Background
Methods
Principle
prevention | to reduce risk of disabling or imparing events |
---|---|
treatment
| to cure diseases, to substitute missing substances |
indispensable to life, to modify or relieve symptoms | |
severity grading of the diseases:
| |
I. acute life-threatening or severe chronic disease | |
II. rehabilitation | |
III. less severe acute or chronic disease | |
IV. application outside a treatment context |
NNT | ARR | Modifier |
---|---|---|
prevention | ||
<20 | 5-100% | 2.0 |
20 - <50 | <5% | 1.75 |
50 - <100 | <2% | 1.5 |
100 - <175 | <1% | 1.25 |
175 - <300 | <0.57% | 1.0 |
300 - <500 | <0.33% | 0.75 |
500 - <1000 | <0.2% | 0.5 |
≥1000 | <0.1% | 0.25 |
treatment
| ||
NNT
|
ARR
|
Modifier
|
<3 | >30% | 2.0 |
3 - <10 | 10-30% | 1.5 |
≥10 | <10% | 1.0 |
Trial settings
Point scoring for efficiency, risk profile, and the EVITA score
RCTs showing evidence of | number of RCT | patient relevant outcome | surrogate outcome |
---|---|---|---|
0
|
0
|
0
| |
superiority
|
1
|
+5.0
|
+2.5
|
≥2
|
+7.5
|
+3.75
| |
0
|
0
|
0
| |
non-inferiority/equivalence
(in the presence of other RCT showing superiority) |
1
|
-1.67
|
-0.83
|
≥2
|
-2.5
|
-1.25
| |
non-inferiority/equivalence
(in the absence of other RCT) |
any
|
0
|
0
|
0
|
0
|
0
| |
non-inferiority/equivalence
(in the presence of other RCT showing inferiority) |
1
|
+1.67
|
+0.83
|
≥2
|
+2.5
|
+1.25
| |
0
|
0
|
0
| |
inferiority
|
1
|
-5.0
|
-2.5
|
≥2
|
-7.5
|
-3.75
| |
sum
|
...
| ||
modifier
|
...
| ||
efficiency score
|
...
|
severity grading | frequency | therapy investigated | therapeutic standard |
---|---|---|---|
adverse events (AE)
| |||
grades 5 + 4
| ≥10% |
-4.0
|
-4.0
|
(death related to AE or life-threatening AE or disabling AE) | ≥1% |
-3.0
|
-3.0
|
≥0.1% |
-2.0
|
-2.0
| |
<0.1% |
-1.0
|
-1.0
| |
0 |
0
|
0
| |
grade 3
| ≥10% |
-2.5
|
-2.5
|
(severe and undesirable AE) | ≥1% |
-2.0
|
-2.0
|
≥0.1% |
-1.0
|
-1.0
| |
<0.1% |
0
|
0
| |
0 |
0
|
0
| |
grades 2 + 1
| ≥10% |
-1.5
|
-1.5
|
(moderate AE or mild AE) | ≥1% |
-1.0
|
-1.0
|
≥0.1% |
-0.5
|
-0.5
| |
<0.1% |
0
|
0
| |
0 |
0
|
0
| |
Interactions
| |||
frequent or serious clinical consequence |
-2.0
|
-2.0
| |
occasional or may have clinical consequence |
-1.5
|
-1.5
| |
dose change |
-1.0
|
-1.0
| |
unlikely/probably or no clinical consequence |
0
|
0
| |
no information available |
-1.0
|
-1.0
| |
sum
|
...
|
...
| |
risk score
|
...
|