
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
Author(s) -
Alexander Ooms,
May Ee Png,
Jonathan Cook,
Melina Dritsaki,
Helen Dakin,
Matthew L. Costa
Publication year - 2020
Publication title -
bone and joint open
Language(s) - English
Resource type - Journals
ISSN - 2633-1462
DOI - 10.1302/2633-1462.16.bjo-2020-0044.r1
Subject(s) - medicine , randomized controlled trial , randomization , wrist , fixation (population genetics) , visual analogue scale , surgery , physical therapy , population , environmental health
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.