Evidence map›Paper›PMID 28891596›Full record

ArticleBritish journal of clinical pharmacology2018

External evaluation of population pharmacokinetic models for ciclosporin in adult renal transplant recipients.

Jun-Jun Mao, Zheng Jiao, Hwi-Yeol Yun, Chen-Yan Zhao, Han-Chao Chen, Xiao-Yan Qiu, Ming-Kang Zhong

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

34 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

7 authors.

Jun-Jun MaoDepartment of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0003-4219-5953
Zheng JiaoDepartment of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0001-7999-7162
Hwi-Yeol YunCollege of Pharmacy, Chungnam National University, Daejeon, South Korea.
Chen-Yan ZhaoDepartment of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.
Han-Chao ChenDepartment of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.
Xiao-Yan QiuDepartment of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.
Ming-Kang ZhongDepartment of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSeveral population pharmacokinetic (popPK) models for ciclosporin (CsA) in adult renal transplant recipients have been constructed to optimize the therapeutic regimen of CsA. However, little is known about their predictabilities when extrapolated to different clinical centres. Therefore, this study aimed to externally evaluate the predictive ability of CsA popPK models and determine the potential influencing factors.

methodsA literature search was conducted and the predictive performance was determined for each selected model using an independent data set of 62 patients (471 predose and 500 2-h postdose concentrations) from our hospital. Prediction-based diagnostics and simulation-based normalized prediction distribution error were used to evaluate model predictability. The influence of prior information was assessed using Bayesian forecasting. Additionally, potential factors influencing model predictability were investigated.

resultsSeventeen models extracted from 17 published popPK studies were assessed. Prediction-based diagnostics showed that ethnicity potentially influenced model transferability. Simulation-based normalized prediction distribution error analyses indicated misspecification in most of the models, especially regarding variance. Bayesian forecasting demonstrated that the predictive performance of the models substantially improved with 2-3 prior observations. The predictability of nonlinear Michaelis-Menten models was superior to that of linear compartmental models when evaluating the impact of structural models, indicating the underlying nonlinear kinetics of CsA. Structural model, ethnicity, covariates and prior observations potentially affected model predictability.

conclusionsStructural model is the predominant factor influencing model predictability. Incorporation of nonlinear kinetics in CsA popPK modelling should be considered. Moreover, Bayesian forecasting substantially improved model predictability.

Indexed as

Models, BiologicalAdultArea Under CurveBayes TheoremCyclosporineFemaleGraft vs Host DiseaseHumansImmunosuppressive AgentsKidney TransplantationMaleMiddle AgedNonlinear DynamicsRetrospective StudiesTransplant RecipientsYoung AdultCyclosporineImmunosuppressive Agentsciclosporinexternal evaluationnonlinear kineticspopulation pharmacokinetics

Identifiers

PMID28891596
PMCPMC5736841

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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.