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Fig. 1 | Trials

Fig. 1

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

Fig. 1

Efficacy versus effectiveness. The illustration depicts the contrast between a classical randomized controlled trial (RCT), which is rigorously controlled and focused on internal validity (efficacy), and a pragmatic RCT, which is intended to mirror clinical practice in the real world and optimized for external validity (effectiveness). When assessing the effectiveness and safety of interventions, healthcare decision-makers must consider both types of trials. Classical RCTs furnish valuable insights into an intervention’s efficacy in a highly controlled environment, while pragmatic RCTs yield insights into an intervention’s real-world performance, potentially offering more comprehensive generalizability. If an intervention proves ineffective in terms of its effectiveness, decision-makers may need to consider prioritizing healthcare resources based on the ethical principle of justice

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