Ivana Tadic

Validation of the osteoporosis quality of life questionnaire QUALEFFO-41 for the Serbian population

BackgroundVertebral fractures could lead to reduced physical, social and mental functioning, and loss of personal independence. Therefore, during the treatment of osteoporosis, it has become necessary to examine the changes in everyday functioning, well-being and health related quality of life (HRQOL). To that effect, this study aims to translate, culturally adapt, and validate the Serbian version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) for patients with vertebral fractures.MethodsNine female patients with osteoporosis participated in the pre-validation study. A validation, case–control study included two groups of female patients: one that consisted of 50 female patients with osteoporosis, and with at least one vertebral fracture, and another one that consisted of 50 control patients with osteoporosis but without fractures. They completed the QUALEFFO-41 and the EuroQol group questionnaire with five dimensions (EQ-5D) twice within a month. The validation study examined internal consistency, concurrent validity, test-retest reliability, sensitivity and specificity.ResultsDuring the pre-validation study, three of the items in the QUALEFFO-41 were slightly changed. Afterwards, during the validation study, the statistically significant differences (adjusted for: age, duration of menopause, current employment and marital status) in the mean values of all domains and total scores between the groups were noted. For the case group, the internal consistency of the QUALEFFO-41 domains and of total questionnaire was above 0.70. The test-retest reliability was tested by the intraclass correlation coefficients (ICC) that were in range 0.87 – 0.96 for the case, and 0.15 – 0.83 for the control group. Correlations between the total scores of the QUALEFFO-41 and the EQ-5D health state value, for both groups were negative and statistically significant (r = -0.78, p<0.001 and r = -0.73, p<0.001, respectively). The QUALEFFO-41 had a better prediction of the value of HRQOL of cases compared to the generic questionnaire EQ-5D (the AUC difference was 0.099, p = 0.013).ConclusionsThe Serbian QUALEFFO-41 version is reliable, valid, sensitive and predictive for examinations of HRQOL in patients with prevalent vertebral fractures and can be used in further studies.

Translation and factor analysis of structural models of Edinburgh Postnatal Depression Scale in Serbian pregnant and postpartum women – Web-based study

BACKGROUND The Edinburgh Postnatal Depression Scale (EPDS) is well accepted for detecting symptoms of postnatal depression. The aim of this study was to examine psychometric properties and to evaluate structural models of the Serbian translation of EPDS in pregnant and postpartum women. METHODS The original English version of the EPDS was translated into Serbian, and checked by means of back-translation. Data were collected via an anonymous online questionnaire posted on a Serbian website devoted to pregnancy topics. The study sample included 201 women (76 pregnant, 125 postpartum). The internal consistency of the scale was measured by Cronbachs α coefficient. Principal component analysis was used to determine scale dimensions while confirmatory factor analysis was used to evaluate model fit. FINDINGS Cronbach α coefficient was 0.84 and 0.83 in pregnant and postpartum women, respectively, which indicated good internal consistency of the Serbian EPDS. Three dimensions of the scale were revealed in both groups of women. Goodness of fit indices described good and excellent model in pregnant and postpartum women, respectively. High level of depression symptoms (score ≥13) was recorded in 27.6% and 24.8% (p>0.05) of pregnant and postpartum women, respectively. Moderate level of depression symptoms (score 10-12) was recorded in 21.1% and 16.8% (p>0.05) of pregnant and postpartum women, respectively. CONCLUSION The Serbian translation of the EPDS showed good consistency and good model characteristics in pregnant and postpartum women. However, cut-off values, sensitivity and specificity of the scale should be determined in the further studies with more representative samples of women.

Are antidepressants effective in quality of life improvement among children and adolescents? A systematic review

There is some evidence indicating that psychotropic medications might lead to health-related quality of life (QOL) improvements among children and adolescents with psychiatric disorders. The aim of this systematic review is to assess evidence regarding whether antidepressant treatment improves QOL among children and adolescents with depressive or anxiety disorders. A comprehensive search resulted in 5 clinical trials to be included in this review: 4 trials with major depressive disorder (MDD) and 1 trial with social anxiety disorder (SAD). In one MDD trial, fluoxetine combined with cognitive behavior therapy (CBT) significantly improved QOL compared to fluoxetine or CBT alone (effect sizes were 0.53 and 0.69, respectively). In 2 combined trials, sertraline alone significantly improved QOL among adolescents with MDD (effect size was 0.29), but not among children with MDD. Essentially, it was observed that antidepressants in these trials had minor positive effects on QOL improvement, which were lower than their potential to improve depressive symptoms. Although fluoxetine with CBT or sertraline monotherapy were shown to have some potential to improve QOL, this systematic review found inconclusive evidence that antidepressant treatments improve QOL among children and adolescents with depressive or anxiety disorders. More research is required, considering that QOL is currently under-evaluated in clinical trials with antidepressants among children and adolescents and available trials have limited methodological quality when reporting QOL data.

Development of a Shorter Version of the Osteoporosis Knowledge Assessment Tool

The aim of the authors of this study was to develop a short version of the Osteoporosis Knowledge Assessment Tool to be used for the target population of young adult Serbian females as an easily implemented add-on questionnaire. The 20-item Osteoporosis Knowledge Assessment Tool was translated and culturally adapted using the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures. The validation study was conducted on a sample of 250 female students studying at the Faculty of Pharmacy at the University of Belgrade, during a two-month period (November–December 2010). The difficulty index, item-total correlations, and internal consistency were calculated first. Afterward, confirmatory factor analysis was applied to test the structure of the Osteoporosis Knowledge Assessment Tool models and develop a short version. The mean total Osteoporosis Knowledge Assessment Tool score was 8.31 (possible range 0–20). The confirmatory factor analysis fit indices indicated poor fit of the data to the originally hypothesized structure. The confirmatory factor analysis fit indices, difficulty indices, and content validity allowed trimming of the original model and development of a short version with nine items. The average chi-square value for the Osteoporosis Knowledge Assessment Tool short version was 31.79 (p = 0.240, SE = 0.176) with Bollen–Stine bootstrap p = 0.249, Tucker–Lewis Index = 0.925, Comparative Fit Index = 0.944 and Root Mean Square Error of Approximation = 0.027. The Osteoporosis Knowledge Assessment Tool thus had acceptable characteristics and may be used for osteoporosis knowledge assessment.

Patients’ willingness to pay for cognitive pharmacist services in community pharmacies

Aim To determine the general population willingness to pay for cognitive pharmacist service in community pharmacy, describe the behavior of participants regarding health care issues, and evaluate correlation between participants’ sociodemographic characteristics or attitudes and their willingness to pay. Methods A questionnaire-based survey was conducted among general population visiting community pharmacies. The participants were asked about receiving cognitive pharmacist services to identify and resolve potential medication therapy problems after the initiation of a new medicine to optimize health outcomes of the patients. A univariate and multivariate analysis were used to analyze associations between different variables and willingness to pay for pharmacy service. Results Of 444 respondents, 167 (38%) reported that they were willing to pay for a medication management service provided in the community pharmacy. Univariate analysis showed significant association between the willingness to pay for pharmacist-provided service and respondents’ socio-demographic factors, health-related characteristics, and behavior, dilemmas, or need for certain pharmacist-provided service. The logistic regression model was statistically significant (χ2 = 4.599, P < 0.001). Conclusions The respondents expressed their willingness to pay for cognitive pharmacist services, which has not been fully recognized within the health care system. In future, pharmacists should focus on practical implementation of the service and models of funding.

Clinical and Economic Outcomes of New Oral Anticoagulants in Orthopaedics

Abstract Venous thromboembolism, including pulmonary embolism and deep vein thrombosis, is a significant factor in morbidity and mortality of patients. New oral anticoagulants, such as apixaban, dabigatran, and rivaroxaban, have recently demonstrated their safety and efficacy in patients undergoing major orthopaedic surgery. Selection of the appropriate drug should be adjusted according to patient needs. Major bleeding is rare with new oral anticoagulants and is comparable with the bleeding rate associated with low-molecular-weight heparins. Clinical data indicate that therapy with apixaban and rivaroxaban was more effective compared to enoxaparin, while dabigatran has a similar efficacy to enoxaparin. Cost-effectiveness studies of new oral anticoagulants showed that these medicines offer higher efficacy with acceptable costs for the healthcare system, even saving costs in certain cases. Clinical practice in Serbia reflects considerably more frequent use of traditional anticoagulant medication therapy compared to new oral anticoagulants.

New drugs for osteoporosis therapy: a review of the clinical trials phase 2 and 3

SUMMARY Osteoporosis is a chronic disease with increasing incidence that predominantly occurs in female population. There are evidences that bisphosphonates, selective estrogen receptor modulators, denosumab, teriparatide and strontium renalate, prevent vertebral fractures while alendronate, risedronate, zoledronic acid, denosumab and strontium renalate prevent hip fractures. Although these drugs are effective in osteoporosis treatment, their use is limited by their side-effects and low-adherence. The aim of this review article was to compare efficacy of new drugs for osteoporosis currently in phase 2 and 3 clinical trials. After reviewing 57 articles available on PubMed and Scopus databases that evaluated efficacy of osteoporosis medications, 10 papers, that fulfilled the review criteria, were selected for the analysis. Finally, the efficacy of five drugs was compared. Efficacy was evaluated by the values of bone mineral density (BMD) and bone turnover markers (BTM). In all the analyzed articles the BMD increased and changes of BTM were noted. The highest increase of lumbar BMD from the baseline values was achieved after six months of subcutaneous application of 20 μg/day teriparatide (11.3%). The lowest increase of BMD in the same region was recorded after six months of risedronate therapy 100 mg per os once monthly (2.1%). From ten selected articles, only one has reported data about fracture risk. Sažetak Osteoporoza je hronična bolest koja je sve više zastupljena i to pretežno kod osoba ženskog pola. Postoje dokazi da bisfosfonati, selektivni modulatori estrogenskih receptora, denosumab, teriparatid i stroncijum ranelat mogu da preveniraju prelom kuka. Iako su ovi lekovi efikasni u lečenju osteoporoze, njihova upotreba je ograničena usled ispoljavanja neželjenih reakcija, a time i postojanja niske adherencije bolesnika. Cilj ovog preglednog rada bio je upoređivanje efikasnosti novih lekova za lečenje osteoporoze koji su trenutno u 2. i 3. fazi kliničkih istraživanja. Nakon pregleda 57 originalnih radova koji su imali za cilj da pokažu efikasnost lekova u lečenju osteoporoze, dostupnih na PubMed i Scopus bazi, za analizu je odabrano 10 radova koji su zadovoljili kriterijume za pretraživanje. Na kraju analize, poređena je efikasnost pet lekova. Efikasnost je evaluirana na osnovu vrednosti mineralne koštane gustine (BMD) i koštanih markera (BTM). Povećanje BMD vrednosti i promene u vrednostima BTM zabeležene su u svim radovima. Najveće povećanje BMD (za 11,3%) lumbalnog skeletnog regiona postignuto je nakon šestomesečne subkutane terapije teriparatidom u dozi 20 μg dnevno. Najmanje povećanje BMD (za 2,1%) istog skeletnog regiona zabeleženo je nakon šestomesečne per os terapije risedronatom u dozi od 100 mg jednom mesečno. Od deset analiziranih studija, samo je jedna prikazala podatke o riziku od frakture.

Do we inform/educate patients well about warfarin therapy?

Aim of study Health literacy concerns the knowledge and competences of an individual person that are necessary for adequate response to information about health(care). Health literacy is strongly associated with educational level and overall literacy. Previous research has shown low (health) literacy to be associated with poor adherence, increased health consumption and poor health outcomes. The assumption of health care providers that their patients can read, understand and respond adequately to the instructions found on prescription drug labels may (sometimes) be unfounded. The aim of this study was to assess understanding of drug label instructions in different (non-native) populations living in the Netherlands. Method Four different populations living in the Netherlands were studied: people born in Iran, Turkey, the (former) Antilles and Surinam (Hindustani). Participants were recruited at meeting places for a particular ethnic group (mosques, cultural centres). Only people with sufficient comprehension of the Dutch language were included (tested by a short screening questionnaire on literacy skills). First year pharmacy students, who were born in the Netherlands, were included as reference group. All participants completed a survey with questions about the correct interpretation of 4 drug label instructions, with instructions like “Complete the prescribed course (antibiotics prescribed for 7 days)” and “Take 1 tablet as needed, maximal 6 tablets a day (acetaminophen)”. For correct interpretations of the instructions presented in the survey experts of the university (staff members, practicing pharmacists) and the Royal Dutch Pharmacist Association were consulted. Results In total, 180 Iranian, 188 Turkish, 168 Antillean, 155 Hindustani born in Suriname and 153 Dutch (reference) participants were included in the study. Some drug label instructions were misunderstood; misunderstanding of instructions occurred both in non-natives and Dutch natives (3 out of 4 labels were misunderstood by the majority of participants), but non-natives had more often problems with the instructions. For example, the instruction “Complete the prescribed course (antibiotics prescribed for 7 days)” was more often correctly answered (use the drugs for 1 week) by the Dutch reference group (95.4 %) compared to the other groups: Iranian (80.6 %), Turkish (88.3 %), Hindustani (91.6 %) and Antillean (81.0 %) participants (p

Analysis of the consumption of dietary supplements for weight loss

BACKGROUND/AIM Overweight and obesity may lead to a large number of health problems. Prevention and adequately timed treatment can lead to successful body mass regulation. The aim of the study was to analyze body mass index (BMI) of the examinees, usage of dietary supplement for weight loss (DSWL) by gender and particular products, types of information source and types of information about DSWL which provide doctors and pharmacists. METHODS The survey was conducted in the region of the town of Nis. The survey was carried out among a random sample of 505 participants, 243 men and 262 women, older than 15 years. The tool used was a questionnaire. RESULTS . There is a positive association between aging and BMI. DSWL are used by 20.39% of the examinees. The most of the examinees that use DSWL were overweight and used it for esthetic reasons. Before the use of DSWL, women usually practice diets and men practice fluid consumption. Television is the most important source of information about DSWL. Health care professionals mostly provide information about DSWL consumption (64.08%), and only a third of them provide all the information (usage, eating regime, fluid consumption, and physical activity). CONCLUSION The prevalence of obesity emphasizes the need for concentrated efforts to prevent obesity in the early age. The only way to reduce the risk of DSWLs misuse is providing all of the necessary information by the health care professionals. As pharmacists are in the direct contact with patients they have the most important role in rational and effective use of DSWL.