TRAUMA
Low-intensity pulsed ultrasound for treatment of tibial fractures: an economic evaluation of the TRUST study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(9):19 Bone Joint J. 2017 Nov;99-B(11):1526-1532501 patients who had undergone intramedullary nail fixation for a fresh tibial fracture were randomized to either active low-intensity pulsed ultrasound (LIPUS) or sham LIPUS. Groups were compared for quality-adjusted life-years, based on the Health Utility Index Mark-3 (HUI-3), costs in 2015 Canadian dollars associated with treatment, and a cost-utility analysis was performed. Active LIPUS demonstrated significantly greater costs compared to the sham group, with no significant difference in QALYs. Incremental cost-effectiveness ratios (ICER) ranged from $146,006/QALY gained to $155,443/QALY gained with the use of LIPUS, and cost-effectiveness acceptability curves (CEAC) estimated 1% likelihood of LIPUS being cost-effective at a willingness-to-pay threshold of $50,000 from a payer perspective.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
4/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
Low-intensity pulsed ultrasound (LIPUS) is currently used as an intervention to reduce time to fracture healing and decrease the risk of nonunion. However, high-quality evidence in support of these benefits has been inconsistent, and most recent evidence has pointed to similar outcomes with and without LIPUS treatment. A cost-utility analysis, performed alongside a large randomized controlled trial (The Trial to Re-evaluate Ultrasound in the Treatment of Tibial Fractures [TRUST]) was thus needed.
Was war die wichtigste Forschungsfrage?
Is the use of LIPUS following operative management of a fresh tibial fracture cost-effective, as measured by incremental cost-effectiveness ratio and against willingness-to-pay thresholds of either $50,000 and $100,000?
Was waren die wichtigsten Ergebnisse?
- Total cost from a payer perspective (ie. not including wage loss) was significantly higher in the LIPUS group ($5656 [95%CI 5389-5923]) compared to the placebo group ($2009 [95%CI 1680-2338]) (p<0.001). Total cost from a societal perspective was also significantly higher in the LIPUS group ($13901[95%CI 12616-15186]) compared to the placebo group ($10475 [95%CI 9128-11823]) (p<0.001).
- Total QALYs gained did not significantly differ between the LIPUS group (0.686 [95%CI 0.666-0.705]) and the placebo group (0.662 [95%CI 0.639-0.685]) (p=0.47).
- From a payer perspective, ICER was $155,443/QALY gained. From a societal perspective, ICER was $146,006/QALY gained.
- From a payer perspective, CEAC demonstrated a 1% probability of LIPUS being cost-effective at a willingness-to-pay threshold of $50,000 and a 23% chance of being cost-effective at a willingness-to-pay threshold of $100,000.
- From a societal perspective, CEAC demonstrated a 5% probability of being cost-effective at a willingness-to-pay threshold of $50,000 and a 31% chance of being cost-effective at a willingness-to-pay threshold of $100,000.
Was sollte ich mir besonders merken?
Following intramedullary nailing of a tibial fracture, low-intensity pulsed ultrasound did not appear to be cost-effective when compared to sham LIPUS.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
The results of this study suggest that routinely prescribing LIPUS use following intramedullary nail fixation of a fresh tibial fracture is unlikely to be a cost-effective practice.
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