Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study).

The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two-week run-in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add-on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between-group mean difference, -0.7% [95% CI, -0.9% to -0.4%]; P-value < 0.0001). The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups. Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.

Core Symptom Index (CSI): testing for bifactor model and differential item functioning.

OBJECTIVES: The Core Symptom Index (CSI) is designed to measure anxiety, depression and somatization symptoms. This study examined the construct validity of CSI using confirmatory factor analysis (CFA) including a bifactor model and explored differential item functioning (DIF) of the CSI. The criterion and concurrent validity were evaluated. METHODS: In all, 803 elderly patients, average age 69.24 years, 70% female, were assessed for depressive disorders and completed the CSI and the geriatric depression scale (GDS). A series involving CFA for ordinal scale was applied. Factor loadings and explained common variance were analyzed for general and specific factors; and Omega was calculated for model-based reliability. DIF was analyzed using the Multiple-Indicator Multiple-Cause model. Pearson's correlation, ANOVA, and ROC analysis were used for associations and to compare CSI and GDS in predicting major depressive disorders (MDD). RESULTS: The bifactor model provided the best fit to the data. Most items loaded on general rather than specific factors. The explained common variance was acceptable, while Omega hierarchical for the subscale and explained common variance for the subscales were low. Two DIF items were identified; 'crying' for sex items and 'self-blaming' for education items. Correlation among CSI and clinical disorders and the GDS were found. AUC for the GDS was 0.83, and for the CSI was 0.81. CONCLUSION: CSI appears sufficiently unidimensional. Its total score reflected a single general factor, permitting users to interpret the total score as a sufficient reliable measure of the general factors. CSI could serve as a screening tool for MDD.

Predictors of polypharmacy among elderly Thais with depressive and anxiety disorders: findings from the DAS study.

BACKGROUND: Polypharmacy is a geriatric syndrome defined variously as the use of potentially inappropriate drugs and/or the concurrent use of multiple medications including prescription and over-the-counter drugs. An association has been shown between polypharmacy and physical health, increased morbidity and increased mortality. However, there is little information regarding the association between polypharmacy and physical disease, personality trait and mental health problems in elderly. The aim of this study was to investigate potential predictive psychosocial factors related to polypharmacy in elderly Thai people. METHODS: The study analysed the secondary data from the Depressive Disorders, Anxiety Disorders, Suicide Risk and Associated Factors Among Elderly Thai People Program (DAS Study) which was funded by National Research Council of Thailand and conducted between January 2012 and April 2013. Demographic and baseline clinical characteristics including sex, age, education, living alone or with others, access to health care privilege and monthly income were described. The number of medication, physical diseases and mental health problems (i.e. depression, anxiety, and personality trait of neuroticism) were analyzed using descriptive statistics, chi-square and proportional odds logistic regression. RESULTS: The 803 participants consumed an average of 2.13 prescribed medicines daily (SD 1.46, median = 2). The largest group used 3 medications (18.6%). Predictors found to be associated with polypharmacy in the logistic regression model included hypertension (OR = 1.985, 95% CI = 1.420-2.775), anxiety disorder (OR = 4.402, 95% CI = 2.630-7.367), number of diseases (OR = 2.140, 95% CI = 1.874-2.445), depressive disorder (OR = 1.470, 95% CI = 1.080-2.001), diabetes mellitus (OR = 1.864, 95% CI = 1.122-3.098) and dyslipidemia (OR = 0.511, 95%CI = 0.325-0.803). CONCLUSIONS: The prevalence of polypharmacy among Thai elderly was relatively high compared to other related studies. Several aspects should be taken into consideration before starting an additional medication in elderly patients. In addition to the number of physical disease that leads to polypharmacy, general practitioners should be aware of anxiety, depression, and personality trait of neuroticism that may be related to polypharmacy. Early detection for such condition as well as non-pharmacological intervention could be one way to help reduce polypharmacy in the elderly.

Confirmatory factor analysis of the revised version of the Thai multidimensional scale of perceived social support among the elderly with depression.

OBJECTIVE: Difficulties in modeling the Multidimensional Scale of Perceived Social Support (MSPSS) have occurred, and these were corrected in the revised version of the Thai MSPSS. However, the revised version has not been tested in elderly populations. The present study aimed at confirming the factor structure of the revised version of the MSPSS among the elderly with depressive disorders, in populations with or without depressive disorders. METHODS: Eight hundred and three elderly patients were recruited from four tertiary hospitals; 190 (23.7%) had depressive disorders. All completed the revised Thai MSPSS consisting of 12 items, using a 7-point Likert scale. Confirmatory factor analysis (CFA) of the MSPSS was conducted in both groups. RESULTS: The mean age was 69.24 years (SD 6.88), and 70% of the sample was female. There were no significant difference in demographic data between two groups. The revised version of the Thai MSPSS provided excellent internal consistency. The three-factor model was clearly superior to other alternative models in both depressed and non-depressed groups. CFA for the whole group revealed an acceptable model fit: χ2 = 147.44, df = 45, p < 0.001; Tucker-Lewis Index 0.975; Comparative Fit Index 0.982; Good Fit Index 0.966; and root-mean-square error of approximation 0.056. The fit statistics in the depressed group was better than in the non-depressed group across all models. CONCLUSIONS: Due to its robust factor structure, these data support the use of the revised MSPSS as a brief instrument for assessing perceived social support in the elderly with or without depressive disorders.

The Geriatric Depression Scale Predicts Glycemic Control in Older Adult with Type 2 Diabetes Mellitus: A Longitudinal Study.

The presence of comorbid depression and diabetes is associated with worse glycemic control, higher complication and greater mortality risk than expected by each condition alone. The association between various levels of severity of depressive symptoms and glycemic control over time among type 2 diabetic older patients was unclear. This study aimed to investigate a longitudinal association between depression and HbA1c among type 2 diabetic older patients. Type 2 diabetes patients aged 60 years and above with normal cognition were recruited from the outpatient department from 1 June 2020 to 1 July 2021. The Thai Geriatric Depression Scale (TGDS) and HbA1c were assessed at five time points (baseline and every 12 weeks) for 1 year. A linear mixed effect model was used. Of the 161 enrolled participants, 146 completed the study. At baseline, 14% were susceptible to depression or having depression (TGDS score 6 and above), and there was a significant correlation between HbA1c and depression (r = 0.26, p ≤ 0.01). The longitudinal analysis indicated that TGDS was a significant predictor of HbA1c in the next visit, and the relationship was J-shaped. A TGDS below 5 was associated with decreasing HbA1c in the next visit, but the association became positive at a TGDS score at 5 or higher. The presence of significant symptoms of depression was associated with glycemic control in the next 3-month interval OPD visit event, although major depressive disorder has not yet been established.

Prevalence, clinical and psychosocial variables of depression, anxiety and suicidality in geriatric tertiary care settings.

OBJECTIVE: The study investigated the prevalence of depressive and anxiety disorders and suicide risk in geriatric outpatients in tertiary care hospitals. MATERIALS AND METHODS: An observational, cross-sectional study was conducted with 803 participants aged 60 and above attending geriatric outpatient clinics in tertiary care hospitals in Thailand. Participants were assessed using DSM-IV-TR criteria to calculate the prevalence of deressive and anxiety disorders, and their suicide risk. Montreal Cognitive Assessment (MoCA), Perceived Stress Scale (PSS), Multidimensional Scale of Perceived Social Support, Core Symptom Index (CSI), 15-item Geriatric Depression Scale (GDS-15), Neuroticism Inventory (NI) and the Revised Experience of Close Relationships Questionnaire (ECR-R) were administered. Quality of life was assessed using the EuroQoL (EQ-5D). RESULTS: The prevalence rate for depressive disorders was 23.7%, anxiety disorders was 6.4%, and current suicide risk was 20.4%. PSS, MSPSS, GDS, CSI, and NI scores were significantly higher in all clinical disorders and a suicide group compared with nonclinical subjects. MoCA and ECR-R did not differentiate between clinical disorder and nonclinical samples. Comparing all four outcomes, the EQ-5D differed most in the mixed depressive-anxiety disorder and nonclinical groups (t = 12.20, p < .001). CONCLUSION: The present findings revealed a high prevalence of depression, anxiety and suicidality among elderly patients attending tertiary care hospitals. Perceived stress, perceived social support, and neuroticism scores were significantly higher in this group. Role of sociodemographic, clinical and psychosocial variables as risk factors for these clinical disorders should be further examined.

Effect of continuous education for evidence-based medicine practice on knowledge, attitudes and skills of medical students.

OBJECTIVE: To assess the effect of the integration of evidence-based medicine (EBM) in a medical curriculum using small-group discussions with case scenario and problem-based learning on the knowledge, attitudes and skills of medical students. METHOD: A quasi-experimental study was conducted in a medical school in southern Thailand during 2008-2009. EBM practice was begun before the completion of the fourth year using case scenario and continued through the fifth year using learner-centred, problem-based self-practice. Knowledge improvement was measured by summative assessment using pre- and post-tests after small-group discussions with a case scenario. Attitudes and skills were measured by self-rating assessments: before initiation of the course (T0) and after the course at week 1, 5, 13, 25 and 37 (T1, T2, T3, T4 and T5), respectively. Data were analyzed using paired t-test and linear mixed-effects model fitted by maximum likelihood. RESULTS: One hundred fourteen students took the course, with a mean age of 22.1 years. Before and after knowledge scores showed a significant improvement (4.93 versus 7.43). The proportion of students who achieved the highest knowledge scores was higher (4% at pre-test versus 54% at post-test). Both self-rated attitudes and skills after EBM practice increased dramatically from the initiation of the course (T0; P < 0.001). Compared with T1, significantly lower scores of attitudes and skills were observed at T2 and T3, but both were higher at T4 assessment. CONCLUSIONS: Continuous EBM education through small-group discussion and learner-centred, problem-based self-practice can be a useful way to improve a medical student's knowledge, attitudes and skills.