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Record W7117551031 · doi:10.1093/biomtc/ujaf170

Maximized sequential probability ratio test regression

2025· article· en· W7117551031 on OpenAlexaffabout
Ivair R. Silva, Joselito Montalban, Fernando L P de Oliveira

Bibliographic record

VenueBiometrics · 2025
Typearticle
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmacovigilance and Adverse Drug Reactions
Canadian institutionsManitoba Health
FundersNational Institute of General Medical SciencesConselho Nacional de Desenvolvimento Científico e TecnológicoFundação de Amparo à Pesquisa do Estado de São Paulo
KeywordsPoisson regressionSequential probability ratio testPoisson distributionRegression analysisRegressionConfoundingConditional probabilityLinear regressionSample size determination

Abstract

fetched live from OpenAlex

Ideally, the sequential monitoring of adverse events following post-licensed drugs and vaccines is correctly adjusted for confounding variables, such as gender and age, that may have an effect on the quality of the events. This is the idea behind the usual fully randomized, the placebo-control, and the self-control designs. Two prominent methods for conducting sequential analysis of the safety of post-market drugs and vaccines are the maximized sequential probability ratio test (MaxSPRT), and its conditional version, the CMaxSPRT. However, even when the assumption of sample homogeneity is realistic prior to the drug/vaccine administration, the effects caused by the drugs and vaccines on the risk of an adverse event, if any, can still vary according to observable covariates. For binomial and Poisson data, a straightforward sequential test method is introduced in order to accommodate a regression structure in the MaxSPRT. The proposed sequential regression test is also applicable for the CMaxSPRT, that is, the regression works for comparing historical and surveillance Poisson data with unknown heterogeneous baseline rates, taking into account seasonality and any other observable confounding covariates. To illustrate the usefulness of such a regression method, we describe the potential applications of the method to monitor vaccine-adverse events in Manitoba, Canada. The numeric results and examples were executed with the R Sequential package.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.033
metaresearch head score (Gemma)0.164
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.033
Threshold uncertainty score0.173

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0330.164
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0040.003
Bibliometrics0.0020.002
Science and technology studies0.0010.002
Scholarly communication0.0020.003
Open science0.0030.002
Research integrity0.0020.003
Insufficient payload (model declined to judge)0.0290.004

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.187
GPT teacher head0.483
Teacher spread0.296 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designTheoretical or conceptual
Domainnot available
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2025
Admission routes2
Has abstractyes

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