Critical Appraisal of Two Clinical Epidemiology Studies

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Course: Clinical Epidemiology
Date: 7/18/2018
Critical Appraisal Clinical Epidemiology
Study 1
dos Santos LV, Souza FH, Brunetto AT, Sasse AD, da Silveira Nogueira Lima JP. Neurokinin-1
receptor antagonists for chemotherapy-induced nausea and vomiting: a systematic review. J Natl
Cancer Inst. 2012 Sep 5;104(17):1280-92. doi:10.1093/jnci/djs335. Epub 2012 Aug 21. Review.
PubMed PMID: 22911671.”
Step 1
• What was the exposure or intervention?
Some patients were subjected to neurokinin-1 receptor (NK1R) antagonists while on
antiemetic regimes in the treatment of chemotherapy-induced nausea and vomiting (CINV. the
outcome was then compared to the previous reports on effects of NK1R antagonists.
• What was the outcome variable(s) (endpoint(s)?
The primary outcome of the analysis was that CR and nausea were enhanced across
the phases together with sub-groups. The endpoint; anticipated side effects from NK1R antagonists
and those from previous reports had a very small difference. There was a rise from 2% to 6%
critical infection cases in the NK1R antagonist category as revealed by the study.

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• What was the study question(s) / aims?
The questions of the analysis included; CR and nausea improvement using NK1R.Effects
of NK1R antagonists on CINV in the overall phase, acute phase, and the delayed phase. The
effectiveness of sNK1R at both moderately and extremely emetogenic chemotherapy regimens and
lastly, NK1R use in relation to escalated rates of infection.
• What was the study about?
The study was about treatment efficacy of NK1R antagonists on CINV regimens. The
results were positive since NK1R improved nausea and Complete Response treatment.
• Determine the type of the study
The type of study was a systemic review. The study design was a meta-analysis one. the
study was aimed at assessing the capability of NK1R antagonists in improving nausea and
complete response treatment and its impacts on the different regime phases.
• Determine the Study Design
CENTRAL. MEDLINE as well as EMBASE were used as sources for randomized trials .
these experiments enabled examination of the NK1R antagonists together with the standard
antiemetic cure to prevent CINV infection. The absence of emesis and presence of rescue
treatments was explained by a full reaction to CR treatment.
• What was the study population

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Study evaluation population involved 8740 patients on whom, seventeen trials were
performed on. The whole period rate of the complete response was escalated from 54% to 72% ,
0.51, 95%CI=0.46 to 0.57,P<.001. Nausea and complete response enhancement was recorded at all
stages and subgroups. NK1R side effects anticipated almost matched the previous results.
Step 2
THERAPY STUDY: Are the results of the trial valid? (Internal Validity)
What question did the study ask?
Patients –
Intervention -
Comparison -
Outcome(s) –
What question (PICO) did the systematic review address?
What is best? Where do I find the information?
The randomized, scientific tests results in more
accurate results. Involving many participant acts a
backup plan in case of a situation.
The methods section
This paper: Yes  No  Unclear 
Comment:
F - Is it unlikely that important, relevant studies were missed?
What is best? Where do I find the information?
No, there were systematic reference to
the MEDLINE,CENTRAL and EMPACE
information centers.
The methods section
This paper: Yes  No  Unclear 
Comment:
A - Were the criteria used to select articles for inclusion appropriate?
What is best? Where do I find the information?
Yes. systematic criteria reduces any
chances for errors to be experienced in the
course of the tests or in the long run
outcome of an experiment.
The methods section
This paper: Yes  No  Unclear 
Comment:

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A - Were the included studies sufficiently valid for the type of question asked?
What is best? Where do I find the information?
No. The unblinding P-1 tests would change
the results although to an insignificant
magnitude.
The results
This paper: Yes  No  Unclear 
Comment:
T - Were the results similar from study to study?
What is best? Where do I find the information?
Yes, there was observed reduction in
osteoporotic fractures as in the earlier
reports. Also relative risks of stroke , deep
vein thrombosis and cataracts also
depicted similar results as was in the initial
research.
The results section
This paper: Yes  No  Unclear 
Comment:
What were the results?
1. How large was the treatment effect?
Rates of breast cancer together with those of other events were analyzed using the risk
ratios and a95% confidence intervals. Approximations of the achievements of the 5-year
treatment were put in comparison according to the race, age and breast cancer forecast
groups. The statistical tests were also two sided.
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.
In our example, the RR = 0.10/0.15 =
0.67
Since the RR < 1, the treatment decreases the
risk of death.