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Journal Club 7/2/19- Trial of Decompressive Craniectomy for Traumatic ... (Thread closed)

sohail
06:10PM
Hi is this the JC discussing the neurosurgical paper?

Daniel Lewis
06:18PM
Hi Sohail, it will be I think.

Sarah Michael
06:19PM
Hi everyone, welcome to our first journal club of the year

Sarah Michael
06:27PM
Sorry we seem to have an issue with some people not being able to log in

Just going to give them a few minutes to try and sort the issue out

Dominic Ng
06:28PM
Hi everyone

sharanniyan
06:30PM
Hello everyone

EdwinKoubeh
06:30PM
Hello

Won
06:34PM
Hello

Will Reynolds
06:34PM
Evening All

Sarah Michael
06:34PM
Shall we make a start? The others can join in later

wkoubeh1
06:35PM
Okay

Saad Salman
06:35PM
Hello.

Daniel Lewis
06:35PM
What did everyone think of the paper?

wkoubeh1
06:36PM
I thought that it quite conclusively showed that the procedure provides advantages over normal medical methods

sharanniyan
06:36PM
I felt it was quite a well executed and well written randomised trial

Saad Salman
06:37PM
I thought it was quite interesting the way they’ve designed to carry out this trial, and it seems to possibly be successful in the future.

Dominic Ng
06:38PM
I think the use of the primary outcome was interesting but I would have like to see better blinding of the treatment options

Daniel Lewis
06:38PM
I guess firstly any comments on the journal it was published in and how that influences your opinion of the paper immediately?

EdwinKoubeh
06:38PM
I thought that the trial was generally quite good but the way that they have measured the dependant variable, using the extended glasgow scale is subjective.

sharanniyan
06:39PM
Anything in the NEJM would of course be of excellent standard

sohail
06:39PM
NEJM has a high impact factor, coupled with the fact that this was a multi centre singl-eblinded RCT makes this decent evidence?

sharanniyan
06:39PM
Exactly sohail

Daniel Lewis
06:40PM
Very true, although 70% plus of the recruited patients were from the UK so whilst it was an international trial the results may not be directly translatable to other healthcare systems

Was their clinical question clearly defined?

wkoubeh1
06:41PM
The treatment surely would be the same or very similar wherever it is carried out?

Given that the healthcare system using it has adequate resources

sohail
06:42PM
so their qq was asking the effectiveness of cranectomy as a last-tier intervention in TBI pts w/ raised ICP but didn't specify the outcome

although the authors mentioned the GOS-E in methods to measure the different outcomes

used * not mentioned

Daniel Lewis
06:45PM
Correct although  I believe the primary outcome was GO-E at 6 months and then the secondary outcome was that score at 12 months. They had calculated the sample sizes based on looking for a 15% difference in these outcomes at 6 months

Saad Salman
06:45PM
Could Results could vary from country to country depending upon the doctors which carry out the procedure?

Daniel Lewis
06:46PM
Possibly and the level of criticla care monitoring (ICP, CVP, BP etc) may vary depending on country's wealth etc

The key thing about their clinical question as Sohail said was that it was investigating it as a last tier intervention. Is anyone familiar with the preceeding DECRA study?

Sarah Michael
06:49PM
No, would you be able to explain it to us?

Daniel Lewis
06:51PM
Essentially DECRA was another international study looking at decompressive craniectomy in trauma which showed that patients undergoing surgery had worse outcomes. It was criticised for a number of reasons though. On e reason was that patients were enrolled for surgery very early on, after only 15 mins of raised ICP above 20 and after only 1st tier measures had been tried

wkoubeh1
06:52PM
Was this published by NEJM as well?

Daniel Lewis
06:52PM
In this study, however, patients had to have ICP > 25 for more than hour and the intracranial pressure was elevated despite tier 1(sitting patinet up, sedation etc) and tier 2 therapies (mannitol, hyeprtonic saline, CSF drainage)

It was https://www.nejm.org/doi/full/10.1056/NEJMoa1102077

Saad Salman
06:52PM
I hope you don’t mind me asking but what is ICP?

suhaibamin
06:53PM
Intracranial Pressure

Daniel Lewis
06:53PM
Not at all, it's intracranial pressure and increases in significant head trauma due to brain swelling, bleeidng etc

Saad Salman
06:54PM
Thankyou.

wkoubeh1
06:54PM
So, does this not almost invalidate the point that papers published by NEJM are reliable?

suhaibamin
06:55PM
Has anyone else tried after tier 2 methods instead?

sohail
06:56PM
it's hard to compare between the papers because the 2016 paper: patients had surgery after multiple interventions suggesting that their ICP was resistent/patients were more unwell. whereas the 2011 paper, the patients were enrolled for surgery after only stage 1 interventions

Daniel Lewis
06:56PM
Not necessarily, because DECRA answered a specific question. Does 'early' decompressive craniectomy improve outcomes and the answer is no

Abraham Davis
06:57PM
just a q: if treatment is used as a last resort, wouldn't the outcome of the treatment vary greatly on a case by case basis? just due to differing states of the patients and how urgent the the surgery is from patient to patient?

Daniel Lewis
06:57PM
Exactly and that's why the mortality rate across both groups is much higher in this study compared to DECRA, the patients were more unwell

wkoubeh1
06:58PM
There's a sample size of over 400 patients, so could this not balance out the inherent variation that is expected on a case by case basis?

suhaibamin
06:59PM
Could anti inflammatory's not be used instead of Craniectomy?

Daniel Lewis
07:00PM
It's a good question Abraham, due to patients having to have failed tier 2 interventions they were all by definition at the severe end of the TBI spectrum but not so severe as to be unsurvivable.

sohail
07:00PM
@Bram, the study compares the medical intervention group against the surgical group

@Daniel, better explanation than mine, thanks

Daniel Lewis
07:02PM
Did all the participants stay in their allocated treatment group?

Saad Salman
07:02PM
Could patients personality change following the procedure and therefore would this create ethical dilemmas.

xenia sara
07:03PM
I feel that perhaps them surviving is more of a pertinent issue in this situation

Abraham Davis
07:04PM
it says somewhere i think that the patients would have had surgery anyway if their condition deteriorated. i cant find where it says this however and i may be mixing things uo

sohail
07:05PM
in the surgical group, some pts were unable to have surgery, and there was a group that had an unknown type of craniectomy. Also, 37% of the medical group ended up having a surgical decompression too

so in short: no?

Daniel Lewis
07:05PM
Saad- because these patients are unconscious initially and may never regain capacity relatives were asked to consent for their inclusion in the study, but it is an ethical issue and a study such as this would have taken time to go through full ethical approval.

Correct, is the 37% crossover an issue?

sharanniyan
07:06PM
I found that particularly interesting as I have never come across a paper where consent was not attained from patients themselves

wkoubeh1
07:06PM
Does that not mean that we can not be sure about what has caused the results, since there are multiple independent variables?

Sarah Michael
07:07PM
Potentially as they had the benefits of both treatments so could make decompression seem better than it is?

Saad Salman
07:07PM
Thanks Daniel, that makes sense but what if they survive and have a huge difference in personality and never behave the same way again?

Would this not affect the relatives.

wkoubeh1
07:08PM
That doesn't change the fact that there is lower mortality rates and severe disability incidence when using the procedure as opposed to medical treatments

suhaibamin
07:08PM
True. I feel like it should a last case option.

sohail
07:08PM
Do we know if those in the 37% remained in the medical group for the final analysis, or if they were moved to the surgical group?

Daniel Lewis
07:09PM
You make a good point Saad and one we will come to in the results. On the crossover point, this is an important issue as they were treated on an intention to treat basis. ie when you look at the results the medical Tx group who had surgery were left in the medicla group for the analysis

As such the medical group may have had lower mortality/ better outcomes than it should have had. the treatment effect may have been diluted

Does this make sense to everyone? Another issue is that they lost ten patients to follow up due to withdrawl of consent either by the family or the patient themselves

suhaibamin
07:13PM
It makes sense to me

Saad Salman
07:14PM
Yes, would be better to take the risk of treatment than to led pressure build up that may cause death.

sohail
07:14PM
Is it possible to do an analysis with the 37% moved into the surgical group, and then seeing if there is a significant difference between intention-to-treat versus the new groups (i.e. actual treatment recieved)

xenia sara
07:15PM
Why did they not exclude the 37% from the data sets?

Abraham Davis
07:15PM
yh that would seem to make more sense

suhaibamin
07:15PM
I agree

sohail
07:16PM
However, the 37% recieved barbiturate treatment so i guess they cant just be added into the surgical group right?

Daniel Lewis
07:16PM
It's a good question and I think they may have done but I cannot find the result myself. The problem with excluding those patients is your are then selecting the medical group patients who responded for analysis

sharanniyan
07:17PM
Yea I was thinking the same thing

Abraham Davis
07:17PM
biasing the results...

sharanniyan
07:17PM
Would that need make it seem as if the data is manipulated

Abraham Davis
07:17PM
makes sense

sharanniyan
07:17PM
*not

Daniel Lewis
07:18PM
Sadly in a study such as this, the crossover is unavoidable because as you say some families would have wanted everything doing for their relative

What are the main results then?

Abraham Davis
07:19PM
that surgery seems to have better outcomes than non surgery in terms of survival rate?

sharanniyan
07:20PM
surgery seems to be the better option instead of medical intervention?

wkoubeh1
07:20PM
Yes, the adverse effects of surgery seem to be more minor

suhaibamin
07:20PM
surgery seemed to have better mortality rates

EdwinKoubeh
07:21PM
Surgery appears to be be better than medical intervention but has high rates of vegitative state

sohail
07:21PM
the primary outcome showed lower mortality for the surgical group with higher morbidity compared with the medical group

the higher morbiddity could be explained by the better survival rate from surgery therefore meaning patients are left with greater disabilies

wkoubeh1
07:23PM
Exactly

Daniel Lewis
07:24PM
Your all correct. So no-one will agree that surgery has a clear survival benefit, but that is not that surprising . The contentious bit which has caused som debate is the favourable outcome or not

Saad Salman
07:25PM
Yeah I feel like it also needs to be done in other countries other than the UK because 70% of the data wasn’t collected here which may be be reproducible elsewhere.

70% of the data was collected here*

Daniel Lewis
07:26PM
In the paper they dichotomize favourable vs non-favourable outcome at GOS 3/4. What this meant was that upper severe disability was classed as favourable

sharanniyan
07:26PM
Dr Lewis could you clarify what upper severe disability means?

Daniel Lewis
07:26PM
So patients who are unable to leave the house but can be left at home for 8 hrs

Abraham Davis
07:27PM
this could be said to be favourable simply because the average outcome for this stage of injury is so bad though right?

even what could be considered a bad quality of life could be considered a good outcome if the average outcome is worse?

Daniel Lewis
07:28PM
This caused some debate because traditionally upper severe disability has been classed as unfavourable and if you go with the conventional split there is no difference between medical and surgical groups

RESCUEicp and the Eye of the Beholder

wkoubeh1
07:29PM
Is it not possible to simply do both medical and surgical treatments if they each provide their own benefits?

xenia sara
07:30PM
We are reaching an interesting point in the conversation however we are about to come to time

If you would all like to make your concluding comments

suhaibamin
07:30PM
I think surgical methods should be tried after medical in case of any mishaps

Saad Salman
07:30PM
Would that not have a lot of risks associated with it warren?

sohail
07:31PM
Really good article @Daniel, thanks

Sarah Michael
07:31PM
Thank you Dan for being a fantastic moderator as always. For the Sixth form students, we've created a facebook group chat now for us to have a discussion about how you think it went and Xenia and I will be waiting for your viewpoints on it.

Abraham Davis
07:31PM
agreed

Saad Salman
07:32PM
Thankyou Sarah. Thankyou Daniel for the discussion today.

Daniel Lewis
07:32PM
For those interested in the debate around this study, see also https://lifeinthefastlane.com/beholders-or-patients-and-families/.

sharanniyan
07:32PM
Thank you Dr Lewis for moderating, it was an insightful discussion.

suhaibamin
07:32PM
thank you Dan. I'll be sure to give that a read

Dr Lewis*

EdwinKoubeh
07:33PM
Thanks you Dr Lewis and Sarah