PMID- 34187822
OWN - NLM
STAT- MEDLINE
DCOM- 20210803
LR  - 20231107
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 6
DP  - 2021 Jun 29
TI  - Protocol for surgical and non-surgical treatment for metacarpal shaft fractures 
      in adults: an observational feasibility study.
PG  - e046913
LID - 10.1136/bmjopen-2020-046913 [doi]
LID - e046913
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published 
      by BMJ.
FAU - Taha, Rowa
AU  - Taha R
AUID- ORCID: 0000-0002-2403-5107
AD  - Academic Orthopaedics, Trauma & Sports Medicine, University of Nottingham School 
      of Medical and Surgical Sciences, Nottingham, UK rowa.taha@nottingham.ac.uk.
FAU - Leighton, Paul
AU  - Leighton P
AD  - Division of Primary Care, University of Nottingham, Nottingham, UK.
FAU - Bainbridge, Chris
AU  - Bainbridge C
AD  - Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.
FAU - Montgomery, Alan
AU  - Montgomery A
AD  - Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
FAU - Davis, Tim
AU  - Davis T
AD  - Trauma and Orthopaedics, Nottingham University Hospitals NHS Trust, Nottingham, 
      UK.
FAU - Karantana, Alexia
AU  - Karantana A
AD  - Surgery, University of Nottingham Faculty of Medicine and Health Sciences, 
      Nottingham, UK.
LA  - eng
SI  - ISRCTN/ISRCTN13922779
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210629
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Feasibility Studies
MH  - Humans
MH  - *Metacarpal Bones/surgery
MH  - Multicenter Studies as Topic
MH  - Observational Studies as Topic
MH  - Patient Reported Outcome Measures
MH  - Prospective Studies
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - State Medicine
PMC - PMC8245430
OTO - NOTNLM
OT  - clinical trials
OT  - hand & wrist
OT  - health economics
OT  - orthopaedic & trauma surgery
OT  - qualitative research
OT  - statistics & research methods
COIS- Competing interests: RT, AK and AM report grants from the National Institute for 
      Health Research (NIHR) and the British Society for Surgery of the Hand (BSSH). 
      This protocol is independent research supported by the National Institute for 
      Health Research (NIHR Doctoral Fellowship - Stage 2, Miss Rowa Taha, NIHR300197).
EDAT- 2021/07/01 06:00
MHDA- 2021/08/04 06:00
PMCR- 2021/06/29
CRDT- 2021/06/30 05:50
PHST- 2021/06/30 05:50 [entrez]
PHST- 2021/07/01 06:00 [pubmed]
PHST- 2021/08/04 06:00 [medline]
PHST- 2021/06/29 00:00 [pmc-release]
AID - bmjopen-2020-046913 [pii]
AID - 10.1136/bmjopen-2020-046913 [doi]
PST - epublish
SO  - BMJ Open. 2021 Jun 29;11(6):e046913. doi: 10.1136/bmjopen-2020-046913.