By Dieter Menne (Menne Biomed Consulting, Tübingen) and Werner Schwizer (UniversitätsSpital Zürich)
The EraFlux score was developed to quantify the severity of gastro-esophageal reflux (GERD) in the clinical study EraFlux; it is also the basic relapse criterion in the current mulitcenter study ERASTRAT. The symptoms are assessed by the study physician or a study nurse in face-to-face interviews or in telephone interviews.
Click here for a javascript-program to calculate the Eraflux score on-line.
Definition of Symptoms
To define the severity of GERD, four symptoms were used
- Retrosternal pain (Brustschmerzen)
- Heartburn ( Magenbrennen; Sodbrennen)
- Regurgitation (Saures Aufstoßen)
- Dysphagia (Schwierigkeiten beim Schlucken, Steckenbleiben)
Grading of Symptoms
- Number of episodes in the last 2 weeks (5 levels, never...daily)
- Number of episodes per day (6 levels, never...4 or more, not used for dysphagia)
- Duration of episodes ( 7 levels, none...60 minutes or more, not used for regurgitation and dysphagia)
- Intensity of episodes ( 6 levels, none...very strong)
Definition of Just-Below-Critical Cases
We used our professional medical expertise to define symptom patterns just below a level we rated critical. Identical sets of conditions were used for retrosternal pain and heartburn, a separate set was defined for dysphagia.
The example in the above table means that one mild episode of 5-9 minutes per day was just below the critical level. The same conditions, with two episodes instead of one episode per day , would be considered critical. No attempt was made to create a set of boundary conditions that were internally consistent. Instead, the boundary conditions were used to create a set of weights for the symptom gradings that minimized the inconsistencies inherent in every mapping of multi-dimensional patterns to a linear score.
Score Weights
The additive weights for each level of symptom grading were derived using an exhaustive search under the following constraints
- The score at the absence of symptoms was defined as zero.
- All score-sum values below 25 were defined as subcritical; values of 25 or above were critical.
- The weights for each level of retrosternal pain and heartburn had to be equidistant whole numbers (e.g. 0, 3, 6 for none, very mild, mild). For regurgitation and dysphagia, the numbers had also to be equidistant, but could have decimals.
- As many as possible score sums marked yellow in the tables below had to be just under 25.
- For reguritation, the tables for heartburn were used. Because duration is not meaningful for regurgitation, the weights of the other symptom details were increased accordingly.
Eraflux Score
We defined the Eraflux score as the maximum of the symptom scores for retrosternal pain, heartburn, regurgitation and dysphagia. We first considered using a sum criterion, but found that it did not adequately follow the general well-being of the patients.
Just-Below-Critical Symptom Gradings for Retrosternal Pain and Heartburn
Note that some lower levels of symptoms (e.g. once per week for episodes, very mild for intensity are not shown in the figures below, because these were always considered uncritical.
Just-Below-Critical Symptom Gradings for Dysphagia
Score Weights for Retrosternal Pain and Heartburn
Number of Episodes | none 0 |
1/week 3 |
every 3 days 6 |
every 2 days 9 |
daily 12 |
|||
---|---|---|---|---|---|---|---|---|
Episodes per day | none 0 |
1/day 2 |
2/day 4 |
3/day 6 |
4/day 8 |
>4/day 10 |
||
Duration | none 0 |
<1 min 1 |
< 5 min 2 |
< 10 min 3 |
<30 min 4 |
<60 min 5 |
>60 min 6 |
|
Intensity | none 0 |
very mild 3 |
mild 6 |
moderate 9 |
strong 12 |
very strong 15 |
||
Sum of Pain or Sum of Heartburn |
Score Weights for Regurgitation
Number of Episodes | none 0 |
1/week 3.4 |
every 3 days 6.8 |
every 2 days 10.2 |
daily 13.6 |
||
---|---|---|---|---|---|---|---|
Episodes per day | none 0 |
1/day 2.2 |
2/day 4.4 |
3/day 6.6 |
4/day 8.8 |
>4/day 11.0 |
|
Intensity | none 0 |
very mild 3.4 |
mild 6.8 |
moderate 10.2 |
strong 13.6 |
very strong 17 |
|
Sum of Regurgitation |
Score Weights for Dysphagia
Number of Episodes | none 0 |
1/week 6.3 |
every 3 days 12.5 |
every 2 days 18.8 |
daily 25.0 |
||
---|---|---|---|---|---|---|---|
Intensity | none 0 |
very mild 6.3 |
mild 12.5 |
moderate 18.8 |
strong 25.0 |
very strong 31.3 |
|
Sum of Dysphagia |
The EraFlux score is the maximum of the symptom scores for retrosternal pain, heartburn, regurgitation and dysphagia.