METHODS: A prospective, randomized, single-blinded clinical trial to assess the efficacy of autologous blood in place of fibrin glue in pterygium surgery. A total of 120 eyes of 111 patients were randomized according to pterygium morphology, to undergo pterygium surgery with autografting using either autologous blood or fibrin glue. All patients were operated by a single surgeon; 58 eyes were operated using fibrin glue and 62 eyes had a conjunctival autograft with autologous blood. Patients were seen on postoperative day 1, 1 week, 1 month, 6 months, and 1 year after surgery. Graft stability and pterygium recurrence were graded by an independent observer who was masked to the method of treatment.
RESULTS: All 120 eyes completed the 1-year follow-up. Graft loss was seen only in the autologous blood group. Of the 62 eyes in this group, a total of 15 (24.2%) grafts dislodged. Recurrence was calculated after excluding grafts that were dislodged. Of the 105 patients, there were a total of 7 recurrences, 2 (3.4%) from the fibrin adhesive method and 5 (10.6%) from the autologous blood method. This was not statistically significant (P = 0.238).
CONCLUSIONS: Autologous blood does not exhibit similar graft stability seen with fibrin glue. Although the recurrence rate may not be significant, careful patient selection and a standard method needs to be laid out before the use of this method is widely accepted.
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).
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.
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: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year.
RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction.
CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).
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
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.