Critical appraisal:Cancer Prevention Network, Falk GW, Buttar NS, Foster NR, Ziegler KL, Demars CJ, et al 2012 2

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Critical Appraisal

Article being appraised

Falk GW, Buttar NS, Foster NR, Ziegler KL, Demars CJ, Romero Y, et al. A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. Gastroenterology 2012 Oct;143(4):917-26.e1 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22796132.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

122


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: Inadequate detail on method of randomisation and concealment

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?
I am reasonably certain that the trial was double-blinded (eg identical placebo, active placebo, double-dummy, no revealing side-effects).
Was the treatment allocation schedule concealed?
No concealment or unclear (e.g. no approach described, open randomisation lists, person doing recruitment tossing a coin).
Were all randomised participants included in the analysis?
Exclusions not likely to cause bias (>80% follow-up for all groups, <5% difference in follow-up between groups)
The field below is not considered when calculating the risk of bias rating
How was the allocation schedule generated?
Inadequate or not reported
Size of effect
2 Reason for decision: possible range of change in high dose aspirin and esomprazole group crosses 0
Relevance of evidence
2 Additional comments: surrogate marker only (PGE2) with plausible biological relevance (effects on apoptosis and angiogenesis)
Result of appraisal

Jutta's tick icon.png Included




Completed by

Dr Andrew Taylor MBBS MD FRACP


Jutta's tick icon.png This appraisal has been completed.


Article
Falk GW, Buttar NS, Foster NR, Ziegler KL, Demars CJ, Romero Y, et al. A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. Gastroenterology 2012 Oct;143(4):917-26.e1 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22796132.
Assigned to
User:Andrew.taylor
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


Section below only relevant for Cancer Council Project Officer

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