+1 862 207 3288 Assignment requirements
Critically appraise the article provided – use as guide the supplied instrument/tool (THERAPY
STUDY)
Complete comments in the supplied instrument/tool (THERAPY STUDY)
Are there other biases (in article) that need to be considered that are not highlighted by the
tool you utilised? If so, please highlight these and their possible implications.
Come to a clinical decision for the Case Study below (based on the information/evidence
you found in the article). That is, explain recommendation to the patient. Take into account
risk:benefit considerations, patient autonomy, and any other factors you believe are relevant
to this case.
CASE STUDY
Sarrah Fawcett is a 54 year old woman and long-time resident of Tasmania. She has recently been
diagnosed with osteoarthritis (OA) of her right knee. ‘It makes bowls far less fun than it used to
be’ she says. ‘My left knee has a bit of stiffness, but it is my right one that causes me grief.’ She
tells you that she is reluctant to take any pharmaceuticals for her OA and would prefer natural
treatments. ‘My bowls partner Kate told me that she swears by krill oil to keep a spring in her step.
And I saw an ad for some in my local chemist.’ She wants your opinion as to whether she should
use krill oil to treat her OA. She is not currently taking any pharmaceutical medications and, upon
questioning, the only CM she is taking is vitamin D (1000 IU/day).
Instrument/Tool
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 and often used in multicentred trials. Smaller trials may
use an independent person (e.g, the
hospital pharmacy) to “police” the
randomization.
The Methods should tell you how
patients were allocated to groups and
whether or not randomisation was
concealed.
This paper: Yes No Unclear
Comment:
1b. R- Were the groups similar at the start of the trial?
What is best? Where do I find the information?
If the randomisation process worked
(that is, achieved comparable groups)
the groups should be similar. The
more similar the groups the better it
is.
There should be some indication of
whether differences between groups
are statistically significant (ie. p
The Results should have a table of
“Baseline Characteristics” comparing
the randomized groups on a number
of variables that could affect the
outcome (ie. age, risk factors etc). If
not, there may be a description of
group similarity in the first
values). paragraphs of the Results section.
This paper: Yes No Unclear
Comment:
2a. A – Aside from the allocated treatment, were groups treated
equally?
What is best? Where do I find the information?
Apart from the intervention the
patients in the different groups
should be treated the same, eg.,
additional treatments or tests.
Look in the Methods section for the
follow-up schedule, and permitted
additional treatments, etc and in
Results for actual use.
This paper: Yes No Unclear
Comment:
2b. A – Were all patients who entered the trial accounted for? – and
were they analysed in the groups to which they were randomised?
What is best? Where do I find the information?
Losses to follow-up should be minimal
– preferably less than 20%.
However, if few patients have the
outcome of interest, then even small
losses to follow-up can bias the
results. Patients should also be
analysed in the groups to which they
were randomised – ‘intention-to-treat
analysis’.
The Results section should say how
many patients were 3andomised (eg.,
Baseline Characteristics table) and
how many patients were actually
included in the analysis. You will need
to read the results section to clarify
the number and reason for losses to
follow-up.
This paper: Yes No Unclear
Comment:
3. M – Were measures objective or were the patients and clinicians
kept “blind” to which treatment was being received?
What is best? Where do I find the information?
It is ideal if the study is ‘doubleblinded’ – that is, both patients and
investigators are unaware of
treatment allocation. If the outcome
is objective (eg., death) then blinding
is less critical. If the outcome is
subjective (eg., symptoms or
function) then blinding of the
outcome assessor is critical.
First, look in the Methods section to
see if there is some mention of
masking of treatments, eg., placebos
with the same appearance or sham
therapy. Second, the Methods section
should describe how the outcome was
assessed and whether the assessor/s
were aware of the patients’
treatment.
This paper: Yes No Unclear
Comment:
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 treatment group
/ risk of the outcome in the
control group.
The relative risk tells us how many times
more likely it is that an event will occur in
the treatment group relative to 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.
Absolute Risk Reduction (ARR) =
risk of the outcome in the
control group – risk of the
outcome in the treatment group.
This is also known as the
absolute risk difference.
The absolute risk reduction tells us the
absolute difference in the rates of
events between the two groups and gives
an indication of the baseline risk and
treatment effect. An ARR of 0 means
that there is no difference between the
two groups thus, the treatment had no
effect.
Relative Risk Reduction (RRR) =
absolute risk reduction / risk of
the outcome in the control group.
An alternative way to calculate
the RRR is to subtract the RR
from 1 (eg. RRR = 1 – RR)
The relative risk reduction is the
complement of the RR and is probably the
most commonly reported measure of
treatment effects. It tells us the
reduction in the rate of the outcome in
the treatment group relative to that in
the control group.
Number Needed to Treat
(NNT) = inverse of the ARR and
is calculated as 1 / ARR.
The number needed to treat represents
the number of patients 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.
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?
• Reference using Vancouver style
• Use justified margins.
• Use Times New Roman font size of 12 points.
• Use an English Dictionary for spelling (not American).
• ORIGINAL WORK
• CRITICAL APPRAISAL THE ARTICLE PROVITED
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