Medical Communication News provides an executive summary of noteworthy articles exploring recent news, research, and trends in the field of medical communication. Read past issues in the online archive.

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INDUSTRY NEWS

AMWA-EMWA-ISMPP Joint Position Statement on Medical Publications, Preprints, and Peer Review

New recommendations from the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) aim to protect the integrity of published medical and scientific research. Particularly during a health emergency such as the COVID-19 pandemic, there is added pressure to publish credible medical information as quickly as possible, but pre-publication review is still important. The joint statement was "developed to provide practical and implementable suggestions to uphold data integrity and quality, and the transparency of medical publications," the groups write. The recommendations discuss preprints, post-publication peer review, and traditional peer review, along with possible issues and suggested solutions for each format. For all submissions, the authors note the importance of quality control, including using existing publication standards and available checklists as well as providing training in peer review for authors, peer reviewers, and editors. The role of professional medical writers is also highlighted, as evidence suggests their use can improve publication quality and speed. When medical writers are involved, they should be involved in the process early and provided access to the clinical study report, source data, and related documents. Professional medical writers should also contribute to ensuring the high quality of the publications and could be included in pre-publication vetting as well. "To maintain confidence in published science, each involved party (including the reader) must take responsibility for exercising their best judgment and selecting information from sources with good publishing practices that are rigorous and transparent," the authors conclude.

UC Secures Landmark Open Access Deal With World's Largest Scientific Publisher

Two years after cutting ties with the publisher, the University of California (UC) recently announced an open-access agreement with Elsevier, the world's largest scientific publisher. Under the four-year agreement — the largest of its kind in North America thus far — open access will be the default option for all research with a UC lead author published in Elsevier's portfolio of hybrid and open access journals. This is the first such deal that includes the Cell Press and Lancet families of journals. Additionally, UC researchers will have access to articles published in Elsevier journals. "Our agreement with UC delivers a real win for the world-class researchers across the UC system, supporting them to publish open access in Elsevier journals and access high-quality, trusted research by others," said Kumsal Bayazit, chief executive officer of Elsevier. "Both sides showed flexibility to reach a truly tailored approach, based on the needs of the research-intensive UC community, so we can test and learn from author choices and enable a sustainable transition to universal open access to UC research." The University of California, which produces almost a tenth of all U.S. research output, had ended its subscriptions with Elsevier in 2019, after negotiations for open access broke down.

Preferred Reporting Items for Journal and Conference Abstracts of Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy Studies (PRISMA-DTA for Abstracts): Checklist, Explanation, and Elaboration

Readers of biomedical systematic reviews and meta-analyses often get all of their information from the journal and conference abstracts of those articles. However, considering evidence suggesting details on study design, objectives, and primary findings are often incomplete or not informative enough in this section, reporting of journal and conference abstracts has much room for improvement. "Abstracts are not a replacement for full text articles in informing clinical practice, policy decisions, or other research," the developers acknowledge. "However, they must present an accurate and trustworthy account of the research conducted and reported." Abstracts describing diagnostic test accuracy studies are no exception, prompting developers across the United States, Canada, and Europe to build on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Diagnostic Test Accuracy studies (PRISMA-DTA) and PRISM for Abstracts international guidelines. The subsequent PRISMA-DTA for Abstracts checklist includes 12 essential items to be included in journal and conference abstracts, but recent research indicates only about half of the items were consistently reported. Developers responded with a companion document providing examples and explanations for each item. The PRISMA-DTA for Abstracts material is available at no cost on the EQUATOR and PRISMA websites.

The Fight Against Fake-Paper Factories That Churn Out Sham Science

An analysis by Nature reveals journals have retracted since January 2020 no less than 370 papers traced back to paper mills: third-party sellers of phony scientific manuscripts, many with suspiciously similar titles and other elements. The publishing community is pushing back against the practice, in part by openly acknowledging an embarrassing issue often swept under the rug. The London-based Committee on Publication Ethics (COPE) dedicated a forum to the topic in September. Meanwhile, after retracting dozens of papers this year from RSC Advances, Royal Society of Chemistry—which is also based in London—went public with claims of having fallen victim to "the systemic production of falsified research." The openness of the admission was notable, says Elisabeth Bik, a research-integrity analyst who along with other image detectives exposed more than 1,300 articles as of March 2021 as potentially being sourced from paper mills. By Nature's estimate, more than a quarter of them have been retracted or flagged for concerns, with many others still under scrutiny. Bik and other speakers at the COPE forum estimate there are thousands to tens of thousands of additional fake manuscripts still in the literature. Faced with the growing possibility they could be duped, some journals have revised their editorial-review processes to hopefully prevent future fraud. Others are recruiting analysts to detect manipulated images and other problems as submissions trickle in, and some publishers are working with researchers on software solutions. Meanwhile, COPE plans to offer updated guidance on how periodicals should handle manipulation of the publication process.

Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals

The past couple of years have seen a rapid proliferation in preprint studies, which are not yet peer-reviewed. While not all preprints will ultimately make their way to journal pages, a recent study probed how much and in what ways the reporting differs when they do. Researchers identified 47 clinical studies posted to the medRxiv preprint server since June 11, 2019, that eventually also appeared in high-impact journals. Comparisons revealed all but one of the preprint-journal pairs reported the same first and senior authors, and more than three-quarters had the same total number of authors. Additionally, most of the pairs had concordant funding statements, institutional review board disclosures, reported sample sizes, and primary outcomes. "Although preprints are preliminary reports that should be critically assessed, similar to prior studies of text content," the study authors wrote, "our findings suggest that the overarching study interpretations, as well as other study design details described in preprints of clinical studies that are subsequently published in high-impact journals, did not change markedly." However, they added, the results did not indicate whether changes that were observed improved the accuracy of research reporting.

Data Sharing Goals for Nonprofit Funders of Clinical Trials

Nonprofit funding organizations, such as disease advocacy and patient-focused organizations, are in a unique position to advance the agenda for data sharing. Despite their probable influence, they have limited power to enforce policies and contracts with individual investigators and also are challenged by the need to balance investment between data sharing and other research priorities. With this understanding, a set of collaborative solutions is proposed for nonprofits to build into existing funding policies. After discussions in July 2016 and November 2017, 48 participants meeting under the Sharing Clinical Trial Data Action Collaborative ultimately came up with seven data-sharing objectives for nonprofit funders of clinical trials. They include encouraging co-development of such policies with patient and lay communities; incorporating data-sharing concepts and policies as soon as possible in the trial process; developing or adopting transparent approval processes for data access; promoting the development of a sustainable and feasible data-sharing infrastructure; promoting and supporting development and adoption of standards, standard language, and common data elements; including incentives and enforcing requirements in funding structures; and providing funding for data sharing as a line item in grants and contracts. The authors hope the paper and the goals set forth in it will serve as the starting point for development of a toolkit for nonprofit funders that might include guidance, templates, general information, and other helpful resources.

Science Academies of G-7 Nations Call for Action to Reach Net-Zero Emissions, Reverse Declines in Biodiversity, and Improve Data-Sharing to Prepare for Future Health Emergencies

A new statement from the science academies of the G-7 nations urges their governments to take action on data sharing for future health emergencies. The academies believe much can be learned from international responses to the COVID-19 pandemic, and G-7 nations should use this opportunity to develop "a trustworthy and trusted international data system for health emergencies." They suggest the creation of a commission to accomplish this goal, with the first objective identifying data-sharing procedures employed during the pandemic that could be adapted for longer-term use. Additionally, they recommend their governments join forces on principle-based governance systems for securing safe sharing and use of data for health emergencies; establish the necessary operational systems, infrastructures, and technologies for equitable use of data in health emergencies; and promote the skills and capabilities at all levels for trusted use of data. Two other new statements from the science academics address reversing declines in biodiversity and building a net-zero emissions, climate-resilient future. "Our shared future on the planet depends upon international cooperation, collaboration, and initiative on these critical issues," said U.S. National Academy of Sciences President Marcia McNutt. "With science as their guide, G-7 nations can — and should — help lead the way toward a more resilient, sustainable world for us all."

Please join us in congratulating Immediate Past President, Ann Winter-Vann, PhD as a recipient of the Drug Information Association (DIA) Medical Affairs and Scientific Communication (MASC) Forum Excellence in Service Award. Ann has made significant contributions to the field of medical communication including serving as AMWA's 2019-2020 President.

Evaluating information through critical thinking is a necessary skill for all medical communicators. In this on-demand video, learn to define critical thinking and scientific literacy, identify major logical fallacies, and apply critical thinking and scientific literacy skills to medical writing. Free for AMWA members in AMWA Online Learning through the end of April!

News summaries © copyright 2021 SmithBucklin

The American Medical Writers Association (AMWA) is the leading professional organization for writers, editors, and other communicators of medical information. AMWA's mission is to promote excellence in medical communication and to provide educational resources in support of that goal.

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