Health-related quality of life with rivaroxaban plus aspirin vs. aspirin alone in chronic stable cardiovascular disease: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial

AIMS: This study aimed to compare the effects of the combination of rivaroxaban and aspirin with aspirin alone on health-related quality of life in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. METHODS and results: Health-related quality of life assessed using the EQ-5D-3L. The treatment effects on health utility and EQ visual analogue scale (EQ VAS) scores were compared between rivaroxaban plus aspirin and aspirin alone in terms of adjusted mean difference in change from baseline and odds ratio of having deterioration events. Nine thousand forty-nine (98.9%) and 6916 (75.5%) completed the EQ-5D-3L at baseline and at final visit, respectively. Nine thousand twenty-eight (98.9%) and 6887 (76.3%) completed the EQ-5D-3L at baseline and final visit, respectively. Mean (standard deviation) health utility and EQ VAS scores at baseline were 0.871 (0.141) and 76.0 (15.3), respectively, for the rivaroxaban plus aspirin group, compared with 0.873 (0.139) and 75.8 (15.1) for the aspirin group. Adjusted mean difference in change from baseline utility was -0.002 [95% confidence interval (CI), -0.006, 0.002, P = 0.30] between the combination therapy group and the aspirin group. The odds ratio (95% CI) of experiencing deterioration in health utility was 1.01 (95% CI, 0.93, 1.10, P = 0.81) between the two groups. Adjusted mean difference in change from baseline EQ VAS was 0.02 (95% CI, -0.43, 0.47, P = 0.93) between the two groups. CONCLUSION: This analysis of the COMPASS trial demonstrated that the quality of life of patients was similar between the rivaroxaban plus aspirin group and the aspirin alone group. REGISTRATION: Trial registration number: ClinicalTrials.gov number (NCT01776424). Trial protocol and statistical analysis plan: https://www.nejm.org/doi/full/10.1056/NEJMoa1709118#APPNEJMoa1709118PRO.

Nomogram to predict the risk of adverse outcomes in patients with residual stones following percutaneous nephrolithotomy

ABSTRACT Purpose: To investigate the risk factors associated with adverse outcomes in patients with residual stones after percutaneous nephrolithotomy (PCNL) and to establish a nomogram to predict the probability of adverse outcomes based on these risk factors. Methods: We conducted a retrospective review of 233 patients who underwent PCNL for upper urinary tract calculi and had postoperative residual stones. The patients were divided into two groups according to whether adverse outcomes occurred, and the risk factors for adverse outcomes were explored by univariate and multivariate analyses. Finally, we created a nomogram for predicting the risk of adverse outcomes in patients with residual stones after PCNL. Results: In this study, adverse outcomes occurred in 125 (53.6%) patients. Multivariate logistic regression analysis indicated that the independent risk factors for adverse outcomes were the diameter of the postoperative residual stones (P < 0.001), a positive urine culture (P = 0.022), and previous stone surgery (P = 0.004). The above independent risk factors were used as variables to construct the nomogram. The nomogram model was internally validated. The calculated concordance index was 0.772. The Hosmer- Lemeshow goodness-of-fit test was performed (P > 0.05). The area under the ROC curve of this model was 0.772. Conclusions: Larger diameter of residual stones, positive urine culture, and previous stone surgery were significant predictors associated with adverse outcomes in patients with residual stones after PCNL. Our nomogram could help to assess the risk of adverse outcomes quickly and effectively in patients with residual stones after PCNL

Nomogram to predict the risk of adverse outcomes in patients with residual stones following percutaneous nephrolithotomy.

PURPOSE: To investigate the risk factors associated with adverse outcomes in patients with residual stones after percutaneous nephrolithotomy (PCNL) and to establish a nomogram to predict the probability of adverse outcomes based on these risk factors. METHODS: We conducted a retrospective review of 233 patients who underwent PCNL for upper urinary tract calculi and had postoperative residual stones. The patients were divided into two groups according to whether adverse outcomes occurred, and the risk factors for adverse outcomes were explored by univariate and multivariate analyses. Finally, we created a nomogram for predicting the risk of adverse outcomes in patients with residual stones after PCNL. RESULTS: In this study, adverse outcomes occurred in 125 (53.6%) patients. Multivariate logistic regression analysis indicated that the independent risk factors for adverse outcomes were the diameter of the postoperative residual stones (P < 0.001), a positive urine culture (P = 0.022), and previous stone surgery (P = 0.004). The above independent risk factors were used as variables to construct the nomogram. The nomogram model was internally validated. The calculated concordance index was 0.772. The Hosmer-Lemeshow goodness-of-fit test was performed (P > 0.05). The area under the ROC curve of this model was 0.772. CONCLUSIONS: Larger diameter of residual stones, positive urine culture, and previous stone surgery were significant predictors associated with adverse outcomes in patients with residual stones after PCNL. Our nomogram could help to assess the risk of adverse outcomes quickly and effectively in patients with residual stones after PCNL.

Temporal Trends and Factors Associated With the Inclusion of Patient-Reported Outcomes in Heart Failure Randomized Controlled Trials: A Systematic Review.

Background Patient-reported outcomes (PROs) are important measures of treatment response in heart failure. We assessed temporal trends in and factors associated with inclusion of PROs in heart failure randomized controlled trials (RCTs). Methods and Results We searched MEDLINE, Embase, and CINAHL for studies published between January 2000 and July 2020 in journals with an impact factor ≥10. We assessed temporal trends using the Jonckheere-Terpstra test and conducted multivariable logistic regression to explore trial characteristics associated with PRO inclusion. We assessed the quality of PRO reporting using the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. Of 417 RCTs included, PROs were reported in 226 (54.2%; 95% CI, 49.3%-59.1%), with increased reporting between 2000 and 2020 (P<0.001). The odds of PRO inclusion were greater in RCTs that were published in recent years (adjusted odds ratio [aOR] per year, 1.08; 95% CI, 1.04-1.12; P<0.001), multicenter (aOR, 1.89; 95% CI, 1.03-3.46; P=0.040), medium-sized (aOR, 2.35; 95% CI, 1.26-4.40; P=0.008), coordinated in Central and South America (aOR, 5.93; 95% CI, 1.14-30.97; P=0.035), and tested health service (aOR, 3.12; 95% CI, 1.49-6.55; P=0.003), device/surgical (aOR, 6.66; 95% CI, 3.15-14.05; P<0.001), or exercise (aOR, 4.66; 95% CI, 1.81-12.00; P=0.001) interventions. RCTs reported a median of 4 (interquartile interval , 3-6) of a possible of 11 CONSORT PRO items. Conclusions Just over half of all heart failure RCTs published in high impact factor journals between 2000 and 2020 included PROs, with increased inclusion of PROs over time. Trials that were large, tested pharmaceutical interventions, and coordinated in North America / Europe had lower adjusted odds of reporting PROs relative to other trials. The quality of PRO reporting was modest.

Untargeted Contrast-Enhanced Ultrasound Versus Contrast-Enhanced Computed Tomography: A Differential Diagnostic Performance (DDP) Study for Kidney Lesions.

OBJECTIVES: Histopathology is the 'gold standard' for diagnosing renal cell carcinoma but is limited by sample size. Contrast-enhanced ultrasound can differentiate malignant and benign lesions, but the Chinese guidelines on the management of renal cell carcinoma do not include this method. The purpose of this study was to compare the diagnostic parameters of contrast-enhanced ultrasound against those of contrast-enhanced computed tomography for detecting kidney lesions, with histopathology considered the reference standard. METHODS: Patients with suspected kidney lesions from prior grayscale ultrasonography and computed tomography were included in the analysis (n=191). The contrast-enhanced ultrasound, contrast-enhanced computed tomography, and histopathology data were collected and analyzed. A solid, enhanced mass was considered a malignant lesion, and an unenhanced mass or cyst was considered a benign lesion. The Bosniak criteria were used to characterize the lesions. RESULTS: Contrast-enhanced ultrasound and contrast-enhanced computed tomography both detected that 151 patients had malignant tumors and 40 patients had benign tumors. No significant differences in the tumors and their subtypes were reported between contrast-enhanced ultrasound and histopathology (p=0.804). Chromophobe renal cell carcinoma was detected through contrast-enhanced computed tomography (n=1), but no such finding was reported by contrast-enhanced ultrasound. A total of 35 cases of papillary renal cell carcinoma were reported through contrast-enhanced ultrasound while 32 were reported through histopathology. CONCLUSIONS: Contrast-enhanced ultrasound might be safe and as accurate as histopathology in diagnosing kidney lesions, especially renal cell carcinoma. Additionally, this study provides additional information over histopathology and has an excellent safety profile. LEVEL OF EVIDENCE: III.

Untargeted contrast-enhanced ultrasound versus contrast-enhanced computed tomography: a differential diagnostic performance (DDP) study for kidney lesions

OBJECTIVES: Histopathology is the 'gold standard' for diagnosing renal cell carcinoma but is limited by sample size. Contrast-enhanced ultrasound can differentiate malignant and benign lesions, but the Chinese guidelines on the management of renal cell carcinoma do not include this method. The purpose of this study was to compare the diagnostic parameters of contrast-enhanced ultrasound against those of contrast-enhanced computed tomography for detecting kidney lesions, with histopathology considered the reference standard. METHODS: Patients with suspected kidney lesions from prior grayscale ultrasonography and computed tomography were included in the analysis (n=191). The contrast-enhanced ultrasound, contrast-enhanced computed tomography, and histopathology data were collected and analyzed. A solid, enhanced mass was considered a malignant lesion, and an unenhanced mass or cyst was considered a benign lesion. The Bosniak criteria were used to characterize the lesions. RESULTS: Contrast-enhanced ultrasound and contrast-enhanced computed tomography both detected that 151 patients had malignant tumors and 40 patients had benign tumors. No significant differences in the tumors and their subtypes were reported between contrast-enhanced ultrasound and histopathology (p=0.804). Chromophobe renal cell carcinoma was detected through contrast-enhanced computed tomography (n=1), but no such finding was reported by contrast-enhanced ultrasound. A total of 35 cases of papillary renal cell carcinoma were reported through contrast-enhanced ultrasound while 32 were reported through histopathology. CONCLUSIONS: Contrast-enhanced ultrasound might be safe and as accurate as histopathology in diagnosing kidney lesions, especially renal cell carcinoma. Additionally, this study provides additional information over histopathology and has an excellent safety profile. Level of evidence: III.

Fumigant toxicity and biochemical properties of (α + β) thujone and 1, 8-cineole derived from Seriphidium brevifolium volatile oil against the red imported fire ant Solenopsis invicta (Hymenoptera: Formicidae)

ABSTRACT The excessive use of chemical insecticides has led to negative effects on human health and the environment. Volatile oils are one of the possible potential alternatives to chemical insecticides. Traditionally Seriphidium brevifolium (Wall. ex DC.) Ling & Y.R.Ling, Asteraceae, powder from its leaves is used to treat gastric problems and expel intestinal worms by local peoples, but yet there is no literature available regarding its insecticidal activity. In this study fumigant toxicity and enzyme inhibition activities of the S. brevifolium volatile oil collected from the highlands of Skardu Baltistan, Pakistan, was evaluated against the red imported fire ant Solenopsis invicta. The phytochemical studies indicated that monoterpenes were the most abundant constituents, accounting for 88% of the total oil. The major dominant constituents were 2-bornanone (28.2%), 1,8-cineole (19.9%), α-thujone (7.5%), β-thujone (6.7%) which accounts for 62.3% of total constituents identified, with volatile oil yield of 4.11% (w/w). The fumigation assay indicated that the volatile oil was acutely toxic to fire ants, with an LC50 of 16.47 µl/l. Among the constituents tested, only (α + β) thujone and 1,8-cineole were toxic, with LC50 of 17.68 and 30.66 µl/ after 12 h of exposure. The volatile oil, (α + β) thujone and 1, 8-cineole showed strong fumigant activity against the red imported fire ant workers in a time- and dose-dependent manner. The volatile oil caused 100% mortality of the red imported fire ant workers, even at the lowest concentration of 20 µl/l after 24 h of exposure. In addition, the volatile oil and 1,8-cineole inhibited acetylcholinesterase activity, while (α + β) thujone inhibited carboxylesterase activity in the fire ant workers. It has been concluded that the volatile oil and some of the compounds from S. brevifolium might be developed as eco-friendly approaches for the control of red imported fire ants.

Forty-two systematic reviews generated 23 items for assessing the risk of bias in values and preferences' studies.

OBJECTIVES: In systematic reviews of studies of patients' values and preferences, the objective of the study was to summarize items and domains authors have identified when considering the risk of bias (RoB) associated with primary studies. STUDY DESIGN AND SETTING: We conducted a systematic survey of systematic reviews of patients' values and preference studies. Our search included three databases (MEDLINE, EMBASE, and PsycINFO) from their inception to August 2015. We conducted duplicate data extraction, focusing on items that authors used to address RoB in the primary studies included in their reviews and the associated underlying domains, and summarized criteria in descriptive tables. RESULTS: We identified 42 eligible systematic reviews that addressed 23 items relevant to RoB and grouped the items into 7 domains: appropriate administration of instrument; instrument choice; instrument-described health state presentation; choice of participants group; description, analysis, and presentation of methods and results; patient understanding; and subgroup analysis. CONCLUSION: The items and domains identified provide insight into issues of RoB in patients' values and preference studies and establish the basis for an instrument to assess RoB in such studies.

Instrument-Defined Estimates of the Minimally Important Difference for EQ-5D-5L Index Scores.

BACKGROUND: The five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) is a preference-based measure of health-related quality of life (HRQOL), which yields an index score anchored at 0 (dead) and 1 (full health). We lack evidence on estimates for the minimally important difference (MID) of the EQ-5D-5L that will help in interpreting differences or changes in HRQOL measured by this scale score. OBJECTIVES: To estimate the MID of the EQ-5D-5L index score for available scoring algorithms including algorithms from Canada, China, Spain, Japan, England, and Uruguay. METHODS: A simulation-based approach based on instrument-defined single-level transitions was used to estimate the MID values of the EQ-5D-5L for each country-specific scoring algorithm. RESULTS: The simulation-based instrument-defined MID estimates (mean ± SD) for each country-specific scoring algorithm were as follows: Canada, 0.056 ± 0.011; China, 0.069 ± 0.007; Spain, 0.061 ± 0.008; Japan, 0.048 ± 0.004; England, 0.063 ± 0.013; and Uruguay, 0.063 ± 0.019. Differences in MID estimates reflect differences in population preferences, in valuation techniques used, as well as in modeling strategies. After excluding the maximum-valued scoring parameters, the MID estimates (mean ± SD) were as follows: Canada, 0.037 ± 0.001; China, 0.058 ± 0.005; Spain, 0.045 ± 0.009; Japan, 0.044 ± 0.004; England, 0.037 ± 0.008; and Uruguay, 0.040 ± 0.010. CONCLUSIONS: Simulation-based estimates of the MID of the EQ-5D-5L index score were generally between 0.037 and 0.069, which are similar to the MID estimates of other preference-based HRQOL measures.

The effect of heavy metal contamination on the bacterial community structure at Jiaozhou Bay, China

Abstract In this study, determination of heavy metal parameters and microbiological characterization of marine sediments obtained from two heavily polluted sites and one low-grade contaminated reference station at Jiaozhou Bay in China were carried out. The microbial communities found in the sampled marine sediments were studied using PCR-DGGE (denaturing gradient gel electrophoresis) fingerprinting profiles in combination with multivariate analysis. Clustering analysis of DGGE and matrix of heavy metals displayed similar occurrence patterns. On this basis, 17 samples were classified into two clusters depending on the presence or absence of the high level contamination. Moreover, the cluster of highly contaminated samples was further classified into two sub-groups based on the stations of their origin. These results showed that the composition of the bacterial community is strongly influenced by heavy metal variables present in the sediments found in the Jiaozhou Bay. This study also suggested that metagenomic techniques such as PCR-DGGE fingerprinting in combination with multivariate analysis is an efficient method to examine the effect of metal contamination on the bacterial community structure.

The effect of heavy metal contamination on the bacterial community structure at Jiaozhou Bay, China

In this study, determination of heavy metal parameters and microbiological characterization of marine sediments obtained from two heavily polluted sites and one low-grade contaminated reference station at Jiaozhou Bay in China were carried out. The microbial communities found in the sampled marine sediments were studied using PCR-DGGE (denaturing gradient gel electrophoresis) fingerprinting profiles in combination with multivariate analysis. Clustering analysis of DGGE and matrix of heavy metals displayed similar occurrence patterns. On this basis, 17 samples were classified into two clusters depending on the presence or absence of the high level contamination. Moreover, the cluster of highly contaminated samples was further classified into two sub-groups based on the stations of their origin. These results showed that the composition of the bacterial community is strongly influenced by heavy metal variables present in the sediments found in the Jiaozhou Bay. This study also suggested that metagenomic techniques such as PCR-DGGE fingerprinting in combination with multivariate analysis is an efficient method to examine the effect of metal contamination on the bacterial community structure.(AU)

The effect of heavy metal contamination on the bacterial community structure at Jiaozhou Bay, China.

In this study, determination of heavy metal parameters and microbiological characterization of marine sediments obtained from two heavily polluted sites and one low-grade contaminated reference station at Jiaozhou Bay in China were carried out. The microbial communities found in the sampled marine sediments were studied using PCR-DGGE (denaturing gradient gel electrophoresis) fingerprinting profiles in combination with multivariate analysis. Clustering analysis of DGGE and matrix of heavy metals displayed similar occurrence patterns. On this basis, 17 samples were classified into two clusters depending on the presence or absence of the high level contamination. Moreover, the cluster of highly contaminated samples was further classified into two sub-groups based on the stations of their origin. These results showed that the composition of the bacterial community is strongly influenced by heavy metal variables present in the sediments found in the Jiaozhou Bay. This study also suggested that metagenomic techniques such as PCR-DGGE fingerprinting in combination with multivariate analysis is an efficient method to examine the effect of metal contamination on the bacterial community structure.

Tratamento de trombose intravascular com ultra-som de baixa frequencia e microbolhas / low frequency ultrasound and intravenous microbubbles for the treatment of acute intravascular thrombi

Introdução: Estudos experimentais têm demonstrado que ultra-som terapêutico(UST) de baixa frequencia e microbolhas(MB) podem ser utilizados para dissolver trombos intravasculares. Recentemente novas modalidades de imagem de ultra-som diagnóstico(USD) que utilizam baixo índice mecânico foram desenvolvidas e permitem a detecção de pequenas quantidades de MB, sem causar sua destruição. Assim, a monitoração das MB dentro do trombo com USD tem o potencial de otimizar o processo de trombólise com UST. Objetivo: Estudar o valor do UST mais MB na recanalização de trombos arteriais e o papel do USD na otimização do tratamento em modelo experimental. Métodos: Em modelo canino de trombose de enxerto arteriovenoso agudo, foram aplicados três tipos randomizados de tratamentos: MB injetadas por via endovenosa com aplicação de UST (1 MHz) guiada pelo USD para determinar o momento de maior concentração de MB no trombo (n igual 12), MB injetadas por via endovenosa com aplicação de UST não guiada (n igual 6), e aplicação de UST sem MB (controle, n igual 6). O sucesso do tratamento foi definido como fluxo escore 3 no enxerto pela angiografia. Resultados: Sucesso do tratamento foi maior no grupo MB mais UST mais USD que nos demais grupos..

Detecção de disfunção endotelial com microbolhas. Papel do complemento no mecanismo fisiopatológico / Detection of endothelial dysfunction with microbubbles. Rule of complement in the pathophysiologic mechanism

Introdução: Recentemente demonstramos que a detecção de microbolhas de albumina aderidas à parede de artérias de grande calibre pode ser utilizada para detecção não-invasiva de disfunção endotelial. Objetivo: Estudar o papel do componente C3 do complemento no mecanismo de adesão de microbolhas às artérias com disfunção endotelial. Método: Ligação de C3 às microbolhas foi determinada in vitro por citometria de fluxo utilizando anticorpos monoclonais. Para avaliação in vivo, estudamos nove camundongos três wild-type, três wild-type nos quais depleção de C3 foi induzida com fator veneno de cobra (FVC), e três geneticamente modificados deficientes com C3 (DC3). Disfunção endotelial foi reduzida por hipertrigliceridemia e a adesão de microbolhas ao endotelio da aorta foi confirmada com microscopia eletrônica de varredura (MEV). Resultados: pelos estudos com citometria de fluxo, demonstramos ligação de C3 às microbolhas de albumina. A MEV demonstrou adesão de microbolhas ao endotelio da aorta em todos os camundongos wild-type durante hipertrigliceridemia. Somente isoladas microbolhas foram detectadas na aorta de camundongos tratados com FVC ou DC3. A quantificação foi de 19 mais ou menos 10 microbolhas/campo no grupo wild-type, 2 mais ou menos 1 microbolhas/campo no grupo pré-tratado com FVC e 1 mais ou menos 1 microbolhas/campo no grupo DC3 (p menor 0,001). Conclusão: C3 exerce papel fundamental no mecanismo de adesão de microbolhas ao endotelio arterial na presença de disfunção endotelial. Uma vez que as microbolhas aderidas, mantêm suas propriedades acústica, podem ser usadas como método não-invasivo de detecção de ativação de complemento e inflamação na superficie endotelial.