Evidence-Based Medicine and the Problem of Healthy Volunteers

Ann Hepatol. 2017;16(6):832-834. doi: 10.5604/01.3001.0010.5272.

Abstract

Healthy controls are subjects without the disease being studied but may have other conditions indirectly affecting outcome. In the present epidemics of obesity a few subjects with undiagnosed nonalcoholic fatty liver disease enter clinical studies as controls, producing biased results. Stricter selection criteria should be considered to prevent this risk.

Keywords: Clinical trials. Control group. Liver Enzymes. NAFLD. Obesity.

MeSH terms

  • Evidence-Based Medicine / methods*
  • Healthy Volunteers*
  • Humans
  • Liver Function Tests
  • Non-alcoholic Fatty Liver Disease / diagnosis
  • Non-alcoholic Fatty Liver Disease / epidemiology*
  • Obesity / diagnosis
  • Obesity / epidemiology*
  • Patient Selection*
  • Predictive Value of Tests
  • Reference Values