Cost‐effectiveness of swab versus tissue sampling for infected diabetic foot ulcers from the CODIFI2 randomised controlled trial
- Trial stopped early due to low recruitment; planned 730 participants for 90% power to detect 12.5% difference in healing at 52 weeks
Authors' conclusion
Because of higher costs, lower QALYs and lack of evidence of benefit, potentially due to the trial being underpowered, tissue sampling was dominated by wound swabbing in the cost-effectiveness analysis.
Study context
- Population
- Patients with infected DFU, 21 UK sitesstopped early
- Participants
- 149 patients
- Comparison
- Wound swabbing vs tissue sampling
- Swabn = 75
- Tissuen = 74reference
- Primary endpoint
- Cost-effectiveness: costs (UK NHS perspective) and QALYs from EQ-5D-3L
- Follow-up
- 52-104 week period
Methodological detailsCODIFI2, multi-centre, Phase III, prospective, unblinded, two-arm parallel group, UK NHS perspective, 2021/2022 price-year, probabilistic sensitivity analysis, Recruitment 07 May 2019 to 28 April 2022; last follow-up 28 April 2023
- CODIFI2
- Multi-centre
- Phase III
- Prospective
- Unblinded
- Two-arm parallel group
- UK NHS perspective
- 2021/2022 price-year
- Probabilistic sensitivity analysis
- Recruitment 07 May 2019 to 28 April 2022; last follow-up 28 April 2023
Primary result
As reported in the abstract
weeks 26, 52 and 104
- Expected quality-adjusted life-years (QALYs) greater with swab than tissue sampling at weeks 26, 52 and 104
- Cost of tissue sampling greater than swabbing when including antibiotics and hospitalisation
- Swab: higher QALYs and lower costs across weeks 26-52, reducing slightly by week 104
- Tissue sampling dominated by wound swabbing
- Regression-based adjustment for imbalances such as age
Original publication
Cost‐effectiveness of swab versus tissue sampling for infected diabetic foot ulcers from the CODIFI2 randomised controlled trial. Diabet Med. Published 27 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →