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An analysis reveals differences between pragmatic and explanatory diagnostic accuracy studies.

Patrick M Bossuyt1, Maria Olsen1, Chris Hyde2

  • 1Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands.

Journal of Clinical Epidemiology
|September 28, 2019
PubMed
Summary

Understanding the difference between pragmatic and explanatory diagnostic accuracy studies is key. Pragmatic studies guide clinical decisions, while explanatory studies explore test behavior, impacting study design and interpretation.

Keywords:
Diagnostic accuracyExplanatory studiesPragmatic studiesReference standardSensitivitySpecificityTest evaluation

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Area of Science:

  • Medical research methodology
  • Diagnostic test evaluation

Background:

  • Medical research distinguishes between pragmatic and explanatory approaches.
  • This distinction is applicable to diagnostic accuracy studies.

Purpose of the Study:

  • To clarify the differences between pragmatic and explanatory approaches in diagnostic accuracy studies.
  • To define a continuum for these approaches in diagnostic accuracy research.

Main Methods:

  • Adapted definitions from intervention trials (Schwartz and Lellouch) to diagnostic accuracy studies.
  • Defined characteristics of pragmatic vs. explanatory diagnostic accuracy studies.

Main Results:

  • Explanatory studies focus on test behavior, often with selective recruitment and ROC curve analysis.
  • Pragmatic studies aim to support clinical decisions, using representative patient groups and sensitivity/specificity analysis.

Conclusions:

  • Differentiating pragmatic and explanatory approaches aids in designing, analyzing, and interpreting diagnostic accuracy studies.
  • This distinction clarifies debates on study design appropriateness, validity, and applicability of findings.