Critical appraisal:Sie C, Bright T, Schoeman M, Game P, Tam W, Devitt P, et al 2013 2

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Critical Appraisal

Article being appraised

Sie C, Bright T, Schoeman M, Game P, Tam W, Devitt P, et al. Argon plasma coagulation ablation versus endoscopic surveillance of Barrett's esophagus: late outcomes from two randomized trials. Endoscopy 2013 Sep 9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24019134.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

129


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: Follow up endoscopies were performed blinded to the original therapy. Whilst the allocation of patients was randomised there is no description of the randomisation protocol.

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?
Trial was double-blinded but may have limitations (eg method of blinding inappropriate, tablet vs injection with no double-dummy, different treatment schedules, side-effects may unblind)

or
single-blinded (eg outcomes assessed blind, objective outcomes, 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: It is not clear that ablation of non-dysplastic Barrett's has clinical relevance.
Relevance of evidence
3 Additional comments: The study focuses on treatment of non-dysplastic Barrett's. Whilst ablation is effective it not clear if this is of benefit in long term outcome for the patients. There is a trend to a larger number of patients developing dysplasia in the control group compared to the treated group.
Result of appraisal

Jutta's tick icon.png Included




Completed by

Dr Mark Schoeman MBBS, PhD, FRACP, AGAF


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


Article
Sie C, Bright T, Schoeman M, Game P, Tam W, Devitt P, et al. Argon plasma coagulation ablation versus endoscopic surveillance of Barrett's esophagus: late outcomes from two randomized trials. Endoscopy 2013 Sep 9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24019134.
Assigned to
User:Mark.schoeman
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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