457 research outputs found
Evaluation of preclinical and clinical studies published in medical journals of Bosnia and Herzegovina: Methodology issues
No full text© 2020 Slobodan M. Jankovic, Izet Masic Introduction: Results of preclinical and clinical studies in medicine could be trusted only if their design and statistical analysis were appropriate. Aim: The aim of our study was to investigate whether preclinical and clinical studies published in medical journals of Bosnia and Herzegovina satisfy basic requirements for appropriate design and statistical interpretation of data. Methods: Preclinical and clinical studies published in medical journals of Bosnia and Herzegovina were retrieved from the PubMed database, and the sample for analysis was randomly chosen from the retrieved publications. Implementation rate of basic principles of experimental design (local control, randomization and replication) and rate of the most common errors in design of clinical/observational studies was established by careful reading of the sampled publications and their checking against predefined criteria. Results: Our study showed that only a minority of experimental preclinical studies had basic principles of design completely implemented (7%), while implementation rate of single aspects of appropriate experimental design varied from as low as 12% to as high as 77%. Only one of the clinical/observational studies had none of the errors searched for (2%), and specific errors rates varied from 10% to 89%. Average impact factor of the surveyed studies was around one, and average publication date recent, less than 5 years ago. Conclusion: Prevalence of preclinical studies that did not follow completely basic principles of research design, and that of clinical/observational studies with errors are high, raising suspicion to validity of their results. If incorrect and not protected against bias, results of published studies may adversely influence future research
Injectable interferon beta-1b for the treatment of relapsing forms of multiple sclerosis
No full textSlobodan M JankovicPharmacology Department, Medical Faculty, University of Kragujevac, Kragujevac, SerbiaAbstract: Multiple sclerosis (MS) is chronic inflammatory and demyelinating disease with either a progressive (10%–15%) or relapsing-remitting (85%–90%) course. The pathological hallmarks of MS are lesions of both white and grey matter in the central nervous system. The onset of the disease is usually around 30 years of age. The patients experience an acute focal neurologic dysfunction which is not characteristic, followed by partial or complete recovery. Acute episodes of neurologic dysfunction with diverse signs and symptoms will then recur throughout the life of a patient, with periods of partial or complete remission and clinical stability in between. Currently, there are several therapeutic options for MS with disease-modifying properties. Immunomodulatory therapy with interferon beta-1b (IFN-β1b) or -1a, glatiramer and natalizumab shows similar efficacy; in a resistant or intolerant patient, the most recently approved therapeutic option is mitoxantrone. IFN-β1b in patients with MS binds to specific receptors on surface of immune cells, changing the expression of several genes and leading to a decrease in quantity of cell-associated adhesion molecules, inhibition of major histocompatibility complex class II expression and reduction in inflammatory cells migration into the central nervous system. After 2 years of treatment, IFN-β1b reduces the risk of development of clinically defined MS from 45% (with placebo) to 28% (with IFN-β1b). It also reduces relapses for 34% (1.31 exacerbations annually with placebo and 0.9 with higher dose of IFN-β1b) and makes 31% more patients relapse-free. In secondary-progressive disease annual rate of progression is 3% lower with IFN-β1b. In recommended doses IFN-β1b causes the following frequent adverse effects: injection site reactions (redness, discoloration, inflammation, pain, necrosis and non-specific reactions), insomnia, influenza-like syndrome, asthenia, headache, myalgia, hypoesthesia, nausea, paresthesia, myasthenia, chills and depression. Efficacy of IFN-β1b in  relapsing-remitting MS is higher than that of IFN-β1a, and similar to the efficacy of glatiramer acetate. These facts promote IFN-β1b as one of the most important drugs in the spectrum of immunological therapies for this debilitating disease.Keywords: multiple sclerosis, interferon beta 1b, mechanism of action, efficacy, safet
Migracije u kontekstu krize na Balkanu i u Evropi
No full textEuropean migrant crisis occurs in context of wider economic,
institutional, cultural crisis of EU and candidate countries for the EU
membership. These countries are in the Balkan Peninsula. Balkan or Eastern
Mediterranean migrant route passes through states that have also strong
demographic crisiswith two features: lowfertility and higherrates of emigration.
Second chapter of the study deals with EU context of crisis, with crisis of
common asylum and migration policy, its shortcomings and adjustments.
Authors clearly point to the pressure made on Germany with record numbers
of asylum applicants, transformation of Frontex and failures to develop joint
and effective reaction at the EU level. In third chapter Jankovic and Djordjevic
examine Balkan and Serbian response and local emigration crisis.In conclusion,
authors present picture of security and other challenges to precarious Balkan
political situation utterly destabilized by European migrant crisis
Evaluation of Published Preclinical Experimental Studies in Medicine: Methodology Issues
No full text© 2019 Slobodan M. Jankovic, Belma Kapo, Aziz Sukalo, Izet Masic. Introduction: Inappropriate design of experimental studies in medicine inevitably leads to inaccurate or false results, which serve as basis for erroneous and biased conclusions. Aim: The aim of our study was to investigate prevalence of implementing basic principles of experimental design (local control, replication and randomization) in preclinical experimental studies, performed either on animals in vivo, or animal/human material in vitro. Material and Methods: Preclinical experimental studies were retrieved from the PubMed database, and the sample for analysis was randomly chosen from the retrieved publications. Implementation rate of basic experimental research principles (local control, randomization and replication) was established by careful reading of the sampled publications and their checking against predefined criteria. Results: Our study showed that only a minority of experimental preclinical studies had basic principles of design completely implemented (7%), while implementation rate of single aspects of appropriate experimental design varied from as low as 9% to maximum 86%. Average impact factor of the surveyed studies was high, and publication date relatively recent, suggesting generalizability of our results to highly ranked contemporary journals. Conclusion: Prevalence of experimental preclinical studies that did not implement completely basic principles of research design is high, raising suspicion to validity of their results. If incorrect and biased, results of published studies may mislead authors of future studies and cause conduction of fruitless research that will waste precious resources
Middle East conflicts: Basic features
No full textThe paper explores the causes of the Middle East conflicts. The author considers that apart from historical and religious roots the main causes are the importance of the energy deposits, great and regional powers competition and collisions over energy resources, the complexity of water management in the region for its scarcity, traditional, religious and ethnic differences social differentiations and conflicts, growing poverty among majority of people, demographic problems. The persistence and not solving of these problems clearly indicate that local terrorisms, wars and armed confrontations remain the ominous feature of the region, concludes the author
Comparison of EMA and FDA guidelines for drug interactions: An overview
No full text© 2014 Informa Healthcare USA, Inc. In 2013, the regulatory authorities of the European Union and the US issued, almost simultaneously, new editions of the industry guidelines for the requirements of drug testing during their development for drug-drug and drug-food interactions. That being said, there are significant differences in the requirements set by both guidelines, and the aim of this article is to point out those differences. In this review, the author carefully and comprehensively compared the publicly available guidelines via the official Food and Drug Administation's (FDA) and European Medicine Agency's (EMA) websites, highlighting the differences between the two sets. Unlike the guidelines provided by the FDA, the EMA guidelines lack set requirements for testing interactions with therapeutic proteins as well as with the usage of pharmacodynamics end-points. It also does not set standards for the use of the 'no interaction' declaration in the summary of product characteristics. On the other hand, the FDA currently lacks guidance for testing drug-food interactions, the use of the Relative Induction Score correlation method, and proving existence of reversible inhibition and mechanism-based inactivation. It is important to note that, while there are differences in the requirements for the FDA's and the EMA's drug interaction guidelines, they are not substantial and are mostly relating to the scope of requirements and precision of the standards set
The surgical lips deformity corrected with hyaluronic fillers: A case report
No full text© 2015, Dragan Stolic, Maja Jankovic, Marija Draskovic, Slobodan Georgiev, Marina Stolic. Background: Hyaluronic filler is a sterile, biodegradable, viscoelastic, isotonic, transparent injectable gel implant which was approved by Food and Drug Administration (FDA) 1996. It is used for face reconstruction and modelling. Case presentation: We report the case of a 40-year-old Serbian woman who presented after surgery of cleft lip, primary and secondary palate. We performed a biphasic therapy; in the first stage in the zone semimucosis lips is initially carried incision scar tissue. The second stage is placed hyaluronan implant. Conclusion: This case illustrates that, although hyaluronic fillers used mainly for correction of healthy tissue can be successfully used in the treatment of postoperative scars
The South and East Mediterranean power struggle: cases of Libya and Syria
No full textIn this paper, the author uses the neoclassical geopolitical approach to
analyse the powerstruggle in the Mediterranean as an echo of the changing world
order by studying two war theatres in the Mediterranean, Libyan and Syrian.
jankovic firstly explained the importance of the Mediterranean Sea for the world
economy and politics and examined the political and geographical features
important for understanding the wars in these two countries.
In the second chapter, the author presents the Italian neoclassical geopolitical
school. In the third part of the study, he overviews the geopolitical significance
of the two mentioned countries. In the fourth chapter, the author argues that
certain geographic elements and historical heritage account for understanding the
political action of various actors in the Libyan and Syrian wars. Through the lens
of the Italian neoclassical geopoliticalschool, he questionsregional policies of the
USA, Russia, France, Turkey, Egypt, and Israel. Finally, the author has two
conclusions: a) he argues that the traditional geopolitical school of the Apennines
is valid for the analysis of Mediterranean power politics, and b) he indicates that
the warsin Libya and Syria are clearly showing that multipolarity auspicated by the
Russian president in 2007 has come to this part of the world
Serbian Translation and Cross-Cultural Validation of the Questionnaire for Assessing Patient Satisfaction with Endoscopic Examination of the Digestive Tract
No full textAbstract
Patient satisfaction is a key indicator to assess the quality of gastrointestinal endoscopy. The aim of this study was to examine the Serbian translation and cross-cultural validation of the questionnaire for the assessment of satisfaction in patients who underwent gastrointestinal endoscopy.
After obtaining the consent of the author of the original questionnaire, translation and cross-cultural validation of the GESQ (Gastrointestinal Endoscopy Satisfaction Questionnaire) were carried out in accordance with the conductors of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The study was conducted in the Center for Gastroenterohepatology (GEH) of the Kragujevac Clinical Center and included 165 patients. The reliability of the Serbian translation of the GESQ was estimated by calculating Cronbach’s alpha for the whole questionnaire in order to implement the structural validation. The overall score of the questionnaire was compared and correlated with the total scores on the Short Subjective Well-being scale (KSB) and visual analogue scale (VAS), which were administered to the same patients.
The Serbian translation of the GESQ showed high reliability with a Cronbach’s alpha coefficient of 0.763, good structure and homogeneity by randomly sharing the questionnaire into two parts. Exploratory factor analysis indicated the existence of four factors that explain 57.200% of the variability.
The Serbian version of the GESQ showed similar psychometric characteristics to the original English questionnaire, with a similar factor structure, and represented a valid, reliable and acceptable tool for the assessment of patient satisfaction with the endoscopic examination of the digestive tract.</jats:p
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