Publications by authors named "Gudrun Pregartner"

58 Publications

Long-term clinical outcome in patients with acute and subacute hypothenar hammer syndrome undergoing endovascular thrombolysis.

J Vasc Interv Radiol 2021 May 8. Epub 2021 May 8.

Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.

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http://dx.doi.org/10.1016/j.jvir.2021.04.022DOI Listing
May 2021

Hypomagnesemia Is a Risk Factor for Infections after Kidney Transplantation: A Retrospective Cohort Analysis.

Nutrients 2021 Apr 14;13(4). Epub 2021 Apr 14.

Division of Nephrology, Department of Internal Medicine, Medical University of Graz, A-8036 Graz, Austria.

Introduction: Magnesium (Mg) deficiency is a common finding in the early phase after kidney transplantation (KT) and has been linked to immune dysfunction and infections. Data on the association of hypomagnesemia and the rate of infections in kidney transplant recipients (KTRs) are sparse.

Methods: We conducted a single-center retrospective cohort study of KTRs transplanted between 2005 and 2015. Laboratory data, including serum Mg (median time of the Mg measurement from KT: 29 days), rate of infections including mainly urinary tract infections (UTI), and common transplant-related viral infections (CMV, polyoma, EBV) in the early phase after KT were recorded. The primary outcome was the incidence of infections within one year after KT, while secondary outcomes were hospitalization due to infection, incidence rates of long-term (up to two years) infections, and all-cause mortality.

Results: We enrolled 376 KTRs of whom 229 patients (60.9%) suffered from Mg deficiency defined as a serum Mg < 0.7 mmol/L. A significantly higher incidence rate of UTIs and viral infections was observed in patients with versus without Mg deficiency during the first year after KT (58.5% vs. 47.6%, 0.039 and 69.9% vs. 51.7%, < 0.001). After adjustment for potential confounders, serum Mg deficiency remained an independent predictor of both UTIs and viral infections (odds ratio (OR): 1.73, 95% CI: 1.04-2.86, = 0.035 and OR: 2.05, 95% CI: 1.23-3.41, = 0.006). No group differences according to Mg status in hospitalizations due to infections and infection incidence rates in the 12-24 months post-transplant were observed. In the Cox regression analysis, Mg deficiency was not significantly associated with all-cause mortality (HR: 1.15, 95% CI: 0.70-1.89, = 0.577).

Conclusions: KTRs suffering from Mg deficiency are at increased risk of UTIs and viral infections in the first year after KT. Interventional studies investigating the effect of Mg supplementation on Mg deficiency and viral infections in KTRs are needed.
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http://dx.doi.org/10.3390/nu13041296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8070921PMC
April 2021

Ultrasound for diagnosis and follow-up of chronic axillary vasculitis in patients with long-standing giant cell arteritis.

Ther Adv Musculoskelet Dis 2021 19;13:1759720X21998505. Epub 2021 Mar 19.

Department of Internal Medicine III, Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn, Venusberg-Campus 1, Bonn, Nordrhein-Westfalen 53127, Germany.

Aims: To assess intima-media thickness (IMT) changes measured by ultrasound in axillary arteries of giant cell arteritis (GCA) patients over time and to calculate an ultrasound cut-off value for the diagnosis of chronic axillary artery involvement in patients with longstanding GCA.

Methods: Ultrasound of both axillary arteries was performed in 109 GCA patients at time of diagnosis and at several follow-up visits and in 40 healthy controls (HCs). IMT determined at the prospective follow-up visit was compared between GCA patients with (axGCA) and without (non-axGCA) vasculitis of axillary arteries at baseline, as well as with HCs. Changes in IMT were depicted. Receiver operating characteristics were performed for cut-off calculations. Inter-/intra-rater agreement was evaluated using stored images and intraclass correlation coefficient (ICC).

Results: Seventy-three patients were in the axGCA and 36 in the non-axGCA group. Pathological IMT of axillary arteries (axGCA) declined in the first 18 months of treatment by -0.5 mm, (range -2.77 to 0.50), independent of age and gender. Median IMT, after median disease duration of 48 months (16-137), was 0.90 mm (0.46-2.20) in axGCA and 0.60 mm (0.42-1.0) in the non-axGCA group pooled with HCs. An IMT of 0.87 mm was highly specific (specificity 96%, sensitivity 61%) for diagnosis of chronic axGCA. Intra-rater and inter-reader agreement of ultrasound images were good [ICC 0.96-1.0 (three readers) and 0.87, respectively].

Conclusion: Pathological IMT of the axillary artery declined under treatment. An IMT of 0.87 mm is highly specific for diagnosis of chronic vasculitis of axillary arteries in long-standing GCA patients.
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http://dx.doi.org/10.1177/1759720X21998505DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983430PMC
March 2021

Profiling of circulating tumor DNA and tumor tissue for treatment selection in patients with advanced and refractory carcinoma: a prospective, two-stage phase II Individualized Cancer Treatment trial.

Ther Adv Med Oncol 2021 27;13:1758835920987658. Epub 2021 Feb 27.

Division of Oncology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.

Background: Molecular profiling (MP) represents an opportunity to match patients to a targeted therapy and when tumor tissue is unavailable, circulating tumor deoxyribonucleic acid (ctDNA) can be harnessed as a non-invasive analyte for this purpose. We evaluated the success of a targeted therapy selected by profiling of ctDNA and tissue in patients with advanced and refractory carcinoma.

Patients And Methods: A blood draw as well as an optional tissue biopsy were obtained for MP. Whole-genome sequencing and a cancer hotspot panel were performed, and publicly available databases were used to match the molecular profile to targeted treatments. The primary endpoint was the progression-free survival (PFS) ratio (PFS on MP-guided therapy/PFS on the last evidence-based therapy), whereas the success of the targeted therapy was defined as a PFS ratio ⩾1.2. To test the impact of molecular profile-treatment matching strategies, we retrospectively analyzed selected cases the CureMatch PreciGENE™ decision support algorithm.

Results: Interim analysis of 24 patients yielded informative results from 20 patients (83%). A potential tumor-specific drug could be matched in 11 patients (46%) and eight (33%) received a matched treatment. Median PFS in the matched treatment group was 61.5 days [interquartile range (IQR) 49.8-71.0] compared with 81.5 days (IQR 68.5-117.8) for the last evidence-based treatment, resulting in a median PFS ratio of 0.7 (IQR 0.6-0.9). Hence, as no patient experienced a PFS ratio ⩾1.2, the study was terminated. Except for one case, the CureMatch analysis identified either a two-drug or three-drug combination option.

Conclusions: Our study employed a histotype-agnostic approach to harness molecular profiling data from both ctDNA and metastatic tumor tissue. The outcome results indicate that more innovative approaches to study design and matching algorithms are necessary to achieve improved patient outcomes. EudraCT: 2014-005341-44.
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http://dx.doi.org/10.1177/1758835920987658DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923987PMC
February 2021

Vitamin D Concentrations at Term Do Not Differ in Newborns and Their Mothers with and without Polycystic Ovary Syndrome.

J Clin Med 2021 Feb 2;10(3). Epub 2021 Feb 2.

Division of Obstetrics and Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Medical University of Graz, 8036 Graz, Austria.

Studies suggest that non-pregnant women with polycystic ovary syndrome (PCOS) may be at elevated risk of 25 hydroxyvitamin D (25(OH)D) deficiency. Furthermore, there is evidence suggesting that 25(OH)D may also play an important role during pregnancy. Data regarding 25(OH)D deficiency during pregnancy in PCOS patients and its association with perinatal outcome is scarce. The aim of the study was to investigate whether mothers with and without PCOS have different 25(OH)D levels at term, how maternal 25(OH)D levels are reflected in their offspring, and if 25(OH)D levels are associated with an adverse perinatal outcome. Therefore, we performed a cross-sectional observational study and included 79 women with PCOS according to the ESHRE/ASRM 2003 definition and 354 women without PCOS and an ongoing pregnancy ≥ 37 + 0 weeks of gestation who gave birth in our institution between March 2013 and December 2015. Maternal serum and cord blood 25(OH)D levels were analyzed at the day of delivery. Maternal 25(OH)D levels did not differ significantly in women with PCOS and without PCOS ( = 0.998), nor did the 25(OH)D levels of their respective offspring ( = 0.692). 25(OH)D deficiency (<20 ng/mL) was found in 26.9% and 22.5% of women with and without PCOS ( = 0.430). There was a strong positive correlation between maternal and neonatal 25(OH)D levels in both investigated groups (r ≥ 0.79, < 0.001). Linear regression estimates of cord blood 25(OH)D levels are about 77% of serum 25(OH)D concentrations of the mother. Compared to healthy controls, the risk for maternal complications was increased in PCOS women (48% vs. 65%; = 0.009), while there was no significant difference in neonatal complications (22% and 22%; = 1.0). However, 25(OH)D levels were similar between mothers and infants with and without perinatal complications. Although the share of women and infants with 25(OH)D deficiency was high in women with PCOS and without PCOS, it seems that the incidence of adverse perinatal outcome was not affected. The long-term consequences for mothers and infants with a 25(OH)D deficiency have to be investigated in future studies.
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http://dx.doi.org/10.3390/jcm10030537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7867163PMC
February 2021

Effect of short-interval rituximab and high-dose corticosteroids on kidney function in systemic sclerosis: Long-term experience of a single centre.

Int J Clin Pract 2021 Feb 4:e14069. Epub 2021 Feb 4.

Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.

Introduction: Scleroderma renal crisis (SRC) is a rare but one of the most recognised complications of systemic sclerosis (SSc). Corticosteroid (CS) use has been considered as a major risk factor for SRC. Several studies reported the efficacy of rituximab (RTX) with an acceptable safety profile in SSc. However, data on the long-term effect of high-dose CS concomitant to RTX on kidney function are lacking.

Methods: We retrospectively analysed SSc patients (n = 35) treated with a lower dosage and short-interval RTX and concomitant high-dose CS at the Department of Internal Medicine at the Medical University of Graz between 2010 and 2019. The kidney function was assessed using the estimated glomerular filtration rate (eGFR) at every RTX admission. The annual decline of kidney function was evaluated by linear mixed model analysis.

Results: At the RTX initiation, one patient had a decreased kidney function indicated by eGFR < 60 mL/min/1.73 m (median: 96 mL/min/1.73 m ; interquartile range (IQR): 43-136). Patients received RTX and complementary high-dose CS for a median follow-up time of 3.4 years (range 0.6-9.5). A linear mixed model analysis with the patient as random effect and time from first RTX as fixed effect estimated an annual decline of 1.98 mL/min/1.73 m of the eGFR (95% confidence interval: [-2.24, -1.72]; P <.001). During the follow-up period, no patient experienced SRC or a significant drop in kidney function.

Conclusions: A regular, high-dose CS given contemporary to RTX seems to be a safe option for kidney function in patients with SSc. Our findings provide additional knowledge in risk evaluation and planning of individualised therapies or designing clinical studies using RTX.
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http://dx.doi.org/10.1111/ijcp.14069DOI Listing
February 2021

Longitudinal Evaluation of Plasma Cytokine Levels in Patients with Invasive Candidiasis.

J Fungi (Basel) 2021 Feb 1;7(2). Epub 2021 Feb 1.

Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria.

Interleukin (IL) 17A plays a decisive role in anti- host defense. Previous data demonstrated significantly increased IL-17A values in candidemic patients. We evaluated levels and time courses of IL-17A, and other cytokines suggested to be involved in -specific immunity (IL-6, IL-8, IL-10, IL-17F, IL-22, IL-23, interferon-γ, tumor necrosis factor-α, Pentraxin-related protein 3, transforming growth factor-β) in patients with invasive candidiasis (IC) compared to bacteremic patients (, ) and healthy controls (from previous 4 days up to day 14 relative to the index culture (-4; 14)). IL-17A levels were significantly elevated in all groups compared to healthy controls. In IC, the highest IL-17A values were measured around the date of index sampling (-1; 2), compared to significantly lower levels prior and after sampling the index culture. Candidemic patients showed significantly higher IL-17A values compared to IC other than candidemia at time interval (-1; 2) and (3; 7). No significant differences in IL-17A levels could be observed for IC compared to bacteremic patients. Candidemic patients had higher IL-8, IL-10, IL-22, IFN-γ, PTX3 and TNF-α values compared to non-candidemic. Based on the limited discriminating competence between candidemia and bacteremia, IL-17A has to be considered a biomarker for blood stream infection rather than invasive infection.
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http://dx.doi.org/10.3390/jof7020101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7912850PMC
February 2021

Cholesterol and glaucoma: a systematic review and meta-analysis.

Acta Ophthalmol 2021 Jan 28. Epub 2021 Jan 28.

Department of Ophthalmology, Medical University of Graz, Graz, Austria.

Purpose: Intraocular pressure is the main risk factor for glaucoma; however, additional risk factors may also matter. This systematic review and meta-analysis were conducted to summarize the evidence regarding the association of cholesterol parameters (total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels) and glaucoma.

Methods: Four electronic databases were searched for all publications containing 'glaucoma' and one of various forms of 'cholesterol' or 'lipoprotein'. Two independent reviewers screened abstracts and potentially full texts of identified articles for eligibility. Risk of bias was assessed with the Newcastle-Ottawa Scale. A random-effects meta-analysis was used to investigate the differences in total cholesterol, LDL and HDL levels between patients with and without glaucoma.

Results: Overall, 29 observational studies were included in the systematic review and 26 reported quantitative information to investigate differences in cholesterol parameters between patients with glaucoma (N = 7196) and patients without glaucoma (N = 350 441). Patients with glaucoma had significantly higher total cholesterol levels than patients without glaucoma (Mean Difference (MD) 7.9 mg/dl, 95% CI 3.3 to 12.5, p = 0.001) and lower mean HDL levels (MD -2.0 mg/dl, 95% CI: -3.1 to -0.9, p = 0.001). Patients with glaucoma had higher mean LDL levels than patients without glaucoma, albeit not statistically significant (MD 6.1 mg/dl, 95% CI: -4.3 to 16.4, p = 0.251).

Conclusion: This systematic review and meta-analysis of observational studies found an association of glaucoma and high total cholesterol and low HDL levels, respectively. Although this supports the hypothesis that lipid levels pose an additional risk for glaucoma development, heterogeneity was substantial and causality cannot be presumed from identified observational studies.
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http://dx.doi.org/10.1111/aos.14769DOI Listing
January 2021

Endothelial Lipase Modulates Paraoxonase 1 Content and Arylesterase Activity of HDL.

Int J Mol Sci 2021 Jan 13;22(2). Epub 2021 Jan 13.

Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/6, 8010 Graz, Austria.

Endothelial lipase (EL) is a strong modulator of the high-density lipoprotein (HDL) structure, composition, and function. Here, we examined the impact of EL on HDL paraoxonase 1 (PON1) content and arylesterase (AE) activity in vitro and in vivo. The incubation of HDL with EL-overexpressing HepG2 cells decreased HDL size, PON1 content, and AE activity. The EL modification of HDL did not diminish the capacity of HDL to associate with PON1 when EL-modified HDL was incubated with PON1-overexpressing cells. The overexpression of EL in mice significantly decreased HDL serum levels but unexpectedly increased HDL PON1 content and HDL AE activity. Enzymatically inactive EL had no effect on the PON1 content of HDL in mice. In healthy subjects, EL serum levels were not significantly correlated with HDL levels. However, HDL PON1 content was positively associated with EL serum levels. The EL-induced changes in the HDL-lipid composition were not linked to the HDL PON1 content. We conclude that primarily, the interaction of enzymatically active EL with HDL, rather than EL-induced alterations in HDL size and composition, causes PON1 displacement from HDL in vitro. In vivo, the EL-mediated reduction of HDL serum levels and the consequently increased PON1-to-HDL ratio in serum increase HDL PON1 content and AE activity in mice. In humans, additional mechanisms appear to underlie the association of EL serum levels and HDL PON1 content.
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http://dx.doi.org/10.3390/ijms22020719DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828365PMC
January 2021

Structure, content, unsafe abbreviations, and completeness of discharge summaries: A retrospective analysis in a University Hospital in Austria.

J Eval Clin Pract 2021 Jan 9. Epub 2021 Jan 9.

Research Unit for Safety in Health, c/o Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.

Rationale And Objective: The discharge summary (DS) is one of the most important instruments to transmit information to the treating general physician (GP). The objective of this study was to analyse important components of DS, structural characteristics as well as medical and general abbreviations.

Method: One hundred randomly selected DS from five different clinics were evaluated by five independent reviewers regarding content, structure, abbreviations and conformity to the Austrian Electronic Health Records (ELGA) using a structured case report form. Abbreviations of all 100 DS were extracted. All items were scored on a 4-point Likert-type scale ranging from "strongly agree" to "strongly disagree" (or "not relevant"). Subsequently, the results were discussed among reviewers to achieve a consensus decision.

Results: The mandatory fields, reason for admission and diagnosis at discharge were present in 80% and 98% of DS. The last medication was fully scored in 48% and the recommended medication in 94% of 100 DS. There were significant overall differences among clinics for nine mandatory items. In total, 750 unexplained abbreviations were found in 100 DS.

Conclusions: In conclusion, DS are often lacking important items. Particularly important are a detailed medication history and recommendations for further medication that should always be listed in each DS. It is thus necessary to design and implement changes that improve the completeness of DS. An important quality improvement can be achieved by avoiding the use of ambiguous abbreviations.
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http://dx.doi.org/10.1111/jep.13533DOI Listing
January 2021

Micro-RNA-125a mediates the effects of hypomethylating agents in chronic myelomonocytic leukemia.

Clin Epigenetics 2021 Jan 6;13(1). Epub 2021 Jan 6.

Division of Hematology, Medical University of Graz, Auenbruggerplatz 38, 8036, Graz, Austria.

Background: Chronic myelomonocytic leukemia (CMML) is an aggressive hematopoietic malignancy that arises from hematopoietic stem and progenitor cells (HSPCs). Patients with CMML are frequently treated with epigenetic therapeutic approaches, in particular the hypomethylating agents (HMAs), azacitidine (Aza) and decitabine (Dec). Although HMAs are believed to mediate their efficacy via re-expression of hypermethylated tumor suppressors, knowledge about relevant HMA targets is scarce. As silencing of tumor-suppressive micro-RNAs (miRs) by promoter hypermethylation is a crucial step in malignant transformation, we asked for a role of miRs in HMA efficacy in CMML.

Results: Initially, we performed genome-wide miR-expression profiling in a Kras-induced CMML mouse model. Selected candidates with prominently decreased expression were validated by qPCR in CMML mice and human CMML patients. These experiments revealed the consistent decrease in miR-125a, a miR with previously described tumor-suppressive function in myeloid neoplasias. Furthermore, we show that miR-125a downregulation is caused by hypermethylation of its upstream region and can be reversed by HMA treatment. By employing both lentiviral and CRISPR/Cas9-based miR-125a modification, we demonstrate that HMA-induced miR-125a upregulation indeed contributes to mediating the anti-leukemic effects of these drugs. These data were validated in a clinical context, as miR-125a expression increased after HMA treatment in CMML patients, a phenomenon that was particularly pronounced in cases showing clinical response to these drugs.

Conclusions: Taken together, we report decreased expression of miR-125a in CMML and delineate its relevance as mediator of HMA efficacy within this neoplasia.
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http://dx.doi.org/10.1186/s13148-020-00979-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789782PMC
January 2021

Complications and mortality of cardiovascular emergency admissions during COVID-19 associated restrictive measures.

PLoS One 2020 24;15(9):e0239801. Epub 2020 Sep 24.

Division of Cardiology, Medical University of Graz, Graz, Austria.

While hospital admissions for myocardial infarction (MI) and pulmonary embolism (PE) are decreased during the COVID-19 pandemic, controversy remains about respective complication and mortality rates. This study evaluated admission rates, complications, and intrahospital mortality for selected life-threatening cardiovascular emergencies (MI, PE, and acute aortic dissection (AAD)) during COVID-19-associated restrictive social measures (RM) in Styria, Austria. By screening a patient information system for International Statistical Classification of Diseases and Related Health Problems (ICD) diagnosis codes covering more than 85% of acute hospital admissions in the state of Styria (~1.24 million inhabitants), we retrospectively identified patients with admission diagnoses for MI (I21, I22), PE (I26), and AAD (I71). Rates of complications such as cardiogenic shock and cardiopulmonary resuscitation, treatment escalations (thrombolysis for PE), and mortality were analyzed by patient chart review during 6 weeks following onset of COVID-19 associated RM, and during respective time frames in the years 2016 to 2019. 1,668 patients were included. Cumulative admissions for MI, PE and AAD decreased (RR 0.77; p<0.001) during RM compared to previous years. In contrast, intrahospital mortality increased by 65% (RR 1.65; p = 0.041), mainly driven by mortality following MI (RR 1.80; p = 0.042). PE patients received more frequently thrombolysis treatment (RR 3.63; p = 0.006), while rates of cardiogenic shock and cardiopulmonary resuscitation remained unchanged. Of 226 patients hospitalized during RM, 81 patients with suspected COVID-19 disease were screened for SARS-CoV-2 infection with only 5 testing positive. Thus, cumulative hospital admissions for cardiovascular emergencies decreased during COVID-19 associated RM while intrahospital mortality increased.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239801PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7514100PMC
October 2020

Impact of intraocular lens characteristics on intraocular lens dislocation after cataract surgery.

Br J Ophthalmol 2020 Sep 19. Epub 2020 Sep 19.

Department of Ophthalmology, Medical University of Graz, Graz, Austria.

Background: To assess the influence of intraocular lens (IOL) characteristics on IOL dislocations after cataract surgery.

Methods: Patients who underwent cataract surgery at the Department of Ophthalmology Graz, Austria, between 1996 and 2017 were included and medical records were reviewed. Cox proportional-hazard regression models were used to assess the influence of IOL characteristics on IOL dislocation.

Results: From 68 199 eyes out of 46 632 patients (60.2% women, mean age: 73.71 SD±10.82 years), 111 (0.16%) had an in-the-bag (ITB) disloaction and 35 (0.05%) had an out-of-the-bag (OTB) dislocation. The HRs adjusted for predisposing factors significantly associated with a higher risk for an ITB dislocation were 2.35 (95% CI, 1.45 to 3.8) for hydrophilic IOLs, 2.01 for quadripode IOLs (95% CI, 1.04 to 3.86) and 1.61 (95% CI, 1.04 to 2.48) for haptic angulation. A lower risk was observed for three-piece IOLs (HR=0.58, 95% CI, 0.34 to 0.98) and larger overall IOL diameter (HR=0.79, 95% CI, 0.66 to 0.95). For an OTB dislocation, the HR associated with a higher risk was 18.81 (95% CI, 5.84 to 60.58) for silicone IOLs and 2.12 (95% CI, 0.62 to 7.29) for hydrophilic IOLs. Larger overall IOL diameter (HR 0.40, 95% CI; 0.25 to 0.63) showed a lower risk.

Conclusion: Hydrophilic IOLs, quadripode IOLs and haptic angulation were associated with a higher risk for an ITB dislocation, whereas three-piece IOLs and a larger overall diameter were associated with a lower risk. Risk factors for OTB dislocation were silicone IOLs, hydrophilic IOLs and a smaller overall IOL diameter.
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http://dx.doi.org/10.1136/bjophthalmol-2020-317124DOI Listing
September 2020

The Graz Liver Allocation Strategy-Impact of Extended Criteria Grafts on Outcome Considering Immunological Aspects.

Front Immunol 2020 4;11:1584. Epub 2020 Aug 4.

General, Visceral, and Transplant Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.

Transplant centers are forced to use livers of extended criteria donors for transplantation due to a dramatic organ shortage. The outcome effect of extended donor criteria (EDCs) remains unclear. Thus, this study was designed to assess the impact of EDCs on outcome including immunological aspects after liver transplantation (LT). Between November 2016 and March 2018, 49 patients (85.7% male) with a mean age of 57 ± 11 years underwent LT. The impact of EDCs on outcome after LT was assessed retrospectively using both MedOcs and ENIS (Eurotransplant Network Information System). About 80% of grafts derived from extended criteria donors. Alanine aminotransferase/aspartate aminotransferase (AST/ALT) levels elevated more than three times above normal values in organ donors was the only significant risk factor for primary dysfunction (PDF) and primary non-function (PNF)/Re-LT and early non-anastomotic biliary strictures (NAS). Balance of risk (BAR) score did not differ between EDC and non-EDC recipients. PDF (14.3% of all patients) and PNF (6.1% of all patients) occurred in 23.1% of EDC-graft recipients and in 10.0% of non-EDC-graft recipients (RR 2.31, = 0.663). The 90-day mortality was 3.6%. There was no difference of early non-anastomotic biliary tract complications and biopsy proven rejections (BPR). There was no correlation of PDF/PNF with BPR and NAS, respectively; however, 66.7% of the patients with BPR also developed early NAS ( < 0.001). With the Graz liver allocation strategy, excellent survival can be achieved selecting livers with no more than 2 not outcome-relevant EDCs for patients with MELD >20. Further, BPR is associated with biliary complications.
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http://dx.doi.org/10.3389/fimmu.2020.01584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427688PMC
April 2021

Effects of both Pro- and Synbiotics in Liver Surgery and Transplantation with Special Focus on the Gut-Liver Axis-A Systematic Review and Meta-Analysis.

Nutrients 2020 Aug 15;12(8). Epub 2020 Aug 15.

General, Visceral, and Transplant Surgery, Department of Surgery, Medical University of Graz, 8036 Graz, Austria.

The gut-liver axis is of upmost importance for the development of infections after surgery. Further bacterial translocation due to surgery-related dysbiosis is associated with limited detoxification function of the liver compromising outcome of surgical therapy. After liver surgery, about 30% of patients develop a bacterial infection, with the risk of bacteremia or even sepsis-associated liver failure and mortality in >40%. The potential benefit of pro-/synbiotics given before surgery is still under debate. Thus, a systematic literature search on trials comparing patients with or without supplementation and outcome after liver resection or transplantation was performed. Our search strategy revealed 12 relevant studies on perioperative administration of pro-/synbiotics in liver surgery. The pro-/synbiotic combinations and concentrations as well as administration timeframes differed between studies. Five studies were performed in liver transplantation and 7 in liver resection. All studies but one reported lower infection rates (pooled RR: 0.46, 95% CI: 0.31-0.67) with pro-/synbiotics. Liver function was assessed after LT/LR in 3 and 5 studies, respectively. Pro-/synbiotics improved function in 1/3 and 2/5 studies, respectively. Concluding, perioperative pro-/synbiotics clearly reduce infection after liver surgery. However, standard protocols with both well-defined probiotic strain preparations and administration timeframes are pending.
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http://dx.doi.org/10.3390/nu12082461DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7468972PMC
August 2020

Platelet-rich Plasma for Androgenetic Alopecia Treatment: A Randomized Placebo-controlled Pilot Study.

Acta Derm Venereol 2020 Aug 18;100(15):adv00247. Epub 2020 Aug 18.

Department of Dermatology, Medical University of Graz, AT-8036 Graz, Austria.

Platelet-rich plasma injections have been presented as an effective treatment for androgenetic alopecia; however, reliable study data concerning this therapy are lacking. The current randomized, placebo-controlled pilot study explored this novel therapy in 30 healthy male subjects with androgenetic alopecia. Five platelet-rich plasma treatments, at intervals of 4-6 weeks, and 2 follow-up examinations were performed. Twenty subjects were injected intracutaneously with platelet-rich plasma and 10 with physiological saline. Treatment efficacy was assessed by changes in hair number and diameter, measured with the TrichoScan system. A secondary objective was to assess clinical improvement, which was evaluated by an independent reviewer using patient photographs and a 5-point Likert scale. In addition, subject satisfaction was assessed by survey. No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment. In conclusion, these results suggest that treatment with platelet-rich plasma as a monotherapy does not improve hair growth in men with androgenetic alopecia.
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http://dx.doi.org/10.2340/00015555-3609DOI Listing
August 2020

How Do Type of Preoperative P2Y Receptor Inhibitor and Withdrawal Time Affect Bleeding?

Ann Thorac Surg 2021 01 18;111(1):77-84. Epub 2020 Jun 18.

Division of Anesthesiology for Cardiovascular Surgery and Intensive Care Medicine, Medical University of Graz, Graz, Austria.

Background: Despite recommendations for standardized preoperative waiting of at least 3, 5, and 7 days for ticagrelor, clopidogrel, and prasugrel, respectively, there is still substantial interinstitutional variation in preoperative discontinuation of dual antiplatelet therapy in patients needing coronary artery bypass grafting (CABG).

Methods: In 299 patients undergoing CABG with or without valve intervention less than 7 days after last P2Y receptor inhibition, this study evaluated calculated red blood cell loss and Bleeding Academic Research Consortium type 4 (BARC-4) bleeding.

Results: A total of 83% of patients underwent CABG less than 48 hours after last drug intake. Calculated blood loss was lower in patients taking clopidogrel as compared with prasugrel or ticagrelor (1063 mL [690 to 1394 mL] vs 1351 mL [876 to 1829 mL] vs 1330 mL [994 to 1691 mL]; P < .001). Overall, 135 (45%) patients sustained BARC-4 bleeding; the incidence differed among the groups (P = .015) and was significantly higher in prasugrel-treated patients, as compared with clopidogrel-treated patients. In multivariable linear regression analysis, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), aspirin dose, cardiopulmonary bypass time, drug withdrawal time, and type of P2Y receptor inhibitor were significantly associated with red blood cell loss. Compared with 0 to 24 hours, a period of more than 48 hours of preoperative discontinuation substantially reduced calculated blood loss by 37% to 48% and BARC-4 bleeding by 58% to 71%, depending on the P2Y receptor inhibitor.

Conclusions: Exposure to prasugrel and ticagrelor 24 hours or less before CABG increases both calculated blood loss and BARC-4 bleeding as compared with clopidogrel. Although discontinuation for longer than 48 hours substantially reduced calculated blood loss and BARC-4 bleeding across all P2Y receptor inhibitors, our single-center data further support strict adherence to the 2017 guidelines whenever justified by stable hemodynamics and nonjeopardized myocardium.
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http://dx.doi.org/10.1016/j.athoracsur.2020.04.126DOI Listing
January 2021

Functional Classification of Mutations in Acute Myeloid Leukemia.

Cancers (Basel) 2020 Mar 10;12(3). Epub 2020 Mar 10.

Division of Hematology, Medical University of Graz, A-8036 Graz, Austria.

Mutations of the gene occur in a subset of patients with acute myeloid leukemia (AML) and confer an exceedingly adverse prognosis. However, whether different types of mutations exert a uniformly poor outcome has not been investigated yet. Here, we addressed this issue by analyzing data of 1537 patients intensively treated within protocols of the German-Austrian AML study group. We classified mutations depending on their impact on protein structure and according to the evolutionary action (EAp53) score and the relative fitness score (RFS). In 98/1537 (6.4%) patients, 108 mutations were detected. While the discrimination depending on the protein structure and the EAp53 score did not show a survival difference, patients with low-risk and high-risk AML-specific RFS showed a different overall survival (OS; median, 12.9 versus 5.5 months, = 0.017) and event-free survival (EFS; median, 7.3 versus 5.2 months, = 0.054). In multivariable analyses adjusting for age, gender, white blood cell count, cytogenetic risk, type of AML, and TP53 variant allele frequency, these differences were statistically significant for both OS (HR, 2.14; 95% CI, 1.15-4.0; = 0.017) and EFS (HR, 1.97; 95% CI, 1.06-3.69; = 0.033). We conclude that the AML-specific RFS is of prognostic value in patients with TP53-mutated AML and a useful tool for therapeutic decision-making.
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http://dx.doi.org/10.3390/cancers12030637DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7139772PMC
March 2020

Immunosuppression with generic tacrolimus in liver and kidney transplantation-systematic review and meta-analysis on biopsy-proven acute rejection and bioequivalence.

Transpl Int 2020 04 12;33(4):356-372. Epub 2020 Feb 12.

General, Visceral, and Transplant Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.

While rejection prevention with innovator tacrolimus (Tac) is one of the key factors for long-lasting graft function, the use of generic Tac is still under debate. Thus, we performed a systematic review and meta-analysis to provide an overview on the current body of evidence for the effect of generic Tac in adult liver (LT) and kidney transplantation (KT) with focus on both biopsy-proven acute rejection (BPAR) and bioequivalence. A systematic literature search for trials comparing generic versus innovator Tac was conducted accordingly. Seventeen studies (5 LT, 11 KT, 1 LT/KT) including 1412 patients were identified. About 92.9% (13/14; 5/5 LT, 8/9 KT) of studies reported the same or lower BPAR with generics (pooled RR: 0.84, 95% CI: 0.65-1.09); however, de novo studies showed a significantly lower risk with generic Tac (RR: 0.75, 95% CI: 0.63-0.90), whereas conversion studies showed increased risk (RR: 1.93, 95% CI: 1.00-3.70). Bioequivalence was demonstrated primarily in studies on conversion. The current evidence is mostly based on observational data and studies showing some risk of bias. In conclusion, whereas overall there was no significant difference in terms of BPAR, there is some evidence suggesting lower BPAR risk with generic Tac for de novo use.
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http://dx.doi.org/10.1111/tri.13581DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154701PMC
April 2020

Attitudes of physicians towards target groups and content of the discharge summary: a cross-sectional analysis in Styria, Austria.

BMJ Open 2019 12 17;9(12):e034857. Epub 2019 Dec 17.

Executive Department for Quality and Risk Management, Hospital of the Federal State of Styria and University Hospital Graz, Graz, Austria.

Objectives: The discharge summary (DS) represents one of the most important instruments to ensure a safe patient discharge from the hospital. They sometimes have poor quality in content and often include medical jargon, which the patient and their relatives cannot easily understand. Therefore, many risks for patient safety exist. This study investigated the questions for whom the DS is and which contents are necessary to ensure a safe treatment.

Design: Cross-sectional analysis.

Setting: Styria, Austria.

Participants: 3948 internal and external physicians were consulted.

Interventions: An online survey consisting of 24 questions was conducted. The survey was distributed to physicians working in the province of Styria, Austria, in 2018 over a period of 6 months.

Main Outcomes And Measures: Attitudes of internal and external physicians in terms of target group, content and health literacy.

Results: In total, 1060 physicians participated in the survey. The DS is considered as a communication tool among physicians (97.9%) and the patients are also indicated as addressees (73.5%). Furthermore, there is a high level of agreement that understandable information in the DS leads to fewer questions of the patients (67.9%).

Conclusion: In conclusion, the DS is not only seen as a document for the further treating physician but is also relevant for the patient. Incorporating the patient into their treatment at all levels may possibly strengthen the individual health literacy of the patient and their caring relatives.
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http://dx.doi.org/10.1136/bmjopen-2019-034857DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937118PMC
December 2019

Hand hygiene compliance in intensive care units: An observational study.

Int J Nurs Pract 2020 Apr 31;26(2):e12789. Epub 2019 Oct 31.

Research Unit for Safety in Health, Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.

Aim: Health care-associated infections along with antibiotic resistance are a leading risk for patient safety in intensive care units. Hygienic hand disinfection is still regarded as the most effective, simplest, and most cost-effective measure to reduce health care-associated infections. To improve hand hygiene compliance and to prevent health care-associated infections, interventions of the "German Clean Hands Campaign" were implemented in a university hospital.

Methods: Observational single-center study using direct observation and feedback. Hand hygiene performance was assessed in 12 intensive care units between 2013 and 2017. Linear mixed model regression analyses were used to estimate the compliance trend over time.

Results: In total, 10 315 "my five moments for hand hygiene" were observed. The mean hand hygiene compliance rates increased from 75.1% to 88.6% during the study period, yielding an estimated increase of about 4.5% per year. However, there are differences in compliance between occupational groups (physicians: between 61.2% and 77.1%; nurses: between 80.2% and 90.9%; others: between 61.3% and 82.4%).

Conclusions: After implementation of the "German Clean Hands Campaign" interventions, an overall significant improvement of hand hygiene was detected. Compliance measurements helped to raise awareness among health care professional groups.
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http://dx.doi.org/10.1111/ijn.12789DOI Listing
April 2020

Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices - results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment).

BMC Health Serv Res 2019 Aug 1;19(1):539. Epub 2019 Aug 1.

Institute of General Practice, Goethe University Frankfurt am Main, Theodor-Stern-Kai 7, 60590, Frankfurt/Main, Germany.

Background: In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential through implementation of case management, have not yet been investigated satisfactorily. Based on results of a cluster-randomized controlled trial, we aimed to assess whether OAC quality can be improved, any variations between practices exist and determine practice- and patient-level factors.

Methods: The PICANT trial (2012-2015) was performed in 52 GP practices in Hesse, Germany. Adult patients with long-term indication for OAC received best practice case management in the intervention group. International normalized ratio (INR) values were recorded from anticoagulation passes. The Rosendaal method was used to calculate Time in Therapeutic Range (TTR) at patient level, and mean pooling to obtain center-specific TTR (cTTR) at practice level. The quality of OAC was assessed by TTR and cTTR. Linear model analyses were used to investigate associations between practice-/ patient-level factors and TTR.

Results: Inclusion of 736 patients (49.6% intervention and 50.4% control patients); 690 (93.8%) received phenprocoumon. Within 24 months, the TTR was 75.1% (SD 17.6) in the intervention versus 74.3% (SD 17.8) in the control group (p = 0.670). The cTTR averaged 75.1% (SD 6.5, range: 60.4 to 86.7%) in the intervention versus 74.3% (SD 7.2, range: 52.7 to 85.7%) in the control group (p = 0.668). At practice level, the TTR was significantly lower in practices with a male physician and certification in quality management. At patient level, the TTR was significantly higher in patients with moderate to high compliance, in men, and in patients that performed self-management. The TTR was significantly lower in patients with certain comorbidities, and who were hospitalized.

Conclusions: The intervention did not effectively improve OAC quality compared to routine care. Quality of INR control was generally good, but considerable variation existed between GP practices. The variability indicates optimization potential in some practices. The demonstrated association between patient-level factors and TTR highlights the importance of considering patient characteristics that may impede achieving high quality therapeutic outcomes.

Trial Registration: ISRCTN registry, ISRCTN41847489 , registered 27 February 2012.
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http://dx.doi.org/10.1186/s12913-019-4372-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676561PMC
August 2019

Serum concentrations of free fatty acids are associated with 3-month mortality in acute heart failure patients.

Clin Chem Lab Med 2019 Oct;57(11):1799-1804

Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstr. 6/6, 8010 Graz, Austria.

Background Plasma free fatty acids (FFA) are higher in heart failure (HF) patients compared to healthy controls. Considering that the extent of FFA elevation in HF might mirror the severity of HF, we hypothesized that the serum levels of FFA may be a useful prognostic indicator for 3-month mortality in acute heart failure (AHF). Methods We analyzed the serum samples of AHF patients obtained at admission to the emergency department. Serum levels of FFA were analyzed using an enzymatic reagent on an automatic analyzer. Results Out of 152 included AHF patients that were originally included, serum samples of 132 patients were available for the quantification of FFA. Of these, 35 (26.5%) died within 3 months of onset of AHF. These patients had significantly higher serum levels of FFA compared to AHF patients who were alive 3 months after onset of AHF. Univariable logistic regression analyses showed a significant positive association of FFA levels with 3-month mortality (odds ratio [OR] 2.76 [95% confidence interval 1.32-6.27], p = 0.010). Importantly, this association remained significant after adjusting for age and sex, as well as for further clinical and laboratory parameters that showed a significant association with 3-month mortality in the univariate analyses. Conclusions We conclude that the admission serum levels of FFA are associated with 3-month mortality in AHF patients. Therefore, measurements of circulating FFA levels may help identifying high-risk AHF patients.
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http://dx.doi.org/10.1515/cclm-2019-0037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6779572PMC
October 2019

Allergic rhinitis is associated with complex alterations in high-density lipoprotein composition and function.

Biochim Biophys Acta Mol Cell Biol Lipids 2019 10 8;1864(10):1280-1292. Epub 2019 Jun 8.

Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010 Graz, Austria.; BioTechMed Graz, Mozartgasse 12/II, 8010 Graz, Austria. Electronic address:

Despite strong evidence that high-density lipoproteins (HDLs) modulate the immune response, the role of HDL in allergies is still poorly understood. Many patients with allergic rhinitis (AR) develop a late-phase response, characterized by infiltration of monocytes and eosinophils into the nasal submucosa. Functional impairment of HDL in AR-patients may insufficiently suppress inflammation and cell infiltration, but the effect of AR on the composition and function of HDL is not understood. We used apolipoprotein (apo) B-depleted serum as well as isolated HDL from AR-patients (n = 43) and non-allergic healthy controls (n = 20) for detailed compositional and functional characterization of HDL. Both AR-HDL and apoB-depleted serum of AR-patients showed decreased anti-oxidative capacity and impaired ability to suppress monocyte nuclear factor-κB expression and pro-inflammatory cytokine secretion, such as interleukin (IL)-4, IL-6, IL-8, tumor necrosis factor alpha and IL-1 beta. Sera of AR-patients showed decreased paraoxonase and cholesteryl-ester transfer protein activities, increased lipoprotein-associated phospholipase A2 activity, while lecithin-cholesterol acyltransferase activity and cholesterol efflux capacity were not altered. Surprisingly, apoB-depleted serum and HDL from AR-patients showed an increased ability to suppress eosinophil effector responses upon eotaxin-2/CCL24 stimulation. Mass spectrometry and biochemical analyses showed reduced levels of apoA-I and phosphatidylcholine, but increased levels of apoA-II, triglycerides and lyso-phosphatidylcholine in AR-HDL. The changes in AR-HDL composition were associated with altered functional properties. In conclusion, AR alters HDL composition linked to decreased anti-oxidative and anti-inflammatory properties but improves the ability of HDL to suppress eosinophil effector responses.
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http://dx.doi.org/10.1016/j.bbalip.2019.06.007DOI Listing
October 2019

Author Correction: Acute Heart Failure developed as worsening of Chronic Heart Failure is associated with increased mortality compared to de novo cases.

Sci Rep 2019 Jun 5;9(1):8403. Epub 2019 Jun 5.

Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/6, 8010, Graz, Austria.

A correction to this article has been published and is linked from the HTML and PDF versions of this paper. The error has been fixed in the paper.
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http://dx.doi.org/10.1038/s41598-019-44069-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6549248PMC
June 2019

Serum Concentrations of Citrate, Tyrosine, 2- and 3- Hydroxybutyrate are Associated with Increased 3-Month Mortality in Acute Heart Failure Patients.

Sci Rep 2019 05 1;9(1):6743. Epub 2019 May 1.

Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/6, 8010, Graz, Austria.

Considering the already established relationship between the extent of the metabolic dysfunction and the severity of heart failure (HF), it is conceivable that the metabolomic profile of the serum may have a prognostic capacity for 3-month mortality in acute heart failure (AHF). Out of 152 recruited patients, 130 serum samples were subjected to the metabolomic analyses. The 3-month mortality rate was 24.6% (32 patients). Metabolomic profiling by nuclear magnetic resonance spectroscopy found that the serum levels of 2-hydroxybutyrate (2-HB), 3-hydoxybutyrate (3-HB), lactate, citrate, and tyrosine, were higher in patients who died within 3 months compared to those who were alive 3 months after onset of AHF, which was confirmed by univariable logistic regression analyses (p = 0.009, p = 0.005, p = 0.008, p<0.001, and p<0.001, respectively). These associations still remained significant for all tested metabolites except for lactate after adjusting for established prognostic parameters in HF. In conclusion, serum levels of 2-HB, 3-HB, tyrosine, and citrate measured at admission are associated with an increased 3-month mortality rate in AHF patients and might thus be of prognostic value in AHF.
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http://dx.doi.org/10.1038/s41598-019-42937-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6494857PMC
May 2019

Quality of teamwork in multidisciplinary cancer team meetings: A feasibility study.

PLoS One 2019 15;14(2):e0212556. Epub 2019 Feb 15.

Research Unit for Safety in Health, c/o Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.

Background: Tumor boards (TB) play an important role to formulate a management plan for the treatment of patients with a malignancy. Recent evidence suggests that optimally functioning teams (teamwork, communication and decision making) are major prerequisites to conduct efficient TB meetings. The aims of this study were i) to use a readily published tool as a template for the development of a teamwork perspective extended assessment tool and ii) to evaluate the tool in a feasibility study by clinical and non-clinical observers.

Methods: A systematic literature search in four databases revealed the "Metric for the Observation of Decision-making (MODe)" to be consistently used. MODe served as a template for the clinical evaluation, additional, notably teamwork items were integrated, and the resulting tool was tested in a feasibility study in TBs by clinical and non-clinical observers. The percentage of agreement between observers was assessed in a two-step approach: first, agreement of raters on discussion of items by TB members, and second, agreement of raters based on ordinal scale.

Results: In total, 244 patients were discussed in 27 TB sessions, thereof 136 (56%) fast track cases and 108 (44%) complex cases. In 228 (93%) of all cases an agreement for recommendation of a treatment plan was reached. Observers showed in general high agreement on discussion of the items. For the majority of items, the percentage of agreement between the different pairs of rater was similar and mostly high.

Conclusion: A newly developed TB team performance tool using MODe as a template was piloted in a German-speaking country and enabled the assessment of specialized multidisciplinary teams with a special focus on teamwork patterns. The developed assessment tool requires evaluation in a larger collective for validation, and additional assessment whether it can be applied equally by non-clinicians and clinicians.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212556PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377131PMC
November 2019

Cost-effectiveness analysis of case management for optimized antithrombotic treatment in German general practices compared to usual care - results from the PICANT trial.

Health Econ Rev 2019 Feb 7;9(1). Epub 2019 Feb 7.

Institute of General Practice, Goethe-University Frankfurt am Main, Frankfurt, Germany.

Background: By performing case management, general practitioners and health care assistants can provide additional benefits to their chronically ill patients. However, the economic effects of such case management interventions often remain unclear although how to manage the burden of chronic disease is a key question for policy-makers. This analysis aimed to compare the cost-effectiveness of 24 months of primary care case management for patients with a long-term indication for oral anticoagulation therapy with usual care.

Methods: This analysis is part of the cluster-randomized controlled Primary Care Management for Optimized Antithrombotic Treatment (PICANT) trial. A sample of 680 patients with German statutory health insurance was initially considered for the cost analysis (92% of all participants at baseline). Costs included all disease-related direct health care costs from the payer's perspective (German statutory health insurers) plus case management costs for the intervention group. A-Quality Adjusted Life Year (QALY) measurement (EQ-5D-3 L instrument) was used to evaluate utility, and incremental cost-effectiveness ratio (ICER) to assess cost-effectiveness. Mean differences were calculated and displayed with 95%-confidence intervals (CI) from non-parametric bootstrapping (1000 replicates).

Results: N = 505 patients (505/680, 74%) were included in the cost analysis (complete case analysis with a follow-up after 12 and 24 months as well as information on cost and QALY). After two years, the mean difference of direct health care costs per patient (€115, 95% CI [- 201; 406]) and QALYs (0.03, 95% CI [- 0.04; 0.11]) in the two groups was small and not significant. The costs of case management in the intervention group caused mean total costs per patient in this group to rise significantly (mean difference €503, 95% CI [188; 794]). The ICER was €16,767 per QALY. Regardless of the willingness of insurers to pay per QALY, the probability of the intervention being cost-effective never rose above 70%.

Conclusions: A primary care case management for patients with a long-term indication for oral anticoagulation therapy improved QALYs compared to usual care, but was more costly. However, the results may help professionals and policy-makers allocate scarce health care resources in such a way that the overall quality of care is improved at moderate costs, particularly for chronically ill patients.

Trial Registration: Current Controlled Trials ISRCTN41847489 .
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http://dx.doi.org/10.1186/s13561-019-0221-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734317PMC
February 2019

Primary care management for patients receiving long-term antithrombotic treatment: A cluster-randomized controlled trial.

PLoS One 2019 9;14(1):e0209366. Epub 2019 Jan 9.

Institute of General Practice, Goethe-University Frankfurt am Main, Frankfurt am Main, Germany.

Purpose: To examine whether applying case management in general practices reduces thromboembolic events requiring hospitalization and major bleeding events (combined primary outcome). Secondary endpoints were mortality, frequency and duration of hospitalization, severe treatment interactions, adverse events, quality of anticoagulation, health-related quality of life and intervention costs, patients' assessment of chronic illness care, self-reported adherence to medication, GP and HCA knowledge, patient knowledge and satisfaction with shared decision-making.

Methods: Cluster-randomized controlled trial undertaken at 52 general practices in Germany with adult patients with a long-term indication for oral anticoagulation. The complex intervention included training for healthcare assistants, information and quality circles for general practitioners and 24 months of case management for patients. Assessment was after 12 and 24 months. The intention-to-treat population included all randomized practices and patients, while the per-protocol analysis included only those that received treatment without major protocol violations.

Results: The mean (SD) age of the 736 patients was 73.5 (9.4) years and 597 (81.1%) had atrial fibrillation. After 24 months, the primary endpoint had occurred in 40 (11.0%) intervention and 48 (12.9%) control patients (hazard ratio 0.83, 95% CI 0.55 to 1.25; P = .37). Patients' perceived quality of care, their knowledge, and HCAs' knowledge, had improved significantly at 24 months. The other secondary endpoints did not differ between groups. In the intervention group, hospital admissions were significantly reduced in patients that received treatment without major protocol deviations.

Conclusions: Even though the main outcomes did not differ significantly, the intervention appears to have positively influenced several process parameters under 'real-world conditions'.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0209366PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326474PMC
September 2019