Critical appraisal:Hage M, Siersema PD, van Dekken H, Steyerberg EW, Haringsma J, van de Vrie W, et al 2004

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Critical Appraisal

Article being appraised

Hage M, Siersema PD, van Dekken H, Steyerberg EW, Haringsma J, van de Vrie W, et al. 5-aminolevulinic acid photodynamic therapy versus argon plasma coagulation for ablation of Barrett's oesophagus: a randomised trial. Gut 2004 Jun;53(6):785-90 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15138203.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

40


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: Randomisation appeared good and ablation outcomes were assessed blindly by two observers. Follow up was complete. The study appears to have been well conducted. Three treatment arms were including making numbers in each group relatively small. There were two groups treated with different PDT protocols and the third group was treated with APC.

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
2 Reason for decision: The actual p value for the difference in outcome between the three groups is not quoted. A p value of <0,05 is only given. Nonetheless the effect is consistent in all three groups and clearly the treatments do cause regression of Barrett's mucosa.
Relevance of evidence
2 Additional comments: The outcome was assessment of Barrett's regression which a relevant outcome. The treated group were mostly non-dysplastic with a few subjects included with low grade dysplasia. Whether the outcome is transferrable to patients with high grade dysplasia or early stage Barrett's cancer is not clear.
Result of appraisal

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Completed by

Dr Mark Schoeman MBBS, PhD, FRACP, AGAF


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Article
Hage M, Siersema PD, van Dekken H, Steyerberg EW, Haringsma J, van de Vrie W, et al. 5-aminolevulinic acid photodynamic therapy versus argon plasma coagulation for ablation of Barrett's oesophagus: a randomised trial. Gut 2004 Jun;53(6):785-90 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15138203.
Assigned to
User:Mark.schoeman
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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