Evidence map›Paper›PMID 27237061›Full record

ReviewJournal of clinical epidemiology2016

Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses.

Miguel A Hernán, Brian C Sauer, Sonia Hernández-Díaz, Robert Platt, Ian Shrier

2 registry-linked trialsAbstract readReview
In one paragraph

Review in Journal of clinical epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 557 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
557citing papers in PubMed, 4 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.

NCT07465926 completedstarted 2017, after this paper: background citation

Associations of Early Add-On GLP-1 Receptor Agonist and SGLT2 Inhibitor Therapy With Mortality and Kidney Outcomes in Adults With Obesity and Type 2 Diabetes Across Cardiovascular-Kidney-Metabolic Stages 2-3: A Target-Trial Emulation

Ran2017Enrolled451,036Registered outcomes12Posted comparisons0ConditionsCardiovascular Disease Risk Factor, Cardiovascular-kidney-metabolic Syndrome, Kidney Disease, Obesity & OverweightArmsGLP-1 receptor agonist, SGLT2 inhibitor
Open the trial in the graph
NCT06645990 recruitingnot on this map

Early Left Ventricular unLoading by Impella (ECMELLA) or Intra-aortic Balloon Pump for Cardiogenic Shock in Patients on VA-ECMO

TypeobservationalSponsorUniversity Hospital, MontpellierRan2010 to 2025Enrolled500ConditionsCardiogenic ShockArmsImpella, IABP
3 · Its place in the literature

Who cites it

557 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Steroid-sparing drugs in children and young adults with nephrotic syndrome: a target trial emulation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Trial
  6. Effectiveness of treatment initiation for secondary fracture prevention in the older population: Japanese Bone-fracture Osteoporosis in Late-stage population Database study (J-BOLD) - emulation of a randomized target trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Trial
  7. Effect of Initiation and Continuous Adherence to ARBs Versus ACEIs on Risk of Adjudicated Mild Cognitive Impairment or Dementia.The journals of gerontology. Series A, Biological sciences and medical sciences · 2025
    Trial
  8. Observational
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  13. Review
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497 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

5 authors.

Miguel A HernánDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02215, USA; Harvard-MIT Division of Health Sciences and Technology, 77 Massachusetts Avenue, E25-518, Cambridge, MA 02139, USA. Electronic address: miguel_hernan@post.harvard.edu.
Brian C SauerSalt Lake City Veterans Affairs Medical Center, Division of Epidemiology, Department of Internal medicine, University of Utah, 500 S Foothill Blvd, Salt Lake City, UT 84149, USA.
Sonia Hernández-DíazDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.
Robert PlattDepartment of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, Quebec H3A 1A2, Canada; Research Institute of the McGill University Health Centre, 1020 Pine Avenue West, Montreal, Quebec H3A 1A2, Canada; Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, 3755 Côte Ste-Catherine Road, Montreal, Quebec H3T 1E2, Canada.
Ian ShrierCentre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, 3755 Côte Ste-Catherine Road, Montreal, Quebec H3T 1E2, Canada.

Funding

University of Utah Center for Clinical and Translational ScienceUL1TR001067 · NCATS · UNIVERSITY OF UTAH · PI DERE, WILLARD H., HESS, RACHEL · 2013 to 2017
$19.8M
Statistical Methods for Analysis of Massive Genetic and Genomic Data in Cancer ResearchR35CA197449 · NCI · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI XIHONG LIN · 2015 to 2026
$10.9M
Statistical Methods for the Spatio-Temporal Assessment of Social Disparities in CancerP01CA134294 · NCI · HARVARD SCHOOL OF PUBLIC HEALTH · PI HANEUSE, SEBASTIEN, HERNAN, MIGUEL · 2008 to 2017
$6.8M
NCATS NIH HHS UL1 TR001067NCI NIH HHS P01 CA134294NCI NIH HHS R35 CA197449
6 · The paper itself

Abstract

Many analyses of observational data are attempts to emulate a target trial. The emulation of the target trial may fail when researchers deviate from simple principles that guide the design and analysis of randomized experiments. We review a framework to describe and prevent biases, including immortal time bias, that result from a failure to align start of follow-up, specification of eligibility, and treatment assignment. We review some analytic approaches to avoid these problems in comparative effectiveness or safety research.

Indexed as

Epidemiologic Research DesignBiasComparative Effectiveness ResearchHumansObservational Studies as TopicSelection BiasTime FactorsComparative effectiveness researchImmortal time biasObservationalSelection biasstudiesTarget trialTime zero

Identifiers

PMID27237061
PMCPMC5124536

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

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.