scholarly journals Dolutegravir Reported Adverse Drug Reactions: A Systematic Review Protocol

Author(s):  
Lesley Wadesango ◽  
Ebenezer Wiafe ◽  
Neelaveni Padayachee ◽  
Kofi Mensah ◽  
Varsha Bangalee

Abstract Background: Until recently, the first-line regimen for the management of Human Immunodeficiency Virus (HIV) was Tenofovir (TDF)-Emtricitabine (FTC) and Efavirenz (EFV). However, the use of EFV has now been limited due to adverse neurosensory effects and a low genetic barrier to resistance. This regimen has been replaced by the Dolutegravir (DTG)-based regimen since DTG has a high genetic barrier to resistance. Studies have reported a higher risk of Immune Reconstitution Inflammatory Syndrome (IRIS), weight gain, insomnia, and neural tube defects amongst people who received DTG. This review aims to assess the adverse drug reaction (ADR) profile of Dolutegravir by identifying and classifying Dolutegravir-associated adverse drug reactions.Methods: Studies will be identified from an electronic database search. Studies that are potentially eligible will be selected through screening. Two team members will independently screen all citations, full-text articles, and abstract data; conflicts will be resolved through discussion. The (PRISMA-P) flow diagram that outlines all phases of screening and reasons for exclusion will be used during the selection process. After the selection of the final study sample, a data extraction form will be used as a collection tool. The data will be entered into Cochrane Collaboration Review Manager (RevMan 5.2) for storage and management. All the evidence gathered will be assessed for bias through the use of the Risk of Bias tool RoB 2.0 of Cochrane Collaboration. Reported ADRs will then be classified. We will also provide data for the effect of different demographic factors on ADRs as well as the effects of co-administration of DTG with other drugs on ADRs. We will additionally provide information on how Dolutegravir use in different regimens affects the ADRs. Results from the review will be summarized quantitatively through meta-analysis. A forest plot will be used to present results from the meta-analysis. Conclusion: A review of existing studies will aid in establishing the safety profile of this drug. This review will make significant contributions to healthcare practice. It will aid in improving prescribers' and dispensers’ knowledge of the drug. Additionally, it will also aid in patient education of the potential ADRs to DTG.Systematic review registration DOI: doi.org/10.17605/OSF.IO/Z9YAF

2017 ◽  
Vol 8 (6) ◽  
pp. 199-210 ◽  
Author(s):  
Paulo Henrique Santos Andrade ◽  
Adriano da Silva Santos ◽  
Carlos Adriano Santos Souza ◽  
Iza Maria Fraga Lobo ◽  
Wellington Barros da Silva

Background: The main objective of the present systematic review is to identify potential risk factors for adverse drug reactions (ADRs) through prospective cohort studies in pediatric inpatients. Methods: The data search was done in the following electronic databases PubMed/MEDLINE; Scopus; LILACS and Web of Science from the earliest record until 31 May 2015. Two reviewers independently screened each study and one of them assessed the methodological quality according to the Newcastle–Ottawa scale for cohort studies. The data extraction was conducted according to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative for cohort studies. Results: The only risk factor observed in all studies was the increase in the number of prescription drugs. However, other factors were identified, such as the increase in the length of stay or the number of low- or high-risk drugs prescribed, use of general anesthesia and oncological diagnosis. The cumulative incidence of ADR was 16.4% (95% confidence interval: 15.6 to 17.2). The main professional responsible for ADR identification was the pharmacist and the dominant category among the ADRs were gastrointestinal disorders. In addition, analgesics, antibacterial agents and corticosteroids were the drug classes commonly associated with ADRs. The methodology used in this study was tried to homogenize the data extracted; however, this was not sufficient to correct the discrepancies so it was not possible to perform a meta-analysis. Conclusions: The increase in the number of prescription drugs was the main risk factor in this population. However, additional studies are required to identify the risk factors for ADRs in pediatric inpatients.


CNS Drugs ◽  
2021 ◽  
Vol 35 (2) ◽  
pp. 161-176
Author(s):  
Israa Alfares ◽  
Muhammad Shahid Javaid ◽  
Zhibin Chen ◽  
Alison Anderson ◽  
Ana Antonic-Baker ◽  
...  

2016 ◽  
Vol 96 (6) ◽  
pp. 876-887 ◽  
Author(s):  
Tasha R. Stanton ◽  
Hayley B. Leake ◽  
K. Jane Chalmers ◽  
G. Lorimer Moseley

Background Despite common use of proprioceptive retraining interventions in people with chronic, idiopathic neck pain, evidence that proprioceptive dysfunction exists in this population is lacking. Determining whether proprioceptive dysfunction exists in people with chronic neck pain has clear implications for treatment prescription. Purpose The aim of this study was to synthesize and critically appraise all evidence evaluating proprioceptive dysfunction in people with chronic, idiopathic neck pain by completing a systematic review and meta-analysis. Data Sources MEDLINE, CINAHL, PubMed, Allied and Complementary Medicine, EMBASE, Academic Search Premier, Scopus, Physiotherapy Evidence Database (PEDro), and Cochrane Collaboration databases were searched. Study Selection All published studies that compared neck proprioception (joint position sense) between a chronic, idiopathic neck pain sample and asymptomatic controls were included. Data Extraction Two independent reviewers extracted relevant population and proprioception data and assessed methodological quality using a modified Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. Data Synthesis Thirteen studies were included in the present review. Meta-analysis on 10 studies demonstrated that people with chronic neck pain perform significantly worse on head-to-neutral repositioning tests, with a moderate standardized mean difference of 0.44 (95% confidence interval=0.25, 0.63). Two studies evaluated head repositioning using trunk movement (no active head movement thus hypothesized to remove vestibular input) and showed conflicting results. Three studies evaluated complex or postural repositioning tests; postural repositioning was no different between groups, and complex movement tests were impaired only in participants with chronic neck pain if error was continuously evaluated throughout the movement. Limitations A paucity of studies evaluating complex or postural repositioning tests does not permit any solid conclusions about them. Conclusions People with chronic, idiopathic neck pain are worse than asymptomatic controls at head-to-neutral repositioning tests.


2020 ◽  
Author(s):  
José Gerardo Serrano-Robles ◽  
Ana Karen Pérez-Vázquez ◽  
Alejandro Navas-Pérez ◽  
Enrique O Graue-Hernandez ◽  
Arturo Ramirez-Miranda ◽  
...  

Abstract Background: Dry eye disease (DED) is a condition that affects the ocular surface and affects millions of people around the world. In recent years a stepped scheme has been proposed for the treatment of DED, with the use of an artificial tear being the mainstay of treatment. In this scheme, the use of secretagogues is suggested as part of the treatment for patients with moderate to severe affectation. With this systematic review we aim to evaluate the effectiveness and safety of secretagogues for DED.Methods: Electronic databases will be searched; we will include randomized controlled trials that compare secretagogues and artificial tears. Study inclusion will not be restricted on the basis of language or publication status. We will use Google Translate to assess studies written in languages other than English and Spanish. Identification, evaluation, data extraction and assessment of risk of bias will be conducted by two authors of the review, a third review author will resolve any disagreement. The outcomes will be the ocular surface disease index score, osmolarity and tear film break-up time. We will use the Cochrane Collaboration Risk of Bias (RoB) tool for assessing the risk of bias of the included studies. Based on the heterogeneity of the included studies, we will combine the findings in a meta-analysis using a random versus a fixed effect model. If we deem meta-analysis as inappropriate, we will document the reasons and report findings from the individual studies narratively.Discussion: Based on the evidence obtained we will evaluate the effect of Pilocarpine, Cevimeline and Diquafosol and compare it to artificial tears on multiple outcome measures.This systematic review aims to determine the efficacy and safety of the secretagogues pilocarpine, cevimeline and diquafosol to help clinicians in the decision-making process.Registration: PROSPERO CRD42020218407


2019 ◽  
Vol 77 (9) ◽  
pp. 630-645 ◽  
Author(s):  
Taylor K Bloedon ◽  
Rock E Braithwaite ◽  
Imogene A Carson ◽  
Dorothy Klimis-Zacas ◽  
Robert A Lehnhard

Abstract Context Supplementing with fruits high in anthocyanins to reduce exercise-induced oxidative stress and inflammation has produced mixed results. Objective This systematic review and meta-analysis aims to discuss the impact of whole fruits high in anthocyanins, including processing methods and the type and amount of fruit, on inflammation and oxidative stress. Data Sources PICOS reporting guidelines and a customized coding scheme were used to search 5 databases (SPORTDiscus, Science Direct, Web of Science [BIOSIS], Medline [Pubmed], and the Cochrane Collaboration) with additional cross-referencing selection. Data Extraction A random-effects meta-analysis was used to measure effects of the fruit supplements with 3 statistics; the QTotal value based on a χ2 distribution, τ2 value, and I2 value were used to determine homogeneity of variances on 22 studies (out of 807). Outliers were identified using a relative residual value. Results A small significant negative summary effect across the sum of all inflammatory marker outcomes (P < 0.001) and a moderate negative effect for the sum of all oxidative stress marker outcomes (P = 0.036) were found. Moderator analyses did not reveal significant (P > 0.05) differences between subgrouping variables. Conclusions Results indicate that consumption of whole fruit high in anthocyanins can be beneficial for reducing inflammation and oxidative stress.


BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e032850
Author(s):  
Birhan Alemnew ◽  
Alebachew Fasil ◽  
Tesfahun Mulatu ◽  
Nigus Bililign ◽  
Setegn Esthetie ◽  
...  

IntroductionPodoconiosis is a non-filarial swelling of the lower extremity endemic in tropical regions, North America and India. The aetiology and pathophysiology of the disease remain unknown. We propose conducting a systematic review and meta-analysis to evaluate the burden and risk factors of podoconiosis in Ethiopia reported in studies from 2009 to 2019.Methods and analysisWe will search the following electronic databases: PubMed (MEDLINE), EMBASE, Hinari, Cumulative Index to Nursing and Allied Health Literature, ISI (Web of Science) and Google Scholar. Medical subject headings will be used to extensively search relevant literature on electronic databases using related keywords such as epidemiology or prevalence, magnitude or burden, podoconiosis, and Ethiopia. Grey literature and manual search will also be performed to retrieve unindexed research articles. Two reviewers will screen all retrieved articles, conduct data extraction and then critically appraise all identified studies. We will analyse data using STATA V.14 statistical software. We will demonstrate pooled estimates of podoconiosis and associated factors with effect size and 95% CI. The presence of heterogeneity among studies will be examined by forest plot as well as the I2heterogeneity test. Potential causes of heterogeneity will be explored by carrying out sensitivity and subgroup analyses. The presence of publication bias will also be examined by observing funnel plots and objectively by Egger’s regression test. If the funnel plot is asymmetric and/or Egger’s test was found to be statistically significant (p<0.05), the trim and fill (Duval and Tweedie’s) analysis will be performed.Ethics and disseminationThe study will use publicly available data and will not identify the authors of the publication by name. In light of these and as has been indicated, research ethics clearance is not required for evidence syntheses in such reviews. The results of this study will be published in a peer-reviewed journal and presented at national and international conferences.PROSPERO registration numberCRD42019127459.


2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Brendan Kelly ◽  
Conor Judge ◽  
Stephanie M. Bollard ◽  
Simon M. Clifford ◽  
Gerard M. Healy ◽  
...  

Abstract Introduction There has been a recent explosion of research into the field of artificial intelligence as applied to clinical radiology with the advent of highly accurate computer vision technology. These studies, however, vary significantly in design and quality. While recent guidelines have been established to advise on ethics, data management and the potential directions of future research, systematic reviews of the entire field are lacking. We aim to investigate the use of artificial intelligence as applied to radiology, to identify the clinical questions being asked, which methodological approaches are applied to these questions and trends in use over time. Methods and analysis We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines and by the Cochrane Collaboration Handbook. We will perform a literature search through MEDLINE (Pubmed), and EMBASE, a detailed data extraction of trial characteristics and a narrative synthesis of the data. There will be no language restrictions. We will take a task-centred approach rather than focusing on modality or clinical subspecialty. Sub-group analysis will be performed by segmentation tasks, identification tasks, classification tasks, pegression/prediction tasks as well as a sub-analysis for paediatric patients. Ethics and dissemination Ethical approval will not be required for this study, as data will be obtained from publicly available clinical trials. We will disseminate our results in a peer-reviewed publication. Registration number PROSPERO: CRD42020154790


Author(s):  
Nicholas Moore (NO NEW ASSIGNMENTS) ◽  
Nicolas Thurin ◽  
Pauline Bosco-Lévy ◽  
Patrick Blin ◽  
cecile Droz

Thrombotic events are common during COVID-19 infection. Aspirin might be beneficial. Objective: Systematic review and meta-analysis of deaths in users and non-users of aspirin. Data sources: Pubmed Medline, Google scholar, Clinicaltrials.gov, Cochrane, to June 8, 2021, Study selection: Studies providing adjusted or matched evaluation of association of exposure to aspirin and death in COVID-19 patients were included. Data extraction and synthesis: Data were used as published, as Odds ratio, hazard ratio or relative risks and 95% CI from which log(OR) and SE were recalculated. These were entered in an inverse variance odds ratios random-effects model, using RevMan 5.4 (the Cochrane Collaboration). Main outcomes and measure: The prespecified outcome studied was death. Results: Nine studies (8 observational, one interventional) included 14989 patients exposed to aspirin and 15857 unexposed. Overall Odds Ratio of death in aspirin exposed patients in a random effects model was 0.63, 95% confidence interval [0.40-0.99], I2 94%. Using a fixed-effect model did not change much the result (0.76 [0.71-0.81], removing the Recovery trial (OR 0.43 [0.38-0.49], I271%, or the two largest studies (0.66 [0.47-0.93], I2 38%) reduced heterogeneity without materially altering the results. The funnel plot showed no evident publication bias Conclusion: this meta-analysis suggests that the use of aspirin may be associated with a lower risk of death in COVID-19. Considering the results of the Recovery Study, it would appear preferable to continue aspirin in patients who have a non-covid indication, but possibly useless to add it if they don’t.


2017 ◽  
Vol 72 (7) ◽  
pp. 1871-1879 ◽  
Author(s):  
Kathryn Schnippel ◽  
Cynthia Firnhaber ◽  
Rebecca Berhanu ◽  
Liesl Page-Shipp ◽  
Edina Sinanovic

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