Non-Inferiority Analysis

Comparisons

Evidence quality

Other

Highlighted claims

• The non-inferiority margin is an adjusted absolute risk difference of 10 percentage points. — Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM
• The planned sample size is based on per-protocol analysis, one-sided alpha 0.025, 90% power, a 10% non-inferiority margin, and 5% expected loss or dropout. — Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM
• The per-protocol analysis is the primary analysis, although both per-protocol and modified intention-to-treat analyses will be performed. — Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM
• Maintenance will be declared non-inferior if the upper bound of the 95% confidence interval for the adjusted risk difference does not exceed 10%. — Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM
• The investigators expect clinically significant postpolypectomy haemorrhage in 7% of patients in both groups. — Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM