Critical appraisal:Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al 2014 2

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Critical Appraisal

Article being appraised

Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency ablation vs endoscopic surveillance for patients with Barrett esophagus and low-grade dysplasia: a randomized clinical trial. JAMA 2014 Mar 26;311(12):1209-17 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24668102.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

68


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: very difficult for treatment allocation to be blinded to the patient of researcher - not a blinded study.

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?
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?
Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)
Size of effect
1 Reason for decision: clinically and statistically relevant effect
Relevance of evidence
2 Additional comments: clinically relevant outcome measures of HGD/cancer
Result of appraisal

Jutta's tick icon.png Included



Comments

clearly reduced rate of cancer and HGD in non-treatment group. factors that may limit generalisability are pathological diagnosis of LGD; pre-treatment scope not necessarily performed by expert; in non-treatment arm, they waited another 6m after assessment scope to have next surveillance scope (so may be 1 year); half of progression in the control group was within 1y, so likely prevalent HGD/cancer rather than progression.

Completed by

Dr Andrew Taylor MBBS MD FRACP


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


Article
Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency ablation vs endoscopic surveillance for patients with Barrett esophagus and low-grade dysplasia: a randomized clinical trial. JAMA 2014 Mar 26;311(12):1209-17 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24668102.
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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