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CISE Journal Level of Evidence

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The Level of Evidence should be assigned for all Clinical articles according to the definitions in the following table.

Levels of Evidence for Primary Research Question
Study Type Question Level I Level II Level III Level IV Level V

Diagnosis

investigating a test for diagnosis

Is this (diagnosis or early dectection) or test worthwhile or accurate?

  • 1) Randomized controlled trial
  • 2) Test for developed (previously) diagnostic criteria with consecutive patients and consistently applied reference standard
  • 1) Prospective cohort (non-randomized comparative) study
  • 2) Developing diagnostic criteria with consecutive patients and consistently applied reference standard
  • 1) Retrospective cohort (non-randomized comparative) study
  • 2) Case-control study
  • 3) No consistently applied reference standard
  • 1) Case series
  • 2) Nonindependent reference standard
  • Mechanism-based reasoning
Prognosis

investigating the effect of patient characteristics on the outcomes of a disease

What is the natural history of the disease if we do not add a therapy?

Prospective cohort study (all patients entrolled at an early and uniform point in the course of the disease

Prospective cohort (non-randomized comparative) study (patients enrolled at different points in the course of the disease

  • 1) Retrospective cohort (non-randomized comparative) study
  • 2) Case-control study
  • Case series
  • Mechanism-based reasoning
Therapy

investigating the outcomes of a treatement
Does this treatment has benefit?
  • Randomized controlled trial
  • Prospective cohort (non-randomized comparative) study
  • 1) Retrospective cohort (non-randomized comparative) study
  • 2) Case-control study
  • Case series
  • Mechanism-based reasoning


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