Pragmatic randomised evaluation of stable thoracolumbar fracture treatment outcomes (PRESTO): study protocol for a randomised controlled feasibility trial combined with a qualitative study and survey.
Feasibility
Fracture
Pilot
Qualitative
Randomised controlled trial
Surgical fixation
Survey
Thoracolumbar
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
2020
2020
Historique:
received:
16
07
2019
accepted:
17
02
2020
entrez:
20
3
2020
pubmed:
20
3
2020
medline:
20
3
2020
Statut:
epublish
Résumé
A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit. Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial. PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures. The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).
Sections du résumé
BACKGROUND
BACKGROUND
A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit.
METHODS
METHODS
Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial.
DISCUSSION
CONCLUSIONS
PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures.
TRIAL REGISTRATION
BACKGROUND
The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).
Identifiants
pubmed: 32190347
doi: 10.1186/s40814-020-00574-5
pii: 574
pmc: PMC7068894
doi:
Types de publication
Journal Article
Langues
eng
Pagination
38Subventions
Organisme : Department of Health
ID : 15/154/07
Pays : United Kingdom
Informations de copyright
© The Author(s) 2020.
Déclaration de conflit d'intérêts
Competing interestsThe authors declare that they have no conflicts of interest.
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