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jamesheathers's profile
James Heathers
James Heathers
James Heathers
@jamesheathers

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James Heathers

@jamesheathers

CSO @cipherskin. Biosignals, digital health, wearables, meta-science, error detection, noises. Journal ghoul. Washed up meathead. Bylines in Fancy Places.

Uncle Sam
linktr.ee/jamesheathers
Joined September 2011

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    1. James Heathers‏ @jamesheathers 29 Apr 2020

      Sometimes it becomes clear after you start that the registration is incomplete or wrong. Sometimes you have a better idea after you start. Sometimes your thinking changes. Other times, you're trying to cherry-pick the results.

      1 reply 3 retweets 65 likes
      Show this thread
    2. James Heathers‏ @jamesheathers 29 Apr 2020

      Outcome switching is not a new thing. We did a whole hour's worth of podcast on it a year ago with @HenryMDrysdale, part of @bengoldacre's team on COMPARE. They've studied it for years. It's a common enough problem.https://everythinghertz.com/79 

      1 reply 6 retweets 56 likes
      Show this thread
    3. James Heathers‏ @jamesheathers 29 Apr 2020

      Now, I was already a bit suspicious of this trial. Not much - it's amazing (we'll get to that in a minute). Why? (1) we haven't actually *seen* it yet. There was a press release well in advance of the text being released. This has become normal, and always sucks.

      1 reply 7 retweets 57 likes
      Show this thread
    4. James Heathers‏ @jamesheathers 29 Apr 2020

      James Heathers Retweeted James Heathers

      (2) the results in the press release. I call this 'two results, four sentences' - press releases describe the results in incredibly brief terms, usually the two most positive outcomes w the briefest explanation possible. He's me bitching about it earlier.https://twitter.com/jamesheathers/status/1255555192365424643 …

      James Heathers added,

      James Heathers @jamesheathers
      Replying to @venkmurthy @VPrasadMDMPH and 4 others
      Of course, this paper, in this context, right now, would give us that p-value. Just what we needed. Presumably if those are the 'two results in four lines' etc. etc. of a typical press release, there's some fun things they AREN'T saying... can we have the goddamn study now pls
      2 replies 4 retweets 43 likes
      Show this thread
    5. James Heathers‏ @jamesheathers 29 Apr 2020

      In the past (not necessarily here, calm down) this approach has been been seen in the company of some serious spin. If you have two 'good' results, and then twenty bad or uninterpretable ones, what are you going to tell people?

      1 reply 2 retweets 31 likes
      Show this thread
    6. James Heathers‏ @jamesheathers 29 Apr 2020

      (3) a similar clinical trial dropped from China today... it tested the same drug under similar circumstances, and while the study is incomplete, the result was far from positive.https://eurekalert.org/pub_releases/2020-04/tl-tlf042920.php …

      1 reply 6 retweets 40 likes
      Show this thread
    7. James Heathers‏ @jamesheathers 29 Apr 2020

      Now. I know the internet likes losing its goddamn mind, and especially right now, but don't fly off the handle yet. Anyone going FAKE NEWS and popping off here will be mocked and blocked. I have zero patience, none, for shenanigans. Here's what I'd propose instead. Ready?

      1 reply 4 retweets 57 likes
      Show this thread
    8. James Heathers‏ @jamesheathers 29 Apr 2020

      (1) when this trial is published - and it will be, somewhere, very soon - *look to see if there's an explanation as to why the outcomes were switched*. There may be a plausible one. It may not be mentioned. If it is not mentioned or explained, let's find out why.

      2 replies 6 retweets 94 likes
      Show this thread
    9. James Heathers‏ @jamesheathers 29 Apr 2020

      (2) look carefully in that paper also for our demoted primary-to-secondary outcome. What happened to that poor fellow, and why was he demoted?

      2 replies 1 retweet 59 likes
      Show this thread
    10. James Heathers‏ @jamesheathers 29 Apr 2020

      (3) get the damned data. The primary outcome of any given piece of research is the data, not the stories we tell about it. If it isn't available, scrape the graphs for data points. If that's impossible, maybe we can think of something else.

      1 reply 8 retweets 70 likes
      Show this thread
      James Heathers‏ @jamesheathers 29 Apr 2020

      Here's what I'm afraid of: (a) more news cycles until the study can be inspected (b) glossy mentions of the new primary outcome being successful (c) no mention of the previous primary outcome they took out back and shot (d) no data (e) resistance to criticism (f) ⬆️taking weeks

      8:07 PM - 29 Apr 2020
      • 19 Retweets
      • 111 Likes
      • Dr. Thiago Duarte Matthias Apfelthaler Anders W. Dow Rieder Milan Wiedemann Marius Loots fitnessasylum1 Maria Theresa Norn James.pdf
      3 replies 19 retweets 111 likes
        1. New conversation
        2. James Heathers‏ @jamesheathers 29 Apr 2020

          None of that may come to fruition. Maybe everything is fine. I WOULD LIKE THAT TO BE THE CASE. But this is presently the most important clinical trial on the planet, and that means it deserves every possible aspect of reasonable scrutiny.

          1 reply 5 retweets 90 likes
          Show this thread
        3. James Heathers‏ @jamesheathers 29 Apr 2020

          Clinical trials are a vicious way to make a living. Expensive, time-consuming, difficult, and miserable. To run one this size, in DAYS, is *an astonishing effort*. Look at the list of enrolled sites. All of em need comms, ethics, protocols, drugs, data reporting platforms etc...

          3 replies 6 retweets 67 likes
          Show this thread
        4. James Heathers‏ @jamesheathers 29 Apr 2020

          I would hate for the phenomenal hustle on display here to lack the appropriate impact, one way or the other.

          1 reply 1 retweet 40 likes
          Show this thread
        5. James Heathers‏ @jamesheathers 29 Apr 2020

          UPDATE: via DM it is pointed out they had independent oversight, and this decision was definitely reviewed. Good. Excellent. Maybe there's a great reason for the above. Let's assume said board was both independent and responsible. https://www.nidcr.nih.gov/research/human-subjects-research/interventional-studies/data-and-safety-monitoring-board-guidelines …

          1 reply 2 retweets 70 likes
          Show this thread
        6. James Heathers‏ @jamesheathers 29 Apr 2020

          That does not obviate releasing these results via press release, or explain why the changes - which, I'm assuming, were requested by the researchers - were made. A DSMB doesn't just parachute in a specific new analytical question themselves, do they?

          1 reply 2 retweets 34 likes
          Show this thread
        7. James Heathers‏ @jamesheathers 29 Apr 2020

          So, again: let's see the paper, and how it's described there. And the data, please and thank you.

          1 reply 2 retweets 39 likes
          Show this thread
        8. James Heathers‏ @jamesheathers 29 Apr 2020

          UPDATE: of course, because this is Twitter, someone else noted this HOURS ago. Full credit to @ExcludedMuddle and @walidgellad and presumably others who were getting into the guts of this while I was eating a sandwich and watching old Tommy Hearns fights on my lunch break.

          4 replies 3 retweets 66 likes
          Show this thread
        9. James Heathers‏ @jamesheathers 29 Apr 2020

          James Heathers Retweeted Walid Gellad, MD MPH

          For more chat, have a go at this as well.https://twitter.com/walidgellad/status/1255581527972417536 …

          James Heathers added,

          Walid Gellad, MD MPHVerified account @walidgellad
          Since NIH remdesivir trial is in the news... was there an explanation about why the primary outcome (now positive) was changed last month to 'time until clinical recovery?' @matthewherper https://clinicaltrials.gov/ct2/history/NCT04280705?A=10&B=16&C=Side-by-Side#StudyPageTop … pic.twitter.com/W1hAACnO1r
          Show this thread
          2 replies 3 retweets 34 likes
          Show this thread
        10. James Heathers‏ @jamesheathers 30 Apr 2020

          James Heathers Retweeted Didier Raoult

          UPDATE: pot now officially calling for an explanation of potential soot and calcium deposits on kettle. h/t @gorskonhttps://twitter.com/raoult_didier/status/1255835517511483394 …

          James Heathers added,

          Didier RaoultVerified account @raoult_didier
          Could Anthony Fauci explain why the investigators of the NIAID remdesivir trial did change the primary outcome during the course of the project (16th April)? Removing "death" from primary outcome is a surprising decision. https://clinicaltrials.gov/ct2/history/NCT04280705?A=10&B=15&C=Side-by-Side#OutcomeMeasures … pic.twitter.com/Rq47FHqGyO
          5 replies 7 retweets 74 likes
          Show this thread
        11. James Heathers‏ @jamesheathers 30 Apr 2020

          UPDATE: the OG @garyschwitzer with a little more on the background. My shite radar is still going off, maybe even pinging a little louder.https://www.healthnewsreview.org/2020/04/what-the-public-didnt-hear-about-the-nih-remdesivir-trial/ …

          1 reply 6 retweets 23 likes
          Show this thread
        12. James Heathers‏ @jamesheathers 30 Apr 2020

          James Heathers Retweeted Meg Tirrell

          UPDATE: here's an explanation for the outcome switching. Big ups for @megtirrell for retrieving it. This is *at least* plausible.https://twitter.com/megtirrell/status/1255960631892721666 …

          James Heathers added,

          Meg TirrellVerified account @megtirrell
          NIAID explains why endpoint of remdesivir trial was changed: pic.twitter.com/Zpl08nd4PL
          Show this thread
          1 reply 6 retweets 44 likes
          Show this thread
        13. James Heathers‏ @jamesheathers 30 Apr 2020

          And this is why I said "Sometimes you have a better idea after you start. Sometimes your thinking changes." Because it goddamn does. Ask anyone who's done a messy clinical trial. Put them on a pedestal all you want, they're still fraught. HOWEVER.

          1 reply 1 retweet 25 likes
          Show this thread
        14. James Heathers‏ @jamesheathers 30 Apr 2020

          I would note that today we're now talking about plausible defenses of the study protocol changes... in the absence of the study. With still nothing more than a press release and a cryptic trial registration. "Trust but verify"? We cannot.

          3 replies 2 retweets 50 likes
          Show this thread
        15. End of conversation

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