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

Stanley Xu; Simon J. Hambidge; David L. McClure; Matthew F. Daley; Jason M. Glanz

doi:10.1002/sim.5733

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

Biometrical Journal ◽

10.1002/bimj.201300012 ◽

2014 ◽

Vol 56 (3) ◽

pp. 513-525 ◽

Cited By ~ 8

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

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

American Journal of Epidemiology ◽

10.1093/aje/kwt211 ◽

2013 ◽

Vol 178 (12) ◽

pp. 1750-1759 ◽

Cited By ~ 3

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

Epidemiology and Infection ◽

10.1017/s0950268811001531 ◽

2011 ◽

Vol 139 (12) ◽

pp. 1805-1817 ◽

Cited By ~ 47

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.

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

Expert Review of Vaccines ◽

10.1080/14760584.2022.2020108 ◽

2021 ◽

Author(s):

Xiaolu Nie ◽

Lu Xu ◽

Yi Bai ◽

Zuoxiang Liu ◽

Zhike Liu ◽

...

Keyword(s):

Systematic Review ◽

Case Series ◽

Vaccine Safety ◽

Series Design

Use of Fixed Effects Models to Analyze Self-Controlled Case Series Data in Vaccine Safety Studies

Journal of Biometrics & Biostatistics ◽

10.4172/2155-6180.s7-006 ◽

2012 ◽

Vol 01 (S7) ◽

Cited By ~ 1

Author(s):

Stanley Xu

Keyword(s):

Fixed Effects ◽

Case Series ◽

Vaccine Safety ◽

Series Data ◽

Fixed Effects Models ◽

Safety Studies

Drug safety studies and measures of effect using the self-controlled case series design

Pharmacoepidemiology and Drug Safety ◽

10.1002/pds.3337 ◽

2012 ◽

Vol 22 (1) ◽

pp. 108-110 ◽

Cited By ~ 4

Author(s):

Kumanan Wilson ◽

Steven Hawken

Keyword(s):

Drug Safety ◽

Case Series ◽

The Self ◽

Series Design ◽

Safety Studies

Increasing Anticipatory Pleasure in Major Depression through Enhancing Episodic Future Thinking: A Randomized Single-Case Series Trial

10.31234/osf.io/9uy42 ◽

2019 ◽

Author(s):

David John Hallford ◽

Manoj Kumar Sharma ◽

David W. Austin

Keyword(s):

Major Depressive Disorder ◽

Major Depression ◽

Mental Imagery ◽

Single Case ◽

Case Series ◽

Episodic Future Thinking ◽

Future Thinking ◽

Major Depressive ◽

Positive Events ◽

Series Design

Depressed individuals have difficulty anticipating pleasure, which can impact motivation and functioning. One factor in this may be impairments in their episodic future thinking (EFT). This study examined whether enhancing EFT through increasing detail/vividness and mental imagery would increase anticipatory pleasure among individuals with Major Depressive Disorder. A randomized start-point, single case series design was used. Depressed outpatients (N = 7) completed surveys through the day over two weeks to nominate upcoming positive events and rate them on EFT detail/vividness, mental imagery, and anticipatory pleasure. At a randomized start-point, activities to enhance the detail/vividness and mental imagery for these upcoming events were introduced. Significant increases in detail and imagery were observed when EFT activities were introduced, which correlated with increases in how pleasurable it was thought the activities would be and how pleasurable it was thinking about them. Enhancing EFT may be a mechanism to increase anticipatory pleasure in depression. Implications for treatment are discussed.

Smoking and Stroke in Appalachian Kentucky

Neurology and Neurobiology ◽

10.31487/j.nnb.2018.10.006 ◽

2018 ◽

pp. 1-4

Author(s):

Dignan Mark ◽

Kitzman Patrick ◽

S Gutti Subhash ◽

N Gutti Swathi ◽

...

Keyword(s):

Medical Records ◽

Case Series ◽

Eastern Region ◽

Retrospective Case ◽

Series Design ◽

Stroke Prevalence ◽

Appalachian Kentucky ◽

The Mean ◽

Stroke Type ◽

Stroke Belt

This project used a retrospective case series design to investigate factors associated with stroke in a rural area in Appalachian Kentucky. The south-eastern region of the U.S. is often referred to as the ‘stroke belt,’ and includes the Appalachian region of the state of Kentucky. Data were collected from medical records of patients from a neurology practice and regional hospital with a diagnosis of stroke from March 2012 through November 2015. Data were collected without personal identifiers and included demographic characteristics, stroke type, treatments received, and referrals for additional care including rehabilitation. Data from a total of 84 stroke cases diagnosed between March 2012 and November 2015 were included. Of the 84 cases, 46 (54.8%) were female and all but one was Caucasian. The distribution by race is consistent with the population of the region. The stroke cases ranged in age from 41 to 92 (M=66.3) and the age at stroke diagnosis ranged from 40 to 90 (M=65.7). Fourteen (16.7%) had evidence of a previous stroke at diagnosis. For smokers, the mean age at diagnosis was 62.7 for smokers while for non-smokers it was 67.5. The study reported smoking rates that were nearly three-times the national average, and the smokers in this study were found to have stroke onset approximately five-years earlier than non-smokers. The results from this case series support the need for further investigation on stroke prevalence and factors contributing to continued risk for stroke in Appalachia.

Risk of Infective Endocarditis After Invasive Dental Treatments

Circulation ◽

10.1161/circulationaha.117.033131 ◽

2018 ◽

Vol 138 (4) ◽

pp. 356-363 ◽

Cited By ~ 5

Author(s):

Tzu-Ting Chen ◽

Yi-Chun Yeh ◽

Kuo-Liong Chien ◽

Mei-Shu Lai ◽

Yu-Kang Tu

Keyword(s):

Infective Endocarditis ◽

Confidence Interval ◽

Regression Model ◽

Conditional Logistic Regression ◽

Case Series ◽

Crossover Design ◽

The Self ◽

Series Design ◽

Case Crossover ◽

Study Designs

Background: Invasive dental treatments (IDTs) can yield temporary bacteremia and have therefore been considered a potential risk factor of infective endocarditis (IE). It is hypothesized that, through the trauma caused by IDTs, bacteria gain entry to the bloodstream and may attach to abnormal heart valves or damaged heart tissue, giving rise to IE. However, the association between IDTs and IE remains controversial. The aim of this study is to estimate the association between IDTs and IE. Methods: The data in this study were obtained from the Health Insurance Database in Taiwan. We selected 2 case-only study designs, case-crossover and self-controlled case series, to analyze the data. The advantage of these methods is that confounding factors that do not vary with time are adjusted for implicitly. In the case-crossover design, a conditional logistic regression model with exposure to IDTs was used to estimate the risks of IE following an IDT with 4, 8, 12, and 16 weeks delay, respectively. In the self-controlled case series design, a conditional Poisson regression model was used to estimate the risk of IE for the risk periods of 1 to 4, 5 to 8, 9 to 12, and 13 to 16 weeks following an IDT. Results: In total, 9120 and 8181 patients with IE were included in case-crossover design and self-controlled case series design, respectively. In the case-crossover design, 277 cases and 249 controls received IDTs during the exposure period, and the odds ratio was 1.12 (95% confidence interval, 0.94–1.34) for 4 weeks. In the self-controlled case series design, we observed that 407 IEs occurred during the first 4 weeks after IDTs, and the age-adjusted incidence rate ratio was 1.14 (95% confidence interval, 1.02–1.26) for 1 to 4 weeks after IDTs. Conclusions: In both study designs, we did not observe a clinically larger risk for IE in the short periods after IDTs. We also found no association between IDTs and IE among patients with a high risk of IE. Therefore, antibiotic prophylaxis for the prevention of IE is not required for the Taiwanese population.

Risks of suicide attempts after prescription of zolpidem in people with depression: a nationwide population study in South Korea

SLEEP ◽

10.1093/sleep/zsz235 ◽

2019 ◽

Vol 43 (3) ◽

Author(s):

Hyewon Kim ◽

Yuwon Kim ◽

Woojae Myung ◽

Maurizio Fava ◽

David Mischoulon ◽

...

Keyword(s):

Suicide Attempt ◽

Medical Records ◽

Suicide Attempts ◽

Case Series ◽

Population Based ◽

Additional Increase ◽

Series Design ◽

Increased Risk ◽

Before And After ◽

Rate Ratios

Abstract Objectives To investigate the association between zolpidem prescription and suicide attempts in people with depression Methods A nationwide, population-based electronic medical records database from the Health Insurance Review & Assessment Service of South was used to investigate the incidence rate ratios (IRRs) of suicide attempts and probable suicide attempts in people with depression before and after zolpidem prescription using self-controlled case series design. Results In a total of 445 people who attempted suicide and 23 141 people who attempted probable suicide attempt, the IRRs of suicidal behavior during the risk periods before and after zolpidem prescription increased compared with those at the baseline. The IRRs gradually increased and peaked immediately before the prescription of zolpidem. The IRR was 70.06 (95% CI: 25.58–191.90) on day 2 before zolpidem prescription and 63.35 (95% CI: 22.99–174.59) on day 1 after zolpidem prescription in the suicide attempt group. The IRR was 24.07 (95% CI: 20.50–28.26) on the day before zolpidem prescription and 14.96 (95% CI: 12.21–18.34) on the day after zolpidem prescription in the probable suicide attempt group. The ratios declined eventually after zolpidem was prescribed. Conclusions Although zolpidem prescription was associated with an increased risk of suicide attempts in people with depression, the risk increased and peaked immediately before zolpidem prescription. The risk declined gradually thereafter. This result indicates that the risk of suicide attempts increases at the time of zolpidem prescription. However, zolpidem prescription does not contribute to additional increase in the risk of suicide attempts.