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: 2020;1-6:245-252.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677726 | PMC |
| http://dx.doi.org/10.1302/2633-1462.16.BJO-2020-0044.R1 | DOI Listing |
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