title: The HONEYPOT randomized controlled trial statistical analysis plan.
abstract: BACKGROUND
  The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients.
  
  
  OBJECTIVE
  To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial.
  
  
  METHODS
  Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes.
  
  
  RESULTS
  A statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
  
  
  CONCLUSIONS
  Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.
authors.affiliation: School of Medicine, University of Queensland, Brisbane, Australia.
authors.forename: Elaine Mary
authors.initials: EM
authors.lastname: Pascoe
authors.forename: Serigne
authors.initials: S
authors.lastname: Lo
authors.forename: Anish
authors.initials: A
authors.lastname: Scaria
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Badve
authors.forename: Elaine Mary
authors.initials: EM
authors.lastname: Beller
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.forename: Carmel Mary
authors.initials: CM
authors.lastname: Hawley
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
mesh_terms: D055499:Catheter-Related Infections / Q000517:prevention & control*; D002408:Catheters, Indwelling / Q000382:microbiology*; D005260:Female; D006722:Honey; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D009666:Nose / Q000382:microbiology; D010530:Peritoneal Dialysis; D012107:Research Design; D013203:Staphylococcal Infections / Q000517:prevention & control; D013211:Staphylococcus aureus / Q000302:isolation & purification
keywords: International Conference on Harmonization; Randomized controlled trial; catheter-associated infections; intention-to-treat; outcome reporting bias; pre-specified statistical analyses; statistical analysis plan