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Comparative effectiveness trials in asthma - how will I recognize one?

Sharmilee M Nyenhuis1, Andrea J Apter2, Michael Schatz3

  • 1Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois at Chicago, Chicago, Illinois.

Current Opinion in Pulmonary Medicine
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This summary is machine-generated.

Three tools, including PRECIS, PRECIS-2, and PRACTAS, help classify clinical trials on the efficacy-effectiveness spectrum. These tools offer reliable classification for research, aiding evidence-based decision-making in healthcare settings.

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Area of Science:

  • Clinical trial design
  • Health services research
  • Evidence-based medicine

Background:

  • Comparative efficacy trials assess health care interventions in controlled research settings.
  • Comparative effectiveness trials aim to bridge evidence gaps for real-world clinical decision-making.
  • Classifying trials along the efficacy-effectiveness continuum is crucial for interpreting research findings.

Purpose of the Study:

  • To review and compare existing tools for classifying clinical trials.
  • To evaluate methods for placing trials on the efficacy-to-effectiveness continuum.
  • To inform researchers and stakeholders on trial design classification.

Main Methods:

  • Review of three classification tools: PRECIS, PRECIS-2, and PRACTAS.
  • Analysis of the design elements and structure of each tool.
  • Assessment of interrater reliability for the classification tools.

Main Results:

  • PRECIS, PRECIS-2, and PRACTAS utilize star diagrams to visualize trial design elements on the efficacy-effectiveness continuum.
  • The tools vary in the number and type of design elements assessed (e.g., PRECIS/PRACTAS have 10 elements, PRECIS-2 has nine; PRACTAS includes stakeholder engagement).
  • Substantial interrater reliability was observed across all three tools, with variations across specific design elements (ICC 0.4-0.8).

Conclusions:

  • PRECIS, PRECIS-2, and PRACTAS are viable options for classifying trials along the efficacy-effectiveness spectrum.
  • Disagreements between researchers and stakeholders may arise regarding the classification of trials.
  • These tools aid in understanding how trial designs align with efficacy versus effectiveness goals.