Therapy Studies What Question Did The Study Ask?

Critical Appraisal for Therapy Articles Worksheet
THERAPY STUDIES
What question did the study ask?
Patients – Intervention - Comparison - Outcome(s) –
Step 1: Are the results of the trial valid? (Internal Validity)

1a. R- Was the assignment of patients to treatments randomised?
What is best? Where do I find the information?
Centralised computer randomisation is ideal and often The Methods should tell you how patients were allocated
used in multi-centred trials. Smaller trials may use an to groups and whether or not randomisation was
independent person (e.g, hospital pharmacy) to “police” concealed.
the randomization.
This paper: Yes No Unclear
Comment:
1b. R- Were the groups similar at the start of the trial?
If the randomisation process worked (that is, achieved The Results should have a table of "Baseline
comparable groups) the groups should be similar. The Characteristics" comparing the randomized groups on a
more similar the groups the better it is. number of variables that could affect the outcome (ie. age,
There should be some indication of whether differences risk factors etc). If not, there may be a description of group
between groups are statistically significant (ie. p values). similarity in the first paragraphs of the Results section.
Comment:
2a. A – Aside from the allocated treatment, were groups treated equally?
Apart from the intervention the patients in the different Look in the Methods section for the follow-up schedule,
groups should be treated the same, eg., additional and permitted additional treatments, etc and in Results for
treatments or tests. actual use.
Comment:
2b. A – Were all patients who entered the trial accounted for? – and were
they analysed in the groups to which they were randomised?
Losses to follow-up should be minimal – preferably less The Results section should say how many patients were
than 20%. However, if few patients have the outcome of andomised (eg., Baseline Characteristics table) and how
interest, then even small losses to follow-up can bias the many patients were actually included in the analysis. You
results. Patients should also be analysed in the groups to will need to read the results section to clarify the number
which they were randomised – ‘intention-to-treat analysis’. and reason for losses to follow-up.
Comment:
3. M - Were measures objective or were the patients and clinicians kept
“blind” to which treatment was being received?
It is ideal if the study is ‘double-blinded’ – that is, both First, look in the Methods section to see if there is some
patients and investigators are unaware of treatment mention of masking of treatments, eg., placebos with the
allocation. If the outcome is objective (eg., death) then same appearance or sham therapy. Second, the Methods
blinding is less critical. If the outcome is subjective (eg., section should describe how the outcome was assessed
symptoms or function) then blinding of the outcome and whether the assessor/s were aware of the patients'
assessor is critical. treatment.
Comment:
Centre for Evidence-based Medicine, University of Oxford, 2010

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Critical Appraisal for Therapy Articles Worksheet
Step 2: What were the results?

1. How large was the treatment effect?
Most often results are presented as dichotomous outcomes (yes or not outcomes that happen or don't happen) and can
include such outcomes as cancer recurrence, myocardial infarction and death. Consider a study in which 15% (0.15) of
the control group died and 10% (0.10) of the treatment group died after 2 years of treatment. The results can be
expressed in many ways as shown below.
What is the measure? What does it mean?

Relative Risk (RR) = risk of the outcome in the The relative risk tells us how many times more likely it is that
treatment group / risk of the outcome in the control an event will occur in the treatment group relative to the control
group. group. An RR of 1 means that there is no difference between the
two groups thus, the treatment had no effect. An RR < 1 means
that the treatment decreases the risk of the outcome. An RR > 1
means that the treatment increased the risk of the outcome.
In our example, the RR = 0.10/0.15 = 0.67 Since the RR < 1, the treatment decreases the risk of death.
Absolute Risk Reduction (ARR) = risk of the The absolute risk reduction tells us the absolute difference in the
outcome in the control group - risk of the outcome rates of events between the two groups and gives an indication
in the treatment group. This is also known as the of the baseline risk and treatment effect. An ARR of 0 means
absolute risk difference. that there is no difference between the two groups thus, the
treatment had no effect.
In our example, the ARR = 0.15 - 0.10 = 0.05 or 5% The absolute benefit of treatment is a 5% reduction in the death
rate.
Relative Risk Reduction (RRR) = absolute risk The relative risk reduction is the complement of the RR and is
reduction / risk of the outcome in the control group. probably the most commonly reported measure of treatment
An alternative way to calculate the RRR is to effects. It tells us the reduction in the rate of the outcome in the
subtract the RR from 1 (eg. RRR = 1 - RR) treatment group relative to that in the control group.
In our example, the RRR = 0.05/0.15 = 0.33 or 33% The treatment reduced the risk of death by 33% relative to that
Or RRR = 1 - 0.67 = 0.33 or 33% occurring in the control group.
Number Needed to Treat (NNT) = inverse of the The number needed to treat represents the number of patients
ARR and is calculated as 1 / ARR. we need to treat with the experimental therapy in order to
prevent 1 bad outcome and incorporates the duration of
treatment. Clinical significance can be determined to some
extent by looking at the NNTs, but also by weighing the NNTs
against any harms or adverse effects (NNHs) of therapy.
In our example, the NNT = 1/ 0.05 = 20 We would need to treat 20 people for 2 years in order to prevent
1 death.
2. How precise was the estimate of the treatment effect?
The true risk of the outcome in the population is not known and the best we can do is estimate the true risk based on
the sample of patients in the trial. This estimate is called the point estimate. We can gauge how close this estimate is
to the true value by looking at the confidence intervals (CI) for each estimate. If the confidence interval is fairly narrow
then we can be confident that our point estimate is a precise reflection of the population value. The confidence interval
also provides us with information about the statistical significance of the result. If the value corresponding to no effect
falls outside the 95% confidence interval then the result is statistically significant at the 0.05 level. If the confidence
interval includes the value corresponding to no effect then the results are not statistically significant.
Step 3: Will the results help me in caring for my patient?

(ExternalValidity/Applicability)
The questions that you should ask before you decide to apply the results of the study to your patient are:
• Is my patient so different to those in the study that the results cannot apply?
• Is the treatment feasible in my setting?
• Will the potential benefits of treatment outweigh the potential harms of treatment for my patient?
Centre for Evidence-based Medicine, University of Oxford, 2010

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Critical Appraisal for Therapy Articles Worksheet

Step 1: Are the results of the trial valid? (Internal Validity)

Centre for Evidence-based Medicine, University of Oxford, 2010

Step 2: What were the results?

What is the measure? What does it mean?

Step 3: Will the results help me in caring for my patient?

Centre for Evidence-based Medicine, University of Oxford, 2010

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