BACKGROUND: The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns.
METHODS: In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months.
RESULTS: Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: dpost-procedure = 0.41, d6 months = 1.00, d12 months = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% [IQR: 21.0% to 40.7%] for the Mirage, 18.2% [IQR: 13.1% to 31.6%] for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups.
CONCLUSIONS: At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.
Objective: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients.
Design, Setting, and Participants: Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT.
Interventions: Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter.
Main Outcomes and Measures: The primary end point was occurrence of confirmed herpes zoster cases.
Results: Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P
Methods: A single blind randomized controlled trial on 34 patients with COPD was conducted. The participants were divided into two groups, including honey (n = 22) and standard care (n = 12). St. George's Respiratory Questionnaire (SGRQ) was used to assess the QoL. The QoL total score was analysed using repeated measure ANOVA.
Result: There were no significant differences between the honey and standard care groups for socio-demographic and QoL variables. The within-time analysis showed statistically significant differences between baseline and post 2, 4 and 6-months in the total QoL score in the honey group. Otherwise, only marginally significant difference was detected between baseline and post 2-months in the standard care group. A comparison of total QoL score between the two groups, based on time (between and within), favoured the honey group. The honey group demonstrated a significantly lower mean total QoL score compared with the standard group at 4-months (28.89; 95% CI: 21.19, 36.59 vs 42.38; 95% CI: 31.95, 52.81) and 6 months (22.91; 95% CI: 14.94, 30.87 vs 41.95; 95% CI: 31.17, 52.73).
Conclusion: Supplementation of honey in patients with COPD results in better intermediate and long-term changes in the overall QoL.
METHOD: A single-blind RCT was conducted among 30 randomized patients with dental phobia to either VRET or informational pamphlet (IP) condition. Primary outcome anxiety measures (VAS-A, MDAS and DFS) were evaluated at baseline, pre- and post-intervention, 1-week, 3-months and 6-months follow-up. Secondary outcome measures assessed were pre-post behavioral avoidance, temporal variations of heart rate and VR-experience during and post-VRET, and dental treatment acceptance in both conditions at 6-month follow-up.
RESULTS: Intention to treat analysis, using a repeated measures MANOVA, revealed a multivariate interaction effect between time and condition (p = 0.015) for all primary outcome measures (all ps
OBJECTIVE: To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects.
METHODS: Using a crossover design, randomized controlled trial in abdominally overweight men and women, we compared the effects of substitution of 7% energy as carbohydrate or MUFA for SAFA for a period of 6 weeks each. Fasting and postprandial blood samples in response to corresponding SAFA, carbohydrate, or MUFA-enriched meal-challenges were collected after 6 weeks on each diet treatment for the assessment of outcomes.
RESULTS: As expected, postprandial nonesterified fatty acid suppression and elevation of C-peptide, insulin and glucose secretion were the greatest with high-carbohydrate (CARB) meal. Interestingly, CARB meal attenuated postprandial insulin secretion corrected for glucose response; however, the insulin sensitivity and disposition index were not affected. SAFA and MUFA had similar effects on all markers except for fasting glucose-dependent insulinotropic peptide concentrations, which increased after MUFA but not SAFA when compared with CARB.
CONCLUSION: In conclusion, a 6-week lower-fat/higher-carbohydrate (increased by 7% refined carbohydrate) diet may have greater adverse effect on insulin secretion corrected for glucose compared with isocaloric higher-fat diets. In contrast, exchanging MUFA for SAFA at 7% energy had no appreciable adverse impact on insulin secretion.
METHODS: A 6-month parallel multicenter two-arm, single-blind randomized controlled trial involving 14 pharmacists at seven primary care clinics was conducted in Johor, Malaysia. Pharmacists without prior specialized diabetes training were trained to use the tool. Patients were randomized within each center to either Simpler care (SC), receiving care from pharmacists who used the tool (n =55), or usual care (UC), receiving usual care and dispensing services (n = 69).
RESULTS: Compared with UC, SC significantly reduced HbA1c (mean reduction 1.59% [95% confidence interval {CI} -2.2, -0.9] vs 0.25% [95% CI -0.62, 0.11], respectively; P ≤ 0.001), and significantly improved systolic BP (-6.28 mmHg [95% CI -10.5, 2.0] vs 0.26 mmHg [95% CI -3.74, 0.43], respectively; P = 0.005). A significantly higher proportion of patients in the SC than UC arm reached the Malaysian guideline treatment goals for HbA1c (14.3% vs 1.5%; P = 0.020), systolic BP (80% vs 42%; P = 0.001), and low-density lipoprotein cholesterol (60.5% vs 40.4%; P = 0.046).
CONCLUSIONS: Using the Simpler tool facilitated the delivery of comprehensive evidence-based diabetes management and significantly improved clinical outcomes. The Simpler tool supported pharmacists in providing enhanced structured diabetes care.
METHODS: This was a single-center, prospective, and single-blind randomized controlled trial conducted at the University Malaya Medical Centre. Patients older than 65 years presenting to the hospital emergency department or geriatric clinic with 1 injurious fall or 2 falls in the past year and with impaired functional mobility were included in the study. The intervention group received a modified OEP intervention (n = 34) for 3 months, while the control group received conventional care (n = 33). All participants were assessed at baseline and 6 months.
RESULTS: Twenty-four participants in both OEP and control groups completed the 6-month follow-up assessments. Within-group analyses revealed no difference in grip strength in the OEP group (P = 1.00, right hand; P = .55, left hand), with significant deterioration in grip strength in the control group (P = .01, right hand; P = .005, left hand). Change in grip strength over 6 months significantly favored the OEP group (P = .047, right hand; P = .004, left hand). Significant improvements were also observed in mobility and balance in the OEP group.
CONCLUSIONS: In addition to benefits in mobility and balance, the OEP also prevents deterioration in upper limb strength. Additional benefits of exercise interventions for secondary prevention of falls in term of sarcopenia and frailty should also be evaluated in the future.
OBJECTIVE: This study aims to develop, implement, and evaluate the effectiveness of Stop and Play, a digital parental health education intervention to reduce excessive screen time among preschoolers from low socioeconomic families in Malaysia.
METHODS: A single-blind, 2-arm cluster randomized controlled trial was conducted among 360 mother-child dyads attending government preschools in the Petaling district, who were randomly allocated into the intervention and waitlist control groups between March 2021 and December 2021. This 4-week intervention, developed using whiteboard animation videos, infographics, and a problem-solving session, was delivered via WhatsApp (WhatsApp Inc). Primary outcome was the child's screen time, whereas secondary outcomes included mother's screen time knowledge, perception about the influence of screen time on the child's well-being, self-efficacy to reduce the child's screen time and increase physical activity, mother's screen time, and presence of screen device in the child's bedroom. Validated self-administered questionnaires were administered at baseline, immediately after the intervention, and 3 months after the intervention. The intervention's effectiveness was evaluated using generalized linear mixed models.
RESULTS: A total of 352 dyads completed the study, giving an attrition rate of 2.2% (8/360). At 3 months after the intervention, the intervention group showed significantly reduced child's screen time compared with the control group (β=-202.29, 95% CI -224.48 to -180.10; P