KEY TAKEAWAY

• Data sharing is an essential component of open science. The EQUATOR executive are calling for its inclusion in reporting guidelines.

Mandatory data sharing has been gaining pace in recent years, with data underlying US federally funded research soon needing to be made available immediately on publication. Since its inception in 2006, the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, best known for hosting an online library of research reporting guidelines, has been an important advocate for improving the quality and transparency of medical research reporting. Now, in a recent article for The BMJ, the EQUATOR executive group explain how data sharing could be made standard practice as the next goal for open science.

Are current reporting guidelines sufficient?

The authors describe data sharing as a broad concept, from study registration to protocol availability, then data availability. While many stakeholders have emphasised trial registration and transparency, the requirement to discuss data sharing is missing from most reporting guidelines. A notable exception is a 2020 addition to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklist.

“While many stakeholders have emphasised trial registration and transparency, the requirement to discuss data sharing is missing from most reporting guidelines.”

The EQUATOR executive encourage new or updated reporting guidelines to cover data sharing, to ensure authors:

• describe data sharing in protocol and results publications
• are encouraged to share data
• report on items linked to data sharing, like sharing of code and protocols.

What can authors do now?

While awaiting formal guidance on reporting data sharing, the EQUATOR executive suggest authors include the following in publications:

• data definition, collection, and management methods
• manuals or videos used in delivering the intervention
• the statistical analysis plan, including any coding
• any barriers to sharing data and other materials from the study.

The EQUATOR executive also encourage authors to adopt the findable, accessible, interoperable, and reusable (FAIR) and collective benefit, authority to control, responsibility, and ethics (CARE) principles when sharing data.

What’s next?

Beyond reporting guidelines, the authors signpost journal policies, funder expectations, and research assessment criteria as avenues to drive increased data sharing. They also point to data management and sharing plans, and suggest an opportunity for the EQUATOR Network to provide guidance on reporting these in a standardised way to further boost data sharing.

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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

• A partnership between the EQUATOR Network and the Centre for Open Science (COS) could further the objectives of both organisations and raise awareness of best practices for open science.
• Anticipated activities include educational outreach for researchers and updated reporting guidelines.

The open science movement aims to improve the transparency, accessibility, and reproducibility of scientific research. In May this year, the EQUATOR Network and Center for Open Science (COS) announced a 3-year collaboration in the hopes of accelerating the uptake of open science practices in health research through a series of shared activities.

A shared mission

Since launching the open science framework in 2012 – a project management tool designed to streamline collaboration on, and dissemination of, scientific research – COS have been on a mission to facilitate and incentivise open research practices. This approach is highly complementary to EQUATOR’s objective to improve research quality and transparency, leading the organisations to collaborate on development of the Transparency and Openness Promotion Guidelines in 2015.

Nearly a decade later, the two are joining forces officially.

What can we expect?

Planning is ongoing, but several potential strategies are being explored:

• Educating researchers on processes such as writing and protocol creation, through a combination of outreach materials and toolkits
• Developing toolkits to guide reviewers in assessing data sharing practices and protocol deviation
• Increasing the visibility and use of existing tools, such as COS registration templates and EQUATOR reporting guidelines, through shared hosting
• Integrating practices such as protocol posting, data sharing, and study replication into existing EQUATOR reporting guidelines, where these are not yet included.

In particular, COS is keen to utilise EQUATOR’s existing systems to enhance research credibility by promoting the uptake of preregistration.

The potential impact

Open science practices are already included in CONSORT, but inclusion in further reporting guidelines could scale-up adoption substantially. In addition, the robustness of EQUATOR’s reporting standards could offer further structure and visibility to COS’ ongoing research.

Director of the EQUATOR Network, David Moher, has expressed his excitement around the partnership:

“Since its inception in 2006, the EQUATOR Network has worked hard to help improve comprehensive and transparent reporting of research. Collaborating with COS will help further achieve this objective.”

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KEY TAKEAWAYS

• The LATITUDES Network provides a much-needed resource for identifying and accessing reliable validity assessment tools, for use during evidence synthesis.
• LATITUDES is a parallel resource to the EQUATOR Network, with both acting to disseminate best practice in health research.

The LATITUDES Network was launched in late 2023 as a parallel resource to the EQUATOR Network. LATITUDES provides key validity assessment tools as part of a drive to “disseminate best methods and practice” for health research studies.

Why LATITUDES?

Although the EQUATOR Network has been instrumental in promoting transparent and accurate reporting guidelines, an equivalent resource for accessing appropriate, validated, and reliable critical appraisal tools has been lacking to date. These tools, also known as validity assessment tools, assess study quality in terms of:

• risk of bias or systematic error
• applicability of findings to real-world settings
• reporting quality.

How will LATITUDES help?

The LATITUDES Library lists tools that meet 4 specified inclusion criteria, such as being applicable to the wider research community, and assessing multidimensional aspects of validity within a study. Those which fulfil an additional 4 criteria are designated LATITUDES key tools. These tools:

• focus on risk of bias
• are developed by multidisciplinary teams
• avoid use of summary numerical quality scores
• incorporate domain specific or overall assessment of risk of bias.

The LATITUDES Network believes the library will benefit “anyone needing to assess the validity of their evidence base as part of an evidence synthesis”.

The library will benefit “anyone needing to assess the validity of their evidence base as part of an evidence synthesis”.

How to get started?

The LATITUDES Network provides a range of resources that can help researchers get to grips with validity tools — including guidance on which tool to use and training resources — or enable them to register a tool for inclusion.

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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

• The SPIRIT-Outcomes 2022 Extension addresses the need for better guidance in describing outcomes in clinical trial protocols.
• The new extension should be used in conjunction with the original SPIRIT 2013 Statement to improve transparency and integrity of clinical trial reporting.

The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-Outcomes 2022 Extension aims to provide harmonised, evidence- and consensus-based outcome reporting standards for clinical trial protocols. An addition to the existing suite of extensions supporting the original SPIRIT 2013 Statement, the latest extension was recently published in JAMA by Dr Nancy Butcher and colleagues.

The SPIRIT-Outcomes 2022 Extension recommends nine items that should be included in trial protocols, regardless of trial design and population, to define and justify the chosen primary, secondary and other outcomes of the trial. The nine items cover:

• defining and justifying the chosen study outcomes, including the timing of their measurement and what constitutes a minimal important difference for use in sample size calculations
• describing who will assess the outcome, and the responsiveness of the chosen outcome assessment tools in the target population
• describing any statistical methods to account for multiplicity in the analysis or interpretation of the primary and secondary outcomes.

Developed using the EQUATOR methodology for developing reporting guidelines, the authors highlight that these nine checklist items define the minimally required outcome-specific information that should be included in a trial protocol in addition to the items included in the SPIRIT 2013 Statement. The SPIRIT-Outcomes 2022 Extension was developed in parallel with the associated CONSORT-Outcomes 2022 Extension and the authors noted how the two should be used together to maximise their utility in improving the transparency of clinical trial reporting and addressing selective nonreporting of trial results.

The SPIRIT-Outcomes 2022 Extension should be used in conjunction with the CONSORT-Outcomes 2022 Extension to improve the transparency of clinical trial reporting and address selective nonreporting of trial results.

An important aspect in the development of both extensions was representation from patient and public partners on the expert panels. The authors call for such patient and public partnerships when developing future guidelines to bring in a broader range of perspectives, which will ultimately benefit patient-centricity.

The SPIRIT-Outcomes 2022 Extension guidelines are hoped to be particularly useful to trial protocol authors, ethics review boards and journal editors. The authors urge the use of these guidelines for transparency and integrity in trial reporting, and welcome feedback from users of the extension to inform future updates.

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KEY TAKEAWAYS

• Researchers from the Chinese and Canadian EQUATOR centres found insufficient reporting and data sharing from COVID-19 vaccine trials.
• The researchers recommended real-time data sharing, and reporting guidelines for vaccine trials are due to be published later this year.

Open science continues to pick up steam, with transparency and data availability becoming a priority for both scientists and publishers. As we recently reported, World Health Organization (WHO), the National Institutes of Health (NIH), and Public Library of Science (PLOS) all now require data sharing. The EQUATOR network is also now looking at how to improve both reporting and data sharing for vaccine trials.

In a recent study, researchers from the Chinese and Canadian EQUATOR Centres evaluated levels of reporting and data sharing in 36 articles on randomised controlled COVID-19 vaccine trials. In each case, they assessed the reporting of CONSORT checklist items and compliance with practices that support and facilitate open science. The researchers found insufficient reporting of several checklist items, highlighting that 75% of the articles “had selective reporting, lacked primary outcome clarity, or failed to report harms”.

75% of the articles [reporting on COVID-19 vaccine trials] “had selective reporting, lacked primary outcome clarity, or failed to report harms”.

Strikingly, while most articles contained data sharing statements, only 25/36 provided access to individual patient data. Restrictions and limitations relating to data sharing varied markedly and were not always clear. None of the articles provided a direct link to datasets.

The researchers concluded that reporting and data sharing remain suboptimal and recommend establishing a real-time data sharing system for COVID-19 vaccine trials. The Chinese EQUATOR centre is now developing the VAccine cLinical research reporting gUidEline (VALUE) reporting guidelines, which aim to enhance the quality of reporting in vaccine clinical trials. We look forward to seeing the guidelines, which are due to be published later this year.

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KEY TAKEAWAYS

• Authors may soon be able to use the GoodReports.org website to generate a manuscript template incorporating the recommended reportable items from the most appropriate set of EQUATOR reporting guidelines.
• The GRReaT trial will evaluate whether the templates improve research reporting compared to the use of reporting checklists alone.

The GoodReports.org website, which helps researchers choose the most appropriate reporting guidelines for their study, may soon be able to provide authors with an editable article template to help implement good reporting practices earlier on in the manuscript writing process. The GoodReports Randomized Trial (GRReaT) is looking for authors to help test if the article templates result in more completely reported articles than simply signposting authors to a checklist of reportable items.

It is estimated that only 20% of medical research contributes to the advancement of knowledge, with poor reporting a recognised factor in this alarming statistic.

A recent BMC Series blog by EQUATOR (Enhancing the Quality and Transparency of Health Research) Network team member Caroline Struthers described how a series of Lancet articles on the topic of research waste inspired the initial development of the EQUATOR-headed GoodReports.org website. Since its launch in 2018, user feedback showed that authors thought they would receive greater benefit from the tool if guidance was given earlier in the writing process and in a more implementable, non-checklist format, prompting the evaluation of editable manuscript templates.

The Medical Research Council-funded GRReaT trial is looking for medical researchers working on the following types of health-related studies to contribute:

• cohort studies
• case-control studies
• cross-sectional studies
• observational studies in nutrition or dietetics
• systematic reviews (of healthcare interventions)
• randomised trials of pharmaceuticals, medical devices, procedures, or social or psychological interventions.

The results of the GRReaT trial will provide an important insight into how comprehensive reporting in medical research can be better supported. In exchange for their contributions, trial participants will receive a manuscript ‘completeness’ report from experts at the UK EQUATOR centre with tips on how to improve their manuscript prior to peer review.

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KEY TAKEAWAYS

• Mendelian randomisation studies are increasingly used to analyse the causal effects of exposures and outcomes in diseases, but are often inadequately reported.
• The STROBE-MR reporting checklist has been developed to improve the reporting of Mendelian randomisation studies.

Mendelian randomisation (MR) is a popular method in epidemiology that uses genetic variation as a proxy for environmental exposures to understand the cause of diseases. Despite the increasing use and relevance of the technique, there is a lack of consensus on how to report MR studies. To address this need, a new STROBE guideline, Strengthening the Reporting of Observational Studies in Epidemiology using Mendelian Randomisation (STROBE-MR), has been published in the Journal of the American Medical Association (JAMA), with the explanation and elaboration paper published in The BMJ.

Associations between exposures and health outcomes reported in observational epidemiology studies are not always reliable due to confounding, or other forms of bias. Advances in technology have enabled identification of associations between genetic variations and exposures, traits, and health outcomes. MR uses these genetic variations as instrumental variables to analyse the effects of exposures on diseases. MR studies can therefore help understand the influence of exposure on various health, social and economic outcomes. As genetic variation is randomly inherited and cannot be affected by certain confounding factors, bias associated with other epidemiological study designs can be avoided using MR.

Mendelian randomisation studies provide an opportunity to study the causal association between an exposure and an outcome while reducing the risk of certain biases associated with traditional observational study designs.

Items in the existing STROBE checklist were either too general or did not apply to MR studies, while items specific to MR studies were missing. To help improve reporting on MR studies, a separate checklist was developed based on the STROBE guidelines, with 20 items covering specific recommendations for publications reporting MR studies. The checklist is also available on the EQUATOR Network website.

It is hoped that adoption of the STROBE-MR checklist by authors, reviewers and journal editors will improve the quality of MR study reports and enable consistent and transparent communication in this field.

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The 9^th European Medical Writers Association (EMWA) symposium, entitled ‘Clinical Trials – New Trends’ took place on 6 May. The symposium explored the latest trends in the design, conduct and reporting of clinical trials over 3 sessions, focusing on insights relevant to medical writers and communicators.

A summary of session 1 of the symposium is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.

You can also read our summaries of session 2 and session 3.

Session 1: general overview

Session 1, chaired by Beatrix Doerr (Coriuvar Consulting), set out to provide an overview of new trends in clinical trials.

A medical writer’s guide to scientific evidence types: it’s child’s play!

Simon Page (Ipsen) opened the session with a guide to the different types of studies and their position in the ‘hierarchy of evidence’. Reviewing the characteristics of outputs from systematic reviews/meta-analyses, randomised controlled trials (RCTs), observational studies, case reports and basic research, Page highlighted how evidence gained from each type of study provides complementary insights. While systematic reviews and meta-analyses top the hierarchy by providing the highest quality of evidence, they rely on the studies lower in the hierarchy to contribute evidence to amalgamate. RCTs definitively test efficacy under closely controlled conditions, but observational studies can provide insights on effectiveness in real world settings. When it comes to reporting study results, Page highlighted the guidelines to be followed for each study type, which can all be found on the EQUATOR Network website.

New trends in medical device trials: from basket to umbrella – implementing learnings from pharma trials

Autumn Lang (confinis CPM) then considered developments related to trials of medical devices, focusing on study design strategy, risk assessment and cross-communication. ‘Basket’ and ‘umbrella’ study designs are among the innovations being used in the assessment of medical devices, drawing on experience in fields such as oncology. A ‘basket’ design allows the same device to be tested in multiple groups of patients with different diseases, while in an ‘umbrella’ study, multiple devices are tested in a single patient population. Adaptive approaches are also being used, where the study design can be modified based on interim results. Lang also noted the growing drive for medical device studies to provide evidence not only of technical performance (for example, sensitivity, specificity and precision of a diagnostic device) but also of clinical utility and the extent to which health outcomes are improved.

Lang also noted the growing drive for medical device studies to provide evidence not only of technical performance…but also of clinical utility and the extent to which health outcomes are improved.

Risk assessments are an important consideration when trialling medical devices, although, currently, no clear guidelines exist. Lang rounded off her presentation by highlighting the valuable role medical writing professionals can play in communicating the results of clinical evaluations of medical devices, specifically with reviewing and evaluating the clinical literature to allow comparison with competitor devices.

New trends in in vitro diagnostic trials: case example COVID-19 tests

Turning to trials of in vitro diagnostics, Holger Kloess (QUNIQUE) took the evaluation of COVID-19 antigen tests as a case study. While these tests gained registration based on evaluations conducted by individuals with expertise in processing the tests, and were originally developed for use by nurses and other healthcare professionals, they are now being handed out for use by the general public. This raises questions around the extent to which the performance demonstrated in registration studies is reproducible when testing is carried out by untrained individuals. It also highlights the need for real world evidence on top of that from highly controlled studies.

Kloess then considered the evolving regulatory landscape in in vitro diagnostics. Diagnostic assays are increasingly incorporated into devices, many linked to mobile phone apps – these and the associated control software all require assessment. While 9% of in vitro diagnostics are currently registered as devices, this is expected to rise dramatically. These devices will need to be assessed according to the recently updated ISO 14155 guidelines, which require application of Good Clinical Practice in device trials, robust trial designs, pre-defined risk tolerance limits and clinical safety thresholds, and full quality control.

New trends in veterinary medicine trials

In the penultimate talk of the session, Rachel Dean (VetPartners) reviewed developments in animal medicine and the particular challenges of running, reporting, and researching veterinary clinical trials. While the methodological basis of an RCT is the same regardless of whether it is conducted in humans or animals, veterinary trials have the added complication of covering a wide range of species and settings, ranging from pets in the home to animals in the wild. At the same time, many of the challenges in veterinary trials are seen across species, and include:

• studies not addressing the right questions
• poor design and execution of studies
• studies not being reported, or being reported poorly
• lack of access to, or awareness of, studies.

The majority (~70%) of veterinary trials are currently run by the pharmaceutical industry for licensing purposes…end users are rarely consulted, or their needs addressed.

Dean highlighted that the majority (~70%) of veterinary trials are currently run by the pharmaceutical industry for licensing purposes, and that end users are rarely consulted, or their needs addressed. Trials are often too small and lack clearly defined, appropriate outcomes. There is no registry for veterinary trials and negative studies are often not published, leading to a positive bias in available results. When studies are published, they often sit behind journal paywalls and, with the exception of CAB Abstracts, most bibliographic databases cover only around half of the journals relevant to veterinary medicine.

There is no registry for veterinary trials and negative studies are often not published, leading to a positive bias in available results.

Looking to the future, Dean hopes that trials will be more reflective of the real world and the needs of end users rather than those of the pharmaceutical industry and academia. Trial designs should be bolder, bigger and simpler, with trials carried out in real life settings. Greater use should be made of electronic patient records and all veterinary trials should be registered, although progress on this objective has been limited to date. Greater involvement of professional medical writers was discussed as making a positive contribution to the quality of reporting of veterinary studies.

Patient perspective on new trends in clinical trials: think about patient value, not provider value!

The take-home message from the last presentation in the session by Jan Geissler (Patvocates) was that studies need to focus on the value for patients, not providers. Developments in digital technology are opening up a range of opportunities to design studies that are more aligned with the needs of patients than researchers.

Developments in digital technology are opening up a range of opportunities to design studies that are more aligned with the needs of patients than researchers.

 It is increasingly feasible to move care and research to where the patient is, rather than requiring the patient to travel to the research centre. Remote monitoring and mobile apps can provide greater support, faster access to test results and improved safety. At the same time, it is important to consider the downsides. The shift to remote interactions runs the risk of leaving individuals isolated: people can be left cut off from care if they fall on the wrong side of the digital and educational divide. Finally, there are complex ethical issues on privacy and data ownership that need to be addressed.

When designing studies for the digital, decentralised era, it is essential to engage patients as co-designers of trials. Geissler considered that, at present, patients are often engaged as ‘beta testers’ rather than designers, with studies being developed in their interests but without their input. Studies need to reflect the fact that not all patients are the same, and the assessment of risks and benefits needs to account for variations in patient characteristics and preferences. Medical writers have an important role to play in reporting trial results in ways that are meaningful and relevant to patients.

When designing studies for the digital, decentralised era, it is essential to engage patients as co-designers of trials.

The additional costs involved in engaging patients early in the study design process were raised, and discussions noted that it was important to consider the cost impact across the study lifecycle. Investing in patient engagement has the potential to enhance the design of studies and improve patient retention, thus saving costs down the line, as well as aligning with the principle of ‘No research about us without us’.

Why not also read our summaries of sessions 2 and 3 of the symposium?

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Written as part of a Media Partnership between EMWA and The Publication Plan.

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