94 research outputs found

    Comparisons of oncological and functional outcomes among radical retropubic prostatectomy, high dose rate brachytherapy, cryoablation and high-intensity focused ultrasound for localized prostate cancer: A prospective, controlled, nonrandomized trial

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    Background: Several clinical decision rules (CDRs) are available to exclude acute pulmonary embolism (PE), but they have not been directly compared. Objective: To directly compare the performance of 4 CDRs (Wells rule, revised Geneva score, simplified Wells rule, and simplified revised Geneva score) in combination with D-dimer testing to exclude PE. Design: Prospective cohort study. Setting: 7 hospitals in the Netherlands. Patients: 807 consecutive patients with suspected acute PE. Intervention: The clinical probability of PE was assessed by using a computer program that calculated all CDRs and indicated the next diagnostic step. Results of the CDRs and D-dimer tests guided clinical care. Measurements: Results of the CDRs were compared with the prevalence of PE identified by computed tomography or venous thromboembolism at 3-month follow-up. Results: Prevalence of PE was 23%. The proportion of patients categorized as PE-unlikely ranged from 62% (simplified Wells rule) to 72% (Wells rule). Combined with a normal D-dimer result, the CDRs excluded PE in 22% to 24% of patients. The total failure rates of the CDR and D-dimer combinations were similar (1 failure, 0.5% to 0.6% [upper-limit 95% CI, 2.9% to 3.1%]). Even though 30% of patients had discordant CDR outcomes, PE was not detected in any patient with discordant CDRs and a normal D-dimer result. Limitation: Management was based on a combination of decision rules and D-dimer testing rather than only 1 CDR combined with D-dimer testing. Conclusion: All 4 CDRs show similar performance for exclusion of acute PE in combination with a normal D-dimer result. This prospective validation indicates that the simplified scores may be used in clinical practice. Primary Funding Source: Academic Medical Center, VU University Medical Center, Rijnstate Hospital, Leiden University Medical Center, Maastricht University Medical Center, Erasmus Medical Center, and Maasstad Hospital. © 2011 American College of Physicians

    Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban

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    Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case-control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4-week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty-four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01-12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5-16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1-1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5-3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. We were unable to identify other risk factors, mainly due to limited statistical power.Thrombosis and Hemostasi

    D-dimer and clinical probability to rule out pulmonary embolism in cancer patients: An explorative study to increase the clinical utility

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    Background: A substantial proportion of patients with suspected pulmonary embolism (PE) have active malignancy. Although a clinical decision rule (CDR) combined with D-dimer testing is safe to rule out PE in cancer patients, this combination is less applicable in cancer patients due to a lower specificity. Therefore, we analysed whether elevating the D-dimer cut-off increases the clinical utility in cancer patients. Methods: Consecutive cancer patients with suspected PE from a large management study were included. The proportion of patients with an unlikely clinical probability according to the Wells (cut-off ≤ 4) or Simplified Wells rule (cut-off <1) were assessed and combined with different D-dimer cut-off levels. Safety was determined as a PE failure rate below 2.5% after three months of follow up. Results: Of a total of 3306 with suspected PE, 474 (14%) were cancer patients. Combined with the traditional Wells rule, the D-dimer cutoff level could safely be increased to 700 μg/L. At this level, the proportion of patients in whom PE could be ruled out increased from 48 (10%,) to 67 (14%), whereas the failure rate was 2.1% (95% confidence interval [CI], 0.0-11%) with the new and 1.4% (95%CI, 08%) with the traditional 500 μg/L cut-off, respectively. Combined with the Simplified Wells rule, the D-dimer cut-off could be raised to 1100 μg/L, increasing the proportion of cancer patients in whom PE was ruled out from 25 (5%) to 77 (16%), with a failure rates of 0.0% (95%CI 0-13%) and 0.0% (95%CI 0-6.2%), respectively. Conclusion: Increasing the D-dimer cut-off to exclude PE in cancer patients with an unlikely clinical probability for PE results in only a modest increase in clinical utility. This implies that additional diagnostic methods will remain necessary in the large majority cancer patients with suspected PE, irrespective of the D-dimer cut-off value
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