biostudies-literatureOoms AGNational Institute for Health Research (NIHR)245-252https://www.ebi.ac.uk/biostudies/studies/S-EPMC7677726biostudies-literatureUnknown1(6)<h4>Aims</h4>Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.<h4>Methods</h4>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.<h4>Results</h4>This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously.<h4>Conclusion</h4>The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses.Cite this article: <i>Bone Joint Open</i> 2020;1-6:245-252.Bone & joint openStatistical 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.PMC767772615/27/01Dritsaki MCosta MLCook JAOoms AGDakin HAPng MEfalseStatistical 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.<h4>Aims</h4>Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.<h4>Methods</h4>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.<h4>Results</h4>This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously.<h4>Conclusion</h4>The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses.Cite this article: <i>Bone Joint Open</i> 2020;1-6:245-252.2020-01-01T00:00:00Z2020 Jun2024-11-12T23:45:54.193Z2021-02-19T20:01:55ZS-EPMC76777263322529610.1302/2633-1462.16.BJO-2020-0044.R1