RESUMEN
BACKGROUND: Although economic evaluations (EEs) have been increasingly applied to medical devices, little discussion has been conducted on how the different health realities of specific populations may impact the application of methods and the ensuing results. This is particularly relevant for pediatric populations, as most EEs on devices are conducted in adults, with specific aspects related to the uniqueness of child health often being overlooked. This study provides a review of the published EEs on devices used in paediatrics, assessing the quality of reporting, and summarising methodological challenges. METHODS: A systematic literature search was performed to identify peer-reviewed publications on the economic value of devices used in paediatrics in the form of full EEs (comparing both costs and consequences of two or more devices). After the removal of duplicates, article titles and abstracts were screened. The remaining full-text articles were retrieved and assessed for inclusion. In-vitro diagnostic devices were not considered in this review. Study descriptive and methodological characteristics were extracted using a structured template. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist was used to assess the quality of reporting. A narrative synthesis of the results was conducted followed by a critical discussion on the main challenges found in the literature. RESULTS: 39 full EEs were eligible for review. Most studies were conducted in high-income countries (67%) and focused on high-risk therapeutic devices (72%). Studies comprised 25 cost-utility analyses, 13 cost-effectiveness analyses and 1 cost-benefit analysis. Most of the studies considered a lifetime horizon (41%) and a health system perspective (36%). Compliance with the CHEERS 2022 items varied among the studies. CONCLUSIONS: Despite the scant body of evidence on EEs focusing on devices in paediatrics results highlight the need to improve the quality of reporting and advance methods that can explicitly incorporate the multiple impacts related to the use of devices with distinct characteristics, as well as consider specific child health realities. The design of innovative participatory approaches and instruments for measuring outcomes meaningful to children and their families should be sought in future research.
RESUMEN
Non-invasive assessment of the elastic properties of the arterial wall is often performed with ultrasound (US) imaging. The purpose of this study is to estimate mechanical properties of the vascular wall using in vitro inflation testing on biological tissue and two-dimensional (2-D) US elastography, and investigate the performance of the proposed methodology for physiological conditions. An inflation experiment was performed on 12 porcine aortas for (a) a large pressure range (0-140mmHg); and (b) physiological pressures (70-130mmHg) to mimic in vivo hemodynamic conditions. Two-dimensional radiofrequency (RF) data were acquired for one longitudinal and two transverse cross-sections for both experiments, and were analyzed to obtain the geometry and diameter-time behavior. The shear modulus (G) was estimated from these data for each pressure range applied. In addition, an incremental study based on the static data was performed to (1) investigate the changes in G for increasing mean arterial pressure (MAP) for a certain pressure difference (30, 40, 50 and 60mmHg); (2) compare the results with those from the dynamic experiment, for the same pressure range. The resulting stress-strain curves and shear moduli G (94±16kPa) for the static experimentare in agreement with literature and previous work. A linear dependency on MAP was found for G, yet the effect of the pulse pressure difference was negligible. The dynamic data revealed a G of 250±20kPa, whereas the incremental shear modulus (Ginc) was 240±39kPa. For all experiments, no significant differences in the values of G were found between different image planes. This study shows that 2-D US elastography of aortas during inflation testing is feasible and reproducible under controlled and physiological circumstances. In future studies, the in vivo, dynamic experiment should be repeated for a range of MAPs, and pathological vessels should be examined.
