The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
Evaluating efficiency and statistical power of self-controlled case series and self-controlled risk interval designs in vaccine safety
Open accessAbstract
The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have recently become widely used in the field of post-licensure vaccine safety monitoring to detect potential elevated risks of adverse events following vaccinations. The SCRI design can be viewed as a subset of the SCCS method in that a reduced comparison time window is used for the analysis. Compared to the SCCS method, the SCRI design has less statistical power due to fewer events occurring in the shorter control interval. In this study, we derived the asymptotic relative efficiency (ARE) between these two methods to quantify this loss in power in the SCRI design. The equation is formulated as [Formula: see text] (a: control window-length ratio between SCRI and SCCS designs; b: ratio of risk window length and control window length in the SCCS design; and [Formula: see text]: relative risk of exposed window to control window). According to this equation, the relative efficiency declines as the ratio of control-period length between SCRI and SCCS methods decreases, or with an increase in the relative risk [Formula: see text]. We provide an example utilizing data from the Vaccine Safety Datalink (VSD) to study the potential elevated risk of febrile seizure following seasonal influenza vaccine in the 2010-2011 season.
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Such comparisons can be executed rapidly and can play a key role in early detection of potential vaccine safety signals or when regulatory and public health agencies need rapid assessment of an emerging safety signal.
“Such comparisons can be executed rapidly and can play a key role in early detection of potential vaccine safety signals or when regulatory and public health agencies need rapid assessment of an emerging safety signal [4,6].”
From COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals (2024) · cites this paper as [6]
The Introduction (page unavailable) says a shorter SCRI control interval is important for prompt signal detection, and the Discussion (page unavailable) says it can shorten surveillance delays and chart-review turnaround. The paper also says near-real-time analyses were generally delayed; it does not establish that such comparisons can generally be executed rapidly or specifically discuss rapid assessments by regulatory or public health agencies. (LLM, conf=0.82)
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“This could be addressed by conducting association studies specific to individual outcomes by applying methodologies such as the self-controlled case series (SCCS) to validate the associations [6].”
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Metadata
- Authors
- Li, R., Stewart, B., & Weintraub, E.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Corresponding author
- Li, Rongxia
- Venue
- Journal of Biopharmaceutical Statistics
- Publisher
- Informa UK Limited
- Published
- 2016-01-08
- Volume
- 26
- Issue
- 4
- Pages
- 686-693
- ISSN
- 1054-3406 (ISSN-L)
- 1520-5711
- PMC
- PMC10878473
- OpenAlex
- W2229943628
- Cited by
- 29
- References
- 13
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 8 · 2023: 2 · 2022: 4 · 2021: 5 · 2020: 1 · 2019: 3 · 2018: 1 · 2017: 1
- FWCI
- 0.53
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Biopharmaceutical Statistics (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (CC999999)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- self-controlled case series, vaccine safety, asymptotic relative efficiency, statistical power, vaccine adverse events, febrile seizures, seasonal influenza vaccine, Vaccine Safety Datalink
- MeSH terms
- Data Interpretation, Statistical, Humans, Influenza Vaccines, Research Design, Safety, Vaccination, Risk Assessment
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