Dataset Information

Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

ABSTRACT: Magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) is an innovative treatment for patients with painful bone metastases. The adoption of MR-HIFU will be influenced by several factors beyond its effectiveness. To identify contextual factors affecting the adoption of MR-HIFU, we conducted a group concept mapping (GCM) study in four European countries. The GCM was conducted in two phases. First, the participants brainstormed statements guided by the focus prompt "One factor that may influence the uptake of MR-HIFU in clinical practice is...". Second, the participants sorted statements into categories and rated the statements according to their importance and changeability. To generate a concept map, multidimensional scaling and cluster analysis were conducted, and average ratings for each (cluster of) factors were calculated. Forty-five participants contributed to phase I and/or II (56% overall participation rate). The resulting concept map comprises 49 factors, organized in 12 clusters: "competitive treatments", "physicians' attitudes", "alignment of resources", "logistics and workflow", "technical disadvantages", "radiotherapy as first-line therapy", "aggregating knowledge and improving awareness", "clinical effectiveness", "patients' preferences", "reimbursement", "cost-effectiveness" and "hospital costs". The factors identified echo those from the literature, but their relevance and interrelationship are case-specific. Besides evidence on clinical effectiveness, contextual factors from 10 other clusters should be addressed to support adoption of MR-HIFU.

SUBMITTER: Simoes Correa Galendi J

PROVIDER: S-EPMC9858703 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

Simões Corrêa Galendi Julia J Siefen Ann-Cathrine AC Moretti Debora M DM Yeo Sin Yuin SY Grüll Holger H Bratke Grischa G Morganti Alessio Giuseppe AG Bazzocchi Alberto A Gasperini Chiara C De Felice Francesca F Blanco Sequeiros Roberto R Huhtala Mira M Nijholt Ingrid M IM Boomsma Martijn F MF Bos Clemens C Verkooijen Helena M HM Müller Dirk D Stock Stephanie S

International journal of environmental research and public health 20230107 2

Magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) is an innovative treatment for patients with painful bone metastases. The adoption of MR-HIFU will be influenced by several factors beyond its effectiveness. To identify contextual factors affecting the adoption of MR-HIFU, we conducted a group concept mapping (GCM) study in four European countries. The GCM was conducted in two phases. First, the participants brainstormed statements guided by the focus prompt "One fact ...[more]

PMID: 36673840

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Project description:BackgroundHigh-intensity focused ultrasound (HIFU) is considered to be an alternative to surgery. Extracorporeal ultrasound-guided HIFU (USgFU) has been clinically used to treat solid tumors. Preliminary trials in a small sample of a Western population suggested that this modality was safe. Most trials are performed in China thereby providing comprehensive data for understanding the safety profile. The aim of this study was to evaluate adverse events of USgFU therapy.Methods and findingsClinical data were searched in 2 Chinese databases. Adverse events of USgFU were summarized and compared with those of magnetic resonance-guided HIFU (MRgFU; for uterine, bone or breast tumor) and transrectal ultrasound-guided HIFU (for prostate cancer or benign prostate hyperplasia). USgFU treatment was performed using 7 types of device. Side effects were evaluated in 13262 cases. There were fewer adverse events in benign lesions than in malignant lesions (11.81% vs. 21.65%, p<0.0001). Rates of adverse events greatly varied between the disease types (0-280%, p<0.0001) and between the applied HIFU devices in both malignant (10.58-44.38%, p<0.0001) and benign lesions (1.67-17.57%, p<0.0001). Chronological analysis did not demonstrate a decrease in the rate of adverse events. Based upon evaluable adverse events, incidences in USgFU were consistent with those in MRgFU or transrectal HIFU. Some side effects frequently occurred following transrectal HIFU were not reported in USgFU. Several events including intrahepatic metastasis, intraoperative high fever, and occlusions of the superior mesenteric artery should be of particular concern because they have not been previously noted. The types of adverse events suggested that they were ultrasonic lesions.ConclusionThe frequency of adverse events depended on the location of the lesion and the type of HIFU device; however, side effects of USgFU were not yet understood. USgFU did not decrease the incidence of adverse events compared with MRgFU.

Project description:IntroductionMagnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive treatment option for palliative patients with painful bone metastases. Early evidence suggests that MR-HIFU is associated with similar overall treatment response, but more rapid pain palliation compared to external beam radiotherapy (EBRT). This modelling study aimed to assess the cost-effectiveness of MR-HIFU as an alternative treatment option for painful bone metastases from the perspective of the German Statutory Health Insurance (SHI).Materials and methodsA microsimulation model with lifelong time horizon and one-month cycle length was developed. To calculate the incremental cost-effectiveness ratio (ICER), strategy A (MR-HIFU as first-line treatment or as retreatment option in case of persistent pain or only partial pain relief after EBRT) was compared to strategy B (EBRT alone) for patients with bone metastases due to breast, prostate, or lung cancer. Input parameters used for the model were extracted from the literature. Results were expressed as EUR per quality-adjusted life years (QALYs) and EUR per pain response (i.e., months spent with complete or partial pain response). Deterministic and probabilistic sensitivity analyses (PSA) were performed to test the robustness of results, and a value of information analysis was conducted.ResultsCompared to strategy B, strategy A resulted in additional costs (EUR 399) and benefits (0.02 QALYs and 0.95 months with pain response). In the base case, the resulting ICERs (strategy A vs. strategy B) are EUR 19,845/QALY and EUR 421 per pain response. Offering all patients MR-HIFU as first-line treatment would increase the ICER by 50% (31,048 EUR/QALY). PSA showed that at a (hypothetical) willingness to pay of EUR 20,000/QALY, the probability of MR-HIFU being cost-effective was 52%. The expected value of perfect information (EVPI) for the benefit population in Germany is approximately EUR 190 Mio.ConclusionAlthough there is considerable uncertainty, the results demonstrate that introducing MR-HIFU as a treatment alternative for painful bone metastases might be cost-effective for the German SHI. The high EVPI indicate that further studies to reduce uncertainty would be worthwhile.

Project description:High-intensity focused ultrasound (HIFU) is a non-invasive method of selective placental vascular occlusion, providing a potential therapy for conditions such as twin-twin transfusion syndrome. In order to translate this technique into human studies, evidence of prolonged fetal recovery and maintenance of a healthy fetal physiology following exposure to HIFU is essential. At 116 ± 2 days gestation, 12 pregnant ewes were assigned to control ( n = 6) or HIFU vascular occlusion ( n = 6) groups and anaesthetized. Placental blood vessels were identified using colour Doppler ultrasound; HIFU-mediated vascular occlusion was performed through intact maternal skin (1.66 MHz, 5 s duration, in situ ISPTA 1.8-3.9 kW cm-2). Unidentifiable colour Doppler signals in targeted vessels following HIFU exposure denoted successful occlusion. Ewes and fetuses were then surgically instrumented with vascular catheters and transonic flow probes and recovered from anaesthesia. A custom-made wireless data acquisition system, which records continuous maternal and fetal cardiovascular data, and daily blood sampling were used to assess wellbeing for 20 days, followed by post-mortem examination. Based on a comparison of pre- and post-treatment colour Doppler imaging, 100% (36/36) of placental vessels were occluded following HIFU, and occlusion persisted for 20 days. All fetuses survived. No differences in maternal or fetal blood pressure, heart rate, heart rate variability, metabolic status or oxygenation were observed between treatment groups. There was evidence of normal fetal maturation and no evidence of chronic fetal stress. There were no maternal injuries and no placental vascular haemorrhage. There was both a uterine and fetal burn, which did not result in any obstetric or fetal complications. This study demonstrates normal long-term recovery of fetal sheep from exposure to HIFU-mediated placental vascular occlusion and underlines the potential of HIFU as a potential non-invasive therapy in human pregnancy.

Dataset Information

Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

Publications

Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

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