Levels of Evidence

The purpose of this page is to create a reference to describe our methodology for assigning levels of evidence to regimens.

A bit of background: We have taken a simplified approach to information visualization, based on a three-color "traffic signal" metric. Generally, a regimen should be evaluated in a randomized fashion with an adequate patient sample to be considered a "green" regimen. We have defined adequate as 20 or more patients per arm. Non-randomized studies and randomized studies with fewer than 20 patients per arm are considered to be "yellow" regimens. Finally, case reports or non-randomized studies with fewer than 20 patients enrolled are considered to be "red" regimens. 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

Examples

Case report Red label code: Case report

Phase II Yellow label code: Phase II

Phase III Green label code: Phase III

Levels of Evidence

Examples

Navigation menu

Search