Evidence map›Paper›PMID 39475336›Full record

ArticlePharmaceutical statistics

Prediction Intervals for Overdispersed Poisson Data and Their Application in Medical and Pre-Clinical Quality Control.

Max Menssen, Martina Dammann, Firas Fneish, David Ellenberger, Frank Schaarschmidt

Abstract read
In one paragraph

Article in Pharmaceutical statistics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

5 authors.

Max MenssenDepartment of Biostatistics, Leibniz University Hannover, Hanover, Germany.ORCID 0000-0003-2888-8542
Martina DammannExperimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
Firas FneishGerman MS-Register, MS Forschungs- und Projektentwicklungs-gGmbH [MSFP], Hanover, Germany.ORCID 0000-0001-8279-8463
David EllenbergerGerman MS-Register, MS Forschungs- und Projektentwicklungs-gGmbH [MSFP], Hanover, Germany.
Frank SchaarschmidtDepartment of Biostatistics, Leibniz University Hannover, Hanover, Germany.ORCID 0000-0002-6599-3803

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In pre-clinical and medical quality control, it is of interest to assess the stability of the process under monitoring or to validate a current observation using historical control data. Classically, this is done by the application of historical control limits (HCL) graphically displayed in control charts. In many applications, HCL are applied to count data, for example, the number of revertant colonies (Ames assay) or the number of relapses per multiple sclerosis patient. Count data may be overdispersed, can be heavily right-skewed and clusters may differ in cluster size or other baseline quantities (e.g., number of petri dishes per control group or different length of monitoring times per patient). Based on the quasi-Poisson assumption or the negative-binomial distribution, we propose prediction intervals for overdispersed count data to be used as HCL. Variable baseline quantities are accounted for by offsets. Furthermore, we provide a bootstrap calibration algorithm that accounts for the skewed distribution and achieves equal tail probabilities. Comprehensive Monte-Carlo simulations assessing the coverage probabilities of eight different methods for HCL calculation reveal, that the bootstrap calibrated prediction intervals control the type-1-error best. Heuristics traditionally used in control charts (e.g., the limits in Shewhart c- or u-charts or the mean ± 2 SD) fail to control a pre-specified coverage probability. The application of HCL is demonstrated based on data from the Ames assay and for numbers of relapses of multiple sclerosis patients. The proposed prediction intervals and the algorithm for bootstrap calibration are publicly available via the R package predint.

Indexed as

Quality ControlAlgorithmsComputer SimulationData Interpretation, StatisticalHumansModels, StatisticalMonte Carlo MethodMultiple SclerosisPoisson DistributionAmes‐testbootstrap‐calibrationhistorical control datanegative‐binomial distributionquasi‐likelihoodShewhart control chart

Identifiers

PMID39475336
PMCPMC11889705

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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.