Communication, information, and the parent-caregiver relationship in neonatal intensive care units: A review of the literature.

This literature review focuses on the neonatal context. It provides an update of knowledge on the psychosocial consequences and communication needs expressed by parents. It highlights the obstacles to communication and proposes lines of thought for the development of new training systems to improve the communication practices of caregivers. OBJECTIVE: This review aims to assess and categorize the specific needs and expectations of families in terms of communication within the neonatal intensive care unit (NICU). METHODS: A bibliographic search was carried out on the Web of Sciences, PubMed and PsycArticles databases with the following keywords: "neonat* AND new* AND communication AND parent*". RESULTS: In total, 16 papers were selected showing that information and communication are particular needs for parents in NICUs. They are confronted with a stressful situation and have to deal with the fear and anticipation of the situation in a context of uncertainty. Parents are satisfied with the caregiver-parent relationship when the type of communication is adapted to the context and to their changing needs. Conversely, they feel excluded when they cannot be involved as they would like to be in the care or in the decision-making process. CONCLUSION: The development of new communication training methods and tools such as simulation would allow healthcare workers to acquire new communication skills focused on the needs of families.

Antineoplastic treatment class modulates COVID-19 mRNA-BNT162b2 vaccine immunogenicity in cancer patients: a secondary analysis of the prospective Vax-On study.

BACKGROUND: Preliminary analysis from the Vax-On study did not find a correlation between cancer treatment type and antibody response to COVID-19 vaccination. We carried out a secondary subgroup analysis to verify the effects of comprehensive cancer treatment classification on vaccine immunogenicity. METHODS: The Vax-On study prospectively enrolled patients who started a two-dose messenger RNA-BNT162b2 vaccine schedule from 9 March 2021 to 12 April 2021 (timepoint-1). Those on active treatment within the previous 28 days accounted for the exposed cases. Patients who had discontinued such treatment by at least 28 days or received intravesical therapy represented the control cases. Quantification of immunoglobulin G (IgG) antibodies against the receptor binding domain of the S1 subunit of the SARS-CoV-2 spike protein was carried out before the second dose (timepoint-2) and 8 weeks thereafter (timepoint-3). Seroconversion response was defined at ≥50 arbitrary units/ml IgG titer. Classification of antineoplastic agents was based on their pharmacodynamic properties. RESULTS: Three hundred and sixty-six patients were enrolled (86 and 260 as control and exposed cases, respectively). Univariate analysis revealed a significantly lower IgG titer after both doses of vaccine in subgroups treated with tyrosine kinase inhibitors (TKIs), multiple cytotoxic agents, alkylating agents, and topoisomerase inhibitors. At timepoint-3, seroconversion response was significantly impaired in the topoisomerase inhibitors and mechanistic target of rapamycin (mTOR) inhibitors subgroups. After multivariate testing, treatment with alkylating agents and TKIs was significantly associated with a reduced change in IgG titer at timepoint-2. Treatment with mTOR inhibitors resulted in a similar interaction at each timepoint. Cyclin-dependent kinase 4/6 inhibitor treatment was independently correlated with an incremental variation in IgG titer at timepoint-3. Specific subgroups (TKIs, antimetabolites, alkylating agents, and multiple-agent chemotherapy) predicted lack of seroconversion at timepoint-2, but their effect was not retained at timepoint-3. Eastern Cooperative Oncology Group performance status 2, immunosuppressive corticosteroid dosing, and granulocyte colony-stimulating factor use were independently linked to lower IgG titer after either dose of vaccine. CONCLUSIONS: Drugs interfering with DNA synthesis, multiple-agent cytotoxic chemotherapy, TKIs, mTOR and cyclin-dependent kinase 4/6 inhibitors differentially modulate humoral response to messenger RNA-BNT162b2 vaccine.

The electron-ion collider: assessing the energy dependence of key measurements.

We provide an assessment of the energy dependence of key measurements within the scope of the machine parameters for a US based electron-ion collider (EIC) outlined in the EIC White Paper. We first examine the importance of the physics underlying these measurements in the context of the outstanding questions in nuclear science. We then demonstrate, through detailed simulations of the measurements, that the likelihood of transformational scientific insights is greatly enhanced by making the energy range and reach of the EIC as large as practically feasible.

Intake of polyunsaturated fat in relation to mortality among statin users and non-users in the Southern Community Cohort Study.

BACKGROUND AND AIMS: Consumption of polyunsaturated fatty acids (PUFA), especially the n3-series, may protect against cardiovascular disease (CVD), but recent randomized studies have failed to demonstrate these benefits. One of the prevailing hypotheses is that PUFA intake may not confer benefits beyond those provided by statins, but studies comparing statin users to non-users with regard to effects of PUFA are lacking. METHODS AND RESULTS: Black and white men and women (n = 69,559) in the Southern Community Cohort Study were studied. Cox regression models adjusting for age, sex, race, BMI, recruitment site, education, income, smoking, diabetes, and dietary variables were used. RESULTS: At baseline the mean ± SD age was 52 ± 9 years, 60% of participants were women, 54% had hypertension and 16% used statins. We observed modest inverse associations between n3-PUFA and n6-PUFA intake with mortality among non-statin users but not among statin users. In adjusted analyses, the HRs (95% CIs) for all-cause mortality (6,396 deaths over a median of 6.4 years) comparing the highest to the lowest quintile were 0.90 (0.82-1.00) for n3-PUFA and 0.80 (0.70-0.92) for n6-PUFA among non-statin users, whereas they were 1.06 (0.87-1.28) and 0.96 (0.78-1.19) for n3-PUFA and n6-PUFA, respectively, among statin users. CONCLUSIONS: Our results suggest potential benefits of PUFA consumption on mortality which are only apparent in the absence of statin therapy. It seems prudent to consider the potential benefit of PUFA consumption in the primary prevention of CVD among patients who are not candidates for statin therapy but are at increased risk for CVD and mortality.

Free fatty acids are associated with metabolic syndrome and insulin resistance but not inflammation in systemic lupus erythematosus.

Free fatty acids (FFAs) are implicated in the pathogenesis of insulin resistance and atherosclerosis. Inflammatory cytokines promote lipolysis and increase FFAs, a cause of endothelial dysfunction and increased atherosclerosis risk. We hypothesized that increased inflammation is associated with increased FFAs, resulting in insulin resistance and atherosclerosis in patients with systemic lupus erythematosus (SLE). We measured clinical variables, serum FFAs, homeostasis model assessment for insulin resistance (HOMA), inflammatory cytokines, markers of endothelial activation, cholesterol concentrations and coronary artery calcium in 156 patients with SLE and 90 controls. We compared FFAs in patients with SLE and controls using Wilcoxon rank sum tests and further tested for the independent association between FFAs and disease status with adjustment for age, race and sex using multivariable regression models. We assessed the relationship between FFAs and continuous variables of interest using Spearman correlation and multivariable regression analysis. Levels of FFAs were higher in patients with SLE than controls (0.55 mmol/l (0.37-0.71) vs 0.44 mmol/l (0.32-0.60), P = 0.02). Levels of FFAs remained significantly higher among patients with SLE after adjustment for age, race and sex (P = 0.03) but not after further adjustment for body mass index (P = 0.13). FFA levels did not differ according to the usage of current immunosuppressive medications in univariate and adjusted analysis (all P > 0.05). Among patients with SLE, concentrations of FFAs were higher among those with metabolic syndrome compared to those without (0.66 mmol/l (0.46-0.81) vs 0.52 mmol/l (0.35-0.66), P < 0.001). FFAs were positively correlated with insulin resistance (HOMA) (rho = 0.23, P = 0.004, P adjusted = 0.006) and triglyceride levels (rho = 0.22, P = 0.01, P adjusted = 0.004). FFAs were not associated with inflammatory cytokines (IL-6, TNF-α) (all P > 0.05) but were positively associated with levels of E-selectin (rho = 0.33, P = < 0.001, P adjusted = 0.001) and ICAM-1 (rho = 0.35, P < 0.001, P adjusted = 0.001). FFAs were correlated with coronary artery calcium score (rho = 0.20, P = 0.01) but this was attenuated after adjustment for age, race and sex (P = 0.33). From our study we concluded that FFAs are elevated in patients with SLE, particularly those with metabolic syndrome. FFAs in patients with SLE are not associated with markers of generalized inflammation but are associated with insulin resistance and markers of endothelial activation.

Efficacy and safety of bevacizumab in glioblastomas.

Glioblastoma multiforme (GBM) is a common and malignant primary brain tumor arising from glial precursors the survival of which is estimated to be about 14 months after diagnosis despite current standard care with radiotherapy, surgery, and chemotherapies. Therapeutic approaches were greatly improved in the last years; however, GBM still represents the most lethal subtype of glioma. Actually, it has been estimated that only about 3.4% of patients will survive at the most five years when obtaining the best outcome from treatment; however, this depends on tumor resistance, which is generally related to repairing radiation injury, and self- improving cell growth repair and survival. All GBMs recur after initial therapy, limiting patients � survival at 20-25% within 1 year after diagnosis of recurrent disease. Moreover, for recurrent GBM response rates are less than 10% (ranging from 5% to 9%), and progression free survival at 6-month (PFS-6) rates ranges between 9% and 28% (median 15%). The development of targeted therapy based on tumor vascular blockade led to the approval of bevacizumab for recurrent or progressive glioblastoma, since it was proven that this offers a new opportunity for patients suffering from this malignancy. Bevacizumab is a recombinant antivascular monoclonal antibody binding to circulating Vascular Endothelial Growth Factor (VEGF) preventing this cytokine from reaching its receptors (VEGFR1 and VEGFR2) on endothelium, resulting in an inhibition of cells proliferation and vessels sprouting. The aim of this review is to address bevacizumab mode of action in malignant gliomas and provide a summary on currently available data on efficacy and safety.

Lifestyle determinants of C-reactive protein in middle-aged, urban Chinese men.

BACKGROUND AND AIM: Increased levels of C-reactive protein (CRP), common in aging populations, are associated with higher risk for chronic diseases, including diabetes and coronary heart disease. The aim of this study was to investigate associations between lifestyle factors and high CRP among middle-aged men living in Shanghai, China. METHODS AND RESULTS: In this cross-sectional study, 3978 urban Chinese men aged 40-74 years who were free of type-2 diabetes at baseline provided fasting blood samples, anthropometric measurements and information on lifestyle factors and disease history. Dietary patterns were assessed by factor analysis. Participants were categorised into two groups according to CRP level: normal (≤ 3 mg/L) and high (> 3 mg/L). Associations between CRP categories and lifestyle factors were investigated by using logistic regression. Obesity, weight gain, cigarette smoking and alcohol intake were positively associated with high CRP levels, while physical activity and a dietary pattern with high consumption of fruit were inversely related to high CRP levels. A positive trend of marginal significance between quintiles of a dietary pattern with high consumption of meat and high CRP levels was also observed. No association between tea intake and CRP level was observed. CONCLUSIONS: Components of an adverse lifestyle were associated with high CRP levels. Obesity, smoking and alcohol intake were associated with high CRP, a biomarker of low-grade inflammation in middle-aged men, while a dietary pattern rich in fruit and high physical activity were inversely associated with the prevalence of high CRP.

Purine-rich foods, protein intake, and the prevalence of hyperuricemia: the Shanghai Men's Health Study.

BACKGROUND AND AIMS: Diet may play an important role in the development of hyperuricemia and gout. However, the association between dietary factors and hyperuricemia remains unclear, and few studies have investigated direct links between food intake and hyperuricemia. The aim of this study was to investigate associations between high purine-content foods and protein intake with the prevalence of hyperuricemia by using data from a cross-sectional study of 3978 men aged 40-74 yrs living in Shanghai, China. METHODS AND RESULTS: Hyperuricemia was defined as blood uric acid level >7.0 mg/dl. One quarter of this population had hyperuricemia. Dietary information was collected by using a food frequency questionnaire. We collected information on anthropometric measurements and lifestyle factors and other potential confounding factors and disease history via interviews. Total protein consumption was not associated with hyperuricemia. We found a positive association between protein from animal sources and prevalence of hyperuricemia and an inverse association between protein from plant sources and hyperuricemia. However, these associations failed to reach significance in mutually adjusted analysis. Seafood intake was associated with higher prevalence of hyperuricemia. The ORs for quintiles of seafood intake (including fish and shellfish) were 1.00, 1.49, 1.35, 1.34, and 1.56 (p for trend: 0.01). An inverse association approaching significance between soy food consumption and hyperuricemia was observed (ORs: 1.00, 0.90, 0.70, 0.89, and 0.77 for quintiles of intake; p for trend: 0.07). No associations between consumption of purine-rich vegetables or meat and prevalence of hyperuricemia were observed. CONCLUSIONS: Our data suggest a direct association between seafood consumption and hyperuricemia and an inverse association between consumption of soy food and hyperuricemia among middle-aged, Chinese men.

Evaluation of macrophage-specific promoters using lentiviral delivery in mice.

In gene therapy, tissue-specific promoters are useful tools to direct transgene expression and improve efficiency and safety. Macrophage-specific promoters (MSPs) have previously been published using different delivery systems. In this study, we evaluated five different MSPs fused with green fluorescent protein (GFP) to delineate the one with highest specificity using lentiviral delivery. We compared three variants of the CD68 promoter (full length, the 343-bp proximal part and the 150-bp proximal part) and two variants (in forward and reverse orientation) of a previously characterized synthetic promoter derived from elements of transcription factor genes. We transduced a number of cell lines and primary cells in vitro. In addition, hematopoietic stem cells were transduced with MSPs and transferred into lethally irradiated recipient mice. Fluorescence activated cell sorting analysis was performed to determine the GFP expression in different cell populations both in vitro and in vivo. We showed that MSPs can efficiently be used for lentiviral gene delivery and that the 150-bp proximal part of the CD68 promoter provides primarily macrophage-specific expression of GFP. We propose that this is the best currently available MSP to use for directing transgene expression to macrophage populations in vivo using lentiviral vectors.

Long-term efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidaemic patients with diabetes or metabolic syndrome.

AIMS: To assess the efficacy and safety of ezetimibe/simvastatin (E/S) plus extended-release niacin (N) in hyperlipidaemic patients with diabetes mellitus (DM), metabolic syndrome (MetS) without DM (MetS/non-DM) or neither (non-DM/non-MetS). METHODS: A subgroup analysis of a double-blind, 64-week trial of 1220 randomized patients who received E/S (10/20 mg) + N (to 2 g) or E/S (10/20 mg) for 64 weeks, or N (to 2 g) for 24 weeks then E/S (10/20 mg) + N (2 g) or E/S (10/20 mg) for 40 additional weeks. The evaluable populations of this analysis included n = 765 patients at 24 weeks and n = 574 at 64 weeks. Among those receiving N, only those who attained the 2-g dose were included in the analysis. RESULTS: E/S+N improved levels of low-density lipoprotein cholesterol, other lipids and lipoprotein ratios compared with N and E/S at 24 weeks and E/S at 64 weeks. The combination increased high-density lipoprotein cholesterol and apolipoprotein AI comparably to N and more than E/S. E/S+N reduced high-sensitivity C-reactive protein (hsCRP) levels more effectively than N and similarly to E/S. E/S+N was generally well tolerated. Discontinuations due to flushing with N and E/S+N were comparable and greater than E/S in all subgroups. Fasting glucose trended higher for N vs. E/S. Glucose elevations from baseline to 12 weeks were highest for patients with DM (24.9 mg/dl for N, 21.2 mg/dl for E/S+N, 17.5 mg/dl for E/S); fasting glucose then declined to pretreatment levels at 64 weeks in all subgroups. New-onset DM was more frequent among MetS patients than those without MetS during the first 24 weeks and trended higher among those assigned to N-containing regimens [n = 5(5.1%) for N, n = 2(1.7%) for E/S, n = 21(8.8%) for E/S+N]; during the 24-64 week extension study, diabetes was diagnosed in five additional patients in the E/S(cumulative incidence of 5.9%) and one in the E/S+N (cumulative incidence of 9.2%). Treatment-incident elevations in uric acid levels were increased among subjects assigned to N-containing regimens, but there were no effects on symptomatic gout. CONCLUSION: Combination E/S+N is a safe treatment option for hyperlipidaemic patients including those with DM and MetS, but requires monitoring of glucose and potentially uric acid levels.

Jaw osteonecrosis in patients treated with bisphosphonates: an ultrastructural study.

Osteonecrosis of the jaw is a severe bone disorder traditionally associated with periodontal disease, local malignancy, chemotherapy, glucocorticoid therapy, or trauma. Recently a growing number of publications reported the occurrence of osteonecrosis of the jaw in patients undergoing treatment with bisphosphonates. The mechanism by which bisphosphonates might contribute to the development of osteonecrosis of the jaw is far from being fully elucidated. Suppression of bone turnover, infection, tissue hypoxia and cellular toxicity were proposed as possible mechanisms by which bisphosphonates may exert adverse effects on bone metabolism. Here, we studied 25 consecutive patients treated with bisphosphonates for osteoporosis or tumoral pathologies. We provide good evidence of hyperactive osteoclastic bone resorption and suggest a direct cytotoxic effect of bisphosphonates on bone tissue through induction of osteocyte cell death. We also demonstrate that bisphosphonates only have limited adverse effects on bone vascular network.

Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study.

BACKGROUND AND AIMS: Some nutraceuticals are prescribed as lipid-lowering substances. However, doubts remain about their efficacy. We evaluated the effects of a nutraceutical combination (NC), consisting of 500 mg berberine, 200mg red yeast rice and 10mg policosanols, on cholesterol levels and endothelial function in patients with hypercholesterolemia. METHODS AND RESULTS: In this single centre, randomized, double-blind, placebo-controlled study, 50 hypercholesterolemic patients (26 males and 24 females, mean age 55±7 years, total cholesterol 6.55±0.75 mmol/l, BMI 28±3.5) were randomized to 6 weeks of treatment with a daily oral dose of NC (25 patients) or placebo (25 patients). In a subsequent open-label extension of 4 weeks, the whole sample received NC. The main outcome measure was decrease total cholesterol (C) levels in the NC arm. Secondary outcome measures were decreased low-density lipoprotein cholesterol (LDL-C) and triglyceride levels, and improved endothelial-dependent flow-mediated dilation (FMD) and insulin sensitivity in relation to NC. Evaluation of absolute changes from baseline showed significant reductions in NC versus placebo for C and LDL-C (C: -1.14±0.88 and -0.03±0.78 mmol/l, p<0.001; LDL-C: -1.06±0.75 and -00.4±0.54 mmol/l, p<0.001), and a significant improvement of FMD (3±4% and 0±3% respectively, p<0.05). After the extension phase, triglyceride levels decreased significantly from 1.57±0.77 to 1.26±0.63 mmol/l, p<0.05 and insulin sensitivity improved in a patient subgroup with insulin resistance at baseline (HOMA: from 3.3±0.4 to 2.5±1.3, p<0.05). No adverse effect was reported. CONCLUSIONS: This NC reduces cholesterol levels. The reduction is associated with improved endothelial function and insulin sensitivity.

Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients.

In this postmarketing study 9657 patients (5181 children) with bronchitis (acute or chronic bronchial inflammatory disease) were treated with a syrup containing dried ivy leaf extract. After 7 days of therapy, 95% of the patients showed improvement or healing of their symptoms. The safety of the therapy was very good with an overall incidence of adverse events of 2.1% (mainly gastrointestinal disorders with 1.5%). In those patients who got concomitant medication as well, it could be shown that the additional application of antibiotics had no benefit respective to efficacy but did increase the relative risk for the occurrence of side effects by 26%. In conclusion, it is to say that the dried ivy leaf extract is effective and well tolerated in patients with bronchitis. In view of the large population considered, future analyses should approach specific issues concerning therapy by age group, concomitant therapy and baseline conditions.

Inclusive K(S);(0)K(S);(0) resonance production in ep collisions at HERA.

Inclusive K_{S};{0}K_{S};{0} production in ep collisions at the DESY ep collider HERA was studied with the ZEUS detector using an integrated luminosity of 0.5 fb;{-1}. Enhancements in the mass spectrum were observed and are attributed to the production of f_{2}(1270)/a_{2};{0}(1320), f_{2};{'}(1525) and f_{0}(1710). Masses and widths were obtained using a fit which takes into account theoretical predictions based on SU(3) symmetry arguments, and are consistent with the Particle Data Group values. The f_{0}(1710) state, which has a mass consistent with a glueball candidate, was observed with a statistical significance of 5 standard deviations. However, if this state is the same as that seen in gammagamma-->K_{S};{0}K_{S};{0}, it is unlikely to be a pure glueball state.

Anticholinergic drug-induced delirium in an elderly Alzheimer's dementia patient.

Drug-induced delirium is a common matter in the elderly and anticholinergics, together with a number of different drugs, may significantly contribute to the delirium onset, especially in demented people. We report a case of a probable anticholinergic drug-induced delirium in an elderly patient. An 80-year-old man with Alzheimer's dementia presented with wandering, depressed mood with crying, somatic worries, anedonism and suicide recurrent ideas. A first external psychiatric assessment led to the diagnosis of melancholic depression and therapy with haloperidol 2mg/day, orphenadrine 100mg daily, amitriptyline 40 mg/day, lorazepam 2mg/day was started. Two weeks later patient suddenly developed delirium, characterized by nocturnal agitation, severe insomnia, daytime sedation, confusion, hallucinations and persecutory delusions. These symptoms progressively worsened, with the consequent caregiver's stress. A geriatric consultation excluded the main causes of delirium, therefore both Operative Units of Pharmacovigilance and Psychiatry were activated, for a clinical pharmacological and psychiatric assessment. Haloperidol, amitriptyline and orphenadrine were promptly dismissed. The patient began a treatment with quetiapine 25mg/day for two days, then twice a day, and infusion of saline 1000 ml/day for two days; psychiatric symptoms gradually diminished and therapy with galantamine was begun. We postulate that this clinical report is suggestive for an anticholinergic drug- induced delirium since the Naranjo probability scale indicated a probable relationship between delirium and drug therapy. In conclusion, a complete geriatric, pharmacological, and psychiatric evaluation might be necessary in order to reduce the adverse drug reactions in older patients treated with many drugs.

Retrospective evaluation of adverse drug reactions induced by nonsteroidal anti-inflammatory drugs.

BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most widely prescribed drugs, and their use can be complicated by the development of adverse drug reactions (ADRs). The aim of this study was to assess the frequency of NSAID-induced ADRs in hospitalised patients in the Clinical Divisions of the Catanzaro and Cosenza hospitals. METHODS: We retrospectively analysed NSAID-induced ADRs after evaluating all ADRs recorded by the Clinical Divisions of the Catanzaro and Cosenza hospitals over a 10-year period, from January 1995 to December 2004. RESULTS: NSAIDs were found to be responsible for 55.2% of the episodes of ADRs overall. Diclofenac and aspirin (acetylsalicylic acid) were the drugs most frequently involved in the development of ADRs, while the skin was the body system most susceptible to NSAID-induced ADRs (43%). We determined that the drug-ADR relationship was probable in 62% of the reports; withdrawal of NSAID therapy led to a resolution of the clinical features of ADRs in 86% of episodes. CONCLUSION: NSAID therapy represents a common cause of ADRs in hospitalised patients. Their use should be carefully considered, especially in the presence of polydrug therapy.