Evidence map›Paper›PMID 30989691›Full record

ArticleStatistics in medicine2019

A Bayesian approach for individual-level drug benefit-risk assessment.

Kan Li, Sheng Luo, Sammy Yuan, Shahrul Mt-Isa

Abstract read
In one paragraph

Article in Statistics in medicine, 2019. 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. Review
  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

4 authors.

Kan LiMerck Research Lab, Merck & Co, North Wales, Pennsylvania.ORCID 0000-0002-5762-7440
Sheng LuoDepartment of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.ORCID 0000-0003-4214-5809
Sammy YuanMerck Research Lab, Merck & Co, North Wales, Pennsylvania.
Shahrul Mt-IsaBiostatistics and Research Decision Sciences, MSD, London, UK.

Funding

Statistical Methods for Clinical Trials with Multivariate Longitudinal OutcomesR01NS091307 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI LUO, SHENG · 2015 to 2018
$1.2M
NINDS NIH HHS R01 NS091307
6 · The paper itself

Abstract

In existing benefit-risk assessment (BRA) methods, benefit and risk criteria are usually identified and defined separately based on aggregated clinical data and therefore ignore the individual-level differences as well as the association among the criteria. We proposed a Bayesian multicriteria decision-making method for BRA of drugs using individual-level data. We used a multidimensional latent trait model to account for the heterogeneity of treatment effects with latent variables introducing the dependencies among outcomes. We then applied the stochastic multicriteria acceptability analysis approach for BRA incorporating imprecise and heterogeneous patient preference information. We adopted an efficient Markov chain Monte Carlo algorithm when implementing the proposed method. We applied our method to a case study to illustrate how individual-level benefit-risk profiles could inform decision-making.

Indexed as

Bayes TheoremDecision Support TechniquesAlgorithmsComputer SimulationHumansMarkov ChainsMonte Carlo MethodPharmaceutical PreparationsRisk AssessmentStochastic ProcessesTreatment OutcomePharmaceutical Preparationslatent trait modelMCMCpatient centered approachSMAA

Identifiers

PMID30989691
PMCPMC6681911

What OpenQuestion holds

Textmetadata
LicenceTDM
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.