BackgroundMild cognitive impairment (MCI) is a phase in cognitive decline when it is still possible to intervene to reverse the decline. Cognitive stimulation delivered through psychosocial interventions provides both psychological intervention and social stimulation to improve cognition. A pilot open-label parallel-arms randomized controlled trial was undertaken to examine the effects of art therapy (AT) and music reminiscence activity (MRA) compared to the control, on the primary outcome of neurocognitive domain assessments in elderly people with MCI.MethodsCommunity-living elderly people with MCI (Petersen’s criteria), assessed for study eligibility, were randomized using a web-based system with equal allocation to two intervention arms: AT (guided viewing of art pieces and production of visual arts) and MRA (listening, and recalling memories related to music) and a control arm (standard care without any intervention). Interventions were led by trained therapists weekly for 3 months, then fortnightly for 6 months. Neurocognitive domains (mean of memory, attention, and visuo-spatial abilities standardized scores), psychological wellbeing (subsyndromal depression and anxiety) and telomere length as a biological marker of cellular ageing, were assessed by intervention-blinded assessors at baseline, 3 months and 9 months.ResultsIn total, 250 people were screened and 68 were randomized and included in the analysis. In the AT arm, neurocognitive domains improved compared to the control arm at 3 months (mean difference (d) = 0.40; 90% CI 0.126, 0.679) and were sustained at 9 months (d = 0.31; 90% CI 0.068, 0.548). There was some improvement in depression and anxiety at 3 and 9 months and in telomere length at 9 months, but this was not significant. Similar improvements were observed in the MRA arm over the control arm, but they were not significant. There were no intervention-related adverse effects.ConclusionsArt therapy delivered by trained staff as “art as therapy” and “art psychotherapy” may have been the significant contributor to cognitive improvements. The findings support cognitive stimulation for elderly people with cognitive decline and signal the need for larger studies and further investigation of carefully designed psycho-social interventions for this group.Trial registrationClinical Trials.gov, NCT02854085. Registered on 7 July 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2988-6) contains supplementary material, which is available to authorized users.
Background Klebsiella pneumoniae liver abscess (KLA) is emerging worldwide due to hypermucoviscous strains with a propensity for metastatic infection. Treatment includes drainage and prolonged intravenous antibiotics. We aimed to determine whether oral antibiotics were noninferior to continued intravenous antibiotics for KLA. Methods This noninferiority, parallel group, randomized, clinical trial recruited hospitalized adults with liver abscess and K. pneumoniae isolated from blood or abscess fluid who had received ≤7 days of effective antibiotics at 3 sites in Singapore. Patients were randomized 1:1 to oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics for 28 days. If day 28 clinical response criteria were not met, further oral antibiotics were prescribed until clinical response was met. The primary endpoint was clinical cure assessed at week 12 and included a composite of absence of fever in the preceding week, C-reactive protein <20 mg/L, and reduction in abscess size. A noninferiority margin of 12% was used. Results Between November 2013 and October 2017, 152 patients (mean age, 58.7 years; 25.7% women) were recruited, following a median 5 days of effective intravenous antibiotics. A total of 106 (69.7%) underwent abscess drainage; 71/74 (95.9%) randomized to oral antibiotics met the primary endpoint compared with 72/78 (92.3%) randomized to intravenous antibiotics (risk difference, 3.6%; 2-sided 95% confidence interval, −4.9% to 12.8%). Effects were consistent in the per-protocol population. Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group. Conclusions Oral antibiotics were noninferior to intravenous antibiotics for the early treatment of KLA. Clinical Trials Registration NCT01723150.
Aims and Objectives: Malnutrition is common in children with congenital heart disease and may contribute to adverse outcomes. This study evaluates the impact of pre-operative nutritional status on outcomes after congenital heart surgery.Methods: We conducted a retrospective cohort study enrolling children under 10 years old who underwent congenital heart surgery at a tertiary children's hospital from 2012 to 2016. Patients who had patent ductus arteriosus ligation only, genetic syndromes, or global developmental delay were excluded. Outcome measures included 30-day mortality, intensive care unit (ICU) length of stay (LOS), hospital LOS, duration of mechanical ventilation, and number of inotropes used post-operatively. We performed univariate/multivariable logistic regression analysis, adjusting for age, cyanotic cardiac lesion, co-morbidity, and Risk Adjustment for Congenital Heart Surgery (RACHS-1) score.Results: Three hundred two children of median age 16.2 [interquartile range (IQR) 3.1, 51.4)] months were included. The most common cardiac lesions were ventricular septal defect (27.8%), atrial septal defect (17.9%), and Tetralogy of Fallot (16.6%). Median weight-for-age z-score (WAZ) was −1.46 (IQR −2.29, −0.61), height-for-age z-score (HAZ) was −0.94 (IQR −2.10, −0.10), and body mass index (BMI)-for-age z-score (BAZ) was −1.11 (IQR −2.19, −0.30). In multivariable analysis, there was an increased risk of 30-day mortality for WAZ ≤−2 vs. WAZ >−2 [adjusted odds ratio (aOR): 4.01, 95% CI: 1.22, 13.13; p = 0.022]. For HAZ ≤-2 vs. HAZ > −2, there was increased risk of hospital LOS ≥ 7 days (aOR: 2.08, 95% CI: 1.12, 3.89; p = 0.021), mechanical ventilation ≥48 h (aOR: 2.63, 95% CI: 1.32, 5.24; p = 0.006) and of requiring ≥3 inotropes post-operatively (aOR: 3.00, 95% CI: 1.37, 6.59; p = 0.006).Conclusion: In children undergoing congenital heart surgery, WAZ ≤ −2 is associated with higher 30-day mortality, while HAZ ≤ −2 is associated with longer durations of hospital LOS and mechanical ventilation, and increased risk of use of 3 or more inotropes post-operatively. Future studies are necessary to develop safe and efficacious peri-operative nutritional interventions, particularly in patients with WAZ and HAZ ≤ −2.
Background: The home literacy environment (HLE) and joint parent-child book reading are key factors in children's language and literacy acquisition. Child-centered literacy orientation (CCLO) refers to the child's level of engagement in literacy events. Aim: To describe the HLE and identify demographic and HLE variables associated with a poor CCLO at 12 months of age. Methods: Parents of Singaporean children enrolled in the Growing Up in Singapore Towards healthy Outcomes (GUSTO; n = 1152, birth cohort 2009-2010) completed a childhood literacy questionnaire at 12 months to obtain scores on HLE (0-17) and CCLO (0-6). Logistic regression analyses were employed to identify predictors of low CCLO. Results: Parents of 525 children completed the questionnaire. Mothers were the main caregivers in half the households. Mandarin was the main language (34%). Majority of the respondents had a library card that was used less than weekly, and had fewer than 10 children's books. 18% of parents read to the child daily, of whom one-quarter read at bedtime. Amongst half of the families who had a CCLO score of 0, two-thirds had the lowest HLE scores (0-2). Correlational analyses indicated significant association between HLE with CCLO at 12 months (p < 0.001). Non-English speaking caregivers and mothers who had only completed primary education were at high risk of a poor 12-month CCLO. Conclusion: A literacy-rich home environment is associated with 12-month child-centered literacy orientation. Pediatricians and early years' professionals may be able to promote benefits of literacy related activities to families at risk of poor childcentered literacy orientation.
Objectives: Preclinical and clinical studies indicate a role for MLC901 (NeuroAiD II) in Alzheimer's disease (AD). The primary aim was to investigate its safety as add-on therapy to standard treatment and the secondary aims its effect on cognition and slowing disease progression. Design: Randomized double-blind placebo-controlled delayed-start study. Setting and Participant: Patients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n ¼ 125), were randomized to receive MLC901 (early starters) or placebo (delayed starters) for 6 months, followed by a further 6 months when all patients received MLC901, in a delayed-start design (clinical trial registration: ClinicalTrials.gov, NCT03038035). Methods: The primary outcome measure was occurrence of serious adverse events (SAEs) at 6 months. Secondary outcomes included the Alzheimer's Disease Assessment ScaleeCognitive subscale (ADAS-Cog) and other assessment scales. Results: There was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference À4.4%, 90% CI e16.9% to 8.3%). Similarly, there was no significant difference in the risk of adverse events and the occurrence of stroke or vascular events between early and delayed starters throughout the 12-month study period. Early starters did not differ significantly on ADAS-Cog from delayed starters at M6 [mean difference (MD) À1.0, 95% CI e3.3 to 1.3] and M12 (MD e2.35, 95% CI e5.45 to 0.74) on intention-to-treat analysis. Other cognitive assessment scales did not show significant differences. Conclusions and Implications: This study of 125 persons with dementia found no evidence of a significant increase in adverse events between MLC901 and placebo, thus providing support for further studies on both efficacy and safety. Analyses suggest the potential of MLC901 in slowing down AD progression, but this requires further confirmation in larger and longer studies using biomarkers for AD.
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