Outcomes analysis of hospital management model in restricted budget conditions

Facing conditions of market economy and financial crisis, the head of any healthcare facility has to take adequate decisions about the cost-effective functioning of the hospital. Along with cost reduction, the main problem is how to maintain a high level of health services. The aim of our study was to analyse the quality of healthcare services after the implementation of control over expenses due to a reduction in the budgetary resources in Military Medical Academy (MMA, Sofia, Bulgaria). Data from the hospital information system and the Financial Department about the incomes and expenditures for patient treatment were used. We conducted a retrospective study on the main components of clinical indicators in 2013 to reveal the main problems in the hospital management. In 2014, control was imposed on the use of the most expensive medicines and consumables. Comparative analysis was made of the results of the medical services in MMA for 2013 and 2014. Our results showed that despite the limited budget in MMA over the last year, the policy of control over operational costs succeeded in maintaining the quality of healthcare services. While reducing the expenses for medicines, consumables and laboratory investigations by ∼26%, some quality criteria for healthcare services were observed to be improved by ∼9%. Financial crisis and budget reduction urge healthcare economists to create adequate economical instruments to assist the normal functioning of hospital facilities. Our analysis showed that when a right policy is chosen, better results may be achieved with fewer resources

Standardization and approbation of the Bulgarian version of the TEMPS-A for temperament evaluation. An example of “delinquent temperament” assessment

The aim of this study was to approbate the Bulgarian version of the international instrument for evaluation of temperamental traits, TEMPS-A (Temperament Evaluation of the Memphis, Pisa, Paris, and San Diego –Autoquestionnaire), and to prove the need to include it in the instruments for research and diagnosis of personality. The study included 901 subjects, 540 of whom are healthy volunteers. One month after the initial test, 118 subjects from the control group were retested with a set of clinical tools to check the reliability of the instrument (temporal stability). The TEMPS-A scales showed high test–retest reliability and high internal consistency. The number of scales was verified and the construct validity of the Bulgarian version of TEMPS-A was confirmed. The results outline the limit for predictive scores on the axis normal–pathological values. The observed correlations did not prove a causal link between the measured variables but verified a statistically significant correlation between the TEMPS-A and Eysenck Personality Questionnaire results, which proved that the two instruments measure the same basic personality characteristics, namely the temperamental construct. The analysis verified the successful standardization and approbation of the Bulgarian version of TEMPS-A for Bulgaria. The comparative analysis of a group of 74 persons serving custodial sentence on the territory of Bulgaria and a control group (N = 74) showed statistically significant differences between the mean scores in the two groups on all TEMPS-A scales, except for hyperthymic temperament, suggesting that delinquent behaviour is connected with an individual's temperamental characteristics

Mavoglurant in Obsessive-Compulsive Disorder Resistant to Selective Serotonin Reuptake Inhibitor: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 study

This study was conducted to determine if mavoglurant (modified release) as an add-on therapy to selective serotonin reuptake inhibitors (SSRIs) could have beneficial effects by reducing Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score in patients with obsessive-compulsive disorder (OCD) resistant to SSRI treatment. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Non-smoker men and women aged 18-65 years primarily diagnosed with OCD as per Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; DSM-IV-TR) criteria were randomized (1:1) to mavoglurant or placebo groups. After 50 patients were randomized, an interim analysis was conducted to support the decision concerning the present clinical study or the Sponsor’s clinical development projects. The primary outcome measure was absolute change in Y-BOCS from baseline at Week 17. Safety was assessed by recording adverse events (AEs) and serious adverse events (SAEs). RESULTS: Interim analysis led to a decision to terminate the study. 38(76.0%) participants completed 17 weeks of treatment and 37(74.0%) completed the study. There was no significant difference in LS mean change from baseline at Week 17 in Y-BOCS total score for mavoglurant compared with placebo groups (-6.9[1.75] vs. -8.0[1.78], respectively; LS mean difference: 1.1; 95% CI(-3.9,6.2); p-value: 0.671). The incidence of AEs was higher in the mavoglurant compared with the placebo group (80.8% versus 70.8%, respectively). During the study, six SAEs were reported in three patients (mavoglurant [n=1]; placebo [n=2]). CONCLUSION: The study of mavoglurant in OCD was terminated due to the lack of efficacy at interim analysis. Both mavoglurant and placebo treatment led to a modest reduction in OCD symptom severity in patients who had failed to respond adequately to SSRIs, with no significant difference between the two groups. This study did not support the use of an antagonist of mGluR5 receptors for OCD treatment

Mavoglurant Augmentation in OCD Patients Resistant to Selective Serotonin Reuptake Inhibitors: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 Study.

INTRODUCTION To determine if mavoglurant (modified release) as an augmentation therapy to selective serotonin reuptake inhibitors (SSRIs) could have beneficial effects reducing Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score in patients with obsessive-compulsive disorder (OCD) resistant to SSRI treatment. METHODS This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2 study. Patients remained on their SSRI treatment and mavoglurant or placebo was added on. Non-smoking men and women aged 18-65 years primarily diagnosed with OCD according to Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; DSM-IV-TR) criteria were randomized (1:1) to mavoglurant or placebo groups. After 50 patients were randomized, an interim analysis was conducted to determine whether the study should be continued. The primary outcome measure was absolute change in Y-BOCS from baseline at week 17. Safety was assessed by recording adverse events (AEs) and serious adverse events (SAEs). RESULTS Interim analysis led to a decision to terminate the study. In total 38 (76.0%) participants completed 17 weeks of treatment and 37 (74.0%) completed the study. There was no significant difference in least squares (LS) mean change from baseline at week 17 in Y-BOCS total score for mavoglurant compared with placebo groups [-6.9 (1.75) vs. -8.0 (1.78), respectively; LS mean difference 1.1; 95% CI -3.9, 6.2; p = 0.671]. The incidence of AEs was higher in the mavoglurant compared with the placebo group (80.8% vs. 70.8%, respectively). CONCLUSION This study of mavoglurant in OCD was terminated because of the lack of efficacy at interim analysis. The study did not support the use of an antagonist of mGluR5 receptors for OCD treatment. TRIAL REGISTRATION The study was registered with ClinicalTrials.gov: NCT01813019. FUNDING This study was sponsored by Novartis Pharma AG, Basel, Switzerland

Mavoglurant Augmentation in OCD Patients Resistant to Selective Serotonin Reuptake Inhibitors: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 Study

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