METHOD: A single-blind cluster randomized controlled trial will conduct at six districts in Selangor. Randomly selected respondents who fulfilled the inclusion criteria will be invited to participate in the study. Health education module based on Health Believed Theory will be delivered via health talks and videos coordinated by liaison officers. Data at three-time points at baseline, immediate, and 3 months post-intervention will be collected. A validated questionnaire will assess participants' background characteristics, knowledge, skill, and preparedness on disaster preparedness and perception towards disaster. Descriptive and inferential statistics will be applied for data analysis using IBM Statistical Package for Social Sciences version 25. Longitudinal correlated data on knowledge, skills, preparedness, and perception score at baseline, immediate post-intervention, and 6 months post-intervention will be analyzed using Generalized Estimating Equations (GEE).
DISCUSSION: It is expected that knowledge, skills, preparedness, and flood disaster perception score are more significant in the intervention group than the control group, indicating the Health Education Based Intervention (HEBI).
TRIAL REGISTRATION: Thai Clinical Trial TCTR20200202002 .
METHODS: A two-armed, parallel, double-blinded, randomized, controlled trial, intervention and wait-list control groups will be conducted amongst 106 NCSM's cancer survivors. The programme is developed based on a Social Cognitive Theory that combines both psychoeducation and social media approaches to behavioural intervention. The duration of intervention will be 2 months, in which data will be collected at baseline, 2- month (immediately post-intervention) and 4-month. The primary outcome of the study is to determine the PA level of the participant which will be measured as METminutes/ week of PA using the International Physical Activity Questionnaire (IPAQ). There are four measurements of PA that are measured which are moderate and vigorous PA (MVPA) MET-minutes/week, light PA MET-minutes/week, moderate PA MET-minutes/week and vigorous PA METminutes/ week. A Generalised Estimating Equation (GEE) analysis will be used to evaluate the effectiveness of the intervention, adjusted for baseline covariates on both continuous and categorical outcomes. This study will utilize a significance level of 0.05 with a confidence interval of 95% for means estimation in rejecting null hypothesis. The trial registered to the Australian New Zealand Clinical Trials (ANZCTR) with the Registration Number, ACTRN12620000039987.
CONCLUSION: The programme will be useful as a supplementary prescription to assist policy makers to strengthen non-pharmacological cancer management options and to empower cancer survivors to be self-reliant and self-sufficient to include PA as part of their recovery process.
METHODS: We systematically searched PubMed, Cochrane Central Register of Controlled Trials, Google Scholar, and preprint repository databases (up to February 28, 2021). Random-effects and inverse variance heterogeneity meta-analysis were used to pool the odds ratio of individual trials. The risk of bias was appraised using Version 2 of the Cochrane risk-of-bias tool for randomized trials.
RESULTS: Six randomized controlled trials were included in this analysis with a total of 658 patients who were randomized to receive ivermectin and 597 patients randomized in the control group who did not receive ivermectin. Of six trials, four had an overall high risk of bias. The estimated effect of ivermectin indicated mortality benefits (pooled odds ratio = 0.21; 95% confidence interval 0.11-0.42, n = 1255), with some evidence against the hypothesis of 'no significant difference' at the current sample size.
CONCLUSION: We observed a preliminary beneficial effect on mortality associated with ivermectin use in patients with COVID-19 that warrants further clinical evidence in appropriately designed large-scale randomized controlled trials.
MATERIALS AND METHODS: Searches of electronic databases (PubMed, Embase, CINAHL, Cochrane) were undertaken for randomized controlled trials describing weight loss outcomes in adults at 5 years postoperatively. Where sufficient data was available to undertake meta-analysis, the Hartung-Knapp-Sidik-Jonkman estimation method for random effects model was utilized. The review was registered with PROSPERO and reported following in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
RESULTS: Five studies met the inclusion criteria totaling 1028 patients (LVSG=520, LRYGB=508). Moderate but comparable levels of bias were observed within studies. Statistically significant body mass index loss ranged from -11.37 kg/m (range: -6.3 to -15.7 kg/m) in the LVSG group and -12.6 kg/m (range: -9.5 to -15.4 kg/m) for LRYGB at 5 years (P<0.001). Systematic review suggested that LRYGB produced a greater weight loss expressed as percent excess weight and percent excess body mass index loss than LVSG: this was not corroborated in the meta-analysis.
CONCLUSIONS: Five year weight loss outcomes suggest both LRYGB and LVSG are effective in achieving significant weight loss at 5 years postoperatively, however, differences in reporting parameters limit the ability to reliably compare the outcomes using statistical methods. Furthermore, results may be impacted by large dropout rates and per protocol analysis of the 2 largest included studies. Further long-term studies are required to contradict or validate the results of this meta-analysis.
METHODS: A systematic literature search was performed in electronic databases to identify randomized controlled trials comparing the clinical outcomes between intermediate/ therapeutic anticoagulation and prophylactic anticoagulation. Meta-analyses with random-effects models were used to estimate the pooled odds ratio (OR) for outcomes of interest at a 95% confidence interval (CI).
RESULTS: Eight randomized controlled trials were included, with a total of 5405 hospitalized patients with COVID-19. The meta-analysis revealed no statistically significant difference in the odds of mortality (pooled OR = 0.92; 95% CI 0.71-1.19) but a statistically significant reduction in the odds of development of thrombotic events (pooled OR = 0.55; 95% CI 0.42-0.72), and significantly increased odds of development of major bleeding (pooled OR = 1.81; 95% CI 1.20-2.72) with the use of intermediate/therapeutic anticoagulation, relative to prophylactic anticoagulation. Subgroup analysis in patients with a severe course of COVID-19 observed a statistically significant reduction in the odds of development of thrombotic events (pooled OR = 0.66; 95% CI 0.45-0.98) but no significant difference in the odds of development of major bleeding events (pooled OR = 1.37; 95% CI 0.74-2.56), with the use of intermediate/therapeutic anticoagulation, relative to prophylactic anticoagulation.
CONCLUSION: There could be net clinical benefits with higher-intensity dosing of anticoagulation relative to prophylactic-dosing of anticoagulation among hospitalized patients with severe COVID-19.
METHODS: A systematic literature search was performed in electronic databases to identify eligible randomized controlled trials. Meta-analyses with the random-effects and IVhet models were used to estimate the pooled odds ratio (OR) for outcomes of interest with the administration of LR relative to NS, at 95% confidence intervals (CIs).
RESULTS: There was a significant reduction in the odds of intensive care unit admission and development of local complications, respectively, with the administration of LR among hospitalized patients with acute pancreatitis relative to administration of NS (pooled ORs, 0.33 [95% CI, 0.13-0.81] and 0.43 [95% CI, 0.21-0.89], respectively).
CONCLUSIONS: Our findings are able to assist clinicians in the navigation of the proper choice of fluid in patients with acute pancreatitis.
OBJECTIVE: To assess the evidence of health interventions in addressing inequity among migrants.
METHODS: We adopted a two-stage searching approach to ensure the feasibility of this review. First, reviews of interventions for migrants were searched from five databases: PubMed, Cochrane, CINAHL, PsycINFO, and EMBASE until June 2017. Second, full articles included in the identified reviews were retrieved. Primary studies included in the identified reviews were then evaluated as to whether they met the following criteria: experimental studies which include equity aspects as part of their outcome measurement, based on equity attributes defined by PROGRESS-Plus factors (place of residence, race/ethnicity, occupation, gender, religion, education, socio-economic status, social capital, and others). We analysed the information extracted from the selected articles based on the PRISMA-Equity guidelines and the PROGRESS-Plus factors.
RESULTS: Forty-nine reviews involving 1145 primary studies met the first-stage inclusion criteria. After exclusion of 764 studies, the remaining 381 experimental studies were assessed. Thirteen out of 381 experimental studies (3.41%) were found to include equity attributes as part of their outcome measurement. However, although some associations were found none of the included studies demonstrated the effect of the intervention on reducing inequity. All studies were conducted in high-income countries. The interventions included individual directed, community education and peer navigator-related interventions.
CONCLUSIONS: Current evidence reveals that there is a paucity of studies assessing equity attributes of health interventions developed for migrant populations. This indicates that equity has not been receiving attention in these studies of migrant populations. More attention to equity-focused outcome assessment is needed to help policy-makers to consider all relevant outcomes for sound decision making concerning migrants.
METHODS: Electronic databases (Pubmed, EMBASE, CINAHL) were searched for RCTs conducted in adults (>18y) that compared the 5-year- outcomes of LVSG to LRYGB and described comorbidity outcomes were included. Where data allowed, effect sizes were calculated using the Hartung-Knapp-Sidik-Jonkman estimation method for random effects model. Presence of bias was assessed with Cochrane Risk of Bias 2.0 and funnel plots, and certainty of evidence evaluated by GRADE. The study prospectively registered with PROSPERO (CRD42018112054).
RESULTS: Three RCTs (LVSG=254, LRYGB=255) met inclusion criteria and reported on chronic disease outcomes. Improvement and/or resolution of hypertension favoured LRYGB (odds ratio 0.49, 95% CI 0.29, 0.84; P =0.03). Trends favoring LRYGB were seen for type 2 diabetes and dysplidemia, and LVSG for sleep apnea and back/joint conditions ( P >0.05). The certainty of evidence associated with each assessed outcome ranged from low to very low, in the setting of 'some' to 'high' bias assessed as being present.
CONCLUSION: Both LRYGB and LVSG are effective in providing long-term improvements in commonly experienced obesity-related comorbidities; however, the limited certainty of the evidence does not allow for strong clinical conclusions to be made at this time regarding benefit of one procedure over the other.
OBJECTIVE: This review aimed to assess the influence of tai chi on postural stability and quality of life in older adults with abnormal gait.
METHOD: According to the literature retrieval principles, the works published from the inception date to May 2023 were retrieved, including the following databases: PubMed, Scopus, Web of Science, China National Knowledge Infrastructure, EBSCOhost, and Google Scholar. Subsequently, literature screening and quality assessment were performed.
RESULTS: A total of 16 randomized controlled trials were included in this study, Tai Chi intervention can affect populations with Parkinson's disease (PD), no exercise, mild cognitive impairment (MCI), chronic stroke, sedentary, fear of falling, or history of falling. Postural instability is associated with balance, gait, the Unified Parkinson's Disease Rating Scale Motor Subscale 3 (UPDRS III), mobility, lower body strength, and falls. Only two articles looked at quality of life. The Yang style is the most commonly used in the intervention. Nonetheless, most studies were performed on female participants, hence, more research on older male populations is needed.
CONCLUSION: Tai Chi intervention benefits postural balance in patients with gait disorders. 12 weeks is the most common intervention period for patients with gait disorders. The frequency of intervention is seven articles twice a week, and the intervention time is about 60 minutes. The Tai Chi intervention methods in this study involve Yang Style, Sun Style, Taoist Tai Chi, and Health Qigong Tai Chi, but the Yang Style Tai Chi intervention is the most widely used.
OBJECTIVES: The objectives of this systematic review and meta-analysis were to assess the efficacy, acceptability, and tolerability of nonstimulants in adults with ADHD.
METHODS: Data sources, searches, and study selection were based on a previously published network meta-analysis of randomized clinical trials (RCTs) by Cortese at al. (Lancet Psychiatry 5(9):727-738, 2018), which we updated in March 2022. Specifically, we searched PubMed, BIOSIS Previews, CINAHL, the Cochrane Central Register of Controlled Trials, EMBASE, ERIC, MEDLINE, PsycINFO, OpenGrey, Web of Science Core Collection, ProQuest Dissertations and Theses (UK and Ireland), ProQuest Dissertations and Theses (abstracts and international), and the WHO International Trials Registry Platform, including ClinicalTrials.gov for double-blind RCTs with a placebo arm, lasting at least one week, including adults with a diagnosis of ADHD based on DSM-III, DSM-III-R, DSM-IV(TR), DSM-5 or ICD-9- or 10, and reporting data on efficacy, tolerability (drop-out due to side effects) and acceptability (drop-out due to any cause) of guanfacine, clonidine, or atomoxetine. Additionally, we searched for RCTs of viloxazine extended release (ER), approved for ADHD in 2021. Random-effects meta-analyses were conducted, and the risk of bias for individual RCTs was assessed using the Cochrane Risk of Bias tool.
RESULTS: We included 18 studies in the meta-analyses (4308 participants) plus one additional study in the narrative synthesis (374 participants). The meta-analysis showed that atomoxetine (15 RCTs) (Hedge's g = - 0.48, 95% CI [- 0.64; - 0.33]), guanfacine (two RCTs) (Hedge's g = - 0.66, 95% CI [- 0.94; - 0.38]) and viloxazine ER (one RCT) were significantly more efficacious than placebo. Atomoxetine was less well tolerated than placebo, while tolerability of guanfacine and viloxazine ER could not be meta-analysed, since only one study, for each medication, reported on it.
CONCLUSIONS: All investigated nonstimulants were more efficacious in the treatment of ADHD in adults, than placebo, while the placebo had better acceptability and tolerability.
PROTOCOL: https://osf.io/5vnmt/?view_only=2bf87ed12ba94645babedceeee4c0120 .
MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, and parallel design trial will be carried out in a public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n = 30) or a placebo (n = 30). The intervention is carried out using press needle or press placebo on abdomen area (10 sessions of treatment). Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (-week 0), and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQoL will be measured at the time of recruitment (-week 0), after completion of 5 sessions (week 3/4), and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit.
DISCUSSION: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQoL of type 2 diabetes mellitus.
TRIAL REGISTRATION NUMBER: NCT04829045.
OBJECTIVE: This scoping review aimed to map the factors influencing cardiopulmonary resuscitation skills retention among healthcare providers.
METHODS: A literature search was conducted using the Web of Sciences, Scopus, Cochrane, Google Scholar and PubMed electronic databases. The inclusion criteria were original publications published during the last five years (2018 - 2022), availability of full texts in English and evidence of the retention of pertinent cardiopulmonary resuscitation in terms of knowledge and abilities.
RESULTS: Three cross-sectional studies, two prospective studies, one each of prospective descriptive-analytical study, randomised controlled trial, intervention and prospective interventional study, prospective pre-post study, retrospective study, cluster randomised control trial and randomised education trial study comprise the 14 publications including in this study. The thematic analysis identified four major themes that influence the retention of cardiopulmonary resuscitation skills: experience, training type, training frequency and other factors. The final theme identified infrastructure access, evidence-based practice review meetings and healthcare providers' educational background.
CONCLUSION: To retain skills in cardiopulmonary resuscitation, healthcare providers must be regularly updated and trained on the latest cardiopulmonary resuscitation guidelines.
METHODS AND RESULTS: Data from two HF registries and five HFrEF RCTs were used to create three subpopulations: one RCT population (n = 16 917; 21.7% females), registry patients eligible for RCT inclusion (n = 26 104; 31.8% females), and registry patients ineligible for RCT inclusion (n = 20 810; 30.2% females). Clinical endpoints included all-cause mortality, cardiovascular mortality, and first HF hospitalization at 1 year. Males and females were equally eligible for trial enrolment (56.9% of females and 55.1% of males in the registries). One-year mortality rates were 5.6%, 14.0%, and 28.6% for females and 6.9%, 10.7%, and 24.6% for males in the RCT, RCT-eligible, and RCT-ineligible groups, respectively. After adjusting for 11 HF prognostic variables, RCT females showed higher survival compared to RCT-eligible females (standardized mortality ratio [SMR] 0.72; 95% confidence interval [CI] 0.62-0.83), while RCT males showed higher adjusted mortality rates compared to RCT-eligible males (SMR 1.16; 95% CI 1.09-1.24). Similar results were also found for cardiovascular mortality (SMR 0.89; 95% CI 0.76-1.03 for females, SMR 1.43; 95% CI 1.33-1.53 for males).
CONCLUSION: Generalizability of HFrEF RCTs differed substantially between the sexes, with females having lower trial participation and female trial participants having lower mortality rates compared to similar females in the registries, while males had higher than expected cardiovascular mortality rates in RCTs compared to similar males in registries.
METHODS AND ANALYSIS: This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3 months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke.
ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication.
TRIAL REGISTRATION NUMBER: Protocol was registered at ClinicalTrials.gov (NCT05157347) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.
Settings and Design: Randomized Controlled Trial.
Materials and Methods: Fifty-two edentulous participants treated with mandibular overdentures using either single implant (n = 26) or two implants (n = 26) with immediate loading protocol by a single operator. The low-profile stud-attachments (LOCATOR; Zest Anchors) were attached to the implants and female attachments were picked up within 0-7 days of implant placement. The OHRQoL was recorded using Oral Health Impact Profile-14 (OHIP-14) questionnaire either in English or in the Malay language before treatment and 1 month and 1 year after treatment.
Statistical Analysis Used: Kruskal Wallis test was used to find out significant difference amongst 3 timepoints and 7 OHIP-14 domains and Mann-Whitney-U test to compare 1IMO or 2IMO groups.
Results: Compared to baseline OHIP-14 scores, participants had a statistically significant decrease in total OHIP-14 at 1 month and 1 year after-treatment time points in both 1IMO and 2IMO groups (P < 0.05). The difference between 1 month and 1 year after-treatment total and subscale scores were also found to be statistically significant (P < 0.05). The overall QoL improvement was comparatively higher in 2IMO group than 1IMO group. The OHIP-14 scores were statistically different within seven domains (P < 0.05). Overall total scores between 1IMO and 2IMO groups were also found to be statistically significant (P < 0.05) at baseline and insignificant (P > 0.05) at 1 month and 1 year.
Conclusions: Mandibular single and 2IMO improve the QoL of elderly edentulous Malaysian participants at 1 month of immediate loading and 1 year of recall. 1IMO may provide comparable QoL with the elderly patients using 2 implants.