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The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study

BACKGROUND: Accurate prediction of outcomes following surgery with high morbidity and mortality rates is essential for informed shared decision-making between patients and clinicians. It is unknown how accurately healthcare professionals predict outcomes following major lower-limb amputation (MLLA)....

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Autores principales: Gwilym, Brenig L, Waldron, Cherry-Ann, Thomas-Jones, Emma, Preece, Ryan, Milosevic, Sarah, Brookes-Howell, Lucy, Pallmann, Philip, Harris, Debbie, Massey, Ian, Burton, Jo, Stewart, Philippa, Samuel, Katie, Jones, Sian, Cox, David, Edwards, Adrian, Twine, Chris, Bosanquet, David C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8634116/
https://www.ncbi.nlm.nih.gov/pubmed/34849576
http://dx.doi.org/10.1093/bjsopen/zrab118
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author Gwilym, Brenig L
Waldron, Cherry-Ann
Thomas-Jones, Emma
Preece, Ryan
Milosevic, Sarah
Brookes-Howell, Lucy
Pallmann, Philip
Harris, Debbie
Massey, Ian
Burton, Jo
Stewart, Philippa
Samuel, Katie
Jones, Sian
Cox, David
Edwards, Adrian
Twine, Chris
Bosanquet, David C
author_facet Gwilym, Brenig L
Waldron, Cherry-Ann
Thomas-Jones, Emma
Preece, Ryan
Milosevic, Sarah
Brookes-Howell, Lucy
Pallmann, Philip
Harris, Debbie
Massey, Ian
Burton, Jo
Stewart, Philippa
Samuel, Katie
Jones, Sian
Cox, David
Edwards, Adrian
Twine, Chris
Bosanquet, David C
author_sort Gwilym, Brenig L
collection PubMed
description BACKGROUND: Accurate prediction of outcomes following surgery with high morbidity and mortality rates is essential for informed shared decision-making between patients and clinicians. It is unknown how accurately healthcare professionals predict outcomes following major lower-limb amputation (MLLA). Several MLLA outcome-prediction tools have been developed. These could be valuable in clinical practice, but most require validation in independent cohorts before routine clinical use can be recommended. The primary aim of this study is to evaluate the accuracy of healthcare professionals’ predictions of outcomes in adult patients undergoing MLLA for complications of chronic limb-threatening ischaemia (CLTI) or diabetes. Secondary aims include the validation of existing outcome-prediction tools. METHOD: This study is an international, multicentre prospective observational study including adult patients undergoing a primary MLLA for CLTI or diabetes. Healthcare professionals’ accuracy in predicting outcomes at 30-days (death, morbidity and MLLA revision) and 1-year (death, MLLA revision and ambulation) will be evaluated. Sixteen existing outcome-prediction tools specific to MLLA will be examined for validity. Data collection began on 1 October 2020; the end of follow-up will be 1 May 2022. The C-statistic, Hosmer–Lemeshow test, reclassification tables and Brier score will be used to evaluate the predictive performance of healthcare professionals and prediction tools, respectively. STUDY REGISTRATION AND DISSEMINATION: This study will be registered locally at each centre in accordance with local policies before commencing data collection, overseen by local clinician leads. Results will be disseminated to all centres, and any subsequent presentation(s) and/or publication(s) will follow a collaborative co-authorship model.
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spelling pubmed-86341162021-12-01 The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study Gwilym, Brenig L Waldron, Cherry-Ann Thomas-Jones, Emma Preece, Ryan Milosevic, Sarah Brookes-Howell, Lucy Pallmann, Philip Harris, Debbie Massey, Ian Burton, Jo Stewart, Philippa Samuel, Katie Jones, Sian Cox, David Edwards, Adrian Twine, Chris Bosanquet, David C BJS Open Protocol BACKGROUND: Accurate prediction of outcomes following surgery with high morbidity and mortality rates is essential for informed shared decision-making between patients and clinicians. It is unknown how accurately healthcare professionals predict outcomes following major lower-limb amputation (MLLA). Several MLLA outcome-prediction tools have been developed. These could be valuable in clinical practice, but most require validation in independent cohorts before routine clinical use can be recommended. The primary aim of this study is to evaluate the accuracy of healthcare professionals’ predictions of outcomes in adult patients undergoing MLLA for complications of chronic limb-threatening ischaemia (CLTI) or diabetes. Secondary aims include the validation of existing outcome-prediction tools. METHOD: This study is an international, multicentre prospective observational study including adult patients undergoing a primary MLLA for CLTI or diabetes. Healthcare professionals’ accuracy in predicting outcomes at 30-days (death, morbidity and MLLA revision) and 1-year (death, MLLA revision and ambulation) will be evaluated. Sixteen existing outcome-prediction tools specific to MLLA will be examined for validity. Data collection began on 1 October 2020; the end of follow-up will be 1 May 2022. The C-statistic, Hosmer–Lemeshow test, reclassification tables and Brier score will be used to evaluate the predictive performance of healthcare professionals and prediction tools, respectively. STUDY REGISTRATION AND DISSEMINATION: This study will be registered locally at each centre in accordance with local policies before commencing data collection, overseen by local clinician leads. Results will be disseminated to all centres, and any subsequent presentation(s) and/or publication(s) will follow a collaborative co-authorship model. Oxford University Press 2021-11-30 /pmc/articles/PMC8634116/ /pubmed/34849576 http://dx.doi.org/10.1093/bjsopen/zrab118 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Protocol
Gwilym, Brenig L
Waldron, Cherry-Ann
Thomas-Jones, Emma
Preece, Ryan
Milosevic, Sarah
Brookes-Howell, Lucy
Pallmann, Philip
Harris, Debbie
Massey, Ian
Burton, Jo
Stewart, Philippa
Samuel, Katie
Jones, Sian
Cox, David
Edwards, Adrian
Twine, Chris
Bosanquet, David C
The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study
title The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study
title_full The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study
title_fullStr The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study
title_full_unstemmed The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study
title_short The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study
title_sort perceive quantitative study: prediction of risk and communication of outcome following major lower-limb amputation: protocol for a collaborative study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8634116/
https://www.ncbi.nlm.nih.gov/pubmed/34849576
http://dx.doi.org/10.1093/bjsopen/zrab118
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