Evidence map›Paper›PMID 39532374›Full record

SynthesisBMJ open2024

Conducting observational analyses with the target trial emulation approach: a methodological systematic review.

Noémie Simon-Tillaux, Guillaume L Martin, David Hajage, Carole Scheifer, Maxime Beydon, Agnes Dechartres, Florence Tubach

Registry-linked trialAbstract readSystematic Review
In one paragraph

Synthesis in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07508865 (Sustainable Anesthesia in Myocardial Revascularization Surgery), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT07508865 recruitingnot on this map

Sustainable Anesthesia in Myocardial Revascularization Surgery: a Non-randomized Interventional Study

Typeobservational_patient_registrySponsorUniversidad de La FronteraRan2024 to 2026Enrolled116ConditionsCoronary Artery Bypass, Anesthesia, SustainabilityArmsOptimized recovery, Standard Anesthetic Practice
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Active Monitoring versus Surgical Excision for Atypical Ductal Hyperplasia.Cancer prevention research (Philadelphia, Pa.) · 2026
    Observational
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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

7 authors.

Noémie Simon-TillauxOffice of Biostatistics and Epidemiology, Gustave Roussy, Oncostat U1018, Inserm, University Paris-Saclay, labeled Ligue Contre le Cancer, Villejuif, France simon.noemie@ymail.com.ORCID http://orcid.org/0000-0001-7138-5364
Guillaume L MartinSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.
David HajageSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.
Carole ScheiferSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.
Maxime BeydonSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.
Agnes Dechartres *Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.
Florence Tubach *Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTarget trial emulation is an approach that is increasingly used to improve transparency in observational studies and help mitigate biases. For studies declaring that they emulated a target trial, we aimed to evaluate the specification of the target trial, examine its consistency with the observational emulation and assess the risk of bias in the observational analysis.

designMethodological systematic review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA SOURCES: The database MEDLINE (Medical Literature Analysis and Retrieval System Online) was interrogated for all studies published from 1 January 2021 to 3 July 2022. We performed an additional manual search of 20 general medical and specialised journals that spanned the same period. ELIGIBILITY CRITERIA: All studies that declared emulating a hypothetical or real randomised trial were eligible. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers performed the whole systematic review process (screening and selection of studies, data extraction and risk of bias assessment). The main outcomes were the definition of the key protocol components of the target trial and its emulation, consistency between the target trial and its emulation and risk of bias according to the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool.

resultsAmong the selected sample of 100 studies, 24 (24%) did not specify the target trial. Only 40 studies (40%) provided detailed information on all components of the target trial protocol. Eligibility criteria, intervention strategies and outcomes were consistent between the target trial and its emulation in 35 studies (46% of those specifying the target trial). Overall, 28 studies (28%) exhibited serious risk of bias and 41 (41%) had misalignments in the timing of eligibility assessment, treatment assignment and the start of follow-up (time-zero). As compared with studies that did not specify the target trial, those that did specify the trial less frequently seemed to have both time-zero issues (39% vs 52%) and serious risk of bias (26% vs 33%).

conclusionsOne-quarter of studies declaring that they emulated a target trial did not specify the trial. Target trials and their emulations were particularly inconsistent for studies emulating a real randomised trial. Risk of methodological issues seemed lower in observational analyses that specified versus did not specify the target trial.

Indexed as

Observational Studies as TopicBiasHumansRandomized Controlled Trials as TopicResearch DesignEPIDEMIOLOGYObservational StudySTATISTICS & RESEARCH METHODS

Identifiers

PMID39532374
PMCPMC11574403

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.