METHODS: A systematic literature search in eight databases from January 2000 to July 2023 focusing on RCTs that compared a pharmacological intervention with a placebo for enhancing sleep in people with AD. The authors registered the study protocol at Prospero, followed the PRISMA guidelines, and produced the pooled estimates using random-effect or IVhet models.
RESULTS: Eight different interventions and 29 different sleep outcomes were examined in 14 RCTs included in this review. Eszopiclone positively affected sleep efficiency, as did orexin antagonists. However, there was no difference when melatonin was used. The interventions demonstrated low discontinuation rates and a few adverse drug reactions.
CONCLUSION: Although melatonin was the most investigated intervention, the evidence for its efficacy is inconclusive. On the other hand, trazodone and orexin receptor antagonists showed promising results; however, more RCTs are needed for definite answers.
METHOD: This is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value
METHODS: A pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants.
DISCUSSION: Results from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections.
ETHICS AND DISSEMINATION: Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences.
TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.
METHODS: In two phase 3 trials, we assessed iptacopan monotherapy over a 24-week period in patients with hemoglobin levels of less than 10 g per deciliter. In the first, anti-C5-treated patients were randomly assigned to switch to iptacopan or to continue anti-C5 therapy. In the second, single-group trial, patients who had not received complement inhibitors and who had lactate dehydrogenase (LDH) levels more than 1.5 times the upper limit of the normal range received iptacopan. The two primary end points in the first trial were an increase in the hemoglobin level of at least 2 g per deciliter from baseline and a hemoglobin level of at least 12 g per deciliter, each without red-cell transfusion; the primary end point for the second trial was an increase in hemoglobin level of at least 2 g per deciliter from baseline without red-cell transfusion.
RESULTS: In the first trial, 51 of the 60 patients who received iptacopan had an increase in the hemoglobin level of at least 2 g per deciliter from baseline, and 42 had a hemoglobin level of at least 12 g per deciliter, each without transfusion; none of the 35 anti-C5-treated patients attained the end-point levels. In the second trial, 31 of 33 patients had an increase in the hemoglobin level of at least 2 g per deciliter from baseline without red-cell transfusion. In the first trial, 59 of the 62 patients who received iptacopan and 14 of the 35 anti-C5-treated patients did not require or receive transfusion; in the second trial, no patients required or received transfusion. Treatment with iptacopan increased hemoglobin levels, reduced fatigue, reduced reticulocyte and bilirubin levels, and resulted in mean LDH levels that were less than 1.5 times the upper limit of the normal range. Headache was the most frequent adverse event with iptacopan.
CONCLUSIONS: Iptacopan treatment improved hematologic and clinical outcomes in anti-C5-treated patients with persistent anemia - in whom iptacopan showed superiority to anti-C5 therapy - and in patients who had not received complement inhibitors. (Funded by Novartis; APPLY-PNH ClinicalTrials.gov number, NCT04558918; APPOINT-PNH ClinicalTrials.gov number, NCT04820530.).
METHOD: A comprehensive search of Medline, Embase, Web of Science, and the Cochrane Library was conducted from database inception to October, 2023. Included studies were randomized controlled trials (RCTs) reporting the effects of exercise on JIA patients. Two independent reviewers assessed the literature quality using the Cochrane Collaboration's risk of bias tool. Standardized mean differences (SMD) were combined using random or fixed effects models. The level of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
RESULT: Five RCTs met the inclusion criteria, containing 216 female participants and 90 males. The meta-analysis results showed that exercise had no significant effect on JIA patients based on the Child Health Assessment Questionnaire (CHAQ) (SMD=-0.32, 95%CI: -0.83, 0.19; I2 = 73.2%, P = 0.011) and Quality of Life (QoL) (SMD = 0.27, 95%CI: -0.04, 0.58; I2 = 29.4%, P = 0.243) and no significant effect on peak oxygen uptake (VO2peak). However, exercise significantly reduced visual analog scale (VAS) pain scores in JIA patients (SMD = 0.50, 95%CI: -0.90, -0.10; I2 = 50.2%, P = 0.134). The quality of evidence assessed by GRADE was moderate to very low.
CONCLUSION: Exercise does not significantly affect the quality of life and exercise capacity in JIA patients but may relieve pain. More RCTs are needed in the future to explore the effects of exercise on JIA.
METHODS: This protocol was drafted in agreement with the ROBUST-statement, and is submitted for publication before database lock and primary data analysis. The primary outcome is health-related quality of life as measured by the EQ-5D-5L health utility score and is longitudinally assessed. Secondary outcomes comprise the 6-min walking test and handgrip strength over the entire follow-up period (longitudinal analyses), and 60-day mortality, duration of mechanical ventilation, and EQ-5D-5L health utility scores at 30, 90 and 180 days (cross-sectional). All analyses will primarily be performed under weakly informative priors. When available, informative priors elicited from contemporary literature will also be incorporated under alternative scenarios. In all other cases, objectively formulated skeptical and enthusiastic priors will be defined to assess the robustness of our results. Relevant identified subgroups were: patients with acute kidney injury, severe multi-organ failure and patients with or without sepsis. Results will be presented as absolute risk differences, mean differences, and odds ratios, with accompanying 95% credible intervals. Posterior probabilities will be estimated for clinically important benefit and harm.
DISCUSSION: The proposed secondary, pre-planned Bayesian analysis of the PRECISe trial will provide additional information on the effects of high protein on functional and clinical outcomes in critically ill patients, such as probabilistic interpretation, probabilities of clinically important effect sizes, and the integration of prior evidence. As such, it will complement the interpretation of the primary outcome as well as several secondary and subgroup analyses.
OBJECTIVE: The systematic review and meta-analysis in this study aimed to explore the effect of exercise intervention on health-related quality of life of colorectal cancer survivors.
METHODS: The current study followed guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020) to identify relevant literature. Comprehensive searches were conducted using EBSCOhost, Web of Science (WOS), Scopus, Science Direct, and PubMed. The inclusion criteria included are randomised control trials studies written in English, with no restrictions for the time of publication that reported the effects of exercise intervention on health-related quality of live among colorectal cancer survivors. Meta-analysis was conducted by pooling the mean and standard deviation of post-intervention scores across randomised control trial studies using a random effects model.
RESULT: A total of 467 articles were identified but only seven articles were randomised control trials (RCT) (n = 7) with PEDro scores ranging from 6 to 9 showing good internal validity were included in the review. The results of the meta-analysis of pooled data from six RCTs studies on HRQoL showed no significant effect of exercise intervention on HRQoL in the intervention group compared to control group [SMD = 0.25; 95% CI; -0.0, 0.51; Z = 1.88; p = 0.06; I2 = 30.8%].
CONCLUSION: This meta-analysis provides key insights into the effect of exercise on the health-related quality of life (HRQoL) of colorectal cancer (CRC) survivors. Therefore, more experimental studies should be carried out with rigorous methodology to evaluate the effectiveness of exercise interventions before it is recommended as a routine activity in post-treatment management for CRC survivors.
METHODS: This is a post hoc analysis of a cluster-randomized clinical trial that assesses the effect of implementing a feeding protocol on mortality in critically ill patients. Patients who stayed in the ICUs for at least 7 days and received exclusive EN were included in this analysis. Multivariable Cox hazard regression models and restricted cubic spline models were used to assess the relationship between the different doses of EN delivery and 28-day mortality. Subgroups with varying lactate levels at enrollment were additionally analyzed to address the potential confounding effect brought in by the presence of shock-related hypoperfusion.
RESULTS: Overall, 1322 patients were included in the analysis. The median (interquartile range) daily energy and protein delivery during the first week of enrollment were 14.6 (10.3-19.6) kcal/kg and 0.6 (0.4-0.8) g/kg, respectively. An increase of 5 kcal/kg energy delivery was associated with a significant reduction (approximately 14%) in 28-day mortality (adjusted hazard ratio [HR] = 0.865, 95% confidence interval [CI]: 0.768-0.974, P = 0.016). For protein intake, a 0.2 g/kg increase was associated with a similar mortality reduction with an adjusted HR of 0.868 (95% CI 0.770-0.979). However, the benefits associated with enhanced nutrition delivery could be observed in patients with lactate concentration ≤ 2 mmol/L (adjusted HR = 0.804 (95% CI 0.674-0.960) for energy delivery and adjusted HR = 0.804 (95% CI 0.672-0.962) for protein delivery, respectively), but not in those > 2 mmol/L.
CONCLUSIONS: During the first week of critical illness, enhanced nutrition delivery is associated with reduced mortality in critically ill patients receiving exclusive EN, only for those with lactate concentration ≤ 2 mmol/L.
TRIAL REGISTRATION: ISRCTN12233792, registered on November 24, 2017.
METHODS: From personal files, citation searching, and three databases searched up to 29-5-2023, we included randomized controlled trials (RCTs) of adult critically ill patients that compared higher vs lower protein delivery with similar energy delivery between groups and reported clinical and/or patient-centred outcomes. We conducted random-effect meta-analyses and subsequently trial sequential analyses (TSA) to control for type-1 and type-2 errors. The main subgroup analysis investigated studies with and without combined early physical rehabilitation intervention. A subgroup analysis of AKI vs no/not known AKI was also conducted.
RESULTS: Twenty-three RCTs (n = 3303) with protein delivery of 1.49 ± 0.48 vs 0.92 ± 0.30 g/kg/d were included. Higher protein delivery was not associated with overall mortality (risk ratio [RR]: 0.99, 95% confidence interval [CI] 0.88-1.11; I2 = 0%; 21 studies; low certainty) and other clinical outcomes. In 2 small studies, higher protein combined with early physical rehabilitation showed a trend towards improved self-reported quality-of-life physical function measurements at day-90 (standardized mean difference 0.40, 95% CI - 0.04 to 0.84; I2 = 30%). In the AKI subgroup, higher protein delivery significantly increased mortality (RR 1.42, 95% CI 1.11-1.82; I2 = 0%; 3 studies; confirmed by TSA with high certainty, and the number needed to harm is 7). Higher protein delivery also significantly increased serum urea (mean difference 2.31 mmol/L, 95% CI 1.64-2.97; I2 = 0%; 7 studies).
CONCLUSION: Higher, compared with lower protein delivery, does not appear to affect clinical outcomes in general critically ill patients but may increase mortality rates in patients with AKI. Further investigation of the combined early physical rehabilitation intervention in non-AKI patients is warranted.
PROSPERO ID: CRD42023441059.
OBJECTIVE: This systematic review and meta-analysis aimed to determine the effectiveness of mobile applications on medication adherence, functional outcomes, cardiovascular risk factors, quality of life and knowledge on stroke in stroke survivors.
METHODS: A review of the literature was conducted using key search terms in PubMed, EMBASE, Cochrane and Web of Science databases until 16 March 2023 to identify eligible randomized controlled trials (RCTs) or controlled clinical trial (CCTs) of mobile application interventions among stroke survivors. Two reviewers independently screened the literature in accordance with the eligibility criteria and collected data from the articles included. Outcomes included medication adherence,functional outcomes,cardiovascular risk factors, quality of life,and knowledge of stroke.
RESULTS: Twenty-three studies involving 2983 participants across nine countries were included in this review. Sixteen trials involved health care professionals in app use, and seven trials reported measures to ensure app-based intervention adherence. Mobile applications targeting stroke survivors primarily encompassed three areas: rehabilitation, education and self-care. The participants in the studies primarily included young and middle-aged stroke survivors. Meta-analysis results demonstrated that mobile application intervention significantly improved trunk control ability (mean differences [MD] 3.00, 95% CI [1.80 to 4.20]; P
BACKGROUND: AVFs are preferred for haemodialysis access but are limited by high rates of early failure.
METHODS: A post hoc analysis of 353 participants from ANZ and Malaysia included in the FAVOURED randomised-controlled trial undergoing de novo AVF surgery was performed. Composite AVF failure (thrombosis, abandonment, cannulation failure) and its individual components were compared between ANZ (n = 209) and Malaysian (n = 144) participants using logistic regression adjusted for patient- and potentially modifiable clinical factors.
RESULTS: Participants' mean age was 55 ± 14.3 years and 64% were male. Compared with ANZ participants, Malaysian participants were younger with lower body mass index, higher prevalence of diabetes mellitus and lower prevalence of cardiovascular disease. AVF failure was less frequent in the Malaysian cohort (38% vs 54%; adjusted odds ratio (OR) 0.53, 95% confidence interval (CI) 0.31-0.93). This difference was driven by lower odds of cannulation failure (29% vs 47%, OR 0.45, 95% CI 0.25-0.80), while the odds of AVF thrombosis (17% vs 20%, OR 1.24, 95% CI 0.62-2.48) and abandonment (25% vs 23%, OR 1.17, 95% CI 0.62-2.16) were similar.
CONCLUSIONS: The risk of AVF failure was significantly lower in Malaysia compared to ANZ and driven by a lower risk of cannulation failure. Differences in practice patterns, including patient selection, surgical techniques, anaesthesia or cannulation techniques may account for regional outcome differences and warrant further investigation.
METHODS: To achieve this goal, a systematic literature search was conducted in several databases, including Web of Science, ScienceDirect (EBSCO), SpringerLink, PubMed, and Wiley Online Library. The inclusion criteria were strictly implemented to ensure the quality of the studies included in the meta-analysis. In the end, a total of 5 studies, with 139 participants diagnosed with IGD and 139 healthy controls, were included in the analysis.
RESULTS: Meta-analysis revealed large effect sizes of N2 and P3 amplitudes in individuals with IGD, indicating that these two ERP components could be potential indicators of inhibitory control ability. Specifically, the N2 and P3 amplitude was significantly larger in individuals with IGD than in the healthy control group, suggesting deficits in inhibitory control function and increased impulsivity in the IGD group. In the inhibition control task, the IGD group required more cognitive resources to suppress impulsive responses.
CONCLUSION: Overall, the findings of this meta-analysis shed light on the potential use of N2 and P3 amplitudes as reliable indicators of inhibitory control ability in individuals with IGD. The results provide crucial insights into the neural mechanisms underlying inhibitory control impairment in IGD, which could inform the development of effective interventions for this condition. Further research is needed to explore the functional significance of these ERP components and their potential clinical applications in the diagnosis and treatment of IGD.
AIMS: This study aims to develop and evaluate the effectiveness of the safety and health programme TRIMOSH (Theory-Based Intervention Module on Occupational Safety and Health) in improving the knowledge, attitude, and practice among food industry workers.
METHODS: TRIMOSH intervention study is a two-arm randomised, single-blinded, controlled, parallel trial that will be conducted among food industry workers in Selangor, Malaysia. In a partnership with Food Handler Training Schools in Selangor, 10 pairs of Food Handler Training Schools with 12 participants per group (n = 240) will be recruited for balanced randomisation intervention and control conditions. Furthermore, data collection of all participants was conducted at four time points: baseline (T0), immediately (T1), one month (T2), and three months (T3) post-intervention. Generalised Linear Mixed Model (GLMM) will be conducted to determine the effects of intervention within and between study groups. Subsequently, the primary outcomes increase the knowledge, attitude, and practice (KAP) of safety and health at food premises. Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on October 2022 with the ClinicalTrials.gov Identifier: NCT05571995. This study has also been approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia (JKEUPM-2022-346). All participants are required to provide consent prior to participation.
CONCLUSIONS: The characteristics of the respondents are expected to show no difference between the groups. It is hypothesised that TRIMOSH is effective in improving the knowledge, attitude, and practices of food industry workers in Selangor. The results will be reported and presented in international peer-reviewed journals, conferences, and other platforms. In addition, the TRIMOSH programme will be offered at the national level by the relevant authorities for the benefit of food industry workers.
METHODS AND ANTICIPATED RESULTS: A cluster randomized controlled study will be conducted, involving 250 Middle Eastern adolescents, in Arabic schools in Malaysia. The participants will be randomly assigned to the intervention and control groups. While the intervention group participates in six weeks of fortnightly six sessions (45 minutes per session), the control group will carry on with their regular curriculums, and normal physical activity routines. The variables which will be evaluated include anthropometric measurements, knowledge, attitude, daily routines, physical activity, sedentary behaviour, food assessment, eating attitudes test-26, and a structured questionnaire based on the HBM. Data will be collected from the intervention and control groups at baseline, post-intervention, and two months following the intervention. Data analysis will be performed by way of the SPSS Statistics software version 26. The generalized estimating equation (GEE) will be used, to test the effect of the intervention program, with regards to the selected variables (outcomes), between and within-group at baseline, as well as six weeks and two months following intervention, after adjusting for clustering. Outcomes will be assessed at each time point, along with a derived average over all three-time points; thus, ensuring that both the cumulative and overall effects are determined.
CONCLUSIONS: This trial will provide useful information for improving the knowledge, attitude, and practices of Middle Eastern adolescents, with regards to body weight status, physical activity level, nutrition status (BMI and dietary intake), and disordered eating. This will go a long way, towards ensuring their adherence to appropriate physical activities, and a healthy diet, to keep non-communicable diseases at bay.
TRIAL REGISTRATION: This study is registered at NCT: NCT05694143.
METHODS: A total of five international databases including PubMed, SCOPUS, Web of Science, CINAHL Plus, and EBSCOhost were searched with keywords related to "active video games," "physical activity," and "obese college students" from July 2022. A systematic review was conducted using the PRISMA guidelines and randomised controlled trial (RCT) studies that met the inclusion criteria were included. Furthermore, the quality assessment of the studies was measured using the PEDro scale.
RESULTS: One thousand and twenty-three articles were retrieved, of which eight randomised controlled trial studies met the inclusion criteria. AVGs can reduce sedentary behaviour and positively affect physical activity, time spent on moderate-to-vigorous physical activity (MVPA), positive psychological factors, and game attendance rate. Combining AVGs with other assistive devices (such as mini-trampolines and stationary bikes) can enhance the effects of AVGs and provide greater physiological stimulation. Different types of AVGs and game modes can achieve different emotional responses, physiological stimulation, and physical activity levels.
CONCLUSION: The research findings prove that AVGs can be a viable intervention to increase physical activity in overweight or obese college students, ultimately reaching the recommended physical activity level(PAL). Physical activity can be further increased by incorporating assistive devices or using features supported by self-determination theory (SDT). As a new modality, AVGs could be a potential alternative to traditional physical activity.Systematic Review Registration:https://www.crd.york.ac.uk/prospero, identifier: CRD42022363993.
MATERIAL AND METHODS: This cluster randomised controlled trial (RCT) will involve 207 Arab students (14-18 years old) from 12 Arabic schools in the Klang Valley. The schools will be assigned randomly to an intervention (online life skills programme) or control group at a 1:1 ratio. The researcher will deliver eight one-hour sessions to the intervention group weekly. The control group will receive the intervention at the evaluation end. Both groups will complete assessments at baseline, and immediately and three months after the intervention. The primary outcome is anxiety, depression, and stress [Depression Anxiety and Stress Scale-21 (DASS-21)]. The secondary outcomes are self-efficacy (General Self-Efficacy Scale) and coping skills (Brief COPE Inventory). Data analysis will involve the Generalised Estimation Equation with a 95% confidence interval. P < .05 will indicate significant inter- and intra-group differences.
DISCUSSION: This will be the first cluster RCT of an online life skills education programme involving Arab adolescent migrants in Malaysia. The results could support programme effectiveness for improving the participants' mental health problems (depression, anxiety, stress), increasing their self-efficacy, and enhancing their coping skills. The evidence could transform approaches for ameliorating migrant children and adolescents' mental well-being.
TRIAL REGISTRATION: The study is registered with the Clinical Trial Registry (Identifier: NCT05370443).