Statistical analysis plan for the 'Does longer peripheral intravenous catheter Length optimise Antimicrobial Delivery: a randomised controlled trial to reduce interruptions to intravenous antimicrobial delivery (The LEADER Study)'.
El-Heneidy, A.; Ware, R. S.; O Brien, C.; Larsen, E.; Marsh, N.; Corley, A.
Show abstract
The "Does longer peripheral intravenous catheter (PIVC) Length optimise Antimicrobial Delivery: a randomised controlled trial to reduce interruptions to intravenous antimicrobial delivery (The LEADER Study)", is a randomised controlled trial (RCT). This RCT aims to assess if long peripheral intravenous catheters (PIVCs) (4.5-6.4 cm) when compared with short-PIVCs (<4 cm) optimise antimicrobial delivery by reducing PIVC failure rates. The purpose for this document is to minimise bias and ensure transparency and internal validity for the findings of the trial, by defining and making publicly available the analysis approach prior to reviewing or analysing trial data. The statistical analysis plan (SAP) will inform analysis and reporting of the main effectiveness findings of the trial. It provides a detailed description of the primary and secondary trial outcomes and the methods for statistical comparison.
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