scholarly journals Immunologic Response, Efficacy, and Safety of Vaccines Against COVID-19 in Children and Adolescents Aged 2 - 21 Years Old: A Systematic Review

2022 ◽  
Author(s):  
Sara Sadeghi ◽  
yasamin kalantari ◽  
Sima Shokri ◽  
Morteza Fallahpour ◽  
Nahid Nafissi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Immune Response ◽  
Clinical Trials ◽  
Children And Adolescents ◽  
English Language ◽  
Severe Infection ◽  
Underlying Disease ◽  
Cochrane Library ◽  
Healthy Children ◽  
Efficacy And Safety

Backgrounds: Children and adolescnets form a large proportion of societies and play an important role in the transmission of Covid-19. On the other hand, their education, mental and physical wellness, and safety are compromised which makes vaccination a crucial step to return to normal life. Aim and Objectives: To collect and summarize all data about the immune response, effectiveness, and safety of available Covid-19 vaccines for people aged 2 - 21 years old. Methods: A thorough systematic review was performed on available publications in English language regarding immunogenicity, efficacy, and safety of Covid-19 vaccines in individuals aged 2 - 21 years old. Types of selected studies were clinical trials, observational studies, and cohort. Searched databases comprised Ovid Medline, Cochrane Library, Embase, Scopus, Web of Sciences, Google Scholar, and ClinicalTrials.gov website. Data extraction and analysis were performed in Microsoft Word software, version 16.56. Results: the Covid-19 vaccination was evaluated in a total of 50,148 children and adolescents in 22 published studies and 5,279 participants in two ongoing clinical trials. Data was collected about multiple vaccines including BNT162b2 (Pfizer), mRNA-1273 (Moderna), JNJ-78436735 (Johnson and Johnson), CoronaVac (Sinovac), BBIBP-CorV (Sinopharm), adenovirus type-5-vectored vaccine, ZyCov-D, and BBV152 (Covaxin). The immune response and efficacy of such vaccines were 96% - 100% in healthy children and adolescents and were also acceptable in those with underlying disease and suppressed immune system. The current systematic review revealed favourable safety profiles of employed vaccines in children and adolescents; however, adverse reactions such as myocarditis and myopericarditis were reported which were transient and resolved entirely. Conclusion: Vaccinating children and adolescents aged 2 - 21 years old is beneficial to abort the Covid-19 pandemic. Moreover, the risk-benefit assessments revealed favourable results for vaccinating children and adolescents, especially those with underlying disease, alongside adults to prevent transmission, severe infection, negative outcomes, and new variants formation. Keywords: Covid-19; Vaccination; Immunization; Children; Adolescents; Systematic Review

Outcomes of allogeneic hematopoietic cell transplantation in patients with myelofibrosis: A systematic review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7045-7045
Author(s):  
Jan Philipp Bewersdorf ◽  
Amar Sheth ◽  
Shaurey Vetsa ◽  
Alyssa Grimshaw ◽  
Smith Giri ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
Controlled Vocabulary ◽  
Hematopoietic Cell ◽  
Cochrane Library ◽  
Free Text ◽  
Cell Transplant ◽  
Efficacy And Safety ◽  
Significant Difference

7045 Background: Allogeneic hematopoietic cell transplant (allo-HCT) remains the only potentially curative therapeutic modality for patients with primary or secondary myelofibrosis (MF). However, many patients (pts) are ineligible for allo-HCT and transplant-related mortality can be substantial. Data on the efficacy and safety of allo-HCT are mixed and largely derived from retrospective studies. Methods: To synthesize the available evidence, we conducted a systematic review and meta-analysis searching Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection from inception to October 11, 2020 for studies on allo-HCT in MF. Databases were searched using a combination of controlled vocabulary and free text terms for relevant studies on the efficacy and safety of allo-HCT in pts with primary and secondary MF. This study protocol has been registered on PROSPERO (CRD42020188706). Random-effects models were used to pool response rates for the co-primary outcomes of 1-year, 2-year and 5-year overall survival (OS). Results: We identified 4247 studies after duplicate removal. 393 studies were assessed as full-texts for eligibility and 43 studies (38 retrospective, 1 prospective study, 4 phase II clinical trials) with 8739 pts were included in this meta-analysis. Study quality was limited by the absence of randomized clinical trials and retrospective design of most studies. Rates of 1-year, 2-year, and 5-year OS were 66.7% (95% confidence interval: 63.5-69.8%), 64.4% (57.6-70.6%), and 55.0% (51.8-58.3%), respectively. Rates of 1-year, 2-year, and 5-year non-relapse mortality were 25.9% (23.3-28.7%), 29.7% (24.5-35.4%), and 30.5% (25.9-35.5%), respectively. Among evaluable studies, rates of 1-year, 2-year, and 5-year relapse-free survival were 65.3% (56.5-73.1%), 56.2% (41.6-69.8%), and 53.6% (39.9-66.9%), respectively. Adverse events related to all-HCT were manageable with rates of acute and chronic graft-versus-host disease in 44.0% (39.6-48.4%; grade III/IV: 15.2%) and 46.5% of patients (42.2-50.8%; extensive or moderate/severe: 26.1%), respectively. Subgroup analyses did not show any significant difference between conditioning regimen intensity (myeloablative vs reduced-intensity), median patient age, and proportion of DIPSS-intermediate-2/high pts. Conclusions: Given the poor prognosis of patients not receiving transplant and in the absence of curative non-transplant therapies, our results support consideration of allo-HCT for eligible pts with MF. However, additional studies in pre- and post-allo-HCT setting are necessary to enhance patient selection (e.g. by incorporation of molecular markers), to optimize transplant strategies (e.g. peri-transplant ruxolitinib, conditioning regimens, and donor selection), symptom management and decrease non-relapse mortality.

scholarly journals Interventions promoting physical activity among adults and children in the six Gulf Cooperation Council countries: protocol for a systematic review

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e037122
Author(s):  
Fiona Pearson ◽  
Peijue Huangfu ◽  
Farah M Abu-Hijleh ◽  
Susanne F Awad ◽  
Laith J Abu-Raddad ◽  
...  
Keyword(s):  
Physical Activity ◽  
Systematic Review ◽  
Clinical Trials ◽  
Data Extraction ◽  
Gulf Cooperation Council ◽  
Cochrane Library ◽  
Healthy Children ◽  
Gcc Countries ◽  
Obesity And Diabetes ◽  
Adults And Children

IntroductionPrevalence of overweight, obesity and diabetes are high and rising across the Gulf Cooperation Council (GCC) countries (Oman, Bahrain, Kuwait, Qatar, Saudi Arabia and the United Arab Emirates). In parallel, physical activity (PA) levels are low relative to international standards. PA aids weight control and reduces risk of non-communicable diseases including diabetes and cardiovascular disease. It is likely interventions developed elsewhere will not translate to GCC countries due to unique environmental, social and cultural factors. This protocol is for a systematic review assessing the efficacy of interventions promoting PA within GCC countries among generally healthy adults and children. The primary outcome of interest is change in objectively measured or self-reported PA levels, the secondary outcomes of interest are changes in anthropometry or chronic disease risk factors (eg, blood pressure). Interventions will be compared with no intervention or those of differing PA intensity or duration. The relationships between PA change and the following will be assessed: intervention intensity or duration, season in which intervention occurs, sex, age, nationality and sustainability over time.Methods and analysisA systematic search strategy will identify indexed publications on the efficacy of interventions promoting PA. Randomised controlled trials and quasi-experimental studies recruiting predominantly healthy children and adults will be included. Studies of exercise rehabilitation will be excluded. Medline, Embase, Cinahl, Cochrane Library, SportDiscus, Web of Science, Index Medicus for the Eastern Mediterranean Region and Qscience will be searched. Clinical trial registries including the International Clinical Trials Registry Platform, the Iranian Registry of Clinical Trials and ClinicalTrials.gov will be searched for ongoing and unpublished studies. Searches will be ran from database inception until 1 May 2020 and be supplemented by checking references of key articles. Two reviewers will independently screen identified citations then full texts using prespecified inclusion and exclusion criteria. Piloted data extraction forms will be used in duplicate. Inconsistencies in screening or data extraction will be resolved by a third investigator or study author contact. Risk of bias will be independently assessed by two reviewers using validated tools. A narrative summary of findings will be produced supplemented with meta-analyses and exploration of heterogeneity as appropriate.Ethics and DisseminationThe review aims to strengthen the findings of the primary studies it incorporates and explore the impact of setting. It will synthesise existing published aggregate patient data. If publications or data with ethical concerns are identified, they will be excluded from the review. Results of the systematic review will be published in full and authors will engage directly with research audiences and key stakeholders to share findings.PROSPERO registration number131817.

scholarly journals Anti-hypertensive drugs deprescribing: an updated systematic review of clinical trials

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Salvatore Crisafulli ◽  
Nicoletta Luxi ◽  
Raffaele Coppini ◽  
Annalisa Capuano ◽  
Cristina Scavone ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Experimental Studies ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Systematic Assessment ◽  
Grade Approach

Abstract Background Polypharmacy is defined as the prescription of at least 5 different medicines for therapeutic or prophylactic effect and is a serious issue among elderly patients, who are frequently affected by multi-morbidity. Deprescribing is one of the proposed approaches to reduce the number of administered drugs, by eliminating those that are inappropriately prescribed. The aim of this systematic review is to provide an updated and systematic assessment of the benefit-risk profile of deprescribing of anti-hypertensive drugs, which are among the most commonly used drugs. Methods MEDLINE, EMBASE and The Cochrane Library were searched for studies assessing the efficacy and safety of anti-hypertensive drugs deprescribing in the period between January, 12,016 and December, 312,019. The quality of randomized clinical trials (RCTs) was assessed using the GRADE approach for the evaluation of the main outcomes. The risk of bias assessment was carried out using the Cochrane risk-of-bias tool. Results Overall, two RCTs were identified. Despite summarized evidence was in favor of anti-hypertensive deprescribing, the overall risk of bias was rated as high for each RCT included. According to the GRADE approach, the overall quality of the RCTs included was moderate regarding the following outcomes: systolic blood pressure < 150 mmHg after 12 weeks of follow-up, quality of life, frailty and cardiovascular risk. Conclusions This updated systematic review of the efficacy and safety of anti-hypertensive treatment deprescribing found two recently published RCTs, in addition to the previous guideline of the National Institute for Health and Care Excellence (NICE). Evidence points towards non-inferiority of anti-hypertensive deprescribing as compared to treatment continuation, despite the quality of published studies is not high. High quality experimental studies are urgently needed to further assess the effect of deprescribing for this drug class in specific categories of patients.

scholarly journals Safety, Immunogenicity, and Efficacy of COVID-19 Vaccine in Children and Adolescents: A Systematic Review

2021 ◽  
Author(s):  
Meng Lv ◽  
Xufei Luo ◽  
Quan Shen ◽  
Ruobing Lei ◽  
Xiao Liu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Immune Response ◽  
Clinical Trials ◽  
Children And Adolescents ◽  
Protective Efficacy ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Large Sample Size ◽  
Protective Effects

AbstractAimTo identify the safety, immunogenicity, and protective efficacy of COVID-19 vaccine in children and adolescents.MethodsWe conducted a systematic review. Databases including PubMed, Web of Science, WHO COVID-19 database, and CNKI were searched on 23 July 2021. International Clinical Trials Registry Platform (ICTRP) was also searched to collect ongoing trials. We included published researches or ongoing clinical trials related to the safety, immunogenicity, and efficacy of COVID-19 vaccine in children or adolescents (aged ≤18 years). Meta-analysis was performed if the consistency of the included studies was high. If not, descriptive analyses were performed.ResultsEight published studies with 2851 children or adolescents and 28 ongoing clinical trials were included. Among eight published studies, two (25.0%) were RCTs, two (25.0%) case series, and four (50.0%) case reports. The results showed selected COVID-19 vaccines had a good safety profile in children and adolescents. Injection site pain, fatigue, headache, and chest pain were the most common adverse events. Some studies reported a few cases of myocarditis and pericarditis. Two RCTs showed that the immune response to BNT162b2 in adolescents aged 12-15 years was non-inferior to that in young people aged 16-25 years, while a stronger immune response was detected with 3μg CoronaVac injection. Only one single RCT showed the efficacy of BNT162b2 was 100% (95% CI: 75.3 to 100). Of the 28 ongoing clinical trials, twenty-three are interventional studies. Fifteen countries are conducting interventional clinical trials of COVID-19 vaccines in children and adolescents. Among them, China (10, 43.5%) and United Stated (9, 39.1%) were the top two countries with the most trials. BNT162b2 was the most common vaccine, which is under testing.ConclusionSome of the COVID-19 vaccines have potential protective effects in children and adolescents, but awareness is needed to monitor possible adverse effects after injection. Clinical trials of the COVID-19 vaccine in children and adolescents with long follow-up, large sample size, and different vaccines are still urgently needed.

Crizotinib Versus Chemotherapy on ALK-positive NSCLC: A Systematic Review of Efficacy and Safety

2018 ◽  
Vol 19 (1) ◽  
pp. 41-49 ◽  
Author(s):  
Mingxia Wang ◽  
Guanqi Wang ◽  
Haiyan Ma ◽  
Baoen Shan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Objective Response Rate ◽  
Retrospective Studies ◽  
Response Rate ◽  
Objective Response ◽  
Treated Group ◽  
Efficacy And Safety ◽  
Alk Positive

Introduction: Crizotinib was approved to treat anaplastic lymphoma kinase (ALK)- positive non-small cell lung cancer (NSCLC) by the Food and Drug Administration in 2011.We conducted a systematic review of clinical trials and retrospective studies to compare the efficacy and safety of crizotinib with chemotherapy. </P><P> Methods: We searched electronic databases from inception to Dec. 2016. Clinical trials and retrospective studies regarding crizotinib and crizotinib versus chemotherapy in treatment of NSCLC were eligible. The primary outcomes were the objective response rate (ORR) and disease control rate (DCR). Results: Nine studies (five clinical trials and four retrospective studies) including 729 patients met the inclusion criteria. Crizotinib treatment revealed 1-year OS of 77.1% and PFS of 9.17 months. And crizotinib had a better performance than chemotherapy in ORR (OR: 4.97, 95%CI: 3.16 to 7.83, P<0.00001, I2=35%). DCR revealed superiority with crizotinib than chemotherapy (OR: 3.42, 95% CI: 2.33 to 5.01, P<0.00001, I2=0%). PR (partial response) were significant superior to that of chemotherapy through direct systematic review. No statistically significant difference in CR (complete response) was found between crizotinib-treated group and chemotherapy-treated group. Regarding SD (stable disease), chemotherapy-treated group had a better performance than crizotinib-treated group. Common adverse events associated with crizotinib were visual disorder, gastrointestinal side effects, and elevated liver aminotransferase levels, whereas common adverse events with chemotherapy were fatigue, nausea, and hematologic toxicity. This systematic review revealed improved objective response rate and increased disease control rate in crizotinib group comparing with chemotherapy group. Crizotinib treatment would be a favorable treatment option for patients with ALK-positive NSCLC. ALK inhibitors may have future potential applications in other cancers driven by ALK or c-MET gene mutations.

scholarly journals Efficacy of dialectical behavior therapy for adolescent self-harm and suicidal ideation: a systematic review and meta-analysis

2021 ◽  
pp. 1-11
Author(s):  
Oswald D. Kothgassner ◽  
Andreas Goreis ◽  
Kealagh Robinson ◽  
Mercedes M. Huscsava ◽  
Christian Schmahl ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Suicidal Ideation ◽  
Dialectical Behavior Therapy ◽  
Meta Analysis ◽  
Adolescent Psychopathology ◽  
Cochrane Library ◽  
Behaviour Therapy ◽  
Clinical Consequences ◽  
Self Harm

Abstract Background Given the widespread nature and clinical consequences of self-harm and suicidal ideation among adolescents, establishing the efficacy of developmentally appropriate treatments that reduce both self-harm and suicidal ideation in the context of broader adolescent psychopathology is critical. Methods We conducted a systematic review and meta-analysis of the Dialectical Behaviour Therapy for Adolescents (DBT-A) literature on treating self-injury in adolescents (12–19 years). We searched for eligible trials and treatment evaluations published prior to July 2020 in MEDLINE/PubMed, Scopus, Google Scholar, EMBASE, and the Cochrane Library databases for clinical trials. Twenty-one studies were identified [five randomized-controlled trials (RCTs), three controlled clinical trials (CCTs), and 13 pre-post evaluations]. We extracted data for predefined primary (self-harm, suicidal ideation) and secondary outcomes (borderline personality symptoms; BPD) and calculated treatment effects for RCTs/CCTs and pre-post evaluations. This meta-analysis was pre-registered with OSF: osf.io/v83e7. Results Overall, the studies comprised 1673 adolescents. Compared to control groups, DBT-A showed small to moderate effects for reducing self-harm (g = −0.44; 95% CI −0.81 to −0.07) and suicidal ideation (g = −0.31, 95% CI −0.52 to −0.09). Pre-post evaluations suggested large effects for all outcomes (self-harm: g = −0.98, 95% CI −1.15 to −0.81; suicidal ideation: g = −1.16, 95% CI −1.51 to −0.80; BPD symptoms: g = −0.97, 95% CI −1.31 to −0.63). Conclusions DBT-A appears to be a valuable treatment in reducing both adolescent self-harm and suicidal ideation. However, evidence that DBT-A reduces BPD symptoms was only found in pre-post evaluations.

scholarly journals Efficacy and safety of anti-epidermal growth factor receptor agents for the treatment of oesophageal cancer: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046352
Author(s):  
Lijuan Zhang ◽  
Yanli Song ◽  
Nan Jiang ◽  
Yaqi Huang ◽  
Bo Dong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Growth Factor ◽  
Outcome Measures ◽  
Oesophageal Cancer ◽  
Meta Analysis ◽  
Growth Factor Receptor ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Positive Effects

ObjectivesDespite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.DesignMeta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.SettingRCTs from any country and healthcare setting.ParticipantsPatients with OC.InterventionsCombination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.Primary and secondary outcome measuresOverall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.ResultsIn total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.ConclusionsOverall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.Trial registration numberCRD42020169230.

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