scholarly journals Palivizumab and prevention of childhood respiratory syncytial viral infection: protocol for a systematic review and meta-analysis of breakthrough infections

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029832
Author(s):  
Shelly Jun ◽  
Meghan Sebastianski ◽  
Robin Featherstone ◽  
Joan Robinson

IntroductionChildhood respiratory syncytial virus (RSV) infection is a global phenomenon that can lead to fatal respiratory illness. Palivizumab is a drug that is routinely used in affluent countries as a prophylaxis against RSV infection; nevertheless, breakthrough infections are often reported. In light of new findings on potential RSV resistance to palivizumab, an up-to-date synthesis of evidence on effectiveness is needed. Furthering existing reviews, a broadened scope to better reflect effectiveness in a ‘real world’ clinical context is also important. This systematic review and meta-analysis will enhance our understanding of the effectiveness of palivizumab in varying populations of children. Findings from this review will inform recommendations for best practices regarding palivizumab use for childhood RSV infection as well as research priorities in RSV vaccine development.Methods and analysisWe will conduct a systematic review of primary population-based studies that examine the incidence of palivizumab breakthrough infections in children, published between 1997 to present. In collaboration with a research librarian, four electronic databases (MEDLINE, Embase, Cochrane Library, Web of Science) and additional sources will be searched. Study screening and quality assessment will be performed in duplicate. Data will be extracted by one reviewer, with partial and random verification by a second reviewer. The primary outcomes to assess breakthrough RSV infection will be hospitalisation, length of stay and the need for intensive care unit admission and mechanical ventilation in children receiving palivizumab. The secondary outcome will be RSV-associated mortality. We will conduct a meta-analysis using pooled effectiveness data, and include subgroup analyses by patient comorbidities and drug compliance. Sensitivity analyses for risk of bias and study design will also be performed.Ethics and disseminationThis systematic review will only include data from previously published literature and is therefore exempt from ethics approval. Final results will be disseminated through peer-reviewed publication and presented at academic conferences and scientific meetings engaging paediatric researchers and healthcare providers. Should findings from this review necessitate updates to current clinical practice guidelines, we intend to establish a working group to engage relevant health administrators and decision makers.PROSPERO registration numberCRD42019122120.

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e040129 ◽  
Author(s):  
Biruk Beletew Abate ◽  
Ayelign Mengesha Kassie ◽  
Mesfin Wudu Kassaw ◽  
Teshome Gebremeskel Aragie ◽  
Setamlak Adane Masresha

ObjectiveTo assess the sex difference in the prevalence of COVID-19 confirmed cases.DesignSystematic review and meta-analysis.SettingPubMed, Cochrane Library and Google Scholar were searched for related information. The authors developed a data extraction form on an Excel sheet and the following data from eligible studies were extracted: author, country, sample size, number of female patients and number of male patients. Using STATA V.14 for analysis, the authors pooled the overall prevalence of men and/or women using a random-effect meta-analysis model. The authors examined the heterogeneity in effect size using Q statistics and I2 statistics. Subgroup and sensitivity analyses were performed. Publication bias was also checked.ParticipantsStudies on COVID-19 confirmed cases were included.InterventionSex (male/female) of COVID-19 confirmed cases was considered.Primary and secondary outcome measuresThe primary outcome was prevalence of COVID-19 among men and women.ResultsA total of 57 studies with 221 195 participants were used in the analysis. The pooled prevalence of COVID-19 among men was found to be 55.00 (51.43–56.58, I2=99.5%, p<0.001). Sensitivity analysis showed the findings were not dependent on a single study. Moreover, a funnel plot showed symmetrical distribution. Egger’s regression test p value was not significant, which indicates absence of publication bias in both outcomes.ConclusionsThe prevalence of symptomatic COVID-19 was found to be higher in men than in women. The high prevalence of smoking and alcohol consumption contributed to the high prevalence of COVID-19 among men. Additional studies on the discrepancies in severity and mortality rate due to COVID-19 among men and women and the associated factors are recommended.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e046575
Author(s):  
Chenghui Zhou ◽  
Hanjun Pei ◽  
Yiming Gao ◽  
Yulin Zhang ◽  
Liang Cao ◽  
...  

IntroductionAcute myocardial injury in patients with COVID-19 infection has been recognised as one important complication associated with in-hospital mortality. The potential dose–response effect of cardiac troponin (cTn) concentrations on adverse clinical outcomes has not been systematically studied. Hence, we will conduct a comprehensive dose–response meta-analysis to quantitatively evaluate the relationship between elevated cTn concentrations and in-hospital adverse clinical outcomes in patients with COVID-19.MethodsWe will search PubMed, EMBASE, Cochrane Library and ISI Knowledge via Web of Science databases, as well as preprint databases (medRxiv and bioRxiv), from inception to October 2021, to identify all retrospective and prospective cohorts and randomised controlled studies using related keywords. The primary outcome will be all-cause mortality during hospitalisation. The secondary outcome will be major adverse event (MAE). To conduct a dose–response meta-analysis of the potential linear or restricted cubic spline regression relationship between elevated cTn concentrations and all-cause mortality or MAE, studies with three or more categories of cTn concentrations will be included. Univariable or multivariable meta-regression and subgroup analyses will be conducted to compare elevated and non-elevated categories of cTn concentration. Sensitivity analyses will be used to assess the robustness of our results by removing each included study at one time to obtain and evaluate the remaining overall estimates of all-cause mortality or MAE.Ethics and disseminationIn accordance with the Institutional Review Board/Independent Ethics Committee of Fuwai Hospital, ethical approval was waived for this systematic review protocol. This meta-analysis will be disseminated through a peer-reviewing process for journal publication and conference communication.PROSPERO registration numberCRD42020216059.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050329
Author(s):  
Johannes Julian Bürkle ◽  
Johannes Caspar Fendel ◽  
Stefan Schmidt

IntroductionCognitive–behavioural therapy (CBT) with exposure and response prevention is the recommended standard for the treatment of obsessive–compulsive disorder (OCD). However, a high proportion of patients refuse this treatment, do not respond or relapse shortly after treatment. Growing evidence suggests that mindfulness-based and acceptance-based programmes (MABPs) are an effective option for the treatment of OCD. This systematic review and meta-analysis will examine the effectiveness of MABPs in treating OCD. We also aimed to explore potential moderators of the programmes’ effectiveness.Methods and analysisWe will systematically search MEDLINE, Embase, PsycINFO, PSYINDEX, Web of Science, CINAHL and Cochrane Register of Controlled Trials (no language restrictions) for studies that evaluate the effect of MABPs on patients with OCD. We will conduct backward and forward citation searches of included studies and relevant reviews and contact corresponding authors. The primary outcome will be pre-post intervention change in symptom severity. A secondary outcome will be change in depressive symptoms. Two reviewers will independently screen the records, extract the data and rate the methodological quality of the studies. We will include both controlled and uncontrolled trials. Randomised controlled trials will be meta-analysed, separately assessing between-group effects. A second meta-analysis will assess the within-group effect of all eligible studies. We will explore moderators and sources of heterogeneity such as the specific programme, study design, changes in depressive symptoms, hours of guided treatment, control condition and prior therapy (eg, CBT) using metaregression and subgroup analyses. We will perform sensitivity analyses using follow-up data. A narrative synthesis will also be pursued. We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the quality of the evidence.Ethics and disseminationEthical approval is not required. Results will be published in peer-reviewed journals and presented at international conferences.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046352
Author(s):  
Lijuan Zhang ◽  
Yanli Song ◽  
Nan Jiang ◽  
Yaqi Huang ◽  
Bo Dong ◽  
...  

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.


BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030536
Author(s):  
Kanika Chaudhri ◽  
Madeleine Kearney ◽  
Richard O Day ◽  
Anthony Rodgers ◽  
Emily Atkins

IntroductionForgetting to take a medication is the most common reason for non-adherence to self-administered medication. Dose administration aids (DAAs) are a simple and common solution to improve unintentional non-adherence for oral tablets. DAAs can be in the form of compartmentalised pill boxes, automated medication dispensing devices, blister packs and sachets packets. This protocol aims to outline the methods that will be used in a systematic review of the current literature to assess the impact of DAAs on adherence to medications and health outcomes.Methods and analysisRandomised controlled trials will be identified through electronic searches in databases including EMBASE, MEDLINE, CINAHL and the Cochrane Library, from the beginning of each database until January 2020. Two reviewers will independently screen studies and extract data using the standardised forms. Data extracted will include general study information, characteristics of the study, participant characteristics, intervention characteristics and outcomes. Primary outcome is to assess the effects of DAAs on medication adherence. Secondary outcome is to evaluate the changes in health outcomes. The risk of bias will be ascertained by two reviewers in parallel using The Cochrane Risk of Bias Tool. A meta-analysis will be performed if data are homogenous.Ethics and disseminationEthics approval will not be required for this study. The results of the review described within this protocol will be disseminated through publication in a peer-reviewed journal and relevant conference presentations.PROSPERO registration numberCRD42018096087


2020 ◽  
Vol 4 (1) ◽  
pp. e000662 ◽  
Author(s):  
Nick Brown ◽  
Antti Juhani Kukka ◽  
Andreas Mårtensson

BackgroundDespite advances in vaccination and case management, pneumonia remains the single largest contributor to early child mortality worldwide. Zinc has immune-enhancing properties, but its role in adjunctive treatment of pneumonia in low-income and middle-income countries (LMICs) is controversial and research still active.MethodsSystematic review and meta-analysis of randomised controlled trials of zinc and placebo in pneumonia in children aged 2 to 60 months in LMICs. Databases included MEDLINE, the Cochrane Library, EMBASE, LILACS, SciELO, the WHO portal, Scopus, Google Scholar and ClinicalTrials.gov. Inclusion criteria included accepted signs of pneumonia and clear measure of outcome. Risk of bias was independently assessed by two authors. ORs with 95% CI were used for calculating the pooled estimate of dichotomous outcomes including treatment failure and mortality. Time to recovery was expressed as HRs. Sensitivity analyses considering risk of bias and subgroup analyses for pneumonia severity were performed.ResultsWe identified 11 trials published between 2004 and 2019 fulfilling the a priori defined criteria, 7 from South Asia and 3 from Africa and 1 from South America. Proportional treatment failure was comparable in both zinc and placebo groups when analysed for all patients (OR 0.95 (95% CI 0.80 to 1.14)) and only for those with severe pneumonia (OR 0.93 (95% CI 0.75 to 1.14)). No difference was seen in mortality between zinc and placebo groups (OR 0.64 (95% CI 0.31 to 1.31)). Time to recovery from severe pneumonia did not differ between the treatment and control groups for patients with severe pneumonia (HR 1.01 (95% CI 0.89 to 1.14)). Removal of four studies with high risk of bias made no difference to the conclusions.ConclusionThere is no evidence that adjunctive zinc treatment improves recovery from pneumonia in children in LMICs.Trial registration numberCRD42019141602.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035691
Author(s):  
Li-xian He ◽  
Ken Shao ◽  
Jie Ma ◽  
Yuan-yuan Zhao ◽  
Yun-tai Yao

IntroductionCough is often observed when administrating a bolus of opioids. Opioid-induced cough (OIC) is mostly transient, benign and self-limiting, but could be associated with adverse effects. Numerous pharmacological and non-pharmacological interventions have been used to manage OIC with controversial efficacy and safety. Recent studies suggested that, pretreatment of intravenous dezocine (DZC) could completely suppress OIC during anaesthesia induction. To address this knowledge lack, we will perform a systemic review and meta-analysis to evaluate the efficacy of DZC on OIC and possible complications. We provide here a protocol that will outline the methods and analyses planned for the systematic review.MethodsPubMed, Embase, Cochrane Library, Web of Science as well as Chinese BioMedical Literature & Retrieval System (SinoMed), China National Knowledge Infrastructure, Wanfang Data and VIP Data will be searched from 1978 to 31 December 2019 to identify all randomised controlled trials comparing DZC with placebo on the incidence and severity of OIC. Primary outcomes of interest include the incidence and severity of OIC. Secondary outcomes of interest include possible complications or adverse effects of DZC. Two authors will independently extract relevant variables and outcome data. For continuous variables, treatment effects will be calculated as weighted mean difference and 95% CI. For dichotomous data, treatment effects will be calculated as OR and 95% CI. Each outcome will be tested for heterogeneity, and randomised-effects or fixed-effects model will be used in the presence or absence of significant heterogeneity. Sensitivity analyses will be done by examining the influence of statistical model and individual trial(s) on estimated treatment effects. Publication bias will be explored through visual inspection of funnel plots of the outcomes. Statistical significance will be defined as p<0.05.Ethics and disseminationThis study is a protocol of meta-analysis of previously published literatures, ethical approval was not necessary according to the Ethical Committee of Fuwai Hospital. The study will be submitted to a peer-reviewed journal and disseminated via research presentations.PROSPERO registration numberCRD42019141255.


2018 ◽  
Author(s):  
Amelia Romeo ◽  
Sarah Edney ◽  
Ronald Plotnikoff ◽  
Rachel Curtis ◽  
Jillian Ryan ◽  
...  

BACKGROUND Smartphone apps are a promising tool for delivering accessible and appealing physical activity interventions. Given the large growth of research in this field, there are now enough studies using the “gold standard” of experimental design—the randomized controlled trial design—and employing objective measurements of physical activity, to support a meta-analysis of these scientifically rigorous studies. OBJECTIVE This systematic review and meta-analysis aimed to determine the effectiveness of smartphone apps for increasing objectively measured physical activity in adults. METHODS A total of 7 electronic databases (EMBASE, EmCare, MEDLINE, Scopus, Sport Discus, The Cochrane Library, and Web of Science) were searched from 2007 to January 2018. Following the Population, Intervention, Comparator, Outcome and Study Design format, studies were eligible if they were randomized controlled trials involving adults, used a smartphone app as the primary or sole component of the physical activity intervention, used a no- or minimal-intervention control condition, and measured objective physical activity either in the form of moderate-to-vigorous physical activity minutes or steps. Study quality was assessed using a 25-item tool based on the Consolidated Standards of Reporting Trials checklist. A meta-analysis of study effects was conducted using a random effects model approach. Sensitivity analyses were conducted to examine whether intervention effectiveness differed on the basis of intervention length, target behavior (physical activity alone vs physical activity in combination with other health behaviors), or target population (general adult population vs specific health populations). RESULTS Following removal of duplicates, a total of 6170 studies were identified from the original database searches. Of these, 9 studies, involving a total of 1740 participants, met eligibility criteria. Of these, 6 studies could be included in a meta-analysis of the effects of physical activity apps on steps per day. In comparison with the control conditions, smartphone apps produced a nonsignificant (P=.19) increase in participants’ average steps per day, with a mean difference of 476.75 steps per day (95% CI −229.57 to 1183.07) between groups. Sensitivity analyses suggested that physical activity programs with a duration of less than 3 months were more effective than apps evaluated across more than 3 months (P=.01), and that physical activity apps that targeted physical activity in isolation were more effective than apps that targeted physical activity in combination with diet (P=.04). Physical activity app effectiveness did not appear to differ on the basis of target population. CONCLUSIONS This meta-analysis provides modest evidence supporting the effectiveness of smartphone apps to increase physical activity. To date, apps have been most effective in the short term (eg, up to 3 months). Future research is needed to understand the time course of intervention effects and to investigate strategies to sustain intervention effects over time.


2020 ◽  
Author(s):  
Amer Alsaied ◽  
Nazmul Islam ◽  
Lukman Thalib

Abstract Background: Necrotizing Enterocolitis (NEC) is a major cause of morbidity and mortality in the Neonatal Intensive Care Unit (NICU), yet the global incidence of NEC has not been systematically evaluated. We conducted a systematic review and meta-analysis of cohort studies reporting the incidence of NEC in infants with Very Low Birth Weight (VLBW).Methods: The databases searched included PubMed, MEDLINE, the Cochrane Library, EMBASE and grey literature. Eligible studies were cohort or population-based studies of newborns including registry data reporting incidence of NEC. Data were extracted from the selected papers included incidence of NEC cases and size of population at risk, author and publication details, follow up period covered by the study, location and setting of the study and whether it was VLBW infants or preterm infants. Additionally, risk of bias assessment of the included studies were carried out using a validated tool. Bias adjusted Quality Effect Model (QEM) were used to pool the estimates. In the presence of substantial heterogeneity, Random Effect Models (REM) were used as an additionally sensitivity analyses. The heterogeneity between studies were evaluated using the Cochrane Q statistics and Higgin’s I2 value. Subgroup analysis and meta-regression were used to explore the sources of heterogeneity. Funnel plots as appropriate for ratio measures were used to assess publication bias. Results: A systematic and comprehensive search of databases identified 27 cohort studies reporting the incidence of NEC. The pooled estimate of the global incidence of NEC was 6.0% (95% CI: 4.0%-9.0%). There were substantial heterogeneity (I2 = 100%) between studies. Funnel plots showed no evidence of publication bias.Conclusion: Seven out of 100 of all VLBW infants in NICU are likely to develop NEC. However, there were considerable heterogeneity between studies. High quality studies assessing incidence of NEC along with associated risk factors are warranted.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S7-S8
Author(s):  
Angela Branche ◽  
Lisa Saiman ◽  
Edward E Walsh ◽  
Ann R Falsey ◽  
William Sieling ◽  
...  

Abstract Background Respiratory syncytial virus (RSV) infection has been increasingly recognized as an important cause of acute respiratory illness (ARI) and a trigger for exacerbation of underlying cardiopulmonary disease in adults. Incidence of hospitalized RSV infection remains uncertain as adults have not been systematically screened. Previous incidence estimates, derived primarily from modeling studies, have ranged from 84 to 190/100K population in adults >65 years of age. Accurate burden data are critical to inform RSV vaccine development for adults. We used active surveillance among hospitalized adults to determine population-based incidence rates of RSV infection. Methods Hospitalized adults ≥ 18 years old residing in the surveillance area with >2 ARI symptoms or exacerbation of underlying cardiopulmonary disease were screened for eligibility during October 2017–April 2018 and October 2018 to April 2019 in 3 hospitals in Rochester, NY and New York City. Respiratory specimens were tested for RSV using PCR assays. RSV incidence per 100,000 persons (per 2010 US Census data) was adjusted by percent market share for study hospitals in their catchment area. Results In total, 8,217 hospitalized adults residing in the surveillance area that met the surveillance case definition were tested for RSV; 768 (9.4%) were positive. Adults were aged 18–49 (12%), 50–64 (30%), and ≥65 years old (58%); 55% were female. RSV infection incidence varied from year 1 to year 2 and was highest in patients aged ≥65 years old (table). Conclusion This is the largest prospective RSV incidence study to date. Preliminary results indicate that the incidence of RSV infection may be higher than previously reported, especially in urban-dwelling adults >65 years of age. Results confirm the need for vaccines to prevent RSV infections in older adults. Disclosures All Authors: No reported Disclosures.


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