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Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study

INTRODUCTION: Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and c...

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Autores principales: Taha, Rowa, Leighton, Paul, Bainbridge, Chris, Montgomery, Alan, Davis, Tim, Karantana, Alexia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245430/
https://www.ncbi.nlm.nih.gov/pubmed/34187822
http://dx.doi.org/10.1136/bmjopen-2020-046913
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author Taha, Rowa
Leighton, Paul
Bainbridge, Chris
Montgomery, Alan
Davis, Tim
Karantana, Alexia
author_facet Taha, Rowa
Leighton, Paul
Bainbridge, Chris
Montgomery, Alan
Davis, Tim
Karantana, Alexia
author_sort Taha, Rowa
collection PubMed
description INTRODUCTION: Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults. METHODS AND ANALYSIS: This is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods. ETHICS AND DISSEMINATION: This study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN13922779.
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spelling pubmed-82454302021-07-13 Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study Taha, Rowa Leighton, Paul Bainbridge, Chris Montgomery, Alan Davis, Tim Karantana, Alexia BMJ Open Surgery INTRODUCTION: Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults. METHODS AND ANALYSIS: This is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods. ETHICS AND DISSEMINATION: This study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN13922779. BMJ Publishing Group 2021-06-29 /pmc/articles/PMC8245430/ /pubmed/34187822 http://dx.doi.org/10.1136/bmjopen-2020-046913 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Surgery
Taha, Rowa
Leighton, Paul
Bainbridge, Chris
Montgomery, Alan
Davis, Tim
Karantana, Alexia
Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
title Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
title_full Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
title_fullStr Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
title_full_unstemmed Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
title_short Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
title_sort protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245430/
https://www.ncbi.nlm.nih.gov/pubmed/34187822
http://dx.doi.org/10.1136/bmjopen-2020-046913
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