Evidence map›Paper›PMID 25598384›Full record

ArticleHealth services research2015

Control Outcomes and Exposures for Improving Internal Validity of Nonrandomized Studies.

Stacie B Dusetzina, M Alan Brookhart, Matthew L Maciejewski

Abstract read
In one paragraph

Article in Health services research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
–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

42 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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  13. Observational
  14. Article
  15. Article
  16. Propensity Score Methods for Confounding Control in Observational Studies of Therapeutics for COVID-19 Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  17. Article
  18. Uncontrolled pain: a call for better study design.Frontiers in veterinary science · 2024
    Review
  19. Structural Racism and Well-Being Among Young People in the U.S.American journal of preventive medicine · 2023
    Article
  20. Negative controls: Concepts and caveats.Statistical methods in medical research · 2023
    Review
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

3 authors.

Stacie B DusetzinaDivision of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC.
M Alan BrookhartCecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Matthew L MaciejewskiCenter for Health Services Research in Primary Care, Department of Veterans Affairs, Duke University Medical Center, Durham, NC.

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
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
UNC BIRCWH CAREER DEVELOPMENT PROGRAMK12HD001441 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BOGGESS, KIM A · 2000 to 2019
$9.3M
Propensity Scores and Preventive Drug Use in the ElderlyR01AG023178 · NIA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI STURMER, TIL · 2005 to 2014
$2.7M
Cascading Impacts of Bundled Payment on Peritoneal Dialysis Provision & OutcomesR01DK097165 · NIDDK · DUKE UNIVERSITY · PI WANG, VIRGINIA · 2013 to 2017
$1.9M
A retrospective cohort study of the safety of testosterone therapy in older menR01AG042845 · NIA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BROOKHART, MAURICE ALAN · 2012 to 2013
$476k
Patterns of use, comparative effectiveness, and safety of rotavirus vaccinesR21HD080214 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BROOKHART, MAURICE ALAN · 2014 to 2015
$413k
Fragmentation of Medication Management in MedicareR01HS023085 · AHRQ · DUKE UNIVERSITY · PI MACIEJEWSKI, MATTHEW L · 2014 to 2014
$377k
Continuity of Medication Management in MedicaidR01HS023099 · AHRQ · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FARLEY, JOEL F. · 2014 to 2014
$376k
AHRQ HHS R01 HS023085AHRQ HHS R01HS023085AHRQ HHS R01 HS023099NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1TR001111NCATS NIH HHS UL1 TR002489NIA NIH HHS R01 AG023178NIA NIH HHS R01 AG042845NIA NIH HHS R01AG042845NICHD NIH HHS K12 HD001441NICHD NIH HHS R21 HD080214NIDDK NIH HHS R01 DK097165
6 · The paper itself

Abstract

objectiveControl outcomes and exposures can improve internal validity of nonrandomized studies by assessing residual bias in effect estimates. Control outcomes are those expected to have no treatment effect or the opposite effect of the primary outcome. Control exposures are treatments expected to have no effect on the primary outcome. We review examples of control outcomes and exposures from prior studies and provide recommendations for conducting and reporting these analyses. DATA SOURCES AND STUDY

designReview in Google Scholar and Medline of research studies employing control outcomes or exposures. We abstracted publication year, control outcome, control exposure, primary outcome, primary exposure, control outcome/exposure effect, proposed source of bias, and causal criteria. PRINCIPAL

findingsThere is inconsistent terminology for these concepts, making study identification challenging. Six of 11 studies found null associations between treatments and negative control outcomes/exposures, providing greater confidence that the primary study findings were not biased. Five studies found unexpected associations, suggesting bias in the primary association.

conclusionsThe rigor of nonrandomized studies can be improved with inclusion of control outcomes and exposures for bias detection. Given ongoing concern about clinical and policy inferences from nonrandomized studies, we recommend adoption of these measurement tools.

Indexed as

Research DesignClinical Studies as TopicHumansReproducibility of Resultscontrol exposuresControl outcomesfalsification testsnonequivalent exposuresnonequivalent outcomes

Identifiers

PMID25598384
PMCPMC4600355

What OpenQuestion holds

Textmetadata
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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.