Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.
S. Evans, P. Waller, and S. Davis. Pharmacoepidemiology and drug safety, 10 (6):
483-6(2001)2961<m:linebreak></m:linebreak>Mesures d'associació.
DOI: 10.1002/pds.677
Abstract
BACKGROUND: The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised. METHODS: Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4. FINDINGS: The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation. IMPLICATIONS: Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.
%0 Journal Article
%1 Evans2001
%A Evans, S J
%A Waller, P C
%A Davis, S
%D 2001
%J Pharmacoepidemiology and drug safety
%K AdverseDrugReactionReportingSystems AdverseDrugReactionReportingSystems:statistic DataInterpretation Databases Factual Software Statistical
%N 6
%P 483-6
%R 10.1002/pds.677
%T Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.
%U http://www.ncbi.nlm.nih.gov/pubmed/11828828
%V 10
%X BACKGROUND: The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised. METHODS: Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4. FINDINGS: The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation. IMPLICATIONS: Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.
@article{Evans2001,
abstract = {BACKGROUND: The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised. METHODS: Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4. FINDINGS: The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation. IMPLICATIONS: Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.},
added-at = {2023-02-03T11:44:35.000+0100},
author = {Evans, S J and Waller, P C and Davis, S},
biburl = {https://www.bibsonomy.org/bibtex/201c9ba33bcbff5974ef5c5e7d0491692/jepcastel},
doi = {10.1002/pds.677},
interhash = {c3d5f7130d09f187ca3f6197f86f6908},
intrahash = {01c9ba33bcbff5974ef5c5e7d0491692},
issn = {1053-8569},
journal = {Pharmacoepidemiology and drug safety},
keywords = {AdverseDrugReactionReportingSystems AdverseDrugReactionReportingSystems:statistic DataInterpretation Databases Factual Software Statistical},
note = {2961<m:linebreak></m:linebreak>Mesures d'associació},
number = 6,
pages = {483-6},
pmid = {11828828},
timestamp = {2023-02-03T11:44:35.000+0100},
title = {Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11828828},
volume = 10,
year = 2001
}