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 Bias Correction of Risk Estimates in Vaccine Safety Studies With Rare Adverse Events Using a Self-controlled Case Series Design

2013 ◽  
Vol 178 (12) ◽  
pp. 1750-1759 ◽  
Author(s):  
C. Zeng ◽  
S. R. Newcomer ◽  
J. M. Glanz ◽  
J. A. Shoup ◽  
M. F. Daley ◽  
...  
Keyword(s):  
Adverse Events ◽  
Bias Correction ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Risk Estimates ◽  
Safety Studies

Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice

2011 ◽  
Vol 139 (12) ◽  
pp. 1805-1817 ◽  
Author(s):  
Y. G. WELDESELASSIE ◽  
H. J. WHITAKER ◽  
C. P. FARRINGTON
Keyword(s):  
Adverse Events ◽  
Best Practice ◽  
Good Practice ◽  
Case Series ◽  
Vaccine Safety ◽  
The Self ◽  
Series Method ◽  
Safety Studies ◽  
Definition Of ◽  
Study Designs

SUMMARYThe self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.

scholarly journals A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design

2013 ◽  
Vol 32 (19) ◽  
pp. 3290-3299 ◽  
Author(s):  
Stanley Xu ◽  
Simon J. Hambidge ◽  
David L. McClure ◽  
Matthew F. Daley ◽  
Jason M. Glanz
Keyword(s):  
Case Series ◽  
Vaccine Safety ◽  
Scan Statistic ◽  
Series Design ◽  
Safety Studies

Self-controlled case series design in vaccine safety: a systematic review

2021 ◽  
Author(s):  
Xiaolu Nie ◽  
Lu Xu ◽  
Yi Bai ◽  
Zuoxiang Liu ◽  
Zhike Liu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design

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

Adverse events associated with aprepitant pediatric bone cancer patients

2018 ◽  
Vol 25 (3) ◽  
pp. 735-738 ◽  
Author(s):  
Lucas M Okumura ◽  
Sacha A da Silva Ries ◽  
Clarice F Meneses ◽  
Mariana B Michalowski ◽  
Maria Angelica P Ferreira ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Adverse Events ◽  
Cancer Patients ◽  
Drug Information ◽  
Case Series ◽  
Bone Cancer ◽  
European Medicines Agency ◽  
Safety Studies ◽  
Official Sources

An eight-year long case series follow-up study with pediatric bone cancer patients was conducted to compare the occurrence of adverse events associated with aprepitant with official sources of drug information (manufacturer’s leaflet, clinical trials, and European Medicines Agency leaflet). All patients admitted were analyzed, representing 192 aprepitant cycles. Anorexia, febrile neutropenia, and headache were observed in frequencies over 43.8 per 100 patients, which was higher than previous estimates. Adverse events were classified as probable or possible, by using Naranjo score. The increased rates of adverse events, especially on the risk febrile neutropenia, warrant further safety studies on this population.

scholarly journals Olaparib dose re‐escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series

2021 ◽  
Vol 17 (S3) ◽  
pp. 3-11
Author(s):  
Siew‐Fei Ngu ◽  
Ka‐Yu Tse ◽  
Mandy M. Y. Chu ◽  
Hextan Y. S. Ngan ◽  
Karen K. L. Chan
Keyword(s):  
Ovarian Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Case Series

scholarly journals Ocular adverse events associated with immune checkpoint inhibitors: a novel multidisciplinary management algorithm

2021 ◽  
Vol 13 ◽  
pp. 175883592199298
Author(s):  
Orthi Shahzad ◽  
Nicola Thompson ◽  
Gerry Clare ◽  
Sarah Welsh ◽  
Erika Damato ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Case Reports ◽  
Case Series ◽  
Simple Algorithm ◽  
Cancer Therapeutics ◽  
Management Algorithm ◽  
Ocular Symptoms ◽  
Systemic Corticosteroids ◽  
Permanent Loss

Ocular immune-related adverse events (IrAEs) associated with use of checkpoint inhibitors (CPIs) in cancer therapeutics are relatively rare, occurring in approximately 1% of treated patients. Recognition and early intervention are essential because the degree of tissue damage may be disproportionate to the symptoms, and lack of appropriate treatment risks permanent loss of vision. International guidelines on managing ocular IrAEs provide limited advice only. Importantly, local interventions can be effective and may avoid the need for systemic corticosteroids, thereby permitting the continuation of CPIs. We present a single institution case series of eight affected patients managed by our multidisciplinary team. Consistent with previously published series and case reports, we identified anterior uveitis as the most common ocular IrAE associated with CPIs requiring intervention. Based on our experience, as well as published guidance, we generated a simple algorithm to assist clinicians efficiently manage patients developing ocular symptoms during treatment with CPIs. In addition, we make recommendations for optimising treatment of uveitis and address implications for ongoing CPI therapy.

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