scholarly journals Efficacy, immunogenicity and safety of a recombinant tetravalent dengue vaccine (CYD-TDV) in children aged 2–17 years: systematic review and meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e019368 ◽  
Author(s):  
Bruno Rodrigues Rosa ◽  
Antonio José Ledo Alves da Cunha ◽  
Roberto de Andrade Medronho

BackgroundRandomised controlled trials have evaluated the recombinant tetravalent dengue vaccine (CYD-TDV). However, individual results may have little power to identify differences among the populations studied.ObjectiveTo evaluate efficacy, immunogenicity and safety of CYD-TDV in the prevention of dengue in children aged 2–17 years.DesignSystematic review and meta-analysis.Data sourcesMEDLINE (from 1950 to 5 December 2018), EMBASE (from 1947 to 5 December 2018) and Cochrane (from 1993 to 5 December 2018).Eligibility criteria of studiesRandomised trials comparing efficacy, immunogenicity and safety of CYD-TDV with placebo or other vaccines for preventing dengue cases in children aged 2–17 years.Outcome measuresEfficacy, immunogenicity and safety of CYD-TDV.Study appraisal and methodsCalculations were made of relative risk (RR) and mean difference (MD) for dichotomous and continuous outcomes, respectively. All estimates were calculated considering a 95% CI estimate. A p<0.05 was considered statistically significant.ResultsNine studies involving 34 248 participants were included. The overall efficacy of CYD-TDV was 60% (RR 0.40 (0.30 to 0.54)). Serotype-specific efficacy of the vaccine was 51% for dengue virus type-1 (DENV-1) (RR 0.49 (0.39 to 0.63)); 34% for DENV-2 (RR 0.66 (0.50 to 0.86)); 75% for DENV-3 (RR 0.25 (0.18 to 0.35)) and 77% for DENV-4 (RR 0.23 (0.15 to 0.34)). Overall immunogenicity (MD) of CYD-TDV was 225.13 (190.34 to 259.93). Serotype-specific immunogenicity was: DENV-1: 176.59 (123.36 to 229.83); DENV-2: 294.21 (181.98 to 406.45); DENV-3: 258.78 (146.72 to 370.84) and DENV-4: 189.35 (141.11 to 237.59). The most common adverse events were headache and pain at the injection site.LimitationsThe main limitation of this study was unclear or incomplete data.Conclusions and implications of key findingsCYD-TDV is considered safe and able to partially protect children and adolescents against four serotypes of DENV for a 1-year period. Despite this, research should prioritise improvements in vaccine efficacy, thus proving higher long-term protection against all virus serotypes.PROSPERO registration numberCRD42016043628.

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017868
Author(s):  
Joey S.W. Kwong ◽  
Sheyu Li ◽  
Wan-Jie Gu ◽  
Hao Chen ◽  
Chao Zhang ◽  
...  

IntroductionEffective selection of coronary lesions for revascularisation is pivotal in the management of symptoms and adverse outcomes in patients with coronary artery disease. Recently, instantaneous ‘wave-free’ ratio (iFR) has been proposed as a new diagnostic index for assessing the severity of coronary stenoses without the need of pharmacological vasodilation. Evidence of the effectiveness of iFR-guided revascularisation is emerging and a systematic review is warranted.Methods and analysisThis is a protocol for a systematic review of randomised controlled trials and controlled observational studies. Electronic sources including MEDLINE via Ovid, Embase, Cochrane databases and ClinicalTrials.gov will be searched for potentially eligible studies investigating the effects of iFR-guided strategy in patients undergoing coronary revascularisation. Studies will be selected against transparent eligibility criteria and data will be extracted using a prestandardised data collection form by two independent authors. Risk of bias in included studies and overall quality of evidence will be assessed using validated methodological tools. Meta-analysis will be performed using the Review Manager software. Our systematic review will be performed according to the guidance from the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Ethics and disseminationEthics approval is not required. Results of the systematic review will be disseminated as conference proceedings and peer-reviewed journal publication.Trial registration numberThis protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42017065460.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Michael Kelly ◽  
Gerard McKnight ◽  
Alisdair J. Scott

Abstract Aims Pre-operative oral antibiotics (OAB) and mechanical bowel preparation (MBP) may reduce rates of post-operative infectious complications following colorectal surgery but their effects on post-operative ileus (POI) are not well-established. We conducted a systematic review and meta-analysis to address this question. Methods Medline and Embase databases were searched to identify randomised controlled trials and cohort studies comparing pre-operative MBP or OAB to control in patients undergoing elective colorectal resection and reporting the rate of POI as an outcome. Risk ratios were pooled using a random-effects model to generate a summary risk ratio and 95% confidence interval. Results Five randomised trials and three cohort studies were included which reported the effect of pre-operative MBP on POI. Some 29056 patients received MBP compared to 13077 who did not. The rates of POI were 10.0% vs 12.0% respectively. Meta-analysis gave a risk ratio of 0.85 (0.80-0.91, p &lt; 0.0001) for the development of POI with MBP versus control. Four randomised trials and four cohort studies were included which reported the effect of pre-operative OAB on POI. Some 9.5% of 19,903 patients receiving OAB developed POI compared to 11.8% of 23,884 control patients. The pooled risk ratio for the development of POI with OAB compared to control was 0.86 (0.81-0.91, p &lt; 0.0001). However, when limiting analyses to randomised trials alone, neither MBP (RR 1.13, 0.67-1.90) nor OAB 1.01, 0.75-1.35) had a significant effect on the rate of POI. Conclusions Pre-operative MBP or OAB may reduce POI following colorectal resection but this has not been confirmed in randomised trials.


2019 ◽  
Vol 25 (1) ◽  
pp. 33-37 ◽  
Author(s):  
Julie McLellan ◽  
Clare R Bankhead ◽  
Jason L Oke ◽  
F D Richard Hobbs ◽  
Clare J Taylor ◽  
...  

BackgroundGUIDE-IT, the largest trial to date, published in August 2017, evaluating the effectiveness of natriuretic peptide (NP)-guided treatment of heart failure (HF), was stopped early for futility on a composite outcome. However, the reported effect sizes on individual outcomes of all-cause mortality and HF admissions are potentially clinically relevant.ObjectiveThis systematic review and meta-analysis aims to combine all available trial level evidence to determine if NP-guided treatment of HF reduces all-cause mortality and HF admissions in patients with HF.Study selectionEight databases, no language restrictions, up to November 2017 were searched for all randomised controlled trials comparing NP-guided treatment versus clinical assessment alone in adult patients with HF. No language restrictions were applied. Publications were independently double screened and extracted. Fixed-effect meta-analyses were conducted.Findings89 papers were included, reporting 19 trials (4554 participants), average ages 62–80 years. Pooled risk ratio estimates for all-cause mortality (16 trials, 4063 participants) were 0.87, 95% CI 0.77 to 0.99 and 0.80, 95% CI 0.72 to 0.89 for HF admissions (11 trials, 2822 participants). Sensitivity analyses, restricted to low risk of bias, produced similar estimates, but were no longer statistically significant.ConclusionsConsidering all the evidence to date, the pooled effects suggest that NP-guided treatment is beneficial in reducing HF admissions and all-cause mortality. However, there is still insufficient high-quality evidence to make definitive recommendations on the use of NP-guided treatment in clinical practice.Trial registration numberSystematic Review Cochrane Database Number: CD008966.


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029727 ◽  
Author(s):  
Imran Ahmed ◽  
Adam Jonathan Boulton ◽  
Sana Rizvi ◽  
William Carlos ◽  
Edward Dickenson ◽  
...  

Introduction and objectivesSurgical site infections (SSIs) represent a common and serious complication of all surgical interventions. Microorganisms are able to colonise sutures that are implanted in the skin, which is a causative factor of SSIs. Triclosan-coated sutures are antibacterial sutures aimed at reducing SSIs. Our objective is to update the existing literature by systematically reviewing available evidence to assess the effectiveness of triclosan-coated sutures in the prevention of SSIs.MethodsA systematic review of EMBASE, MEDLINE, AMED (Allied and complementary medicine database) and CENTRAL was performed to identify full text randomised controlled trials (RCTs) on 31 May 2019.InterventionTriclosan-coated sutures versus non-triclosan-coated sutures.Primary outcomeOur primary outcome was the development of SSIs at 30 days postoperatively. A meta-analysis was performed using a fixed-effects model.ResultsTwenty-five RCTs were included involving 11 957 participants. Triclosan-coated sutures were used in 6008 participants and non triclosan-coated sutures were used in 5949. Triclosan-coated sutures significantly reduced the risk of SSIs at 30 days (relative risk 0.73, 95% CI 0.65 to 0.82). Further sensitivity analysis demonstrated that triclosan-coated sutures significantly reduced the risk of SSIs in both clean and contaminated surgery.ConclusionTriclosan-coated sutures have been shown to significantly reduced the risk of SSIs when compared with standard sutures. This is in agreement with previous work in this area. This study represented the largest review to date in this area. This moderate quality evidence recommends the use of triclosan-coated sutures in order to reduce the risk of SSIs particularly in clean and contaminated surgical procedures.PROSPERO registration numberCRD42014014856


2019 ◽  
Vol 5 (1) ◽  
pp. e000501 ◽  
Author(s):  
Manuel Trinidad-Fernandez ◽  
Manuel Gonzalez-Sanchez ◽  
Antonio I Cuesta-Vargas

ObjectiveTo assess whether Functional Movement Screen (FMS) score is associated with subsequent injuries in healthy sportspeople.DesignSystematic review and meta-analysis.Data sourcesThe following electronic databases were searched to December 2017: Medline, PubMed, PsycINFO, SPORTDiscus, Cumulative Index of Nursing and Allied Health Literature, Scopus, Embase, and Physiotherapy Evidence Database.Eligibility criteria for selecting studiesEligibility criteria included (1) prospective cohort studies that examined the association between FMS score (≤14/21) and subsequent injuries, (2) a sample of healthy and active participants without restrictions in gender or age, and (3) the OR was the effect size and the main outcome.ResultsThirteen studies met the criteria for the systematic review and 12 were included in the meta-analysis. In 5 of the 12 studies, and among female athletes in 1 study, FMS score ≤14 out of 21 points was associated with subsequent injuries. The overall OR of the selected studies in the meta-analysis was 1.86 (95% CI 1.32 to 2.61) and showed substantial heterogeneity (I2=70%).Summary/ConclusionWhether or not a low FMS score ≤14 out of 21 points is associated with increased risk of injury is unclear. The heterogeneity of the study populations (type of athletes, age and sport exposure) and the definition of injury used in the studies make it difficult to synthesise the evidence and draw definitive conclusions.Trial registration numberCRD42015015579.


Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2070 ◽  
Author(s):  
Fatma Ilgaz ◽  
Alex Pinto ◽  
Hülya Gökmen-Özel ◽  
Julio César Rocha ◽  
Esther van Dam ◽  
...  

There is an ongoing debate regarding the impact of phenylketonuria (PKU) and its treatment on growth. To date, evidence from studies is inconsistent, and data on the whole developmental period is limited. The primary aim of this systematic review was to investigate the effects of a phenylalanine (Phe)-restricted diet on long-term growth in patients with PKU. Four electronic databases were searched for articles published until September 2018. A total of 887 results were found, but only 13 articles met eligibility criteria. Only three studies had an adequate methodology for meta-analysis. Although the results indicate normal growth at birth and during infancy, children with PKU were significantly shorter and had lower weight for age than reference populations during the first four years of life. Impaired linear growth was observed until the end of adolescence in PKU. In contrast, growth impairment was not reported in patients with mild hyperphenylalaninemia, not requiring dietary restriction. Current evidence indicates that even with advances in dietary treatments, “optimal” growth outcomes are not attained in PKU. The majority of studies include children born before 1990s, so further research is needed to show the effects of recent dietary practices on growth in PKU.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047273
Author(s):  
Mei-Ying Kwan ◽  
Kit-Lun Yick ◽  
Joanne Yip ◽  
Chi-Yung Tse

ObjectiveThe treatment effect of orthoses for hallux valgus (HV) is unclear with little interventional studies, the design involves multiple complex factors, and therefore a systematic analysis with meta-analysis is necessary. The objective of this systematic review and meta-analysis is to determine whether current foot orthoses are effective in treating HV.DesignSystematic review with meta-analysis.Data sourcesElectronic databases (PubMed, Scopus, Cinahl and Medline) are searched up to February 2020.Eligibility criteria for selecting studiesInterventional studies with content focus on HV orthosis design and any of the outcomes related to effectiveness for treating HV are included. The standardised mean differences are calculated. The risk of bias in included studies is assessed using the Cochrane Collaboration’s risk of bias tools.ResultsIn total, 2066 articles are identified. Among them, nine are selected and quality rated, and data are extracted and closely examined. A meta-analysis is conducted, where appropriate. The main causes of potential bias are missing outcome data and outcome measurement error. The results show that orthosis with a toe separator has the best effect of correcting the HV angle (standardised mean difference: 0.50, 95% CI: 0.189 to 0.803).ConclusionThe orthoses design with a toe separator or an element that allows for the foot anatomic alignment is critical for reducing the HV angle and relieving foot pain. The results contribute to a better selection of treatment for patients.PROSPERO registration numberCRD42021260403.


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