Critical appraisal:Bright T, Watson DI, Tam W, Game PA, Astill D, Ackroyd R, et al 2007 2

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Critical Appraisal

Article being appraised

Bright T, Watson DI, Tam W, Game PA, Astill D, Ackroyd R, et al. Randomized trial of argon plasma coagulation versus endoscopic surveillance for barrett esophagus after antireflux surgery: late results. Ann Surg 2007 Dec;246(6):1016-20 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18043104.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

58


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: Well conducted study looking at the long term outcome after ablation using APC. The investigators were not blinded to the outcome. Follow up 5 years after initial therapy is important information for the question being addressed. Follow up after 5 years fell off to about 70% of the initial groups. Drop outs occurred equally in the two groups and are unlikely to influence results.

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?
Outcomes not blinded, substantial side-effects, or not reported.
Was the treatment allocation schedule concealed?
Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).
Were all randomised participants included in the analysis?
Too many exclusions, differential loss in comparison groups, or not reported.
The field below is not considered when calculating the risk of bias rating
How was the allocation schedule generated?
Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)
Size of effect
2 Reason for decision: There was regression seem in both treatment and control arms of the study. The effect in the treatment group was significantly greater.
Relevance of evidence
2 Additional comments: The study was conducted in patients with non-dysplastic Barrett's mucosa.
Result of appraisal

Jutta's tick icon.png Included



Comments

Important study as it contributes to the question as to the durability of the Barrett's mucosa regression after ablation. The significant regression seen in the control arm is probably due to the fact that the study population was confined to patients whose reflux was controlled with a surgical fundoplication rather than medical therapy. This is a very important distinction as nearly all if not all studies evaluating ablation therapy use medical therapy (medication) to control reflux as part of their study design. The adequacy of reflux disease appears important to the outcome of all ablation therapies.

Completed by

Dr Mark Schoeman MBBS, PhD, FRACP, AGAF


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


Article
Bright T, Watson DI, Tam W, Game PA, Astill D, Ackroyd R, et al. Randomized trial of argon plasma coagulation versus endoscopic surveillance for barrett esophagus after antireflux surgery: late results. Ann Surg 2007 Dec;246(6):1016-20 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18043104.
Assigned to
User:Mark.schoeman
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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