New paper – Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative

March 18, 2020 ~ BS

I report often on this blog about new papers that I have co-authored. Every time I highlight something that is special about that particular publication. This time I want to highlight a paper that I co-authored, but also didn’t. Let me explain.

https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3000576#sec014

The paper, with the title, Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative, was published in PLOS Biology and describes the QUEST center. The author list mentions three individual QUEST researchers, but it also has this interesting “on behalf of the QUEST group” author reference. What does that actually mean?

Since I have reshuffled my research, I am officially part of the QUEST team, and therefore I am part of that group. I gave some input on the paper, like many of my colleagues, but nowhere near enough to justify full authorship. That would, after all, require the following 4(!) elements, according to the ICMJE,

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
Drafting the work or revising it critically for important intellectual content; AND
Final approval of the version to be published; AND
Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

This is what the ICMJE says about large author groups: “Some large multi-author groups designate authorship by a group name, with or without the names of individuals. When submitting a manuscript authored by a group, the corresponding author should specify the group name if one exists, and clearly identify the group members who can take credit and responsibility for the work as authors. The byline of the article identifies who is directly responsible for the manuscript, and MEDLINE lists as authors whichever names appear on the byline. If the byline includes a group name, MEDLINE will list the names of individual group members who are authors or who are collaborators, sometimes called non-author contributors, if there is a note associated with the byline clearly stating that the individual names are elsewhere in the paper and whether those names are authors or collaborators.”

I think that this format should be used more, but that will only happen if people take the collaborator status seriously as well. Other “contribution solutions” can help to give some insight into what it means to be a collaborator, such as a detailed description like in movie credits or a standardized contribution table. We have to start appreciating all forms of contributions.

REWARD | EQUATOR Conference 2020 in Berlin

June 26, 2019June 21, 2019 ~ BS

https://www.reward-equator-conference-2020.com

Almost 5 years ago something interesting happened in Edinburgh. REWARD and EQUATOR teamed up and organized a joint conference on “Increasing value and reducing waste in biomedical research “. Over the last five years, that topic has dominated Meta-research and research improvement activities all over the world. Now 5 years later, it is again time for another REWARD and EQUATOR conference, this time in Berlin. And I have the honor to serve on the local organizing committee.

My role is so small, that the LOC is currently not even mentioned on the website. But the website does show some other names, promising a great event! it starts with the theme. which is “Challenges and opportunities for Improvement for Ethics Committees and Regulators, Publishers, Institutions and Researchers, Funders – and Methods for measuring and testing Interventions”. That is not a sexy title like 5 years ago, but it shows that the field has outgrown the alarmistic phase and is now looking for real and lasting changes for the better – a move I can only encourage. See you in Berlin?

Results dissemination from clinical trials conducted at German university medical centers was delayed and incomplete.

June 25, 2019June 21, 2019 ~ BS

My interests are broader than stroke, as you can see my tweets as well as my publications. I am interested in how the medical scientific enterprise works – and more importantly how it can be improved. The latest paper looks at both.

The paper, with the relatively boring title “Results dissemination from clinical trials conducted at German university medical centres was delayed and incomplete.” is a collaboration with QUEST, and carried by DS and his team. The short form of the title might just as well have been “RCT don’t get published, and even if they do it is often too late.”

Now, this is not a new finding, in the sense that older publications also showed high rates of non-publishing. Newer activities in this field, such as the trial trackers for the FDAA and the EU, confirm this idea. The cool thing about these newer trackers is that they rely on continuous data collection through bots that crawl all over the interwebs to look for new trials. This upside thas a couple of downsides though: with constant being updated, these trackers do not work that well as a benchmarking tool. Second, they might miss some obscure type of publication which might lead to underreporting of reporting. Third, to keep the trackers simple they tend to only use one definition as what counts as “timely publication” even though the field, nor the guidelines, are conclusive.

So our project is something different. To get a good benchmark, we looked at whether trials executed by/at German University medical centers were published in a timely fashion. We collected the data automatically as far as we could, but also did a complete double check by hand to ensure we didn’t skip publications (hint, we did, hand search is important, potentially because of the language thing). Then we put all the data in a database, made a shiny app so that readers themselves can decide what definitions and subsets they are interested in. The bottomline, on average only ~50% of trials get published within two years after their formal end. That is too little and too slow.

This is a cool publication because it provides a solid benchmark that truly captures the current state. Now, it is up to us, and the community to improve our reporting. We should track progress in the upcoming years by automated trackers, and in 5 years or so do the whole manual tracking once more. But that is not the only reason why it was so inspiring to work on the projects; it was the diverse team of researchers from many different groups that made the work fun to do. The discussions we had on the right methodology were complex and even led to an ancillary paper by DS and his group. But the way this publication was published in the most open way possible (open data, preprint, etc) was also a good experience.

The paper is here on Pubmed, the project page on OSF can be found here and the preprint is on bioRxiv, and let us not forget the shiny app where you can check out the results yourself. Kudos go out to DS and SW who really took the lead in this project.