Transparent Reporting of Observational Studies Emulating a Target Trial-The TARGET Statement.

Area of Science:

• Epidemiology
• Biostatistics
• Health Research Methodology

Background:

• Observational studies are crucial for causal inference when randomized trials are not feasible.
• Existing reporting practices for observational studies emulating target trials lack standardization.
• There is a need for clear guidance to ensure the transparency and reliability of these studies.

Purpose of the Study:

• To develop consensus-based reporting guidelines for observational studies that emulate a hypothetical pragmatic randomized trial (target trial).
• To enhance the quality and transparency of health research by providing a standardized reporting framework.

Main Methods:

• The Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) guideline was developed using the EQUATOR framework.
• Methods included a systematic review, expert surveys, a consensus meeting, and stakeholder pilot testing.
• The guideline development involved 18 experts and feedback from 108 stakeholders over a 1.5-year period.

Main Results:

• A 21-item TARGET checklist was developed, organized into six sections: abstract, introduction, methods, results, discussion, and other information.
• Key recommendations include identifying the study as a target trial emulation, specifying the causal question and protocol, and reporting causal estimands and sensitivity analyses.
• The checklist guides reporting for parallel group, individually randomized target trial emulations with baseline confounder adjustment.

Conclusions:

• The TARGET guideline aims to improve the transparency and peer review of observational studies emulating target trials.
• Adherence to the TARGET checklist will help researchers, clinicians, and readers better interpret and apply findings from these studies.
• This standardized reporting will enhance the utility of observational studies for informing causal questions in health research.