Evidence map›Paper›PMID 20962127›Full record

ArticleJournal of the American Medical Informatics Association : JAMIA

Development and evaluation of a common data model enabling active drug safety surveillance using disparate healthcare databases.

Stephanie J Reisinger, Patrick B Ryan, Donald J O'Hara, Gregory E Powell, Jeffery L Painter, Edward N Pattishall, Jonathan A Morris

Open access · bronzeAbstract read
In one paragraph

Article in Journal of the American Medical Informatics Association : JAMIA. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
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

69 citing papers in PubMed, 107 citations in OpenAlex.

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9 more citing papers are in PubMed but not listed here.

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

7 authors at 4 institutions in 2 countries.

Stephanie J ReisingerProSanos Corporation, Harrisburg, Pennsylvania 17101, USA. steph.reisinger@prosanos.com
Patrick B Ryan
Donald J O'Hara
Gregory E Powell
Jeffery L Painter
Edward N Pattishall
Jonathan A Morris
TE Connectivity (Switzerland) · CHAdvanced Composite Products (United States) · USGlaxoSmithKline (United States) · USResearch Triangle Park Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveActive drug safety surveillance may be enhanced by analysis of multiple observational healthcare databases, including administrative claims and electronic health records. The objective of this study was to develop and evaluate a common data model (CDM) enabling rapid, comparable, systematic analyses across disparate observational data sources to identify and evaluate the effects of medicines.

designThe CDM uses a person-centric design, with attributes for demographics, drug exposures, and condition occurrence. Drug eras, constructed to represent periods of persistent drug use, are derived from available elements from pharmacy dispensings, prescriptions written, and other medication history. Condition eras aggregate diagnoses that occur within a single episode of care. Drugs and conditions from source data are mapped to biomedical ontologies to standardize terminologies and enable analyses of higher-order effects. MEASUREMENTS: The CDM was applied to two source types: an administrative claims and an electronic medical record database. Descriptive statistics were used to evaluate transformation rules. Two case studies demonstrate the ability of the CDM to enable standard analyses across disparate sources: analyses of persons exposed to rofecoxib and persons with an acute myocardial infarction.

resultsOver 43 million persons, with nearly 1 billion drug exposures and 3.7 billion condition occurrences from both databases were successfully transformed into the CDM. An analysis routine applied to transformed data from each database produced consistent, comparable results.

conclusionA CDM can normalize the structure and content of disparate observational data, enabling standardized analyses that are meaningfully comparable when assessing the effects of medicines.

Indexed as

Drug Information ServicesInformation SystemsProduct Surveillance, PostmarketingSystems IntegrationAdolescentAdultAgedChildCyclooxygenase 2 InhibitorsData MiningFemaleHumansLactonesMaleMiddle AgedModels, TheoreticalCyclooxygenase 2 InhibitorsLactonesrofecoxibSulfones

Identifiers

PMID20962127
PMCPMC3000752
OpenAlexW2163649042

What OpenQuestion holds

Textmetadata
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.