APPRAISING VALIDITY in the conservative arm withdrew consent, and was excluded.

The remaining 103 patients were followed up until day 90.

 Consists of 8 criteria
 The more yes answers, the less bias or the odds in favour of one
group.

Were patients randomly assigned to treatment groups?

 Yes. This prospective randomized parallel-group trial was

conducted at four university-affiliated, multidisciplinary ICUs in
Australia, New Zealand, and France.

NICE TO KNOW!

“The random assignments ensures that the groups are comparable” – Solinap, 2020

Was allocation concealed?

 Yes. Randomization was done in a masked fashion, using

opaque sealed envelopes, with a unique computer-generated,
permuted block randomization method with random block sizes.

Were the baseline characteristics similar at the start of the trial?

 Assessing the Drop-out of the Study (ICU interpretation of Drop-
out; see Table 2 in appendix)
 Yes. Demographic and clinical characteristics at baseline were
similar in the two groups (see appendix for Table 1) Conservative Liberal
ICU Oxygenation Oxygenation
NICE TO KNOW! (n=52) (n=51)
Death 12/52=23% 12//51=23.6%
“Randomization baseline characteristic in RCT tend to be similar. Sometimes inequality may arise
Drop-outs 1 due to chance alone.”
0
Worst scenario for
12+1/52+1=24.5% 12+0/51=23.6%
treatment
“This third criteria checks how successful randomization, allocation, and group
concealment were in comparing the treatment and control group in RCT
Best scenario for
12+0/53+0=22.6% 12+0/51=23.6%
treatment group
Were patients blinded to treatment assignment?  Assessing the Drop-out of the Study (90-day interpretation of
Drop-out; see Table 2 in appendix)
 Yes. Patients were unaware of their assigned group but blinding
of treating clinicians was not considered feasible. Conservative Liberal
90 day Oxygenation Oxygenation
Were caregivers blinded to treatment assignment? (n=52) (n=51)
Death 20/52=38% 19/51=37%
 No. After treatment allocation the bedside nurse titrated the FiO2 Drop-outs 1 0
within a range of 0.21 to 0.80 to achieve the assigned targets of Worst scenario for
88-92% SpO2 for the conservative oxygenation group or greater 20+1/52+1=39% 19+0/51=37%
treatment group
than or equal to 96% SpO2 for the liberal oxygenation Best scenario for
20/53=37% 19/51=37%
treatment group
Were outcome assessors blinded to treatment assignment?

 No. There was no mention regarding outcome assessors but APPRAISING RESULTS
researchers used computer generated data.
How large was the effect of treatment?
Were all analysed in the groups to which they were originally
randomized?  The magnitude of the treatment may be expressed bycomparing
outcomes in the treatment and control groups
 No. One patient in the conservative arm was treated according to  Outcomes can be:
liberal oxygenation protocol in error. However results were o Continuous variable
unchanged in per-protocol analysis  Change in weight
 Change in quality of life on scale of 0-1
Was follow-up rate adequate? o Dichotomous variables: have only two possible results
 Dead or alive
 Yes. There are 104 patients who enrolled in the study. Of these,  Hospitalized or not
53 patients were assigned to the conservative oxygenation group
and 51 patients to the liberal oxygenation group. Only one patient

CPU College of Medicine | Revised By: VictoresValetudinis | 2022

 Summary of Comparison of R c −Rt
OUTCOME Results within results between two
each group groups Reduction (%)
Rc
Relative risk, 25 %−24 %
Proportion >0%: Beneficial ICU = 0.04%
absolute risk
-0%: No effect
25 %
reduction, relative 90 Day = 0.08%
(deaths per 100 <0% Harmful
risk reduction
patients) 40 %−37 %
Dichotomous
Hazard ratio:
40 %
Rate Formula =
rate∈treament Rc −R t
(deaths per 100
patients per year) rate∈control group Absolute Risk ICU = 1%
Reduction
24 %−24 %−1 %
Mean difference 90 Day = 3%
Mean 37%−40 %=3 %
Continuous
(mean control – Formula:
(mean blood
pressure)
mean in treatment Rt
group) Relative Risk
(decimal) Rc
>0%: Beneficial
24 %
 For this exercise, data is dichotomous since we are looking at the ICU = 0.96%
mortality rate. -0%: No effect 25 %
<0% Harmful 90 Day = 0.93%
Conservative Liberal P 37 %
90 day Oxygenation Oxygenation value 40 %
(n=52) (n=51)
ICU Mortality
13 (25%) 12 (24%) 0.86  Interpretation:
Rate
o RRR: Treatment group is beneficial since it is 0.04% and
90-d Mortality
21 (40%) 19 (37%) 0.74 0.08% which are less than 0%.
Rate
o AR = About 1% and 3% risk reduction
NICE TO KNOW! o RR: Treatment is beneficial since it is greater than 0
NIC
NICE TO KNOW!
“Mortality rate ang gina-tan-aw mo kay ang treatment effect ang basehan. It is also best to look for the objectives of this study. Sometimes, they

RRR: tell you by how much the treatment reduces the risk of
 Since data is dichotomous, we are going to compute for the bad outcomes relative to the control group who did not have the
absolute risk reduction and relative risk reduction. treatment.
o Rc = Control
o Rt = Trial ARR or the risk difference: is most useful way of presenting
results for your decision-making.

(see appendix)

COMPUTATION
How precise was the estimate of effect?
Relative Risk Formula:

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 Yes. By convention, interval estimates are estimated at a 95%
level of confidence,
 When we state 95% confidence intervals (95% CI), we mean that
we are 95% sure that the true effect of the treatment lies within
this range (see appendix)

NICE TO KNOW !

The power of research is only 80% CI and above. Lowest possible CI you could give for the research to be acceptabl.

Basic Tenets

1. When both ends of the CI are on the side of benefit, the

treatment is definitely beneficial.
2. When both ends of the CI are on the side of harm, the
treatment is definitely harmful.
3. When one end reflects important harm, then study is
inconclusive.
4. When one end reflects a small unimportant benefit and the
other end reflects a small unimportant harm, then for all
intents and purposes the two treatments being compared
are equal.

APPENDIX

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 TOPIC 2 (You can copy an

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