Predictors of vocational status in schizophrenia patients--Results from the Polish nationwide survey.

BACKGROUND: Steady employment constitutes one of most important aspects of functional recovery in schizophrenia. Therefore, there is a need for understanding clinical and demographic factors predicting vocational status in schizophrenia. METHODS: Clinical and demographic data of 1,010 schizophrenia patients were gathered from public outpatient clinics. We compared patients who maintained employment between the diagnosis time point and the day of assessment, with the patients who were employed in the diagnosis time point but were unemployed on the day of assessment with respect to clinical and demographic variables. RESULTS: Lower educational attainment, lower-income region of residence, medical comorbidities (obesity, diabetes and hypertension), first hospitalization at inpatient unit in comparison with the day hospital, higher total number of hospitalizations and the number of inpatient hospitalizations were found to serve as predictors of unemployment throughout the course of schizophrenia. After application of Bonferroni correction and logistic binary regression analysis, lower educational attainment, higher number of inpatient hospitalizations and obesity predicted unemployment. CONCLUSION: Education, obesity and the number of inpatient hospitalizations seem to predict vocational outcome in schizophrenia. This study warrants further investigation of medical comorbidities in schizophrenia in terms of social consequences in order to indicate the direction of this relationship.

Costs of diabetes and its complications in Poland.

OBJECTIVE: Diabetes mellitus (DM) is a major health problem with severe complications and a significant impact on quality of life. It constitutes an enormous burden of disease due to high prevalence, severe co-morbidities and high costs for society. This study is the first comprehensive study on the direct and indirect costs of DM (type 1 and type 2) and associated complications in Poland. METHODS: In order to estimate the direct medical costs of DM and its complications, including the costs of medical consultation, hospitalisation, rehabilitation, drugs and medical equipment, data from the National Health Fund were used. Indirect costs on loss of productivity due to diabetes and its complications were based on data obtained from the ZUS (Social Insurance Institution) and from GUS (Poland's Central Statistical Office). Attributable risk methodology was used to assess the burden of DM complications. RESULTS: A continuous increase of the direct costs of diabetes has been observed since the year 2005. In the analysed time period (2005-2009) the direct costs of medical services for both types of DM doubled. DM is a cause of significant sickness absence and incapacity for work and therefore is associated with a growing productivity decline in Poland. The highest direct costs and indirect costs are associated with treatment of diabetes-related complications. Direct costs of hospital complication treatment were EUR 332 million, which exceeded by more than five times the direct costs of hospital treatment of diabetes per se, which in the same year amounted to EUR 58.5 million. The indirect costs of diabetes-related complications were higher by 41% compared with indirect costs related to DM itself. Total costs of health care services for DM and its complications amounted to EUR 654 million, which constitutes a 2.8% of total health care costs in Poland. Total DM cost in Poland in 2009 amounted EURO 1.5 billion. CONCLUSIONS: DM is causing a growing economic burden on the health care system and on Polish society in terms of health care and productivity losses. Most of the total cost of diabetes are indirect costs caused by productivity losses. Both direct and indirect costs are driven by the cost of diabetes complications.

Economic analysis of the implementation of guidelines for type 2 diabetes control developed by Diabetes Poland: what increase in costs is justified by clinical results?

INTRODUCTION: Diabetes Poland has recently published guidelines for the treatment of type 2 diabetes. Treatment according to these guidelines is more expensive and requires more involvement of the patient than is the case in current clinical practice. OBJECTIVES: The aim of the study was to assess to what extent the cost of type 2 diabetes treatment according to the Diabetes Poland guidelines may be increased when compared with the cost of the current treatment, so that the introduction of the guidelines remains cost-effective in the Polish setting. PATIENTS AND METHODS: Two hypothetical patients were defined, John and Peter, representing the population of newly diagnosed type 2 diabetic patients. The disease progression was simulated assuming that John is treated according to the current practice and Peter is treated to achieve and maintain the goals defined by Diabetes Poland. The simulation was performed using the CORE model, which has been constructed based on the published scientific evidence and includes more than a dozen of diabetes complications. The model has been widely validated by numerous studies and is broadly used; it enables a reliable estimation of costs and clinical effects associated with diabetes. The parameters of the model were adapted to the Polish conditions. The analysis was conducted in a life-long perspective, discounting of costs/effects was included, and the acceptability threshold was set at 25,511 EUR per quality-adjusted life-year (QALY). RESULTS: The quality-adjusted life expectancy of John will be 0.3 QALY lower than the life expectancy of Peter. The treatment of diabetic complications will be 400 EUR more expensive in the case of John compared with that of Peter. Assuming the willingness to pay at the level of 7500 EUR/QALY, the cost of diabetes treatment of Peter may be 250 EUR higher than that of John's treatment. For the threshold level of 15,000 EUR/QALY, the difference in cost may be 450 EUR, and for the threshold level of 25,000 EUR/QALY - 725 EUR per year. CONCLUSIONS: Treatment according to the guidelines of Diabetes Poland may be cost-effective provided that the additional costs associated with intensification of therapy will not exceed 725 EUR per year.

Review articles, systematic reviews and meta-analyses: which can be trusted?

A large number of scientific articles published every year requires from practicing physicians the ability to choose among them and to use secondary studies, such as guidelines, review articles, meta-analyses and systematic reviews. The aim of this article was to discuss basic differences between meta-analyses and systematic reviews. Meta-analysis is a mathematical method of pooling the results of several or more studies; a meta-analysis may be based on a systematic review, but this is not always the case. A systematic review is a multistage process aimed at the identification of all reliable evidence regarding a specific clinical problem. Systematic reviews make it possible to objectively address particular issues according to the current state of clinical knowledge and therefore constitute a reliable basis for clinical decision-making. An appropriate systematic review should include: 1) a defined clinical question, 2) pre-specified inclusion and exclusion criteria, 3) complex search for medical evidence sources according to a search strategy, 4) critical evaluation of reliability of identified clinical trials, 5) qualitative or quantitative data synthesis and 6) evidence based conclusions. These simple criteria, formulated by Cook et al. more than 10 years ago, allow to differentiate between a reliable systematic review and a "quasi-systematic" one, as well as between a reliable meta-analysis based on a systematic review and a potentially misleading meta-analysis without a systematic review.

The role of surrogate endpoints in the evaluation of efficacy and safety of therapeutic interventions in diabetes mellitus.

In this paper, we examine the concept of surrogate endpoints (i.e. substitute outcome measures) and review their use in clinical trials involving therapies for diabetes mellitus using the example of metformin. Trials such as DCCT and UKPDS, in which patient-important endpoints were evaluated, are relatively rare in diabetology. Clinical decisions, therefore, are often based on evidence obtained using surrogate outcomes, usually fasting or postprandial glycemia or glycated hemoglobin level. In contrast to patient-important endpoints, surrogates do not describe direct clinical benefit to the patient. However, a proven association between a surrogate and patient-important endpoint is essential to draw appropriate therapeutic conclusions. In the process of new drug development, the duration of follow-up, sample size and methodology of the studies initially available are often inadequate to demonstrate the effect of the intervention on patient-important endpoints. Evidence concerning the effect of an intervention on surrogate outcomes usually comes first, followed only later by reports describing its influence on patient-important endpoints. Metformin may serve as an example in several ways. The first publications reported beneficial effects on glycemic control and body weight. Outcomes from the subsequent UKPDS study suggested the patient-important efficacy of metformin measured as a reduction in mortality and a decrease in the incidence of diabetic complications, including myocardial infarction. This reasoning process worked for some but not all strategies. It is particularly questionable whether a change in surrogate endpoint was associated with a potential deterioration in patient-important outcomes. Defining the general relationship between surrogates widely used as measures of metabolic control and patient-important endpoints remains an important challenge in contemporary diabetology.