Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Sample size calculations for single group post-marketing cohort studies

P Tubert-Bitter1, B Bégaud, Y Moride

  • 1INSERM U.169, Villejuif, France.

Journal of Clinical Epidemiology
|April 1, 1994
PubMed
Summary

This study introduces Poisson distribution calculations for adverse drug reaction incidence in single group cohort studies. These methods improve sample size accuracy when expected events are few, unlike normal approximations.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Early exposure of pregnant women to non-steroidal anti-inflammatory drugs delivered outside hospitals and preterm birth risk: nationwide cohort study.

BJOG : an international journal of obstetrics and gynaecology·2021
Same author

[Use and misuse of benzodiazepines out of France].

Presse medicale (Paris, France : 1983)·2018
Same author

Efficacy, Effectiveness and the "Efficacy-To-Effectiveness Gap": Review of the Current State of Play and Perspectives. First Results From the Imi Getreal Consortium.

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research·2016
Same author

Impact of allopurinol on risk of myocardial infarction.

Annals of the rheumatic diseases·2014
Same author

Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects.

Journal of internal medicine·2013
Same author

A new self-controlled case series method for analyzing spontaneous reports of adverse events after vaccination.

American journal of epidemiology·2013

Area of Science:

  • Pharmacoepidemiology
  • Biostatistics
  • Drug Safety

Background:

  • Single group cohort studies are common in pharmacoepidemiology for adverse drug reaction (ADR) incidence assessment.
  • Traditional sample size calculations often rely on normal distribution, which can be inadequate when few events are expected.
  • Accurate sample size determination is crucial for the statistical validity of these studies.

Purpose of the Study:

  • To propose sample size calculation methods for single group cohort studies using the Poisson distribution.
  • To provide tables derived from Poisson distribution for practical application in pharmacoepidemiological research.
  • To address limitations of normal distribution approximations in scenarios with low expected event counts.

Main Methods:

  • Development of sample size and critical event number calculations based on the Poisson distribution.

Related Experiment Videos

  • Utilized a one-sided test with a 0.05 significance level and powers of 0.9 and 0.8.
  • Defined two key parameters: expected incidence under the null hypothesis and the minimum risk ratio to detect.

    • Main Results:

    • Tables derived from the Poisson distribution provide direct means for determining required sample size and critical event numbers.
    • Demonstrated that normal approximation can lead to underestimation of the necessary sample size.
    • The proposed Poisson-based method offers a more reliable approach for studies with sparse event data.

    Conclusions:

    • The Poisson distribution offers a robust framework for sample size calculations in single group cohort studies for ADRs.
    • The provided tables facilitate accurate planning for studies where few adverse events are anticipated.
    • Adopting Poisson-based calculations enhances the reliability and accuracy of pharmacoepidemiological research findings.