Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Penetration-Aspiration Scale (PAS) change |
PAS is an 8-point scale used to determine swallowing safety. Levels 1 and 2 are considered safe, levels >3 indicate penetration or aspiration and are considered unsafe. |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Primary |
Yale Residue Severity Rating Scale (YRSRS) change |
YRSRS is a validated measure of swallowing efficiency using an image-based assessment to determine post-swallow pharyngeal residue: location and severity. It is assessed using a 5-point ordinal scale (from 1=0 % residue to 5=50 % residue). |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Primary |
Iowa Oral Performance Instrument (IOPI) change |
IOPI is a device which measures tongue strength (in kilopascals; kPa) and endurance (in seconds) while the participant presses the bulb with the front or the base of their tongue to the hard palate. |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Primary |
Mann Assessment of Swallowing Ability (MASA) change |
MASA is a standard clinical swallowing assessment protocol administered by the speech-language therapist. Total score ranges from 38-200. Lower score indicates higher impairment. |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Primary |
Eating Assessment Tool 10 (EAT-10) change |
EAT-10 is a validated self-administered dysphagia severity symptom survey including 10 items and a five-point scale (0=no problem to 4=sever problem). Higher total score indicates higher impairment. |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Primary |
Swallowing Quality of Life Questionnaire (SWAL-QoL) change |
SWAL-QoL is a 44-item standardised psychometric scale that measures swallowing-related QoL across 10 domains. Scores for each individual domain and a total SWAL-QoL score are calculated. Total score ranges from 0-100 (100 indicating the most favourable state). |
At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion |
|
Primary |
Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change |
The questionnaire comprises 10 questions. The participants specify their level of agreement on a five-point Likert-type scale (1=strongly disagree, 5= strongly agree). |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
ALS Functional Rating Scale-Revised (ALSFRS-R) change |
ALSFRS-R is a 12-tem ALS-specific assessment of global functioning using a five-point scale (0=not able, 4= normal ability), with 48 points representing normal function. |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
Functional Oral Intake Scale (FOIS) change |
FOIS is a validated 7-point scale demonstrating an individual's ability of daily oral food intake (1=no oral intake, 7=total oral intake with no restrictions). |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
Dysphagia Outcome and Severity Scale (DOSS) change |
DOSS is a 7-point scale that rates the functional severity of dysphagia based on objective assessment and provides information on diet recommendations, independence level and type of nutrition necessary (level 7=normal swallowing function, level 1=severe dysphagia). |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
BMI change |
Body mass index (in kg/m^2) |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
Forced Vital Capacity (FVC) change |
Standard clinical respiratory assessment of FVC (in %) |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
Peak Cough Flow (PCF) change |
Standard clinical respiratory assessment of PCF (in L/min) |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
Maximal Inspiratory Pressure (MIP) change |
Standard clinical respiratory assessment of MIP (in cmH2) |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|
Secondary |
Maximal Expiratory Pressure (MEP) change |
Standard clinical respiratory assessment of MEP (in cmH2) |
Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months) |
|