METHODS AND ANALYSIS: The study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5-8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.
ETHICS AND DISSEMINATION: The project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.
OBJECTIVES: Our main objective was to evaluate the effectiveness and safety of TES when employed to improve bowel function and constipation-related symptoms in children with constipation.
SEARCH METHODS: We searched MEDLINE (PubMed) (1950 to July 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 7, 2015), EMBASE (1980 to July 2015), the Cochrane IBD Group Specialized Register, trial registries and conference proceedings to identify applicable studies .
SELECTION CRITERIA: Randomized controlled trials that assessed any type of TES, administered at home or in a clinical setting, compared to no treatment, a sham TES, other forms of nerve stimulation or any other pharmaceutical or non-pharmaceutical measures used to treat constipation in children were considered for inclusion.
DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for inclusion, extracted data and assessed risk of bias of the included studies. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for categorical outcomes data and the mean difference (MD) and corresponding 95% CI for continuous outcomes.
MAIN RESULTS: One study from Australia including 46 children aged 8 to 18 years was eligible for inclusion. There were multiple reports identified, including one unpublished report, that focused on different outcomes of the same study. The study had unclear risk of selection bias, high risks of performance, detection and attrition biases, and low risks of reporting biases.There were no significant differences between TES and the sham control group for the following outcomes: i).number of children with > 3 complete spontaneous bowel movements (CSBM) per week (RR 1.07, 95% CI 0.74 to 1.53, one study, 42 participants) (
QUALITY OF EVIDENCE: very low, due to high risk of bias and serious imprecision ), ii). number of children with improved colonic transit assessed radiologically (RR 5.00, 95% CI 0.79 to 31.63; one study, 21 participants) (
QUALITY OF EVIDENCE: very low, due to high risk of bias, serious imprecision and indirectness of the outcome). However, mean colonic transit rate, measured as the position of the geometric centre of the radioactive substance ingested along the intestinal tract, was significantly higher in children who received TES compared to sham (MD 1.05, 95% CI 0.36 to 1.74; one study, 30 participants) (
QUALITY OF EVIDENCE: very low, due to high risk of bias , serious imprecision and indirectness of the outcome). There was no significant difference between the two groups in the number of children with improved soiling-related symptoms (RR 2.08, 95% CI 0.86 to 5.00; one study, 25 participants) (
QUALITY OF EVIDENCE: very low, due to high risk of bias and serious imprecision). There was no significant difference in the number of children with improved quality of life (QoL) (RR 4.00, 95% CI 0.56 to 28.40; one study, 16 participants) (
QUALITY OF EVIDENCE: very low, due to high risk of bias issues and serious imprecision ). There were also no significant differences in in self-perceived (MD 5.00, 95% CI -1.21 to 11.21) or parent-perceived QoL (MD -0.20, 95% CI -7.57 to 7.17, one study, 33 participants for both outcomes) (QUALITY OF EVIDENCE for both outcomes: very low, due to high risk of bias and serious imprecision). No adverse effects were reported in the included study.
AUTHORS' CONCLUSIONS: The very low quality evidence gathered in this review does not suggest that TES provides a benefit for children with chronic constipation. Further randomized controlled trials assessing TES for the management of childhood constipation should be conducted. Future trials should include clear documentation of methodologies, especially measures to evaluate the effectiveness of blinding, and incorporate patient-important outcomes such as the number of patients with improved CSBM, improved clinical symptoms and quality of life.
METHODS: Nine databases were searched through November 2017. Randomized controlled trials that reported the smoking cessation effect of V. cinerea were included. Data were extracted by two independent researchers. Study quality was assessed using the Cochrane risk of bias and JADAD score. The estimates of pooled effects were calculated as relative risk (RR) with 95% CI using a random-effects model.
RESULTS: Five trials with 347 smokers were included. V. cinerea treatment group was significantly associated with cessation rate higher than that in the control group with no evidence of heterogeneity for both continuous abstinence rate (CAR) at week 8 with risk ratio (RR): 1.69, 95% CI [1.00, 2.86]; week 12 RR: 2.18, 95% CI [1.17, 4.04]) and 7-day point prevalence abstinence rate (PAR) (week 8 RR: 1.51, 95% CI [1.01, 2.27]; week 12 RR: 1.93, 95% CI [1.24, 2.99]) at week 8 and 12, respectively. There was no significant difference of all adverse events between the treatment and the control groups.
CONCLUSION: Our study demonstrates that V. cinerea has potential efficacy for smoking cessation. Further well-design RCTs of standardized V. cinerea compared with standard treatment should be conducted to strengthen this evidence.
METHODS: Electronic databases including CENTRAL, CINAHL, EMBASE, MEDLINE were searched up to April 2018 for relevant RCTs. Journal and conference proceedings were also searched. Two review authors independently selected trials, extracted data, assessed the risks of bias in included trials and graded the quality of evidence. Meta-analyses were conducted for studies presenting similar outcomes.
RESULTS: Ten RCTs involving 1164 participants were included. These RCTs varied in terms of patients' grade of haemorrhoids, length of trials, and outcome assessed. Most of the studies did not describe adequately the process of randomisation and allocation concealment. The pooled analysis of data from three studies indicated that there was significant difference between groups for the bleeding outcome, favoring the MPFF group (RR 1.46; 95% CI 1.10-1.93; p = 0.008). Except for bleeding, the current evidence did not show MPFF has significant effects on all the other outcomes examined when compared with placebo. Even then, the quality of evidence for bleeding was judged as low due to the small number and inconsistent results among the included studies.
CONCLUSION: This review highlights the need for further rigorous research if MPFF was to be routinely used for the treatment of haemorrhoid symptoms.
MATERIAL AND METHODS: Randomized controlled trials evaluating the effects of these 2 treatment modalities were searched from PubMed and other electronic databases between January 1991 and July 2018. The outcome variables analyzed included operating time, complications, recurrence of HH or wrap migration, reoperation, hospital stay and quality of life.
RESULTS: Five randomized controlled trials totaling 478 patients (suture=222, mesh=256) were analyzed. For reoperation variable, the odds ratio was significantly 3.26 times higher for the suture group. For recurrence of HH, the odds ratio for the suture group was nonsignificantly 1.65 times higher compared with the mesh group. Comparable effects were noted for all other variables.
CONCLUSIONS: Mesh repair seems to be superior to suture cruroplasty for large HH repair. Therefore, the routine use of mesh may be advantageous in selected cases.
METHODS: PubMed, EBSCOhost, and Scopus databases were searched. Additional searching was performed in clinical trial registry, reference lists of systematic reviews, and textbooks. Randomized clinical trials (RCTs) published in the English language through October 2017 comparing the success of pulpotomies in vital primary molars with a follow-up of at least 6 months were selected. Study selection, data extraction, and risk of bias assessment were performed. MA by random effects model, TSA, and GRADE were performed.
RESULTS: Eight RCTs (n = 474) were included. Two RCTs had low risk of bias. No significant difference was observed between MTA and BD in clinical success at 6 months (risk ratio [RR], 1.00; 95% confidence interval [95% CI], 0.97-1.02; I2 = 0%), 12 months (RR, 1.00; 95% CI, 0.96-1.05; I2 = 0%), and 18 months (RR, 1.00; 95% CI, 0.93-1.08; I2 = 0%). No difference was observed in radiographic success at follow-up of 6 months (RR, 0.99; 95% CI, 0.96-1.02; I2 = 0%), 12 months (RR, 1.02; 95% CI, 0.47-2.21; I2 = 0%), and 18 months (RR, 1.02; 95% CI, 0.91-1.15; I2 = 0%). TSA indicated lack of firm evidence for the results of the meta-analytic outcomes on clinical and radiographic success. GRADE assessed the evidence from the MA comparing the effect of MTA and BD in pulpotomy to be of low quality.
CONCLUSION: BD and MTA have similar clinical and radiographic success rates based on limited and low-quality evidence. Future high-quality RCTs between MTA and BD is required to confirm the evidence.
METHODS AND ANALYSIS: A 2×2 cross-over randomised mechanistic dietary trial will allocate 16 participants with NAFLD to a 2-week either HGI or LGI diet followed by a 4-week wash-out period and then the LGI or HGI diet, alternative to that followed in the first 2 weeks. Baseline and postintervention (four visits) outcome measures will be collected to assess liver fat content (using MRI/S and controlled attenuation parameter-FibroScan), gut microbiota composition (using 16S RNA analysis) and blood biomarkers including glycaemic, insulinaemic, liver, lipid and haematological profiles, gut hormones levels and short-chain fatty acids.
ETHICS AND DISSEMINATION: Study protocol has been approved by the ethics committees of The University of Nottingham and East Midlands Nottingham-2 Research Ethics Committee (REC reference 19/EM/0291). Data from this trial will be used as part of a Philosophy Doctorate thesis. Publications will be in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT04415632.
METHODS: We systematically searched PubMed, Cochrane Central Register of Controlled Trials, Google Scholar, and medRxiv (preprint repository) databases (up to 7 January 2021). Pooled effect sizes with 95% confidence interval (CI) were generated using random-effects and inverse variance heterogeneity models. The risk of bias of the included RCTs was appraised using version 2 of the Cochrane risk-of-bias tool for randomized trials.
RESULTS: Six RCTs were included: two trials with an overall low risk of bias and four trials had some concerns regarding the overall risk of bias. Our meta-analysis did not find significant mortality benefits with the use of tocilizumab among patients with COVID-19 relative to non-use of tocilizumab (pooled hazard ratio = 0.83; 95% CI 0.66-1.05, n = 2,057). Interestingly, the estimated effect of tocilizumab on the composite endpoint of requirement for mechanical ventilation and/or all-cause mortality indicated clinical benefits, with some evidence against our model hypothesis of no significant effect at the current sample size (pooled hazard ratio = 0.62; 95% CI 0.42-0.91, n = 749).
CONCLUSION: Despite no clear mortality benefits in hospitalized patients with COVID-19, tocilizumab appears to reduce the likelihood of progression to mechanical ventilation.
METHOD: We searched PubMed, Embase, EBSCOhost and ClinicalTrials.gov for the eligible RCTs which compared the efficacy and safety of combined atezolizumab and nab-paclitaxel with nab-paclitaxel alone. The outcomes analyzed included overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and treatment-related adverse effects (AEs).
RESULTS: A total of six RCTs were included in this MA. For efficacy, although OS was not significantly prolonged with combined atezolizumab and nab-paclitaxel (HR 0.90, 95% CI [0.79, 1.01], p=0.08), this combination therapy significantly improved PFS (HR 0.72, 95% CI [0.59, 0.87], p=0.0006) and ORR (RR 1.25, 95% CI [0.79, 1.01] p<0.00001). For safety, any AEs, haematological, gastrointestinal, and liver AEs showed no statistically significant differences between the atezolizumab and nab-paclitaxel combination group and nab-paclitaxel alone group. However, serious AEs, high grade, dermatological, pulmonary, endocrine, and neurological AEs were significantly lower with nab-paclitaxel alone compared to atezolizumab and nab-paclitaxel combined (p-value range from <0.00001 to 0,02).
CONCLUSION: Atezolizumab combined with nab-paclitaxel was associated with improved outcomes in the treatment of TNBC; however, this combination resulted in more toxicity compared to nab-paclitaxel alone. While nab-paclitaxel alone produced chemotherapy-related AEs, the combination of atezolizumab with nab-paclitaxel produced AEs, especially immune-related AEs such as haematological, pulmonary, endocrine, and neurological AEs.
TRIAL REGISTRATION: This research work of systematic review has been registered on PROSPERO (Registration number: CRD42022297952).
METHODS: We conducted an extensive search via Cochrane Library, PubMed, Scopus, and Web of Science databases to acquire the reported RCTs up to October 2020.
RESULTS: The results showed no effects of α-tocopherol supplementation on lipid profile in DM patients except when used ≥12 weeks.
CONCLUSIONS: α-tocopherol supplementation in DM patients had no significant effect on lipid profiles.
METHODS: A systematic literature search with no language restriction was performed in electronic databases and preprint repositories to identify eligible studies published up to 29 June 2021. The outcomes of interest were hospital admission and all-cause mortality. A random-effects model was used to estimate the pooled odds ratio (OR) for outcomes of interest with the use of neutralizing monoclonal antibodies relative to nonuse of neutralizing monoclonal antibodies, at 95% confidence intervals (CI).
RESULTS: Our systematic literature search identified nine randomized controlled trials. Three trials had an overall low risk of bias, while four trials had some concerns in the overall risk of bias. The meta-analysis revealed no statistically significant difference in the odds of mortality (pooled OR = 0.69; 95% CI 0.33-1.47), but a statistically significant reduction in the odds of hospital admission (pooled OR = 0.29; 95% CI 0.21-0.42), with the administration of a neutralizing monoclonal antibody among patients with COVID-19, relative to non-administration of a neutralizing monoclonal antibody, at the current sample size.
CONCLUSION: The reduced risk of hospital admission with neutralizing monoclonal antibodies use suggests that the timing of neutralizing antibodies administration is key in preventing hospital admission and, ultimately, death. Future randomized trials should aim to determine if the clinical outcomes with neutralizing monoclonal antibodies differ based on serostatus.