Imperial College London
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ProfessorVictoriaCornelius

Faculty of Medicine, School of Public Health

Professor in Medical Statistics and Trials Methodology
 
 
 
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Contact

 

+44 (0)20 7594 1218v.cornelius

 
 
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Assistant

 

Mrs Ranjit Rayat +44 (0)20 7594 3445

 
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Location

 

111Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Cro:2018:10.1186/s40814-017-0223-y,
author = {Cro, SM and Mehta, S and Farhadi, J and Coomber, B and Cornelius, V},
doi = {10.1186/s40814-017-0223-y},
journal = {Pilot and Feasibility Studies},
title = {Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery; study protocol and statistical analysis plan for the PREHEAT trial},
url = {http://dx.doi.org/10.1186/s40814-017-0223-y},
volume = {4},
year = {2018}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundEssential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local heat preconditioning could help improve the provision of this procedure by reducing skin necrosis. Before testing the effectiveness of heat preconditioning in a definitive randomised controlled trial (RCT), we must first establish the best way to measure skin necrosis and estimate the event rate using this definition.MethodsPREHEAT is a single-blind randomised controlled feasibility trial comparing local heat preconditioning, using a hot water bottle, against standard care on skin necrosis among breast cancer patients undergoing reconstructive breast surgery. The primary objective of this study is to determine the best way to measure skin necrosis and to estimate the event rate using this definition in each trial arm. Secondary feasibility objectives include estimating recruitment and 30 day follow-up retention rates, levels of compliance with the heating protocol, length of stay in hospital and the rates of surgical versus conservative management of skin necrosis. The information from these objectives will inform the design of a larger definitive effectiveness and cost-effectiveness RCT.DiscussionThis article describes the PREHEAT trial protocol and detailed statistical analysis plan, which includes the pre-specified criteria and process for establishing the best way to measure necrosis. This study will provide the evidence needed to establish the best way to measure skin necrosis, to use as the primary outcome in a future RCT to definitively test the effectiveness of local heat preconditioning. The pre-specified statistical analysis plan, developed prior to unblinded data extraction, sets out the analysis strategy and a comparative framework to support a committee evaluation of skin necrosis measurements. It will increase the transparency of the dat
AU  - Cro,SM
AU  - Mehta,S
AU  - Farhadi,J
AU  - Coomber,B
AU  - Cornelius,V
DO  - 10.1186/s40814-017-0223-y
PY  - 2018///
SN  - 2055-5784
TI  - Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery; study protocol and statistical analysis plan for the PREHEAT trial
T2  - Pilot and Feasibility Studies
UR  - http://dx.doi.org/10.1186/s40814-017-0223-y
UR  - http://hdl.handle.net/10044/1/55422
VL  - 4
ER  -
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