Evidence Based Medicine Critical Appraisal

Running Head: EVIDENCE BASED MEDICINE CRITICAL APPRAISAL
EVIDENCE BASED MEDICINE CRITICAL APPRAISAL
Name of the Student:
Name of the University:
Author Note:

EVIDENCE BASED MEDICINE CRITICAL APPRAISAL1
Study Design Questions:
Question 1
The study (Cannon et al, 2015) design that had been applied in the mentioned study has been
conducted with the help of randomized controlled trial, where the people are subjected to receive
one of several clinical interventions. The survey state that a randomized trial was conducted on
18,144 patients who had been under hospitalization due to acute coronary syndrome with LDL
cholesterol levels that range from 50 to 100 mg per deciliter.
Question 2
Placebo-controlled studies are a way to assess a medical intervention by which a different
control sample, in reference to a community of patients undergoing the care to be tested,
experiences a simulated "placebo" medication that is primarily designed to have very little
tangible effect. The study (Cannon et al, 2015) conducted was a placebo-controlled study where
the patients who participated in the double-blind fashioned randomized controlled trial, were
given either simvastatin at a dosage of 40 mg along with ezetimibe at a dosage of 10 mg along
with the other mono group or the placebo group being only given simvastatin. The study for
placebo controlled group was conducted as the placebos are generally used as a passive trigger in
clinical trials, since the scientists can properly assess the totally accurate impact of the drug
therapy under analysis.
Question 3
The study projected that the control groups and the treatment groups were comparable
(Cannon et al, 2015) that the danger ratio was found out for minimizing significant coronary

EVIDENCE BASED MEDICINE CRITICAL APPRAISAL2
accidents. The simvastatin-ezetimibe group was compared to the simvastatin-monotherapy
group and is supported by data from several other statin experiments that evaluated the relation
between LDL shift and medical benefits.
Question 4
Blinding is mainly used in the clinical trials in tandem with randomization. Blinding is being
mainly used to restrict the frequency of rational and irrational disadvantages in the execution of
drug trials (performance bias) and result perception (ascertainment bias). Both the experimenters
as well as the participants in the survey were blinded in the said trial as they had no idea of
which of the either group was receiving the placebo-monotherapy treatment or the simvastatin-
ezetimibe treatment.
Question 5
The analysis methodology of the results was conducted on the basis of post-hoc tests. Post-hoc
tests are usually the comparisons conducted by the researchers post collecting data. Here in the
mentioned study, a total amount of 18, 144 patients were considered in the randomized trial from
1147 sites placed in 39 countries between 26th October, 2005 and 8th July, 2010.
Question 6
The study (Cannon et al, 2015) was funded by the Merck; IMPROVE-IT ClinicalTrials.gov
number, NCT00202878. The 80-mg simvastatin dosage was used more in the simvastatin
monotherapy (placebo) community than those in the simvastatin– ezetimibe group. Relevant
conflict of interests were detected in between both the study groups. Either of the predetermined
protection data sources or the risk of cessation of test treatment are caused due to adverse effects.

EVIDENCE BASED MEDICINE CRITICAL APPRAISAL3
Hemorrhagic stroke rates are found to be much higher though, with simvastatin – ezetimibe,
however not substantially so, than those of simvastatin monotherapy (placebo), a result close to
that seen with statin therapy associated with placebo.
Question 7
The primary end point or outcome for the study was cardiovascular death, nonfatal
myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization
(≥30 days after randomization), or nonfatal stroke. The review of findings related to these
primary end points revealed that simvastatin monotherapy resulted in primary outcomes such as
cardiovascular deaths and nonfatal stroke in 34.7% of patient and for patients receiving
combination therapy, 32.7% experienced these symptoms. This rate was for seven years with a
hazard ratio of 95% and P value of 0.016. Measurement of these outcome was clinically
appropriate as the research has revealed that high dose statin therapy leads to increased risk of
cardiovascular events (Dorresteijn et al., 2013). Thus, to compare the efficacy of different statin
therapies, collecting data related to cardiovascular events was most appropriate to understand
which therapies have low safety concerns.
Statistical Analysis and reporting of the result as well as Clinical significance
Question 1
Throughout the ultimate report, relative risk was more for the primary endpoint with
simvastatin–ezetimibe than with simvastatin monotherapy. Moreover, it was determined that in
order to recognize a 9.375 percent reduction. Both safety and effectiveness analyzes were
performed in the community intended-to-treat. The panel of information and resources managers
completed 10 safety tests. However, after 45.7 percent, 76.1 percent, and 86.9 percent of the