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center Ljubljana, Slovenia

Stupnik T.,Univerzitetni klinicni center Ljubljana | Perme M.P.,University of Ljubljana
Statistics in Medicine | Year: 2016

When analyzing time to disease recurrence, we sometimes need to work with data where all the recurrences are recorded, but no information is available on the possible deaths. This may occur when studying diseases of benign nature where patients are only seen at disease recurrences or in poorly-designed registries of benign diseases or medical device implantations without sufficient patient identifiers to obtain their dead/alive status at a later date. When the average time to disease recurrence is long enough in comparison with the expected survival of the patients, statistical analysis of such data can be significantly biased. Under the assumption that the expected survival of an individual is not influenced by the disease itself, general population mortality tables may be used to remove this bias. We show why the intuitive solution of simply imputing the patient's expected survival time does not give unbiased estimates of the usual quantities of interest in survival analysis and further explain that cumulative incidence function analysis does not require additional assumptions on general population mortality. We provide an alternative framework that allows unbiased estimation and introduce two new approaches: an iterative imputation method and a mortality adjusted at risk function. Their properties are carefully studied, with the results supported by simulations and illustrated on a real-world example. © 2016 John Wiley & Sons, Ltd. Source


Cvenkel B.,Univerzitetni klinicni center Ljubljana
Zdravniski Vestnik | Year: 2016

Patients with glaucoma have an increased prevalence of dry eye (DE) compared to age-matched population without glaucoma. Clinical presentation of DE varies among individuals and may significantly reduce quality of life. The onset and deterioration of DE is caused by the toxic-inflammatory effects of preservatives in eye drops, active substance itself, and added, pharmacologically inactive substances or excipients. Ocular surface changes most frequently include superficial punctate keratitis, tear film instability, and allergic reactions. Despite the lack of symptoms, clinical signs may indicate ocular surface damage. The discordance between signs and symptoms is partly caused by decreased corneal sensitivity induced by neurotoxicity of the preservative benzalkonium chloride (BAK). Therefore, it is also important to evaluate ocular surface before initiating glaucoma therapy and during follow-up in asymptomatic patients. A preservative-free and/or BAK-free therapy is indicated in patients with severe DE and allergy to preservatives, and recommended in patients with DE of moderate severity, blepharitis, in symptomatic patients, before filtering surgery to reduce preoperative inflammation, in those with moderate fluorescein staining of grade 2 according to Oxford scheme, and reduced tear film break-up time. © 2016, Slovene Medical Society. All rights reserved. Source


Background: Retrospective analyses of unselected patients with acute myeloid leukaemia (AML), treated at individual centres, provide an estimate of treatment success in real world, in contrast to artificially designed conditions in clinical trials. We analysed the treatment outcome of adult patients with AML at the University Medical Centre of Ljubljana over the last four years. Results: From year 2008 to 2011, 222 patients with AML were treated at our centre. Out of the 222 treated patients, 19 patients had acute promyelocytic leukaemia (APL) and they received a combination of tretinoin and anthracycline based chemotherapy. Four patients died in the period of induction therapy, while the remaining patients reached molecular remission, which still lasts. In the group of 203 non-APL patients, 129 patients (of these 76 younger and 53 older than 59 years) received intensive chemotherapy. Non-intensive treatment was given to 74 patients. The intensive treatment included daunorubicin-cytarabine- based induction therapy (DA3+10). In 22 % of younger patients the time from diagnosis to the beginning of intensive treatment lasted more than 5 days. The percentage of early deaths (less than 33 days after the beginning of treatment) was 12 % for younger, and 19 % for older patients. The remission rate was 67 % in younger and 47 % in older patients. The estimated medianof overall survival was 13 months and relapsefree survival was 12.5 months. Three-year survival rate was 31 %. Allogeneic stem-cell transplantation was performed in 36 patients; in 10 of these patients transplantation was induction treatment. Remission was achieved in a half of the patients,8 patients died and of these only 2 survived more than a year. Allogeneic stem cell transplantation was a part of consolidation treatment in 26 patients. In four cases AML relapsed and 10 patients died (38 %). Relapse of the disease was the cause of death in two cases only.Conclusions: The remission rate in our study is comparable with the reports of several randomized trials. For survival analysis, if we are critical, the duration of follow-up in our study might be too short. Suggested measures for the improvement of treatment outcome are: once a diagnosis of APL is suspected, treatment with tretinoin (and blood products) should be started immediately, in younger patients with AML the time from diagnosis to treatment initiation should be under 5 days, patient-specific and leukaemia-associated factors should be analysed carefully before the treatment decisions, especially in older patients. Source


Kopac M.,Univerzitetni klinicni center Ljubljana
Zdravniski Vestnik | Year: 2015

Congenital anomalies of the kidneys and urinary tract are the commonest congenital anomalies in children, often detected prenatally with ultrasound. This method is useful for assesing the degree of dilatation of the collecting system, the structure of the kidney parenchyma, amount of amniotic fluid and the urinary bladder. Hydronephrosis is the most common among them. Anomalies can be either bilateral or unilateral, and different defects may coexist in an individual child. Anomalies of other organs and organ systems are often associated with the anomalies of the kidneys and urinary tract described in numerous syndromes. Congenital anomalies of the kidneys and urinary tract can be divided in anomalies of the renal parenchyma development, renal embryonic migration and position, cystic kidney diseases and anomalies of the urinary tract (collecting system of the kidneys, ureters, urinary bladder and urethra). They are the commonest cause of end-stage renal disease in children. © 2015, Slovene Medical Society. All rights reserved. Source


Grant
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-24-2015 | Award Amount: 18.47M | Year: 2016

The management of febrile patients is one of the most common and important problems facing healthcare providers. Distinction between bacterial infections and trivial viral infection on clinical grounds is unreliable, and as a result innumerable patients worldwide undergo hospitalization, invasive investigation and are treated with antibiotics for presumed bacterial infection when, in fact, they are suffering from self-resolving viral infection. We aim to improve diagnosis and management of febrile patients, by application of sophisticated phenotypic, transcriptomic (genomic, proteomic) and bioinformatic approaches to well characterised large-scale, multi-national patient cohorts already recruited with EU funding. We will identify, and validate promising new discriminators of bacterial and viral infection including transcriptomic and clinical phenotypic markers. The most accurate markers distinguishing bacterial and viral infection will be evaluated in prospective cohorts of patients reflecting the different health care settings across European countries. By linking sophisticated new genomic and proteomic approaches to careful clinical phenotyping, and building on pilot data from our previous studies we will develop a comprehensive management plan for febrile patients which can be rolled out in healthcare systems across Europe.

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