scholarly journals The efficacy of remdesivir in coronavirus disease 2019 (COVID-19): a systematic review

2020 ◽  
Author(s):  
Amirhossein Roshanshad ◽  
Alireza Kamalipour ◽  
Mohammad Ali Ashraf ◽  
Romina Roshanshad ◽  
Sirous Jafari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Cohort Studies ◽  
Clinical Improvement ◽  
Day Treatment ◽  
Mortality Rates ◽  
Severe Adverse Event ◽  
Adverse Event Rate ◽  
Significant Difference ◽  
Event Rates

Background and Objectives: Researchers all around the world are working hard to find an effective treatment for the new coronavirus 2019. We performed a comprehensive systematic review to investigate the latest clinical evidence on the efficacy and safety of treatment with Remdesivir in hospitalized patients with COVID-19. Materials and Methods: We performed a systematic search in Pubmed, Embase, Web of Science, Google scholar and MedRxiv for relevant observational and interventional studies. The outcomes measures were mortality rates, improvement rates, time to clinical improvement, all adverse event rates and severe adverse event rates. Results: Three randomized controlled trials and 2 cohort studies were included in our study. In the 2 cohort studies, patients received Remdesivir for 10 days. 2 RCTs evaluated 10-day efficacy of treatment with Remdesivir versus placebo group and the other RCT compared its 5-day regimen versus 10-day regimen. Visual inspection of the forest plots revealed that the efficacy of Remdesivir was not much different in reducing 28-day mortality versus 14-day mortality rates. Besides, 10-day treatment regimen overpowered 5-day treatment and placebo in decreasing time to clinical improvement. All adverse event rates did not have a significant difference; however, severe adverse event rate was lower in the 5-day Remdesivir group compared to the 10-day and placebo groups. Conclusion: 5-day course of Remdesivir therapy in COVID-19 patients is probably efficacious and safe, and patients without invasive mechanical ventilation benefit the most. Treatment can be extended to 10 days if satisfactory improvement is not seen by day 5. Most benefits from Remdesivir therapy take place in the first 14 days of the start of the treatment.

scholarly journals Remdesivir Efficacy in Coronavirus Disease 2019 (COVID-19): A Systematic Review

2020 ◽  
Author(s):  
Amirhossein Roshanshad ◽  
Alireza Kamalipour ◽  
Mohammad Ali Ashraf ◽  
Romina Roshanshad ◽  
Mohammad Reza Akbari
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Clinical Improvement ◽  
Day Treatment ◽  
Invasive Mechanical Ventilation ◽  
Mortality Rates ◽  
Severe Adverse Event ◽  
Adverse Event Rate ◽  
Significant Difference ◽  
Event Rates

AbstractBackgroundResearchers are working hard to find an effective treatment for the new coronavirus 2019. We performed a comprehensive systematic review to investigate the latest clinical evidence on the treatment efficacy and safety of Remdesivir in hospitalized patients with COVID-19.MethodsWe performed a systematic search of the Pubmed, Embase, Web of Science, Google scholar, and MedRxiv for relevant observational and interventional studies. Measured outcomes were mortality rates, improvement rates, time to clinical improvement, all adverse event rates and severe adverse event rates.Results3 RCTs and 2 cohorts were included in our study. In 2 cohort studies, patients received Remdesivir for 10 days. 2 RCTs evaluated 10-day treatment of Remdesivir efficacy versus placebo group and the other RCT compared its 5-day regimen versus 10-day regimen. Visual inspection of the forest plots revealed that Remdesivir efficacy was not much different in reducing 28-day mortality versus 14-day mortality rates. Besides, 10-day treatment regimen overpowers 5-day treatment and placebo in decreasing time to clinical improvement. All adverse event rates did not have significant difference; however, severe adverse event rate was lower in 5-day Remdesivir group compared to 10-day and placebo groups.Conclusion5-day course of Remdesivir therapy in COVID-19 patients is probably efficacious and safe and patients without invasive mechanical ventilation benefit the most. Treatment can be extended to 10 days if satisfactory improvement is not seen by day 5. Most benefits from Remdesivir therapy take place in the first 14 days of the start of the treatment.

TM2-2 Analysis of adverse events in the management of chronic headache by occipital nerve stimulation

2019 ◽  
Vol 90 (3) ◽  
pp. e13.2-e13
Author(s):  
S Miller ◽  
L Watkins ◽  
M Matharu
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Nerve Stimulation ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Occipital Nerve Stimulation ◽  
Occipital Nerve ◽  
Significant Difference ◽  
Event Rates ◽  
The Impact

ObjectivesTo analyse long-term adverse events of occipital nerve stimulation (ONS).DesignProspective open-label observational study.Subjects134 patients with refractory headaches implanted between 2007–2014 in a single specialised centre.MethodsInformation was collected on ONS device, implantable pulse generator (IPG) site and adverse event rates. The impact of implanter experience and the association between IPG site and adverse event rates was also explored.ResultsMean follow up was 46 months (6–108 months). A total of 139 adverse events were recorded in 75 patients (56%). A total of 59 additional surgeries were needed in 39 patients. A significant difference was seen in the rates of adverse events recorded between 2007–2010 and 2011–2014 (60.7% vs 42.6%, p=0.002). A significant reduction in ONS revision was seen over time (25.7% vs 5.9%, p=0.002). Analysis of adverse events with IPG site showed those with abdominal implants recorded higher adverse event rate that those with an IPG in the chest (65.8% vs 40.3%, p=0.004).ConclusionsIn specialist centres, adverse event rates of ONS can be much lower than reported in the literature. Our results suggest implanter experience and IPG site both have an effect on adverse event rate.

P4697Complications and mortality related to non-cardiac surgery in adult congenital heart disease: Results of a nationwide study including 20,450 cases

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G P Diller ◽  
E Freisinger ◽  
L Bronstein ◽  
J Koeppe ◽  
J Gerss ◽  
...  
Keyword(s):  
Congenital Heart Disease ◽  
Adverse Event ◽  
Heart Disease ◽  
Surgical Procedures ◽  
Congenital Heart ◽  
Cardiac Surgical Procedures ◽  
Mortality Rates ◽  
Adverse Event Rate ◽  
Major Adverse Event ◽  
Mortality And Morbidity

Abstract Background Adults with congenital heart disease (ACHD) represent a growing patient population with high morbidity and increasing health resource utilization. In addition to acute and chronic cardiac complications, these patients require numerous non-cardiac surgical procedures during their life-time. Limited data on the morbidity and mortality risk related to non-cardiac surgical procedures exist in contemporary CHD patients. The aim of this study was to analyse the frequency and outcome of non-cardiac surgical procedures in contemporary ACHD patients based on all hospital admissions in Germany between 2011 and 2016. Methods Based on the German diagnosis related groups data of patients treated between 2011 and 2016 we identified all ACHD patients treated surgically as inpatients for non-cardiac problems. The dataset contains information on patient demographics, primary and secondary diagnoses, interventional or surgical procedures, duration of stay and outcome including mortality. The primary endpoint of the study was surgery related mortality as well as major adverse events (defined as death or myocardial infarction, stroke, pulmonary embolism, sepsis or resuscitation). Results Overall, 48,872 ACHD cases were hospitalized during the study period. Of these, 20,450 (41.8%) were hospitalized for non-cardiac surgical procedures. The median age at surgery was 50.0 years and 62.9% of patients were male. The overall mortality rate following non-cardiac operations was 2.8% (95% CI 2.6–3.0%). The highest mortality rates were observed for procedure codes involving pharynx, larynx or trachea (27.2%; 95% CI: 22.3–32.1%) and lung surgery (15.4%; 95% CI: 13.3–17.8%). Abdominal surgery (9.2%; 95% CI: 7.7–10.9) and neurosurgical procedures (7.8%; 95% CI: 5.4–10.9) also had relative high mortality rates. The major adverse event rate overall was 12.7% (95% CI 11.7–12.7%). The highest major adverse event rates were observed for surgery of the airways (43.2%; 95% CI: 40.2%-46.4%). Conclusions Non-cardiac surgical procedures are common in ACHD patients and are associated with considerable mortality and morbidity in this cohort. Especially, surgical procedures involving the airways or neurosurgery emerged as risky procedures. However, even for routine abdominal or orthopaedic surgery considerable mortality and morbidity was observed. Overall, our data support careful pre-operative patient evaluation and concentration of surgical procedures at centres with extensive surgical and anaesthetic experience with ACHD patients.

scholarly journals Perioperative outcomes and adverse events of minimally invasive versus open posterior lumbar fusion: meta-analysis and systematic review

2016 ◽  
Vol 24 (3) ◽  
pp. 416-427 ◽  
Author(s):  
Christina L. Goldstein ◽  
Kevin Macwan ◽  
Kala Sundararajan ◽  
Y. Raja Rampersaud
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Adverse Events ◽  
Minimally Invasive ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Perioperative Outcomes ◽  
Estimated Blood Loss ◽  
Significant Difference ◽  
Patient Reported

OBJECT The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF). METHODS A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted. RESULTS The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p < 0.00001), 3.5 days (p = 0.0006), and 2.9 days (p < 0.00001), respectively. Operative time was not significantly different between the surgical techniques (p = 0.78). There was no significant difference in surgical adverse events (p = 0.97), but MIS cases were significantly less likely to experience medical adverse events (risk ratio [MIS vs open] = 0.39, 95% confidence interval 0.23–0.69, p = 0.001). No difference in nonunion (p = 0.97) or reoperation rates (p = 0.97) was observed. Mean Oswestry Disability Index scores were slightly better in the patients undergoing MIS (n = 346) versus open TLIF/PLIF (n = 346) at a median follow-up time of 24 months (mean difference [MIS – open] = 3.32, p = 0.001). CONCLUSIONS The result of this quantitative systematic review of clinical comparative effectiveness research examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias.

Comparing Demographic Characteristics and Adverse Event Rates at Two Dermatologic Surgery Practices

2014 ◽  
Vol 18 (5) ◽  
pp. 337-340 ◽  
Author(s):  
Jenna L. O'Neill ◽  
Brandon Shutty ◽  
Yun Sun Lee ◽  
James A. Solomon ◽  
Nikita Patel ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Geographic Location ◽  
Common Adverse Event ◽  
Adverse Event Rate ◽  
Dermatologic Surgery ◽  
Patient Demographics ◽  
Logistic Regression Procedure ◽  
Event Rates ◽  
Procedure Type

Background: Patient demographics and operative techniques may contribute to adverse events after surgeries. Objective: To identify differences in adverse event rates between different dermatologic surgery centers and potential contributing features affecting these rates. Methods: Data regarding demographics, procedure type, and adverse events were collected at two dermatologic surgery centers. Results: The most common adverse event at both sites was infection: 2.1% at site 1 versus 0.5% at site 2 ( p < .001). Using multivariate logistic regression, procedure type (Mohs surgery), geographic location (being at site 1), older age, and anatomic location of surgery were associated with a higher risk of infection. Conclusion: Adverse event rate appears to correlate with patient demographics, procedure type, and setting of surgery more than use of prophylactic antibiotics. Identification of differences in adverse event rates and potential contributing variables at different practices may allow for identification of opportunities to prevent adverse events.

scholarly journals P547 Safety and efficacy of vedolizumab in the treatment of patients with moderate to severe Ulcerative Colitis: a systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S516-S517
Author(s):  
M Khorshid Fasge ◽  
M Alboraie ◽  
W Abbas ◽  
Z E Sayed ◽  
M El-Nady
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Cohort Studies ◽  
Clinical Response ◽  
Clinical Remission ◽  
Assessment Tool ◽  
Meta Analysis ◽  
P Value ◽  
Severe Ulcerative Colitis ◽  
Significant Difference

Abstract Background To perform a systematic review and meta-analysis discussing the efficacy and safety of vedolizumab (VDZ) treatment in patients with active moderate to severe ulcerative colitis (UC). Methods Using relevant keywords, we searched PubMed, Web of Science, Scopus, and Cochrane Central databases, until June 2020. We included interventional and observational cohort studies which assessed the safety and effectiveness of VDZ 300 mg intravenous infusion, in patients with active moderate to severe UC. We used the Cochrane risk of bias assessment tool and the Newcastle-Ottawa scale to assess the quality of included interventional and cohort studies, respectively. Dichotomous outcomes were pooled as proportion, 95% Confidence interval (CI), and p-value under the random-effects model in the open meta-analyst software. Results We found 10 interventional studies and 35 cohort studies, including 4,794 patients eligible for our review. Most of the included citations were single-arm studies. Our meta-analysis showed that VDZ therapy could induce a significant clinical response in UC patients up to 54 weeks (proportion 0.516, 95% CI [0.453, 0.578], p &lt; 0.001). VDZ was associated with clinically significantly clinical remission and steroid-free clinical remission after 54 weeks (p &lt; 0.0001). Durable clinical remission, histological remission, and endoscopic response rates were maintained in UC patients taking VDZ at the 52nd week. There was no significant difference between VDZ and placebo regarding the incidence of drug-related serious adverse events (p = 0.113) and death rates (p = 0.085). Conclusion Our systematic review and meta-analysis showed that the use of VDZ in patients with active moderate to severe UC was associated with high percentages of clinical response and remission rates in induction and maintenance treatment stages. VDZ seems to be well tolerated in UC patients, apart from some infections and inflammations. Future RCTs should compare VDZ to active treatments for longer follow-up periods with larger sample size.

scholarly journals Repurposing of drugs for Covid-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Pinky Kotecha ◽  
Alexander Light ◽  
Enrico Checcucci ◽  
Daniele Amparore ◽  
Cristian Fiori ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Cochrane Library ◽  
Control Group ◽  
Significant Difference

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)

Measuring adverse event rates in oncology inpatients using trigger tools: An assessment of measurement properties.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 235-235
Author(s):  
Thea Otto Mattsson ◽  
Kim Brixen ◽  
Janne Lehmann Knudsen ◽  
Jorn Herrstedt
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Retrospective Chart Review ◽  
Measurement Properties ◽  
Statistical Process ◽  
Equal Distribution ◽  
Moderate Agreement ◽  
Significant Difference ◽  
Event Rates ◽  
Over Time

235 Background: The Institute for Healthcare Improvement developed the Global Trigger Tool (GTT) for measuring harm rates over time in 2006. Few studies have been published on the measurement properties of GTT and no studies have assessed the value of adding specific modules to the generic GTT. We, therefore, aimed to determine inter-rater reliability, and to evaluate the effect of interrater variation on the reliability of the generic GTT to detect adverse event rates over time. Furthermore to evaluate the effect of adding an oncology specific module to the generic GTT on number and category of adverse events (AEs) identified. Methods: A retrospective chart review was performed by two teams consisting of two primary reviewers. One team used the general GTT, and the other used an oncology specific GTT (GTTO); consisting of the general GTT module plus an additional oncology module. A random sample of 10 charts was selected every two weeks between all discharged patients from a Department of Oncology in 2010. n=240. All charts were reviewed by both teams using standard GTT methods and measures. AEs per 1,000 admission days and AEs per 100 admissions where used to draw Statistical process control (SPC) charts for evaluation of the patient safety process. Inter-rater variability between review teams was assessed calculating the Kappa Cohen coefficient using data from the identical general GTT module. Results: Reliability between the two teams of reviewers to identify an AE was moderate [K=0.45]. A comparison of SPC charts, using the results from the identical general module, showed that moderate agreement gave rise to different conclusions on the patient safety process between teams. Comparing GTT with GTTO we found no significant difference (CI 95% [0.06-0.08]) in number of identified AEs and an equal distribution of the events on harm categories. GTT and GTTO identified 56 and 57 AEs respectively. Conclusions: Moderate agreement between review teams gave rise to different conclusions on the patient safety process suggesting limited use of the GTT to track harm rates over time. Addition of an oncology specific module showed no significant effect on the total number or distribution of AEs on harm categories.

scholarly journals Effect of ambulatory versus hospital treatment for gestational diabetes or hyperglycemia on infant mortality rates: a systematic review

2013 ◽  
Vol 131 (5) ◽  
pp. 331-337
Author(s):  
Marilza Vieira Cunha Rudge ◽  
Silvana Andrea Molina Lima ◽  
Regina Paolucci El Dib ◽  
Gabriela Marini ◽  
Claudia Magalhaes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mortality Rates ◽  
Small Sample ◽  
University Hospital ◽  
Hospital Treatment ◽  
Maternal Complications ◽  
Neonatal Deaths ◽  
Significant Difference ◽  
Reduction Of Mortality ◽  
Small Sample Sizes

CONTEXT AND OBJECTIVE: Pregnancies complicated by diabetes are associated with increased neonatal and maternal complications. The most serious maternal complication is the risk of developing type 2 diabetes, 10-12 years after the delivery. For rigorous control over blood glucose, pregnant women are treated through ambulatory management or hospitalization. The aim of this study was to evaluate the effectiveness of ambulatory management versus hospitalization in pregnancies complicated by diabetes or hyperglycemia. DESIGN AND SETTING: Systematic review conducted in a public university hospital. METHODS: A systematic review of the literature was performed and the main electronic databases were searched. The date of the most recent search was September 4, 2011. Two authors independently selected relevant clinical trials, assessed their methodological quality and extracted data. RESULTS: Only three studies were selected, with small sample sizes. There was no statistically significance different between ambulatory management and hospitalization, regarding mortality in any of the subcategories analyzed: perinatal and neonatal deaths (relative risk [RR] 0.65; 95% confidential interval [CI]: 0.11 to 3.84; P = 0.63); neonatal deaths (RR 0.29; 95% CI: 0.01 to 6.07; P = 0.43); and infant deaths (RR 0.29; 95% CI: 0.01 to 6.07; P = 0.43). CONCLUSIONS: This review, based on studies with high or moderate risk of bias, showed that there was no statistically significant difference between ambulatory management and hospital care, regarding reduction of mortality rates in pregnancies complicated by diabetes or hyperglycemia. It also suggested that there is a need for further randomized controlled trials on this issue.

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