Self-Controlled Case Series Studies

Farrington, Paddy; Whitaker, Heather; Ghebremichael‐Weldeselassie, Yonas

doi:10.1201/9780429491313

Cited by 63 publications

(86 citation statements)

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“…The SCCS method is a case-only design in which a cohort consists only of cases (individuals with the outcome or adverse event of interest) 31 . The aim of the SCCS method was to investigate the association between the outcome and exposure of interest, by comparing the incidence rate during risk-increased periods due to exposure (exposed periods), with the incidence rate at other times (unexposed periods), intra- www.nature.com/scientificreports/ personally 24 .…”

Section: Methodsmentioning

confidence: 99%

Risk of domperidone induced severe ventricular arrhythmia

Song

Lee

et al. 2020

Sci Rep

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There has been controversy over the cardiovascular safety of domperidone, attributable to the lack of a well-designed study as well as inconsistent results. this study aimed to examine the risk of severe domperidone-induced ventricular arrhythmia (VA), compared to mosapride, itopride, or non-use of all three prokinetics, in the general population. We conducted a population-based, self-controlled case series analysis. enrolled subjects were individuals who were diagnosed with severe VA and were prescribed domperidone, mosapride, or itopride from 2003 to 2013 in the National Health Insurance Service-national Sample cohort. the incidence rate ratio for severe VA was measured during exposure to prokinetics and compared with unexposed periods and itopride (no-proarrhythmic effect)-exposure periods, as control. A total of 2,817 subjects were included. Domperidone, mosapride, or itopride use was associated with increased risk of severe VA, compared with non-use (adjusted incidence rate ratios (IRR) of 1.342 (95% CI 1.096-1.642), 1.350 (95% CI 1.105-1.650), and 1.486 (95% CI 1.196-1.845), respectively). The risk of severe domperidone-induced VA was lower, compared to that of itopride [adjusted IRR of 0.548 (95% CI 0.345-0.870)]. Of the subjects who had been prescribed all three prokinetics, domperidone-exposure was associated with a lower risk of severe VA, compared to itopride-exposure (crude IRR, 0.571; 0.358-0.912). Mosapride-exposure did not show IRR difference for severe VA, compared to itopride-exposure. Domperidone, mosapride, or itopride use is associated with an increased risk of severe VA. However, the magnitude of association was modest and domperidone use does not increase further the risk, compared with other prokinetics. Abbreviations VA Ventricular arrhythmia SCCS Self-controlled case series NHIS-NSC National Health Insurance Service National Sample Cohort CI Confidence intervals CV Cardiovascular TdP Torsades de pointes SCD Sudden cardiac death Domperidone is effective for treating nausea and vomiting, delayed gastric emptying, and dyspepsia 1,2 and is preferred to other commonly prescribed prokinetic agents such as metoclopramide and mosapride 2. It is not associated with central nervous system side effects because it does not readily cross the blood-brain barrier 1,2. Domperidone is more effective than other prokinetic agents in treating gastroparesis 3,4. and exhibits concomitant central antiemetic activity through dopamine receptors within the chemoreceptor trigger zone 5. Despite all these advantages, the clinical use of oral domperidone is currently limited to individuals with an FDA Investigational New Drug exemption (treatment-refractory gastroparesis), owing to the risk of severe ventricular arrhythmia (VA) 2. Cardiac safety concerns were raised in the 1980s, when several serious cardiac events were reported 6-9. Intravenous domperidone has since been withdrawn from the market, with limited use of oral domperidone because of a possible association with cardiotoxicity 10-14. Although case series a...

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Section: Methodsmentioning

confidence: 99%

Risk of domperidone induced severe ventricular arrhythmia

Song

Lee

et al. 2020

Sci Rep

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“…Figure 1 is present to illustrate the SCCS study design in this cohort. The SCCS model was applied using the SCCS package in R (Farrington et al ., 2018). Furthermore, a moderation analysis based on the SCCS model was conducted to examine whether the neurodevelopment disorders (i.e.…”

Section: Methodsmentioning

confidence: 99%

Methylphenidate and the risk of burn injury among children with attention-deficit/hyperactivity disorder

Chen

Kuo

et al. 2020

Epidemiol Psychiatr Sci

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Aims Attention-deficit/hyperactivity disorder (ADHD) is associated with a higher risk of burn injury than in the normal population. Nevertheless, the influence of methylphenidate (MPH) on the risk of burn injury remains unclear. This retrospective cohort study analysed the effect of MPH on the risk of burn injury in children with ADHD. Method Data were from Taiwan's National Health Insurance Research Database (NHIRD). The sample comprised individuals younger than 18 years with a diagnosis of ADHD (n = 90 634) in Taiwan's NHIRD between January 1996 and December 2013. We examined the cumulative effect of MPH on burn injury risk using Cox proportional hazards models. We conducted a sensitivity analysis for immortal time bias using a time-dependent Cox model and within-patient comparisons using the self-controlled case series model. Results Children with ADHD taking MPH had a reduced risk of burn injury, with a cumulative duration of treatment dose-related effect, compared with those not taking MPH. Compared with children with ADHD not taking MPH, the adjusted hazard ratio for burn injury was 0.70 in children taking MPH for <90 days (95% confidence interval (CI) 0.64–0.77) and 0.43 in children taking MPH for ≥90 days (95% CI 0.40–0.47), with a 50.8% preventable fraction. The negative association of MPH was replicated in age-stratified analysis using time-dependent Cox regression and self-controlled case series models. Conclusion This study showed that MPH treatment was associated with a lower risk of burn injury in a cumulative duration of treatment dose-related effect manner.

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“…This study was analysed using a self-controlled case series approach [22,23], often used in investigating adverse events after administration of medications and especially vaccinations. This approach uses each patient as their own control by identifying an exposure period (shortly after vaccination) and baseline (remainder of the observation period) and comparing the frequency of adverse events of interest between them [24].…”

Section: Methodsmentioning

confidence: 99%

“…All statistical analysis was performed using R 3.4.4 [25] and the packages tidyverse version 1.2.1 [26], SCCS version 1.1 [23], lubridate [27], epitools [28], and tableone [29]. Graphical output was generated using the packages ggplot2 [30] and ggthemes version 3.5.0 [31].…”

Section: Methodsmentioning

confidence: 99%

Adverse Events of Interest Vary by Influenza Vaccine Type and Brand: Sentinel Network Study of Eight Seasons (2010-2018)

et al. 2019

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Background: Influenza contributes significantly to the burden of disease worldwide; the United Kingdom has a policy of vaccination across all ages. Influenza vaccinations are known to be associated with common minor adverse events of interest (AEIs). The European Medicines Agency (EMA) recommends ongoing surveillance of AEIs following influenza vaccination to monitor common and detect infrequent but important AEIs. Methods: A retrospective cohort study using computerised medical record data from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network database 2010-2018 (N = 848,375). We extracted data about vaccine exposure (n = 3,121,334) and consultations for AEIs within seven days of receiving vaccinations specified by the EMA (1,488,870 consultations by 430,029 unique individuals). We used a self-case series design which employs a likelihood estimation method using conditioning of observed adverse events. Such a model assumes non-homogenous Poisson intensity processes for each exposure period and age interval. We compared AEI between QIV and TIV reporting relative incidence (RI) of AEIs. A RI < 1 signified lower AEI rate compared to TIV. Results: QIV was associated with a RI of AEIs of 1.14 (95%CI, 1.10-1.18, p < 0.01), though the number of years exposure was limited. By way of contrast, LAIV had a lower rate 0.60 (95%CI 0.63-0.68, p < 0.001). Cellular manufacture was also associated with a lower rate 0.78 (95%CI 0.61-0.99, p = 0.04). AEIs varied by season: Rash and musculoskeletal conditions are particularly pronounced in the 2014/15 season and respiratory conditions in 2016/17. In an analysis of all seasons, we found an elevated relative incidence of AEIs of 1.78 (95%CI, 1.62-1.95) in pregnant women and 1.76 (95%CI, 1.56-1.99) in children under 5 years. Conclusion: Routine sentinel network data can be used to contrast AEIs between vaccine types and may provide a consistent method of observation of vaccine benefit-risk over time.

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Self-Controlled Case Series Studies

Cited by 63 publications

References 0 publications

Risk of domperidone induced severe ventricular arrhythmia

Risk of domperidone induced severe ventricular arrhythmia

Methylphenidate and the risk of burn injury among children with attention-deficit/hyperactivity disorder

Adverse Events of Interest Vary by Influenza Vaccine Type and Brand: Sentinel Network Study of Eight Seasons (2010-2018)

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