Evidence map›Paper›PMID 30767254›Full record

ArticleBritish journal of clinical pharmacology2019

Handling interoccasion variability in model-based dose individualization using therapeutic drug monitoring data.

João A Abrantes, Siv Jönsson, Mats O Karlsson, Elisabet I Nielsen

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
7.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

João A AbrantesDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.ORCID 0000-0002-7752-0229
Siv JönssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.ORCID 0000-0001-8240-0865
Mats O KarlssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Elisabet I NielsenDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.ORCID 0000-0003-0725-214X
Uppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis study aims to assess approaches to handle interoccasion variability (IOV) in a model-based therapeutic drug monitoring (TDM) context, using a population pharmacokinetic model of coagulation factor VIII as example.

methodsWe assessed 5 model-based TDM approaches: empirical Bayes estimates (EBEs) from a model including IOV, with individualized doses calculated based on individual parameters either (i) including or (ii) excluding variability related to IOV; and EBEs from a model excluding IOV by (iii) setting IOV to zero, (iv) summing variances of interindividual variability (IIV) and IOV into a single IIV term, or (v) re-estimating the model without IOV. The impact of varying IOV magnitudes (0-50%) and number of occasions/observations was explored. The approaches were compared with conventional weight-based dosing. Predictive performance was assessed with the prediction error percentiles.

resultsWhen IOV was lower than IIV, the accuracy was good for all approaches (50

conclusionsBased on the studied scenarios and theoretical expectations, the best approach to handle IOV in model-based dose individualization is to include IOV in the generation of the EBEs but exclude the portion of unexplained variability related to IOV in the individual parameters used to calculate the future dose.

Indexed as

Drug Dosage CalculationsDrug MonitoringModels, BiologicalAdolescentAdultAgedChildCoagulantsComputer SimulationFactor VIIIHemophilia AHemostasisHumansMaleMiddle AgedTreatment OutcomeCoagulantsFactor VIIINONMEMpharmacokineticspopulation analysistherapeutic drug monitoring

Identifiers

PMID30767254
PMCPMC6533430
OpenAlexW2911945528

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.