Literature DB >> 27237061

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

Miguel A Hernán1, Brian C Sauer2, Sonia Hernández-Díaz3, Robert Platt4, Ian Shrier5.   

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. Copyright Â
© 2016 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Comparative effectiveness research; Immortal time bias; Observational; Selection bias; Target trial; Time zero; studies

Mesh:

Year:  2016        PMID: 27237061      PMCID: PMC5124536          DOI: 10.1016/j.jclinepi.2016.04.014

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  21 in total

1.  When to start treatment? A systematic approach to the comparison of dynamic regimes using observational data.

Authors:  Lauren E Cain; James M Robins; Emilie Lanoy; Roger Logan; Dominique Costagliola; Miguel A Hernán
Journal:  Int J Biostat       Date:  2010       Impact factor: 0.968

2.  Dynamic regime marginal structural mean models for estimation of optimal dynamic treatment regimes, Part II: proofs of results.

Authors:  Liliana Orellana; Andrea Rotnitzky; James M Robins
Journal:  Int J Biostat       Date:  2010-03-03       Impact factor: 0.968

3.  Immortal time bias in observational studies of drug effects.

Authors:  Samy Suissa
Journal:  Pharmacoepidemiol Drug Saf       Date:  2007-03       Impact factor: 2.890

Review 4.  Immortal time bias in pharmaco-epidemiology.

Authors:  Samy Suissa
Journal:  Am J Epidemiol       Date:  2007-12-03       Impact factor: 4.897

5.  Observational data for comparative effectiveness research: an emulation of randomised trials of statins and primary prevention of coronary heart disease.

Authors:  Goodarz Danaei; Luis A García Rodríguez; Oscar Fernández Cantero; Roger Logan; Miguel A Hernán
Journal:  Stat Methods Med Res       Date:  2011-10-19       Impact factor: 3.021

6.  Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.

Authors:  Miguel A Hernán; James M Robins
Journal:  Am J Epidemiol       Date:  2016-03-18       Impact factor: 4.897

7.  Does cardiac transplantation prolong life? A reassessment.

Authors:  M H Gail
Journal:  Ann Intern Med       Date:  1972-05       Impact factor: 25.391

8.  The prevention and treatment of missing data in clinical trials.

Authors:  Roderick J Little; Ralph D'Agostino; Michael L Cohen; Kay Dickersin; Scott S Emerson; John T Farrar; Constantine Frangakis; Joseph W Hogan; Geert Molenberghs; Susan A Murphy; James D Neaton; Andrea Rotnitzky; Daniel Scharfstein; Weichung J Shih; Jay P Siegel; Hal Stern
Journal:  N Engl J Med       Date:  2012-10-04       Impact factor: 91.245

9.  Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease.

Authors:  Miguel A Hernán; Alvaro Alonso; Roger Logan; Francine Grodstein; Karin B Michels; Walter C Willett; Joann E Manson; James M Robins
Journal:  Epidemiology       Date:  2008-11       Impact factor: 4.822

10.  Evaluating medication effects outside of clinical trials: new-user designs.

Authors:  Wayne A Ray
Journal:  Am J Epidemiol       Date:  2003-11-01       Impact factor: 4.897

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  124 in total

Review 1.  The Healthy Worker Survivor Effect: Target Parameters and Target Populations.

Authors:  Daniel M Brown; Sally Picciotto; Sadie Costello; Andreas M Neophytou; Monika A Izano; Jacqueline M Ferguson; Ellen A Eisen
Journal:  Curr Environ Health Rep       Date:  2017-09

2.  Novel methods for the analysis of stepped wedge cluster randomized trials.

Authors:  Lee Kennedy-Shaffer; Victor de Gruttola; Marc Lipsitch
Journal:  Stat Med       Date:  2019-12-26       Impact factor: 2.373

3.  The meaning of confounding adjustment in the presence of multiple versions of treatment: an application to organ transplantation.

Authors:  Kerollos Nashat Wanis; Arin L Madenci; Mary Katherine Dokus; Mark S Orloff; Mark A Levstik; Roberto Hernandez-Alejandro; Miguel A Hernán
Journal:  Eur J Epidemiol       Date:  2019-01-23       Impact factor: 8.082

4.  Metformin, Diabetes, and Survival among U.S. Veterans with Colorectal Cancer-Response.

Authors:  Jessica K Paulus; Christina D Williams; Furha I Cossor; Michael J Kelley; Robert E Martell
Journal:  Cancer Epidemiol Biomarkers Prev       Date:  2017-05-15       Impact factor: 4.254

5.  Caution: work in progress : While the methodological "revolution" deserves in-depth study, clinical researchers and senior epidemiologists should not be disenfranchised.

Authors:  Miquel Porta; Francisco Bolúmar
Journal:  Eur J Epidemiol       Date:  2016-07-14       Impact factor: 8.082

6.  Electronic medical records can be used to emulate target trials of sustained treatment strategies.

Authors:  Goodarz Danaei; Luis Alberto García Rodríguez; Oscar Fernández Cantero; Roger W Logan; Miguel A Hernán
Journal:  J Clin Epidemiol       Date:  2018-04       Impact factor: 6.437

Review 7.  Benchmarking Observational Analyses Against Randomized Trials: a Review of Studies Assessing Propensity Score Methods.

Authors:  Shaun P Forbes; Issa J Dahabreh
Journal:  J Gen Intern Med       Date:  2020-03-19       Impact factor: 5.128

8.  Emulating a target trial in case-control designs: an application to statins and colorectal cancer.

Authors:  Barbra A Dickerman; Xabier García-Albéniz; Roger W Logan; Spiros Denaxas; Miguel A Hernán
Journal:  Int J Epidemiol       Date:  2020-10-01       Impact factor: 7.196

9.  How to estimate the effect of treatment duration on survival outcomes using observational data.

Authors:  Miguel A Hernán
Journal:  BMJ       Date:  2018-02-01

10.  Emulating a target trial of antiretroviral therapy regimens started before conception and risk of adverse birth outcomes.

Authors:  Ellen C Caniglia; Rebecca Zash; Denise L Jacobson; Modiegi Diseko; Gloria Mayondi; Shahin Lockman; Jennifer Y Chen; Mompati Mmalane; Joseph Makhema; Miguel A Hernán; Roger L Shapiro
Journal:  AIDS       Date:  2018-01-02       Impact factor: 4.177

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