Evidence map›Paper›PMID 38581098›Full record

ArticleThe Journal of antimicrobial chemotherapy2024

Ten-year results of an international external quality control programme for measurement of anti-tuberculosis drug concentrations.

Ralf Stemkens, Chaima Mouhdad, Eric J F Franssen, Daniel Touw, Jan-Willem Alffenaar, Lindsey H M Te Brake, Marieke G G Sturkenboom, Rob E Aarnoutse

Abstract read
In one paragraph

Article in The Journal of antimicrobial chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. Article
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

8 authors.

Ralf StemkensDepartment of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0009-0008-6912-4163
Chaima MouhdadDepartment of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.
Eric J F FranssenDepartment of Clinical Pharmacy, OLVG Hospital, 1066 CX Amsterdam, The Netherlands.
Daniel TouwDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
Jan-Willem AlffenaarDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0001-6703-0288
Lindsey H M Te BrakeDepartment of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.
Marieke G G SturkenboomDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-3420-0591
Rob E AarnoutseDepartment of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.

Funding

Radboudumc, Nijmegen, The Netherlands
6 · The paper itself

Abstract

objectivesParticipation in an external (interlaboratory) quality control (QC) programme is an essential part of quality assurance as it provides laboratories with valuable insights into their analytical performance. We describe the 10 year results of an international QC programme for the measurement of anti-tuberculosis (TB) drugs.

methodsEach year, two rounds were organized in which serum (or plasma) samples, spiked with known concentrations of anti-TB drugs, were provided to participating laboratories for analysis. Reported measurements within 80%-120% of weighed-in concentrations were considered accurate. Mixed model linear regression was performed to assess the effect of the measured drug, concentration level, analytical technique and performing laboratory on the absolute inaccuracy.

resultsBy 2022, 31 laboratories had participated in the QC programme and 13 anti-TB drugs and metabolites were included. In total 1407 measurements were reported. First-line TB drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) represented 58% of all measurements. Overall, 83.2% of 1407 measurements were accurate, and the median absolute inaccuracy was 7.3% (IQR, 3.3%-15.1%). The absolute inaccuracy was related to the measured anti-TB drug and to the performing laboratory, but not to the concentration level or to the analytical technique used. The median absolute inaccuracies of rifampicin and isoniazid were relatively high (10.2% and 10.9%, respectively).

conclusionsThe 10 year results of this external QC programme illustrate the need for continuous external QC for the measurement of anti-TB drugs for research and patient care purposes, because one in six measurements was inaccurate. Participation in the programme alerts laboratories to previously undetected analytical problems.

Indexed as

Antitubercular AgentsQuality ControlDrug MonitoringHumansIsoniazidLaboratoriesTuberculosisAntitubercular AgentsIsoniazid

Identifiers

PMID38581098
PMCPMC11144482

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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.