KEY TAKEAWAYS

• The ICMJE has strengthened its guidance on how to detect predatory journals.
• Sharing knowledge of predatory journals – what they are, how they operate, and known entities of concern – within the scientific community is key to tackling predatory journals.

Predatory journals are an enduring and growing issue in open access publishing, with at least 15,000 estimated globally in 2021. Pseudo- or predatory journals intentionally misrepresent themselves for financial gain, and authors continue to fall prey to them, believing their authenticity or following unethical motivators linked to the pressure to publish. The International Committee of Medical Journal Editors (ICMJE) has recently updated its guidance on how publishers and authors can protect themselves, along with the release of a dedicated editorial authored by Professor Christine Laine and colleagues.

Detecting a predatory journal

Predatory journals may employ clever tricks to appear legitimate, such as:

• using similar names to well-established journals
• using faked editorial boards
• fabricating indexing and citation records
• claiming membership of respected publication bodies such as the Committee on Publication Ethics.

Authors should be aware of hallmark behaviours identifying predatory journals, including:

• lack of transparency about fees
• absent peer review processes
• promise of rapid turnaround
• failure to respond to queries in a timely manner.

The editorial also recommends taking the following steps:

• Use the ThinkCheckSubmit checklist of features associated with trusted journals and publishers.
• Carefully check email addresses and URLs for discrepancies with the claimed sender.
• Forward any invitations to submit papers or to join an editorial board to the legitimate journal, to verify the source.

How can we tackle predatory journals?

The key to tackling predatory publishing is raising awareness of these journals and their tactics. Prof. Laine and colleagues note information about journals of concern should be shared with the scientific community, including with the journals who have been imitated, who may alert their readership or pursue legal action.

“The key to tackling predatory publishing is raising awareness of these journals and their tactics.”

The authors remind us that all stakeholders must take action to protect the scientific community – and the wider public – from the dangers of predatory journals.

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KEY TAKEAWAYS

• Key updates to the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals include guidance on the use of AI by authors, editors, and reviewers.
• Other important updates include statements on fair authorship assignment, sustainability goals, funding support declarations, and protection of research participants.

The International Committee of Medical Journal Editors (ICMJE) recently updated its Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Key updates provide guidance on appropriate authorship of research carried out in low- and middle-income countries (LMICs) and the use of artificial intelligence (AI) in generating and reporting data. The latest recommendations and an annotated version of the previous recommendations are both freely available on the committee’s website, and a summary of all updates is provided below.

• Authorship: local investigators should be included as authors on publications reporting data from LMICs. As well as ensuring fairness, local author contributions provide additional context on the implications of research.
• Use of AI (authors): if AI is used to provide writing assistance, this should be clearly stated in the article acknowledgements. The use of AI by researchers to help collect data or generate figures should be noted in the methods.
• Use of AI (editors and reviewers): journal editors should be aware of potential confidentiality concerns if AI is used in the review process. Reviewers must request permission from the journal before using AI assistance.
• Carbon emissions: all stakeholders in medical publishing should collaborate to work towards net zero carbon emissions.
• Acknowledging funding support: funding statements should relate directly to the work being reported, for example: “This study was funded by A; Dr. F’s time on the work was supported by B.” Other potential conflicts of interest and general funding support should be included in the disclosures section.
• Protection of research participants: authors should be prepared to provide approval documentation for their study if requested by editors.
• Citations: wherever possible, cited references should be published articles rather than abstracts.

In an editorial published in Cureus, Sankalp Yadav takes a detailed look at the evolution of the recommendations and their impact on medical publishing, describing the latest updates as a “beacon of ethical guidance in the ever-evolving domain of biomedical research and publishing”. Yadav also discusses some of the ongoing challenges in implementing the ICMJE guidance, such as the promotion of fair and ethical authorship practices and keeping pace with new developments – something that may be particularly true for AI and its increasing impact across all areas of medical research and publishing.

If AI is used to provide writing assistance, this should be clearly stated in the article acknowledgements.

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KEY TAKEAWAYS

• Inaccurate author disclosures continue to be an issue in medical publishing. A recent study shows that most authors fail to report, or under-report, ‘potential conflicts of interest’.
• The study’s authors call for action from journals to help remove stigma and increase transparency.

The fully transparent disclosure of relationships between authors of scientific research and other stakeholders is paramount to maintaining the credibility of research and upholding public confidence. Nevertheless, inadequacies in reporting practices remain a challenge. A recent study by Dr Mary Guan and colleagues shed more light on current practices through a detailed comparison of author-disclosed ‘potential conflicts of interest’ versus pharma-reported payments to healthcare professionals.

What did the research reveal?

Guan et al. reviewed disclosures from the first, second, and final US authors of 150 clinical manuscripts from the top 3 US rheumatology journals, in articles from January 2019 onwards. The researchers then compared this information with entries in the Open Payments database. The group’s analyses yielded some surprising findings:

• Disclosures were inaccurate in 92% of papers that involved authors deemed to have ‘potential conflicts of interest’.
• Of the 135 authors with ‘potential conflicts of interest’, 87% disclosed inaccurately.
• Where data were available, the total monetary value of undisclosed potential conflicts was found to be nearing $5.2 million. For those that were ‘under-disclosed’, the total value was just above $4.1 million.
• Among the 14 papers that reported clinical trial data, all authors failed to report a potential conflict of interest and in some cases also under-reported potential conflicts.

So, what can we do to improve reporting accuracy?

In recent years, the International Committee of Medical Journal Editors moved to using the term ‘disclosure of relationships’ rather than ‘conflicts of interest’. This was in part to ensure that guidance was simple for authors to follow in a consistent way: all relationships should be disclosed, and readers draw their own conclusions as to which may constitute a potential conflict of interest. Guan et al. point out that perceived stigma surrounding the term ‘potential conflict of interest’ could also deter authors from accurate reporting, and that a more neutral term may encourage better compliance. Furthermore, they propose that “journals must clearly articulate their reporting expectations and also must clearly emphasise that industry payments do not, a priori, impair the validity of a manuscript”.

“Journals must clearly articulate their reporting expectations and also must clearly emphasise that industry payments do not, a priori, impair the validity of a manuscript”.

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KEY TAKEAWAYS

• A recent systematic review revealed that incomplete reporting of interventional studies remains a widespread issue.
• The authors encourage journals to require a reporting checklist as part of the submission process.

An extensive repository of openly accessible reporting guidelines to aid complete reporting of interventional studies is available at the click of a button. However, a recent commentary published in Trials highlights that incomplete reporting remains a substantial problem.

The commentary describes a systematic synthesis of 51 randomised controlled trials reporting on 53 school-based physical activity interventions published between 2015 and 2020. Despite a growth in the availability and promotion of reporting guidelines since previous reviews were conducted, only one training programme (ie 2% of those analysed) provided complete information covering all intervention components. Even simple information, such as the intervention location, was absent from most reports.

Of the 33 journals that published articles included in the review, only one required reporting checklists for all aspects of the intervention to be submitted.

Strikingly, of the 33 journals that published articles included in the review, only one required reporting checklists for all aspects of the intervention to be submitted. Ryan et al contacted the editors of the other 32 journals suggesting that they update their submission guidelines to include mandatory submission of a reporting checklist. Twenty seven journals responded, 26% of whom welcomed the advice and amended their submission guidelines accordingly.

The authors stress that current systems, including journal submission policies, are allowing wasteful practices to continue. They ask, “how much more waste will be tolerated before action is taken?”

But, why is incomplete reporting a problem anyway?:

• Incomplete reporting impedes the readers’ interpretation of study results and prevents effective replication.
• This ultimately leads to poor outcomes for both study funders and participants.

The authors recommend a resource from the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network to help spark discussion about complete reporting among researchers, editorial teams, funders, and reviewers. They also signalled a clear call to action: all journals that publish interventional research should review their submission requirements to mandate completion of reporting checklists.

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KEY TAKEAWAYS

• Recent survey data reveal that questionable research practices remain relatively common.
• Unearned authorship is of particular concern and thought to be caused by misunderstandings surrounding what counts as a substantial contribution to a publication.

Transgressions of research integrity can undermine the reputation of academic institutions and threaten public trust in scientific findings. In a recent Nature Index article, Dalmeet Singh Chawla reported on a large-scale survey that suggests questionable research practices (QRPs) are still commonplace, with differing attitudes towards research integrity in Europe and the US.

The International Research Integrity Survey (IRIS), which forms part of the 4-year ‘Standard Operating Procedures for Research Integrity’ (SOPs4RI) project, asked 45,000 Europe-based and 2,300 US-based academics about their experience of 8 QRPs and how they perceived their own and their organisation’s efforts to maintain high research integrity standards. The results, published on the preprint server MetaArXiv in October 2022, revealed that:

• The most commonly encountered QRP in both Europe and the US was unearned authorship (69% vs 55%), followed by poor supervision of junior colleagues (56% vs 49%) and inadequate peer review (54% vs 50%).
• 74% of US-based respondents were ‘very confident’ in maintaining high research integrity standards, compared with only 52% in Europe.
• Less than half of US-based and less than a third of Europe-based researchers expressed confidence in their organisation’s effectiveness in supporting research integrity.

The higher confidence in meeting integrity standards among American researchers was attributed by some academics to the more competitive working culture in the US, which could result in under-reporting of QRPs.

The most commonly encountered QRP in both Europe and the US was unearned authorship (69% vs 55%), followed by poor supervision of junior colleagues (56% vs 49%) and inadequate peer review (54% vs 50%).

Singh also called attention to data from an Australian survey, which show that the frequency of QRPs has increased in recent years, with 47% of respondents reporting that they were affected by QRPs in 2022, compared with 38% in a similar 2019 survey.

Nick Allum, the lead author of the IRIS study, points out in Singh’s report that there is no standard definition for what constitutes an adequate contribution to a publication, which likely contributes to the high prevalence of unearned authorship. Tools such as the ISMPP Authorship Algorithm can be helpful in guiding ethical author selection. However, as noted by Allum et al, creating and maintaining a culture of research integrity will require a collective commitment from researchers, their institutions, and funders.

KEY TAKEAWAYS

• The ICMJE has updated their Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
• Key update stipulates that results can be published in medical journals even if they have been previously included in health technology assessment or medical regulators’ reports.

The International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals were updated in May 2022. An annotated PDF of the recommendations is freely available and can be found here.

The ICMJE Recommendations guide accurate and unbiased reporting of industry-sponsored clinical trial data in medical journals. The two key updates in this version concern:

• Duplicate publication: results or data contained in reports published by health technology assessment agencies or regulatory agencies are no longer considered to be duplicate publications.
• Reporting of trial participants: authors should discuss how representative the study sample is of the larger population of interest; in cases where race or ethnicity data were not collected, authors should explain why not.

The guidance has been welcomed by industry campaigners, who in January 2022 wrote an open letter to ICMJE, requesting an update to the recommendations on duplicate publications to allow more rapid dissemination of data to the public and easier development of economic evaluations and indirect comparison analyses.

We look forward to seeing these recommendations implemented and hope the updated guidance will contribute to more timely and transparent reporting of medical research.

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KEY TAKEAWAYS

• The accuracy of COI disclosures, including those in high-impact journals, remains questionable, despite adoption of the ICMJE disclosure form.
• Baraldi et al call for readers to compare COI disclosures in journals with payment data provided by the medical industry to prevent potential bias going unnoticed.

Conflict-of-interest (COI) disclosure is an important tool for identifying potential bias associated with medical research. Although efforts to improve COI disclosure have been made by various parties (including the US Government, The International Committee of Medical Journal Editors (ICMJE), and medical journals themselves), issues around transparent reporting remain.

To assess the scale of the problem in high-impact journals, Baraldi et al examined original clinical-trial research articles published in NEJM and JAMA in 2017, and compared physician-authors’ self-disclosures of general payments with their Open Payments data. The payments were categorised as ‘disclosed,’ ‘undisclosed,’ ‘indeterminate,’ or ‘unrelated’, per definitions based on the ICMJE form used by both journals:

• Disclosed: The author disclosed a payment from a company that matched the data from Open Payments.
• Undisclosed: The author received a payment during the relevant disclosure period that did not match any disclosures provided to the journal, AND the company offers, or offered at the time of the payment, a product that could broadly be considered related to the area of inquiry.
• Indeterminate: The author received a payment during the relevant disclosure period that did not match any disclosures provided to the journal, BUT the company was a subsidiary or parent company of a company listed on the disclosure, AND/OR it could not be determined whether that company offers, or offered at the time of the payment, a product that could broadly be considered related to the area of inquiry, AND/OR the payment has been disputed.
• Unrelated: The payment was not disclosed, AND the company from which the payment originated does not offer a product that could broadly be considered related to the area of inquiry.”

Thirty-one articles each from NEJM and JAMA met the study inclusion criteria, totalling 118 unique physician-authors. Of the 106 (90%) authors who received general payments, 86 (81%) received undisclosed payments, with 18 (21%) and 33 (38%) of those disclosing less than half and none of their payment amounts, respectively. No significant difference in COI disclosure rates was found between NEJM and JAMA authors.

Of the authors who received general payments, 86 (81%) received undisclosed payments, with 18 (21%) and 33 (38%) of those disclosing less than half and none of their payment amounts, respectively.

Baraldi et al concluded that self-disclosure of COIs is insufficient to ensure accurate reporting of potential bias, and call for readers to compare COI disclosures in journals with payment data provided by the medical industry.

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The ISMPP Authorship Algorithm Tool is designed to help determine whether an author’s contributions are sufficiently substantial to meet the International Committee of Medical Journal Editors (ICMJE) Recommendations for Authorship. The  tool is now available and free for companies to use. To learn more watch the recent 90-minute ISMPP U webinar, which is available to both ISMPP members and non-members.

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KEY TAKEAWAYS

• ISMPP Authorship Task Force has developed definitions of what does and does not qualify as a ‘substantial contribution’ for authorship to clarify ICMJE criterion 1.
• These definitions form the basis of the ISMPP Authorship Algorithm Tool.

How should authors be selected for a scientific paper reporting industry-sponsored research? The International Committee of Medical Journal Editors (ICMJE) recommends four criteria that should all be met to guide ethical author selection. The first criterion states that all authors should have made ‘substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work’. But what defines ‘substantial contributions’?

The ISMPP Authorship Task Force carried out a member survey and literature review to investigate how ICMJE criterion 1 is defined and applied. The findings highlighted a general lack of clarity around its interpretation and inadequate documentation of contributions.

The International Society for Medical Publication Professionals (ISMPP) Authorship Task Force carried out a member survey and literature review to investigate how ICMJE criterion 1 is defined and applied. The findings highlighted a general lack of clarity around its interpretation and inadequate documentation of contributions. It was concluded that more needed to be done to ensure decisions about authorship were appropriate and transparent. To this end, the group developed consensus recommendations for objective and consistent interpretation of ICMJE criterion 1 to aid in selecting authors of industry-sponsored research; these were recently published in Current Medical Research and Opinion.

Definitions were broken down into each category within ICMJE criterion 1:

• Concept and design: development or substantial modification of research idea, study design, methodology protocol, statistical analysis plan, or a combination of these activities; or
• Data acquisition: significant contribution of data (quality and quantity) to the final analyses; or
• Data analysis: performance of the data analysis and assurance of the integrity of the data and statistical analyses; or
• Data interpretation: derivation of conclusions, placement of results into context, or identification of knowledge gaps for future exploration.

The Task Force also provided examples of contributions that were not intellectual or substantial enough to warrant authorship and would be more suited for an acknowledgement.

These new recommendations form the basis of the ISMPP Authorship Algorithm Tool. You can read our interview with Avishek Pal, leader of the Working Group involved in developing the tool, here.

We look forward to seeing whether the ISMPP definitions will help to optimise documentation of contributions and increase transparency around authorship decisions moving forward.

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KEY TAKEAWAYS:

• A new quantitative algorithm aims to identify “deserving contributors” and determine the order of authorship on clinical study manuscripts.
• The tool uses attributes from the ICMJE authorship criteria and Good Publication Practice 3 guidelines.

The International Committee of Medical Journal Editors (ICMJE) criteria and Good Publication Practice (GPP) 3 guidelines are widely used to support the authorship decision-making process. But how can sponsors ensure all contributors to clinical trial manuscripts are appropriately credited whilst sticking to these guidelines? Authorship algorithms, like that recently announced by ISMPP, are hoped to provide a quantitative method of identifying who qualifies as an author for pharmaceutical industry-sponsored research.

“…with the ever-expanding field of clinical research publications and evolving transparency and ethical requirements, there are often deficiencies or limitations in putting [ICMJE and GPP3] guidelines into practice.”

Dr Sam T. Mathew et al have developed a new quantitative authorship decision support tool using attributes of clinical trial publications based on the ICMJE’s four criteria of authorship and the GPP3 guidelines. Overall, 26 attributes were identified, including study concept/design, data acquisition/analysis/interpretation, content development/review, and accountability. Contributors are ranked for each attribute on a Likert scale (0–5) or dichotomous scale (yes=1, no=0) in an easy-to-use algorithm in Microsoft Excel.

The tool identifies substantial contributors and orders them using the following rules:

• Contributors with a minimum score of 78/120 (65%) qualify for authorship (the threshold can be amended by users if necessary).
• First author is the person with the highest overall score, followed by the others in order of their score (the tool has provisions to resolve any ties in scores).
• Senior author has the maximum score for study design or concept, content, and accountability.
• Corresponding author has the maximum score for content development and accountability.

The creators hope that their algorithm will help reduce author inflation and ensure authorship is appropriately assigned by quantifying contributions to all parts of the clinical study. Dr Mathew and colleagues plan to further develop the tool as a web-based system, and we look forward to seeing how this and other algorithms will be implemented in publication development moving forward.

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