Critical appraisal:Van Vilsteren FG, Phoa KN, Alvarez Herrero L, Pouw RE, Sondermeijer CM, Visser M, et al 2013

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Critical Appraisal

Article being appraised

van Vilsteren FG, Phoa KN, Alvarez Herrero L, Pouw RE, Sondermeijer CM, Visser M, et al. A simplified regimen for focal radiofrequency ablation of Barrett's mucosa: a randomized multicenter trial comparing two ablation regimens. Gastrointest Endosc 2013 Jul;78(1):30-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23528655.


Applicable clinical question

Key Facts

Study Design

case series

Number of Patients:

40


Includes an economic evaluation

no

Evidence ratings

Level of evidence

III-3

Risk of bias
Moderate risk of bias Comments: The study population had already had some treatment for Barrett's and this study looked at response to subsequent treatment. The population is therefore biased due to selection based on their initial treatment response. Power calculations suggested 46 patients were required but only 45 were included due a protocol violation in one patient. In 5 patients comparisons of the treatment modalities were compared twice. I am not sure if this is a valid as this could introduce bias.

Risk of bias assessment: case series

Subject selection:
Selected group (e.g. multi-institution study)
Were the outcome measures blind to pre/post-intervention?
No, but objective measures used
Follow-up complete and all patients included in the analysis?
Yes (follow-up >95%)
Size of effect
1 Reason for decision: The confidence interval is -10.6 to +20.9 which crosses 1 and suggests that the two compared interventions are not significant different.
Relevance of evidence
2 Additional comments: RFA has been shown to successfully ablate Barrett's mucosa. This study looks at two different methods of RFA application which were subsequently found to be non-inferior (comparable)
Result of appraisal

Jutta's exclamation mark icon.png Excluded

Reason for decision

The study looks at 2 variations of RFA treatment in a group already selected as probable responders. There is no control group and the treatments are repeated in some patients and counted twice. I do not think this data contributes to answering the posed question.


Completed by

Dr Mark Schoeman MBBS, PhD, FRACP, AGAF


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


Article
van Vilsteren FG, Phoa KN, Alvarez Herrero L, Pouw RE, Sondermeijer CM, Visser M, et al. A simplified regimen for focal radiofrequency ablation of Barrett's mucosa: a randomized multicenter trial comparing two ablation regimens. Gastrointest Endosc 2013 Jul;78(1):30-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23528655.
Assigned to
User:Mark.schoeman
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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