Critical appraisal:Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM 2010

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Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)

Random sequence generation
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.Jutta's question mark icon.png
An independent clinical research organisation used a computer-generated randomisation schedule with a block size of eight to assign eligible patients to treatment on days 1 and 2 (Arm A) or days 1 and 8 (Arm B) and within each group to treatment with ingenol mebutate gel, 0.0025%, 0.01% or 0.05% or matching vehicle gel. Patients were randomised and assigned to active treatment or vehicle in a ratio of 8:2.
What was the risk of bias from the random sequence generation?Jutta's question mark icon.png
Allocation concealment
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of or during, enrolment.Jutta's question mark icon.png
Study medication was labelled with a patient number before the trial commenced and patients were allocated sequentially at each centre according to the randomisation schedule.

Active and vehicle gels were physically indistinguishable and identical packaging was used to maintain concealment of both the investigator and patients regarding allocation to treatment.

What was the risk of bias from the allocation concealment?Jutta's question mark icon.png
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.Jutta's question mark icon.png
Active and vehicle gels had same packaging
What was the risk of bias from the blinding of participants and personnel and outcome assessors?Jutta's question mark icon.png
Incomplete outcome data
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.Jutta's question mark icon.png
Arm A (n=30) Arm B (n=30)

2 patients (1x0.01% IM; 1x0.05% IM) in the Arm A group discontinued due to AE.

Response rates
No attrition/exclusions

What was the risk of bias from incomplete outcome data?Jutta's question mark icon.png
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.Jutta's question mark icon.png
Safety and efficacy of IM gel was reported on by authors
What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).Jutta's question mark icon.png
Other sources of bias
Describe any other sources of biasJutta's question mark icon.png
No response
What was the risk of bias from other sources?Jutta's question mark icon.png
Overall risk of bias
Low risk of bias Additional comments:

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

Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. Australas J Dermatol 2010 May;51(2):99-105 Available from:
Assigned to
Topic area
Guidelines:Keratinocyte carcinoma/Private
Clinical question
Form:Quality appraisal rct-cochrane

Section below only relevant for Cancer Council Project Officer

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