Academic Journal
Προβολή σε EDS
Συνδεδεμένο Πλήρες Κείμενο

Practical elements to consider when emulating a target trial.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: Practical elements to consider when emulating a target trial.
Συγγραφείς: Tran VT; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France. Electronic address: thi.tran-viet@aphp.fr., Porcher R; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France., Perrodeau E; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France., Yaacoub S; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France., Boutron I; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France., Ravaud P; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, NY, USA.
Πηγή: Journal of clinical epidemiology [J Clin Epidemiol] 2026 Jun; Vol. 194, pp. 112205. Date of Electronic Publication: 2026 Feb 27.
Τύπος έκδοσης: Journal Article
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Elsevier Country of Publication: United States NLM ID: 8801383 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5921 (Electronic) Linking ISSN: 08954356 NLM ISO Abbreviation: J Clin Epidemiol Subsets: MEDLINE
Imprint Name(s): Publication: New York : Elsevier
Original Publication: Oxford ; New York : Pergamon Press, c1988-
Ιατρικοί όροι (MeSH): Randomized Controlled Trials as Topic*/methods , Observational Studies as Topic*/methods , Research Design*, Humans ; Bias
Περίληψη: Background and Objectives: Target trial emulation, i.e., the analysis of observational data by explicitly emulating the design components of a randomized controlled trial (RCT), has gained attention in recent years as an approach to estimate causal effects of pharmacological or nonpharmacological interventions that are, on average, similar to those of RCTs.
Methods: This article addresses 2 objectives. First, we examine factors that may explain discrepancies in treatment effect estimates between RCTs and their target trial emulations, beyond issues related to bias or imperfect replication of the original trial. Second, we outline 11 practical considerations for the design and planning of a target trial emulation.
Results: Treatment effect estimates from RCTs and their target trial emulations may differ because of differences in the underlying populations (beyond formal eligibility criteria), the definition of interventions, the measurement and definition of outcomes, and the causal estimand being targeted. To improve the validity of target trial emulations, several design elements should be considered. For example, control and intervention groups should be concomitant and geographically comparable, and temporal changes in clinical practice should be accounted for. Also, when grace periods are used, they should reflect logistical delays in treatment initiation while maintaining assignment at time zero. Finally, emulations necessitate adequate sample size and sufficiently rich data to address imbalances in prognostic factors.
Conclusion: This article provides key elements to consider when planning a target trial emulation.
(Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.)
Competing Interests: Declaration of competing interest None.
Contributed Indexing: Keywords: Bias; Conduct; Estimands; Observational studies; Randomized controlled trials; Target trial emulation
Entry Date(s): Date Created: 20260301 Date Completed: 20260709 Latest Revision: 20260709
Update Code: 20260711
DOI: 10.1016/j.jclinepi.2026.112205
PMID: 41765347
Βάση Δεδομένων: MEDLINE
FullText Links:
  – Type: other
    Url: https://resolver.ebsco.com:443/public/rma-ftfapi/ejs/direct?AccessToken=45FE8171E77A9E599AF6&Show=Object
Text:
  Availability: 0
CustomLinks:
  – Url: https://www.doi.org/10.1016/j.jclinepi.2026.112205?
    Name: ScienceDirect (all content) (s7799221)
    Category: fullText
    Text: View record from ScienceDirect
    MouseOverText: View record from ScienceDirect
Header DbId: cmedm
DbLabel: MEDLINE
An: 41765347
AccessLevel: 3
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Practical elements to consider when emulating a target trial.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Tran+VT%22">Tran VT</searchLink>; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France. Electronic address: thi.tran-viet@aphp.fr.<br /><searchLink fieldCode="AU" term="%22Porcher+R%22">Porcher R</searchLink>; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France.<br /><searchLink fieldCode="AU" term="%22Perrodeau+E%22">Perrodeau E</searchLink>; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France.<br /><searchLink fieldCode="AU" term="%22Yaacoub+S%22">Yaacoub S</searchLink>; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France.<br /><searchLink fieldCode="AU" term="%22Boutron+I%22">Boutron I</searchLink>; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France.<br /><searchLink fieldCode="AU" term="%22Ravaud+P%22">Ravaud P</searchLink>; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, NY, USA.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%228801383%22">Journal of clinical epidemiology</searchLink> [J Clin Epidemiol] 2026 Jun; Vol. 194, pp. 112205. <i>Date of Electronic Publication: </i>2026 Feb 27.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article
– Name: Language
  Label: Language
  Group: Lang
  Data: English
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>8801383 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1878-5921 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2208954356%22">08954356 </searchLink><i>NLM ISO Abbreviation: </i>J Clin Epidemiol <i>Subsets: </i>MEDLINE
– Name: PublisherInfo
  Label: Imprint Name(s)
  Group: PubInfo
  Data: <i>Publication</i>: New York : Elsevier<br /><i>Original Publication</i>: Oxford ; New York : Pergamon Press, c1988-
– Name: SubjectMESH
  Label: MeSH Terms
  Group: Su
  Data: <searchLink fieldCode="MM" term="%22Randomized+Controlled+Trials+as+Topic%22">Randomized Controlled Trials as Topic*</searchLink>/<searchLink fieldCode="MM" term="%22Randomized+Controlled+Trials+as+Topic+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Observational+Studies+as+Topic%22">Observational Studies as Topic*</searchLink>/<searchLink fieldCode="MM" term="%22Observational+Studies+as+Topic+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Research+Design%22">Research Design*</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Bias%22">Bias</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background and Objectives: Target trial emulation, i.e., the analysis of observational data by explicitly emulating the design components of a randomized controlled trial (RCT), has gained attention in recent years as an approach to estimate causal effects of pharmacological or nonpharmacological interventions that are, on average, similar to those of RCTs.<br />Methods: This article addresses 2 objectives. First, we examine factors that may explain discrepancies in treatment effect estimates between RCTs and their target trial emulations, beyond issues related to bias or imperfect replication of the original trial. Second, we outline 11 practical considerations for the design and planning of a target trial emulation.<br />Results: Treatment effect estimates from RCTs and their target trial emulations may differ because of differences in the underlying populations (beyond formal eligibility criteria), the definition of interventions, the measurement and definition of outcomes, and the causal estimand being targeted. To improve the validity of target trial emulations, several design elements should be considered. For example, control and intervention groups should be concomitant and geographically comparable, and temporal changes in clinical practice should be accounted for. Also, when grace periods are used, they should reflect logistical delays in treatment initiation while maintaining assignment at time zero. Finally, emulations necessitate adequate sample size and sufficiently rich data to address imbalances in prognostic factors.<br />Conclusion: This article provides key elements to consider when planning a target trial emulation.<br /> (Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.)
– Name: Abstract
  Label: Competing Interests
  Group: Ab
  Data: Declaration of competing interest None.
– Name: SubjectMinor
  Label: Contributed Indexing
  Group:
  Data: <i>Keywords: </i>Bias; Conduct; Estimands; Observational studies; Randomized controlled trials; Target trial emulation
– Name: DateEntry
  Label: Entry Date(s)
  Group: Date
  Data: <i>Date Created: </i>20260301 <i>Date Completed: </i>20260709 <i>Latest Revision: </i>20260709
– Name: DateUpdate
  Label: Update Code
  Group: Date
  Data: 20260711
– Name: DOI
  Label: DOI
  Group: ID
  Data: 10.1016/j.jclinepi.2026.112205
– Name: AN
  Label: PMID
  Group: ID
  Data: 41765347
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cmedm&AN=41765347
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/j.jclinepi.2026.112205
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 112205
    Subjects:
      – SubjectFull: Humans
        Type: general
      – SubjectFull: Bias
        Type: general
      – SubjectFull: Randomized Controlled Trials as Topic methods
        Type: general
      – SubjectFull: Observational Studies as Topic methods
        Type: general
      – SubjectFull: Research Design
        Type: general
    Titles:
      – TitleFull: Practical elements to consider when emulating a target trial.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Tran VT
      – PersonEntity:
          Name:
            NameFull: Porcher R
      – PersonEntity:
          Name:
            NameFull: Perrodeau E
      – PersonEntity:
          Name:
            NameFull: Yaacoub S
      – PersonEntity:
          Name:
            NameFull: Boutron I
      – PersonEntity:
          Name:
            NameFull: Ravaud P
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 06
              Text: 2026 Jun
              Type: published
              Y: 2026
          Identifiers:
            – Type: issn-electronic
              Value: 1878-5921
          Numbering:
            – Type: volume
              Value: 194
          Titles:
            – TitleFull: Journal of clinical epidemiology
              Type: main
ResultId 1