METHODS: 10 010 high-risk noncardiac surgical patients were randomized aspirin or placebo and clonidine or placebo. Neuraxial block was defined as intraoperative spinal anaesthesia, or thoracic or lumbar epidural anaesthesia. Postoperative epidural analgesia was defined as postoperative epidural local anaesthetic and/or opioid administration. We used logistic regression with weighting using estimated propensity scores.
RESULTS: Neuraxial block was not associated with the primary outcome [7.5% vs 6.5%; odds ratio (OR), 0.89; 95% CI (confidence interval), 0.73-1.08; P=0.24], death (1.0% vs 1.4%; OR, 0.84; 95% CI, 0.53-1.35; P=0.48), myocardial infarction (6.9% vs 5.5%; OR, 0.91; 95% CI, 0.74-1.12; P=0.36) or stroke (0.3% vs 0.4%; OR, 1.05; 95% CI, 0.44-2.49; P=0.91). Neuraxial block was associated with less clinically important hypotension (39% vs 46%; OR, 0.90; 95% CI, 0.81-1.00; P=0.04). Postoperative epidural analgesia was not associated with the primary outcome (11.8% vs 6.2%; OR, 1.48; 95% CI, 0.89-2.48; P=0.13), death (1.3% vs 0.8%; OR, 0.84; 95% CI, 0.35-1.99; P=0.68], myocardial infarction (11.0% vs 5.7%; OR, 1.53; 95% CI, 0.90-2.61; P=0.11], stroke (0.4% vs 0.4%; OR, 0.65; 95% CI, 0.18-2.32; P=0.50] or clinically important hypotension (63% vs 36%; OR, 1.40; 95% CI, 0.95-2.09; P=0.09).
CONCLUSIONS: Neuraxial block and postoperative epidural analgesia were not associated with adverse cardiovascular outcomes among POISE-2 subjects.
METHOD: This is a behavioral randomized controlled trial of patient education intervention with video narratives for patients with stroke lacking medication understanding and use self-efficacy. The study will recruit up to 200 eligible stroke patients at the neurology tertiary outpatient clinic, whereby they will be requested to return for follow-up approximately 3 months once for up to 12 months. Consenting patients will be randomized to either standard patient education care or intervention with video narratives. The researchers will ensure control of potential confounding factors, as well as unbiased treatment review with prescribed medications only obtained onsite.
RESULTS: The primary analysis outcomes will reflect the variances in medication understanding and use self-efficacy scores, as well as the associated factors, such as retention of knowledge, belief and perception changes, whereas stroke risk factor control, for example, self-monitoring and quality of life, will be the secondary outcomes.
DISCUSSION AND CONCLUSION: The study should be able to determine if video narrative can induce a positive behavioral change towards stroke risk factor control via enhanced medication understanding and use self-efficacy. This intervention is innovative as it combines health belief, motivation, and role model concept to trigger self-efficacy in maintaining healthy behaviors and better disease management.
TRIAL REGISTRATION: ACTRN (12618000174280).
OBJECTIVE: We aimed to compare the efficacy and safety of 1.8% SPHNSI and 0.9% commercial isotonic nasal saline irrigation (0.9% CINSI) in patients with AR.
METHODS: A randomised, single-blinded, placebo-controlled trial was performed as a pilot study. Seventy-eight patients with AR were included. Each patient was randomised to nasal irrigation with 80 mL of either 1.8% SPHNSI or 0.9% CINSI twice-daily for 4 weeks. Randomised codes were generated using a computer and a block of 4 procedure. The primary outcome was improvement of quality of life scores in Thai patients with allergic rhinoconjunctivitis (Rcq-36). Secondary outcomes were clinical symptoms using total nasal symptom scores (TNSS) and adverse events. All outcomes were assessed by blinded assessors at baseline, week 2, and week 4.
RESULTS: At week 4, nasal irrigation with 1.8% SPHNSI had significantly improved the Rcq-36 score (54% versus 50%; p < 0.032) and congestion symptom score (96% versus 84%; p < 0.018) compared to nasal irrigation with 0.9% CINSI. Adverse events were comparable for both groups at week 4.
CONCLUSIONS: This pilot study indicates that regular use of 1.8% SPHNSI in AR patients for 4 weeks is safe and has superior efficacy to 0.9% CINSI for alleviating congestion and improving quality of life scores.
OBJECTIVE: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications.
METHODS: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling.
RESULTS: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics).
CONCLUSION: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.
METHODS: A single-blind randomized controlled trial was carried out among 370 female undergraduate students from January 2011 to April 2012 in two selected public universities in Malaysia. Participants were randomized to either the intervention group or the control group. The educational program was delivered to the intervention group. The outcome measures were assessed at baseline, 6, and 12 months after implementing the health educational program. Chi-square, independent samples t-test and two-way repeated measures ANOVA (GLM) were conducted in the course of the data analyses.
RESULTS: Mean scores of knowledge on breast cancer (p<0.003), knowledge on breast self examination (p<0.001), benefits of BSE (p<0.00), barrier of BSE (0.01) and confidence of BSE practice (p<0.00) in the intervention group had significant differences in comparison with those of the control group 6 and 12 months after the intervention. Also, among those who never practiced BSE at baseline, frequency of BSE practice increased 6 and 12 months after the intervention (p<0.05).
CONCLUSION: The Breast Health Awareness program based on health the belief model had a positive effect on knowledge of breast cancer and breast self-examination and practice of BSE among females in Malaysia.
TRIAL REGISTRATION: The ANZCTR clinical trial registry ( ACTRN12616000831482 ), retrospectively registered on Jun 23, 2016 in ANZCTR.org.au.
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.
METHOD: A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses.
RESULTS: In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ2 = 0.66), psychological (p = 0.001, partial Ƞ2 = 0.65), social relationships (p = 0.001, partial Ƞ2 = 0.30), and environment (p = 0.001, partial Ƞ2 = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ2 = 0.23), depression (p = 0.000; partial Ƞ2 = 0.40).
CONCLUSION: The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy.
TRIAL REGISTRATION NUMBER: National Medical Research Register (NMRR) of Malaysia and given a registration number NMRR-12-1057-12,363 on 21 December 2012.
METHODS: This single-blind, prospective, randomized, controlled trial involved intraoperative measurements for 271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options. The difference between femoral component dimensions and the resected surface of distal femur was measured in millimeters at 5 distinct zones.
RESULTS: Overhang of standard femoral component was common in the anterior-medial condyle and anterior-lateral condyle ranging from 50.8% to 99.0% and 21.5% to 88.0%, respectively. With narrow femoral components, the rate of overhang reduced to 21.5%-30.2% and 9.2%-32.1%. Conversely, underhang rates were higher over the anterior flange width, middle medial-lateral and posterior medial-lateral zones. Standard components displayed higher underhang rates at these zones compared to narrow components. The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%. System with narrow option sizing increases the underhang rates in males, while improving the component fit among females at similar zones with rate ranging from 5.2% to 52.9%.
CONCLUSION: Currently available TKA implant designs may not provide a perfect match for the distal femoral shape of the Korean population. The availability of implants with standard and narrow options can substantially improve the optimal fitting of femoral components in the Korean population.
METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.
ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.
RESULTS: Participants in the RPG and CG reported a statistically significant reduction in knee pain and stiffness (p ≤ 0.05) within the group. The reduction in the scores of knee pain was higher in participants in the RPG than that in participants in the CG (p=0.001). Additionally, participants in the RPG reported greater satisfaction (p=0.001) and higher self-reported exercise adherence (p=0.010) and coordinator-reported exercise adherence (p=0.046) than the participants in the CG.
CONCLUSION: Short-term effects of the LLRP appear to reduce knee pain and stiffness only, but not physical function and BMI.