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Conducting observational analyses with the target trial emulation approach: a methodological systematic review
Noémie Simon-Tillaux1,2, Guillaume L Martin2, David Hajage2
1Office of Biostatistics and Epidemiology, Gustave Roussy, Oncostat U1018, Inserm, University Paris-Saclay, labeled Ligue Contre le Cancer, Villejuif, France simon.noemie@ymail.com.
BMJ Open
|November 12, 2024
Summary
Many studies emulating target trials fail to specify them, increasing bias risk. Specifying the target trial in observational studies is linked to fewer methodological issues and lower bias.
Area of Science:
- Epidemiology
- Biostatistics
- Health Research Methodology
Background:
- Target trial emulation enhances transparency and reduces bias in observational studies.
- Evaluating the quality of target trial emulation is crucial for reliable real-world evidence.
Purpose of the Study:
- To assess the specification of target trials in emulated studies.
- To examine the consistency between target trials and their observational emulations.
- To evaluate the risk of bias in observational analyses that emulate target trials.
Main Methods:
- Methodological systematic review following PRISMA guidelines.
- Searched MEDLINE and 20 general/specialized journals (Jan 2021–July 2022).
- Included studies declaring emulation of a randomized trial; assessed protocol components, consistency, and risk of bias (ROBINS-I).
Main Results:
- 100 studies were reviewed; 24% did not specify the target trial.
- Only 40% detailed all target trial protocol components.
- Consistency between target trials and emulations was found in 46% of specified trials.
- 28% of studies had serious risk of bias; 41% had time-zero misalignments.
- Studies specifying the target trial showed lower rates of time-zero issues (39% vs. 52%) and serious bias (26% vs. 33%).
Conclusions:
- A significant proportion of studies emulating target trials lack clear specification of the original trial.
- Inconsistencies were notable in emulations of real randomized trials.
- Specifying the target trial appears associated with reduced methodological issues and bias in observational studies.
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