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"text": "\n163903\np53-expression in patients with renal cell carcinoma correlates with a higher probability of disease progression and increased cancer-specific mortality after surgery but does not enhance the predictive accuracy of robust outcome models.\n\nMorshaeuser, L\n\nMay, M\n\nBurger, M\n\nOtto, W\n\nHutterer, GC\n\nPichler, M\n\nKlatte, T\n\nWild, P\n\nBuser, L\n\nBrookman-May, S\n\nBeiträge in Fachzeitschriften\nISI:000427405500015\n29221641.0\n10.1016/j.urolonc.2017.11.011\nNone\nDue to lacking external validation, molecular biomarkers are currently not applied for risk-stratification of patients with localized renal cell carcinoma. The objective of this study was to externally validate a molecular multi-marker panel included in a previously proposed prognostic nomogram for the prediction of postoperative disease-free survival.\n Besides pathologic tumor stage (pT) and ECOG-Performance Status, the nomogram includes 5 molecular markers (Ki-67, p53, VEGFR-1 endothelial or epithelial, and VEGF-D epithelial). The validation cohort comprised 343 renal cell carcinoma patients treated by radical nephrectomy or nephron-sparing surgery from 1999 to 2004 at a single academic center (median follow-up: 100 months). By multivariable Cox proportional-hazards regression models, the impact of clinical and molecular markers included in the nomogram on disease progression (DP) and cancer-specific mortality (CSM) was assessed; in addition, it was evaluated to what extent molecular markers added to the models' predictive accuracy (PA).\n Of all parameters included in the nomogram, ECOG-PS and pT-stage only revealed a significant impact on both endpoints. p53 (per 10% measures) showed a significant impact on DP (HR = 1.31; P = 0.008), albeit not on CSM, while all other molecular markers did not impact study endpoints. Using Martingale residuals, a cut-off value for p53-expression<20% (negative) vs. ≥20% (positive) yielded the highest impact on DP and CSM. In outcome-models including further well-established histo-pathological factors, p53-expression dichotomized at 20% independently impacted DP (HR = 4.13; P = 0.004) and CSM (HR = 3.74; P = 0.033), while no significant PA gain was achieved.\n p53 showed a statistically significant impact on DP, albeit not on CSM, when applying the 10% expression cut-off as used in the original nomogram, while the prognostic value of all other examined markers included in the nomogram could not be confirmed. When an alternative cut-off of 20% was applied in multivariable models, p53 independently impacted DP and CSM, while the PA was not significantly enhanced. Hence, the clinical significance of p53 is still to be determined. Based on the results of this study it is not recommendable to use p53-expression and the Klatte nomogram in routine clinical decision-making.\n Copyright © 2018 Elsevier Inc. All rights reserved.\n\nHutterer, Georg\n\nPichler, Martin\n\n\n"
},
{
"text": "\n118465\nGenome-wide association study identifies novel loci associated with circulating phospho- and sphingolipid concentrations.\n\nDemirkan, A\n\nvan Duijn, CM\n\nUgocsai, P\n\nIsaacs, A\n\nPramstaller, PP\n\nLiebisch, G\n\nWilson, JF\n\nJohansson, Å\n\nRudan, I\n\nAulchenko, YS\n\nKirichenko, AV\n\nJanssens, AC\n\nJansen, RC\n\nGnewuch, C\n\nDomingues, FS\n\nPattaro, C\n\nWild, SH\n\nJonasson, I\n\nPolasek, O\n\nZorkoltseva, IV\n\nHofman, A\n\nKarssen, LC\n\nStruchalin, M\n\nFloyd, J\n\nIgl, W\n\nBiloglav, Z\n\nBroer, L\n\nPfeufer, A\n\nPichler, I\n\nCampbell, S\n\nZaboli, G\n\nKolcic, I\n\nRivadeneira, F\n\nHuffman, J\n\nHastie, ND\n\nUitterlinden, A\n\nFranke, L\n\nFranklin, CS\n\nVitart, V\n\nDIAGRAM Consortium\n\nNelson, CP\n\nPreuss, M\n\nCARDIoGRAM Consortium\n\nBis, JC\n\nO'Donnell, CJ\n\nFranceschini, N\n\nCHARGE Consortium\n\nWitteman, JC\n\nAxenovich, T\n\nOostra, BA\n\nMeitinger, T\n\nHicks, AA\n\nHayward, C\n\nWright, AF\n\nGyllensten, U\n\nCampbell, H\n\nSchmitz, G\n\nEUROSPAN consortium\n\nBeiträge in Fachzeitschriften\nISI:000300725500014\n22359512.0\n10.1371/journal.pgen.1002490\nPMC3280968\nPhospho- and sphingolipids are crucial cellular and intracellular compounds. These lipids are required for active transport, a number of enzymatic processes, membrane formation, and cell signalling. Disruption of their metabolism leads to several diseases, with diverse neurological, psychiatric, and metabolic consequences. A large number of phospholipid and sphingolipid species can be detected and measured in human plasma. We conducted a meta-analysis of five European family-based genome-wide association studies (N = 4034) on plasma levels of 24 sphingomyelins (SPM), 9 ceramides (CER), 57 phosphatidylcholines (PC), 20 lysophosphatidylcholines (LPC), 27 phosphatidylethanolamines (PE), and 16 PE-based plasmalogens (PLPE), as well as their proportions in each major class. This effort yielded 25 genome-wide significant loci for phospholipids (smallest P-value = 9.88×10(-204)) and 10 loci for sphingolipids (smallest P-value = 3.10×10(-57)). After a correction for multiple comparisons (P-value<2.2×10(-9)), we observed four novel loci significantly associated with phospholipids (PAQR9, AGPAT1, PKD2L1, PDXDC1) and two with sphingolipids (PLD2 and APOE) explaining up to 3.1% of the variance. Further analysis of the top findings with respect to within class molar proportions uncovered three additional loci for phospholipids (PNLIPRP2, PCDH20, and ABDH3) suggesting their involvement in either fatty acid elongation/saturation processes or fatty acid specific turnover mechanisms. Among those, 14 loci (KCNH7, AGPAT1, PNLIPRP2, SYT9, FADS1-2-3, DLG2, APOA1, ELOVL2, CDK17, LIPC, PDXDC1, PLD2, LASS4, and APOE) mapped into the glycerophospholipid and 12 loci (ILKAP, ITGA9, AGPAT1, FADS1-2-3, APOA1, PCDH20, LIPC, PDXDC1, SGPP1, APOE, LASS4, and PLD2) to the sphingolipid pathways. In large meta-analyses, associations between FADS1-2-3 and carotid intima media thickness, AGPAT1 and type 2 diabetes, and APOA1 and coronary artery disease were observed. In conclusion, our study identified nine novel phospho- and sphingolipid loci, substantially increasing our knowledge of the genetic basis for these traits.\n\nMärz, Winfried\n\nMeinitzer, Andreas\n\nPilz, Stefan\n\nRenner, Wilfried\n\nScharnagl, Hubert\n\n\n"
},
{
"text": "\n181334\nProphylaxis and management of graft versus host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation.\n\nPenack, O\n\nMarchetti, M\n\nRuutu, T\n\nAljurf, M\n\nBacigalupo, A\n\nBonifazi, F\n\nCiceri, F\n\nCornelissen, J\n\nMalladi, R\n\nDuarte, RF\n\nGiebel, S\n\nGreinix, H\n\nHoller, E\n\nLawitschka, A\n\nMielke, S\n\nMohty, M\n\nArat, M\n\nNagler, A\n\nPassweg, J\n\nSchoemans, H\n\nSocie, G\n\nSolano, C\n\nVrhovac, R\n\nZeiser, R\n\nKroger, N\n\nBasak, GW\n\nBeiträge in Fachzeitschriften\nISI:000509774700016\nNone\nNone\nNone\nGraft-versus-host disease (GVHD) is a major factor contributing to mortality and morbidity after allogeneic stem-cell transplantation. Because of the small number of results from well designed, large-scale, clinical studies there is considerable variability in the prevention and treatment of GVHD worldwide. In 2014, to standardise treatment approaches the European Society of Blood and Marrow Transplantation published recommendations on the management of GVHD in the setting of HL-identical sibling or unrelated donor transplantation in adult patients with haematological malignancies. Here we update these recommendations including the results of study published after 2014. Evidence was searched in three steps: first, a widespread scan of published trials, meta-analyses, and systematic reviews; second, expert opinion was added for specific issues following several rounds of debate; and third, a refined search to target debated or rapidly updating issues. On the basis of this evidence and the 2014 recommendations, five members of the EBMT Transplant Complications Working Party created 38 statements on GVHD prophylaxis, drug management, and treatment of acute and chronic GVHD. Subsequently, they created the EBMT GVHD management recommendation expert panel by recruiting 20 experts with expertise in GVHD management. An email-based, two-round Delphi panel approach was used to manage the consensus. Modified National Comprehensive Cancer Network categories for evidence and consensus were applied to the approved statements. We reached 100% consensus for 29 recommendations and 95% consensus for nine recommendations. Key updates to these recommendations include a broader use of rabbit anti-T-cell globulin; lower steroid doses for the management of grade 2 acute GVHD with isolated skin or upper gastrointestinal tract manifestations; flu ticasone, azithromycin, and montelukast should be used for bronchiolitis obliterans syndrome; and the addition of newer treatment options for resteroid-refractory acute and chronic GVHD. In addition, we discuss specific aspects of GVHD prophylaxis and management in the setting of haploidentical transplantation and in paediatric patients, but no formal recommendations on those procedures have been provided in this Review. The European Society of Blood and Marrow Transplantation proposes to use these recommendations as a basis for the routine management of GVHD during stem-cell transplantation.\n\nGreinix, Hildegard\n\n\n"
},
{
"text": "\n185903\n[COVID-19 and plastic surgery: aesthetic surgery or essential medical care? - Impact of the COVID-19 pandemic on patient care in the plastic surgery department at an university hospital].\n\nPopp, D\n\nSmolle, C\n\nNischwitz, SP\n\nSawetz, I\n\nSchaunig, C\n\nWinter, R\n\nSpendel, S\n\nKamolz, LP\n\nBeiträge in Fachzeitschriften\nISI:000613901000002\n33530126.0\n10.1055/a-1308-2638\nNone\nIn spring 2020, the COVID-19 pandemic required far-reaching changes and measures of unprecedented extent. These measures were implemented to reduce virus spread and to ensure the continuity of nation-wide medical care, in particular with a view to having sufficient intensive-care capacities in case of a large caseload of patients infected with COVID-19. With regard to surgical specialties, this implied a temporary hold on elective cases for an indefinite period of time. The aim of this study was to assess the impact of these measures on the caseload of a level-three plastic surgery unit.\n This study retrospectively assessed the caseload at the Division of Plastic, Aesthetic and Reconstructive Surgery at Medical University Graz during the so-called lockdown from 16 March 2020 to 27 April 2020 (6 weeks) as well as two weeks before. The data was compared with the corresponding time period of the year 2019. Surgical spectrum, procedural urgency, medical indication of surgical procedures as well as complication rates were compared.\n The suspension of elective cases led to a significant reduction in caseload of 57.5 % (2019: 353, 2020: 150 cases). There was a significant increase in emergency and acute case procedures performed during the lockdown compared with the previous year (2019: 41, 2020: 58 cases, p < 0.001). Furthermore, the number of self-inflicted injuries and suicide attempts increased significantly (2019: 0, 2020: 16 cases, p < 0.001). With regard to private and work-related injuries, there was no significant difference. Also, there was no difference in complication rates (2019: 6.8, 2020: 10 %, p = 0.219).\n A significant amount of surgical procedures in plastic surgery at a supraregional academic health centre consists of emergency, acute and urgent medically necessary cases. During the lockdown, surgical procedures were performed without a significant increase in complication rates. Despite challenges during the pandemic, high-quality patient care was provided throughout. To process less urgent yet important cases accumulated during the lockdown in a reasonable amount of time and maintaining the same level of high-quality care, additional capacities regarding operating rooms, hospital beds and outpatient care are needed. These results point out the importance of plastic surgery for medical care, in particular during times of crisis.\n Thieme. All rights reserved.\n\nKamolz, Lars-Peter\n\nNischwitz, Sebastian Philipp\n\nPopp, Daniel\n\nSawetz, Isabelle\n\nSchaunig, Caroline\n\nSmolle, Christian\n\nSpendel, Stephan\n\nWinter, Raimund\n\n\n"
},
{
"text": "\n182753\nDiffusion-Weighted Imaging, MR Angiography, and Baseline Data in a Systematic Multicenter Analysis of 3,301 MRI Scans of Ischemic Stroke Patients-Neuroradiological Review Within the MRI-GENIE Study.\n\nDrake, M\n\nFrid, P\n\nHansen, BM\n\nWu, O\n\nGiese, AK\n\nSchirmer, MD\n\nDonahue, K\n\nCloonan, L\n\nIrie, RE\n\nBouts, MJRJ\n\nMcIntosh, EC\n\nMocking, SJT\n\nDalca, AV\n\nSridharan, R\n\nXu, H\n\nGiralt-Steinhauer, E\n\nHolmegaard, L\n\nJood, K\n\nRoquer, J\n\nCole, JW\n\nMcArdle, PF\n\nBroderick, JP\n\nJiménez-Conde, J\n\nJern, C\n\nKissela, BM\n\nKleindorfer, DO\n\nLemmens, R\n\nMeschia, JF\n\nRundek, T\n\nSacco, RL\n\nSchmidt, R\n\nSharma, P\n\nSlowik, A\n\nThijs, V\n\nWoo, D\n\nWorrall, BB\n\nKittner, SJ\n\nMitchell, BD\n\nRosand, J\n\nGolland, P\n\nLindgren, A\n\nRost, NS\n\nWassélius, J\n\nBeiträge in Fachzeitschriften\nISI:000549181300001\n32670186.0\n10.3389/fneur.2020.00577\nPMC7330135\nBackground: Magnetic resonance imaging (MRI) serves as a cornerstone in defining stroke phenotype and etiological subtype through examination of ischemic stroke lesion appearance and is therefore an essential tool in linking genetic traits and stroke. Building on baseline MRI examinations from the centralized and structured radiological assessments of ischemic stroke patients in the Stroke Genetics Network, the results of the MRI-Genetics Interface Exploration (MRI-GENIE) study are described in this work. Methods: The MRI-GENIE study included patients with symptoms caused by ischemic stroke (N = 3, 01) from 12 international centers. We established and used a structured reporting protocol for all assessments. Two neuroradiologists, using a blinded evaluation protocol, independently reviewed the baseline diffusion-weighted images (DWIs) and magnetic resonance angiography images to determine acute lesion and vascular occlusion characteristics. Results: In this systematic multicenter radiological analysis of clinical MRI from 3, 01 acute ischemic stroke patients according to a structured prespecified protocol, we identified that anterior circulation infarcts were most prevalent (67.4%), that infarcts in the middle cerebral artery (MCA) territory were the most common, and that the majority of large artery occlusions 0 to 48 h from ictus were in the MCA territory. Multiple acute lesions in one or several vascular territories were common (11%). Of 2, 38 patients with unilateral DWI lesions, 52.6% had left-sided infarct lateralization (P = 0.013 for χ2 test). Conclusions: This large-scale analysis of a multicenter MRI-based cohort of AIS patients presents a unique imaging framework facilitating the relationship between imaging and genetics for advancing the knowledge of genetic traits linked to ischemic stroke.\n Copyright © 2020 Drake, Frid, Hansen, Wu, Giese, Schirmer, Donahue, Cloonan, Irie, Bouts, McIntosh, Mocking, Dalca, Sridharan, Xu, Giralt-Steinhauer, Holmegaard, Jood, Roquer, Cole, McArdle, Broderick, Jiménez-Conde, Jern, Kissela, Kleindorfer, Lemmens, Meschia, Rundek, Sacco, Schmidt, Sharma, Slowik, Thijs, Woo, Worrall, Kittner, Mitchell, Rosand, Golland, Lindgren, Rost and Wassélius.\n\nSchmidt, Reinhold\n\n\n"
},
{
"text": "\n183048\nA European Academy of Neurology guideline on medical management issues in dementia.\n\nFrederiksen, KS\n\nCooper, C\n\nFrisoni, GB\n\nFrölich, L\n\nGeorges, J\n\nKramberger, MG\n\nNilsson, C\n\nPassmore, P\n\nMantoan Ritter, L\n\nReliga, D\n\nSchmidt, R\n\nStefanova, E\n\nVerdelho, A\n\nVandenbulcke, M\n\nWinblad, B\n\nWaldemar, G\n\nBeiträge in Fachzeitschriften\nISI:000552257600001\n32713125.0\n10.1111/ene.14412\nPMC7540303\nDementia is one of the most common disorders and is associated with increased morbidity, mortality and decreased quality of life. The present guideline addresses important medical management issues including systematic medical follow-up, vascular risk factors in dementia, pain in dementia, use of antipsychotics in dementia and epilepsy in dementia.\n A systematic review of the literature was carried out. Based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework, we developed a guideline. Where recommendations based on GRADE were not possible, a good practice statement was formulated.\n Systematic management of vascular risk factors should be performed in patients with mild to moderate dementia as prevention of cerebrovascular pathology may impact on the progression of dementia (Good Practice statement). Individuals with dementia (without previous stroke) and atrial fibrillation should be treated with anticoagulants (weak recommendation). Discontinuation of opioids should be considered in certain individuals with dementia (e.g. for whom there are no signs or symptoms of pain or no clear indication, or suspicion of side effects; Good Practice statement). Behavioral symptoms in persons with dementia should not be treated with mild analgesics (weak recommendation). In all patients with dementia treated with opioids, assessment of the individual risk-benefit ratio should be performed at regular intervals. Regular, preplanned medical follow-up should be offered to all patients with dementia. The setting will depend on the organization of local health services and should, as a minimum, include general practitioners with easy access to dementia specialists (Good Practice statement). Individuals with dementia and agitation and/or aggression should be treated with atypical antipsychotics only after all non-pharmacological measures have been proven to be without benefit or in the case of severe self-harm or harm to others (weak recommendation). Antipsychotics should be discontinued after cessation of behavioral disturbances and in patients in whom there are side effects (Good Practice statement). For treatment of epilepsy in individuals with dementia, newer anticonvulsants should be considered as first-line therapy (Good Practice statement).\n This GRADE-based guideline offers recommendations on several important medical issues in patients with dementia, and thus adds important guidance for clinicians. For some issues, very little or no evidence was identified, highlighting the importance of further studies within these areas.\n © 2020 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.\n\nSchmidt, Reinhold\n\n\n"
},
{
"text": "\n3245\nA binary architectural grading system for uterine endometrial endometrioid carcinoma has superior reproducibility compared with FIGO grading and identifies subsets of advance-stage tumors with favorable and unfavorable prognosis.\n\nLax, SF\n\nKurman, RJ\n\nPizer, ES\n\nWu, L\n\nRonnett, BM\n\nBeiträge in Fachzeitschriften\nISI:000089111000002\n10976693.0\n10.1097%2F00000478-200009000-00002\nNone\nThe International Federation of Gynecology and Obstetrics (FIGO) grading of uterine endometrial endometrioid carcinoma requires evaluation of histologic features that can be difficult to assess, including recognition of small amounts of solid growth, distinction of squamous from nonsquamous solid growth, and assessment of degree of nuclear atypia. The authors describe a novel, binary architectural grading system that uses low-magnification assessment of amount of solid growth, pattern of invasion, and presence of necrosis to divide endometrioid carcinomas into low- and high-grade tumors. The authors analyzed its performance for predicting prognosis and with respect to intra- and interobserver reproducibility. A total of 141 endometrioid carcinomas from hysterectomy specimens were graded according to the FIGO system, nuclear grading, and the binary architectural system. A tumor was classified as high grade if at least two of the following three criteria were present: (1) more than 50% solid growth (without distinction of squamous from nonsquamous epithelium); (2) a diffusely infiltrative, rather than expansive, growth pattern; and (3) tumor cell necrosis. For tumors that were confined to the endometrium, only percent solid growth and necrosis were evaluated, and those with both solid growth of more than 50% and necrosis were considered high grade. All tumors were graded independently by three pathologists on two separate occasions. Both inter- and intraobserver agreement using the binary grading system (kappa = 0.65 and 0.79) were superior compared with FIGO (kappa = 0.55 and 0.67) and nuclear grading (kappa = 0.22 and 0.41). The binary grading system stratified patients into three distinct prognostic groups. Patients with stage I low-grade tumors with invasion confined to the inner half of the myometrium (stages IA and IB) had a 100% 5-year survival rate. Patients with low-grade tumors that invaded beyond the outer half of the myometrium (stage IC and stages II-IV) and those with high-grade tumors with invasion confined to the myometrium (stages IB and IC) had a 5-year survival rate of 67% to 76%. In striking contrast to patients with advance-stage low-grade tumors, patients with advance-stage high-grade tumors had a 26% 5-year survival rate. This binary grading system has advantages over FIGO and nuclear grading that permit greater interobserver and intraobserver reproducibility and should be tested in other studies of endometrial endometrioid carcinomas to validate its reproducibility and use for segregating patients into different prognostic groups.\n\n\n"
},
{
"text": "\n115240\nThe relationship between depression, anxiety and heart disease - a psychosomatic challenge.\n\nKapfhammer, HP\n\nBeiträge in Fachzeitschriften\nISI:000297236800014\n22075746.0\nNone\nNone\nBackground: Depressive and cardiological disorders present a major comorbidity. Their manifold interrelations may be best analysed within a biopsychosocial model of disease. Methods: A systematic research was done on empirical studies published during the last 15 years and dealing with epidemiological, etiopathogenetic and therapeutic dimensions of the comorbidity of depression, anxiety and heart disease. Results: From an epidemiological perspective recurrent depressions are associated with a significantly increased risk of coronary heart disease. Depressive disorders play a major role in triggering critical cardiac events, e.g. myocardial infarction. The prevalence rates of depressive disorders in various cardiological conditions are significantly higher than the frequencies that can be expected in healthy general population. Depression shows a negative impact on the somatic morbidity and mortality during the further course of illness. Anxiety and posttraumatic stress disorders seem to be interrelated with cardiological conditions in quite a similar way, probably contributing even more negatively to critical and lethal cardiological events than depression. From an etiopathogenetic perspective some clusters of depressive symptoms seem to be linked to cardiotoxicity more closely than other, vital exhaustion, anhedonia, and hopelessness probably mediating a special risk. In any case, post-myocardial infarct depression that proves treatment-resistent indicates a negative prognosis of the prevailing cardiological condition. On a level of psychological and psychosocial constructs type-A personality, anger/hostility, type-D personality, and alexithymia have been explored regarding its proper pathogenetic role. Psychological and psychopathological variables have to be set into a context of psychosocial stressors on the one hand, and have to be simultaneously analysed with various underlying psycho-and neurobiological variables on the other. Above all, HPA- and sympathico-medullary dysfunctions, reduced heart rate variability, altered functions of thrombocytes, and increased pro inflammatory processes have to be recognized as significantly contributing to the pathophysiology both of depression and of heart condition. Neurobiological aspects of anxiety and posttraumatic stress disorders must be interlinked with these underpinnings of depression. Differential effects on critical cardiological events must be supposed From a therapeutic perspective several RCTs demonstrate that SSRIs may safely and efficiently treat depressive disorders in cardiological conditions, and may even improve the general somatic prognosis. Cognitive-behavioural psychotherapies have been empirically validated in treating depression and anxiety with cardiological patients. So far, however, a differential indication of psychopharmacological versus psychotherapeutic approaches has not been proved yet. Conclusions: Depression and anxiety disorders in patients with heart disease paradigmatically define a psychosomatic-somatopsychic challenge to any health delivery system. A psychosomatic perspective may best be practised within a Consultation-Liaison psychiatric service that cooperates continuously and closely with cardiological departments and experts.\n\nKapfhammer, Hans-Peter\n\n\n"
},
{
"text": "\n145250\nEstablishment of the first international repository for transfusion-relevant bacteria reference strains: ISBT working party transfusion-transmitted infectious diseases (WP-TTID), subgroup on bacteria.\n\nStörmer, M\n\nArroyo, A\n\nBrachert, J\n\nCarrero, H\n\nDevine, D\n\nEpstein, JS\n\nGabriel, C\n\nGelber, C\n\nGoodrich, R\n\nHanschmann, KM\n\nHeath, DG\n\nJacobs, MR\n\nKeil, S\n\nde Korte, D\n\nLambrecht, B\n\nLee, CK\n\nMarcelis, J\n\nMarschner, S\n\nMcDonald, C\n\nMcGuane, S\n\nMcKee, M\n\nMüller, TH\n\nMuthivhi, T\n\nPettersson, A\n\nRadziwon, P\n\nRamirez-Arcos, S\n\nReesink, HW\n\nRojo, J\n\nRood, I\n\nSchmidt, M\n\nSchneider, CK\n\nSeifried, E\n\nSicker, U\n\nWendel, S\n\nWood, EM\n\nYomtovian, RA\n\nMontag, T\n\nBeiträge in Fachzeitschriften\nISI:000298602400004\n21732948.0\n10.1111/j.1423-0410.2011.01510.x\nNone\nBacterial contamination of platelet concentrates (PCs) still remains a significant problem in transfusion with potential important clinical consequences, including death. The International Society of Blood Transfusion Working Party on Transfusion-Transmitted Infectious Diseases, Subgroup on Bacteria, organised an international study on Transfusion-Relevant Bacteria References to be used as a tool for development, validation and comparison of both bacterial screening and pathogen reduction methods.\n Four Bacteria References (Staphylococcus epidermidis PEI-B-06, Streptococcus pyogenes PEI-B-20, Klebsiella pneumoniae PEI-B-08 and Escherichia coli PEI-B-19) were selected regarding their ability to proliferate to high counts in PCs and distributed anonymised to 14 laboratories in 10 countries for identification, enumeration and bacterial proliferation in PCs after low spiking (0·3 and 0·03 CFU/ml), to simulate contamination occurring during blood donation.\n Bacteria References were correctly identified in 98% of all 52 identifications. S. pyogenes and E. coli grew in PCs in 11 out of 12 laboratories, and K. pneumoniae and S. epidermidis replicated in all participating laboratories. The results of bacterial counts were very consistent between laboratories: the 95% confidence intervals were for S. epidermidis: 1·19-1·32 × 10(7) CFU/ml, S. pyogenes: 0·58-0·69 × 10(7) CFU/ml, K. pneumoniae: 18·71-20·26 × 10(7) CFU/ml and E. coli: 1·78-2·10 × 10(7) CFU/ml.\n The study was undertaken as a proof of principle with the aim to demonstrate (i) the quality, stability and suitability of the bacterial strains for low-titre spiking of blood components, (ii) the property of donor-independent proliferation in PCs, and (iii) their suitability for worldwide shipping of deep frozen, blinded pathogenic bacteria. These aims were successfully fulfilled. The WHO Expert Committee Biological Standardisation has approved the adoption of these four bacteria strains as the first Repository for Transfusion-Relevant Bacteria Reference Strains and, additionally, endorsed as a project the addition of six further bacteria strain preparations suitable for control of platelet contamination as the next step of enlargement of the repository.\n © 2011 The Author(s). Vox Sanguinis © 2011 International Society of Blood Transfusion.\n\n\n"
},
{
"text": "\n148999\nLong term trends in prevalence of neural tube defects in Europe: population based study.\n\nKhoshnood, B\n\nLoane, M\n\nde Walle, H\n\nArriola, L\n\nAddor, MC\n\nBarisic, I\n\nBeres, J\n\nBianchi, F\n\nDias, C\n\nDraper, E\n\nGarne, E\n\nGatt, M\n\nHaeusler, M\n\nKlungsoyr, K\n\nLatos-Bielenska, A\n\nLynch, C\n\nMcDonnell, B\n\nNelen, V\n\nNeville, AJ\n\nO'Mahony, MT\n\nQueisser-Luft, A\n\nRankin, J\n\nRissmann, A\n\nRitvanen, A\n\nRounding, C\n\nSipek, A\n\nTucker, D\n\nVerellen-Dumoulin, C\n\nWellesley, D\n\nDolk, H\n\nBeiträge in Fachzeitschriften\nISI:000365691700002\n26601850.0\n10.1136/bmj.h5949\nPMC4658393\nWhat are the long term trends in the total (live births, fetal deaths, and terminations of pregnancy for fetal anomaly) and live birth prevalence of neural tube defects (NTD) in Europe, where many countries have issued recommendations for folic acid supplementation but a policy for mandatory folic acid fortification of food does not exist?\n This was a population based, observational study using data on 11, 53 cases of NTD not associated with chromosomal anomalies, including 4162 cases of anencephaly and 5776 cases of spina bifida from 28 EUROCAT (European Surveillance of Congenital Anomalies) registries covering approximately 12.5 million births in 19 countries between 1991 and 2011. The main outcome measures were total and live birth prevalence of NTD, as well as anencephaly and spina bifida, with time trends analysed using random effects Poisson regression models to account for heterogeneities across registries and splines to model non-linear time trends.\n Overall, the pooled total prevalence of NTD during the study period was 9.1 per 10, 00 births. Prevalence of NTD fluctuated slightly but without an obvious downward trend, with the final estimate of the pooled total prevalence of NTD in 2011 similar to that in 1991. Estimates from Poisson models that took registry heterogeneities into account showed an annual increase of 4% (prevalence ratio 1.04, 95% confidence interval 1.01 to 1.07) in 1995-99 and a decrease of 3% per year in 1999-2003 (0.97, 0.95 to 0.99), with stable rates thereafter. The trend patterns for anencephaly and spina bifida were similar, but neither anomaly decreased substantially over time. The live birth prevalence of NTD generally decreased, especially for anencephaly. Registration problems or other data artefacts cannot be excluded as a partial explanation of the observed trends (or lack thereof) in the prevalence of NTD.\n In the absence of mandatory fortification, the prevalence of NTD has not decreased in Europe despite longstanding recommendations aimed at promoting peri-conceptional folic acid supplementation and existence of voluntary folic acid fortification.\n The study was funded by the European Public Health Commission, EUROCAT Joint Action 2011-2013. HD and ML received support from the European Commission DG Sanco during the conduct of this study. No additional data available.\n © Khoshnood et al 2015.\n\n\n"
},
{
"text": "\n164626\nTreatment of allergic rhinitis using mobile technology with real-world data: The MASK observational pilot study.\n\nBousquet, J\n\nDevillier, P\n\nArnavielhe, S\n\nBedbrook, A\n\nAlexis-Alexandre, G\n\nvan Eerd, M\n\nMurray, R\n\nCanonica, GW\n\nIllario, M\n\nMenditto, E\n\nPassalacqua, G\n\nStellato, C\n\nTriggiani, M\n\nCarreiro-Martins, P\n\nFonseca, J\n\nMorais Almeida, M\n\nNogueira-Silva, L\n\nPereira, AM\n\nTodo Bom, A\n\nBosse, I\n\nCaimmi, D\n\nDemoly, P\n\nFontaine, JF\n\nJust, J\n\nOnorato, GL\n\nKowalski, ML\n\nKuna, P\n\nSamolinski, B\n\nAnto, JM\n\nMullol, J\n\nValero, A\n\nTomazic, PV\n\nBergmann, KC\n\nKeil, T\n\nKlimek, L\n\nMösges, R\n\nShamai, S\n\nZuberbier, T\n\nMurphy, E\n\nMcDowall, P\n\nPrice, D\n\nRyan, D\n\nSheikh, A\n\nChavannes, NH\n\nFokkens, WJ\n\nKvedariene, V\n\nValiulis, A\n\nBachert, C\n\nHellings, PW\n\nKull, I\n\nMelen, E\n\nWickman, M\n\nBindslev-Jensen, C\n\nEller, E\n\nHaahtela, T\n\nPapadopoulos, NG\n\nAnnesi-Maesano, I\n\nBewick, M\n\nBosnic-Anticevich, S\n\nCruz, AA\n\nDe Vries, G\n\nGemicioglu, B\n\nLarenas-Linnemann, D\n\nLaune, D\n\nMathieu-Dupas, E\n\nO'Hehir, RE\n\nPfaar, O\n\nPortejoie, F\n\nSiroux, V\n\nSpranger, O\n\nValovirta, E\n\nVandenPlas, O\n\nYorgancioglu, A\n\nBeiträge in Fachzeitschriften\nISI:000443222400001\n29336067.0\n10.1111/all.13406\nNone\nLarge observational implementation studies are needed to triangulate the findings from randomized control trials as they reflect "real-world" everyday practice. In a pilot study, we attempted to provide additional and complementary insights on the real-life treatment of allergic rhinitis (AR) using mobile technology.\n A mobile phone app (Allergy Diary, freely available in Google Play and Apple App stores) collects the data of daily visual analog scales (VAS) for (i) overall allergic symptoms, (ii) nasal, ocular, and asthma symptoms, (iii) work, as well as (iv) medication use using a treatment scroll list including all medications (prescribed and over the counter (OTC)) for rhinitis customized for 15 countries.\n A total of 2871 users filled in 17 091 days of VAS in 2015 and 2016. Medications were reported for 9634 days. The assessment of days appeared to be more informative than the course of the treatment as, in real life, patients do not necessarily use treatment on a daily basis; rather, they appear to increase treatment use with the loss of symptom control. The Allergy Diary allowed differentiation between treatments within or between classes (intranasal corticosteroid use containing medications and oral H1-antihistamines). The control of days differed between no [best control], single, or multiple treatments (worst control).\n This study confirms the usefulness of the Allergy Diary in accessing and assessing everyday use and practice in AR. This pilot observational study uses a very simple assessment (VAS) on a mobile phone, shows novel findings, and generates new hypotheses.\n © 2018 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.\n\nTomazic, Peter Valentin\n\n\n"
},
{
"text": "\n176673\nDelivery room interventions to prevent bronchopulmonary dysplasia in preterm infants: a protocol for a systematic review and network meta-analysis.\n\nMitra, S\n\nDisher, T\n\nPichler, G\n\nD'Souza, B\n\nMccord, H\n\nChayapathi, V\n\nJones, K\n\nSchmölzer, G\n\nBeiträge in Fachzeitschriften\nISI:000502537200146\n31427322.0\n10.1136/bmjopen-2018-028066\nPMC6701811\nAs gestational age decreases, incidence of bronchopulmonary dysplasia (BPD) and chronic lung disease increases. There are many interventions used in the delivery room to prevent acute lung injury and consequently BPD in these patients. The availability of different treatment options often poses a practical challenge to the practicing neonatologist when it comes to making an evidence-based choice as the multitude of pairwise systematic reviews including Cochrane reviews that are currently available only provide a narrow perspective through head-to-head comparisons.\n We will conduct a systematic review of all randomised controlled trials evaluating delivery room interventions within the first golden hour after birth for prevention of BPD. The primary outcome includes BPD. Secondary outcomes include death at 36 weeks of postmenstrual age or before discharge; severe intraventricular haemorrhage (grade 3 or 4 based on the Papile criteria); any air leak syndromes (including pneumothorax or pulmonary interstitial emphysema); retinopathy of prematurity (any stage) and neurodevelopmental impairment at 18-24 months. We will search from their inception to August 2018, the following databases: Medline, EMBASE and Cochrane Central Register of Controlled Trials as well as grey literature resources. Two reviewers will independently screen titles and abstracts, review full texts, extract information and assess the risk of bias and the confidence in the estimate (with Grading of Recommendations Assessment, Development and Evaluation approach). This review will use Bayesian network meta-analysis approach which allows the comparison of the multiple delivery room interventions for prevention of BPD. We will perform a Bayesian network meta-analysis to combine the pooled direct and indirect treatment effect estimates for each outcome, effectiveness and safety of delivery room interventions for prevention of BPD.\n The proposed protocol is a network meta-analysis, which has been registered on PROSPERO International prospective register of systematic reviews (CRD42018078648). The results will provide an evidence-based guide to choosing the right sequence of early postnatal interventions that will be associated with the least likelihood of inducing lung injury and BPD in preterm infants. Furthermore, we will identify knowledge gaps and will encourage further research for other therapeutic options. Therefore, its results will be disseminated through peer-reviewed publications and conference presentations. Due to the nature of the design, no ethics approval is necessary.\n © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.\n\nPichler, Gerhard\n\n\n"
},
{
"text": "\n120829\nLaparoscopic approach to acute abdomen from the Consensus Development Conference of the Societa Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE), Associazione Chirurghi Ospedalieri Italiani (ACOI), Societa Italiana di Chirurgia (SIC), Societa Italiana di Chirurgia d'Urgenza e del Trauma (SICUT), SocietA Italiana di Chirurgia nell'Ospedalita Privata (SICOP), and the European Association for Endoscopic Surgery (EAES).\n\nAgresta, F\n\nAnsaloni, L\n\nBaiocchi, GL\n\nBergamini, C\n\nCampanile, FC\n\nCarlucci, M\n\nCocorullo, G\n\nCorradi, A\n\nFranzato, B\n\nLupo, M\n\nMandala, V\n\nMirabella, A\n\nPernazza, G\n\nPiccoli, M\n\nStaudacher, C\n\nVettoretto, N\n\nZago, M\n\nLettieri, E\n\nLevati, A\n\nPietrini, D\n\nScaglione, M\n\nDe Masi, S\n\nDe Placido, G\n\nFrancucci, M\n\nRasi, M\n\nFingerhut, A\n\nUranus, S\n\nGarattini, S\n\n\n\nBeiträge in Fachzeitschriften\nISI:000306215000006\n22736283.0\n10.1007/s00464-012-2331-3\nNone\nIn January 2010, the SICE (Italian Society of Endoscopic Surgery), under the auspices of the EAES, decided to revisit the clinical recommendations for the role of laparoscopy in abdominal emergencies in adults, with the primary intent being to update the 2006 EAES indications and supplement the existing guidelines on specific diseases. Other Italian surgical societies were invited into the Consensus to form a panel of 12 expert surgeons. In order to get a multidisciplinary panel, other stakeholders involved in abdominal emergencies were invited along with a patient's association. In November 2010, the panel met in Rome to discuss each chapter according to the Delphi method, producing key statements with a grade of recommendations followed by commentary to explain the rationale and the level of evidence behind the statements. Thereafter, the statements were presented to the Annual Congress of the EAES in June 2011. A thorough literature review was necessary to assess whether the recommendations issued in 2006 are still current. In many cases new studies allowed us to better clarify some issues (such as for diverticulitis, small bowel obstruction, pancreatitis, hernias, trauma), to confirm the key role of laparoscopy (such as for cholecystitis, gynecological disorders, nonspecific abdominal pain, appendicitis), but occasionally previous strong recommendations have to be challenged after review of recent research (such as for perforated peptic ulcer). Every surgeon has to develop his or her own approach, taking into account the clinical situation, her/his proficiency (and the experience of the team) with the various techniques, and the specific organizational setting in which she/he is working. This guideline has been developed bearing in mind that every surgeon could use the data reported to support her/his judgment.\n\nUranüs, Selman\n\n\n"
},
{
"text": "\n166890\nCost-effectiveness of healthy eating and/or physical activity promotion in pregnant women at increased risk of gestational diabetes mellitus: economic evaluation alongside the DALI study, a European multicenter randomized controlled trial.\n\nBroekhuizen, K\n\nSimmons, D\n\nDevlieger, R\n\nvan Assche, A\n\nJans, G\n\nGaljaard, S\n\nCorcoy, R\n\nAdelantado, JM\n\nDunne, F\n\nDesoye, G\n\nHarreiter, J\n\nKautzky-Willer, A\n\nDamm, P\n\nMathiesen, ER\n\nJensen, DM\n\nAndersen, LL\n\nLapolla, A\n\nDalfra, MG\n\nBertolotto, A\n\nWender-Ozegowska, E\n\nZawiejska, A\n\nHill, D\n\nSnoek, FJ\n\nJelsma, JGM\n\nBosmans, JE\n\nvan Poppel, MNM\n\nvan Dongen, JM\n\nBeiträge in Fachzeitschriften\nISI:000427728700001\n29540227.0\n10.1186/s12966-018-0643-y\nPMC5853142\nGestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective.\n An economic evaluation was performed alongside a European multicenter-randomized controlled trial. A total of 435 pregnant women at increased risk of GDM in primary and secondary care settings in nine European countries, were recruited and randomly allocated to a healthy eating and physical activity promotion intervention (HE + PA intervention), a healthy eating promotion intervention (HE intervention), or a physical activity promotion intervention (PA intervention). Main outcome measures were gestational weight gain, fasting glucose, insulin resistance (HOMA-IR), quality adjusted life years (QALYs), and societal costs.\n Between-group total cost and effect differences were not significant, besides significantly less gestational weight gain in the HE + PA group compared with the usual care group at 35-37 weeks (-2.3;95%CI:-3.7;-0.9). Cost-effectiveness acceptability curves indicated that the HE + PA intervention was the preferred intervention strategy. At 35-37 weeks, it depends on the decision-makers' willingness to pay per kilogram reduction in gestational weight gain whether the HE + PA intervention is cost-effective for gestational weight gain, whereas it was not cost-effective for fasting glucose and HOMA-IR. After delivery, the HE + PA intervention was cost-effective for QALYs, which was predominantly caused by a large reduction in delivery-related costs.\n Healthy eating and physical activity promotion was found to be the preferred strategy for limiting gestational weight gain. As this intervention was cost-effective for QALYs after delivery, this study lends support for broad implementation.\n ISRCTN ISRCTN70595832 . Registered 2 December 2011.\n\nDesoye, Gernot\n\n\n"
},
{
"text": "\n176116\nEstablishing Rules for Ethicists and Ethics Organizations in Academic Publishing to Avoid Conflicts of Interest, Favoritism, Cronyism and Nepotism\n\nda Silva, JAT\n\nKatavic, V\n\nDobranszki, J\n\nAl-Khatib, A\n\nBornemann-Cimenti, H\n\nBeiträge in Fachzeitschriften\nISI:000473801500007\nNone\n10.17646/KOME.75698.87\nNone\nA proliferation of publication venues, scholarly journals, use of social media to disseminate knowledge and research results, scientific information, increased international scientific collaboration, a move towards open knowledge and data sharing, recent scandals such as journal editors' coercive citations, fake peer review, peer review rings, data fabrication, research spin, and retraction of articles, several of the latter within the emergence of a post publication peer review movement, are some of the many reasons why publishing ethics are constantly evolving. These challenges have led to the birth of an increasing number of guidelines and recommendations being issued by multiple organizations and committees around the world in light of the recognized need to salvage peer review, and in an attempt to restore eroding trust in science, scientists and their publications. The principal objective of these guidelines and recommendations is supposedly to provide guidance for editors, reviewers and authors to conduct honest and ethical research and publishing practices, including responsible authorship and editorship, conflict of interest management, maintaining the confidentiality of peer review, and other ethical issues that arise in conducting and reporting research. Despite the fact that scholarly publishing is an international enterprise with global impact, current guidelines and recommendations appear to fall very short on imposing any obligations on their parent members, i.e., committee members who issue guidelines and recommend solutions for ethical dilemmas especially when such organizations are dependent on commercial publishers who may be paying members. Obviously, financial incentives indicate that ethical organizations or ethicists are not in a power position compared to editors or publishers. Imbalanced guidelines risk that hidden conflicts of interest, cronyism, or nepotism may corrupt the decision-making process or the ethical hierarchy that has been put into place to safe-guard research and publishing ethics. Therefore, the ethics gate-keepers to the integrity of scholarly publishing should also be carefully scrutinized, and strict ethical guidelines have to be imposed on them as equally as their rules are imposed on global academia to avoid the risk of further corrupting the scientific process as a result of the absence of strong exterior regulation or oversight. This theoretical paper highlights signs of favoritism and cronyism in ethics. It also offers proposals for rules (limitations and consequences) to avoid them in science publishing. Our guidelines should be used by academics in the position of authors or editors who may sense, perceive or detect abuses of power among ethicists.\n\nBornemann-Cimenti, Helmar\n\n\n"
},
{
"text": "\n187336\nBenralizumab for the Prevention of COPD Exacerbations.\n\nCriner, GJ\n\nCelli, BR\n\nBrightling, CE\n\nAgusti, A\n\nPapi, A\n\nSingh, D\n\nSin, DD\n\nVogelmeier, CF\n\nSciurba, FC\n\nBafadhel, M\n\nBacker, V\n\nKato, M\n\nRamírez-Venegas, A\n\nWei, YF\n\nBjermer, L\n\nShih, VH\n\nJison, M\n\nO'Quinn, S\n\nMakulova, N\n\nNewbold, P\n\nGoldman, M\n\nMartin, UJ\n\nGALATHEA Study Investigators\n\nTERRANOVA Study Investigators\n\nBeiträge in Fachzeitschriften\nNone\n31112385.0\n10.1056/NEJMoa1905248\nNone\nThe efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known.\n In the GALATHEA and TERRANOVA trials, we enrolled patients with COPD (at a ratio of approximately 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. <220 per cubic millimeter]) who had frequent exacerbations despite receiving guideline-based inhaled treatment. Patients were randomly assigned to receive benralizumab (30 or 100 mg in GALATHEA; 10, 30, or 100 mg in TERRANOVA) every 8 weeks (every 4 weeks for the first three doses) or placebo. The primary end point was the treatment effect of benralizumab, measured as the annualized COPD exacerbation rate ratio (benralizumab vs. placebo) at week 56 in patients with baseline blood eosinophil counts of 220 per cubic millimeter or greater. Safety was also assessed.\n In GALATHEA, the estimates of the annualized exacerbation rate were 1.19 per year (95% confidence interval [CI], 1.04 to 1.36) in the 30-mg benralizumab group, 1.03 per year (95% CI, 0.90 to 1.19) in the 100-mg benralizumab group, and 1.24 per year (95% CI, 1.08 to 1.42) in the placebo group; the rate ratio as compared with placebo was 0.96 for 30 mg of benralizumab (P = 0.65) and 0.83 for 100 mg of benralizumab (P = 0.05). In TERRANOVA, the estimates of the annualized exacerbation rate for 10 mg, 30 mg, and 100 mg of benralizumab and for placebo were 0.99 per year (95% CI, 0.87 to 1.13), 1.21 per year (95% CI, 1.08 to 1.37), 1.09 per year (95% CI, 0.96 to 1.23), and 1.17 per year (95% CI, 1.04 to 1.32), respectively; the corresponding rate ratios were 0.85 (P = 0.06), 1.04 (P = 0.66), and 0.93 (P = 0.40). At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. Types and frequencies of adverse events were similar with benralizumab and placebo.\n Add-on benralizumab was not associated with a lower annualized rate of COPD exacerbations than placebo among patients with moderate to very severe COPD, a history of frequent moderate or severe exacerbations, and blood eosinophil counts of 220 per cubic millimeter or greater (Funded by AstraZeneca [GALATHEA and TERRANOVA] and Kyowa Hakko Kirin [GALATHEA]; GALATHEA and TERRANOVA ClinicalTrials.gov numbers, NCT02138916 and NCT02155660.).\n Copyright © 2019 Massachusetts Medical Society.\n\nOlschewski, Horst\n\n\n"
},
{
"text": "\n125265\nThe MAINTAIN study--managing hemoglobin variability with darbepoetin alfa in dialysis patients experiencing a severe drop in hemoglobin.\n\nWatschinger, B\n\nSalmhofer, H\n\nHorn, S\n\nNeyer, U\n\nWiesinger, T\n\nWiesholzer, M\n\nErb, H\n\nJaeger, C\n\nHemetsberger, M\n\nRosenkranz, AR\n\nBeiträge in Fachzeitschriften\nISI:000316251500002\n23299452.0\n10.1007/s00508-012-0311-1\nNone\nDialysis patients, receiving erythropoiesis stimulating agents, typically show signs of hemoglobin variability as a consequence of their dosing patterns, bleeding, infection, etc., which is commonly managed adjusting the dose regimen of the erythropoiesis stimulating agent. However, information on dosing strategies used in daily clinical practice and their outcomes in relation to hemoglobin variability is limited.\n To investigate clinical practice in Austria in relation with the management of hemoglobin variability, defined as a decrease of ³ 1 g/dL within 4 weeks from ³ 11 g/dL to £ 11 g/dL during maintenance therapy with darbepoetin alfa. The nature and incidence of clinical events related to the hemoglobin drop were also assessed.\n The MAINTAIN non-interventional study was conducted in hemodialysis patients, receiving darbepoetin alfa in accordance to the label approved in the European Union at that time. Patient data were documented retrospectively for the 3 months prior to the hemoglobin drop. Data for the 6 months post hemoglobin drop were collected retrospectively or prospectively, depending on the time of patient inclusion respective to the Hb drop.\n A hundred thirty six of 154 patients fulfilled all inclusion/exclusion criteria and had prospective documentation of 6 months. The main causes for the hemoglobin drop included surgical and medical procedures (36.1 %), and infections or infestations (24.4 %). The median treatment period was 273 days. The mean hemoglobin drop was - 1.74 g/dL (95 % confidence interval (CI): - 1.60 to - 1.87). Consequently, 81 % of the patients had their dose of darbepoetin alfa increased within a median Kaplan-Meier time to dose increase of 12.5 days (95 % CI: 6-22). The geometric mean weekly darbepoetin alfa dose increased by a factor of 1.1 from 29.1 mg (95 % CI: 24.6-34.4) in the 3 months before hemoglobin drop to 32.4 (95 % CI: 27.2-38.6) in months 4-6 post hemoglobin drop. Three patients had red blood cell transfusions before hemoglobin drop and nine patients after hemoglobin drop. The mean hemoglobin increase was 0.43 g/dL (95 % CI: 0.24-0.62) from immediately prior to 2 weeks after dose increase. The median Kaplan-Meier time to achieve a hemoglobin ³ 11 g/dL after hemoglobin drop was 36 days (95 % CI: 32-45). Frequent darbepoetin alfa dose adjustments were necessary to sustain maintenance levels. No drug-related adverse events were reported.\n This observational study describes physicians' reactions to a drop in hemoglobin in clinical practice. Using darbepoetin alfa, the drop was generally compensated without leading to overcorrection.\n\nHorn, Sabine\n\nRosenkranz, Alexander\n\n\n"
},
{
"text": "\n142822\nThe association between Hirschsprung's disease and multiple endocrine neoplasia type 2a: a systematic review.\n\nCoyle, D\n\nFriedmacher, F\n\nPuri, P\n\nBeiträge in Fachzeitschriften\nISI:000339724600001\n24972642.0\n10.1007/s00383-014-3538-2\nNone\nThe co-occurrence of Hirschsprung's disease (HSCR) and multiple endocrine neoplasia type 2 (MEN2) is a relatively rare event. The basis for this association is the presence of a "Janus" mutation in the RET proto-oncogene--a mutation that acts simultaneously as both a gain-in-function and a loss-of-function mutation. To date, four mutations in the exon 10 region of RET that are known to cause MEN2A have been implicated in this association: C620, C618, C611 and C609. We performed a systematic review of the published literature on this association to determine its incidence, the prevalence and phenotype of HSCR associated with the 4 RET mutations mentioned above.\n A systematic literature-based search for relevant articles was conducted using three online databases. After exclusion of ineligible publications, we recorded data on all patients with a diagnosis of HSCR or MEN2A with a "Janus" RET mutation, as well as those who carried the mutation but were unaffected. Statistical analysis was performed using SPSS.\n The literature search yielded 885 publications, of which 36 articles, incorporating data on 341 individuals, were eligible for inclusion in the final analysis. Co-occurrence of HSCR and MEN2A was recorded in 84 cases (24.6 %). HSCR occurred alone in 64 carriers of a "Janus" mutation (18.8 %) and MEN2A occurred in isolation in 173 cases (50.7 %). Twenty individuals (5.9 %) were found to carry a "Janus" mutation after screening on the basis of family history but were unaffected by either MEN2A or HSCR. The most common mutation recorded was the C620 mutation [114 cases (48.1 %)]. There was a relatively high incidence of long-segment aganglionosis (29.3 %) and total colonic aganglionosis (17.3 %) in this cohort. This trend was particularly notable in those with C620 mutations, only 33 % of whom had short-segment disease.\n While the overall incidence of HSCR co-occurring with MEN2A is low, both conditions occur with a relatively high frequency in families with a RET mutation at exon 10. The proportion of cases of long-segment HSCR and total colonic aganglionosis is higher than that in the general population with HSCR in those with C620 and C618 mutations. These findings reinforce the importance of RET mutation testing in HSCR when a family history of either HSCR or MEN2 is present. In families with MEN2A and known exon 10 RET mutations, the threshold for investigation for HSCR in those with gastrointestinal symptoms should be very low. High-quality prospective longitudinal studies of large HSCR populations are required to shed greater light on this rare but important phenomenon.\n\n\n"
},
{
"text": "\n161057\nLoss of Cardioprotective Effects at the <i>ADAMTS7</i> Locus as a Result of Gene-Smoking Interactions.\n\nSaleheen, D\n\nZhao, W\n\nYoung, R\n\nNelson, CP\n\nHo, W\n\nFerguson, JF\n\nRasheed, A\n\nOu, K\n\nNurnberg, ST\n\nBauer, RC\n\nGoel, A\n\nDo, R\n\nStewart, AFR\n\nHartiala, J\n\nZhang, W\n\nThorleifsson, G\n\nStrawbridge, RJ\n\nSinisalo, J\n\nKanoni, S\n\nSedaghat, S\n\nMarouli, E\n\nKristiansson, K\n\nHua Zhao, J\n\nScott, R\n\nGauguier, D\n\nShah, SH\n\nSmith, AV\n\nvan Zuydam, N\n\nCox, AJ\n\nWillenborg, C\n\nKessler, T\n\nZeng, L\n\nProvince, MA\n\nGanna, A\n\nLind, L\n\nPedersen, NL\n\nWhite, CC\n\nJoensuu, A\n\nEdi Kleber, M\n\nHall, AS\n\nMärz, W\n\nSalomaa, V\n\nO'Donnell, C\n\nIngelsson, E\n\nFeitosa, MF\n\nErdmann, J\n\nBowden, DW\n\nPalmer, CNA\n\nGudnason, V\n\nFaire, U\n\nZalloua, P\n\nWareham, N\n\nThompson, JR\n\nKuulasmaa, K\n\nDedoussis, G\n\nPerola, M\n\nDehghan, A\n\nChambers, JC\n\nKooner, J\n\nAllayee, H\n\nDeloukas, P\n\nMcPherson, R\n\nStefansson, K\n\nSchunkert, H\n\nKathiresan, S\n\nFarrall, M\n\nMarcel Frossard, P\n\nRader, DJ\n\nSamani, NJ\n\nReilly, MP\n\nBeiträge in Fachzeitschriften\nISI:000403058800011\n28461624.0\n10.1161/CIRCULATIONAHA.116.022069\nPMC5612779\nCommon diseases such as coronary heart disease (CHD) are complex in etiology. The interaction of genetic susceptibility with lifestyle factors may play a prominent role. However, gene-lifestyle interactions for CHD have been difficult to identify. Here, we investigate interaction of smoking behavior, a potent lifestyle factor, with genotypes that have been shown to associate with CHD risk.\n We analyzed data on 60 919 CHD cases and 80 243 controls from 29 studies for gene-smoking interactions for genetic variants at 45 loci previously reported to be associated with CHD risk. We also studied 5 loci associated with smoking behavior. Study-specific gene-smoking interaction effects were calculated and pooled using fixed-effects meta-analyses. Interaction analyses were declared to be significant at a P value of <1.0×10-3 (Bonferroni correction for 50 tests).\n We identified novel gene-smoking interaction for a variant upstream of the ADAMTS7 gene. Every T allele of rs7178051 was associated with lower CHD risk by 12% in never-smokers (P=1.3×10-16) in comparison with 5% in ever-smokers (P=2.5×10-4), translating to a 60% loss of CHD protection conferred by this allelic variation in people who smoked tobacco (interaction P value=8.7×10-5). The protective T allele at rs7178051 was also associated with reduced ADAMTS7 expression in human aortic endothelial cells and lymphoblastoid cell lines. Exposure of human coronary artery smooth muscle cells to cigarette smoke extract led to induction of ADAMTS7. CONCLUSIONS: Allelic variation at rs7178051 that associates with reduced ADAMTS7 expression confers stronger CHD protection in never-smokers than in ever-smokers. Increased vascular ADAMTS7 expression may contribute to the loss of CHD protection in smokers.\n © 2017 American Heart Association, Inc.\n\nMärz, Winfried\n\n\n"
},
{
"text": "\n136281\nMinimal invasive biopsy of intraconal expansion by PET/CT/MRI image-guided navigation: a new method.\n\nReinbacher, KE\n\nPau, M\n\nWallner, J\n\nZemann, W\n\nKlein, A\n\nGstettner, C\n\nAigner, RM\n\nFeichtinger, M\n\nBeiträge in Fachzeitschriften\nISI:000345469900024\n24726395.0\n10.1016/j.jcms.2014.02.006\nNone\nIntraorbital tumours are often undetected for a long period and may lead to compression of the optic nerve and loss of vision. Although CT, MRI's and ultrasound can help in determining the probable diagnosis, most orbital tumours are only diagnosed by surgical biopsy. In intraconal lesions this may prove especially difficult as the expansions are situated next to sensitive anatomical structures (eye bulb, optic nerve). In search of a minimally invasive access to the intraconal region, we describe a method of a three-dimensional, image-guided biopsy of orbital tumours using a combined technique of hardware fusion between (18)F-FDG Positron Emission Tomography ((18)F-FDG PET), magnetic resonance imaging (MRI) and Computed Tomography (CT).\n We present 6 patients with a total of 7 intraorbital lesions, all of them suffering from diplopia and/or exophthalmos. There were 3 female and 3 male patients. The patients age ranged from 20 to 75 years. One of the patients showed beginning loss of vision. Another of the patients had lesions in both orbits. The decision to obtain image-guided needle biopsies for treatment planning was discussed and decided at an interdisciplinary board comprising other sub-specialities (ophthalmology, neurosurgery, maxillofacial surgery, ENT, plastic surgery). All patients underwent 3D imaging preoperatively ((18)F-FDG PET/CT or (18)F-FDG PET/CT plus MRI). Data was transferred to 3D navigation system. Access to the lesions was planned preoperatively on a workstation monitor. Biopsy-needles were then calibrated intraoperatively and all patients underwent three-dimensional image-guided needle biopsies under general anaesthesia.\n 7 biopsies were performed. The histologic subtype was idiopathic orbital inflammation in 2 lesions, lymphoma in 2, Merkel cell carcinoma in 1, hamartoma in 1 and 1 malignant melanoma. The different pathologies were subsequently treated in consideration of the actual state of the art. In cases where surgical removal of the lesion was performed the histological diagnosis was confirmed in all cases.\n There is a wide range of possible treatment modalities for orbital tumours depending on the nature of the lesion. Histological diagnosis is mandatory to select the proper management and operation. The presented method allows minimal-invasive biopsy even in deep intraconal lesions, enabling the surgeon to spare critical anatomical structures. Vascular lesions such as cavernous haemangioma, tumour of the lacrimal gland or dermoid cysts present a contraindication and have to be excluded.\n Copyright © 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.\n\nAigner, Reingard\n\nKlein-Theyer, Angelika Karin\n\nWallner, Jürgen\n\nZemann, Wolfgang\n\n\n"
}
]
}