Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2

Alexander Gert Ooms; May Ee Png; Jonathan A Cook; Melina Dritsaki; Helen A Dakin; Matthew L Costa

doi:10.1302/2633-1462.16.BJO-2020-0044.R1

Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2

Bone Jt Open. 2020 Jun 11;1(6):245-252. doi: 10.1302/2633-1462.16.BJO-2020-0044.R1. eCollection 2020 Jun.

Authors

Alexander Gert Ooms¹, May Ee Png², Jonathan A Cook¹, Melina Dritsaki¹, Helen A Dakin³, Matthew L Costa⁴

Affiliations

¹ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
² Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
³ Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁴ Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

PMID: 33225296
PMCID: PMC7677726
DOI: 10.1302/2633-1462.16.BJO-2020-0044.R1

Abstract

Aims: Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.

Methods: DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.

Results: This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously.

Conclusion: The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses.Cite this article: Bone Joint Open 2020;1-6:245-252.

Keywords: Analysis plan; Economic; Randomised; Statistics; Trial; Wrist fracture.

Grants and funding

15/27/01/DH_/Department of Health/United Kingdom