Signal Detection & Analysis Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Signal Detection & Analysis flashcards as text
What does the term 'signal of disproportionate reporting' (SDR) specifically mean in pharmacovigilance?
Answer: A drug-event combination reported more frequently than expected based on overall reporting patterns
An SDR indicates that a specific drug-event pair appears in the database at a rate disproportionately higher than what would be expected by chance given the overall reporting distribution.
The Proportional Reporting Ratio (PRR) compares the proportion of a specific adverse event for a drug against:
Answer: The proportion of that event for all other drugs in the database
PRR divides the proportion of the event of interest among all reports for the drug by the same proportion across all other drugs in the database.
According to the Evans criteria, a PRR-based signal threshold requires all of the following EXCEPT:
Answer: Background incidence rate below 1 per 10,000 patient-years
The Evans criteria specify PRR ≥2, chi-square ≥4, and N≥3; background incidence rate is not part of the original Evans disproportionality criteria.
In Bayesian signal detection using the Multi-item Gamma Poisson Shrinker (MGPS), what does the EB05 value represent?
Answer: The 5th percentile of the posterior distribution of the EBGM, used as a conservative lower bound
EB05 is the lower 5th percentile of the posterior EBGM distribution, meaning a signal must exceed this value (typically >2) to be considered robust.
Which of the following best describes a 'qualitative' signal detection method in pharmacovigilance?
Answer: Clinical review of individual case reports by medical experts for biological plausibility
Qualitative signal detection relies on expert clinical judgment to evaluate individual cases for causality, novelty, and biological plausibility rather than statistical thresholds.
When stratifying disproportionality analyses by age group, what pharmacovigilance concern is this technique primarily designed to address?
Answer: Confounding by age-related differences in drug use patterns and adverse event susceptibility
Stratification by age controls for confounding because drug exposure patterns and baseline event rates differ substantially by age, which can mask or inflate signals.
What is the purpose of the 'triage' step in the signal management process after initial detection?
Answer: Prioritizing signals based on clinical importance, novelty, and public health impact for further evaluation
Triage ranks detected signals so that limited pharmacovigilance resources are directed toward those with the greatest potential safety implications.