RESUMEN
BACKGROUND: Conventional treatment of displaced midshaft clavicular fractures is nonoperative. Recent studies have implied that operative treatment might result in a faster return to work, resulting in a decreased productivity loss for society. The cost utility of plate fixation vs. nonoperative treatment of displaced midshaft clavicular fractures has not previously been investigated using a societal perspective. METHODS: Decision analytical modeling of incremental costs and quality-adjusted life-years (QALYs) was performed. Data on utility, hospitalization, and productivity costs were retrieved from a Danish randomized controlled trial. Supplementary data were taken from randomized controlled trials identified in the literature. A 1-year time horizon was applied, and all prices were reported with respect to a 2016 level. RESULTS: Operative treatment was associated with a larger QALY gain in patients and a higher cost compared with nonoperative treatment. The incremental cost-effectiveness ratio (ICER) was estimated in Danish currency (Danish krone [kr]) at kr1,360,000 (182,306) per QALY from a health-sector perspective and kr1,388,738 (186,158) per QALY from a societal perspective. Considering a subgroup analysis of patients with a high-load shoulder profession, operative treatment was dominated by nonoperative treatment from a health-sector perspective. Considering a societal perspective, the ICER was estimated at -kr889,091 (-119,181) per reduction of 1 QALY. One-way and probabilistic sensitivity analyses showed that the results were subject to uncertainty. CONCLUSION: Operative treatment is not cost-effective when considering a threshold of 34,000/QALY. However, for a subgroup of patients with a high-load shoulder profession, operative treatment might be cost-effective compared with nonoperative treatment.
Asunto(s)
Clavícula/lesiones , Tratamiento Conservador/economía , Costo de Enfermedad , Fracturas Óseas/economía , Fracturas Óseas/terapia , Procedimientos Ortopédicos/economía , Placas Óseas , Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Dinamarca , Diáfisis/lesiones , Eficiencia , Fijación Interna de Fracturas , Fracturas Óseas/cirugía , Hospitalización/economía , Humanos , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
Numerous exploratory, proof-of-concept and interventional studies have used histaminergic and non-histaminergic human models of itch. However, no reliability studies for such surrogate models have been conducted. This study investigated the test-retest reliability for the response to histamine- and cowhage- (5, 15, 25 spiculae) induced itch in healthy volunteers. Cowhage spiculae were individually applied with tweezers and 1% histamine was applied with a skin prick test (SPT) lancet, both on the volar forearm. The intensity of itch was recorded on a visual analogue scale and self-reported area of itch was assessed 5 and 10 min after itch provocation. Reliability of the evoked itch (area under the curve and peak intensity) was assessed by the coefficient of variation (CV), intra-class correlation coefficient (ICC), and sample size estimation for parallel and cross-over designs. Cowhage (ICC = 0.57-0.77, CVbetween = 97%, CVwithin = 41%) and histamine: (ICC = 0.83-0.93, CVbetween = 97%, CVwithin = 20%) exhibited moderate-to-excellent intra-individual reliability and moderate inter-individual reliability for the itch intensity. For a test-retest observation period of one week, SPT-delivered histamine and application of cowhage-spiculae are reproducible human models of itch. The high inter-individual and low intra-individual variability suggests cross-over designed studies when applicable.