Evidence map›Paper›PMID 29379048›Full record

ArticleScientific reports2018

An MCEM Framework for Drug Safety Signal Detection and Combination from Heterogeneous Real World Evidence.

Cao Xiao, Ying Li, Inci M Baytas, Jiayu Zhou, Fei Wang

Abstract read
In one paragraph

Article in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

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3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

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  13. Developing a Data-driven Medication Indication Knowledge Base using a Large Scale Medical Claims Database.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2019
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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

5 authors.

Cao XiaoAI for Healthcare, IBM Research,, Cambridge, USA.
Ying LiCenter for Computational Health, IBM T. J. Watson Research Center, Yorktown Heights, USA.
Inci M BaytasDepartment of Computer Science and Engineering, Michigan State University, East Lansing, USA.
Jiayu ZhouDepartment of Computer Science and Engineering, Michigan State University, East Lansing, USA.
Fei WangDepartment of Healthcare Policy and Research, Weill Cornell Medical School, Cornell University, New York, USA. few2001@med.cornell.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Delayed drug safety insights can impact patients, pharmaceutical companies, and the whole society. Post-market drug safety surveillance plays a critical role in providing drug safety insights, where real world evidence such as spontaneous reporting systems (SRS) and a series of disproportional analysis serve as a cornerstone of proactive and predictive drug safety surveillance. However, they still face several challenges including concomitant drugs confounders, rare adverse drug reaction (ADR) detection, data bias, and the under-reporting issue. In this paper, we are developing a new framework that detects improved drug safety signals from multiple data sources via Monte Carlo Expectation-Maximization (MCEM) and signal combination. In MCEM procedure, we propose a new sampling approach to generate more accurate SRS signals for each ADR through iteratively down-weighting their associations with irrelevant drugs in case reports. While in signal combination step, we adopt Bayesian hierarchical model and propose a new summary statistic such that SRS signals can be combined with signals derived from other observational health data allowing for related signals to borrow statistical support with adjustment of data reliability. They combined effectively alleviate the concomitant confounders, data bias, rare ADR and under-reporting issues. Experimental results demonstrated the effectiveness and usefulness of the proposed framework.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsBayes TheoremDatabases, FactualDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMonte Carlo MethodProduct Surveillance, PostmarketingReproducibility of ResultsSafety

Identifiers

PMID29379048
PMCPMC5789130

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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.