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A simple and valid tool distinguished efficacy from effectiveness studies.

Gerald Gartlehner1, Richard A Hansen, Daniel Nissman

  • 1University of North Carolina at Chapel Hill, Cecil G. Sheps Center for Health Services Research, NC 27599, USA. gartlehner@schsr.unc.edu

Journal of Clinical Epidemiology
|September 19, 2006
PubMed
Summary

A new seven-criterion instrument effectively distinguishes effectiveness (pragmatic) from efficacy (explanatory) trials. This tool enhances systematic reviews and aids clinicians in assessing study generalizability and external validity.

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Area of Science:

  • Clinical Trial Design
  • Evidence-Based Medicine

Background:

  • Lack of a validated definition for effectiveness studies.
  • Need for clear distinction between pragmatic (effectiveness) and explanatory (efficacy) trials.

Purpose of the Study:

  • Propose and validate a simple instrument to differentiate effectiveness from efficacy trials.
  • Develop a tool to improve the assessment of study generalizability.

Main Methods:

  • Utilized seven study design criteria to create a novel instrument.
  • Directors of 12 Evidence-based Practice Centers selected example studies.
  • Tested instrument validity using selected effectiveness and efficacy studies.

Main Results:

  • A cutoff of six criteria demonstrated optimal balance between sensitivity (0.72) and specificity (0.83).

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  • The instrument reliably distinguishes between effectiveness and efficacy trials with high specificity.

    • Conclusions:

    • The proposed criteria offer a valid and simple tool for distinguishing trial types.
    • Enhances systematic reviews by emphasizing study generalizability.
    • Assists clinicians in evaluating the external validity of research studies.