reviewers and an international patient and public advisory panel also underpins the latest change in compensation.

The BMJ hopes that remuneration will diversify participation in reviews and increase representation.

The BMJ hopes that remuneration will diversify participation in reviews and increase representation across:

• geographic locations
• ethnicities
• genders
• areas of lived patient experiences.

How will this change the future of peer review?

The BMJ announcement acknowledges the value of patient perspectives in medical research, sitting alongside other initiatives to amplify patient engagement in scientific publications and address barriers to participation. However, broader discussions persist around whether clinical peer reviewers should be compensated and how to sustainably improve the peer review process while maintaining quality and integrity. The BMJ plan to monitor the impact of the new policy – we look forward to reading their updates.

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KEY TAKEAWAYS

• In an analysis of 3,000 health research articles, only around 1 in 5 reported patient and public involvement.
• The inclusion of patient and public involvement varied depending on location, research methods and topic, and the source of funding.

A recent study led by Dr Iain Lang found that despite efforts to increase patient and public involvement (PPI) in health research, such as stipulations by state and charitable funding bodies that PPI should be a part of health research, its inclusion is still uncommon, and the extent of its inclusion varies depending on several factors.

In a cross-sectional analysis of 3,000 original research articles published in BMJ Open between 1 January 2020 and 31 December 2020, approximately 21% included PPI. The study also looked at whether the inclusion of PPI differed depending on research location, method, topic, and funding source, and found large variation across these categories:

• by location (the country of the primary affiliation of the first author): 45% of research based in the UK vs 3% of research in China included PPI
• by method (based on a categorisation of words in the title): 39% of articles with mixed methods vs 5% of simulation articles included PPI
• by research topic (based on the section of the journal to which the article was assigned): 37% of articles on mental health vs 3% of articles on medical education and training included PPI
• by funding source (taken from the funding section of each article): 57% of articles funded by the National Institute for Health and Care Research (NIHR) vs 3% of articles funded by a Chinese funding body included PPI.

Further studies are needed to evaluate effects of attitudes, policies, or beliefs at different levels within research organisations on patient and public engagement.

“We will need different methods to study such influences on how and why PPI in health research occurs—and why it does not.”

However, the authors believe the considerable differences identified by their study may indicate ways to increase PPI inclusion in research by targeting the areas with the lowest patient and public involvement.

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KEY TAKEAWAYS

• New CHEERS statement reflects the need for guidance that is more broadly applicable and engages stakeholders.
• It is hoped that the new 28-item checklist will be useful to those who identify, prepare, and interpret health economic evaluations.

The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, originally published in 2013, was developed to help researchers, peer reviewers, and readers in their reporting and interpretation of economic evaluations of health interventions, and to aid reproducibility. Earlier this year, the statement was updated and presented in an article in the BMJ. The CHEERS 2022 statement was also a topic for discussion during a roundtable session at this year’s ISMPP annual meeting, in which attendees talked about publication guidelines.

The update was motivated by the need for guidance that considers recent developments in the field and is more broadly applicable to all types of health economic evaluations and forms of intervention. The revisions also reflect the increased role of stakeholder involvement.

The major changes in the CHEERS 2022 statement include removal of items distinguishing between model-based and study-based measures, and addition of items related to the following:

• patients or service recipients, the general public, and community or stakeholder involvement and engagement
• reporting and availability of a health economic analysis plan
• characterising distributional effects.

In addition, the statement recommends reporting where publicly available models can be found, and encourages sharing of unlocked models with editors and reviewers.

The ISPOR and EQUATOR network guidance was used to advise an expert task force to revise the statement, which was then initially reviewed for its understandability, interpretability, and replicability by a group of patient and public involvement and engagement contributors, and later by experts in the field via a modified Delphi method.

The resultant CHEERS summary is a 28-item checklist, with accompanying recommendations to aid appropriate interpretation. The items can be broadly subdivided into the following categories:

1. Title
2. Abstract
3. Introduction
4. Methods
5. Results
6. Discussion
7. Other relevant information

It is recognised that the volume of information required by the statement for adequate reporting will exceed the space limitations imposed by most journals, so authors are asked to make the necessary information available in supplementary appendices or online resources.

The impact of the original CHEERS statement is being analysed in an ongoing evaluation, with results expected later in 2022, but it is hoped that the revised guidance will improve decision-making in health economic evaluations and, ultimately, the quality of reporting.

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A quarter of a century on from the founding of The Cochrane Collaboration the network appears to be thriving, with 13,000 members and a 2017 income of over £8.6 million. The Cochrane Library, a collection of databases containing systematic reviews that can be used for healthcare decision-making, now boasts over 7,900 reviews. However, following the expulsion from the Cochrane board of one of the founding members — Prof Peter Gøtzsche — four further board members have resigned. Prof Gøtzsche has since published a book entitled, “Death of a whistleblower and Cochrane’s moral collapse”. An article by Melanie Newman in The BMJ explored the history of Cochrane, from its conception to its recent conflict, and examined the question: “Has Cochrane lost its way?”.

The vision of Cochrane is a “world of improved health”, whereby “high-quality, relevant and up-to-date synthesised research evidence” informs healthcare decisions. Work to achieve this is based on ten key principles, including “Collaboration” and “Minimising bias”. Recent growth would suggest success of this model; however, critics interviewed by Newman argue this growth may not be something to celebrate. Former Cochrane board member David Hammerstein suggests that “more does not mean better” when it comes to healthcare. Another critic concurred that Cochrane should shift its focus from “quantity” to producing “methodologically high-quality reviews in areas of importance to patients”, so that it becomes “more of an advocate for evidence based medicine”.

Newman suggests that Cochrane’s current struggles are the culmination of members’ disagreement over the network’s centralisation. Over the years, Cochrane has evolved from a grassroots organisation to what some critics now describe as a “corporate centre focused on income generation and ‘message control’”. A group of members concerned about a “lack of transparency” received over 600 signatures in a petition calling for four major policy changes, described as: 1) Create a culture of open discussion; 2) Refocus the heart of Cochrane; 3) Increase the involvement of Cochrane members; 4) Find a better business model for Cochrane. However, Mark Wilson (CEO) insists it is “not the case” that Cochrane’s strategy is failing, and argues that the “community has grown hugely”. Newman concludes that resolution of the current debate may take some time and must be navigated carefully to retain enthusiasm of Cochrane’s many voluntary members.

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Summary by Emma Prest PhD from Aspire Scientific

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

The 2019 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 22–23 January and attracted more than 300 delegates; the highest number of attendees to date. The meeting’s theme was ‘Scientific Communications in a Fast-Paced World: Fighting Fit for the Future’ and the agenda focused on innovations in data publishing, open access, patient involvement in publications, and the expanding role of the publication professional. Industry newcomers had the opportunity to attend a satellite training session and all delegates were treated to two keynote addresses, lively panel discussions, interactive roundtables and parallel sessions. Delegates also had the chance to present their own research in a poster session.

A summary of the first day of the meeting is provided below for those who could not attend, and as a timely reminder of the highlights for those who did. A summary of the second day of the meeting is available here.

Welcome and warm up/year in review: the 2018 track record

The plenary sessions began with a review of the key events that occurred in medical publishing over the course of 2018, presented by Rick Flemming (The Publication Plan). Flemming revealed that open access, data sharing and transparency, and patient centricity were key industry themes reported by The Publication Plan last year. For example, 2018 saw an increased commitment to open access across the community, notably with the introduction of a mandatory open access publishing policy for Shire-funded research in January, and later, the introduction of an open access option for company-funded research in American Society of Clinical Oncology (ASCO) journals. In September, cOAlition S was launched, an alliance of national research funding organisations working together to implement Plan S, which aims to make publications of publicly funded research freely available to all by January 2020.

In February, TrialsTracker launched a new tool aimed at monitoring compliance with the FDA Amendments Act (FDAAA) 2007 and the ‘Final Rule’. The EU Trials Tracker and The BMJ’s unreported clinical trial of the week feature were subsequently launched, which also highlight academic and industry sponsors that are failing to report the results of clinical trials. New requirements for International Committee of Medical Journal Editors (ICMJE) member journals came into effect in July, mandating inclusion of a data sharing statement concerning deidentified individual participant data in clinical trial publications. Further to this, November saw Wellcome announce data re-use prizes to encourage the extraction of new scientific findings and insights from existing data. Flemming also mentioned the introduction of the EU General Data Protection Regulations (GDPR) and the Food and Drug Administration Modernization Act of 1997 – Section 114 (FDAMA 114) update, topics discussed in a recent article in the MAP newsletter.

The increasing focus on patient involvement in publications was also noted. In September, The BMJ recounted the journal’s positive experiences of involving patients in their editorial process, while a survey of patient and public peer reviewers for The BMJ and Research Involvement and Engagement revealed overwhelming support for patient and public review as well as identifying ways to improve the experience. Finally, the impact of the AMWA–EMWA–ISMPP Joint Position Statement on the Role of Professional Medical Writers and updates to the ICMJE’s Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals were discussed.

Harnessing the power of evidence in a data-led future

The second session of the day looked at how best to channel big data into meaningful content. Moderator Gordon Muir-Jones (Porterhouse Medical US) emphasised that data are meaningless unless interpreted into something actionable, and that inclusion of all pertinent data is important for accuracy. Initiatives such as AllTrials, which campaigns for the reporting of all clinical trial methods and summary results, are just one way in which the volume of accessible medical research data is increasing. In an era of big data, the medical publishing industry needs to address the challenge of how best to disseminate research results.

Valerie Philippon (Shire/Takeda) introduced data sharing as another way in which the pool of available data is widening. She presented the IMCJE’s data sharing statement policy, which calls upon authors to specify not only whether data will be made available, but also to provide details of the data sharing plan. This includes: whether deidentified patient data will be available; what data will be shared; what documents will be available; when data will be available (start and end dates); with whom data may be shared; for what type of analyses; and how data sharing requests should be made. Shire has already stated its commitment to sharing data from company-sponsored research and shared data with 5/7 requesters in 2018. This open approach is not without its challenges: for data from clinical trials involving patients with rare diseases, Philippon reminded delegates of the need to carefully evaluate each request against any risk to patient privacy.

Keith Evans (InScience Communications) explained how the repertoire of data sources expands even further with consideration of real world data. Evans defined this as all data related to health and use of healthcare that are not derived from clinical trials. He emphasised the strengths of real world data and real world evidence, such as the inclusion of a diverse and representative patient population, and highlighted the importance of such data in pharmacovigilance. Furthermore, real world evidence can harness the power of big data and the digitisation of health data, making it easy to collect in large quantities. Potential weaknesses were also identified, such as a lack of recognised common data elements, issues with ownership and privacy, and the potential for bias. One of the main barriers to widespread adoption of real world evidence in healthcare decision making is its current exclusion from regulatory criteria and an entrenched perception of randomised controlled trials as the accepted tool for evaluating healthcare interventions.

Leading on from the exploration of data sources, Tom Rees (OxfordPharmaGenesis) examined ways to maximise the impact of data. Firstly, he underlined the importance of publications as “more than data disclosure”, emphasising the need to explain and contextualise the data. Ancillary activities to publications, such as explanatory videos, infographics, and plain language summaries were cited as valuable tools for reaching a wider audience than via publication in a journal alone. His vision for journal articles as the anchor point to a wider ‘study ecosystem’ was welcomed by delegates as a way to connect multiple outputs from the same study. Navigating this system could utilise metadata tools such as Crossref and PubMed-style automated indexing to signpost related content. Despite the complexities of linking all outputs from a particular dataset, using diverse platforms for data dissemination was viewed as an important way to tailor outputs to different target audiences.

Keynote: PLAN S for open access – what does it mean for scholarly publishing and our industry?

The first of the meeting’s keynote talks centred around Plan S – a hot topic since the announcement in September of the European cOAlition S initiative, which aims to make all publicly funded research freely available by January 2020. This insightful session provided the perspectives of both cOAlition S and a non-profit publisher.

David Sweeney (Research England) kicked things off by recapping the ultimate goal of Plan S: to achieve “full and immediate” open access to publications from publicly funded research. He argued that this will require a paradigm shift towards new models of scholarly publishing that are “more transparent, efficient and fair”; proposals that to date have been met with some controversy. Despite this, Sweeney described a common aspiration among the research community to make research outputs as widely read and disseminated as possible, and encouraged stakeholders to help identify a sustainable model by which to make this a reality. Three possible roads to compliance with Plan S were outlined: 1) Open access journals or platforms (registered with the Directory of Open Access Journals); 2) Deposition of scholarly articles in open access repositories without embargo; 3) Hybrid journals only if under transformative agreements (i.e. with a commitment that the journal will transition to full open access). Open access publication fees (such as article processing charges) were also a topic of discussion. Sweeney outlined that article processing charges should be transparent and fairly reflect the costs involved in publishing a quality open access article, but called for the importance of ‘fee-free’ open access to be recognised.

A non-profit community journal perspective was provided by Claire Moulton (The Company of Biologists). A key takeaway from this presentation was the readiness of such journals to embrace innovation and change; Moulton encouraged an open dialogue in which stakeholders should look to the future and find the best ways forward. A number of key concerns were discussed, including the much-debated stance of Plan S against hybrid open access journals. While Moulton expressed support of hybrid journals as a method of transitioning to open access, she called for publishers to address the issue of ‘double dipping’ (taking both subscription and open access revenue for the same content), and for funders to consider payment of realistic article processing charges for quality publishing. Moulton also expressed concern around the proposed timelines for Plan S, highlighting that not all journals will transition at the same speed. It was suggested that, rather than setting a deadline, Plan S could work with journals to set target transition percentages. Overall, Moulton called for stakeholders to overcome hurdles together to reach the common objective of maximising the dissemination of research outputs.

So, what does the future look like? cOAlition S invites public feedback on the Plan S implementation guidance by 8 February 2019.

Boxing clever: the expanding role of the publication professional 

Jackie Marchington (Caudex) chaired a panel considering the value of publications to different stakeholders. The perspectives of healthcare professionals, payers and the pharmaceutical industry were represented by Pali Hungin (Newcastle University; former President of the British Medical Association), Chris Skedgel (IQVIA) and Clare Baker (Bayer), respectively.

Hungin highlighted the changing trends in how healthcare professionals access publications, moving from browsing paper journals to more selective reading of electronic outputs, often accessed via journal alerts or search services such as PubMed. He emphasised how generalist journals such as The BMJ or JAMA are the first port of call for many clinicians, followed by their individually-favoured specialist journals. Increasingly, conference presentations and proceedings, as well as industry-led symposia, are key ways for healthcare professionals to remain up-to-date with research developments. Hungin identified systematic reviews and meta-analyses as important resources, although noted that interpreting the applicability of these studies, which are based on randomised controlled trials of specific populations, is a challenge and must be supported by considering real world evidence. Finally, Hungin encouraged open peer review as a way to help healthcare professionals to identify potential pitfalls in published research, cautioned against the danger of poor research becoming legitimised through publication in predatory journals, and highlighted that in the current open access environment a revolution in the ‘democratisation of knowledge’ is redefining doctor–patient relationships.

Skedgel presented the importance of publications, including health technology assessments (HTAs) and systematic reviews, from the payer/assessor perspective. Skedgel illustrated how well-structured abstracts are crucial: 80–90% of publications initially identified by keyword-based search strings are screened out at abstract review during systematic literature searches. He also highlighted how data extraction during these searches could be facilitated by the standardisation of publications, such as inclusion of predefined, consistent tables for study characteristics and outcomes. Currently, data extraction frequently involves digitisation of figures, imperfectly extracting data that are used in reanalysis. As such, consistent deposition of original data in databases would be welcomed by payers/assessors. Skedgel suggested that publishers could also facilitate the HTA process by including reporting quality checklists with publications. Skedgel emphasised that from the payer/assessor perspective, publications are viewed as a vehicle for accessing data. Ensuring that data are presented suitably for inclusion in a systematic review helps to ensure their presence in analyses of this type which in turn inform health policy.

From the pharmaceutical industry perspective, Baker described how publications fulfil multiple purposes, including highlighting unmet needs, adding to the evidence base for a specific drug, making cost-effectiveness assessments, fulfilling reporting criteria, providing citable references for scientific communications, and showing leadership in disease understanding or management. Strategic, aligned and focused multi-channel medical communications were perceived as key across Bayer stakeholders. It was recognised that publications reporting clinical trial results alone may not lead to clinical uptake of an intervention, since clinicians require further information concerning real world implementation. Baker suggested that publication planning teams should be ‘rebranded’ to better suit the future, becoming more cross-functional and visible elements of pharmaceutical companies, with proactive, forward-thinking roles in driving strategic scientific communication.

The panel received a number of questions from the audience, including ‘Are reports of randomised controlled trials dead?’. While the unanimous verdict was no, the divergent value of these publications was emphasised, with context reported as crucial for healthcare professionals, and data the essential element for payers. Finally, the potential of artificial intelligence in the future of medical communications was raised: artificial intelligence could facilitate screening of randomised controlled trial and real world evidence publications, aiding the systematic literature review process and helping to deliver the vision of personalised and precision medicine for patients.

Team talk: our ISMPP update

Towards the end of the day, Debby Moss (Caudex; ISMPP CMPP^TM recertification committee) and Al Weigel (ISMPP President/Chief Operating Officer) updated delegates on the Certified Medical Publication Professional (CMPP) qualification and the most notable ISMPP 2018/2019 highlights.

Moss opened her presentation by highlighting that ISMPP is celebrating 10 years of the CMPP^TM qualification. Delegates and the Certification Board were thanked for their support of the programme and continued commitment to best practice across the medical publications industry. Moss went on to outline key updates to the certification and recertification processes. For new CMPP^TM candidates, the Candidate Handbook (updated October 2018) now includes three new sample examination questions and new scoring information. A mentor programme is also available to assist with preparation for the exam. For those already certified, the CMPP Recertification and Credit tracker Handbook (updated December 2018), now includes self-study qualifying activities. A new online learning management system is in development. Upcoming activities include a CMPP^TM survey (due January/February 2019) and a recertification webinar (February/March 2019).

The session was rounded off by Weigel, who underlined the substantial growth of ISMPP over the past 15 years, both in terms of the number of members and the vision of the society itself. The most notable highlights of 2018/2019 were:

• Initiation of an ISMPP open access white paper – aims to provide a comprehensive, multi-stakeholder discussion on open access medical publishing.
• Advancement of an Authorship Algorithm Task Force – created to better understand experiences and challenges associated with the authorship of publications.
• Development of an AMWA–EMWA–ISMPP joint position statement on predatory publishing.
• The first ISMPP West Meeting was held in 2018 in San Diego, California. Following the success of this event, the second meeting will take place in November of this year.
• At the end of 2018, ISMPP announced a new partnership with Pharma Collaboration for Transparent Medical Information (phactMITM), a non-profit association of medical information specialists in the pharmaceutical industry. This partnership will kick-off with a half-day educational meeting immediately following April’s 2019 ISMPP Annual Meeting.

Power walk: poster discussions

Day one was rounded off with poster presentations from ISMPP members, showcasing the depth and breadth of the research carried out within the community.

Watch this space —day 2 summary coming soon!

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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 sponsors, Aspire Scientific Ltd and NetworkPharma Ltd

The BMJ first began working with patient editors over 20 years ago and launched a patient and public partnership strategy in 2014. Alongside this, the journal created an international patient advisory panel of health professionals and policy experts who champion patient empowerment. These strategies have led to a number of editorial initiatives to improve patient involvement in The BMJ’s publishing model, such as mandating that authors report if and how they involved patients and the public in their studies, and establishing patient review alongside standard scientific peer review for all relevant articles.

The BMJ also advocates content written and co-written by patients, including in the ‘What your patient is thinking’ and  ‘The BMJ Opinion Patient Perspectives’ series, and has established guidance for authors on how to involve patients in their articles. The BMJ Events content team are also working to increase patient involvement in conferences.

The changes made by The BMJ as part of their partnership strategy are already having a positive impact, although, as noted in the editorial, there is room for further improvement. The BMJ invites other medical journals to join them in reducing the gap between the aspiration and reality of person-centred care and shared decision making.

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Summary by Louise Niven DPhil, CMPP from Aspire Scientific

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The AllTrials initiative calls on governments, regulators and research bodies to implement changes to ensure that past and present clinical trials are registered, with the complete methods and results reported. Find out more about the story of the AllTrials campaign here. Speaking about the tracker’s findings, AllTrials co-founder Dr Ben Goldacre said “We hope that our data will help trial sponsors to move fast and get their houses in order. We have identified the individual non-compliant sponsors, and trials, in order to help them do so”. Data from an analysis of EUCTR compliance, led by Dr Goldacre, were published in the BMJ this month. Interestingly, this analysis shows that, to date, academic sponsors of clinical trials are lagging behind industry, with only 11% of academic trials having results reported.

Síle Lane, co-founder of AllTrials and campaigns director for Sense about Science, says “The new tracker shows us that some companies and universities are taking this issue seriously. But there’s a vast difference between the best and the worst. There’s no excuse for failing to report results.”

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Summary by Emma Wise, a PhD Biomedical Sciences student registered at Plymouth University. Contact Emma at emmawise@hotmail.com.

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When selecting a journal you may consider aspects such as impact factor, circulation, and associated fees, but do you stop to think about the resources available to the journal during the submission and publication processes? Dr Elizabeth Loder is head of research at The BMJ and is also a volunteer associate editor for two smaller journals. She has recently published an interesting commentary on the disparity between the two roles.

Dr Loder highlights the differing amounts of resource and expertise that is accessible to top- and lower-tier journals. High-impact journals will often have a raft of specialists, including experienced medical and technical editors and statisticians to aid the publication of prominent manuscripts. However, this is not the case for their smaller, less influential counterparts, which often rely on volunteers. Should we be concerned? Well yes if, as suggested by Dr Loder, this disparity equates to a substantial difference in the amount of scrutiny a paper receives prior to publication, potentially allowing studies with quality issues to slip through the net.

Finding solutions to such discrepancies is not easy; Dr Loder highlights the work of The World Association of Medical Editors and the Committee on Publication Ethics, who offer free or inexpensive resources and advice as one way to try and address these inequalities. In the meantime, as Dr Loder recommends, “we should all mind the gap”.

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Summary by Jo Chapman, PhD from Aspire Scientific

The randomised controlled trial, which has not yet begun recruiting participants, will see 568 manuscripts, submitted to one of two journals, reviewed either by scientific reviewers only (the ‘control’ group) or by scientific reviewers as well as one of 24 lay members of the public. The lay trial participants will receive training in reviewing manuscripts and will adhere to journal requirements. Reviewed articles will proceed through the journals’ editorial review processes as normal, with editors using all available reviews to aid their decisions.

The study investigators hypothesise that lay review comments will prove useful to journal editors and will have a clear impact on published manuscripts. They suggest that lay reviewers “will be more likely to comment on relevance to patients and communities, subject diversity, social context, and implementation barriers”.

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Summary by Hannah Mace MPharmacol, CMPP from Aspire Scientific