TY - JOUR
T1 - The HONEYPOT randomized controlled trial statistical analysis plan
AU - Pascoe, Elaine
AU - Lo, Serigne
AU - Scaria, Anish
AU - Badve, Sunil
AU - Beller, Elaine
AU - Cass, Alan
AU - Hawley, Carmel
AU - Johnson, David
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
UR - http://www.pdiconnect.com/content/33/4/426
UR - http://www.scopus.com/inward/record.url?scp=84880066935&partnerID=8YFLogxK
U2 - 10.3747/pdi.2012.00310
DO - 10.3747/pdi.2012.00310
M3 - Article
SN - 0896-8608
VL - 33
SP - 426
EP - 435
JO - Peritoneal Dialysis International
JF - Peritoneal Dialysis International
IS - 4
ER -