Cytisine Versus Varenicline for Smoking Cessation in a Primary Care Setting: A Randomized Non-inferiority Trial.

INTRODUCTION: A smoking-cessation program was implemented as a randomized non-inferiority trial in primary care practices in Croatia and Slovenia to investigate whether a standard 4-week treatment with cytisine was at least as effective and feasible as a standard 12-week treatment with varenicline in helping smokers quit. AIMS AND METHODS: Out of 982 surveyed smokers, 377 were recruited to the non-inferiority trial: 186 were randomly assigned to cytisine and 191 to varenicline treatment. The primary cessation outcome was 7-day abstinence after 24 weeks, while the primary feasibility outcome was defined by adherence to the treatment plan. We also compared the rates of adverse events between the two treatment groups. RESULTS: The cessation rate after 24 weeks was 32.46% (62/191) in the varenicline group and 23.12% (43/186) in the cytisine group (odds ratio [OR]: 95%, credible interval [CI]: 0.39 to 0.98). Of 191 participants assigned to varenicline treatment 59.16% (113) were adherent, while 70.43% (131 of 186) were adherent in the cytisine group (OR: 1.65, 95% CI: 1.07 to 2.56). Participants assigned to cytisine experienced fewer total (incidence rate ratio [IRR]: 0.59, 95% CI: 0.43 to 0.81) and fewer severe or more extreme adverse events (IRR: 0.72, 95% CI: 0.35 to 1.47). CONCLUSIONS: This randomized non-inferiority trial (n = 377) found the standard 4-week cytisine treatment to be less effective than the standard 12-week varenicline treatment for smoking cessation. However, adherence to the treatment plan, ie, feasibility, was higher, and the rate of adverse events was lower among participants assigned to cytisine treatment. IMPLICATIONS: The present study found the standard 12 weeks of varenicline treatment to be more effective than the standard 4 weeks of cytisine treatment for smoking cessation in a primary care setting in Croatia and Slovenia. Participants assigned to cytisine, however, had a higher adherence to the treatment plan and a lower rate of adverse events. Estimates from the present study may be especially suitable for generalizations to high-smoking prevalence populations in Europe. Given the much lower cost of cytisine treatment, its lower rate of adverse events, and higher feasibility (but its likely lower effectiveness with the standard dosage regimen), future analyses should assess the cost-effectiveness of the two treatments for health policy considerations.

Smokers' Characteristics Associated with Successful Smoking Cessation Undergoing Pharmacotherapy in Slovenia.

Introduction: Tobacco use is a major global health problem, contributing to premature death and disability. In Slovenia, the prevalence of smoking is higher than the EU average, emphasizing the need for effective tobacco control measures. The aim of this study was to identify the characteristics of patients most likely to benefit from pharmacotherapy for smoking cessation. Methods: We performed cross-sectional analysis of factors associated with successful smoking cessation using pharmacotherapy for Slovenian smokers. A total of 176 (24.6%) smokers with an average age of 50 years agreed to receive pharmacotherapy for their smoking cessation attempt and were enrolled in the study. Participants were followed up at 4-week intervals during treatment and for 24 weeks after completion of pharmacotherapy. Results: Attempts to quit smoking with prescription medications were successful in 24.4% of those willing to try. Female smokers, older persons, those with more children, with a lower self-perception of health, a higher number of cigarettes per day and a higher nicotine dependence were more likely to attempt to quit smoking. However, the strongest predictors of smoking cessation success were lower nicotine dependence, which was tested using the Fagerström test for nicotine dependence, and higher adherence to pharmacotherapy. Conclusion: Nicotine dependence and adherence to pharmacotherapy are the strongest predictors of a successful smoking cessation attempt. Identification of potential responders, prescription of pharmacotherapy and follow-up are applicable in the primary healthcare setting.

Fatigue Among Family Medicine Physicians in Slovenia.

Background: Different authors define fatigue in different ways even though it is considered a very common symptom in the primary medical care. Objective: To explore level of fatigue among Slovene family physicians and factors contributing to fatigue. Methods: Modified Fatigue Impact Scale was used in our research. The link to the questionnaire website was sent through the mailing list of Medical Chamber of Slovenia, the Family Medicine Union - Praktik.um, the Family Medicine Association and the Young Physicians. Results: 231 physicians answered the questionnaire in full. There were 180 (77.9%) females and 51 (22.1%) males. The average age was 45.3±10.4 years and their capitation amounted to averagely 2245.8±544.2. On average they had spent 13.1±11.3 years working as specialists. Women have significant higher levels of fatigue, 57.2% have scored above the threshold of 38 points. Working in the office after working hours at least three times in a week was significantly associated with total fatigue, adding 10.07 points to the score. The years working as a specialist is not an important statistical factor in differentiating fatigue among physicians, nor is the level of patient load. Working irregular hours is also not an important statistical factor. Conclusion: Slovenian family physicians are tired, as they have exceeded the limit given in the literature. Women are more tired, the most characteristic factor that contributes to fatigue is the extension of work in the clinic at least three times a week.

Development of an Algorithm for Determining of Genetic Risk at the Primary Healthcare Level - A New Tool for Primary Prevention: A Study Protocol.

INTRODUCTION: Family history (FH) is an important part of the patients' medical history during preventive management at model family medicine practices (MFMP). It currently includes a one (or two) generational inquiry, predominately in terms of cardiovascular diseases, arterial hypertension, and diabetes, but not of other diseases with a probable genetic aetiology. Beside family history, no application-based algorithm is available to determine the risk level for specific chronic diseases in Slovenia. METHODS: A web application-based algorithm aimed at determining the risk level for selected monogenic and polygenic diseases will be developed. The data will be collected in MFMP; approximately 40 overall with a sample including healthy preventive examination attendees (approximately 1,000). Demographic data, a three-generational FH, a medical history of acquired and congenital risk factors for the selected diseases, and other important clinical factors will be documented. RESULTS: The results will be validated by a clinical genetic approach based on family pedigrees and the next-generation genetic sequencing method. After the risk of genetic diseases in the Slovenian population has been determined, clinical pathways for acting according to the assessed risk level will be prepared. CONCLUSION: By means of a public health tool providing an assessment of family predisposition, a contribution to the effective identification of people at increased risk of the selected monogenic and polygenic diseases is expected, lessening a significant public health burden.

Characteristics of Elderly Frequent Attendees in Slovene Family Medicine Practices - a Cross-sectional Study.

INTRODUCTION: Frequent attendance in family medicine practices is associated with elderly patients and those with chronic diseases. Longstanding frequent attendees have more social and psychiatric problems, medically unexplained conditions, and chronic diseases, and are prescribed more psychotropic drugs and analgesics. AIM: To fill the lack of data on the factors associated with frequent attendance at family medicine practices by the elderly. METHODS: Forty family physicians (FPs) participated in this cross-sectional study in 2017 and randomly recruited up to 20 of their patients; 624 patients were recruited. From the patients' health records, the FPs collected demographic data, lifestyle factors, all the patients' diagnoses, all the drugs prescribed in the previous 12 months, multi-morbidity (CIRS-G index), the quality of life index (EQ-5D) and the number of visits to the family medicine practice in the previous 12 months. The Self-Rating Depression Scale was administered to the patients. Statistical analysis was carried out using the IBM SPSS 20.0 package, with appropriate non-parametric tests (Mann-Whitney U test, chi-square test) to check significant differences between groups of patients. Multivariate modelling was carried out to evaluate the associations between the number of visits to the FP and independent variables. RESULTS: The number of prescribed drugs (p=0.026), haematological problems (p=0.005) and genitourinary problems (p=0.001) were associated with frequent attendance. Patients with borderline depression were approximately three times more likely to be frequent attendees than non-depressed patients. CONCLUSION: Polypharmacy, haematological and genitourinary problems are associated with frequent attendance in elderly patients. Further longitudinal studies are required to validate our findings.

Impact of demographic factors on recognition of persons with depression and anxiety in primary care in Slovenia.

BACKGROUND: Research has repeatedly shown that family physicians fail to diagnose up to 70% of patients with common mental disorders. Objective of the study is to investigate associations between persons' gender, age and educational level and detection of depression and anxiety by their family physicians. METHODS: We compared the results of two independent observational studies that were performed at the same time on a representative sample of family medicine practice attendees in Slovenia. 10710 patients participated in Slovenian Cross-sectional survey and 1118 patients participated in a first round of a cohort study (PREDICT-D study). Logistic regression was used to examine the effects of age, gender and educational level on detection of depression and anxiety. RESULTS: The prevalence of major depression and Other Anxiety Syndrome (OAS) amongst family practice attendees was low. The prevalence of Panic Syndrome (PS) was comparable to rates reported in the literature. A statistical model with merged data from both studies showed that it was over 15 times more likely for patients with ICD-10 criteria depression to be detected in PREDICT-D study as in SCS survey. In PREDICT-D study it was more likely for people with higher education to be diagnosed with ICD-10 criteria depression than in SCS survey. CONCLUSION: People with higher levels of education should probably be interviewed in a more standardized way to be recognised as having depression by Slovenian family physicians. This finding requires further validation.

Anticholinergic Burden and Most Common Anticholinergic-acting Medicines in Older General Practice Patients.

INTRODUCTION: Anticholinergic burden in older adults has been correlated with cognitive decline, delirium, dizziness and confusion, falls and hospitalisations. Nevertheless, anticholinergic-acting medications remain commonly prescribed in up to a third of older adults in primary care population. Our aim was to study the anticholinergic burden in older adults in Slovenian ambulatory setting and explore the most commonly involved medications which could be avoided by the physicians. METHODS: A cross-sectional study was conducted in 30 general practices in Slovenia as part of a larger trial. Data on prescribed medications were collected for randomly chosen adults of over 65 years of age visiting general practice, who were taking at least one regularly prescribed medication. Anticholinergic burden was calculated using Duran's scale and Drug Burden Index. RESULTS: Altogether, 622 patients were included, 356 (57.2%) female, average age of 77.2 (±6.2), with an average of 5.6 medications. At least one anticholinergic medication was present in 78 (12.5 %) patients. More than half (N=41, 52.6%) of anticholinergic prescriptions were psychotropic medications. Most common individual medications were diazepam (N=10, 1.6%), quetiapine (N=9, 1.4%) and ranitidine (N=8, 1.3%). CONCLUSIONS: Though the prevalence of anticholinergic medications was low compared to international research, the most commonly registered anticholinergic prescriptions were medications that should be avoided according to guidelines of elderly prescriptions. It would be probably clinically feasible to further decrease the anticholinergic burden of older adults in Slovenian primary care setting by avoiding or replacing these medications with safer alternatives.

Nasopharyngeal Carriage of Streptococcus Pneumoniae and Serotypes Indentified among Nursing Home Residents in Comparison to the Elderly and Patients Younger than 65 Years Living in Domestic Environment.

INTRODUCTION: In Slovenia, there is little data available on pneumococcal vaccination rates and no data on asymptomatic NPCR and serotypes in the population of nursing home residents in comparison to the elderly living in domestic environment, therefore the goal was to gain these data. METHODS: A cross sectional epidemiological study was performed. Nasopharyngeal swabs from 151 nursing home residents, 150 elderly living in domestic environment, and 38 adults less than 65 years old were collected twice (in two consecutive years). The swabs were analysed for pneumococcal identification and serotyping. Patient data were collected from medical files and medical history. RESULTS: No statistically significant differences in NPCR were seen between compared groups in two consecutive years. An average NPCR in two consecutive years in nursing home residents was 1.45%, in the elderly living in domestic environment 0.85%, and in adults less than 65 years old 7.05%. Serotypes identified among nursing home residents were 6B and 9N, among the group of elderly living in domestic environment, 6A and among adults less than 65 years old, 35F, 18C and 3. Pneumococcal vaccination rates were low (3.3% in nursing home residents, 6% in the elderly from domestic environment and 0% in the group of adults less than 65 years old). CONCLUSIONS: Our data suggests that NPCR and the proportion of people vaccinated with pneumococcal vaccine among the elderly are low. We identified different serotypes in all groups, only one person was a chronic carrier (serotype 35F).

Prediction of depression in European general practice attendees: the PREDICT study.

BACKGROUND: Prevention of depression must address multiple risk factors. Estimating overall risk across a range of putative risk factors is fundamental to prevention of depression. However, we lack reliable and valid methods of risk estimation. This protocol paper introduces PREDICT, an international research study to address this risk estimation. METHODS/DESIGN: This is a prospective study in which consecutive general practice attendees in six European countries are recruited and followed up after six and 12 months. Prevalence of depression is assessed at baseline and each follow-up point. Consecutive attendees between April 2003 and September 2004 who were aged 18 to 75 were asked to take part. The possibility of a depressive episode was assessed using the Depression Section of the Composite International Diagnostic Interview. A selection of presumed risk factors was based on our previous work and a systematic review of the literature. It was necessary to evaluate the test-retest reliability of a number of risk factor questions that were developed specifically, or adapted, for the PREDICT study. In a separate reliability study conducted between January and November 2003, consecutive general practice attendees in the six participating European countries completed the risk factor items on two occasions, two weeks apart. The overall response rate at entry to the study was 69%. We exceeded our expected recruitment rate, achieving a total of 10,048 people in all. Reliability coefficients were generally good to excellent. DISCUSSION: Response rate to follow-up in all countries was uniformly high, which suggests that prediction will be based on almost a full cohort. The results of our reliability analysis are encouraging and suggest that data collected during the course of PREDICT will have a satisfactory level of stability. The development of a multi-factor risk score for depression will lay the foundation for future research on risk reduction in primary care. Our data will also provide the necessary evidence base on which to develop and evaluate interventions to reduce the prevalence of depression.

The Effects of a Web Application and Medical Monitoring on the Quality of Medication, Adverse Drug Events and Adherence in the Elderly Living at Home: a Protocol of the Study.

BACKGROUND: In more than half of elderly chronically-ill family clinic attendees, drug prescribing deviates from the internationally acknowledged STOPP/START recommendations. Our study will determine whether it is possible to improve the quality of drug prescriptions in chronically-ill elderly people living at home by regularly monitoring the prescribed drugs according to STOPP/START criteria. METHODS: The project started in 2014 and will run until 2017. Forty general practitioners (GPs) are participating in a pragmatic randomized controlled trial. From the patient register, GPs randomly selected 20 patients older than 65 years who regularly receive at least one drug and invited them to participate in the study. We will use the START/STOPP criteria to determine the (in)adequacy of drug prescribing in the elderly by a web application (WA). Expected. RESULTS: The use of the WA will be the basis of the implementation of the final version of the application into the regular family medicine practice, thereby reducing the problems of inappropriate prescribing, correct medication, polypharmacy and adherence; we will identify the stability of the factors of drug prescribing in the elderly. By comparing the test and control groups, it will be possible to distinguish which are related to the WA and which act independently.

Thermal conductivity of the porcine heart tissue.

The porcine heart was used as a model for studying the thermal changes in myocardium at cooling and re-warming during open heart surgery. A section of the heart septum was excised and tissue was cut into two similar square slices. The same shape of the tissue, cut from the surface from the upper lateral wall of the left ventricle, covered with epicardium and fat, was taken for another measurement. A thin (<0.5 mm) square thermal source of the same length of the side as the tissue samples was put between the two slices of tissue. This set was placed in the middle of two identical copper cylinders (2r=50 mm, height=55 mm) used to keep the outer side of the specimen at controlled room temperature. Thermal conductivity of the heart tissue was determined at controlled thermal power, and known difference of the temperature at the edge of the tissue and at the middle of the heater, when steady state was reached. Thermal conductivity calculated from the temperature difference and the geometry of heater and samples was 0.75 W/m.K for septal heart tissue, and 0.60 W/m.K for the lateral wall ventricle tissue with epicardium and fat.

Quality of life in patients with depression, panic syndrome, other anxiety syndrome, alcoholism and chronic somatic diseases: a longitudinal study in Slovenian primary care patients.

AIM: To analyse the correlates between the quality of life and chronic diseases and socio-demographic characteristics of patients in family medicine with a special emphasis on depression, panic syndrome, other anxiety syndrome and alcoholism. METHODS: In a longitudinal study, the data set of 516 family practice attendees recruited from 60 family practices was analysed. Depression, panic syndrome, other anxiety syndrome and alcoholism were diagnosed using appropriate diagnostic interviews. Quality of life was assessed using the SF-12 questionnaire, measuring a mental health score and a physical health score. Data about the number of chronic somatic diseases were obtained from the patients' medical records. RESULTS: Physical health score was negatively associated with higher age (ß = -0.25, p < 0.001), depression (ß = -0.20, p < 0.001) and number of chronic somatic diseases (ß = -0.10, p < 0.016) and positively associated with higher education level (ß = 0.21, p < 0.001), single marital status (ß = 0.09, p < 0.022) and better financial status (ß = 0.14, p < 0.001). Linear regression explained 31.8 % of the variance (R(2) = 0.318; p < 0.001). Similarly, mental health score was negatively associated with depression (ß = -0.45, p < 0.001) and panic syndrome (ß = -0.07, p < 0.001) and positively associated with male gender (ß = 0.10, p < 0.015) and better financial status (ß = 0.13, p < 0.001). Linear regression explained 45.5 % of the variance (R (2) = 0.455; p < 0.001). CONCLUSIONS: In family medicine, special attention should be directed to major depression, panic syndrome and number of chronic somatic diseases as they are associated with poorer quality of life.

Association of common mental disorders and quality of life with the frequency of attendance in Slovenian family medicine practices: longitudinal study.

BACKGROUND: Most research on frequent attendance has been cross-sectional and restricted to one year attendance rates. A few longitudinal studies suggest that frequent attendance is self-limiting. Frequent attenders are more likely to have social and psychiatric problems, medically unexplained physical symptoms, chronic somatic diseases (especially diabetes) and are prescribed more psychotropic medication and analgesics. RESEARCH QUESTION: To describe the attendance rates in a longitudinal study and to test if depression, panic syndrome, other anxiety syndrome, alcohol misuse and general quality of life are associated with frequent attendance in next two consecutive years. METHODS: 1118 consecutive family practice attendees, aged 18 to 75 years from randomly selected family medicine practices were recruited at baseline and followed up at 12 and 24 months. We identified frequent attenders in the top 10 centile within one year. Using a multivariate model, we ascertained if presence of common mental disorders and quality of life assessed at baseline in 2003 predict frequent attendance in 2004 and 2005. RESULTS: 40% of frequent attenders continue to be frequent attenders in the following year and 20% of the frequent attenders were so for the 24 month period. Lower physical scores on the SF-12 questionnaire were strongly associated with future frequent attendance at 12 and 24 months. There was a trend for people with greater than elementary school education to be less likely to become frequent attenders at both 12 and 24 months. For other variables these effects were less consistent. Presence of major depression, panic syndrome, other anxiety syndrome and alcohol misuse were not predictive of frequent attendance in the following two years. CONCLUSION: Low physical quality of life is strongly predictive of higher frequent attendance and similar finding was observed for people with lower educational level but further confirmatory research is required to establish this association.

The pattern of physical comorbidity and the psychosocial determinants of depression: a prospective cohort study on a representative sample of family practice attendees in Slovenia.

Objectives This study aims to present the patterns of physical comorbidity in depressed patients and factors strongly associated with depression in a representative sample of Slovenian family practice attendees.Methods Medical data was obtained for 911 general practice attendees. Of them, 221 (24.3%) were diagnosed as depressed. The depressive states of the subjects were evaluated using the Composite International Diagnostic Interview (CIDI). Physical comorbidity was assessed with a questionnaire covering the most common health problems in the Slovenian adult population. Several psycho-social factors were also analysed.Results Those variables significantly related to ICD depression were included in multivariate binary logistic regression analysis, adjusted by age, gender and education. The calculation included the chi-square, odds ratio (OR) with confidence interval (95% CI) and P-value. A P-value < 0.05 was marked as statistically significant.Conclusions There was no significant difference in the number of concurrent chronic diseases in depressed and non-depressed subjects. The risk of depression was increased by the presence of several concomitant factors. The burden of somatic co-morbidity was shown to be smaller than the impact of psychosocial determinants, which also acted as protective factors: the feeling of safety at home and the absence of problems in intimate relationships. The abuse of alcohol and drugs by a family member and current poor financial situation were strongly associated with depression. The impact of concurrent incontinence and chronic bowel disease was also important, though somewhat weaker.

Longstanding disease, disability or infirmity and depression in primary care.

CONTEXT: Current evidence suggests that depression is much more prevalent among those with chronic medical conditions compared to the general population. Depression will rank second to cardiovascular disease as a global cause of disability by 2020. With ageing of the population physicians are called upon to treat a higher percentage of patients with chronic medical illness. OBJECTIVE: To assess the prevalence and incidence of depression and likelihood for new-onset depression in patients with self-reported longstanding disease, disability or infirmity in the sample of primary care attendees. METHOD: Consecutive family medicine practice attendees aged 18 to 75 years were recruited and followed up after six months. Presence of longstanding disease, disability or infirmity was recorded. RESULTS: Prevalence of major depression was 8.9% in the group of patients reporting longstanding disease compared to 3.1% in the group without longstanding disease. Incidence of major depression after 6 months was 2.7% in the group with longstanding disease and 0.9% in the group without longstanding disease. For the patients with longstanding disease at the baseline it was almost 4 times more likely to have major depression after 6 months than for patients who did not report any longstanding disease at the baseline. CONCLUSION: The associations between longstanding disease and depression are important in primary care setting.