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Related Concept Videos

Confirmation Biases01:31

Confirmation Biases

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The confirmation bias is the tendency to focus on information that confirms our existing beliefs and ignore information that is inconsistent with our expectations. For example, if you think that your professor is not very nice, you notice all of the instances of rude behavior exhibited by the professor while ignoring the countless pleasant interactions he is involved in on a daily basis. Have you ever fallen prey to the confirmation bias, either as the source or target of such bias?
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Bias refers to any tendency that prevents a question from being considered unprejudiced. In research, bias occurs when one outcome or answer is selected or encouraged over others in sampling or testing. Bias can occur during any research phase, including study design, data collection, analysis, and publication.
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Werner Heisenberg considered the limits of how accurately one can measure properties of an electron or other microscopic particles. He determined that there is a fundamental limit to how accurately one can measure both a particle’s position and its momentum simultaneously. The more accurate the measurement of the momentum of a particle is known, the less accurate the position at that time is known and vice versa. This is what is now called the Heisenberg uncertainty principle. He...
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Case-non-case studies: Principle, methods, bias and interpretation.

Jean-Luc Faillie1

  • 1Regional Pharmacovigilance Centre, Department of Medical Pharmacology and Toxicology, CHU de Montpellier, 34295 Montpellier, France; Laboratory of Biostatistics, Epidemiology and Public Health, EA2415, Faculty of Medicine, University of Montpellier, University Institute of Clinical Research, 34295 Montpellier, France.

Therapie
|February 19, 2019
PubMed
Summary

Case-non-case studies analyze drug safety by comparing adverse reaction reports. This method, using the reporting odds ratio (ROR), helps identify potential drug safety signals in pharmacovigilance databases.

Keywords:
BiasCase–non-case studiesDisproportionality analysisPharmacoepidemiologyPharmacovigilanceReporting odds ratio

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Area of Science:

  • Pharmacovigilance and Drug Safety Research
  • Epidemiological Study Designs

Background:

  • Case-non-case studies are a widely adopted method for drug safety assessment.
  • Their utilization has substantially grown over the past few decades.

Purpose of the Study:

  • To elucidate the fundamental principles of case-non-case study design.
  • To detail the calculation and interpretation of the reporting odds ratio (ROR).
  • To discuss the analytical variations, advantages, and limitations of this methodology.

Main Methods:

  • Comparing drug exposure in cases of a specific adverse reaction to that in 'non-cases' (other reported reactions).
  • Utilizing pharmacovigilance databases for disproportionality analysis.
  • Calculating the reporting odds ratio (ROR) and its confidence interval.

Main Results:

  • The reporting odds ratio (ROR) quantifies the association between a drug and an adverse event.
  • Interpretation of ROR values aids in identifying potential pharmacovigilance signals.
  • Analytical modalities and interpretation guidelines are presented.

Conclusions:

  • Case-non-case studies are a valuable tool for signal detection in pharmacovigilance.
  • Understanding ROR calculation and interpretation is crucial for accurate drug safety assessment.
  • The study provides a comprehensive overview of the method, including its strengths and weaknesses.