Evidence map›Paper›PMID 28155198›Full record

ArticleDrug safety2017

Validation of New Signal Detection Methods for Web Query Log Data Compared to Signal Detection Algorithms Used With FAERS.

Susan Colilla, Elad Yom Tov, Ling Zhang, Marie-Laure Kurzinger, Stephanie Tcherny-Lessenot, Catherine Penfornis, Shang Jen, Danny S Gonzalez, Patrick Caubel, Susan Welsh and 1 more

Abstract readComparative StudyValidation Study
PubMed Publisher
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 10% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Alemtuzumab and thrombotic thrombocytopenic purpura: Analysis of an international surveillance database and systematic literature review.Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis · 2025
    Pooled it
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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

11 authors at 6 institutions in 3 countries.

Susan ColillaPharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., Bridgewater, NJ, 08807, USA. susan.colilla@sanofi.com.
Elad Yom TovMicrosoft Research, 13 Shenkar St., 4672513, Herzeliya, Israel.
Ling ZhangPharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., Bridgewater, NJ, 08807, USA.
Marie-Laure KurzingerPharmacoepidemiology & Signal Detection, Global Safety Sciences, Sanofi, 1 Avenue Pierre Brossolette, 91385, Chilly-Mazarin, France.
Stephanie Tcherny-LessenotPharmacoepidemiology & Signal Detection, Global Safety Sciences, Sanofi, 1 Avenue Pierre Brossolette, 91385, Chilly-Mazarin, France.
Catherine PenfornisPharmacoepidemiology & Signal Detection, Global Safety Sciences, Sanofi, 1 Avenue Pierre Brossolette, 91385, Chilly-Mazarin, France.
Shang JenBaxalta US, Inc., Global Drug Safety, 650 E. Kendall St., Cambridge, MA, 02142, USA.
Danny S GonzalezUS Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA.
Patrick CaubelPfizer, Worldwide Safety, 235 E. 42nd St., New York, NY, 10017, USA.
Susan WelshPharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., Bridgewater, NJ, 08807, USA.
Juhaeri JuhaeriPharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., Bridgewater, NJ, 08807, USA.
Sanofi (United States) · USSanofi (France) · FRBaxalta (United States) · USPfizer (United States) · USShenkar College of Engineering and Design · ILUnited States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPost-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions.

methodsRecently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data. In this study, we compare the performance of two other algorithms, the proportional query ratio (PQR) and the proportional query rate ratio (Q-PRR) against that of two reference signal-detection algorithms (SDAs) commonly used with the FDA AE Reporting System (FAERS) database.

resultsIn summary, the web query methods have moderate sensitivity (80%) in detecting signals in web query data compared with reference SDAs in FAERS when the web query data are filtered, but the query metrics generate many false-positives and have low specificity compared with reference SDAs in FAERS.

conclusionFuture research is needed to find better refinements of query data and/or the metrics to improve the specificity of these web query log algorithms.

Indexed as

Adverse Drug Reaction Reporting SystemsAlgorithmsDatabases, FactualData MiningDrug InteractionsDrug-Related Side Effects and Adverse ReactionsHumansInternetProduct Surveillance, PostmarketingTime FactorsUnited StatesUnited States Food and Drug Administration

Identifiers

PMID28155198
OpenAlexW2584770360

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.