Parachute use to prevent death and major trauma when jumping from aircraft : randomized controlled trial

https://twitter.com/user/status/1073267912037814273


BREAKING NEWS !!

In the first ever randomized clinical trial, we demonstrated that parachutes did NOT prevent death or major injury compared to control in individuals jumping from aircraft.

Published today in @bmj_latest: https://www.bmj.com/content/363/bmj.k5094 … #PARACHUTETrial #XmasBMJ

https://blogs.bmj.com/bmj/2018/12/1...without-parachutes-and-lived-to-tell-the-tale

 

(for the full story, follow the twitter link - it's worth it)

 

Are they doing a follow-up study to show that CBT can reduce death and injury?

 

I read somewhere that during one of the World Wars, they needed to drop more troops behind enemy lines that they had trained paratroopers. They asked some regulars troops if any of them would volunteer. One group said that they would if they could be dropped from below a certain height. They were told that they would not have time to get their parachutes open at that height. They responded, "Oh, do we get parachutes".

 

Is it too much to hope that the BMJ might realise that this could have been tailor made as a parody of PACE? (probably)

(Some of the quotes have to be read on the assumption that its is pacing that was proved to be of no value.)

'Beliefs about the efficacy of commonly used, but untested, interventions often influence daily clinical decision making. These beliefs can expose patients to unnecessary risk without clear benefit and increase healthcare costs.'

'Beliefs grounded in biological plausibility and expert opinion have been proven wrong by subsequent rigorous randomized evaluations. The PARACHUTE trial represents one more such historic moment.'

'A minor caveat to our findings is that the rate of the primary outcome was substantially lower in this study than was anticipated at the time of its conception and design, which potentially underpowered our ability to detect clinically meaningful differences, as well as important interactions.'

'Although randomized participants had similar characteristics compared with those who were screened but did not enroll, they could have been at lower risk of death or major trauma because ....'

' In our study, we had to screen many more individuals to identify eligible and willing participants. This is not dissimilar to the experiences of other contemporary trials that frequently enroll only a small fraction of the thousands of patients screened. Previous research has suggested that participants in randomized clinical trials are at lower risk than patients who are treated in routine practice.'

'lack of equipoise often pushes well meaning but ill-informed doctors or study investigators to withhold patients from study participation, as they might believe it to be unethical to potentially deny their patients a treatment they (wrongly) believe is effective.'

'Critics of the PARACHUTE trial are likely to make the argument that even the most efficacious of treatments can be shown to have no effect in a randomized trial if individuals who would derive the greatest benefit selectively decline participation.'

'Second, our study was not blinded to treatment assignment. We did not anticipate a strong placebo effect for our primary endpoint, but it is possible that other subjective endpoints would have necessitated the use of a blinded sham parachute as a control.'

'The PARACHUTE trial satirically highlights some of the limitations of randomized controlled trials. Nevertheless, we believe that such trials remain the gold standard for the evaluation of most new treatments. The PARACHUTE trial does suggest, however, that their accurate interpretation requires more than a cursory reading of the abstract. Rather, interpretation requires a complete and critical appraisal of the study.'

'Second, stronger efforts could be made to ensure that definitive trials are conducted before new treatments become inculcated into routine practice, when greater equipoise is likely to exist.'

'Third, the comparison of baseline characteristics and outcomes of study participants and non-participants should be utilized more frequently and reported consistently to facilitate the interpretation of results and the assessment of study generalizability.'

 

I see the BMJ Christmas special is in full swing.

"Is it time to start using the emoji in biomedical literature?"
https://www.bmj.com/content/363/bmj.k5033

 

This is based on a really old hypothetical argument about EBM. I mentioned it a few times. This goes back many years, its just a more recent instalment. I wonder if they cite the earlier version?

 

This study is a thing of beauty - sort of like an elegant ocean liner - deploying a parachute - as it falls from the sky.​

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Clearly essential, to help overcome the false belief that jumping out of an aircraft in flight can result in physiological trauma. A crucial part of the course is to jump up and down three times after landing, shouting "There, see! Who needed a parachute! I'm not a going to be a dollop of strawberry jam!". It will be clearly evident that for candidates who fail in this, then they simply did not try hard enough and did not really want to do better.

 

Especially regarding ...

 

It is not only the full paper that needs to be read but also the references cited. It cannot safely be assumed that they support, unreservedly, the points for which they supposedly provide evidence.