Introduction/Objective. Although effectiveness of atypical antipsychotics in patients with schizophrenia is mostly similar, there are significant differences in adverse effects rate and treatment costs, making comparison of their cost/effectiveness ratios essential for optimal drug choice. The aim of this study was to compare cost/effectiveness of aripiprazole and olanzapine in long-term treatment of schizophrenia. Methods. A four-state, three-month cycle Markov model was built to compare aripiprazole and olanzapine. The model assumed that patients who relapse on treatment with both aripiprazole and olanzapine are further treated with clozapine. The perspective of the National Health Insurance Fund was chosen, and the period covered by the model was 10 years. The model results were obtained after Monte Carlo microsimulation of a sample with 1,000 virtual patients. Both multiple one-way and probabilistic sensitivity analysis was made. Results. After base-case analysis aripiprazole was dominated by olanzapine, as net monetary benefit was negative (-390,341.96 ?} 29,131.53 RSD) and incremental cost/effectiveness ratio (ICER) was above the willingness-to-pay line of one Serbian gross domestic product per capita per quality-adjusted life year (QALY) gained. Multiple one-way and probabilistic sensitivity analysis confirmed results of the base case simulation. Conclusion. Olanzapine has more beneficial cost/effectiveness ratio than aripiprazole for long-term treatment of schizophrenia in Serbian milieu.
Background/Aim. There are several questionnaires for measuring intensity of nausea after drug administration, but they are either too settings specific (like those measuring chemotherapy-induced nausea), or they were not properly tested for reliability and validity. The aim of this study was to develop and validate a reliable instrument that can measure drug-induced nausea. Methods. The cross-sectional study for assessing reliability and validity of a questionnaire was performed. The questionnaire with 5 items and answers according to the Likert?s scale was developed during two brainstorming sessions of the research team. Its reliability, validity and temporal stability were tested on the sample of 128 outpatients taking iron salts orally. Results. The final version of the Drug-Induced Nausea Scale (DINS) with 5 items showed excellent reliability, both when rated by the investigators (Cronbach?s alpha 0.892) and by the patients themselves (Cronbach?s alpha 0.897). It was temporally stable, and both divergent and convergent validity tests had very good results. Factorial analysis revealed only one factor, which means that the whole scale is measuring only one phenomenon, intensity of nausea, as was originally intended. Conclusion. The DINS is reliable and valid instrument for measuring intensity of drug-induced nausea. Identification of patients with high intensity of druginduced nausea by this questionnaire will help prescribers to decide whether the therapy should be stopped or the patient switched to less emetogenic therapy.
Introduction/Objective. Making a calculator that would recognize patterns of abnormal liver function tests and link them to the most probable etiology could help clinicians in their initial orientation towards a definitive diagnosis in patients with liver damage. The aim of our study was to design, construct, and validate a calculator that based on a pattern of abnormalities in liver function tests of a patient with liver damage would propose the most probable etiology. Methods. Patterns of abnormal liver function tests for certain etiology of liver damage were extracted from distributions of actual values taken from reports in medical literature about patients whose etiology of liver damage was proven by reliable diagnostic tests. After setting up the calculator with the patterns extracted, its diagnostic value was checked under real-life conditions, on a sample of patients with liver damage whose etiology was established by the gold standard of diagnostics (biopsy or else). The calculator validation study was carried out at the Military Medical Academy in Belgrade during a two-year period (2015?2016). Results. For all tested diagnoses, the calculator demonstrated a highly significant difference between the area under the receiver-operator curves? values and the value of 0.5 (p < 0.001), and high level of sensitivity (more than 90%, except for the model for chronic hepatitis) as well as relatively high specificity (more than 75%) were noted, indicating good ability of the calculator to detect etiology of liver damage. Conclusion. New calculators showed satisfactory sensitivity and specificity for revealing major liver damage etiologies.
Background/Aim. The two-part questionnaire called Injection Phobia Scale (IPS)-Anxiety and IPS-Avoidance represents one of the most commonly used questionnaires for assessing the fear of injections. The aim of the present study was to translate and culturally adapt this questionnaire from English into Serbian as well as to assess reliability and validity of the translation. Methods. The translation and cultural adaptation of the IPS?Anxiety and IPS?Avoidance was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Reliability testing, factor analysis and validation of Serbian translation of IPS-Anxiety and IPS-Avoidance were carried out on a sample of 485 students of pharmacy, or medicine at the University of Kragujevac, Serbia. Results. Serbian translation of IPS-Anxiety and IPSAvoidance demonstrated high internal consistency with Cronbach?s alpha of 0.934 for IPS-Anxiety and 0.911 for IPS-Avoidance. Factor analysis of IPS-Anxiety showed that there are two domains, which we have called as Direct Experience (9 items) and Indirect Experience (9 items); factor analysis of IPS-Avoidance also pointed out on two domains referring to direct and indirect fear of injections. Female students scored higher on the scale showing more extensive injection phobia than male students. It is also interesting that students of pharmacy have higher level of injection phobia than students of medicine, and those students of the fifth year of study feel more fear of injections than students from the first four years. Conclusion. Serbian translation of IPS-Anxiety and IPS-Avoidance showed good psychometric properties on population consisted of students medicine and pharmacy.
Background/Aim. Inappropriate prescribing of antibiotics to the patients with acute bronchitis is frequent event in clinical practice with potentially serious consequences, although majority of treatment guidelines do not recommend it. The aim of this study was to reveal risk factors associated with inappropriate prescribing of antibiotics to the patients with acute bronchitis in primary healthcare. Methods. This case/control study included the adult patients with acute bronchitis during the initial encounter with a general practitioner. Prescription of an antibiotic was an event that defined the case, and patients without prescribed antibiotic served as controls. Results. Antibiotics (mostly macrolides and beta-lactams) were prescribed to the majority of patients with diagnosis of acute bronchitis (78.5%). A significant association was found between antibiotic prescription rates and patient age, whether an attending physician is a specialist or not and the average number of patients a physician sees per day [ORadjustedwas 1.029 (1.007?1.052), 0.347 (0.147?0.818) and 0.957 (0.923?0.992), respectively]. Conclusion. When there is primary care encounter with patients suffering from acute bronchitis, older patients are more likely to receive inappropriate antibiotic prescription, especially if their physician is without specialist training and has less patient encounters in his/her office daily.
Background/Aim. After having established an indication for surgery, some patients experience sense of fear, unpleasantness and embarrassment due to the expectance of adverse consequences of surgical intervention. Recently an instrument for measuring fear of surgery – the Surgical Fear Questionnaire (SFQ) was developed and validated on a sample of Dutch patients awaiting surgery. The objective of this study was to translate the SFQ to Serbian language, make cultural adaptation of the translation and test its reliability and validity in a sample of outpatients in Serbia. Methods. The SFQ was translated and adapted according to the accepted international standards (double forward translation, harmonization, backward translation, and piloting). The study was multicentric, involving patients from 7 cities in 3 countries: Serbia, Montenegro, Bosnia and Hercegovina. It was conducted at state-owned health facilities. The sample was of consecutive nature and consisted of 330 outpatients who visited specialists of either internal medicine or general surgery. Results. Translated SFQ showed excellent reliability, both when rated by the investigators (Cronbach’s alpha 0.915), and by the patients themselves (Cronbach’s alpha 0.917). It is temporally stable, and both divergent and convergent validity tests had good results. Factorial analysis revealed one domain on the whole study sample and two domains like in original on the subsample of patients without experience with surgery in general anesthesia. Conclusion. Identification of patients with high level of fear of surgery by this questionnaire should help clinicians to administer measures which may decrease fear and prevent avoidance of absolutely necessary surgery by such patients.
Pandrug-Resistant Pseudomonas Aeruginosa Isolated from Qualitative Endotracheal Aspirate Could Rather be Contaminant than Causative Agent of Respiratory Infections in Intensive Care Unit Patients: Case Study A Slobodan M. Janković1,2, Zorana М. Đorđević2, Danijela B. Jovanović2, Tatjana V. Vulović1,2 A 1 Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia 2 Clinical Center Kragujevac, Serbia
Considering that a small number of drugs are completely safe for use during pregnancy, the right choice and adequate risk assessment are extremely important. The aim of this study was to analyze factors associated with the estimation of high teratogenic risk (as judged by clinical pharmacologist) in pregnant females who were prescribed anti-infective drugs or mild analgesics. A cross-sectional study included 284 pregnant women who came for an advice about teratogenic risk to clinical pharmacologist in Clinical Centre Kragujevac, Serbia during the period from 1997 to 2012. All of the included pregnant women were prescribed mild analgesics and/or anti-infective drugs during the first 3 months of pregnancy. The data were collected from patient files and by phone interviews. Clinical pharmacologists estimated the risk of teratogenicity as ìhighî in pregnant females who were using tetracyclines or propionic acid derivatives. Disorders of development reported by mothers during phone interviews were associated with cephalosporin use during the first 3 months of pregnancy, while miscarriages or abortions happened more often in women who used a tetracycline. Estimate of risk from congenital anomalies after use of drugs during pregnancy, which makes clinical pharmacologists as part of their routine healthcare services, depends on the amount of published data about previous experiences with specific drugs during the first 3 months of pregnancy.
Introduction: Between 30 to 59% of patients with migraine without aura are undiagnosed and improperly treated, because primary care physicians are either too busy or unfamiliar with criteria for diagnosing migraine. Aim: The aim of our study was to translate the Migraine Screen Questionnaire (MS-Q) to BHS (Bosnian/Croatian /Serbian) language and to test reliability and validity of the translation on a sample of primary care patients. Material and Methods: The study was designed as cross-sectional, multi centric, diagnostic accuracy trial of an instrument for screening patients who visit general practitioners, with an aim to reveal migraine without aura. The instrument was the MS-Q, originally written in English and validated in Spanish population, and in this study being translated to BHS language. Results: Translation of the MS-Q to BHS language showed good diagnostic accuracy (sensitivity 80.0% and specificity 87.2%) and reliability (Cohen kappa 0.648) for migraine without aura, with significant screening yield among previously undiagnosed patients of 72.7%. The study also confirmed high percentage of patients with hidden MWA (52.9%) revealed by the MS-Q and ICH criteria that would otherwise remain undiagnosed. Conclusion: The MS-Q translation to BHS language could be considered as valid and reliable clinical instrument for revealing migraine without aura, similar by its performance to original questionnaire. It has considerable screening yield, discovering majority of patients with previously undiagnosed migraine without aura, whose definite diagnosis should later on be confirmed by the attending physicians using the ICH criteria.
Abstract Potentilla reptans is a little studied plant of the genus Potentilla, the family Rosaceae. The aim of this study is to determine antimicrobial effects of aqueous extracts of P. reptans aerial part and rhizome against standardized bacterial strains. The antimicrobial activity of aqueous extracts of P. reptans aerial part and rhizome was tested against one fungus, Candida albicans, and two standard bacterial strains, Staphylococcus aureus and Escherichia coli, using an agar diffusion method. Both examined extracts showed a significant antimicrobial activity against Escherichia coli and Staphylococcus aureus at the concentrations of 10 to 150 mg/ml. The rhizome extract showed stronger antimicrobial effect against the tested strains of bacteria than the aerial part extract. The obtained results represent preliminary results of antimicrobial activity of this plant and suggest that in future, the studies should examine antimicrobial activity against other bacterial strains and minimum inhibitory concentration.
Abstract 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.
Title of Days of AMNuBiH 2018” and “SWEP 2018” is “Ethical Dilemmas in Science Editing and Publishing”. Why? If one wants to create a scientific work, must have on his mind that creating a scientific work requires creativity and openness, honesty, trust, and obeying the ethical principles for writing a scientific paper. While working on a an biomedical research involving human subjects medical workers should have on mind that it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
ABSTRACT Introduction: Recipients of hematopoietic stem cell transplantation (HSCT) are exposed to numerous drugs in both pre- and post-transplantation period, which creates an opportunity for drug–drug interactions (DDIs); if clinically relevant DDIs happen, the risk of adverse treatment outcomes is increased. Areas covered: This review is focused on DDIs in recipients of HSCT that were observed and published as clinical trials, case series or case reports. Relevant publications were found by the systematic search of the following online databases: MEDLINE, SCOPUS, EBSCO, and SCINDEX. Expert opinion: The most important DDIs involve cytostatic or immunosuppressant drug on one side, and antimicrobial drugs on the other. The majority of clinically relevant interactions have pharmacokinetic character, involving drug metabolizing enzymes in the liver. Antifungal azoles inhibit metabolism of many cytostatic and immunosuppressant drugs at cytochromes and increase their plasma concentrations. Macrolide antibiotics and fluoroqunolones should be avoided in HSCT recipients, as they have much larger potential for DDIs than other antibiotic groups. HSCT recipients increasingly receive new immunomodulating drugs, and further observational studies are needed to reveal unsuspected DDIs with clinical relevance.
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