Abstract
Background: Patients with burn injuries may receive a skin graft to achieve healing in a timely manner. However, in around 7% of cases, the skin graft is lost (fails to attach to the wound site) and a re-grafting procedure is necessary. It has been hypothesised that low friction (smooth, more slippery) bedding may reduce the risk of skin-graft loss. A before and after feasibility study comparing low friction with standard bedding in skin grafted patients was conducted in order to collect proof of concept data. The resulting relative risk on the primary outcome (number of patients with skin graft failure) for the non-randomised study provided no evidence of effect but had a large standard error. The aim of this study is to see if an appropriately powered randomised control trial would be worthwhile.
Methods: A probabilistic decision analytic model was constructed to compare low friction bedding to standard care in a population of burn patients who have undergone skin grafting. Results from the before and after study were used as model inputs. Sensitivity of results to bias in the relative risk of graft-loss were conducted. Low friction bedding is considered optimal if expected incremental net benefit (INB) is positive. Uncertainty is assessed using cost-effectiveness acceptability curves. Expected Value of Perfect Partial Information (EVPPI) provides an upper bound for the potential net health benefits of new research for a given model input.
Results: At a willingness to pay threshold of £20,000 per QALY, INB=£151 (95% Credible Interval (CrI) -142 to 814), marginally favouring low friction bedding but with high uncertainty (probability of being cost-effective 70.5%). Expected Value of Perfect Information (EVPI) per patient was £20.29, which results in a population EVPI of £174,765 over a 10-year lifetime for the technology (based on 1000 patients per year who would benefit from the intervention). The parameter contributing most to the uncertainty was the inpatient care cost i.e. information that could be obtained from audit of practice and without an expensive trial. These findings were robust to a wide-range of assumptions about the potential bias due to the observational nature of the comparative evidence.
Conclusions: Our study results suggest an RCT (randomised controlled trial) is unlikely to be worthwhile, but there may be value in a study to estimate the re-graft rates and associated costs in this population.
Methods: A probabilistic decision analytic model was constructed to compare low friction bedding to standard care in a population of burn patients who have undergone skin grafting. Results from the before and after study were used as model inputs. Sensitivity of results to bias in the relative risk of graft-loss were conducted. Low friction bedding is considered optimal if expected incremental net benefit (INB) is positive. Uncertainty is assessed using cost-effectiveness acceptability curves. Expected Value of Perfect Partial Information (EVPPI) provides an upper bound for the potential net health benefits of new research for a given model input.
Results: At a willingness to pay threshold of £20,000 per QALY, INB=£151 (95% Credible Interval (CrI) -142 to 814), marginally favouring low friction bedding but with high uncertainty (probability of being cost-effective 70.5%). Expected Value of Perfect Information (EVPI) per patient was £20.29, which results in a population EVPI of £174,765 over a 10-year lifetime for the technology (based on 1000 patients per year who would benefit from the intervention). The parameter contributing most to the uncertainty was the inpatient care cost i.e. information that could be obtained from audit of practice and without an expensive trial. These findings were robust to a wide-range of assumptions about the potential bias due to the observational nature of the comparative evidence.
Conclusions: Our study results suggest an RCT (randomised controlled trial) is unlikely to be worthwhile, but there may be value in a study to estimate the re-graft rates and associated costs in this population.
| Original language | English |
|---|---|
| Article number | 8 (2020) |
| Number of pages | 9 |
| Journal | Pilot and Feasibility Studies |
| Volume | 6 |
| DOIs | |
| Publication status | Published - 31 Jan 2020 |
Research Groups and Themes
- HEHP@Bristol
Keywords
- cost-effectiveness analysis
- proof of concept study
- randomised controlled trial
- value of information analysis