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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

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


Authors

Rowa Taha

PAUL LEIGHTON PAUL.LEIGHTON@NOTTINGHAM.AC.UK
Associate Professor of Applied Health Services Research

Chris Bainbridge

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Tim Davis

ALEXIA KARANTANA ALEXIA.KARANTANA@NOTTINGHAM.AC.UK
Clinical Associate Professor in Hand Surgery



Abstract

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 NHS. 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 multi-centre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised sub-study 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 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 PROM 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.

Journal Article Type Article
Acceptance Date Apr 15, 2021
Online Publication Date Jun 29, 2021
Publication Date Jun 29, 2021
Deposit Date May 11, 2021
Publicly Available Date Jun 29, 2021
Journal BMJ Open
Electronic ISSN 2044-6055
Peer Reviewed Peer Reviewed
Volume 11
Article Number 046913
DOI https://doi.org/10.1136/bmjopen-2020-046913
Public URL https://nottingham-repository.worktribe.com/output/5524220
Publisher URL https://bmjopen.bmj.com/content/11/6/e046913

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