CHInese medicine NeuroAiD efficacy on stroke recovery - Extension study (CHIMES-E): A multicenter study of long-term efficacy

© 2015 S. Karger AG, Basel. Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.Link_to_subscribed_fulltex

Correction: Ward-based clinical pharmacists and hospital readmission: a non-randomized controlled trial in Sri Lanka (vol 96, pg 155, 2018)

In Lelwala Guruge Thushani Shanika, Shaluka Jayamanne, Chandrani Nirmala Wijekoon, Judith Coombes, Dhineli Perera, et al. Ward-based clinical pharmacists and hospital readmission: a non-randomized controlled trial in Sri Lanka. Bull World Health Organ. 2018 March 1; 96 (3):155–64: on page 158, third column, the third, fourth and fifth sentences under the “Estimated savings” title should read “The difference of drug-related hospital readmissions associated with the pharmacist’s intervention was 16.7% (95% confidence interval, CI: 10.5–23.0). This reduction would result in an estimated 417 adverted readmissions and would save approximately 835 bed days per year

Emotional intelligence and academic performance of medical undergraduates: a cross-sectional study in a selected university in Sri Lanka

Abstract Background Emotional intelligence (EI) has been linked with academic and professional success. Such data are scarce in Sri Lanka. This study was conducted to describe the pattern of EI, to determine its predictors and to determine the effect of EI on academic performance at the final MBBS examination, in medical undergraduates of a Sri Lankan university. Methods This is a cross-sectional study in a selected university, involving those who did final MBBS examination in 2016. Consecutive sampling was done. EI was assessed with self-administered Genos Emotional Intelligence Full Version (7 domains; 70 questions equally weighted; total score 350). Socio-demographic data were obtained using a self-administered questionnaire. Academic performance was assessed with final MBBS results in the first attempt. Results Of 148 eligible students 130 responded (response rate-88%); 61.5% were females; mean age was 26.3 ± 1 years. Mean total EI score was 241.5 (females-245.5, males-235.1; p = 0.045).Among different domains, mean score was highest for Emotional Self-Awareness (36.8/50) and lowest for Emotional Expression (32.6/50). Multiple linear regression analysis indicated that having good family support (p = 0.002), socializing well in university (p = 0.024) and being satisfied with facilities available for learning (p = 0.002), were independent predictors of EI. At the final MBBS examination 51.6% obtained classes, 31.5% passed the examination without classes and 16.9% got repeated. Females had better academic performance than males (p = 0.009). Mean EI of second-class upper division, second-class lower division, pass and repeat groups were 249.4, 246.6, 240.2 and 226.9, respectively (with one-way ANOVA p = 0.015). After adjusting for gender, ordinal regression analysis indicated that, total EI score was an independent predictor of final MBBS results [β-0.018 (95% CI 0.005-0.031); p = 0.006]. Conclusions In the study population, both EI and academic performance were higher among females. Independent of gender, academic performance was better in those who were more emotionally intelligent. Several psychosocial factors were found to be independent predictors of EI. These results suggest that emotional skills development might enhance academic performance of medical undergraduates in Sri Lanka. Further research is needed in this under-explored area

Ward-based clinical pharmacists and hospital readmission: a nonrandomized controlled trial in Sri Lanka

Objective To assess if a ward-based clinical pharmacy service resolving drug-related problems improved medication appropriateness at discharge and prevented drug-related hospital readmissions. Method Between March and September 2013, we recruited patients with noncommunicable diseases in a Sri Lankan tertiary-care hospital, for a non-randomized controlled clinical trial. The intervention group received usual care and clinical pharmacy service. The intervention pharmacist made prospective medication reviews, identified drug-related problems and discussed recommendations with the health-care team and patients. At discharge, the patients received oral and written medication information. The control group received usual care. We used the medication appropriateness index to assess appropriateness of prescribing at discharge. During a six-month follow-up period, a pharmacist interviewed patients to identify drug-related hospital readmissions. Results Data from 361 patients in the intervention group and 354 patients in the control group were available for analysis. Resolutions of drug-related problems were higher in the intervention group than in the control group (57.6%; 592/1027, versus 13.2%; 161/1217; P < 0.001) and the medication was more appropriate in the intervention group. Mean score of medication appropriateness index per patient was 1.25 versus 4.3 in the control group (P < 0.001). Patients in the intervention group were less likely to be readmitted due to drug-related problems (44 patients of 311 versus 93 of 311 in the control group; P < 0.001). Conclusion A ward-based clinical pharmacy service improved appropriate prescribing, reduced drug-related problems and readmissions for patients with noncommunicable diseases. Implementation of such a service could improve health care in Sri Lanka and similar settings

Baseline characteristics and treatment response of patients from the Philippines in the CHIMES study

© 2014 The Authors. Background: The CHIMES Study compared MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 72h. Sites from the Philippines randomized 504 of 1099 (46%) patients in the study. We aimed to define the patient characteristics and treatment responses in this subgroup to better plan future trials. Methods: The CHIMES dataset was used to compare the baseline characteristics, time from stroke onset to study treatment initiation, and treatment responses to MLC601 between patients recruited from Philippines and the rest of the cohort. Treatment effect was analyzed using end-points at month 3 as described in the primary publication, that is, modified Rankin Score, National Institutes of Health Stroke Scale, and Barthel Index. Results: The Philippine cohort was younger, had more women, worse baseline National Institutes of Health Stroke Scale, and longer time delay from stroke onset to study treatment compared with the rest of the cohort. Age (P=0·003), baseline National Institutes of Health Stroke Scale (P<0·001), and stroke onset to study treatment initiation (P=0·016) were predictors of modified Rankin Score at three-months. Primary analysis of modified Rankin Score shift was in favor of MLC601 (adjusted odds ratio 1·41, 95% confidence interval 1·01-1·96). Secondary analyses were likewise in favor of MLC601 for modified Rankin Score dichotomy 0-1, improvement in National Institutes of Health Stroke Scale (total and motor scores), and Barthel Index. Conclusions: The treatment effects in the Philippine cohort were in favor of MLC601. This may be due to inclusion of more patients with predictors of poorer outcome.Link_to_subscribed_fulltex

Effects of MLC601 on early vascular events in patients after stroke: The CHIMES study

BACKGROUND AND PURPOSE - Early vascular events are an important cause of morbidity and mortality in the first 3 months after a stroke. We aimed to investigate the effects of MLC601 on the occurrence of early vascular events within 3 months of stroke onset. METHODS - Post hoc analysis was performed on data from subjects included in the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study, a randomized, placebo-controlled, double-blinded trial that compared MLC601 with placebo in 1099 subjects with ischemic stroke of intermediate severity in the preceding 72 hours. Early vascular events were defined as a composite of recurrent stroke, acute coronary syndrome, and vascular death occurring within 3 months of stroke onset. RESULTS - The frequency of early vascular events during the 3-month follow-up was significantly less in the MLC601 group than in the placebo group (16 [2.9%] versus 31 events [5.6%]; risk difference=-2.7%; 95% confidence interval, -5.1% to -0.4%; P=0.025) without an increase in nonvascular deaths. Kaplan-Meier survival analysis showed a difference in the risk of vascular outcomes between the 2 groups as early as the first month after stroke (Log-rank P=0.024; hazard ratio, 0.51; 95% confidence interval, 0.28-0.93). CONCLUSIONS - Treatment with MLC601 was associated with reduced early vascular events among subjects in the CHIMES study. The mechanisms for this effect require further study. © 2013 American Heart Association, Inc.Link_to_subscribed_fulltex