Efficacy and safety of outpatient treatment with direct oral anticoagulation in pulmonary embolism.

Anticoagulant treatment of acute pulmonary embolism (PE) has traditionally been hospital-based. The lesser need for monitoring with the increasingly used direct acting oral anticoagulants (DOAC) in comparison to warfarin potentially facilitates outpatient treatment of PE with these drugs. This study aimed to evaluate efficacy and safety of outpatient treatment of PE with DOAC. We extracted data from the Swedish quality registry for patients on oral anticoagulation (AuriculA) for all 245 patients in the southernmost hospital region in Sweden (1.3 million inhabitants) selected for outpatient treatment with of PE with DOAC during 2013-2015. Comorbidites, risk factors, and simplified pulmonary embolism severity index were evaluated at baseline, and death, recurrent venous thromboembolism (VTE), and bleeding was recorded during 6 months of follow-up. Outpatient treatment was defined as discharge from the emergency department within 24 h. During 6 months of follow-up, one patient died during DOAC therapy, the cause of death was unrelated to VTE. No VTE recurrences occured, whereas, one patient experienced major bleeding, and five patients experienced minor bleedings. Outpatient treatment of PE with DOAC is efficient and safe in selected patients.

Tobacco sales and marketing within 100 yards of schools in Ahmedabad City, India.

OBJECTIVES: The Government of India passed the Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (COPTA 2003), which prohibits the sale of tobacco products within 100 yards of educational institutions and regulates tobacco advertising. The aim of this research was to monitor compliance with the section of COPTA 2003 regarding the advertisement, display and sale of tobacco products around educational institutions in Ahmedabad City, India. STUDY DESIGN: Observational study around 30 randomly selected schools. METHODS: In March 2010, an observational study was conducted to assess compliance with COPTA 2003 in Ahmedabad City, India. All vendors within a 100-yard radius of 30 randomly selected schools were identified. At locations where tobacco was sold, information was collected regarding type of product sold, sale of tobacco in single units and advertising. RESULTS: Twenty public schools and 10 private schools were sampled. Of these, 87% [n = 26, 95% confidence interval (CI) 69-95%] had tobacco sales within 100 yards of their entrance. Of the 771 vendors observed, 24% (n = 185, 95% CI 18-32%) sold tobacco products. Tobacco advertising in violation of the law was found around 57% of schools (n = 17, 95% CI 39-73%), product displays around 83% of schools (n = 25, 95% CI 65-93%) and single sales around 70% of schools (n = 21, 95% CI 51-84%). CONCLUSIONS: Violation of the sections of COPTA 2003 regarding sale of tobacco products around educational institutions and advertising in general is widespread in Ahmedabad City, India. Effective enforcement of the existing law is necessary to protect the children in India from widespread exposure to the sale and marketing of tobacco products.

Clinical probability assessment and D-dimer determination in patients with suspected deep vein thrombosis, a prospective multicenter management study.

OBJECTIVES: To investigate the reliability of a combined strategy of clinical assessment score followed by a local D-dimer test to exclude deep vein thrombosis. For comparison D-dimer was analysed post hoc and batchwise at a coagulation laboratory. DESIGN: Prospective multicenter management study. SETTING: Seven hospitals in southern Sweden. SUBJECTS: 357 patients with a suspected first episode of deep vein thrombosis (DVT) were prospectively recruited and pre-test probability score (Wells score) was estimated by the emergency physician. If categorized as low pre-test probability, D-dimer was analysed and if negative, DVT was considered to be ruled out. The primary outcome was recurrent venous thromboembolism (VTE) during 3 months of follow up. RESULTS: Prevalence of DVT was 23.5% (84/357). A low pre-test probability and a negative D-dimer result at inclusion was found in 31% (110/357) of the patients of whom one (0.9%, [95% CI 0.02-4.96]) had a VTE at follow up. Sensitivity, specificity, negative predictive value and negative likelihood ratio for our local D-dimer test in the low probability group were 85.7%, 74.5%, 98.2%, and 0,19 respectively compared to 85.6%, 67,6%, 97.9% and 0,23 using batchwise analysis at a coagulation laboratory. CONCLUSION: Pre-test probability score and D-dimer safely rule out DVT in about 30% of outpatients with a suspected first episode of DVT. One out of 110 patients was diagnosed with DVT during follow up. No significant difference in diagnostic performance was seen between local D-dimer test and the post hoc batch analysis with the same reagent in the low probability group.

Mobile phone access and comfort: implications for HIV and tuberculosis care in India and South Africa.

SETTING: India and South Africa shoulder the greatest burden of tuberculosis (TB) and human immunodeficiency virus (HIV) infection respectively, but care retention is suboptimal.OBJECTIVE: We conducted a study in Pune, India, and Matlosana, South Africa, 1) to identify the factors associated with mobile phone access and comfort of use, 2) to assess access patterns.DESIGN: A cross-sectional study assessed mobile phone access, and comfort; a longitudinal study assessed access patterns.RESULTS: We enrolled 261 participants: 136 in India and 125 in South Africa. Between 1 week and 6 months, participant contact decreased from 90% (n = 122) to 57% (n = 75) in India and from 93% (n = 116) to 70% (n = 88) in South Africa. In the latter, a reason for a clinic visit for HIV management was associated with 63% lower odds of contact than other priorities (e.g., diabetes mellitus, maternal health, TB). In India, 57% (n = 78) reported discomfort with texting; discomfort was higher in the unemployed (adjusted OR [aOR] 4.97, 95%CI 1.12-22.09) and those aged ≥35 years (aOR 1.10, 95%CI 1.04-1.16) participants, but lower in those with higher education (aOR 0.04, 95% CI 0.01-1.14). In South Africa, 91% (n = 114) reported comfort with texting.CONCLUSION: Mobile phone contact was poor at 6 months. While mHealth could transform TB-HIV care, alternative approaches may be needed for certain subpopulations.

Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis.

OBJECTIVE: To assess the accuracy of the Wells rule for excluding deep vein thrombosis and whether this accuracy applies to different subgroups of patients. DESIGN: Meta-analysis of individual patient data. DATA SOURCES: Authors of 13 studies (n = 10,002) provided their datasets, and these individual patient data were merged into one dataset. ELIGIBILITY CRITERIA: Studies were eligible if they enrolled consecutive outpatients with suspected deep vein thrombosis, scored all variables of the Wells rule, and performed an appropriate reference standard. MAIN OUTCOME MEASURES: Multilevel logistic regression models, including an interaction term for each subgroup, were used to estimate differences in predicted probabilities of deep vein thrombosis by the Wells rule. In addition, D-dimer testing was added to assess differences in the ability to exclude deep vein thrombosis using an unlikely score on the Wells rule combined with a negative D-dimer test result. RESULTS: Overall, increasing scores on the Wells rule were associated with an increasing probability of having deep vein thrombosis. Estimated probabilities were almost twofold higher in patients with cancer, in patients with suspected recurrent events, and (to a lesser extent) in males. An unlikely score on the Wells rule (≤ 1) combined with a negative D-dimer test result was associated with an extremely low probability of deep vein thrombosis (1.2%, 95% confidence interval 0.7% to 1.8%). This combination occurred in 29% (95% confidence interval 20% to 40%) of patients. These findings were consistent in subgroups defined by type of D-dimer assay (quantitative or qualitative), sex, and care setting (primary or hospital care). For patients with cancer, the combination of an unlikely score on the Wells rule and a negative D-dimer test result occurred in only 9% of patients and was associated with a 2.2% probability of deep vein thrombosis being present. In patients with suspected recurrent events, only the modified Wells rule (adding one point for the previous event) is safe. CONCLUSION: Combined with a negative D-dimer test result (both quantitative and qualitative), deep vein thrombosis can be excluded in patients with an unlikely score on the Wells rule. This finding is true for both sexes, as well as for patients presenting in primary and hospital care. In patients with cancer, the combination is neither safe nor efficient. For patients with suspected recurrent disease, one extra point should be added to the rule to enable a safe exclusion.

Performance of two relatively new quantitative D-dimer assays (Innovance D-dimer and AxSYM D-dimer) for the exclusion of deep vein thrombosis.

INTRODUCTION: D-dimer assays are now widely used as the first-line test in the diagnostic algorithm of suspected deep vein thrombosis (DVT). The aim of this study was to evaluate the performance of two relatively new quantitative D-Dimer assays (Innovance and AxSYM) by comparison with a clinical gold standard. PATIENTS AND METHODS: 311 samples from outpatients with clinical suspicion of DVT, included in a prospective management study, was analysed (prevalence of DVT 23%). The diagnostic workup included estimation of pre-test probability, D-dimer determination, objective imaging as well as 3 month clinical follow up of negative patients. RESULTS: No significant differences were seen in sensitivity and negative predictive values between Innovance, AxSYM and the reference assays. The area under the ROC curve was slightly lower for the AxSYM assay and the correlation to the reference assays was only moderate (r < 0.8) whereas the agreement with the Vidas assay was near excellent (kappa = 0.8). The Innovance assay reached the highest AUC, showed a strong correlation with the reference assays (r > or = 0.9) and a good agreement with the Vidas assay (kappa = 0.76). In combination with a low pre-test probability score the Innovance assay reached a NPV of 100% (95% CI, 92-100) and the AxSYM assay 98% (95% CI, 87-100). CONCLUSION: The Innovance and AxSYM assays show an overall good and comparable performance for the exclusion of DVT when compared to the established assays. Our results for the AxSYM assay indicate that the optimal cut-off value needs to be further evaluated.