Critical appraisal:Van Vilsteren FG, Pouw RE, Seewald S, Alvarez Herrero L, Sondermeijer CM, Visser M, et al 2011 3

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Critical Appraisal

Article being appraised

van Vilsteren FG, Pouw RE, Seewald S, Alvarez Herrero L, Sondermeijer CM, Visser M, et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut 2011 Jun;60(6):765-73 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21209124.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

47


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
Moderate risk of bias Comments: Please replace this text and include any additional comments in regards to your quality rating

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?
Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).
Were all randomised participants included in the analysis?
No exclusions or survival analysis used with all subjects included (>95% follow-up for all groups).
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
1 Reason for decision: Significant clinical difference in stenosis rates.
Relevance of evidence
1 Additional comments: Demonstrates that following endoscopic resection of the neoplastic focus, the rates of remission from neoplasia at median follow up of 24 months were comparably high at 95% and 100%, respectively. There was a significantly increased rate of stenosis in the stepwise resection arm of 88% compared to 14%
Result of appraisal

Jutta's tick icon.png Included




Completed by

Dr Farzan Fahrtash Bahin, MBBS (Hons), MPhil (Med)


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


Article
van Vilsteren FG, Pouw RE, Seewald S, Alvarez Herrero L, Sondermeijer CM, Visser M, et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut 2011 Jun;60(6):765-73 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21209124.
Assigned to
User:Michael.bourke
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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