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Table 2 Advantages and disadvantages of pragmatic RCTs over traditional RCTs

From: Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation

Definition

Advantages

Disadvantages

A pragmatic clinical trial is a study designed to evaluate an intervention’s effectiveness in real-world conditions, reflecting the specific patient population and usual clinical practice. A pragmatic clinical trial aims to provide evidence that can be directly applied to clinical decision-making

Reflects real-world conditions

Results are directly applicable to clinical decision-making

Involves a diverse patient population

May be more cost-effective

May provide information on unexpected benefits or harms of interventions

May reduce the potential for selection bias

More generalizable to broader populations

May require larger sample sizes

May require more extended follow-up periods

May have limited ability to evaluate complex interventions

May have limitations in outcome measurement and data collection