scholarly journals Use of routinely collected electronic healthcare data for postlicensure vaccine safety signal detection: a systematic review

2019 ◽  
Vol 4 (4) ◽  
pp. e001065 ◽  
Author(s):  
Yonatan Moges Mesfin ◽  
Allen Cheng ◽  
Jock Lawrie ◽  
Jim Buttery
Keyword(s):  
Systematic Review ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Signal Detection ◽  
Real Time ◽  
Sequential Analysis ◽  
Vaccine Safety ◽  
Cochrane Library ◽  
Public Confidence ◽  
Healthcare Data

BackgroundConcerns regarding adverse events following vaccination (AEFIs) are a key challenge for public confidence in vaccination. Robust postlicensure vaccine safety monitoring remains critical to detect adverse events, including those not identified in prelicensure studies, and to ensure public safety and public confidence in vaccination. We summarise the literature examined AEFI signal detection using electronic healthcare data, regarding data sources, methodological approach and statistical analysis techniques used.MethodsWe performed a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Five databases (PubMed/Medline, EMBASE, CINAHL, the Cochrane Library and Web of Science) were searched for studies on AEFIs monitoring published up to 25 September 2017. Studies were appraised for methodological quality, and results were synthesised narratively.ResultWe included 47 articles describing AEFI signal detection using electronic healthcare data. All studies involved linked diagnostic healthcare data, from the emergency department, inpatient and outpatient setting and immunisation records. Statistical analysis methodologies used included non-sequential analysis in 33 studies, group sequential analysis in two studies and 12 studies used continuous sequential analysis. Partially elapsed risk window and data accrual lags were the most cited barriers to monitor AEFIs in near real-time.ConclusionRoutinely collected electronic healthcare data are increasingly used to detect AEFI signals in near real-time. Further research is required to check the utility of non-coded complaints and encounters, such as telephone medical helpline calls, to enhance AEFI signal detection.Trial registration numberCRD42017072741

scholarly journals Prioritising recommendations following analyses of adverse events in healthcare: a systematic review

2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Data Extraction ◽  
Data Sources ◽  
Cochrane Library ◽  
High Quality ◽  
Data Synthesis ◽  
Study Selection ◽  
Personal Opinion ◽  
User Friendly

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

scholarly journals Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Chronic Rhinosinusitis ◽  
Randomised Controlled Trials ◽  
Nasal Polyps ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design

2014 ◽  
Vol 56 (3) ◽  
pp. 513-525 ◽  
Author(s):  
Stanley Xu ◽  
Sophia Newcomer ◽  
Jennifer Nelson ◽  
Lei Qian ◽  
David McClure ◽  
...  
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Safety Studies

scholarly journals MANAGEMENT OF ENDOCRINE DISEASE: Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials

2012 ◽  
Vol 166 (4) ◽  
pp. 567-574 ◽  
Author(s):  
A Szypowska ◽  
A Ramotowska ◽  
K Dżygało ◽  
D Golicki
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Real Time ◽  
Continuous Glucose Monitoring ◽  
Insulin Pump ◽  
Meta Analysis ◽  
Glucose Monitoring ◽  
Cochrane Library ◽  
Insulin Regimen

ObjectiveReal-time continuous glucose monitoring (RT-CGM) provides detailed information on glucose patterns and trends, thus allowing the patients to manage their diabetes more effectively.DesignThe aim of this study was to explore the potential beneficial effects of the use of RT-CGM on diabetes management compared with self blood glucose measurement (SBGM) in patients with type 1 diabetes mellitus (T1DM), by means of a systematic review and meta-analysis of randomized controlled trials (RCTs).MethodsMEDLINE, EMBASE, and the Cochrane Library were searched through by two independent investigators for RCTs concerning the use of RT-CGM in patients with T1DM. Only studies with a similar insulin regimen in the experimental and control groups were included in the analysis.ResultsSeven RCTs (n=948) met the inclusion criteria. Combined data from all studies showed better HbA1c reduction in subjects using RT-CGM compared with those using SBGM (mean difference (MD) −0.25; 95% confidence interval (95% CI): from −0.34 to −0.17; P<0.001). Patients treated with insulin pump and RT-CGM had a lower HbA1c level compared with subjects managed with insulin pump and SBGM (four RCTs, n=497; MD −0.26; 95% CI: from −0.43 to −0.10; P=0.002). The benefits of applying RT-CGM were not associated with an increasing rate of major hypoglycemic episodes. The use of RT-CGM for over 60–70% of time was associated with a significant lowering of HbA1c.ConclusionsRT-CGM is more beneficial than SBGM in reducing HbA1c in patients with type 1 diabetes. Further studies are needed to evaluate the efficacy of this system in the pediatric population, especially in very young children.

scholarly journals Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Hui-ru Jiang ◽  
Shuang Ni ◽  
Jin-long Li ◽  
Miao-miao Liu ◽  
Ji Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled ◽  
Central Register

The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21]), SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]), and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]). All trials did not report adverse events. These results were limited by the methodological flaws of trials.

scholarly journals The Safety of Baduanjin Exercise: A Systematic Review

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Jianqi Fang ◽  
Liying Zhang ◽  
Fangzhen Wu ◽  
Jiajia Ye ◽  
Shuhe Cai ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Shoulder Pain ◽  
Knee Pain ◽  
Exercise Therapy ◽  
Chronic Fatigue ◽  
Cochrane Library ◽  
Shortness Of Breath ◽  
Chest Tightness ◽  
Muscle Ache

Objectives. Baduanjin exercise is a form of Qigong exercise therapy that has become increasingly popular worldwide. The aims of the current systematic review were to summarize reported adverse events potentially associated with Baduanjin exercise based on currently available literature and to evaluate the quality of the methods used to monitor adverse events in the trials assessed. Methods. The English databases PubMed, Cochrane library, and EMbase were searched from inception to October 2020 using the keywords “Baduanjin” or “eight session brocade.” Only studies that included Baduanjin exercise therapy were included. Results. Forty-seven trials with a total of 3877 participants were included in this systematic review. Twenty-two studies reported protocols for monitoring adverse events, and two studies reported the occurrence of adverse events during training. The adverse events reported included palpitation, giddiness, knee pain, backache, fatigue, nervousness, dizziness, shoulder pain, chest tightness, shortness of breath, and muscle ache. Conclusions. Only two studies reported adverse events that were potentially caused by Baduanjin exercise. Adverse events related to Baduanjin exercise in patients with chronic fatigue syndrome may include muscle ache, palpitation, giddiness, knee pain, backache, fatigue, nervousness, dizziness, shoulder pain, chest tightness, and shortness of breath. Further studies conducted in accordance with the Consolidated Standards of Reporting Trials statement guideline incorporating monitoring of adverse events are recommended. Additional clinical trials in which Baduanjin exercise is used as a main intervention are needed, and further meta-analysis may be required to assess its safety and reach more informed conclusions in this regard in the future.

scholarly journals Outcomes of operative versus non-operative interventions on rectus abdominis diastasis: a combination of a retrospective analysis and a systematic review

2019 ◽  
Author(s):  
sue yuan ◽  
Yunxia Li ◽  
Qi Li ◽  
Lu Fan ◽  
Jie Zhou
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Rectus Abdominis ◽  
Operative Intervention ◽  
Abdominal Hernia ◽  
Cochrane Library ◽  
Abdominal Muscles ◽  
Recurrence Rates ◽  
Mesh Placement

Abstract Background There is no current consensus on the treatment of Rectus abdominis diastasis (RAD). This study aimed to assess the recurrence rates and adverse events after operative or non-operative intervention.Methods We performed a retrospective study and a systematic review. Patients with a diagnosis of RAD who underwent the mesh placement procedure were eligible. Data were collected from The Research Patient Data Registry. Then, a systematic literature search of Pubmed, Embase, and The Cochrane Library databases was performed. A modified Downs and Black checklist for randomized and non-randomized studies of healthcare interventions (DB) was used to evaluate the methodological quality of the studies.Results Data of 82 patients was collected. The 5-year cumulative incidence of recurrence of abdominal hernia was high (females 37.0% vs males 43.4%, P = 0.557). Of 3908 citations, 27 studies describing 2,372 patients were included into the systematic review. In non-operative group, seven studies (25.93%) with a total of 603 subjects reported no patient relapsed after a follow-up of 12 months; a 40% recurrence rate was reported after a follow-up of 5 years in one study, the adverse events associated with operation mainly included seroma (5.13%), a sensibility disorder of the abdominal skin (2.26%), and minor scarring (1.56%). Muscle strength training, such as training of the pelvic floor muscles, abdominal muscles, rectus abdominis, internal/external oblique, or transverse abdominal muscles, was performed in all included non-surgery studies, neither adverse events nor recurrence was reported.Conclusion Operative intervention may be effective at restoring the functions of the rectus muscles and at improving the stability of abdominal wall in the short-term, while non-operative intervention has a limited effect, especially for those RAD combined with hernia.

scholarly journals Is postoperative nasal packing after septoplasty safe? A systematic review and meta-analysis of randomized controlled studies

2021 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
C.K. Titirungruang ◽  
N. Charakorn ◽  
B. Chaitusaney ◽  
P. Hirunwiwatkul
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Respiratory Distress ◽  
Sleep Disturbance ◽  
Septal Deviation ◽  
Oxygen Desaturation ◽  
Nasal Packing ◽  
Cochrane Library ◽  
Randomized Controlled ◽  
Septal Suture

BJECTIVES: To systemically review and compare post-septoplasty complications between total nasal packing and other techniques. METHODOLOGY: We searched electronic databases (PubMed, Scopus, and Cochrane Library) and additional sources. The most recent search was on November 30th, 2020. Randomized controlled trials (RCTs) comparing adverse events after post-septoplasty nasal packing versus other techniques were included. The outcomes were adverse events, including respiratory distress, oxygen desaturation, pain severity, bleeding, hematoma, sleep disturbance, infection, crusting, epiphora, dysphagia, perforation, adhesion, and residual septal deviation. RESULTS: There were 47 studies (4,087 participants) in this systematic review. Nasal packing was more likely to cause adverse events than other techniques. There were significant increases in respiratory distress, pain, sleep disturbance, crusting, epiphora, dysphagia, and adhesion. There were no statistically significant differences in oxygen desaturation, bleeding, hematoma, infection, perforation, and residual septal deviation. Subgroup analysis found that trans-septal suture was less likely to cause postoperative complications compared with total nasal packing. CONCLUSION: Nasal packing after septoplasty was more likely to cause adverse events, including respiratory distress, pain, sleep disturbance, crusting, epiphora, dysphagia, and adhesion. Furthermore, there were no benefits of nasal packing in preventing bleeding, hematoma, and residual septal deviation when compared with other techniques. Routine nasal packing after septoplasty should be avoided. Trans-septal suture should be considered instead.

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