Avoiding Time-Related Biases: A Feasibility Study on Antidiabetic Drugs and Pancreatic Cancer Applying the Parametric g-Formula to a Large German Healthcare Database

Börnhorst, Claudia; Reinders, Tammo; Rathmann, Wolfgang; Bongaerts, Brenda; Haug, Ulrike; Didelez, Vanessa; Kollhorst, Bianca

doi:10.2147/clep.s328342

Cited by 3 publications

(11 citation statements)

References 47 publications

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“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

“… The included studies spanned 26 fields of medicine, predominately infectious disease (43 [22%]; 27 [14%] on COVID-19), cardiology (30 [15%]), and oncology (30 [15%]) . One hundred and thirty-one studies (66%)…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…One-hundred and fifteen studies (58%) completely reported how the target trial protocol was emulated. Eighty-seven studies (44%) provided both the protocol of the target trial and described how it was emulated (Table 2). The following items of the emulation were frequently reported: eligibility criteria (193 [97%]), treatment strategies (191 [96%]), assignment procedures (173 [87%]), primary outcome (196 [98%]), the follow-up period (186 [93%]), a causal contrast (146 [73%], and an analysis plan (194 [97%]) (Table 2).…”

Section: Resultsmentioning

confidence: 99%

“…Seventy studies (35%) reported in the title that the study aimed to emulate a target trial; 180 (90%) did so in the Methods section. Twenty studies (10%) reported the study was prospectively registered, 16 of these 20 (80%)…”

Section: Resultsmentioning

confidence: 99%

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Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Hansford,

Cashin,

Jones

et al. 2023

JAMA Netw Open

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ImportanceObservational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice.ObjectiveTo assess the reporting of observational studies that explicitly aimed to emulate a target trial.Evidence ReviewWe searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation.FindingsA total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation.Conclusion and RelevanceIn this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

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“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Hansford,

Cashin,

Jones

et al. 2023

JAMA Netw Open

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Emulierung von „target trials“ mit Real-world-Daten

Braitmaier

Didelez

2022

Präv Gesundheitsf

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Zusammenfassung Hintergrund Die „real world data“ (RWD), z. B. Krankenkassendaten, bieten reichhaltige Informationen zu gesundheitsrelevanten Faktoren und können die Basis für Studien zur Arzneimittelsicherheit, Wirksamkeit medizinischer Interventionen u. v. m. darstellen. Ein besonderer Vorteil ist die je nach Datenquelle größere Verallgemeinerbarkeit, wenn z. B. Informationen zu bestimmten Subgruppen der Population vorliegen und ein Volunteer-Bias ausgeschlossen werden kann. Gerade in Fällen, in denen randomisierte kontrollierte Studien („randomized controlled trials“, RCT) nicht durchgeführt werden können, sind Beobachtungsstudien basierend auf RWD eine wichtige Informationsquelle. Die valide Analyse von RWD stellt allerdings einige Herausforderung dar, wobei insbesondere mögliche Verzerrungen, die durch ein sorgfältiges Studiendesign vermeidbar wären, Beachtung finden sollen. Hier setzt das Prinzip der Target-trial-Emulierung (TTE) an. Ziel der Arbeit In diesem Artikel soll aufgezeigt werden, wie die TTE den Herausforderungen bei der Analyse von RWD begegnet. Material und Methoden Die TTE wird allgemein verständlich vorgestellt. Prinzipien, Vorteile, Annahmen und spezifische statistische Aspekte werden anhand relevanter Literatur und praktischer Beispiele erläutert. Ergebnisse Damit die Analyse von RWD valide, kausal interpretierbare Ergebnisse liefern kann, müssen einige Bedingungen erfüllt sein. Neben einem ausreichenden Informationsgehalt der Daten sind auch eine klare Fragestellung und ein geeignetes Studiendesign, das u. a. Selektionseffekte vermeidet, von zentraler Bedeutung. Das Target-trial-Prinzip besteht darin, dass zunächst das Auswertungskonzept für einen RCT erarbeitet wird, welches in einem zweiten Schritt mit Beobachtungsdaten „emuliert“ wird. Somit liefert die TTE quasi eine Anleitung, um die Fragestellung zu definieren und ein geeignetes Studiendesign zu entwerfen. TTE kann mit unterschiedlichen statistischen Methoden kombiniert werden, wobei statistische Effizienz durch sequenzielle Trials und das sog. Klonen gewonnen werden kann. Schlussfolgerung Die TTE ist ein allgemeines und übergreifendes Prinzip, das zentralen Herausforderungen bei der Analyse von Beobachtungsdaten, also auch RWD, systematisch begegnet.

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The implementation of target trial emulation for causal inference: a scoping review

Zuo¹,

Yang²,

Campbell³

et al. 2023

Journal of Clinical Epidemiology

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Avoiding Time-Related Biases: A Feasibility Study on Antidiabetic Drugs and Pancreatic Cancer Applying the Parametric g-Formula to a Large German Healthcare Database

Cited by 3 publications

References 47 publications

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Emulierung von „target trials“ mit Real-world-Daten

The implementation of target trial emulation for causal inference: a scoping review

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