Venous thromboembolism (VTE) is a common complication among patients with cancer that is associated with significant morbidity, mortality and health care costs. There is a significant lack of ...awareness among health care providers and patients leading to delays in seeking medical attention or diagnosis when signs and symptoms of suspected VTE occur as well as underappreciation of potential benefits of different thromboprophylaxis options. Clinical prediction rules (e.g. Khorana risk score) can be used by clinicians to stratify patients according to their underlying risk of VTE. Low-molecular-weight-heparin and direct oral anticoagulants (rivaroxaban and apixaban) have been shown to be safe and effective thromboprophylactic options in this patient population. Health care providers should educate all patients regarding VTE and consider thromboprophylaxis in patients at higher risk of VTE complications. Decisions about thromboprophylaxis should be made with the patients and include a discussion about relative benefits and harms, costs and duration.
•Venous thromboembolism (VTE) is a common complication of cancer.•Health care providers and patients lack awareness about the risk of VTE•VTE is associated with increased morbidity and mortality among cancer patients.•Thromboprophylaxis is safe and effective in ambulatory patients with cancer.
Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or ...total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge.
We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome).
A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval CI, -0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, -0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, -1.07 to 0.47; P=0.43).
Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108 .).
Multiple-detectors computed tomographic pulmonary angiography (CTPA) has a higher sensitivity for pulmonary embolism (PE) within the subsegmental pulmonary arteries as compared with single-detector ...CTPA. Multiple-detectors CTPA might increase the rate of subsegmental PE diagnosis. The clinical significance of subsegmental PE is unknown. We sought to summarize the proportion of subsegmental PE diagnosed with single- and multiple-detectors CTPA and assess the safety of diagnostic strategies based on single- or multiple-detectors CTPA to exclude PE.
A systematic literature search strategy was conducted using MEDLINE, EMBASE and the Cochrane Register of Controlled Trials. We selected 22 articles (20 prospective cohort studies and two randomized controlled trials) that included patients with suspected PE who underwent a CTPA and reported the rate of subsegmental PE. Two reviewers independently extracted data onto standardized forms.
The rate of subsegmental PE diagnosis was 4.7% 95% confidence interval (CI): 2.5-7.6 and 9.4 (95% CI: 5.5-14.2) in patients that underwent a single- and multiple-detectors CTPA, respectively. The 3-month thromboembolic risks in patients with suspected PE and who were left untreated based on a diagnostic algorithm including a negative CTPA was 0.9% (95% CI: 0.4-1.4) and 1.1% (95% CI: 0.7-1.4) for single- and multiple-detectors CTPA, respectively.
Multiple-detectors CTPA seems to increase the proportion of patients diagnosed with subsegmental PE without lowering the 3-month risk of thromboembolism suggesting that subsegmental PE may not be clinically relevant.
Summary
Background
Patient‐reported outcome measures (PROMs) aimed at assessing people with systemic sclerosis (SSc) have rarely involved the target population in the item‐ and domain‐generation ...stage of the instrument construction.
Objectives
To develop a new PROM assessing activities and participation in people with SSc.
Methods
A provisional International Classification of Functioning, Disability and Health (ICF)‐based 65‐item questionnaire previously developed from interviews of people with SSc was sent by email to all patients followed in the internal medicine department of Cochin hospital (n = 184) and enrolled in the Scleroderma Patient‐centered Intervention Network Cohort. Items were reduced according to their metric properties. Dimensional structure of the questionnaire was assessed by principal component analysis, convergent and divergent validities by Spearman's rank correlation coefficient, internal consistency by Cronbach's α, and reliability by a test–retest method using the intraclass correlation coefficient (ICC) and Bland–Altman analysis.
Results
Overall, 113 of 184 patients (61·4%) completed the provisional questionnaire. The item‐reduction process resulted in a 17‐item questionnaire, the Cochin 17‐item Scleroderma Functional scale (CSF‐17). Principal component analysis extracted two dimensions: 10 items related to mobility (CSF‐17 section A) and seven items related to general tasks (CSF‐17 section B). We observed convergent validity of the CSF‐17 total score with global activity limitation, pain, depression and aesthetic burden, and divergent validity with anxiety. Cronbach's α was 0·94 for section A and 0·95 for section B. ICC (n = 25 patients) was 0·92 for the CSF‐17 total score. Bland–Altman analysis did not reveal a systematic trend for the test–retest.
Conclusions
The CSF‐17 is a new PROM assessing activities and participation specifically in people with SSc. Its content and construct validities are very high.
What is already known about this topic?
In the earliest stages of construction patient‐reported outcomes (PROMs) for people with systemic sclerosis (SSc) rarely involve the target population.
Instruments able to capture the specific needs of people with SSc in terms of activities and participation are lacking.
What does this study add?
The Cochin 17‐item Scleroderma Functional Scale (CSF‐17) is a new PROM assessing global activities and participation specifically in people with SSc.
Patients’ perspectives were prioritized at all stages of construction.
What are the clinical implications of this work?
The CSF‐17 could be used in clinical practice and research to assess the efficacy of complex multidisciplinary interventions targeting activity limitations and participation restriction in people with SSc.
Linked Comment: Clark and Denton. Br J Dermatol 2020; 183:610.
Linked Comment: Clark and Denton. Br J Dermatol 2020; 183:610.
Acute Lymphoblastic Leukemia (ALL) is the commonest malignancy in childhood with a second incidence peak in adulthood. Improvements in pediatric therapy including the addition of L-asparaginase ...(L-ASP) have enabled cure rates in excess of 90% to be achieved in children. More recently L-ASP-containing pediatric protocols are being used to treat younger adults with ALL and have improved survival by approximately 2-fold. However, a toxicity associated with L-ASP-containing therapy in ALL is venous thromboembolism (VTE) which is associated with significant morbidity in this patient population and results in interruptions in L-ASP therapy that can impact on survival outcomes. The incidence of VTE among adult patients with ALL receiving L-ASP containing therapy has been reported to be as high as 43%. Despite this, there is a lack of evidence-based recommendations for VTE prophylaxis in this clinical context; low-molecular weight heparin (LMWH) and/or AT replacement have mostly been used. The low-quality data and inconveniences associated with these VTE prophylaxis regimens highlight the need to evaluate alternatives such as direct oral anticoagulants for the prevention of L-ASP-associated VTE in ALL. This narrative will review the body of evidence on primary thromboprophylaxis in adult patients with ALL receiving L-ASP containing therapy.
•L-Asparaginase increases venous thromboembolism in Acute Lymphoblastic Leukemia•Anti-thrombin replacement is associated with an increased rate of leukemia relapse•Efficacy of thromboprophylaxis with low molecular weight heparin is suboptimal•There is a need for clinical trials of Direct-acting Oral Anticoagulants
Purpose
Postoperative pulmonary complications (PPCs) are a common cause of morbidity. Postoperative atelectasis is thought to be a significant risk factor in their development. Recent imaging studies ...suggest that patients’ extubation may result in similar postoperative atelectasis regardless of the intraoperative mechanical ventilation strategy used. In this pilot trial, we hypothesized that a study investigating the effects of an open lung extubation strategy compared with a conventional one on PPCs would be feasible.
Methods
We conducted a pilot, single-centre, double-blinded randomized controlled trial. Adult patients at moderate to high risk of PPCs and scheduled for elective surgery were eligible. Patients were randomized to an open lung extubation strategy (semirecumbent position, fraction of inspired oxygen F
I
O
2
50%, pressure support ventilation, unchanged positive end-expiratory pressure) or to a conventional extubation strategy (dorsal decubitus position, F
I
O
2
100%, manual bag ventilation). The primary feasibility outcome was global protocol adherence while the primary exploratory efficacy outcome was PPCs.
Results
We randomized 35 patients to the conventional extubation group and 34 to the open lung extubation group. We observed a global protocol adherence of 96% (95% confidence interval, 88 to 99), which was not different between groups. Eight PPCs occurred (two in the conventional extubation group
vs
six in the open lung extubation group). Less postoperative supplemental oxygen and better lung aeration were observed in the open lung extubation group.
Conclusions
In this single-centre pilot trial, we observed excellent feasibility. A multicentre pilot trial comparing the effect of an open lung extubation strategy with that of a conventional extubation strategy on the occurrence of PPCs is feasible.
Study registration date
ClinicalTrials.gov (NCT04993001); registered 6 August 2021.
Essentials Clinicians may be hesitant to administer anticoagulation in the setting of brain metastases or glioma. In this meta-analysis, we identified nine retrospective cohort studies that met ...inclusion criteria. Anticoagulation did not increase the risk of intracranial hemorrhage in brain metastasis. In the setting of glioma, anticoagulation resulted in 3.8-fold increase in intracranial hemorrhage.
Background Venous thromboembolism commonly occurs in patients with brain tumors. Because of the high rate of spontaneous intracranial hemorrhage (ICH), the safety of therapeutic anticoagulation is commonly questioned. Objective We performed a meta-analysis to evaluate whether therapeutic anticoagulation is associated with an increased risk of intracranial hemorrhage in patients with brain tumors. Patients/Methods A systematic literature search strategy was conducted. Summary statistics for ICH were obtained by calculating the odds ratio using a random effects model and heterogeneity across studies was estimated by the I(2) statistic. Results A total of nine retrospective cohort studies met the criteria for inclusion. The odds ratio (OR) for ICH in patients receiving therapeutic anticoagulation versus those who did not receive anticoagulation was 2.13 (95% confidence interval CI, 1.00-4.56; I(2) = 46%). In studies evaluating anticoagulation in patients with brain metastases, there was no apparent increased risk of ICH (OR, 1.07; 95% CI, 0.61-1.88; I(2) = 0%). However, in patients with glioma there was an increase in risk of ICH associated with the administration of anticoagulation (OR, 3.75; 95% CI, 1.42-9.95; I(2) = 33%). Conclusions The risk of ICH in patients with brain tumors receiving therapeutic anticoagulation depends on the diagnosis of primary or metastatic brain tumors. Although anticoagulation was not associated with an increased risk of ICH in the setting of brain metastasis, its use resulted in a greater than 3-fold increased risk of ICH in patients with glioma.
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