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The HONEYPOT randomized controlled trial statistical analysis plan

Pascoe, Elaine Mary, Lo, Serigne, Scaria, Anish, Badve, Sunil V., Beller, Elaine Mary, Cass, Alan, Hawley, Carmel and Johnson, David (2013). The HONEYPOT randomized controlled trial statistical analysis plan. Peritoneal Dialysis International,33(4):426-435.

Document type: Journal Article
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IRMA ID 11035xPUB79
Title The HONEYPOT randomized controlled trial statistical analysis plan
Author Pascoe, Elaine Mary
Lo, Serigne
Scaria, Anish
Badve, Sunil V.
Beller, Elaine Mary
Cass, Alan
Hawley, Carmel
Johnson, David
Journal Name Peritoneal Dialysis International
Publication Date 2013
Volume Number 33
Issue Number 4
ISSN 0896-8608   (check CDU catalogue  open catalogue search in new window)
Start Page 426
End Page 435
Total Pages 10
Place of Publication Canada
Publisher Multimed, Inc
HERDC Category C1 - Journal Article (DIISR)
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.

Keywords Randomized controlled trial
Statistical analysis plan
Outcome reporting bias
Pre-specified statistical analysis
International Conference on Harmonization
Intention-to-treat
Catheter-associated infections
DOI http://dx.doi.org/10.3747%2Fpdi.2012.00310   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Open access True
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited
Description for Link Link to CC Attribution 4.0 License
URL https://creativecommons.org/licenses/by/4.0/au/legalcode


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