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--- proportional_reporting_ratio_prr [2021/11/28 03:42]
wes [Criticism of the Use of the PRR in Pharmacovigilance]
+++ proportional_reporting_ratio_prr [2023/01/10 19:55] (current)
liam [Adjusted Rate Ratio (ARR)]
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-=====Proportional Reporting Ratio (PRR)=====
+=====Proportional Reporting Ratio or PRR=====
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 {{:wiki:table-2-prr-guetzkow.png?800|}}
-The PRRs in bold exceed the CDC's threshold defining a "safety signal." These figures have been calculated according to the CDC's own procedures, using real-world data, yet the CDC insists that the adverse events reported through VAERS and vSafe do not represent a safety signal.
+The PRRs in bold exceed the CDC's threshold defining a "safety signal." These figures have been calculated according to the CDC's own procedures, using real-world data, yet the CDC insists that the adverse events reported through VAERS and vSafe do not represent a safety signal((https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC4632204/))((https://pubmed.ncbi.nlm.nih.gov/20850534/)).
 ====Missed Safety Signal for Myocarditis====
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-Part of the failure of PRR analysis to detect safety signals in the COVID-19 vaccines is due to a statistical phenomenon called "signal masking" or simply "masking." In a 2017 paper, Hauben and Maigen explain how masking of high AE magnitude takes place in PRR analysis when drugs or therapeutics are primarily compared with similar medical interventions((Hauben, M., and Maignen, F. "Does serious consequential masking exist? An update." //Pharmacoepidemiology and Drug Safety// 26, no. 6 (2017):727–729. https://onlinelibrary.wiley.com/doi/abs/10.1002/pds.4209)). In the case of the COVID-19 vaccines, this statistical masking means that PRR analysis (or what seems to be a highly similar ARR analysis used in the VSD RCA) would be unlikely to detect large numbers of adverse events as signals for concern. This view is confirmed by Wisniewski, et al. (including authors notably employed by Pfizer and Astra-Zeneca) who conclude that such signals "are not easily interpretable in terms of clinical impact," and that "calculation of PRRs...should not replace nor delay the performance of epidemiological studies."((Wisniewski, A.F.Z., Bate, A., Bousquet, C. et al. "Good Signal Detection Practices: Evidence from IMI PROTECT." //Drug Safety// 39 (2016): 469–490. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC4871909/))
+Part of the failure of PRR analysis to detect safety signals in the COVID-19 vaccines is due to a statistical phenomenon called "signal masking" or simply "masking." In a 2017 paper, Hauben and Maigen explain how masking of high AE magnitude takes place in PRR analysis when drugs or therapeutics are primarily compared with similar medical interventions((Hauben, M., and Maignen, F. "Does serious consequential masking exist? An update." //Pharmacoepidemiology and Drug Safety// 26, no. 6 (2017):727–729. https://onlinelibrary.wiley.com/doi/abs/10.1002/pds.4209)). In the case of the COVID-19 vaccines, this statistical masking means that PRR analysis (or what seems to be a highly similar ARR analysis used in the VSD RCA) would be unlikely to detect large numbers of adverse events as signals for concern. This view is confirmed by Wisniewski, et al. (including authors notably employed by Pfizer and Astra-Zeneca) who conclude that such signals "are not easily interpretable in terms of clinical impact," and that "calculation of PRRs...should not replace nor delay the performance of epidemiological studies."((Wisniewski, A.F.Z., Bate, A., Bousquet, C. et al. "Good Signal Detection Practices: Evidence from IMI PROTECT." //Drug Safety// 39 (2016): 469–490. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC4871909/ (quoted in David Wiseman, Joshua Guetzkow, and Hervé Seligmann, public comment, ACIP Meeting, August 30, 2021, p. 2. https://downloads.regulations.gov/CDC-2021-0089-0023/attachment_1.pdf). ))
 ====Adjusted Rate Ratio (ARR)====
-An Adjusted Rate Ratio (ARR) is a variant of the PRR used by analysts working with the Vaccine Safety Datalink (VSD).  The VSD is a collaborative project between the CDC and nine integrated health care organizations, most of which are part of the Kaiser Parmanente network(("Vaccine Safety Datalink (VSD)." https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html)). The stated goal of the VSD is to use Rapid Cycle Analysis (RCA) to "detect adverse events following vaccination in near real time so the public can be informed quickly of possible risks.(("Rapid Cycle Analysis." https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html#RCA))" The VSD RCA does not completely define what it calls Adjusted Rate Ratios, but the resulting statistics appear to be PRRs with some form of adjustments for data collection sites, demographics, etc. These adjustments, however they are calculated, have nothing to do with the problems inherent in the use of PRR in safety signal detection, however.
+An Adjusted Rate Ratio (ARR) is a variant of the PRR used by analysts working with the [[Vaccine Safety Datalink]] (VSD).  The VSD is a collaborative project between the CDC and nine integrated health care organizations, most of which are part of the [[Kaiser Parmanente]] network.(("Vaccine Safety Datalink (VSD)." https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html)). The stated goal of the VSD is to use Rapid Cycle Analysis (RCA) to "detect adverse events following vaccination in near real time so the public can be informed quickly of possible risks.(("Rapid Cycle Analysis." https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html#RCA))" The VSD RCA does not completely define what it calls Adjusted Rate Ratios, but the resulting statistics appear to be PRRs with some form of adjustments for data collection sites, demographics, etc. These adjustments, however they are calculated, have nothing to do with the problems inherent in the use of PRR in safety signal detection, however.