Critical appraisal:Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, et al 2003

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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
Subjects who successfully completed a 4-week run-in period by consuming at least 80% of the daily 300 mg of lysine acetylsalicylate dispensed were assigned randomly to receive either placebo or lysine acetylsalicylate (160 or 300 mg/day). Randomization was balanced every 4 patients: one was allocated to 160 mg lysine acetylsalicylate, one to 300 mg lysine acetylsalicylate, and 2 were allocated to placebo.


Treatments were allocated by the independent randomization center, which was responsible for randomization, preparation, and distribution of treatment packages.

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
Subjects who successfully completed a 4-week run-in period by consuming at least 80% of the daily 300 mg of lysine acetylsalicylate dispensed were assigned randomly to receive either placebo or lysine acetylsalicylate (160 or 300 mg/day). Randomization was balanced every 4 patients: one was allocated to 160 mg lysine acetylsalicylate, one to 300 mg lysine acetylsalicylate, and 2 were allocated to placebo. Lysine acetylsalicylate was administered in the form of one sachet to be diluted in a glass of water. Placebo with the same appearance and taste was made of the same excipient as the active treatment.
What was the risk of bias from the allocation concealment?Jutta's question mark icon.png
Low
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
Placebo with the same appearance and taste was made of the same excipient as the active treatment. Patients, staff in the Association pour la Pre´vention par l’Aspirine du Cancer Colorectal coordination center, and study investigators were not aware of the treatment assignments
What was the risk of bias from the blinding of participants and personnel and outcome assessors?Jutta's question mark icon.png
Low
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
Of the 272 subjects who were randomized, 238 (87.5%) underwent the colonoscopy 1 year after enroll-ment (Figure 1). No interim examinations before the year 1 colonoscopy were performed. The proportion with year 1 colonoscopies did not differ between the treatment groups (90% of the subjects in the aspirin group and 85% in the placebo group). A full examination of the colon was completed for all patients.
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
The proportion with year 1 colonoscopies did not differ between the treatment groups (90% of the subjects in the aspirin group and 85% in the placebo group).
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
What was the risk of bias from other sources?Jutta's question mark icon.png
Low
Overall risk of bias
High risk of bias Additional comments: Please replace this text and include any additional comments in regards to your risk of bias rating


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


Article
Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, et al. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology 2003 Aug;125(2):328-36 Available from: http://www.ncbi.nlm.nih.gov/pubmed/12891533.
Assigned to
User:Albert.chetcuti
Topic area
Guidelines:Colorectal cancer
Clinical question
Form
Form:Quality appraisal rct-cochrane


Section below only relevant for Cancer Council Project Officer

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