Non-Inferiority Study Design

Other

Highlighted claims

• The study was a prospectively designed, single-centre paired comparison non-inferiority study in a district general hospital in Southwest England. — Clean pulp versus sterile plastic for mid-stream urine collection: a paired equivalence study comparing the microbiological performance of a novel low carbon collection device with the standard of care
• Each patient provided one mid-stream urine sample from which both control and Pee-in-Pot specimens were produced. — Clean pulp versus sterile plastic for mid-stream urine collection: a paired equivalence study comparing the microbiological performance of a novel low carbon collection device with the standard of care
• Microbiology technicians were blinded to whether specimens came from the Pee-in-Pot or control arm. — Clean pulp versus sterile plastic for mid-stream urine collection: a paired equivalence study comparing the microbiological performance of a novel low carbon collection device with the standard of care
• The planned sample size was 1350 paired urine samples with a 2.5% non-inferiority margin for E. coli positive culture rates. — Clean pulp versus sterile plastic for mid-stream urine collection: a paired equivalence study comparing the microbiological performance of a novel low carbon collection device with the standard of care