Comparison between Invasive Intervention and Conservative Treatment in Patients with In-Hospital Myocardial Infarctions: Results from the Regional Myocardial Infarction Registry of Saxony-Anhalt (RHESA) Study.

Background/Objectives: In-hospital myocardial infarctions (AMIs) are less often treated with invasive intervention, compared to out-of-hospital AMIs. We aimed to identify the determinants of invasive intervention in patients with in-hospital AMIs and assess its association with mortality, compared to conservative treatment. Methods: This was a cross-sectional study of in-hospital AMIs in The Regional Myocardial Infarction Registry of Saxony-Anhalt. Patients' characteristics and outcomes were compared based on the treatment strategy (invasive intervention vs. conservative treatment). Logistic regression was performed to assess the determinants of invasive intervention (vs. conservative treatment) and its association with 30-day mortality. Results: Nearly 67% of the patients (259/386) received invasive intervention, and the rest were treated conservatively. Those who were treated with an invasive intervention were younger and had a lower proportion of chronic heart failure than those treated conservatively. Age > 75 years compared to younger patients, pre-existing heart failure, and higher heart rate upon presentation were associated with lower odds of receiving invasive intervention. Hypertension (OR = 2.86, 95% CI [1.45-5.62]) and STEMI vs. NSTEMI (1.96, [1.10-3.68]) were associated with higher odds of invasive intervention. The adjusted odds of 30-day mortality were lower with invasive intervention compared to conservative treatment (0.25, [0.10-0.67]). Conclusions: One-third of the patients with in-hospital AMIs received conservative treatment. Younger age, absence of heart failure, lower heart rate, hypertension, and STEMI were determinants of invasive intervention usage. Invasive intervention had lower odds of 30-day mortality, but longitudinal studies are still needed to assess the efficacy of conservative vs. invasive strategies in in-hospital AMIs.

Differences in the levels of inflammatory markers between metabolically healthy obese and other obesity phenotypes in adults: A systematic review and meta-analysis.

AIMS: The aim of this study was to systematically review and analyze differences in the levels of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) comparing metabolically healthy but obese (MHO) with metabolically healthy non-obese (MHNO), metabolically unhealthy non-obese (MUNO), and metabolically unhealthy obese (MUO) subjects. DATA SYNTHESIS: We searched PubMed, Embase, Web of Science, and Scopus for studies that matched the relevant search terms. Differences in inflammatory marker levels between MHO and the other three phenotypes were pooled as standardized mean differences (SMD) or differences of medians (DM) using a random-effects model. We included 91 studies reporting data on 435,007 individuals. The CRP levels were higher in MHO than in MHNO subjects (SMD = 0.63, 95% CI: 0.49, 0.76; DM = 0.83 mg/L, 95% CI: 0.56, 1.11). The CRP levels were higher in MHO than in MUNO subjects (SMD = 0.16, 95% CI: 0.05, 0.28; DM = 0.39 mg/L, 95% CI: 0.09, 0.69). The CRP levels were lower in MHO than in MUO individuals (SMD = -0.43, 95% CI: -0.54, -0.31; DM = -0.82 mg/L, 95% CI: -1.16, -0.48). The IL-6 levels in MHO were higher than in MHNO while lower than in MUO subjects. The TNF-α levels in MHO were higher than in MHNO individuals. CONCLUSIONS: This review provides evidence that CRP levels in MHO are higher than in MHNO and MUNO subjects but lower than in MUO individuals. Additionally, IL-6 levels in MHO are higher than in MHNO but lower than in MUO subjects, and TNF-α levels in MHO are higher than in MHNO individuals. SYSTEMATIC REVIEW REGISTRATION: PROSPERO number: CRD42021234948.

Body composition parameters predict survival in pancreatic cancer-A retrospective multicenter analysis.

BACKGROUND: Parameters to adapt individual treatment strategies for patients with pancreatic ductal adenocarcinoma (PDAC) are urgently needed. The present study aimed to evaluate body composition parameters as predictors of overall survival (OS) in PDAC patients. METHODS: Measurements of body composition parameters were performed on computed tomography scans at diagnosis. Height-standardized and Body Mass Index- and sex-adjusted regression formulas deriving cut-offs from a healthy population were used. The Kaplan-Meier method with the log-rank test was performed for survival analysis. Independent prognostic factors were identified with uni- and multivariable Cox regression analyses. RESULTS: In total, 354 patients were analyzed. In a multivariable Cox model, besides tumor stage and resection status, only myosteatosis (HR 1.53; 95% CI 1.10-2.14, p = 0.01) was an independent prognostic factor of OS among body composition parameters. Subgroup analyses revealed that the prognostic impact of myosteatosis was higher in patients ≤68 years of age, with advanced tumor stages and patients without curative intended resection. CONCLUSIONS: The analysis of one of the largest Caucasian cohorts to date, demonstrated myosteatosis to be an independent prognostic factor of OS in PDAC. To improve outcomes, prospective trials aiming to investigate the utility of an early assessment of myosteatosis with subsequent intervention by dieticians, sports medicine physicians, and physiotherapists are warranted.

Cardiovascular risk factors, living and ageing in Halle: the CARLA study.

The CARLA study (Cardiovascular Disease, Living and Ageing in Halle) is a longitudinal population-based cohort study of the general population of the city of Halle (Saale), Germany. The primary aim of the cohort was to investigate risk factors for cardiovascular diseases based on comprehensive cardiological phenotyping of study participants and was extended to study factors associated with healthy ageing. In total, 1779 probands (812 women and 967 men, aged 45-83 years) were examined at baseline (2002-2005), with a first and second follow-up performed 4 and 8 years later. The response proportion at baseline was 64.1% and the reparticipation proportion for the first and second follow-up was 86% and 77% respectively. Sixty-four percent of the study participants were in retirement while 25% were full- or partially-employed and 11% were unemployed at the time of the baseline examination. The currently running third follow-up focuses on the assessment of physical and mental health, with an intensive 4 h examination program, including measurement of cardiovascular, neurocognitive, balance and gait parameters. The data collected in the CARLA Study resulted in answering various research questions in over 80 publications, of which two thirds were pooled analyses with other similar population-based studies. Due to the extensiveness of information on risk factors, subclinical conditions and evident diseases, the biobanking concept for the biosamples, the cohort representativeness of an elderly population, and the high level of quality assurance, the CARLA cohort offers a unique platform for further research on important indicators for healthy ageing.

Efficacy and Safety of Neoadjuvant Gemcitabine Plus Nab-Paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Cancer-A Systematic Review and Meta-Analysis.

Therapy with gemcitabine and nab-paclitaxel (GNP) is the most commonly used palliative chemotherapy, but its advantage in the neoadjuvant setting remains unclear. Accordingly, our aim is to evaluate the impact of first-line neoadjuvant therapy with GNP in patients with borderline resectable (BRPC) and locally advanced pancreatic cancer (LAPC). A systematic search for published studies until August 2020 was performed. The primary endpoint included resection and R0 resection rates in the intention-to-treat population. Secondary endpoints were response rate, survival and toxicity. Among 21 studies, 950 patients who received neoadjuvant GNP were evaluated. Treatment with GNP resulted in surgical resection and R0 resection rates as follows: 49% (95% CI 30-68%) and 36% (95% CI 17-58%) for BRPC and 16% (95% CI 7-26%) and 11% (95% CI 5-19%) for LAPC, respectively. The objective response rates and the median overall survival (mOS) ranged from 0 to 67% and 12 to 30 months, respectively. Neutropenia (range 5-77%) and neuropathy (range 0-22%) were the most commonly reported grade 3 to 4 adverse events. Neoadjuvant chemotherapy with GNP can be performed safely and with valuable effects in patients with BRPC and LAPC. The utility of GNP in comparison to FOLFIRINOX in the neoadjuvant setting requires further investigation in prospective randomized trials.

Quality of Life Assessment and Pain Severity in Breast Cancer Patients Prior to Palliative Oncology Treatment in Indonesia: A Cross-Sectional Study.

PURPOSE: Studies assessing quality of life (QOL) in palliative care settings are still scarce. We assessed the QOL score and pain severity in advanced breast cancer patients at the National Cancer Hospital in Indonesia and associations between QOL domains with QOL and pain scores. MATERIALS AND METHODS: A total of 160 patients who met the study inclusion criteria (female, >18 years old, diagnosed with stage III or IV breast cancer) answered the European Organization for Research and Treatment of Cancer QOL questionnaire (EORTC QLQ-C15-PAL) and the visual analogue scale (VAS) tool for pain severity, prior to palliative oncology treatment. Additionally, several sociodemographic and clinical characteristics were collected. Linear regression models, adjusted for age, the Karnofsky Performance Status (KPS) score, and specific QOL domains were used to explore the associations between the global QOL and VAS scores with the different QOL domains. RESULTS: The patients had a mean age of 50 years (range: 29-76). The overall score for QOL and score for VAS was (mean ± SD) 78.02 ± 15.34 and 2.1 ± 2.4, respectively. The analysis demonstrated that the domains of emotional functioning (effect estimate: 0.25; 95% CI: 0.14 to 0.37), fatigue (-0.21; -0.33 to -0.09), pain (-0.13; -0.25 to -0.01), insomnia (-0.25; -0.37 to -0.13), and appetite loss (-0.13; -0.25 to -0.008) were associated with the QOL score. Only the KPS score (-0.28; -0.46 to -0.11) was associated with the VAS score. CONCLUSION: Our study showed high QOL and low VAS scores in advanced breast cancer patients prior to palliative oncology treatment. Several QOL domains (emotional functioning, fatigue, pain, insomnia, and appetite loss) were associated with QOL and the KPS was associated with the pain score. Therefore, these specific QOL domains should be given priority in improving QOL in this patient group.

Patterns of glioblastoma treatment and survival over a 16-years period: pooled data from the German Cancer Registries.

INTRODUCTION: Glioblastoma multiforme (GBM) is a primary malignant brain tumour characterized by a very low long-term survival. The aim of this study was to analyse the distribution of treatment modalities and their effect on survival for GBM cases diagnosed in Germany between 1999 and 2014. METHODS: Cases were pooled from the German Cancer Registries with International Classification of Diseases for Oncology, third edition (ICD-O-3) codes for GBM or giant-cell GBM. Three periods, first (January 1999-December 2005), second (January 2006-December 2010) and a third period (January 2011-December 2014) were defined. Kaplan-Meier plots with long-rank test compared median overall survival (OS) between groups. Survival differences were assessed with Cox proportional-hazards models adjusted for available confounders. RESULTS: In total, 40,138 adult GBM cases were analysed, with a mean age at diagnosis 64.0 ± 12.4 years. GBM was more common in men (57.3%). The median OS was 10.0 (95% CI 9.0-10.0) months. There was an increase in 2-year survival, from 16.6% in the first to 19.3% in the third period. When stratified by age group, period and treatment modalities, there was an improved median OS after 2005 due to treatment advancements. Younger age, female sex, surgical resection, use of radiotherapy and chemotherapy, were independent factors associated with better survival. CONCLUSION: The inclusion of temozolomide chemotherapy has considerably improved median OS in the older age groups but had a lesser effect in the younger age group of cases. The analysis showed survival improvements for each treatment option over time.

Socioeconomic disparities in head and neck cancer survival in Germany: a causal mediation analysis using population-based cancer registry data.

PURPOSE: Despite recent improvements in cancer treatment in Germany, a marked difference in cancer survival based on socioeconomic factors persists. We aim to quantify the effect of socioeconomic inequality on head and neck cancer (HNC) survival. METHODS: Information on 20,821 HNC patients diagnosed in 2009-2013 was routinely collected by German population-based cancer registries. Socioeconomic inequality was defined by the German Index of Socioeconomic Deprivation. The Cox proportional regression and relative survival analysis measured the survival disparity according to level of socioeconomic deprivation with respective confidence intervals (CI). A causal mediation analysis was conducted to quantify the effect of socioeconomic deprivation mediated through medical care, stage at diagnosis, and treatment on HNC survival. RESULTS: The most socioeconomically deprived patients were found to have the highest hazard of dying when compared to the most affluent (Hazard Ratio: 1.25, 95% CI 1.17-1.34). The most deprived patients also had the worst 5-year age-adjusted relative survival (50.8%, 95% CI 48.5-53.0). Our mediation analysis showed that most of the effect of deprivation on survival was mediated through differential stage at diagnosis during the first 6 months after HNC diagnosis. As follow-up time increased, medical care, stage at diagnosis, and treatment played no role in mediating the effect of deprivation on survival. CONCLUSION: This study confirms the survival disparity between affluent and deprived HNC patients in Germany. Considering data limitations, our results suggest that, within six months after HNC diagnosis, the elimination of differences in stage at diagnosis could reduce survival inequalities.

Quality of life of cancer patients at palliative care units in developing countries: systematic review of the published literature.

PURPOSE: This systematic review aims to summarize factors that influence the quality of life (QOL) of advanced cancer patients in palliative care (PC) in developing countries. Understanding this context in developing countries milieu is necessary; however, this outcome is rarely reported. METHODS: Following the PRISMA guidelines, the electronic databases MEDLINE, Embase, CINAHL, and Web of Science were systematically searched using the search terms: QOL, cancer, PC, and names of all developing countries. Studies with less than ten subjects, qualitative or pilot studies, reviews, conference abstracts, and that reported validation of QOL questionnaires were excluded. RESULTS: Fifty-five studies from 15 developing countries in the African (n = 5), Latin America and the Caribbean (n = 10), and Asian (n = 40) region were included in the narrative synthesis. 65.4% were cross-sectional, 27.3% were cohort studies, 7.3% were RCTs or quasi-experimental studies. Around 30 QOL factors were studied with 20 different types of QOL instruments. Advanced cancer patients who were older, married/ever married, participated in additional care within PC, used complementary and alternative medicine (CAM), and practiced spirituality/religiosity showed higher QOL score. Low educational level and high depression were associated with a lower QOL. CONCLUSION: Various factors affect QOL among cancer patients in PC. Patients valued the use of CAMs; however, the quality and safety aspects should be properly addressed. Important factors that influenced the QOL score were social and spiritual support. While there is a general need to develop PC strategies further, recognizing patients' needs should be prioritized in national cancer programs.

Inotropic agents and vasodilator strategies for the treatment of cardiogenic shock or low cardiac output syndrome.

BACKGROUND: Cardiogenic shock (CS) and low cardiac output syndrome (LCOS) are potentially life-threatening complications of acute myocardial infarction (AMI), heart failure (HF) or cardiac surgery. While there is solid evidence for the treatment of other cardiovascular diseases of acute onset, treatment strategies in haemodynamic instability due to CS and LCOS remains less robustly supported by the given scientific literature. Therefore, we have analysed the current body of evidence for the treatment of CS or LCOS with inotropic and/or vasodilating agents. This is the second update of a Cochrane review originally published in 2014. OBJECTIVES: Assessment of efficacy and safety of cardiac care with positive inotropic agents and vasodilator agents in CS or LCOS due to AMI, HF or after cardiac surgery. SEARCH METHODS: We conducted a search in CENTRAL, MEDLINE, Embase and CPCI-S Web of Science in October 2019. We also searched four registers of ongoing trials and scanned reference lists and contacted experts in the field to obtain further information. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs) enrolling patients with AMI, HF or cardiac surgery complicated by CS or LCOS. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures according to Cochrane standards. MAIN RESULTS: We identified 19 eligible studies including 2385 individuals (mean or median age range 56 to 73 years) and three ongoing studies. We categorised studies into 11 comparisons, all against standard cardiac care and additional other drugs or placebo. These comparisons investigated the efficacy of levosimendan versus dobutamine, enoximone or placebo; enoximone versus dobutamine, piroximone or epinephrine-nitroglycerine; epinephrine versus norepinephrine or norepinephrine-dobutamine; dopexamine versus dopamine; milrinone versus dobutamine and dopamine-milrinone versus dopamine-dobutamine. All trials were published in peer-reviewed journals, and analyses were done by the intention-to-treat (ITT) principle. Eighteen of 19 trials were small with only a few included participants. An acknowledgement of funding by the pharmaceutical industry or missing conflict of interest statements occurred in nine of 19 trials. In general, confidence in the results of analysed studies was reduced due to relevant study limitations (risk of bias), imprecision or indirectness. Domains of concern, which showed a high risk in more than 50% of included studies, encompassed performance bias (blinding of participants and personnel) and bias affecting the quality of evidence on adverse events. All comparisons revealed uncertainty on the effect of inotropic/vasodilating drugs on all-cause mortality with a low to very low quality of evidence. In detail, the findings were: levosimendan versus dobutamine (short-term mortality: RR 0.60, 95% CI 0.36 to 1.03; participants = 1701; low-quality evidence; long-term mortality: RR 0.84, 95% CI 0.63 to 1.13; participants = 1591; low-quality evidence); levosimendan versus placebo (short-term mortality: no data available; long-term mortality: RR 0.55, 95% CI 0.16 to 1.90; participants = 55; very low-quality evidence); levosimendan versus enoximone (short-term mortality: RR 0.50, 0.22 to 1.14; participants = 32; very low-quality evidence; long-term mortality: no data available); epinephrine versus norepinephrine-dobutamine (short-term mortality: RR 1.25; 95% CI 0.41 to 3.77; participants = 30; very low-quality evidence; long-term mortality: no data available); dopexamine versus dopamine (short-term mortality: no deaths in either intervention arm; participants = 70; very low-quality evidence; long-term mortality: no data available); enoximone versus dobutamine (short-term mortality RR 0.21; 95% CI 0.01 to 4.11; participants = 27; very low-quality evidence; long-term mortality: no data available); epinephrine versus norepinephrine (short-term mortality: RR 1.81, 0.89 to 3.68; participants = 57; very low-quality evidence; long-term mortality: no data available); and dopamine-milrinone versus dopamine-dobutamine (short-term mortality: RR 1.0, 95% CI 0.34 to 2.93; participants = 20; very low-quality evidence; long-term mortality: no data available). No information regarding all-cause mortality were available for the comparisons milrinone versus dobutamine, enoximone versus piroximone and enoximone versus epinephrine-nitroglycerine. AUTHORS' CONCLUSIONS: At present, there are no convincing data supporting any specific inotropic or vasodilating therapy to reduce mortality in haemodynamically unstable patients with CS or LCOS. Considering the limited evidence derived from the present data due to a high risk of bias and imprecision, it should be emphasised that there is an unmet need for large-scale, well-designed randomised trials on this topic to close the gap between daily practice in critical care of cardiovascular patients and the available evidence. In light of the uncertainties in the field, partially due to the underlying methodological flaws in existing studies, future RCTs should be carefully designed to potentially overcome given limitations and ultimately define the role of inotropic agents and vasodilator strategies in CS and LCOS.

Metabolically Healthy, but Obese Individuals and Associations with Echocardiographic Parameters and Inflammatory Biomarkers: Results from the CARLA Study.

INTRODUCTION: The research on heterogeneity among obese individuals has identified the metabolically healthy, but obese (MHO) phenotype as a distinct group that does not experience the typical cardiovascular-related diseases (CVD). It is unclear if this group differs with regard to preconditions for CVDs. Our aim was to assess differences in echocardiographic parameters and inflammatory biomarkers between MHO and metabolically healthy, normal weight individuals (MHNW). METHODS: The analyses used data from 1412 elderly participants from a German population-based cohort study (CARLA), which collected detailed information on demographic, biochemical, and echocardiographic variables. Participants were subdivided into four groups (MHNW, MHO, MUNW (metabolically unhealthy, normal weight) and MUO (metabolically unhealthy, obese)) based on BMI≥30 kg/m2 (obese or normal weight) and presence of components of the metabolic syndrome. The clinical characteristics of the 4 groups were compared with ANOVA or Chi-Square test, in addition to two linear regression models for 16 echocardiographic parameters. The difference in inflammatory biomarkers (hsCRP, IL-6 and sTNF-RI) between the groups was examined with a multinomial logistic regression model. RESULTS: The MHO individuals were on average 64.2±8.4 years old, with a higher proportion of women (71.6%), low percentage of smokers, larger waist circumference (109.3±10.5 cm vs 89.1±10.8 cm, p<0.0001) and higher odds ratios for hsCRP, IL-6 and sTNF-RI compared to MHNW individuals. Linear regression models revealed greater left atrial (LA) diameter (2.73 (95% CI: 1.35-4.11) mm), LA volume (7.86 (95% CI: 2.88-12.83) mL), and left ventricular mass index (LVMI) (11.82 (95% CI: 4.43-19.22) g/m1.7) in the MHO group compared to the MHNW group. CONCLUSION: The MHO phenotype is associated with echocardiographic markers of cardiac remodeling (LA diameter, volume and LVMI) and higher odds ratios for inflammatory biomarkers.

Lung Cancer Attributed Mortality Among 316,336 Early Stage Breast Cancer Cases Treated by Radiotherapy and/or Chemotherapy, 2000-2015: Evidence From the SEER Database.

OBJECTIVE: To estimate the risk of death from lung cancer in patients treated for breast cancer (BC) in relation to the general population. METHODS: BC data, covering 2000 to 2015, were extracted from the Surveillance, Epidemiology and End Results-18 (SEER-18) cancer registry database. A comparison of lung cancer attributed mortality between BC patients and the general population was performed using standardized mortality ratios (SMRs) and SMRs conditional on survival length (cSMRs). Prognostic factors of lung cancer mortality were identified using flexible parametric modelling. Our model adjusts the effect of downstream (histopathological BC tumor grade and hormone receptor status) and upstream (age at diagnosis, ethnicity, and marital status) factors. RESULTS: The median follow-up was 6.4 years (interquartile range, 3.0-10.3 years). BC cases who received only radiotherapy (cSMR = 0.93; 95%CI: 0.77-1.13), only chemotherapy (cSMR = 0.91; 0.62-1.33), and radio-and chemotherapy (cSMR = 1.04; 0.77-1.39) had no evidence of increased lung cancer mortality relative to the general population. The adjusted model identified that lung cancer mortality was higher for women who were older at diagnosis compared to those <50 years (ranging from HR50-59 = 3.41 [95%CI: 2.72-4.28] to HR70-79 = 10.53 [95%CI: 8.44-13.13]) and for cases with negative estrogen and progesterone receptors (HR =1.38; 95% CI: 1.21-1.57). Compared to married cases, widowed, divorced, single or others had a 76%, 45%, and 25% higher hazard of lung cancer mortality, respectively. Lung cancer mortality was lower for American Indian/Alaska Native and Asian/Pacific Islander ethnicities (HR = 0.51; 95% CI: 0.40-0.64) compared to BC cases with white ethnic background. CONCLUSIONS: There is no evidence for a higher lung cancer mortality in BC patients when compared to the general population.

ECG Voltage in Relation to Peripheral and Central Ambulatory Blood Pressure.

BACKGROUND: The heart ejects in the central elastic arteries. No previous study in workers described the diurnal profile of central blood pressure (BP) or addressed the question whether electrocardiogram (ECG) indexes are more closely associated with central than peripheral BP. METHODS: In 177 men (mean age, 29.1 years), we compared the associations of ECG indexes with brachial and central ambulatory BP, measured over 24 hours by the validated oscillometric Mobil-O-Graph 24h PWA monitor. RESULTS: From wakefulness to sleep, as documented by diaries, systolic/diastolic BP decreased by 11.7/13.1 mm Hg peripherally and 9.3/13.6 mm Hg centrally, whereas central pulse pressure (PP) increased by 4.3 mm Hg (P < 0.0001). Over 24 hours and the awake and asleep periods, the peripheral-minus-central differences in systolic/diastolic BPs averaged 11.8/-1.6, 12.7/-1.8, and 10.3/-1.2 mm Hg, respectively (P < 0.0001). Cornell voltage and index averaged 1.18 mV and 114.8 mV·ms. Per 1-SD increment in systolic/diastolic BP, the Cornell voltages were 0.104/0.086 mV and 0.082/0.105 mV higher in relation to brachial 24-hour and asleep BP and 0.088/0.90 mV and 0.087/0.107 mV higher in relation to central BP. The corresponding estimates for the Cornell indexes were 9.6/8.6 and 8.2/10.5 mV·ms peripherally and 8.6/8.9 and 8.8/10.7 mV·ms centrally. The regression slopes (P ≥ 0.067) and correlation coefficients (P ≥ 0.088) were similar for brachial and central BP. Associations of ECG measurements with awake BP and PP were not significant. CONCLUSIONS: Peripheral and central BPs run in parallel throughout the day and are similarly associated with the Cornell voltage and index.

Association of office and ambulatory blood pressure with blood lead in workers before occupational exposure.

In view of decreasing lead exposure and guidelines endorsing ambulatory above office blood pressure (BP) measurement, we reassessed association of BP with blood lead (BL) in 236 newly employed men (mean age, 28.6 years) without previous lead exposure not treated for hypertension. Office BP was the mean of five auscultatory readings at one visit. Twenty-four-hour BP was recorded at 15- and 30-minute intervals during wakefulness and sleep. BL was determined by inductively coupled plasma mass spectrometry. Systolic/diastolic office BP averaged 120.0/80.7 mm Hg, and the 24-hour, awake, and asleep BP 125.5/73.6, 129.3/77.9, and 117.6/65.0 mm Hg, respectively. The geometric mean of blood lead was 4.5 µg/dL (interquartile range, 2.60-9.15 µg/dL). In multivariable-adjusted analyses, effect sizes associated with BL doubling were 0.79/0.87 mm Hg (P = .11/.043) for office BP and 0.29/-0.25, 0.60/-0.10, and -0.40/-0.43 mm Hg for 24-hour, awake, and asleep BP (P ≥ .33). Neither office nor 24-hour ambulatory hypertension was related to BL (P ≥ .14). A clinically relevant white coat effect (WCE; office minus awake BP, ≥20/≥10 mm Hg) was attributable to exceeding the systolic or diastolic threshold in 1 and 45 workers, respectively. With BL doubling, the systolic/diastolic WCE increased by 0.20/0.97 mm Hg (P = .57/.046). Accounting for the presence of a diastolic WCE, reduced the association size of office diastolic BP with BL to 0.39 mm Hg (95% confidence interval, -0.20 to 1.33; P = .15). In conclusion, a cross-sectional analysis of newly hired workers before lead exposure identified the WCE as confounder of the association between office BP and BL and did not reveal any association between ambulatory BP and BL.

Post-processing reproducibility of the structural characteristics of the common carotid artery in a Flemish population.

INTRODUCTION: Common carotid artery (CCA) intima-media thickness (IMT), lumen diameter, and maximum plaque thickness were assessed on ultrasound images. The objective of the study was to evaluate the intra- and inter-reader reproducibility of the measurements following a standardised protocol. METHODS: Two readers performed the off-line measurements on B-mode ultrasound images of the distal CCA, in a randomly selected subset (n = 60) from a Flemish population cohort (FLEMENGHO). We calculated the coefficient of variation, the interclass correlation coefficient (ICC) and reproducibility according to the Bland-Altman method. RESULTS: The intra-reader bias for the measurements of left and right side CCA IMT were -0.003 ± 0.04 mm (p = 0.55) and 0.01 ± 0.04 mm (p = 0.03), respectively. The intra-reader bias of the lumen diameter was -0.04 ± 0.25 mm (p = 0.27) for the left and 0.02 ± 0.22 mm (p = 0.45) for the right side. The measurements for the maximum plaque thickness showed no intra-reader differences with bias 0.07 ± 0.2 mm (p = 0.26) for the left and -0.03 ± 0.2 mm (p = 0.55) for the right side. The inter-reader analysis showed good reproducibility for the left and right side CCA IMT with bias 0.004 ± 0.06 mm (p = 0.57) and -0.008 ± 0.05 mm (p = 0.19), respectively, but the lumen diameter measurements showed inter-reader differences, with bias 0.17 ± 0.27 mm (p < 0.0001) for the left and 0.10 ± 0.21 mm (p = 0.0006) for the right side. The inter-reader bias for the maximum plaque thickness were 0.07 ± 0.2 mm (p = 0.21) and -0.1 ± 0.4 mm (p = 0.26) for the left and right side, respectively. CONCLUSION: The results demonstrated a reliable reproducibility of carotid wall structural measurements, allowing for an adequate further analysis of the entire population cohort.

Risk for Incident Heart Failure: A Subject-Level Meta-Analysis From the Heart "OMics" in AGEing (HOMAGE) Study.

BACKGROUND: To address the need for personalized prevention, we conducted a subject-level meta-analysis within the framework of the Heart "OMics" in AGEing (HOMAGE) study to develop a risk prediction model for heart failure (HF) based on routinely available clinical measurements. METHODS AND RESULTS: Three studies with elderly persons (Health Aging and Body Composition [Health ABC], Valutazione della PREvalenza di DIsfunzione Cardiaca asinTOmatica e di scompenso cardiaco [PREDICTOR], and Prospective Study of Pravastatin in the Elderly at Risk [PROSPER]) were included to develop the HF risk function, while a fourth study (Anglo-Scandinavian Cardiac Outcomes Trial [ASCOT]) was used as a validation cohort. Time-to-event analysis was conducted using the Cox proportional hazard model. Incident HF was defined as HF hospitalization. The Cox regression model was evaluated for its discriminatory performance (area under the receiver operating characteristic curve) and calibration (Grønnesby-Borgan χ2 statistic). During a follow-up of 3.5 years, 470 of 10 236 elderly persons (mean age, 74.5 years; 51.3% women) developed HF. Higher age, BMI, systolic blood pressure, heart rate, serum creatinine, smoking, diabetes mellitus, history of coronary artery disease, and use of antihypertensive medication were associated with increased HF risk. The area under the receiver operating characteristic curve of the model was 0.71, with a good calibration (χ2 7.9, P=0.54). A web-based calculator was developed to allow easy calculations of the HF risk. CONCLUSIONS: Simple measurements allow reliable estimation of the short-term HF risk in populations and patients. The risk model may aid in risk stratification and future HF prevention strategies.

Quality Assessment of Studies Published in Open Access and Subscription Journals: Results of a Systematic Evaluation.

INTRODUCTION: Along with the proliferation of Open Access (OA) publishing, the interest for comparing the scientific quality of studies published in OA journals versus subscription journals has also increased. With our study we aimed to compare the methodological quality and the quality of reporting of primary epidemiological studies and systematic reviews and meta-analyses published in OA and non-OA journals. METHODS: In order to identify the studies to appraise, we listed all OA and non-OA journals which published in 2013 at least one primary epidemiologic study (case-control or cohort study design), and at least one systematic review or meta-analysis in the field of oncology. For the appraisal, we picked up the first studies published in 2013 with case-control or cohort study design from OA journals (Group A; n = 12), and in the same time period from non-OA journals (Group B; n = 26); the first systematic reviews and meta-analyses published in 2013 from OA journals (Group C; n = 15), and in the same time period from non-OA journals (Group D; n = 32). We evaluated the methodological quality of studies by assessing the compliance of case-control and cohort studies to Newcastle and Ottawa Scale (NOS) scale, and the compliance of systematic reviews and meta-analyses to Assessment of Multiple Systematic Reviews (AMSTAR) scale. The quality of reporting was assessed considering the adherence of case-control and cohort studies to STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) checklist, and the adherence of systematic reviews and meta-analyses to Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) checklist. RESULTS: Among case-control and cohort studies published in OA and non-OA journals, we did not observe significant differences in the median value of NOS score (Group A: 7 (IQR 7-8) versus Group B: 8 (7-9); p = 0.5) and in the adherence to STROBE checklist (Group A, 75% versus Group B, 80%; p = 0.1). The results did not change after adjustment for impact factor. The compliance with AMSTAR and adherence to PRISMA checklist were comparable between systematic reviews and meta-analyses published in OA and non-OA journals (Group C, 46.0% versus Group D, 55.0%; p = 0.06), (Group C, 72.0% versus Group D, 76.0%; p = 0.1), respectively). CONCLUSION: The epidemiological studies published in OA journals in the field of oncology approach the same methodological quality and quality of reporting as studies published in non-OA journals.

Are the Conventional Commercial Yeast Identification Methods Still Helpful in the Era of New Clinical Microbiology Diagnostics? A Meta-Analysis of Their Accuracy.

Accurate identification of pathogenic species is important for early appropriate patient management, but growing diversity of infectious species/strains makes the identification of clinical yeasts increasingly difficult. Among conventional methods that are commercially available, the API ID32C, AuxaColor, and Vitek 2 systems are currently the most used systems in routine clinical microbiology. We performed a systematic review and meta-analysis to estimate and to compare the accuracy of the three systems, in order to assess whether they are still of value for the species-level identification of medically relevant yeasts. After adopting rigorous selection criteria, we included 26 published studies involving Candida and non-Candida yeasts that were tested with the API ID32C (674 isolates), AuxaColor (1,740 isolates), and Vitek 2 (2,853 isolates) systems. The random-effects pooled identification ratios at the species level were 0.89 (95% confidence interval [CI], 0.80 to 0.95) for the API ID32C system, 0.89 (95% CI, 0.83 to 0.93) for the AuxaColor system, and 0.93 (95% CI, 0.89 to 0.96) for the Vitek 2 system (P for heterogeneity, 0.255). Overall, the accuracy of studies using phenotypic analysis-based comparison methods was comparable to that of studies using molecular analysis-based comparison methods. Subanalysis of studies conducted on Candida yeasts showed that the Vitek 2 system was significantly more accurate (pooled ratio, 0.94 [95% CI, 0.85 to 0.99]) than the API ID32C system (pooled ratio, 0.84 [95% CI, 0.61 to 0.99]) and the AuxaColor system (pooled ratio, 0.76 [95% CI, 0.67 to 0.84]) with respect to uncommon species (P for heterogeneity, <0.05). Subanalysis of studies conducted on non-Candida yeasts (i.e., Cryptococcus, Rhodotorula, Saccharomyces, and Trichosporon) revealed pooled identification accuracies of ≥98% for the Vitek 2, API ID32C (excluding Cryptococcus), and AuxaColor (only Rhodotorula) systems, with significant low or null levels of heterogeneity (P > 0.05). Nonetheless, clinical microbiologists should reconsider the usefulness of these systems, particularly in light of new diagnostic tools such as matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry, which allow for considerably shortened turnaround times and/or avoid the requirement for additional tests for species identity confirmation.