Difference between revisions of "Levels of Evidence"

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(added criteria, colors)
(added criteria)
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*Outcomes:
 
*Outcomes:
 
**Overall survival
 
**Overall survival
**Progression-free survival
+
**Progression-free survival (PFS), disease-free survival (DFS)
 
**Quality of life/toxicity
 
**Quality of life/toxicity
 +
**RECIST: Complete response, partial response, stable disease
 +
**Complete/major molecular response (CMR, MMR), complete/major cytogenetic response (CCR/CCyR, MCR/MCyR), complete/partial hematologic response (CHR, PHR)
 
*Number of sites (single, regional, national, international)
 
*Number of sites (single, regional, national, international)
 
*Number of experimental arms
 
*Number of experimental arms

Revision as of 14:24, 2 November 2012

The purpose of this page is to create a reference to describe our methodology for assigning levels of evidence to regimens. We have taken a simplified approach to rating evidence, based on a three-color metric (red/yellow/green). Of course, there are finer gradations of the quality of evidence so this simplified scheme should be taken with a grain of salt.

We are currently collaborating on this list, which is a work in progress. Criteria that may be considered:

  • Phase: I, II, III, IV
  • Interventional/observational
    • Cohort
    • Case-control
    • Cross-sectional study
    • Ecological study
  • Prospective/retrospective
  • Randomized, blind (single/double)
  • Compared against: placebo, standard of care
  • Superiority, non-inferiority, equivalence
  • Outcomes:
    • Overall survival
    • Progression-free survival (PFS), disease-free survival (DFS)
    • Quality of life/toxicity
    • RECIST: Complete response, partial response, stable disease
    • Complete/major molecular response (CMR, MMR), complete/major cytogenetic response (CCR/CCyR, MCR/MCyR), complete/partial hematologic response (CHR, PHR)
  • Number of sites (single, regional, national, international)
  • Number of experimental arms

Colors to be used: Green box text Yellow box text Red box text