Critical appraisal:Kelty CJ, Ackroyd R, Brown NJ, Stephenson TJ, Stoddard CJ, Reed MW 2004

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Critical Appraisal

Article being appraised

Kelty CJ, Ackroyd R, Brown NJ, Stephenson TJ, Stoddard CJ, Reed MW. Endoscopic ablation of Barrett's oesophagus: a randomized-controlled trial of photodynamic therapy vs. argon plasma coagulation. Aliment Pharmacol Ther 2004 Dec;20(11-12):1289-96 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15606390.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial — The title states that the study is "a randomised-controlled trial" but there is in fact no control group. The patients are randomly allocated to one of two treatment arms (PDT vs APC)

Number of Patients:

68


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: The study was not completely blinded but some of the early follow up (outcome) images were scored by two blinded observers. The randomisation was performed by computer but level of concealment is unclear. Some patients were lost to follow up for various reasons not clearly related to therapy. These few were evenly distributed between the two study arms.

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?
Inadequately concealed (e.g. numbered/sealed envelopes, alternation, medical record number, date of birth).
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?
Inadequate or not reported
Size of effect
1 Reason for decision: The p value comparing APC to PDT was 0.0001. This suggests a very significant difference between the two treatment arm.
Relevance of evidence
2 Additional comments: The treatments were able to ablated Barrett's mucosa but APC was statistically more effective than PDT.
Result of appraisal

Jutta's tick icon.png Included



Comments

The study included power calculations with a hypothesis of a possible 25% difference between the two treatment arms. They required 28 patients in each arm and 34 were included in each. A reasonably rigorous study

Completed by

Dr Mark Schoeman MBBS, PhD, FRACP, AGAF


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


Article
Kelty CJ, Ackroyd R, Brown NJ, Stephenson TJ, Stoddard CJ, Reed MW. Endoscopic ablation of Barrett's oesophagus: a randomized-controlled trial of photodynamic therapy vs. argon plasma coagulation. Aliment Pharmacol Ther 2004 Dec;20(11-12):1289-96 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15606390.
Assigned to
User:Mark.schoeman
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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