KEY TAKEAWAYS

• RIGHT-COI&F guides transparent reporting of COIs and funding in healthcare guidelines and policy documents of guideline organisations.
• The checklist can also be used to assess the quality and completeness of reporting in published guidelines.

Healthcare guidelines substantially influence clinical practice and policy and are developed through extensive analysis and decision-making. Amid broader issues with accurate disclosure in medical publishing, a recent Annals of Internal Medicine article by Yangqin Xun and colleagues highlighted that while guidelines are especially sensitive to conflicts of interest (COIs) and funder influence, disclosure is generally poor.

Clear and complete reporting of COIs and funding is crucial for credibility and is monitored as a key open science indicator. Yet existing checklists, such as Reporting Items for practice Guidelines in HealThcare (RIGHT), often lack detail on how to report COIs and funding. Xun et al. aimed to address this, building on RIGHT to develop a COI- and funding-specific extension. RIGHT-COI&F can be used both while developing healthcare guidelines and to assess completeness of COI and funding reporting.

RIGHT-COI&F can be used both while developing healthcare guidelines and to assess completeness of COI and funding reporting.

Checklist development

RIGHT-COI&F development followed the recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, based on a published protocol. Key steps were:

• establishing working groups, including an expert panel
• generating an initial checklist based on existing materials and a stakeholder survey
• agreeing checklist items through surveying experts and consensus meetings
• refining and testing the checklist.

RIGHT-COI&F items: policy and implementation

RIGHT-COI&F has 27 items, 18 focused on COIs and 9 on funding. Most items are related to policy and include:

• defining the types of interest to be disclosed (eg, based on relevance, financial amount, or time period) and by whom
• how accuracy and completeness is verified
• processes for determining whether interests are conflicts
• strategies to manage COIs
• whether accepting funding from certain sources is restricted.

Organisational policies may fulfil these items, alleviating the need for detailed descriptions in individual guidelines.

The remaining items relate to implementation in individual projects, such as ensuring that declared interests are reported in detail, alongside the funding received (and the role of funders).

Next steps

To promote adoption, the authors plan to translate RIGHT-COI&F into multiple languages, disseminate it through academic networks, and seek endorsement by medical journals. Further assessment of real-life feasibility and impact is planned. We look forward to seeing how RIGHT-COI&F helps uphold transparency and trust in the healthcare space.

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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

• Stakeholders at biomedical research institutions agreed on 19 key open science practices that should be monitored to help institutions track their progress.
• Selected open science practices include prospective registration and timely reporting of clinical trials, specifying information to be shared, publishing open access, and disclosing author and funder information.

Open science aims to improve the quality and reproducibility of research through increasing transparency and accessibility. Following the 2021 adoption of the United Nations Educational, Scientific and Cultural Organization (UNESCO) Recommendation on Open Science, the US National Institutes of Health (NIH) and World Health Organization (WHO) have also introduced data sharing policies. ‘Success’ in open science generates effective research outcomes, reduces costs, and improves reputation. However, questions remain on which practices are the most important and how they should be monitored.

A recent publication in PLoS Biology shared results from a 3-round Delphi study asking which open science practices should be monitored at biomedical research institutions globally. 80 participants, including researchers, open science specialists, and librarians, contributed to the study. They reached consensus on 12 traditional and 7 broader transparency practices that should be monitored, including several also assessed in PLOS’ Open Science Indicators initiative.

The key open science practices were related to:

• registration and timely reporting for clinical trials and systematic reviews
• information sharing, eg, stating whether data, study materials, or code were shared openly at the time of publication, and the use of clear licences for any shared information
• use of persistent identifiers, including ORCID identifiers for researchers and digital object identifiers (DOIs) for shared data, study materials, or code
• use of open access publication (including whether open access is immediate or delayed)
• disclosure of author contributions, conflicts of interest, and funding.

Dr Kelly D. Cobey and co-authors now plan to develop a fully automated open science dashboard interface, incorporating the agreed core open science practices where these can be measured accurately and reliably. Dr Cobey and co-authors believe the tool will allow institutions to track their progress adopting open science practices and adhering to mandates, and that it will facilitate open science meta-research, without evoking competition or indicating prestige at the institutional level.

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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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KEY TAKEAWAYS

• The medical product industry is deeply connected to all players in the healthcare ecosystem via financial and non-financial ties, which are seldom transparently reported.
• If left unregulated, these conflicts of interest can impact patient care.

The medical product industry has extensive relationships with virtually every player in the healthcare ecosystem, though these conflicts of interest are rarely described or quantified, according to a study published in The BMJ.

Dr Susan Chimonas and co-authors performed a scoping review of 538 publications covering 37 countries to identify and characterise ties between the medical product industry (pharmaceutical, medical device, and biotechnology companies) and individuals/organisations in healthcare. The latter represented a broad spectrum of constituents making up the healthcare ecosystem: government (eg, regulatory agencies), market supply chain (eg, purchase and distribution agents), healthcare profession (eg, medical schools, journals), and non-profits (eg, advocacy organisations).

A panel of experts was enlisted to validate the team’s findings and aid in mapping the complex relationships. The resulting network map demonstrated that industry players have permeated the healthcare ecosystem, both directly and indirectly, maintaining some level of influence across the following activities:

• research
• clinical care
• health professional education
• guideline development
• formulary selection.

Industry involvement was highest in research (disclosed in 56% of the publications) and lowest in formulary selection (1%).

Industry involvement was highest in research (disclosed in 56% of the publications) and lowest in formulary selection (1%).

Finally, the team assessed whether these conflicts of interest were regulated or documented systematically. While financial ties were sometimes subject to national and/or international oversight (such as the US government’s Open Payments website), non-financial ties were notably less transparent. For instance, the authors found no evidence of oversight for relationships between the industry and public officials, regulators, public health agencies, payers, or purchasing and distribution agents.

These complex, often undisclosed relationships trickle down to affect patient care. The article supplement offers a poignant example of how industry funding and non-financial pressure contributed to the opioid epidemic, which has to date resulted in hundreds of thousands of deaths.

“Medical product industry influence could undermine healthcare equity and sustainability by driving up costs for individual patients and the healthcare system overall”.

The authors cautioned that there are likely many more examples of harm caused by this kind of industry influence, and that without greater regulation, reduced healthcare equity and affordability are to be expected.

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To enable insights into the editorial composition of journals and the potential biases influencing editorial decisions, Andreas Pacher, Tamara Heck, and Kerstin Schoch have created Open Editors, a dataset containing public information on nearly half a million journal editors across 6,833 journals run by 22 academic publishers. For each editor or editorial board member, the following data—or ‘editormetrics’—are collected:

• name
• institutional affiliation
• editorial position
• journal name
• ISSN
• publisher
• URL linking to the journal’s editorial board information
• date of data collection (‘web-scraping’).

The initiative, first outlined in a SocArXiv preprint article in March 2021, has received support from researchers, who believe that it will improve transparency around decision-making in scientific publishing. For instance, it could shed light on gender bias among editorial boards, encouraging publishers to improve equity within these groups. The database could also make it easier to verify key facts such as the editors’ authentic affiliation with the journal, to help identify predatory journals. Aligned with industry efforts toward greater open science, Open Editors is freely available and will be updated annually through at least 2023.

The authors note that “editormetric analyses aim to detect biases and inequalities that are sustained by editorial power within the scientific publication system”.

Pacher and colleagues suggest that the editormetrics they have collected would be even more valuable, and inform on more aspects of diversity, when linked with other datasets. We look forward to seeing how researchers use Open Editors and how these analyses help to improve equity in scientific publishing.

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Last week, the Center for Biomedical Research Transparency (CBMRT) hosted the first of three webinars forming this year’s virtual Biomedical Transparency Summit series. The webinar, entitled ‘Research integrity – developments across the Atlantic’, was opened by the CBMRT’s CEO Sandra Petty (recently interviewed by The Publication Plan) and speakers included Professor Ana Marušić (Standard Operating Procedures for Research Integrity [SOPs4RI]) and Dr Michael Lauer (National Institutes of Health [NIH]).

Professor Marušić spoke about the importance of research ethics and integrity, which together contribute to ‘responsible research’. She also shared the ongoing efforts to develop the SOPs4RI toolbox, funded by the European Commission, which aims to assist research-performing and funding organisations to promote research integrity. SOPs4RI have found that few data exist about how institutions can effectively improve research culture, but have also identified many potential actions that can be taken.

While highlighting diverse examples of research misconduct, Dr Lauer discussed the different stakeholders responsible for ensuring research integrity and discouraging misconduct, emphasising that everyone plays a role. He noted that the NIH have previously clarified that institutions receiving funding are responsible for ensuring that their employees (and final funding recipients) adhere to research best practices, such as disclosing conflicts of interest and preventing issues like falsification of data and plagiarism.

Further topics of discussion included:

• how collegiality impacts research integrity
• the role of authors and peer reviewers in spotting research misconduct
• whistleblower protections in research.

The webinar concluded with a panel discussion moderated by Dr Devon Crawford (National Institute of Neurological Disorders and Stroke) and Dr David Tovey (Journal of Clinical Epidemiology).

You can catch up on the webinar in full by viewing the recording or the slides. You can also read our summaries of the second and third webinars in the series.

Note: There is a poll embedded within this post, please visit the site to participate in this post's poll.

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Summary by Kristian Clausen MPH from Aspire Scientific

While pharmaceutical companies fund around half of all biomedical research, few mandate open access to the study results. In a recent viewpoint article published in European Science Editing, members of the Medical Publishing Insights and Practices (MPIP) initiative Steering Committee share their perspectives on the potential benefits, and challenges, of publishing industry-sponsored research open access.

The authors highlight several benefits of publishing medical research open access, including:

• facilitating engagement of a wider community, strengthening public interest and awareness of current advances in science
• enabling healthcare professionals to keep up to date with advances that inform patient care and to access articles for use in teaching or policy papers to help advocate for their patients
• reducing duplication of existing research, which accelerates the progress of science
• improving the perception of transparency and increasing the credibility of the research.

The authors note that, alongside the main article, supplementary materials should be published open access to maximise benefits for the reader.

Open access publishing models and licenses vary widely in how quickly research can be disseminated. Publishing via the gold open access route with a CC-BY Creative Commons license offers both free and immediate access to the article and allow the research to be shared and reused. However, publishing routes may be restricted depending on the funding source: most medical journals with a high impact factor (>15) do not currently permit pharmaceutical companies to publish under a CC-BY license.

The authors note that such restrictions have hampered the credibility of, and trust in, industry-sponsored research.

MPIP, a collaboration between industry members and the International Society for Medical Publication Professionals (ISMPP), aims to tackle such issues, including through the ‘Transparency Matters’ initiative that highlights the importance of transparency in reporting industry-sponsored research.

Encouragingly, there are promising signs of progress. Although few pharmaceutical companies mandate full open access to their data, others are introducing open access policies that aim to improve the discoverability and accessibility of their research. Furthermore, when medical journal editors were surveyed about the reporting of industry-sponsored clinical trials, 63.5% and 53.2% believed that transparency and credibility, respectively, had improved in 2015 compared with 2010 (correspondingly, only 6.1% and 10.4% of respondents felt that these had worsened).

Disclosing study sponsors, mandatory trial registration and posting study results on ClinicalTrials.gov were all highlighted as factors increasing perceived transparency, while making trial data publicly available improved transparency and credibility.

In closing, the authors emphasise the critical importance of transparency in gaining and retaining public trust in the integrity of research, regardless of the funding source.

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Summary by Beatrice Tyrrell DPhil from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd

The peer review process is essential for maintaining scientific integrity but can take up to six months or longer to complete. Preprints – manuscripts that have not undergone peer review – have gained support in recent times as they can expedite research findings into the public domain. During the current coronavirus pandemic in particular, the use of preprints has increased dramatically in response to the need for rapid data sharing in the global effort to contain the spread of the virus. A recent editorial in The BMJ by Dr van Schalkwyk and colleagues discusses the implications of this increase and whether the potential benefits of preprints outweigh the risks.

The main concerns regarding the use of preprints relate to matters of credibility and misinformation, whether intentional or otherwise. The authors highlight a recent example where two preprints proposing a protective link between smoking and COVID-19 were picked up by the media and widely disseminated. Questions were later raised about the study methods and potential author links to the tobacco industry. The preprints were published on Qeios, which does not warn readers that content is not peer reviewed (unlike other platforms, such as medRxiv) and, until recently, did not require authors to declare potential conflicts of interest.

The authors suggest that preprint platforms require standards in order to maintain scientific integrity and minimise the potential misuse of the preprint publishing process by those with vested interests.

At a minimum, they suggest that declarations of competing interests and funding sources should be made mandatory and transparent policies should be implemented for dealing with industry-funded research. The authors conclude that the use of evolving methods of publication, such as preprints, requires caution. Further scrutiny is needed to ensure that timely access to evidence is not undermined by potential harms resulting from the release and dissemination of unreliable data.

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Summary by Alice Wareham PhD, CMPP from Aspire Scientific

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With thanks to our sponsor, Aspire Scientific Ltd

Posted by MPIP on 30 April 2020.