Evidence map›Paper›PMID 35019190›Full record

ReviewPharmacoepidemiology and drug safety2022

Core concepts in pharmacoepidemiology: Confounding by indication and the role of active comparators.

Rachel Sendor, Til Stürmer

Open access · greenAbstract readReview
In one paragraph

Review in Pharmacoepidemiology and drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 109 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 2 pooled it
30.8field-weighted citation impact, top 1% 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

109 citing papers in PubMed, 2 syntheses or guidelines pooled it, 138 citations in OpenAlex.

  1. Pooled it
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  7. The Association Between Hispanic Ethnicity, Cholecystectomy, and Postoperative Mortality.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2026
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  11. Prophylaxis Regimens forJournal of fungi (Basel, Switzerland) · 2026
    Review
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49 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

2 authors at 1 institution in 1 country.

Rachel SendorDepartment of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0001-7259-1514
Til StürmerDepartment of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0002-9204-7177
University of North Carolina at Chapel Hill · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
Propensity scores and preventive drug use in the elderlyR01AG056479 · NIA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Til Sturmer · 2017 to 2026
$5.0M
Racial Differences in Treatment with Hysterectomy: a Multilevel InvestigationR01MD011680 · NIMHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBINSON, WHITNEY RAGAN · 2017 to 2021
$3.3M
Methods for Estimating Sex Differences in Safety and Effectiveness of DrugsR01HL118255 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JONSSON FUNK, MICHELE LAURA · 2014 to 2017
$1.7M
NCATS NIH HHS UL1 TR002489NHLBI NIH HHS R01 HL118255NIA NIH HHS R01 AG056479NIMHD NIH HHS R01 MD011680
6 · The paper itself

Abstract

Confounding by indication poses a significant threat to the validity of nonexperimental studies assessing effectiveness and safety of medical interventions. While no different from other forms of confounding in theory, confounding by indication often requires specific methods to address the bias it creates in addition to common epidemiological adjustment or restriction methods. Clinical indication influencing treatment prescription is patient-specific and complex, making it challenging to measure within nonexperimental research. Restriction of the study population to patients with the indication for treatment would effectively mitigate confounding by indication and bring about comparability between exposure and comparator populations with respect to probability of the exposure. Active comparators are often an effective practical solution to restrict the study population in this manner when indication cannot be measured accurately. This article discusses various forms of confounding by indication, the utility of active comparators for nonexperimental studies of treatment effects, and the active comparator, new user (ACNU) study design to implicitly condition on indication. Considerations for selecting active comparators and conducting an ACNU study design are discussed to enable increased adoption of these methods, improve quality of nonexperimental studies, and ultimately strengthen our evidence base for intended and unintended treatment effects in relevant target populations.

Indexed as

PharmacoepidemiologyResearch DesignBiasHumansbiasconfoundingepidemiologynonexperimental studiespharmacoepidemiologystudy designtherapy

Identifiers

PMID35019190
PMCPMC9121653
OpenAlexW4206319767

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.