Worksheet Therapy-Cebm

Critical Appraisal for Therapy Articles
THERAPY STUDY: Are the results of the trial valid? (Internal Validity)
What question did the study ask?

Patients
Intervention
Comparison
Outcome(s)
1a. R- Was the assignment of patients to treatments randomised?

What is best? Where do I find the information?
Centralised computer randomisation is ideal The Methods should tell you how patients were allocated to
and often used in multi-centred trials. Smaller groups and whether or not randomisation was concealed.
trials may use an independent person (e.g, the
hospital pharmacy) to police 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, The Results should have a table of "Baseline Characteristics"
achieved comparable groups) the groups comparing the randomized groups on a number of variables that
should be similar. The more similar the groups could affect the outcome (ie. age, risk factors etc). If not, there
the better it is. may be a description of group similarity in the first paragraphs of
There should be some indication of whether the Results section.
differences between groups are statistically
significant (ie. p values).
Comment:
2a. A Aside from the allocated treatment, were groups treated equally?
Apart from the intervention the patients in the Look in the Methods section for the follow-up schedule, and
different groups should be treated the same, permitted additional treatments, etc and in Results for actual
eg., additional treatments or tests. 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 The Results section should say how many patients were
preferably less than 20%. However, if few 1andomised (eg., Baseline Characteristics table) and how many
patients have the outcome of interest, then patients were actually included in the analysis. You will need to
even small losses to follow-up can bias the read the results section to clarify the number and reason for
results. Patients should also be analysed in the losses to follow-up.
groups to which they were randomised
intention-to-treat analysis.
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 First, look in the Methods section to see if there is some
is, both patients and investigators are unaware mention of masking of treatments, eg., placebos with the same
of treatment allocation. If the outcome is appearance or sham therapy. Second, the Methods section
objective (eg., death) then blinding is less should describe how the outcome was assessed and whether
critical. If the outcome is subjective (eg., the assessor/s were aware of the patients' treatment.
symptoms or function) then blinding of the
outcome assessor is critical.
Comment:
University of Oxford, 2005 1

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 The relative risk tells us how many times more likely it is that an
in the treatment group / risk of the event will occur in the treatment group relative to the control group.
outcome in the control 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 absolute risk reduction tells us the absolute difference in the
the outcome in the control group - risk of rates of events between the two groups and gives an indication of the
the outcome in the treatment group. This baseline risk and treatment effect. An ARR of 0 means that there is
is also known as the absolute risk no difference between the two groups thus, the treatment had no
difference. effect.
In our example, the ARR = 0.15 - 0.10 = The absolute benefit of treatment is a 5% reduction in the death rate.
0.05 or 5%
Relative Risk Reduction (RRR) = The relative risk reduction is the complement of the RR and is
absolute risk reduction / risk of the probably the most commonly reported measure of treatment effects.
outcome in the control group. An It tells us the reduction in the rate of the outcome in the treatment
alternative way to calculate the RRR is to group relative to that in the control group.
subtract the RR from 1 (eg. RRR = 1 -
RR)
In our example, the RRR = 0.05/0.15 = The treatment reduced the risk of death by 33% relative to that
0.33 or 33% occurring in the control group.
Or RRR = 1 - 0.67 = 0.33 or
33%
Number Needed to Treat (NNT) = The number needed to treat represents the number of patients we
inverse of the ARR and is calculated as 1 need to treat with the experimental therapy in order to prevent 1 bad
/ ARR. 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.

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?

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Critical Appraisal for Therapy Articles

What question did the study ask?

1a. R- Was the assignment of patients to treatments randomised?

University of Oxford, 2005 1

What were the results?

1. How large was the treatment effect?

What is the measure? What does it mean?

2. How precise was the estimate of the treatment effect?

University of Oxford, 2005 2

University of Oxford, 2005 3

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