| 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
|
|---|---|
| Published in |
Pilot and Feasibility Studies, January 2018
|
| DOI | 10.1186/s40814-017-0223-y |
| Pubmed ID | |
| Authors |
Suzie Cro, Saahil Mehta, Jian Farhadi, Billie Coomber, Victoria Cornelius |
| Abstract |
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. |
X Demographics
The data shown below were collected from the profiles of 19 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 13 | 68% |
| United States | 4 | 21% |
| Unknown | 2 | 11% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 8 | 42% |
| Practitioners (doctors, other healthcare professionals) | 5 | 26% |
| Scientists | 5 | 26% |
| Science communicators (journalists, bloggers, editors) | 1 | 5% |
Mendeley readers
The data shown below were compiled from readership statistics for 30 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 30 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 4 | 13% |
| Other | 3 | 10% |
| Researcher | 3 | 10% |
| Unspecified | 2 | 7% |
| Student > Bachelor | 2 | 7% |
| Other | 3 | 10% |
| Unknown | 13 | 43% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 6 | 20% |
| Unspecified | 2 | 7% |
| Economics, Econometrics and Finance | 2 | 7% |
| Nursing and Health Professions | 1 | 3% |
| Computer Science | 1 | 3% |
| Other | 5 | 17% |
| Unknown | 13 | 43% |
Attention Score in Context
This research output has an Altmetric Attention Score of 11. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 April 2018.
All research outputs
#3,215,601
of 25,402,889 outputs
Outputs from Pilot and Feasibility Studies
#189
of 1,234 outputs
Outputs of similar age
#69,763
of 451,337 outputs
Outputs of similar age from Pilot and Feasibility Studies
#4
of 40 outputs
Altmetric has tracked 25,402,889 research outputs across all sources so far. Compared to these this one has done well and is in the 87th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,234 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.5. This one has done well, scoring higher than 84% of its peers.
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We're also able to compare this research output to 40 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 92% of its contemporaries.