Evidence map›Paper›PMID 18404622›Full record

ArticleStatistics in medicine2008

Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide.

Robert D Gibbons, Eisuke Segawa, George Karabatsos, Anup K Amatya, Dulal K Bhaumik, C Hendricks Brown, Kush Kapur, Sue M Marcus, Kwan Hur, J John Mann

Abstract read
In one paragraph

Article in Statistics in medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Article
  2. Observational
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Should we treat depression with drugs or psychological interventions? A reply to Ioannidis.Philosophy, ethics, and humanities in medicine : PEHM · 2011
    Article
  10. Review
  11. Advances in analysis of longitudinal data.Annual review of clinical psychology · 2010
    Article
  12. Post-approval drug safety surveillance.Annual review of public health · 2010
    Review
  13. 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

10 authors.

Robert D GibbonsCenter for Health Statistics, University of Illinois at Chicago, 1601 W. Taylor, Chicago, IL 60612, U.S.A. rdgib@uic.edu
Eisuke Segawa
George Karabatsos
Anup K Amatya
Dulal K Bhaumik
C Hendricks Brown
Kush Kapur
Sue M Marcus
Kwan Hur
J John Mann

Funding

STATISTICAL METHODS FOR MENTAL HEALTH PREVENTIVE TRIALSR01MH040859 · NIMH · UNIVERSITY OF SOUTH FLORIDA · PI BROWN, C. HENDRICKS · 1986 to 2014
$7.5M
Tools for Optimizing Prescribing, Monitoring and EducationU18HS016973 · AHRQ · UNIVERSITY OF ILLINOIS AT CHICAGO · PI LAMBERT, BRUCE L. · 2007 to 2010
$4.0M
Antidepressant Treatment and Suicidality: Biostatistical/Methodological SolutionsR01MH080122 · NIMH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI GIBBONS, ROBERT D · 2008 to 2011
$2.7M
Mixed-Effects ZIP Models--Mental Health Service ResearchR01MH065556 · NIMH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI GIBBONS, ROBERT D · 2002 to 2004
$661k
Antidepressant Treatment and Suicidality: Biostatistical/Methodological SolutionsR56MH078580 · NIMH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI GIBBONS, ROBERT D · 2006 to 2006
$233k
MHCRC FOR THE STUDY OF SUICIDAL BEHAVIORP30MH046745 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MANN, JOSEPH J · 1993 to 1999
–
SUICIDE CLINICAL RESEARCH CENTERP50MH046745 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MANN, JOSEPH J · 1990 to 1992
–
AHRQ HHS 1U18 HS 016973-01AHRQ HHS HS016973-01AHRQ HHS U18 HS016973NIMH NIH HHS MH 40859NIMH NIH HHS MH 46745NIMH NIH HHS MH 65556NIMH NIH HHS P30 MH046745NIMH NIH HHS R01 MH040859NIMH NIH HHS R01 MH065556NIMH NIH HHS R01 MH080122NIMH NIH HHS R56 MH 078580NIMH NIH HHS R56 MH078580
6 · The paper itself

Abstract

A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Administration (FDA)'s Adverse Event Reporting System (AERS) on the relationship between antidepressants and suicide. We obtain point estimates and 95 per cent confidence (posterior) intervals for the rate multiplier for each drug (e.g. antidepressants), which can be used to determine whether a particular drug has an increased risk of association with a particular AE (e.g. suicide). Confidence (posterior) intervals that do not include 1.0 provide evidence for either significant protective or harmful associations of the drug and the adverse effect. We also examine EB, parametric Bayes, and semiparametric Bayes estimators of the rate multipliers and associated confidence (posterior) intervals. Results of our analysis of the FDA AERS data revealed that newer antidepressants are associated with lower rates of suicide adverse event reports compared with older antidepressants. We recommend improvements to the existing AERS system, which are likely to improve its public health value as an early warning system.

Indexed as

Poisson DistributionProduct Surveillance, PostmarketingAlgorithmsAntidepressive AgentsHealth Care SurveysHumansSuicideAntidepressive Agents

Identifiers

PMID18404622
PMCPMC2423233

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.