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

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.

shiny app

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.

Advertisements

BEMC has a Journal Club now

cropped-favicon_bemc1

After a year of successful BEMC talks and seeing the BEMC grow,  it was time for something new. We are starting a new journal club within the BEMC community, purely focussed on methods. The text below describes what we are going to to do, starting in February. (text comes from the BEMC website)

BEMC is trying something new: a journal club. In february, we will start a monthly journal to accompany the BEMC talks as an experiment. The format is subject to change as we will adapt after gaining more experience in what works and what not. For now, we are thinking along the following lines:

Why another journal club?

Aren’t we already drowning in Journal clubs? Perhaps, but not with this kind of journal club. BEMC JClub is focussed on the methods of clinical research. Many epidemiological inclined researchers work at departments who are not focussed on methodology, but rather on a disease or field of medicine. This is reflected in the topics of the different journal clubs around town. We believe there is a need for a methods journal club in Berlin. Our hope for the BEMC JClub is to fulfill that need through interdisciplinary and methodological discussions of the papers that we read.

Who is going to participate?

First of all, please remember that the BEMC community focussed on researchers with a medium to advanced epidemiological knowledge and skill set. This is not only true for our BEMC talks, but also for our JClub.

Next to this, we hope that we will end up with a good group that reflects the BEMC community. This means that we are looking for a group with a nice mix in background and experience. That means that if you think you have unique background and focus in your work, we highly encourage you to join us and make our group as diverse as possible. We strive for this diversity as we do not want the JClub sessions to become echo chambers or teaching sessions, but truly discussions that promote knowledge exchange between methodologist from different fields.

What will we read?

Anything that is relevant for those who attend. The BEMC team will ultimately determine which papers we will read, but we are nice people and listen carefully to the suggestions of regulars. Sometimes we will pick a paper on the same (or related) topic of the BEMC talk of that month.

Even though the BEMC team has the lead in the organisation, the content of the JClub should come from everybody attending. Everybody that attends the Jclub is asked to provide some points, remarks or questions to jumpstart the discussion.

What about students?

Difficult to say. The BEMC JClub is not designed to teach medical students the basics in epidemiology. Then again, everybody who is smart, can keep up and contribute to the discussion is welcome.

Are you a student and in doubt whether the BEMC JClub is for you? Just send us an email.

Where? When?

Details like this can on the BEMC Jclub website. Just click here.

Berlin Epidemiological Methods Colloquium kicks of with SER event

A small group of epi-nerds (JLR, TK and myself) decided to start a colloquium on epidemiological methods. This colloquium series kicks off with a webcast of an event organised by the Society for Epidemiological Research (SER), but in general we will organize meetings focussed on advanced topics in epidemiological methods. Anyone interested is welcome. Regularly meetings will start in February 2017. All meetings will be held in English.
More information on the first event can be found below or via this link:

“Perspective of relative versus absolute effect measures” via SERdigital

Date: Wednesday, November 16th 2016 Time: 6:00pm – 9:00pm
Location: Seminar Room of the Neurology Clinic, first floor (Alte Nervenklinik)
Bonhoefferweg 3, Charite Universitätsmedizin Berlin- Campus Mitte, 10117 Berlin
(Map: https://www.charite.de/service/lageplan/plan/map/ccm_bonhoefferweg_3)

Description:
Join us for a live, interactive viewing party of a debate between two leading epidemiologists, Dr. Charlie Poole and Dr. Donna Spiegelman, about the merits of relative versus absolute effect measures. Which measure of effect should epidemiologists prioritize? This digital event organized by the Society for Epidemiologic Research will also include three live oral presentations selected from submitted abstracts. There will be open discussion with other viewers from across the globe and opportunities to submit questions to the speakers. And since no movie night is complete without popcorn, we will provide that, too! For more information, see: https://epiresearch.org/ser50/serdigital

If you plan to attend, please register (space limited): https://goo.gl/forms/3Q0OsOxufk4rL9Pu1

 

Diane 35 and thrombosis risk – Zembla broadcast

The oral contraceptive pill ‘Diane 35- was’ in the news again. I wrote about the diane-35 pill on this website before, even twice,  when there was a broadcast of the radio show Argos.

The first time I wrote:

[…] this is a bit strange: there is nothing new about the information that third and fourth generation oral contraceptives have an increased risk of thrombosis compared to the risk conveyed by second generation oral contraceptives. Because the desired effects of the older and newer generation pills are similar (not getting pregnant, preventing or curing acne) there is limited, if any, reason to prescribe the newest and more expensive pills. See also the recent comment by Helmerhorst and Rosendaal in the BMJ. However, still 160.000+ (Diane 35) 500.000 (third generation) women take these newer pills. […]

Those words also fit the broadcast of the TV show Zembla last week. Zembla has a reputation to be ‘activist reporters’ and some of the broadcast is not to my taste. It is however good to see that Zembla tried to figure out how it is possible that Diane-35, which is not registered as an anti-conception pill, still gets prescribed as such. However, the broadcast leaves me unsatisfied for it does not provide answers, or even get to talk to everybody they wanted to? (Why did they reporters did not proceed to work on their WOB? a missed change!)

As in the previous two blog posts on this topic, I feel like these story are important but they also need to have the proper amount of nuance. Therefore, also this time I conclude with saying that the absolute risk of thrombosis in young women (both venous and arterial) is very low, even when using oral contraceptives. But all unnecessary risk without any benefit that can be avoided should be avoided. As always, consult your GP if you have any questions.

Diane 35 and thrombosis risk – Argos broadcast part II

Last week I wrote a post after hearing the radio broadcast of Argos. They concluded that broadcast with the promise to discuss how it is possibe that a more expensive, just as effective medicine which has more side effects still can be prescribed (in large numbers) in the Netherlands.

So I’ve listen with great interest the second part of the story, which can be heard on the Argos website. They journalists did a good job by covering all sides of the story , and they provide insight in the differences between ‘advertisement’ and ‘providing information’. What if information that is provided is only one sided? Does that count as advertisement? and if you want to play a nice game during the broadcast, ‘spot the logical fallacy’ is good suggestion… Gems!

In case you are wondering: the absolute risk of thrombosis in young women is low, even when using oral contraceptives. But I still believe that all unnecessary added risk without any benefit that can be avoided should be avoided by you in dialogue with your GP!

Diane 35 and thrombosis risk – Argos broadcast

The oral contraceptive pill – especially the Diane 35- was in the news again. However, this is a bit strange: there is nothing new about the information that third and fourth generation oral contraceptives have an increased risk of thrombosis compared to the risk conveyed by second generation oral contraceptives. Because the desired effects of the older and newer generation pills are similar (not getting pregnant, preventing or curing acne) there is limited, if any, reason to prescribe the newest and more expensive pills. See also the recent comment by Helmerhorst and Rosendaal in the BMJ. However, still 160.000+ (Diane 35) 500.000 (third generation) women take these newer pills. Since thrombosis risk might be highest in the first few months, it is unclear whether these women all should switch to the safer second generation oral contraceptives. But for women who get their first prescription, a second generation oral contraceptive the best way to go (also according the Dutch GP guidelines).

A lot of the research on this topic has been executed by my colleagues from both the MEGA study and the RATIO study. Want to learn more about the pill controversy, please listen this episode of Argos, a Dutch radio programme.

In case you are wondering: the absolute risk of thrombosis in young women is low, even when using a newer generation oral contraceptives. But all added risk that can be avoided should be avoided by you in dialogue with your GP!

Masterclass “Noordwijk” covered in the LUMC magazine Cicero

The LUMC magazine “Cicero” covered our Masterclass in Noordwijk. Its a nice description (in Dutch) of two weekend of undergrad-die-hard-epidemiology. One of the students is also interviewed and she concludes:

“Het lukt de docenten om de studenten de hele tijd
te blijven boeien, gedurende twee weekenden van donderdagavond tot zaterdagmiddag. Ik was bang dat ik dat niet zou volhouden. Maar het ging, en het bleef nog leuk ook.”

The text of the article can be found below and here in pdf (cicero 29 jan 2013).  More articles etc can be found on the media page.

Continue reading “Masterclass “Noordwijk” covered in the LUMC magazine Cicero”