Background/Aim. Despite the widespread use of procalcitonin, C-reactive protein (CRP), and soluble CD14 subtype (sCD14-ST), their diagnostic accuracy in children with sepsis is not yet clear. The aim of the study was to establish and compare the diagnostic accuracy of procalcitonin, CRP, and sCD14-ST in children admitted to the hospital under suspicion of having sepsis. Methods. The study was designed as a retrospective cross-sectional study on children admitted to the Pediatrics Clinic in Kragujevac, Serbia, under suspicion of sepsis, during a 6-month period. Diagnostic accuracy was tested by the construction of receiver operating characteristic (ROC) curves and their comparison in terms of area under the curve (AUC). Results. Procalcitonin had the largest AUC [0.75; 95% confidence interval (CI) 0.63?0.88], followed by CRP (0.68; 95% CI 0.54?0.81) and sCD14-ST (0.65; 95% CI 0.52 ? 0.79). Differences between the areas under the ROC curves were not significant (CRP vs. procalcitonin z = 1.054, p = 0.291; CRP vs. sCD14-ST z = 0.238, p = 0.812; procalcitonin vs. sCD14-ST z = 1.089, p = 0.286). Conclusion. Our study showed relatively low sensitivity and moderate specificity of procalcitonin, C-reactive protein and sCD14-ST in diagnosing sepsis among children, as well as similar diagnostic accuracy of the three biomarkers.
Background/Aim. The Headache Under-Response to Treatment (HURT) questionnaire and the Migraine Disability Assessment Test (MIDAS), which are intended for assessing the headache-related disability, impact (MIDAS) and management (HURT), were not yet translated to Serbian and validated in the population of Serbia. The aim of this study was to translate the HURT and MIDAS from English to Serbian, to make necessary cultural adaptations and to test their psychometric properties in a sample of outpatients with the headache. Methods. The HURT and MIDAS questionnaires were translated and adapted according to the internationally accepted guidelines, and then tested on a sample of Serbian patients with various headache types. Internal consistency was checked through the calculation of Cronbach?s alpha for the questionnaires, and by correlation of each question with the corrected total score. The criterion validity of the translation was tested by correlating scores of individual items, domains and whole questionnaire with the headache characteristics (severity, duration, frequency), and convergent validity was tested by correlating the abovementioned scores with results of an instrument for measurement of headache-related quality of life. Results. There were 171 (79.2%) females and 45 (20.8%) male study participants. The mean age of the patients was 42.3 years, (standard deviation ? SD 13.35; range 18?75); 27 (12.5%) suffered from a migraine and 189 (87.5%) from the episodic tension-type headache (TTH). The Serbian translation of HURT and MIDAS questionneires showed excellent internal consistency, with high values of the Cronbach?s alpha: 0.764 and 0.731, respectively. The validity of the instruments in all aspects (criterion, convergent and discriminant validity) was also excellent for the whole sample and for the subgroup of patients with TTH, while the results for the patients with the migraine were less favorable. The factor analysis suggested the existence of one domain of MIDAS and two domains of HURT questionneires. Conclusion. The Serbian translations of HURT and MIDAS could be used as the reliable and valid specific instruments for measuring a headache-related disability, impact (MIDAS) and management (HURT) in the patients with TTH and probably in the patients with the migraine.
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. Nausea after oral administration of iron is frequent phenomenon (11% of patients) and it is believed to be consequence of accumulation of free radicals in mucosa of gastrointestinal tract. The aim of our study was to measure the extent of nausea in outpatients taking oral supplementation with iron, and to investigate possible factors that may have an influence on it. Methods. The study was of the cross-sectional type, and conducted on a sample of outpatients on oral iron supplementation. The sample was consecutive, including all patients coming to a community pharmacy for oral iron supply during the study period. Frequency and severity of nausea were measured by the 5- item Drug-Induced Nausea Scale (DINS). Results. The mean score of the DINS from the sample of 128 patients was 8.56 ? 5.07 (range from 5 to 25). Each additional cup of coffee per week increased the DINS score for 0.143 points, the history of gastrointestinal disease had protective effect and decreased the DINS score for 5.923 points. Conclusion. Frequency and severity of oral iron-induced nausea are not dependent on oral iron burden, but rather on coffee intake and previous experience of patients with symptoms of gastrointestinal diseases. Modification of diet and education about types and severity of symptoms of gastrointestinal diseases could be useful preventive measures to avoid or at least mitigate oral iron-induced nausea and/or vomiting.
Introduction: A gap between evidence-based recommendations for prescribing antipsychotics and its implementation in practice could be overcome by local guidelines. Aim: The aim of our study was to locally adapt the national guideline for schizophrenia and evaluate its impact on prescribing practice as well as on clinical and humanistic outcomes in a long-stay psychiatric hospital Dobrota in Kotor, Montenegro. Subjects and Methods: This was academic, prospective, IV phase interventional study, which measured outcome before and after investigators intervention within healthcare system. The study was conducted in two six-months phases separated by implementation of the local guidelines. Prescribing practices and treatment outcomes were monitored in both phases of the study. Results: Study included 111 patients. Although the guidelines did not infl uence total volume of prescribed antipsychotics, social functioning and environmental aspects of quality of life were improved. Conclusions: Writing and adopting the guidelines for local use might be associated with some benefi t in humanistic outcomes, but multi-faceted intervention should be considered in order to achieve more substantial impact on prescribing practices and clinical outcomes.
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.
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.
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.
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 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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