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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
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
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
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.
Qual era a principal questão de investigação?
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?
Quais foram os resultados importantes?
- 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.
De que é que me devo lembrar mais?
Following intramedullary nailing of a tibial fracture, low-intensity pulsed ultrasound did not appear to be cost-effective when compared to sham LIPUS.
Como é que isto afectará o tratamento dos meus doentes?
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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