Cro Suzie, Mehta Saahil, Farhadi Jian, Coomber Billie, Cornelius Victoria
1Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
2Guy's and St. Thomas' NHS Foundation Trust, London, UK.
Pilot Feasibility Stud. 2018 Jan 17;4:34. doi: 10.1186/s40814-017-0223-y. eCollection 2018.
Essential 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.
PREHEAT 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.
This 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 data analysis for the PREHEAT trial.
ISRCTN ISRCTN15744669. Registered 25 February 2015.
需要采取必要策略来帮助减少接受乳房重建手术的乳腺癌患者的术后并发症数量及相关费用。有证据表明，局部热预处理可通过减少皮肤坏死来改善该手术效果。在通过确定性随机对照试验（RCT）测试热预处理的有效性之前，我们必须首先确定测量皮肤坏死的最佳方法，并使用此定义估计事件发生率。
PREHEAT是一项单盲随机对照可行性试验，比较了使用热水瓶进行局部热预处理与接受乳房重建手术的乳腺癌患者皮肤坏死的标准护理。本研究的主要目的是确定测量皮肤坏死的最佳方法，并使用此定义估计每个试验组的事件发生率。次要可行性目标包括估计招募率和30天随访保留率、加热方案的依从性水平、住院时间以及皮肤坏死的手术治疗与保守治疗率。这些目标所提供的信息将为更大规模的确定性有效性和成本效益RCT的设计提供参考。
本文描述了PREHEAT试验方案和详细的统计分析计划，其中包括用于确定测量坏死最佳方法的预先指定标准和流程。本研究将提供必要证据，以确定测量皮肤坏死的最佳方法，作为未来RCT的主要结局，从而最终测试局部热预处理的有效性。在未盲法提取数据之前制定的预先指定统计分析计划，阐述了分析策略和比较框架，以支持委员会对皮肤坏死测量进行评估。这将提高PREHEAT试验数据分析的透明度。
ISRCTN ISRCTN15744669。2015年2月25日注册。
