41 research outputs found

    Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

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    Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration:NCT03088150 , January 11th 2017

    Acute erythema of the face after methotrexate

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    Optimal resource allocation in synchronized multi-tier Internet services

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    Modern Internet systems have evolved from simple monolithic systems to complex multi-tiered architectures. For these systems, providing good response times is a key business requirement. Human computer interaction studies show that online users are highly influenced by the variability in the response times. Moreover, synchronization between different tiers is a complicating factor in the optimal control and analysis of the performance. In this paper, we study a generic multi-tier model with synchronization. The system is able to share processing capacity between arriving jobs that need to be send to other tiers and the responses that have arrived after processing from these tiers. We provide structural results on the optimal resource allocation policy and provide a full characterization of the policy in the framework of Markov decision theory. We also highlight important effects of synchronization in the model and discuss their implications for practice. We validate our expressions through extensive experimentations for a wide range of resource configurations

    Prophylactic mastectomy or screening in women suspected to have the BRCA 1/2 mutation: a prospective pilot study of women's treatment choices and medical and decision-analytic recommendations

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    Item does not contain fulltextWomen with a suspected BRCA1/2-mutation may choose between two management options: breast cancer screening or prophylactic mastectomy (PM). Objectives. To compare women's treatment choices, medical and decision analytic recommendations, and to explore variables related to the women's treatment choices. Methods. After provision of information, individual Time tradeoff values for the health outcome 'living after PM' were assessed and incorporated into a decision analytic model, which compared the management options PM and screening with respect to their effect on quality-adjusted life expectancy. Results. Of the 54 women with a suspected BRCA1/2-mutation, 51 women completed the shared decision making procedure. Quality-adjusted life expectancy after PM management was longer for 67% of proven carriers and for 58% of women awaiting the DNA-test result. Twelve proven carriers made a definitive treatment choice; it was the management option PM in eight (67%) and screening in four cases (33%). All carriers treatment choices agreed with the normative decision analytic recommendation. Four carriers (33%) disagreed with the medical recommendations. Of the 36 women awaiting the DNA-test result, 32 made a hypothetical treatment choice. The agreement between these hypothetical treatment choices and the decision analytic recommendation was good (78%). Combining data from all 48 women, being married (OR = 14.00, p = 0.006), having children (OR = 4.71, p = 0.02), a low Desire to Participate (OR = 0.14, p = 0.004), high Decisional stress (OR = 5.22, p = 0.01), a lower estimate of the 'probability of cure for screen-detected breast cancer' (OR = 0.13, p = 0.004), and higher Time tradeoff values for PM (OR = 182, p < 0.0001) made a choice for PM more likely. Conclusions. There was complete agreement between the decision analytic recommendation and the carriers' treatment choices. This suggests that women act in accordance with normative decision theory. The disagreement between the carriers' treatment choices and the medical recommendations suggests that women's choices and physicians recommendations were guided by different arguments. The strong association between the Time tradeoff-value and the treatment choice suggests that the Time tradeoff test is a valid method to assess preferences. Key words: breast cancer; prophylactic mastectomy; screening; preference assessment; shared decision making, utilities
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