scholarly journals SAEFVIC: Surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2018

2020 ◽  
Vol 44 ◽  
Author(s):  
Hazel J Clothier ◽  
Jock Lawrie ◽  
Georgina Lewis ◽  
Melissa Russell ◽  
Nigel W Crawford ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Investigation ◽  
Vaccine Safety ◽  
Indigenous Australians ◽  
Indigenous Status ◽  
Age Cohorts ◽  
Signal Validation ◽  
Clinical Support ◽  
Observational Cohort ◽  
Validation Testing

Background SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018. Methods A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0–12 months); young child (1–4 years); school-aged (5–17 years); adult (18–64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described. Results SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association. Conclusion SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities.

Vaccine Safety and Surveillance for Adverse Events Following Immunization (AEFI) in India

2017 ◽  
Vol 85 (2) ◽  
pp. 139-148 ◽  
Author(s):  
Jyoti Joshi ◽  
Manoja Kumar Das ◽  
Deepak Polpakara ◽  
Satinder Aneja ◽  
Mahesh Agarwal ◽  
...  
Keyword(s):  
Adverse Events ◽  
Vaccine Safety

scholarly journals Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 243 ◽  
Author(s):  
Jacob Puliyel ◽  
Pathik Naik
Keyword(s):  
Heart Disease ◽  
Adverse Events ◽  
Vaccine Safety ◽  
World Health Organisation ◽  
Epidemiological Studies ◽  
World Health ◽  
Causal Association ◽  
Risk Of Death ◽  
Post Marketing Surveillance ◽  
Definition Of

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

scholarly journals Effect of Renamezin upon attenuation of renal function decline in pre-dialysis chronic kidney disease patients: 24-week prospective observational cohort study

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252186
Author(s):  
Hayne Cho Park ◽  
AJin Cho ◽  
Do Hyoung Kim ◽  
Kyu-sang Yun ◽  
Juhee Kim ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Renal Function ◽  
Cohort Study ◽  
Kidney Disease ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Observational Cohort Study ◽  
Prospective Observational Cohort Study ◽  
Renal Function Decline ◽  
Observational Cohort

Renamezin® is a modified capsule-type oral spherical adsorptive carbon which lowers indoxyl sulfate levels in patients with advanced chronic kidney disease (CKD). This 24-week prospective observational cohort study was performed to evaluate the effect of Renamezin® upon attenuation of renal function decline. A total of 1,149 adult patients with baseline serum creatinine 2.0–5.0 mg/dL were enrolled from 22 tertiary hospital in Korea from April 2016 to September 2018. Among them, a total of 686 patients completed the study and were included in the intention-to-treat analysis. A total of 1,061 patients were included in the safety analysis. The mean age was 63.5 years and male patients were predominant (63.6%). Most of the patients (76.8%) demonstrated high compliance with study drug (6g per day). After 24 week of treatment, serum creatinine was increased from 2.86±0.72 mg/dL to 3.06±1.15 mg/dL (p<0.001), but estimated glomerular filtration rate was not changed significantly during observation period (22.3±6.8 mL/min/1.73m2 to 22.1±9.1 mL/min/1.73m2, p = 0.243). Patients with age over 65 years old and those under good systolic blood pressure control <130 mmHg were most likely to get benefit from Renamezin® treatment to preserve renal function. A total of 98 (9.2%) patients out of 1,061 safety population experienced 134 adverse events, of which gastrointestinal disorders were the most common. There were no serious treatment-related adverse events. Renamezin® can be used safely to attenuate renal function decline in moderately advanced CKD patients.

scholarly journals P030: The FAN study: intranasal fentanyl and inhaled nitrous oxide for fracture reduction

CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S88-S88
Author(s):  
J. Hoeffe ◽  
E. D. Trottier ◽  
B. Bailey ◽  
D. Shellshear ◽  
M. Lagacé ◽  
...  
Keyword(s):  
Nitrous Oxide ◽  
Adverse Events ◽  
Pain Scale ◽  
University Of Michigan ◽  
Median Difference ◽  
Nitrous Oxide Oxygen ◽  
Attractive Option ◽  
The Face ◽  
Observational Cohort ◽  
Sedation And Analgesia

Introduction: Recently, intranasal (IN) fentanyl and inhaled nitrous oxide/oxygen (N2O) mixture have been increasingly used for procedural sedation and analgesia (PSA) alone or in combination. There is a lack of data on the efficacy of these combined agents. Methods: The objective was to evaluate the efficacy of IN fentanyl and N2O as PSA for the reduction of mildly-to-moderately displaced fractures and dislocations. We performed a prospective, observational cohort study between September 2014 and October 2015. Patients were recruited at CHU Sainte Justine (Montréal) and Royal Children Hospital (Melbourne, Australia). Patients aged 4 to 18 years were eligible if PSA consisted of IN fentanyl and N2O for the reduction of mildly-to-moderately displaced fractures or dislocations. Patients received at least IN fentanyl 1.5 mcg/kg (100 mcg max) and at least a 50/50% mixture of N2O with oxygen. Primary outcome was the efficacy of PSA measured by the patient assigned Facial Pain Scale-Revised (FPS-R). The Face, Legs, Activity, Cry, Consolability (FLACC) scale was also recorded. Depth of sedation was evaluated using University of Michigan Sedation Scale (UMSS). Adverse events were recorded following criteria of the Consensus Panel on Sedation Research of PERC/PECARN. Additional data concerning satisfaction or discomfort were evaluated via questionnaires, and follow-up telephone calls were made to elicit information on adverse events after discharge. Results: A total of 91 patients aged 9.7 ± 3.0 years were enrolled. There was no difference between the median FPS-R score during the procedure compared to before: Median 2 and 2 (median difference 0 [95% CI 0, 0]), respectively. The FLACC score was higher during the procedure than before: Median 4 and 0 (median difference 2 [95% CI 1, 3]). UMSS was 1 (95% CI 1, 2) during the procedure. 42 (46%) patients had adverse events, all mild: vertigo (20%), nausea (16%)]or vomiting (12%). A total of 85/88 (97%) parents and 82/85 (96%) ED physicians would want the same sedation in another procedure. Conclusion: PSA with IN fentanyl and N2O seems effective in our study, as evaluated by patient assigned FPS-R. Patients were minimally sedated. Adverse events were frequent but mild. Overall, parents and medical staff would want the same agents used in another procedure. Thus, PSA with IN fentanyl and N2O appears to be an attractive option for reduction of mildly displaced fractures or dislocations.

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

Effectiveness of a Domestic Abuse Program for Australian Indigenous Offenders

2020 ◽  
Vol 64 (16) ◽  
pp. 1639-1673
Author(s):  
Chris Blatch ◽  
Kevin O’Sullivan ◽  
Jane Goodman-Delahunty ◽  
Matthew Willis ◽  
Jordan J. Delaney
Keyword(s):  
Domestic Abuse ◽  
Program Completion ◽  
Risk Scores ◽  
Indigenous Australians ◽  
Indigenous Status ◽  
Intention To Treat ◽  
Therapeutic Benefits ◽  
Criminal Histories ◽  
Quasi Experimental ◽  
Actuarial Risk

The subject of this study is to assess the effectiveness of a culture-neutral domestic abuse program (DAP) developed for offenders with domestic and family violence histories, when used for Australian Indigenous offenders, serving community-based supervised orders. The study employed a retrospective quasi-experimental research design and intention-to-treat program definition for 953 DAP-treated men and propensity score–matched controls, from diverse cultural, religious, and racial backgrounds, 19% being Indigenous Australians. Outcomes measured were program completion, time to first reconviction, and reconviction rates. Indigenous men completed the program similar to non-Indigenous men (58% vs. 63%; NS), although significantly more dropped out (22% vs. 18%); 63% of Indigenous DAP-treated men, remained reconviction free versus 49% of Indigenous controls. Significant therapeutic benefits required program completion, 73% Indigenous and 74% of non-Indigenous men remained reconviction free. Indigenous DAP participants, relative to controls, took significantly longer to first reconviction. Survival was associated with prior criminal histories, but not with rural or remote domiciles. Reconviction rates were predicted by Level of Service Inventory–Revised actuarial risk scores and by DAP completion, but not by Indigenous status. Program effect size was d = .477, mean reconvictions for Indigenous DAP enrollees being 50% lower than controls. Generic domestic violence interventions utilising evidence-based theoretical principles can be effective for Indigenous offenders, despite an absence of specific Indigenous cultural, or healing content, and delivery by Indigenous facilitators or Elders.

Observational cohort study of first-line bevacizumab combined with chemotherapy in metastatic colorectal cancer (HGCSG0802): Comparison of infusional FU/oxaliplatin(OX)+BV and oral FU/OX+BV.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 527-527 ◽  
Author(s):  
Kazuteru Hatanaka ◽  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Hiraku Fukushima ◽  
Hirohito Naruse ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cohort Study ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Observational Cohort Study ◽  
Rank Test ◽  
First Line ◽  
Eligibility Criteria ◽  
Significant Difference ◽  
Observational Cohort

527 Background: A few reports have shown no difference between the efficacy of infusional FU and that of oral FU (Capecitabine/S-1) for colorectal cancer, and some studies have reported the non-inferiority between infusional FU/Oxaliplatin (OX) and oral FU/OX for metastatic colorectal cancer (mCRC). We performed a sub-group comparison between infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) from the HGCSG0802 observational cohort study with investigated Japanese patients (pts) treated with first line BV for mCRC. Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), time to treatment-failure (TTF), response rate (RR), safety and so on. The key eligibility criteria of HGCSG0802 were with evaluable lesions, older than 20 years, ECOG PS 0-2, and this analysis used the cohort treated with OX-based regimens.In this analysis, pts characteristics, RR and safety were compared using Fisher’s exact test. PFS and TTF were compared using log-rank test. Results: Of 108 pts (the full analysis set), 95 pts were evaluable for treated with OX-based regimens. Forty-eight pts (50.5%) were treated with iFU and 47 pts (49.5%) were treated with oFU (CapeOX + BV 42 pts/SOX + BV 5 pts). The pts characteristics between those were generally balanced except for PS 0-1 (72.9% in iFU/93.6% in oFU; p=0.012) and synchronous liver metastases (mets) (93.8% in iFU/78.8% in oFU; p=0.040). Adverse events ≥grade 3 were balanced except for leucopenia (25.0% in iFU versus 2.1% in oFU; p=0.002) and neutropenia (43.5% in iFU and 10.9% in oFU; p=0.001). Hand-foot skin reaction was not different between two cohorts. RR was 62.5% in iFU versus 71.1% in oFU (p=0.835). The median PFS was 8.3 months in iFU versus 8.2 months in oFU (p=0.835). Conclusions: The HGCSG0802 could be a database to investigate first line BV for mCRC in clinical practice. As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between infusional FU/OX and oral FU/OX, and the profiles of adverse events varied from each regimens.

Feasibility of telemonitoring for active surveillance of influenza vaccine safety in the primary care setting in the Netherlands

2009 ◽  
Vol 15 (7) ◽  
pp. 362-367 ◽  
Author(s):  
Hubertus JM Vrijhoef ◽  
Joyce JM Janssen ◽  
Michael E Greenberg
Keyword(s):  
Primary Care ◽  
The Netherlands ◽  
Adverse Events ◽  
Care Setting ◽  
Primary Care Setting ◽  
Vaccine Safety ◽  
Incidence Rates ◽  
Paid Work ◽  
Hospital Emergency ◽  
Home Telemonitoring

We examined the feasibility of a commercial home telemonitoring system for monitoring adverse events related to vaccination and influenza-like illness (ILI) signs and outcomes in the primary care setting in the Netherlands. A prospective cohort of people eligible for influenza vaccination was monitored daily between mid-October 2007 and mid-March 2008. Adults from five primary care centres were invited to participate. A total of 245 people participated (response rate 75%). Their mean age was 61 years (SD = 15), 50% were female and 60% had a chronic disease. Most (73%) had no problems with installation of the system and 67% finished all sets of monitoring dialogues. The reported incidence of adverse events in the first week after vaccination was 8–38%. The reported incidence rates of ILI symptoms varied and were higher than reference data. A total of 39% of individuals consulted their general practitioner, 7% the hospital emergency department, 6% were hospitalized and 27% used medication. Of those in paid work, one-third reported absence of work due to ILI. Home telemonitoring appears to be feasible for monitoring vaccine adverse events and ILI symptoms and outcomes.

scholarly journals Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

2014 ◽  
Vol 11 (1) ◽  
pp. 91-94 ◽  
Author(s):  
Cristiano Alicino ◽  
Caterina Merlano ◽  
Simona Zappettini ◽  
Sergio Schiaffino ◽  
Giovanni Della Luna ◽  
...  
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Routine Surveillance
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