Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data.

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting

A(H1N1) pandemic influenza and its prevention by vaccination : Paediatricians’ opinions before and after the beginning of the vaccination campaign

Background: In June 2009, the World Health Organization declared an A(H1N1) influenza pandemic. In October 2009, the largest vaccination campaign in Canadian history began. The aim of this study was to document paediatricians’ knowledge, attitudes and practices (KAP) regarding A(H1N1) pandemic influenza and its prevention by vaccination just after the beginning of the A(H1N1) vaccination campaign and to compare the results with those obtained before campaign initiation. Methods: A self-administered mail-based questionnaire was sent to all Canadian paediatricians. Questionnaires were analyzed in two subsets: those received before and after the beginning of the vaccination campaign. Results: Overall the response rate was 50%. Respondents’ characteristics were comparable between the two subsets. Before the beginning of the campaign, 63% of paediatricians perceived A(H1N1) pandemic infection as a serious disease, that would occur frequently without vaccination compared to more than 75% after. Before the vaccination campaign, half of respondents or less thought that the A(H1N1) vaccine was safe (50%) and effective (35%) compared to 77% and 72% after. The proportion of paediatricians who reported they had received sufficient information on A (H1N1) vaccine increased from 31% before to 73% after the beginning of the vaccination campaign. The majority of respondents intended to get vaccinated against A(H1N1) influenza themselves (84% before and 92% after). Respondents’ intention to recommend the A(H1N1) vaccine to their patients increased from 80% before the beginning of the campaign to 92% after. In multivariate analysis, the main determinants of paediatricians’ intention to recommend the A(H1N1) vaccine were their intention to get vaccinated against A(H1N1) influenza themselves and a belief that A (H1N1) vaccine would be well accepted by health professionals who administer vaccines to the public. Conclusion: Results of this study show important increases in physicians’ level of confidence about A(H1N1) vaccine’s safety and immunogenicity and their willingness to recommend this vaccine to their patients. These changes could be explained, at least partially, by the important effort done by public health authorities to disseminate information regarding A(H1N1) vaccination.Medicine, Faculty ofPediatrics, Department ofNon UBCReviewedFacult

A review on macrobenthic trophic relationships along subtropical sandy shores in southernmost Brazil

Main trophic relationships that occur along the exposed sandy shores in southernmost Brazil (,336 S) are established taking into account several biological compartments operating at morphodynamically distinct environments. Beaches are predominantly of the intermediate type but some stretches of coastline are truly dissipative (Cassino Beach) or tending-to-reflective (Concheiros Beach), presenting thus diverse biological compartments and inhabitant macrobenthic assemblages. Dense concentrations of the surf-zone diatom Asterionellopsis glacialis are responsible - at least for the intermediate shorelines - for the most year-round primary production, sustaining several consumers up to tertiary level. Among them, bivalves Amarilladesma mactroides, Donax hanleyanus and the hippid crab Emerita brasiliensis can account for more than 95% of all the surf-zone secondary production, in addition to the elevated biomass of the suspension-feeder polychaete Spio gaucha and the scavenger isopod Excirolana armata. Crabs, whelks, carnivorous polychaetes, seabirds and surf-zone fishes may also be present and occupy superior trophic levels depending on the beach morphodynamics. Based on the high species richness, abundance and the role of macrobenthic fauna in transferring matter and energy to seabirds and the surf-zone fish assemblages, we address this important issue on the Southwestern Atlantic ecology. Conservation efforts should be implemented for the southernmost Brazilian sandy shores, at least for those non urbanized areas.As principais relac¸o˜ es tro´ ficas observadas ao longo da costa arenosa exposta do extremo sul do Brasil (,336 S) sa˜o estabelecidas levando-se em considerac¸a˜o os va´ rios compartimentos biolo´ gicos que operam em ambientes morfodinamicamente distintos. Estas praias sa˜o predominantemente do tipo intermedia´ rio, embora alguns trechos sejam dissipativos (Praia do Cassino) ou apresentem tendeˆncias reflectivas (Praia dos Concheiros), possuindo compartimentos biolo´ gicos diversificados e associac¸o˜es macrobentoˆnicas residentes. Densas concentrac¸o˜ es da diatoma´cea Asterionellopsis glacialis sa˜o responsa´ veis - pelo menos para as praias intermedia´ rias - por grande parte da produtividade prima´ ria anual, sustentando va´ rios consumidores ate´ o nı´vel tercia´ rio. Entre estes, os bivalves Amarilladesma mactroides, Donax hanleyanus e o crusta´ceo Emerita brasiliensis sa˜o responsa´ veis por mais de 95% de toda a produc¸a˜o secunda´ ria da zona de surfe, em adic¸a˜o a` elevada biomassa do poliqueta suspensı´voro Spio gaucha e do iso´pode necro´fago Excirolana armata. Caranguejos, gastro´ podes, poliquetas carnı´voros, aves marinhas e peixes da zona de surfe tambe´m podem estar presentes, ocupando nı´veis tro´ ficos superiores dependendo da morfodinaˆmica praial. Baseado na alta riqueza de espe´cies, na abundaˆncia e no papel da macrofauna bentoˆ nica em transferir mate´ria e energia para as aves marinhas e as assemble´ias de peixes da zona de surfe, esta importante questa˜o ecolo´ gica do Atlaˆntico Sudoeste foi investigada. Esforc¸os de conservac¸a˜o devem ser implementados nas praias arenosas do extremo sul do Brasil, pelo menos naquelas a´ reas na˜o urbanizadas