A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan.
Aged
Fracture fixation
Plaster casts
Radius fractures
Randomised controlled trial
Recovery of function
Statistical analysis plan
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
15 Jul 2020
15 Jul 2020
Historique:
received:
18
12
2019
accepted:
03
03
2020
entrez:
17
7
2020
pubmed:
17
7
2020
medline:
14
5
2021
Statut:
epublish
Résumé
We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.
Sections du résumé
BACKGROUND
BACKGROUND
We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan.
METHODS/DESIGN
METHODS
A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance.
DISCUSSION
CONCLUSIONS
This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients.
TRIAL REGISTRATION
BACKGROUND
CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.
Identifiants
pubmed: 32669121
doi: 10.1186/s13063-020-4228-0
pii: 10.1186/s13063-020-4228-0
pmc: PMC7364640
doi:
Types de publication
Clinical Trial Protocol
Letter
Langues
eng
Sous-ensembles de citation
IM
Pagination
651Subventions
Organisme : National Health and Medical Research Council
ID : 2016, APP1098550
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