Critical appraisal:Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al 2015 3

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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
minimisation technique
What was the risk of bias from the random sequence generation?Jutta's question mark icon.png
Low
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
local pharmacist that did the randomisation was unmasked for allocated treatment
What was the risk of bias from the allocation concealment?Jutta's question mark icon.png
High
Blinding
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
no details reported
What was the risk of bias from the blinding of participants and personnel and outcome assessors?Jutta's question mark icon.png
Unclear
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
intention to treat population as well as safety analysis for treated pts.
What was the risk of bias from incomplete outcome data?Jutta's question mark icon.png
Low
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
No response
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
Low
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
Low
Overall risk of bias
Unclear risk of bias Additional comments:


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


Article
Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol 2015 May;16(5):522-30 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25840693.
Assigned to
User:Cecilia.taing
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Quality appraisal rct-cochrane


Section below only relevant for Cancer Council Project Officer

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