The Experts below are selected from a list of 42198 Experts worldwide ranked by ideXlab platform
Antoine Pariente - One of the best experts on this subject based on the ideXlab platform.
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Contribution of Causality Assessment for an Automated Detection of Safety Signals: An Example Using the French Pharmacovigilance Database
Drug Safety, 2020Co-Authors: Thomas Berbain, Antoine Pariente, Ghada Miremont-salamé, Aurélie Grandvuillemin, Joelle Micallef, Laurent Chouchana, Mehdi Benkebil, Hélène ThéophileAbstract:Introduction Qualitative approaches based on drug causality assessment estimate the causal link between a drug and the occurrence of an adverse event from individual case safety reports. Quantitative approaches based on Disproportionality analyses were developed subsequently to allow automated statistical signal detection from pharmacovigilance databases. This study assessed the potential value of causality assessment for automated safety signal detection. Methods All drug–serious adverse event pairs with a positive rechallenge and a semiology suggestive of drug causality were identified in the French pharmacovigilance database (BNPV) from 2011 to 2017. The results were compared with those obtained from automated Disproportionality analyses of the BNPV/World Health Organization (WHO) VigiBase^®, complemented by the list of signals validated by the WHO-UMC (Uppsala Monitoring Centre). Summary of Product Characteristics (SmPCs), Martindale^®, Meyler’s^® and MedLINE^® were used as other sources of information for the purpose of comparison. Results Of the 155 pairs of interest, 115 (74.2%) were also identified by another source of information. Since the individual case reporting in the BNPV, 23 (14.8%) of the adverse events (AEs) have been added to the SmPC, seven of which were not identified by Disproportionality. Finally, 40 pairs were not identified by any other source of information, 13 of which were considered as potential new safety signals after analysis of case reports by pharmacovigilance experts. The signals identified by causality assessment involved antineoplastic and immunomodulatory drugs especially, in comparison with signals identified by WHO-UMC or by Disproportionality within the BNPV. Conclusion The approach therefore appears useful as an additional tool for safety signal detection, especially for antineoplastic and immunomodulating agents.
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liver injury with novel oral anticoagulants assessing post marketing reports in the us food and drug administration adverse event reporting system
British Journal of Clinical Pharmacology, 2015Co-Authors: Emanuel Raschi, Antoine Pariente, Elisabetta Poluzzi, Ariola Koci, Francesco Salvo, Maurizio Biselli, Ugo Moretti, Nicholas MooreAbstract:Aim We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS). Methods We extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed Disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications. Results DILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively). Conclusions The Disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury.
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impact of safety alerts on measures of Disproportionality in spontaneous reporting databases the notoriety bias
Drug Safety, 2007Co-Authors: Antoine Pariente, Fleur Gregoire, Annie Fourrierreglat, Francoise Haramburu, Nicholas MooreAbstract:Background: Disproportionality analysis of spontaneous reporting is increasingly used, but it may be influenced in unknown ways by safety alerts (notoriety bias).
David Madigan - One of the best experts on this subject based on the ideXlab platform.
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evaluation of Disproportionality safety signaling applied to healthcare databases
Drug Safety, 2013Co-Authors: David Madigan, Patrick B. Ryan, William Dumouchel, Martijn J SchuemieAbstract:Objective To evaluate the performance of a Disproportionality design, commonly used for analysis of spontaneous reports data such as the FDA Adverse Event Reporting System database, as a potential analytical method for an adverse drug reaction risk identification system using healthcare data.
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Disproportionality methods for pharmacovigilance in longitudinal observational databases
Statistical Methods in Medical Research, 2011Co-Authors: Ivan Zorych, David Madigan, Patrick B. Ryan, Andrew BateAbstract:Data mining Disproportionality methods (PRR, ROR, EBGM, IC, etc.) are commonly used to identify drug safety signals in spontaneous report system (SRS) databases. Newer data sources such as longitudinal observational databases (LOD) provide time-stamped patient-level information and overcome some of the SRS limitations such as an absence of the denominator, total number of patients who consume a drug, and limited temporal information. Application of the Disproportionality methods to LODs has not been widely explored. The scale of the LOD data provides an interesting computational challenge. Larger health claims databases contain information on more than 50 million patients and each patient has records for up to 10 years. In this article we systematically explore the application of commonly used Disproportionality methods to simulated and real LOD data.
Russell J Skiba - One of the best experts on this subject based on the ideXlab platform.
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federal policy on Disproportionality in special education is it moving us forward
Journal of Disability Policy Studies, 2012Co-Authors: Susan Fread Albrecht, Russell J Skiba, Daniel J Losen, Choonggeun Chung, Laura V MiddelbergAbstract:Monitoring requirements in the 1997 amendments to and 2004 reauthorization of the Individuals with Disabilities Education Act (IDEA) acknowledged the existence and extent of racial/ethnic Disproportionality in special education, especially when, in 2004, Congress designated this concern among the top three priority areas for monitoring and enforcement of the law. However, federal interpretations of the 2004 requirements have created confusion at the State (SEA) and Local Education Agency (LEA) levels. This article analyzes data from state Annual Performance Reports to assess the progress made in identifying Disproportionality. Though high levels of Disproportionality remain, an increasing number of states are finding no LEAs with Disproportionality when it must be shown that the Disproportionality was caused by inappropriate identification. The analyses provided suggest that federal interpretations of IDEA 2004 have not been effective in addressing disproportionate representation in special education. Rec...
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achieving equity in special education history status and current challenges
Exceptional Children, 2008Co-Authors: Russell J Skiba, Ada B Simmons, Shana Ritter, Ashley C Gibb, Karega M Rausch, Jason Cuadrado, Choonggeun ChungAbstract:Among the most-longstanding and intransigent issues in the field, the disproportionate representation of minority students in special education programs has its roots in a long history of educational segregation and discrimination. Although national estimates of Disproportionality have been consistent over time, state and local estimates may show varying patterns of Disproportionality. A number of factors may contribute to Disproportionality, including test bias, poverty, special education processes, inequity in general education, issues of behavior management, and cultural mismatch/cultural reproduction. This article provides a report on the history, measurement, status, and factors contributing to disproportionate representation in special education, and offers recommendations based on an understanding of racial and ethnic disparities in special education as a multiply determined phenomenon.
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disparate access the Disproportionality of african american students with disabilities across educational environments
Exceptional Children, 2006Co-Authors: Russell J Skiba, Ada B Simmons, Lori Polonistaudinger, Sarah Gallini, Renae FegginsazzizAbstract:This study investigated the extent to which the overrepresentation of African American students in more restrictive special education settings is attributable to their overrepresentation in disability categories more likely to be served in more restrictive educational environments. Within 5 disability categories (emotional disturbance, mild mental retardation, moderate mental retardation, learning disabilities, and speech and language), African American students were overrepresented in more restrictive educational environments and underrepresented in less restrictive environments relative to all other students with the same disability. Disproportionality was most evident in those disability categories served primarily in general education settings. Given the social consensus regarding inclusion, Disproportionality in restrictiveness of educational environment may represent a more serious challenge than Disproportionality in disability categories.
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The Context of Minority Disproportionality: Practitioner Perspectives on Special Education Referral
Teachers College Record, 2006Co-Authors: Russell J Skiba, Ada B Simmons, Shana Ritter, Kristin Kohler, Michelle HendersonAbstract:Although there is extensive documentation of minority overrepresentation in special education, knowledge of the factors that create the context within which Disproportionality occurs is limited. To gain an understanding of the local processes that may contribute to special education Disproportionality, we interviewed 66 educators about their perspectives on urban education, special education, available and needed resources, and the specific topics of diversity and Disproportionality. A number of clear themes emerged. Teachers and schools feel unprepared to meet the needs of economically disadvantaged students. Classroom behavior appears to be an especially challenging issue for many teachers, and cultural gaps and misunderstandings may intensify behavioral challenges. Special education is perceived by many teachers as the only resource available for helping students who are not succeeding. Finally, there was a surprising reticence among many respondents to discuss issues of race. These results paint a surprisingly complex picture of the factors that may cause and maintain minority Disproportionality in special education. Together, they suggest that successful remediation efforts will avoid simplistic or linear solutions, increase resources to address learning and behavior problems in general education, and seek methods to use data on racial disparity as a stimulus toward reflection and action.
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The Psychology of Disproportionality: Minority Placement in Context.
Multiple Voices for Ethnically Diverse Exceptional Learners, 2003Co-Authors: Russell J Skiba, Ada B Simmons, Shana Ritter, Kristin KohlerAbstract:Racial disparities in special and gifted education cannot be understood independently of a broad legacy of racial inequity woven into American public education. The results of a qualitative study illustrate the context within which minority Disproportionality occurs. School respondents agreed with the NRC panel's conclusion that poverty makes an important contribution to Disproportionality; yet the data suggest that the effect of poverty is by no means linear. Respondents identified a number of contextual factors contributing to racial disparities in special education placement, including high-stakes testing. In particular, we were struck by the difficulty some respondents exhibited in discussing issues of race. To ensure implementation of the panel's recommendations, it becomes highly important to address broader socio-political issues, especially denial of the existence of racial disparities in the schools.
Nicholas Moore - One of the best experts on this subject based on the ideXlab platform.
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liver injury with novel oral anticoagulants assessing post marketing reports in the us food and drug administration adverse event reporting system
British Journal of Clinical Pharmacology, 2015Co-Authors: Emanuel Raschi, Antoine Pariente, Elisabetta Poluzzi, Ariola Koci, Francesco Salvo, Maurizio Biselli, Ugo Moretti, Nicholas MooreAbstract:Aim We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS). Methods We extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed Disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications. Results DILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively). Conclusions The Disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury.
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impact of safety alerts on measures of Disproportionality in spontaneous reporting databases the notoriety bias
Drug Safety, 2007Co-Authors: Antoine Pariente, Fleur Gregoire, Annie Fourrierreglat, Francoise Haramburu, Nicholas MooreAbstract:Background: Disproportionality analysis of spontaneous reporting is increasingly used, but it may be influenced in unknown ways by safety alerts (notoriety bias).
Keith Smolkowski - One of the best experts on this subject based on the ideXlab platform.
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the relative contribution of subjective office referrals to racial Disproportionality in school discipline
School Psychology Quarterly, 2017Co-Authors: Erik James Girvan, Kent Mcintosh, Cody Gion, Keith SmolkowskiAbstract:Objective: In order to improve our understanding of where to target interventions, the study examined the extent to which school discipline Disproportionality between African American and White students was attributable to teachers’ decisions regarding subjectively versus non-subjectively defined behaviors. Method: The sample consisted of office discipline referral (ODR) records for 1,154,686 students enrolled in 1,824 US schools. Analyses compared the relative contributions of Disproportionality in ODRs for subjectively and objectively defined behaviors to overall Disproportionality, controlling for relevant school characteristics. Results: Results showed that Disproportionality in subjective ODRs explained the vast majority of variance in total Disproportionality. Conclusions: These findings suggest that providing educators with strategies to neutralize the effects of implicit and other subtle forms of bias, which are known to influence ambiguous and discretionary decisions, may be a promising avenue for achieving equity in school discipline.
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vulnerable decision points for disproportionate office discipline referrals comparisons of discipline for african american and white elementary school students
Behavioral Disorders, 2016Co-Authors: Keith Smolkowski, Kent Mcintosh, Erik James Girvan, Rhonda N T Nese, Robert H HornerAbstract:Racial disparities in rates of exclusionary school discipline are well documented and seemingly intractable. However, emerging theories on implicit bias show promise in identifying effective interventions. In this study, we used school discipline data from 1,666 elementary schools and 483,686 office discipline referrals to identify specific situations in which Disproportionality was more likely. Results were largely consistent with our theoretical model, indicating increased racial and gender Disproportionality for subjectively defined behaviors, in classrooms, and for incidents classified as more severe. The time of day also substantially affected Disproportionality. These findings can be used to pinpoint specific student-teacher interactions for intervention.
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education not incarceration a conceptual model for reducing racial and ethnic Disproportionality in school discipline
The journal of applied research on children : informing policy for children at risk, 2014Co-Authors: Kent Mcintosh, Erik James Girvan, Robert H Horner, Keith SmolkowskiAbstract:Extension of retribution- and incapacitation-based criminal justice policies and practices to schools has exacerbated racial and ethnic Disproportionality in school discipline, a serious and unsolved threat to equity in education and social opportunity. Common approaches implemented to reduce discipline Disproportionality have not been shown to be widely effective. A more comprehensive, theory-driven understanding of the factors associated with disproportionate discipline is needed to enhance equity. In this article, we propose a conceptual model of how racial and ethnic bias affects school discipline, with direct implications for practical interventions. The model includes a multidimensional view of bias, informed by research from the field of social psychology, with multiple points identified for intervention to reduce Disproportionality over time. The authors conclude with a proposed multicomponent intervention that builds on a foundation of school-wide positive behavioral interventions and supports (SWPBIS) and includes specific strategies for reducing the effects of explicit and implicit bias on school discipline decision making.
