Pharmacoepidemiological research for the development and evaluation of drugs in pediatrics

Kaguelidou, Florentia; Durrieu, Geneviève; Clavenna, Antonio

doi:10.1016/j.therap.2018.09.077

Cited by 6 publications

(5 citation statements)

References 87 publications

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“…Most studies (88.1%) used traditional EHRs or claims data, while 6.9% used abnormal laboratory results 9,26–31 and a prescription only dataset (5%) where prescriptions are used as proxies for diagnoses 32–36 . The aim of our systematic review was to identify original research and so any review articles we identified within scope were only used to provide potential further original research publications for inclusion and their contents were not extracted 4,7,23,37–47 . A third of the studies were published after 2016, year of the latest review on the topic, as shown on Figure 2.…”

Section: Resultsmentioning

confidence: 99%

“… 32 , 33 , 34 , 35 , 36 The aim of our systematic review was to identify original research and so any review articles we identified within scope were only used to provide potential further original research publications for inclusion and their contents were not extracted. 4 , 7 , 23 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 A third of the studies were published after 2016, year of the latest review on the topic, as shown on Figure 2 .…”

Section: Resultsmentioning

confidence: 99%

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Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review

Coste

Wong

Bokern

et al. 2022

Pharmacoepidemiology and Drug

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Purpose: Signal detection is a crucial step in the discovery of post-marketing adverse drug reactions. There is a growing interest in using routinely collected data to complement established spontaneous report analyses. This work aims to systematically review the methods for drug safety signal detection using routinely collected healthcare data and their performance, both in general and for specific types of drugs and outcomes.Methods: We conducted a systematic review following the PRISMA guidelines, and registered a protocol in PROSPERO. MEDLINE, EMBASE, PubMed, Web of Science, Scopus, and the Cochrane Library were searched until July 13, 2021. Results:The review included 101 articles, among which there were 39 methodological works, 25 performance assessment papers, and 24 observational studies.Methods included adaptations from those used with spontaneous reports, traditional epidemiological designs, methods specific to signal detection with real-world data.More recently, implementations of machine learning have been studied in the literature. Twenty-five studies evaluated method performances, 16 of them using the area under the curve (AUC) for a range of positive and negative controls as their main measure. Despite the likelihood that performance measurement could vary by drugevent pair, only 10 studies reported performance stratified by drugs and outcomes, in a heterogeneous manner. The replicability of the performance assessment results was limited due to lack of transparency in reporting and the lack of a gold standard reference set.Conclusions: A variety of methods have been described in the literature for signal detection with routinely collected data. No method showed superior performance in all papers and across all drugs and outcomes, performance assessment and reporting were heterogeneous. However, there is limited evidence that self-controlled designs, high dimensional propensity scores, and machine learning can achieve higher performances than other methods.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review

Coste

Wong

Bokern

et al. 2022

Pharmacoepidemiology and Drug

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“…The dispensed drug amount is registered as defined daily doses (DDD), which is a standardization for the amount of a specific drug that is recommended as a daily maintenance dose when used for its main indication in adults. DDDs for pediatric populations have not yet been developed, which is a challenge within the field of pediatric pharmaco-epidemiology [ 25 ]. However, while DDDs are normally assigned for use in adults, the measure can still be used to conduct overall comparisons of trends in drug use in pediatric populations [ 57 ].…”

Section: Methodsmentioning

confidence: 99%

Killing pain?: a population-based registry study of the use of prescription analgesics, anxiolytics, and hypnotics among all children, adolescents and young adults in Norway from 2004 to 2019

Stangeland

Handal

Aakvaag

et al. 2022

Eur Child Adolesc Psychiatry

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The ongoing opioid epidemic has been a global concern for years, increasingly due to its heavy toll on young people’s lives and prospects. Few studies have investigated trends in use of the wider range of drugs prescribed to alleviate pain, psychological distress and insomnia in children, adolescents and young adults. Our aim was to study dispensation as a proxy for use of prescription analgesics, anxiolytics and hypnotics across age groups (0–29 years) and sex over the last 15 years in a large, representative general population. The study used data from a nationwide prescription database, which included information on all drugs dispensed from any pharmacy in Norway from 2004 through 2019. Age-specific trends revealed that the prevalence of use among children and adolescents up to age 14 was consistently low, with the exception of a substantial increase in use of melatonin from age 5. From age 15–29, adolescents and young adults used more prescription drugs with increasing age at all time points, especially analgesics and drugs with higher potential for misuse. Time trends also revealed that children from age 5 were increasingly dispensed melatonin over time, while adolescents from age 15 were increasingly dispensed analgesics, including opioids, gabapentinoids and paracetamol. In contrast, use of benzodiazepines and z-hypnotics slightly declined in young adults over time. Although trends were similar for both sexes, females used more prescription drugs than their male peers overall. The upsurge in use of prescription analgesics, anxiolytics and hypnotics among young people is alarming.Trial registration The study is part of the overarching Killing Pain project. The rationale behind the Killing Pain research was pre-registered through ClinicalTrials.gov on April 7, 2020. Registration number NCT04336605; https://clinicaltrials.gov/ct2/show/record/NCT04336605.

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“…В большинстве исследований (88,1%) использовались традиционные данные ЭМК, в то время как в 6,9% использовались ненормальные лабораторные результаты [18,[19][20][21][22][23][24] и набор данных только для рецептов (5%), где рецепты используются в качестве прокси для постановки диагноза [25][26][27][28][29]. Поскольку целью систематического обзора было выявление оригинальных исследований, поэтому любые обзорные статьи, которые были определены в рамках области, использовались только для предоставления потенциальных дополнительных оригинальных исследовательских публикаций для включения, и их содержание не было извлечено [4,30,15,[31][32][33][34][35][36][37][38][39][40][41]. LGPS Адаптация метода GPS к продольным данным.…”

Section: результатunclassified

Methods for drug safety signal detection using routinely collected observational electronic health care data: a systematic review

Motrinchuk,

Loginovskaya,

Kolbatov

2023

MyRWD

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Signal detection is a crucial step in the discovery of post-marketing adverse drug reactions. There is a growing interest in using routinely collected data to complement established spontaneous report analyses.The aim. This work aims to systematically review the methods for drug safety signal detection using routinely collected healthcare data and their performance, both in general and for speciﬁc types of drugs and outcomes.Metodology. We conducted a systematic review following the PRISMA guidelines, and registered a protocol in PROSPERO.Results. The review included 101 articles, among which there were 39 methodological works, 25 performance assessment papers, and 24 observational studies. Methods included adaptations from those used with spontaneous reports, traditional epidemiological designs, methods speciﬁc to signal detection with real-world data. More recently, implementations of machine learning have been studied in the literature. Twenty-ﬁve studies evaluated method performances, 16 of them using the area under the curve (AUC) for a range of positive and negative controls as their main measure. Despite the likelihood that performance measurement could vary by drug-event pair, only 10 studies reported performance stratiﬁed by drugs and outcomes, in a heterogeneous manner. The replicability of the performance assessment results was limited due to lack of transparency in reporting and the lack of a gold standard reference set.

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Pharmacoepidemiological research for the development and evaluation of drugs in pediatrics

Cited by 6 publications

References 87 publications

Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review

Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review

Killing pain?: a population-based registry study of the use of prescription analgesics, anxiolytics, and hypnotics among all children, adolescents and young adults in Norway from 2004 to 2019

Methods for drug safety signal detection using routinely collected observational electronic health care data: a systematic review

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