Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program.

BACKGROUND: Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials. OBJECTIVE: The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials. METHODS: Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants' health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation. RESULTS: Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset. CONCLUSIONS: The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. TRIAL REGISTRATION: (1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17454.

The Croatian Adult Health Cohort Study (CroHort) --background, methodology & perspectives.

Health interview surveys are important source of health information. All previous adult population-based health interview surveys in Croatia until CroHort, were one-off projects with very limited possibility of data comparison. CroHort enabled repeated survey of CAHS 2003 respondents with almost identical questionnaire, thus providing comparable data on trends of different risk factors as well as their relation to the specific outcomes. Next follow-up survey of the CroHort cohort is foreseen for 2013. Health interview survey according to Eurostat methodology (EHIS) on the new representative sample of adult Croatian population is planned for 2014. As the data from health interview surveys are valuable in health policy, efforts should be made to increase their use by policymakers in Croatia.

Five-year cumulative incidence of obesity in adults in Croatia: the CroHort study.

The objective of this paper was to evaluate the 5-year incidence of obesity on a sample of 3229 adults and investigate the potential effect of several sociodemographic and lifestyle habits on weight change and obesity incidence in these individuals. The average annual rate of increase in the prevalence of obese adults between 2003 and 2008 was 10.60% for men and 11.08% for women. Analysis showed that development of obesity in 5-year period in women in Croatia is significantly positively associated with frequent consumption of "hidden" fats of animal origin and significantly negative with each higher education level. No significant predictor of obesity has been found in men. Obesity remains a serious health problem for the Croatian population; the alarming rates of excess body weight continue to increase. Preventive measures should urgently be undertaken.

Obesity--new threat to Croatian longevity.

The aim of this study was to examine the association of weight gain and life expectancy at birth in Croatia. Mean body mass index was based on the data from the Croatian Adult Health Survey 2003. Birth rate and mortality data needed for life expectancy calculation were supplied by the Central Bureau of Statistics. The results suggest that the increase in mean body mass index value (1.31 kg m(-2) for women and 1.41 kg m(-2) for men) will shorten life expectancy at birth for one year. Obesity, if unchecked, might have a negative effect on life expectancy in Croatia. Despite widespread knowledge about how to reduce the severity of the problem, observed trends in obesity in Croatia continue to worsen. These trends threaten to diminish the health and life expectancy of current and future generations.

Association of hypertension with long-term overweight status and weight gain: the CroHort study.

Overweight is associated with hypertension, but longitudinal studies on the effect of weight gain on blood pressure are relatively rare. Aim of this study was to investigate association of long-term overweight status as well as of becoming overweight with hypertension. Odds of hypertension in 2008 were calculated for 1,383 respondents from Croatian Adult Health Cohort Study (CroHort) who had normal blood pressure in 2003. The results showed that for women both long-term overweight status and recently becoming overweight (in the last 5 years) were significantly associated with development of hypertension, while for men this was true only for long-term overweight. Prevention activities aimed at maintenance of normal body weight should be important part of primary prevention of hypertension.

Risk of angina pectoris, non-fatal myocardial infarction and non-fatal stroke among hypertensives: the CroHort study.

Aim of this study was to investigate association of controlled and uncontrolled hypertension with angina pectoris, non-fatal myocardial infarction and non-fatal cerebrovascular insult on a cohort from Croatian Adult Health Cohort Study (CroHort). Odds for angina pectoris, non-fatal myocardial infarction and non-fatal cerebrovascular insult were calculated for 227 respondents with controlled hypertension and 1,287 respondents with uncontrolled hypertension compared to 1,353 normotensive respondents. The results showed that among men uncontrolled hypertension was significantly associated with risk of non-fatal stroke, while among women no significant associations were recorded. Primary and secondary prevention of hypertension should be public health priority and would contribute to reducing the risk of stroke in Croatian population.

The CroHort study: cardiovascular behavioral risk factors in adults, school children and adolescents, hospitalized coronary heart disease patients, and cardio rehabilitation groups in Croatia.

Based on repeated measurement of health behaviors the CroHort Study showed that health behavior explains a great deal more of class inequalities in mortality than observed in previous studies. These include decreasing prevalence of smoking and increase in obesity, hypertension and diabetes mellitus. The lowest prevalence of health risks was recorded among children and adolescents, followed by general adult population from the CroHort Study. Hospitalized coronary heart disease patients had higher risks prevalence than general population, while the highest prevalence of risks was recorded among patients in cardiac rehabilitation program. The higher levels of stress were associated to lower financial conditions, poorer social functioning and poorer mental health for both men and women. Higher levels of stress were also associated with heart problems, higher alcohol consumption in men while in women stress was associated to poorer general health, higher age and lower levels of education.

Trends and regional disparities in ischemic heart disease and cerebrovascular disease in Croatia, 1997-2006.

The aim of this study was to analyze mortality and hospital morbidity from ischemic heart disease (IHD) and cerebrovascular disease (CVD) in the population aged 18+ years in different regions of Croatia, in 1997 to 2006 period. Mortality data were supplied by Central Bureau of Statistics, while hospital morbidity data were obtained from hospital discharge database at Croatian National Institute of Public Health. In Mediterranean region rates of IHD mortality were lower, while rates of hospitalization due to IHD have been higher than those for Croatia in the entire period. Rates of IHD mortality for Continental part have not been different from mean rates for Croatia while rates of hospitalization due to IHD have been lower than rates for Croatia in entire period. Rates of CVD mortality and rates of hospitalization due to CVD for Mediterranean part have been lower than rates for Croatia, while both rates for Continental part have been higher than rates for Croatia during entire period. This analysis identified the regions in which significant deviations from the general trend suggest the need for creation of a new national public health intervention model, focusing on changeable behaviour (lifestyles) risk factors.

Health behavior factors associated with obesity in the adult population in Croatia.

The aim of this study was to examine the association of obesity and selected health behaviors, based on the data from Croatian Adult Health Survey 2003. Cross-sectional study on representative random sample of 9070 Croatian adults showed that in both men and women, mean BMI varied significantly with age (p < 0.001). It tended to increased with age until 55-64 years, and then decreased slightly in men, but remained unchanged in women. The prevalence of obesity (BMI > or = 30.0 kg m(-2)) demonstrated almost the same prevalence in men and women, 20.1% and 20.6% respectively. The likelihood of being obese, either in men or women, was more likely in the middle-aged groups, among respondents from rural areas and those from the Continental region of Croatia, with drinking lifestyle pattern, and non-smokers. Women who mostly used animal fat for food preparations were more likely to be obese. Overweight and obesity are major public health problem in the adult population in Croatia, and health promotion strategies based on behavioral correlates are needed to prevent excess weight gain in the Croatian population.

Anthropometric indices of obesity and hypertension in different age and gender groups of Croatian population.

The aim of this study was to investigate the association of hypertension with the obesity indices--body mass index and waist circumference. The study was based on the data from the Croatian Adult Health Survey 2003, which is a cross-sectional study on the representative sample of 9,070 Croatian adults. The results showed that in both men and women aged 18-64 years and 65 years and older increased BMI and waist circumference were associated with higher odds of hypertension. Odds of hypertension for obese (BMI > or = 30) and persons with abdominal obesity (waist circumference > or = 102 cm for men, > or = 88 cm for women) was higher among young and middle aged than among elderly persons. No differences in odds of hypertension were recorded between persons with increased BMI and persons with increased waist circumference. Both BMI and waist circumference exhibited equally strong association with hypertension in Croatian population, in both men and women, and in those who are below or over 65 years of age.

Association of BMI and nutritional habits with hypertension in the adult population of Croatia.

OBJECTIVE: The purpose of the present study was to investigate the distribution of hypertension, its nutritional and other determinants and their association in Croatia. DESIGN: Population-based, cross-sectional study. SETTING: Croatia. SUBJECTS: Representative random sample of 9070 adults (18 years and older) from all Croatian regions, selected using multistage sampling. RESULTS: Overall prevalence of hypertension (arterial blood pressure >or=140/90 mmHg) in Croatia was 45.5 %, of which 40 % were newly diagnosed hypertensives. There was no difference in the percentage of hypertensives between the continental and Mediterranean parts of Croatia. Newly diagnosed hypertension was found to be positively associated with increased BMI, age and alcohol consumption in the total sample and with moderate consumption of coffee in women, as well as inversely associated with regular consumption of fruits and vegetables in the total sample and high consumption of coffee in the total sample and in men. No association with newly diagnosed hypertension was recorded for use of animal fat, consumption of whole milk, smoked meat products, for adding salt, smoking and leisure-time physical activity. CONCLUSIONS: Hypertension is a major public health problem in both continental and Mediterranean parts of Croatia. Maintenance of normal body mass, its reduction if already increased, and regular consumption of fruits and vegetables are proposed as priorities for primary prevention of hypertension in Croatia.