Evidence map›Paper›PMID 37851862›Full record

ReviewAmerican journal of epidemiology2024

The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.

Zafar Zafari, Jeong-Eun Park, Chintal H Shah, Susan dosReis, Emily F Gorman, Wei Hua, Yong Ma, Fang Tian

Abstract readReview
In one paragraph

Review in American journal of epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Negative controls and how to use them: a guidance paper.International journal of epidemiology · 2026
    Article
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  6. Article
  7. Article
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  9. Regression-Based Proximal Causal Inference.American journal of epidemiology · 2024
    Article
  10. 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

8 authors.

Zafar Zafari
Jeong-Eun Park
Chintal H Shah
Susan dosReis
Emily F Gorman
Wei Hua
Yong Ma
Fang Tian

Funding

University of Maryland Center of Excellence in Regulatory Science and InnovationU01FD005946 · FDA · UNIV OF MARYLAND, COLLEGE PARK · PI BENTLEY, WILLIAM E., POLLI, JAMES E · 2016 to 2025
$21.5M
FDA HHS U01 FD005946Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) U01FD005946
6 · The paper itself

Abstract

Uses of real-world data in drug safety and effectiveness studies are often challenged by various sources of bias. We undertook a systematic search of the published literature through September 2020 to evaluate the state of use and utility of negative controls to address bias in pharmacoepidemiologic studies. Two reviewers independently evaluated study eligibility and abstracted data. Our search identified 184 eligible studies for inclusion. Cohort studies (115, 63%) and administrative data (114, 62%) were, respectively, the most common study design and data type used. Most studies used negative control outcomes (91, 50%), and for most studies the target source of bias was unmeasured confounding (93, 51%). We identified 4 utility domains of negative controls: 1) bias detection (149, 81%), 2) bias correction (16, 9%), 3) P-value calibration (8, 4%), and 4) performance assessment of different methods used in drug safety studies (31, 17%). The most popular methodologies used were the 95% confidence interval and P-value calibration. In addition, we identified 2 reference sets with structured steps to check the causality assumption of the negative control. While negative controls are powerful tools in bias detection, we found many studies lacked checking the underlying assumptions. This article is part of a Special Collection on Pharmacoepidemiology.

Indexed as

PharmacoepidemiologyBiasHumanshidden biasnegative control exposurenegative control outcomeunmeasured confounding

Identifiers

PMID37851862
PMCPMC11484649

What Socratic 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 Socratic graph.