Table 1. Overview of primary and secondary outcomes.
Outcome | Definitions | |
---|---|---|
Primary outcome | Proportion of patients with restored or improved nerve function | Using a composite score. Restored: all nerves back to normal function Improved: more restored* and/or improved** nerves than unchanged and/or deteriorated*** nerves Unchanged: same number of nerves impaired Deteriorated: more deteriorated nerves than improved and/or restored nerves |
Secondary outcomes | 1. Proportion of restored, improved, unchanged, deteriorated and fully impaired nerves for each specific nerve–e.g. ulnar nerve | For six sensory nerves and seven motor nerves |
2. Count of impairments | Per patient 26 nerves were assessed. Each impaired nerve adds 1 point to the total score | |
3. Improvement Reaction Severity Scale | Improvement: reduction in RSS of 3 or more points on the total score, or a reduction of 2 or more points on any individual item of the scale | |
4. Improvement in SALSA-scale and P-scale | Improvement: classified in a better category (extreme, severe, moderate, mild, none) | |
5. Proportion of patients with Serious Adverse Events | ||
6. Proportion of patients needing additional steroids for treatment of reaction or worsening NFI |
* restored: back to normal function
** improved: decrease of 3 points for MFT or increase of 1 point for VMT
***: deteriorated: increase of 3 points for MFT or decrease 1 point for VMT