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Hey guys welcome back to the channel in this video we’re gonna be going over the recovery trial or study which focused on dexamethasone and hospice patients with cobra 19 the study mainly focused on bulimia dexamethasone reduce any mortality in hospitalized patients with the corona virus or covered 19 now i’m gonna be going over the abstract of the study and not
The entire study for the sake of time but just for future reference we’re not really making a clinical decision you want to review the entire study and all its demographics procedures and methods in order to make a solid clinical decision reading the abstract is not enough to make a full decision but just for this video and just for learning purposes everything
Going over the abstract and i’m giving us my comments and some of my critiques of the study so let’s get started now if i want to get started with giving a critique our first study is not peer reviewed which you states here this journal metrics is full form i remember being called this study this journal excuse me doesn’t really have a lot of peer reviewed articles
So when i stopped peer review that means other institutions or other experts have not reviewed this study to assess the validity of it in order to deem it really efficacious for clinical use so we take this with a grain of salt when it’s on peer review let’s go ahead and read the abstract of the study so gives a little background information so the methods were
This is like the acronym for recovery it was a randomized controlled open label adaptive platform trial comparing a range of possible treatments with usual care and patients with hospice with cover 19 basically it’s saying it they got it randomized meaning that though the subjects that were in the study were either in the control group or the experimental group
The open label aspect is another critique i have for study because an open label study the researchers other studying know which patients are in the experimental group and which patients are in the control /oc beaucoup so whenever it’s an open label study it gives room for bias because the researchers know and that creates bias in their judgment their assessment
Moving forward we could see that the results 2104 patients were randomly allocated to receive dexamethasone which is the experimental group compared to 4321 patients in the usual care or standard of care group so i’m really a bugs and they’re giving treatment but their treatment isn’t the experimental group they’re not testing to see how effective usual care is
Now giving my critiques while we’re going over it i don’t like the fact that there were not equal amounts of patients in the experimental group compared to the control group i would want this to be very similar i know if you effect when you read the study they saved there’s a two to one ratio between the control group and the experimental group however it’s best
To give equal amounts for statistical significance now let’s talk about the primary outcome of the study the primary outcome of the study is basically their main objective of the study so what they’re trying to find out so what they’re trying to find out is 2010 mortality so they don’t see within 28 days how many patients survived or passed away when they’re
On dexamethasone the experimental compared to usual care which was the control group so let’s go over the results so amongst the dexamethasone group of the experimental group 21.6% passed away compared to twenty four point six percent so about three percent less passed away or died in the dexamethasone group compared to the usual care or control group not like
I always emphasized statistics is a major aspect when you’re analyzing clinical trials or any sort of study so here they use categorical data to use relative risk and so with the statistics they said that it was a relative risk of point eighty-three so it was about a 17% reduction and so relative risk reduction in the dexamethasone group compared to the control
Group with a confidence interval of 0.7 for to 0.92 with a p-value less than point zero zero one all these numbers are basically saying that there was some sort of relative reduction in the experimental group with the dexamethasone group in patients who passed away or died within 28 days when they’re diagnosed recover 19 they’re hospitalized and the confidence
Interval for categorical data if these two values across the value 1 that means the results are statistically significant and the p-value the smarter p-value which is a p-value less than point zero zero one means that these results were not basically due to chance and so looking at this data of just from like just this sentence it seems that there is a statistical
Significance between patients who did get dexamethasone and those who did not get dexamethasone in regards from mortality within 28 days so that’s very important to note and statistics going forward is what i usually use to really assess how valid this study was so let’s move on to the next result so they said the proportion and absol mortality rate reductions
Vary significantly depending on level respiratory support eye randomization dexamethasone reduced deaths by 113 patients receiving invasive mechanical ventilation so patients who are getting mechanical ventilation like a respirator they the deaths were 29 percent compared to 40 percent were a relative risk of 0.65 which is really good for the dexamethasone group
And let’s look at the confidence intervals so this is categorical data and so the confidence intervals between point five one and point eight which does not cross top value one and the p-value is very small so we say this these results are also statistically significant and they have some validity to them does a stain that i clinically significant i want to
Really address the fact that there’s a difference between statistical significance and clinical significance and so these values are also statistically significant so they have some sort of validity and let’s move on forward so 115 patients receiving oxygen without invasive mechanical ventilation was 21.5 percent versus 25 percent lower relative risk of 0.8 with a
Confidence interval of 0.7 0 to 0.92 again we have a relative risk less than 1 which means there is some sort of reduction in mortality in the dexamethasone group compared to the usual care group and the confidence interval does not cross the value 1 so it’s point 7 to 0.92 and the p-value is relatively small as well as at point 0 0 2 however this is not to say
That dexamethasone will make a clinical clinically significant difference as for a physician or any clinician to decide that i’m just objectively viewing these results and let’s go on to the next result then they said but did not reduce the mortality in patients not receiving whisper support our randomization seventeen percent versus thirteen point two percent
At a relative risk of 0.12 tooled with a confidence interval of point nine three to one point six with a p-value point four no this is where i this is where i want to emphasize the difference between what you’re reading and what you are assessing based on the knowledge that you know so but did not reduce the mortality and patients not receiving respiratory support
At randomization so this study is telling you dexamethasone did not reduce or did i help patients survive who were not on any sort of respiratory support or they were not on a ventilator did not receive oxygen if you gave dexamethasone to to these patients this results are saying that they had maybe an increased chance of death 1.2 – so when the relative risk is
Over 1 that means that the experimental group has a higher risk for whatever they’re assessing compared to the control group so when a relative risk of 1.2 – says oh there were 22% more chance of mortality when they’re on dexamethasone and they don’t have any respiratory issues compared to usual care however one thing i want to note especially important to look
At all aspects of systems of statistics is that the confidence interval here crosses the value 1 it goes from point nine three to one point six one which deems it statistically insignificant why is that important because you disk they cannot conclude it did not reduce mortality did you they could only conclude that hey this this part was inconclusive because the
Stats do not make sense if the relative verse was one point two – okay there’s a oh it’s worse off if you take dexamethasone compared to standard of care but then these confidence intervals should not be of crossing also if it was point one zero one two point one six one then this will say it’s a statistically significant factor of dex increasing the mortality
Rate compared to usual care but because this confidence interval cross the one we deem this statistically insignificant and the p-value is not too too high but still too high for my taste i like it below point zero five which is usually a standard a they go by and so that is how i generally assess these results under setting stats is really boring and started the
Funnest thing to do but once you kind of get it down it really gives you a lot of confidence in assessing these clinical studies because you have a sort of a standard to go by hey if the confidence interval crosses one you cannot make a salt conclusion because the stats are insignificant those with their conclusion so their conclusion is inpatient hospital cover
In nineteen dexamethasone reduced 28-day mortality amongst those receiving in vain invasive mechanical ventilation or oxygen i randomization but not among patient not receiving respiratory support so this conclusion i agree you different the most part i don’t agree with this statement what if their demographic wasn’t suited enough to see how much dexamethasone
Helps with patients not receiving respiratory support that conclusion is all fully backed in my opinion and so i wouldn’t say the last part of its conclusion but overall this study did give a lot of good insight about the possible use of dexamethasone and how it’s reducing mortality rates and how splice patients who have some sort of mechanical ventilation or
Oxygen oxygen requirements so this is how i basically reviews the clinical studies in a nutshell of course of course of course you want to read the full study you want to learn the demographics in the study what kind of patients with disease states they had because that’s also some room for critique there but just as a quick overview video of how i go over an
Abstract of a study i wanted to show you guys there if you guys have any comments questions or feedback you guys have for me please leave it in the comment section below i hope you guys learned something watching this video see you guys next time
Transcribed from video
Coronavirus Treatment with Dexamethasone? | Study Review & Analyses | Steroid Medication| Edgy Edge By Edgy EdgeliveBroadcastDetails{isLiveNowfalsestartTimestamp2020-06-30T152847+0000endTimestamp2020-06-30T154142+0000}