A validation sampling approach for consistent estimation of adverse drug reaction risk with misclassified right-censored survival data

2018 ◽  
Vol 37 (27) ◽  
pp. 3887-3903
Author(s):  
Christopher A. Gravel ◽  
Anup Dewanji ◽  
Patrick J. Farrell ◽  
Daniel Krewski
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Survival Data ◽  
Consistent Estimation ◽  
Censored Survival Data ◽  
Validation Sampling ◽  
Sampling Approach

scholarly journals Targeted Minimum Loss-Based Estimation of Causal Effects in Right-Censored Survival Data with Time-Dependent Covariates: Warfarin, Stroke, and Death in Atrial Fibrillation

2013 ◽  
Vol 1 (2) ◽  
pp. 235-254 ◽  
Author(s):  
Jordan C. Brooks ◽  
Mark J. van der Laan ◽  
Daniel E. Singer ◽  
Alan S. Go
Keyword(s):  
Survival Data ◽  
Causal Effect ◽  
Estimating Equation ◽  
Dependent Censoring ◽  
Time Dependent ◽  
Causal Effects ◽  
Consistent Estimation ◽  
Censored Survival Data ◽  
Inverse Probability ◽  
Time Dependent Covariates

AbstractCausal effects in right-censored survival data can be formally defined as the difference in the marginal cumulative event probabilities under particular interventions. Conventional estimators, such as the Kaplan-Meier (KM), fail to consistently estimate these marginal parameters under dependent treatment assignment or dependent censoring. Several modern estimators have been developed that reduce bias under both dependent treatment assignment and dependent censoring by incorporating information from baseline and time-dependent covariates. In the present article we describe a recently developed targeted minimum loss-based estimation (TMLE) algorithm for general longitudinal data structures and present in detail its application in right-censored survival data with time-dependent covariates. The treatment-specific marginal cumulative event probability is defined via a series of iterated conditional expectations in a time-dependent counting process framework. The TMLE involves an initial estimator of each conditional expectation and sequentially updates these such that the resulting estimator solves the efficient influence curve estimating equation in the nonparametric statistical model. We describe the assumptions required for consistent estimation of statistical parameters and additional assumptions required for consistent estimation of the causal effect parameter. Using simulated right-censored survival data, the mean squared error, bias, and 95% confidence interval coverage probability of the TMLE is compared with those of the conventional KM and the inverse probability of censoring weight estimating equation, conventional maximum likelihood substitution estimator, and the double robustaugmented inverse probability of censoring weighted estimating equation. We conclude the article with estimation of the causal effect of warfarin medical therapy on the probability of “stroke or death” within a 1-year time frame using data from the ATRIA-1 observational cohort of persons with atrial fibrillation. Our results suggest that a fixed policy of warfarin treatment for all patients would result in 2% fewer deaths or strokes within 1-year as compared with a policy of withholding warfarin from all patients.

Clinical Aspects of Unpredictable Adverse Drug Reaction and Assessment of Drug Casuality

2018 ◽  
Vol 35 (3) ◽  
pp. 331-339
Author(s):  
김광준 ◽  
권용은 ◽  
최인
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Clinical Aspects

Difficulties in the detection of the culprit drug for an adverse drug reaction in a complicated case

2008 ◽  
Vol 149 (19) ◽  
pp. 883-887 ◽  
Author(s):  
Henriette Kopcsányi ◽  
Julianna Feldmann ◽  
Zsófia Péch ◽  
Ágnes Jurcsik
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Complicated Case ◽  
Erythema Exsudativum Multiforme ◽  
Culprit Drug

Az adverz gyógyszerreakciók különféle klinikai megjelenési formái alapján a kiváltó gyógyszerre nehéz következtetni. A gyanúba vett gyógyszerek elhagyása után fellépő javulás vagy az empirikus tapasztalat, esetleg irodalmi adatok alapján lehet a felelős gyógyszert feltételezni. A gyógyszerérzékenység bizonyítása bonyolult, jól átgondolt orvosi tevékenység útján lehetséges, és azokban az esetekben szükséges, amikor a gyanús gyógyszer más vegyületcsoportba tartozó szerrel nem helyettesíthető, és a betegnek feltétlenül szükséges szednie. A jelen közlemény célja egy eset kapcsán körvonalazni azokat a lehetőségeket és veszélyeket, melyek a kivizsgálás során alkalmazhatók, illetve megjelenhetnek. A kivizsgálás során használt módszerek a gyanúba vett gyógyszerekkel – lamotrigin, risperidon, sertralin – zopiclonum, atorvastatin elvégzett epicutan teszt során egyedül a sertralin adott a multiform tünetekkel azonos pozitív reakciót. A pozitív bőrteszt területéről készült hisztológiai vizsgálat eredménye visszautalt az eredetileg észlelt klinikai formára (erythema exsudativum multiforme Stevens–Johnson-szindróma). A beteg bipoláris affektív zavara miatt a negatív bőrtesztet adó készítményekkel per os provokáció történt, ez azonban a beteg számára kockázatos, de az egyetlen megbízható és biztos módszer. Az elvégzett per os expozíció során a törzsön a lamotrigintől már tört adag bevételét követően három órán belül diffúz erythema, 12 órán belül az alkalmazott szteroid- és antihisztamin-kezelés ellenére scarlatiniform exanthema jelent meg. Az eset érdekessége, hogy a gyanúba vett gyógyszerek során epicutan teszttel egy gyógyszer érzékenysége igazolódott, azonban a másik gyanúba vett készítménnyel végzett pozitív per os expozíciós próba is váratlanul tünetet provokált (scarlatiniform, azonnali reakciót). Megállapítható, hogy csupán egy bizonyos módszer még a klinikai képpel való egyező eredmény alapján sem elegendő adverz gyógyszerreakció provokáló tényezőjének bizonyítására.

1544-P: High Risk of Adverse Drug Reaction (ADR) in Older Adults with Type 1 Diabetes (T1D)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1544-P ◽  
Author(s):  
ELENA TOSCHI ◽  
CHRISTINE SLYNE ◽  
ASTRID ATAKOV-CASTILLO ◽  
KAYLA SIFRE ◽  
ALYSSA B. DUFOUR ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Drug Reaction ◽  
Type 1 Diabetes ◽  
Drug Reaction ◽  
High Risk

scholarly journals Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Safety Data ◽  
Regulatory System ◽  
Basic Structure ◽  
Reaction Reporting ◽  
Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

scholarly journals Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)

2021 ◽  
Vol 57 (1) ◽  
pp. 177-187
Author(s):  
Manju Agrawal ◽  
Preeti Singh ◽  
Usha Joshi
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Retrospective Study
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