scholarly journals Long-term safety of prenatal and neonatal exposure to paracetamol: a protocol for a systematic review

2020 ◽  
Vol 4 (1) ◽  
pp. e000907
Author(s):  
Samira Samiee-Zafarghandy ◽  
Katelyn Sushko ◽  
John Van Den Anker

IntroductionA surge in the use of paracetamol in neonates has resulted in growing concerns about its potential long-term adverse events. In this study, we conduct a systematic review of the long-term safety of prenatal and neonatal exposure to paracetamol in newborn infants.Methods and analysisWe will follow the Joanna Briggs Institute Manual for Evidence Synthesis and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements to conduct and report this review. We will conduct a systematic search of Embase, MEDLINE, Web of Science and Google Scholar for studies with data on long-term adverse events in neonates that were exposed to paracetamol in the prenatal and/or neonatal period. We will not apply language or design limitations. We will use standardised risk of bias assessment tools to perform a quality assessment of each included article.Ethics and disseminationThis systematic review will only involve access to publicly available data, and therefore ethical approval will not be required. The results of this study will be communicated to the target audience through peer-reviewed publication as well as other knowledge exchange platforms, such as conferences, congresses or symposia.Trial registrationThe protocol for this systematic review is submitted for registration to international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).

2022 ◽  
Author(s):  
Felix Mansbart ◽  
Gerda Kienberger ◽  
Andreas Sönnichsen ◽  
Eva Mann

Abstract BackgroundAdrenergic alpha-1 receptor antagonists (alpha-1 antagonists) are frequently used medications in the management of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and in the management of therapy-resistant arterial hypertension, two conditions frequently found in older adults. This systematic review aims at presenting a complete overview of evidence over the benefits and risks of alpha-1 antagonist treatment in people ≥ 65 years, and at deriving recommendations for a safe application of alpha-1 antagonists in older adults from the evidence found.MethodsA comprehensive literature search was performed including multiple databases (Medline/Pubmed, Embase, the Cochrane Library) and using the PICOS framework to define search terms. The selection of the studies was done by two independent reviewers in a two-step approach, followed by a systematic data extraction. Quality appraisal was performed for each study included using standardised appraisal tools. The studies retrieved and additional literature were used for the development of recommendations, which were rated for strength and quality according to the GRADE methodology. ResultsFourteen studies were included: 3 meta-analyses, 6 randomised controlled trials and 5 observational trials. Doxazosin in the management of arterial hypertension was associated with a higher risk of cardiovascular disease, particularly heart failure, than chlorthalidone. Regarding treatment of LUTS suggestive of BPH, alpha-1 antagonists appeared to be effective in the relief of urinary symptoms and improvement of quality of life. They seemed to be less effective in preventing disease progression. Analyses of the risk profile indicated an increase in vasodilation related adverse events and sexual adverse events for some agents. One large observational study points at an increased risk of falls and fractures. The effects of long-term treatment remained unclear. All meta-analyses and 5 out of 6 interventional studies were downgraded in the quality appraisal. 4 out of 5 observational studies were of good quality.ConclusionsIt cannot be recommended to use doxazosin as first-line antihypertensive agent neither in older adults nor in younger patients. In the management of BPH alpha-1 antagonists promise to effectively relieve urinary symptoms with uncertainty regarding their efficacy in preventing long-term progression events.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035513
Author(s):  
Dawn Shu Hui Looi ◽  
Mark Sen Liang Goh ◽  
Sharon Si Min Goh ◽  
Jia Ling Goh ◽  
Rehena Sultana ◽  
...  

IntroductionChildren who suffer from traumatic brain injury (TBI) are at risk of permanent brain damage and developmental deficits. Reports on neurodevelopmental outcomes in paediatric TBI suffer from small sample size and varying outcome definitions in the neurocognitive domains tested. This protocol describes a systematic review and meta-analysis of paediatric TBI in the following key neurocognitive domains: executive function, perceptual–motor function, language, learning and memory, social cognition and complex attention.MethodsA comprehensive search comprising studies from Medline, Cochrane, Embase and PsycINFO published from 1988 to 2019 will be conducted. We will include studies on children ≤18 years old who suffer from mild, moderate and severe TBI as determined by the Glasgow Coma Scale that report neurocognitive outcomes in domains predetermined by the Diagnostic and Statistical Manual of Mental Disorders fifth edition criteria. Systematic reviews, meta-analyses, randomised controlled trials, case–control, cohort and cross-sectional studies will be included. References from systematic reviews and meta-analyses will be hand-searched for relevant articles. A meta-analysis will be performed and effect sizes will be calculated to summarise the magnitude of change in each neurocognitive domain compared at different timepoints and stratified by severity of TBI. Included studies will be pooled using pooled standardised mean differences with a random effects model to determine an overall effect. In the scenario that we are unable to pool the studies, we will perform a narrative analysis.Ethics and disseminationEthics approval is not required for this study.The authors of this study will publish and present the findings in a peer-reviewed journal as well as national and international conferences. The results of this study will provide understanding into the association between different severities of paediatric TBI and long-term neurocognitive outcomes.PROSPERO registration numberCRD42020152680.


2016 ◽  
Vol 11 (2) ◽  
pp. 149 ◽  
Author(s):  
Michelle Maden ◽  
Eleanor Kotas

Objective – Systematic reviews are becoming increasingly popular within the Library and Information Science (LIS) domain. This paper has three aims: to review approaches to quality assessment in published LIS systematic reviews in order to assess whether and how LIS reviewers report on quality assessment a priori in systematic reviews, to model the different quality assessment aids used by LIS reviewers, and to explore if and how LIS reviewers report on and incorporate the quality of included studies into the systematic review analysis and conclusions. Methods – The authors undertook a methodological study of published LIS systematic reviews using a known cohort of published systematic reviews of LIS-related research. Studies were included if they were reported as a “systematic review” in the title, abstract, or methods section. Meta-analyses that did not incorporate a systematic review and studies in which the systematic review was not a main objective were excluded. Two reviewers independently assessed the studies. Data were extracted on the type of synthesis, whether quality assessment was planned and undertaken, the number of reviewers involved in assessing quality, the types of tools or criteria used to assess the quality of the included studies, how quality assessment was assessed and reported in the systematic review, and whether the quality of the included studies was considered in the analysis and conclusions of the review. In order to determine the quality of the reporting and incorporation of quality assessment in LIS systematic reviews, each study was assessed against criteria relating to quality assessment in the PRISMA reporting guidelines for systematic reviews and meta-analyses (Moher, Liberati, Tetzlaff, Altman, & The PRISMA Group, 2009) and the AMSTAR tool (Shea et al., 2007). Results – Forty studies met the inclusion criteria. The results demonstrate great variation on the breadth, depth, and transparency of the quality assessment process in LIS systematic reviews. Nearly one third of the LIS systematic reviews included in this study did not report on quality assessment in the methods, and less than one quarter adequately incorporated quality assessment in the analysis, conclusions, and recommendations. Only nine of the 26 systematic reviews that undertook some form of quality assessment incorporated considerations of how the quality of the included studies impacted on the validity of the review findings in the analysis, conclusion, and recommendations. The large number of different quality assessment tools identified reflects not only the disparate nature of the LIS evidence base (Brettle, 2009) but also a lack of consensus around criteria on which to assess the quality of LIS research. Conclusion – Greater clarity, definition, and understanding of the methodology and concept of “quality” in the systematic review process are required not only by LIS reviewers but also by editors of journals in accepting such studies for publication. Further research and guidance is needed on identifying the best tools and approaches to incorporate considerations of quality in LIS systematic reviews. LIS reviewers need to improve the robustness and transparency with which quality assessment is undertaken and reported in systematic reviews. Above all, LIS reviewers need to be explicit in coming to a conclusion on how the quality of the included studies may impact on their review findings.


2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sandra Lopez-Leon ◽  
Talia Wegman-Ostrosky ◽  
Carol Perelman ◽  
Rosalinda Sepulveda ◽  
Paulina A. Rebolledo ◽  
...  

AbstractCOVID-19 can involve persistence, sequelae, and other medical complications that last weeks to months after initial recovery. This systematic review and meta-analysis aims to identify studies assessing the long-term effects of COVID-19. LitCOVID and Embase were searched to identify articles with original data published before the 1st of January 2021, with a minimum of 100 patients. For effects reported in two or more studies, meta-analyses using a random-effects model were performed using the MetaXL software to estimate the pooled prevalence with 95% CI. PRISMA guidelines were followed. A total of 18,251 publications were identified, of which 15 met the inclusion criteria. The prevalence of 55 long-term effects was estimated, 21 meta-analyses were performed, and 47,910 patients were included (age 17–87 years). The included studies defined long-COVID as ranging from 14 to 110 days post-viral infection. It was estimated that 80% of the infected patients with SARS-CoV-2 developed one or more long-term symptoms. The five most common symptoms were fatigue (58%), headache (44%), attention disorder (27%), hair loss (25%), and dyspnea (24%). Multi-disciplinary teams are crucial to developing preventive measures, rehabilitation techniques, and clinical management strategies with whole-patient perspectives designed to address long COVID-19 care.


Author(s):  
Mariana Branquinho ◽  
María de la Fe Rodriguez-Muñoz ◽  
Berta Rodrigues Maia ◽  
Mariana Marques ◽  
Marcela Matos ◽  
...  

2020 ◽  
Vol 4 (1) ◽  
pp. e000913
Author(s):  
Hamed Seddighi ◽  
Homeira Sajjadi ◽  
Sepideh Yousefzadeh ◽  
Mónica López López ◽  
Meroe Vameghi ◽  
...  

IntroductionChildren are one of the most vulnerable groups in disasters. Improving students’ knowledge and skills to prepare for disasters can play a major role in children’s health. School as a place to teach children can make a significant contribution to provide the necessary skills. This study aims to identify the effects, strengths and weaknesses of interventions in schools to prepare children for disasters.Methods and analysisWe use Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to develop a protocol for this systematic review. The included studies will report on the results of interventions targeting ‘schoolchildren’ defined as individuals between 4 and under 18 years old studying in schools. Different electronic databases will be used for a comprehensive literature search, including MEDLINE, Web of Science, CINAHL, PsycINFO, Cochrane Register of Controlled Trials and EMBASE to identify the records that match the mentioned inclusion criteria published till December 2020. The main search terms are ‘disaster’, ‘preparedness’, ‘children’ and ‘school’. Four types of data will be extracted from the qualified studies including study characteristics (study design, year of publication and geographical region where the study was conducted), participant characteristics (sample size, age and gender), intervention characteristics (aim of intervention, intervention facilitators and barriers) and intervention outcomes. The quality appraisal of the selected papers will be conducted using Cochrane Collaboration’s Risk of Bias for quantitative studies and Critical Appraisal Skills Programme checklist for qualitative studies. We use a narrative synthesis for this systematic review. The narrative synthesis refers to an approach to systematic reviews which focuses mostly on applying words and texts to summarise and explain findings.Ethics and disseminationThis paper is a part of a Ph.D. thesis of Hamed Seddighi at University of Social welfare and Rehabilitation Sciences with ethics code IR.USWR.REC.1399.008 approved by the Ethics Committee of the above-mentioned university.PROSPERO registration numberCRD42020146536.


Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1168
Author(s):  
Cristian Neira ◽  
Rejane Godinho ◽  
Fabio Rincón ◽  
Rodrigo Mardones ◽  
Janari Pedroso

Confinement at home, quarantine, and social distancing are some measures adopted worldwide to prevent the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), which has been generating an important alteration in the routines and qualities of life of people. The impact on health is still being evaluated, and consequences in the nutritional field are not entirely clear. The study objective was to evaluate the current evidence about the impact that preventive measures of physical contact restriction causes in healthy nutrition. A systematic review was carried out according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” PRISMA Group and Cochrane method for rapid systematic reviews. Searching was performed in six electronic databases and evaluated articles published between 2010 and 2020, including among their participants adult subjects who had been exposed to the preventive measures of physical contact restriction. Seven studies met the selection criteria and reported an overall increase in food consumption, weight, Body Mass Index (BMI), and a change in eating style. Findings suggest that healthy nutrition is affected by preventive measures to restrict physical contact as a result of the COVID-19 syndemic.


Sign in / Sign up

Export Citation Format

Share Document