Amyotrophic lateral sclerosis is a fatal disease with progressive degeneration of central and peripheral motor neurons. Weakness of pharyngeal and respiratory muscles lead to dyspnea, which is present in up to 80% of patients. Dyspnea in Amyotrophic Lateral Sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. The aim of this study is to validate the Polish-language version of DALS-15.
Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive degeneration of central and peripheral motor neurons with death occurring usually three to five years after onset. Weakness of pharyngeal and respiratory muscles lead to chronic dyspnea, which is present in up to 80% of patients and which contributes to anxiety, depression, and significant decrease of the quality of life. Moreover, these symptoms, along with daytime sleepiness or apathy may mask the dyspnea itself and the patient may stay unaware of increasing respiratory insufficiency. Recognizing the time of the onset of respiratory insufficiency is on the other hand important for the planning of respiratory assistance therapy, which in ALS includes continuous positive airway pressure, as well as the noninvasive and the invasive ventilation. Dyspnea in amyotrophic lateral sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. It is a 15-item tool. Particular items are descriptions of the severity of subjective dyspnea or refer to daily consequences of dyspnea such as avoiding the sleep in supine position or refer to the situations when dyspnea may occur, such as physical effort. Each item may be answered with "never", "occasionally" or "often", which are scored 0, 1 and 2, respectively. The total, arithmetical score, which ranges from 0 to 30 is then transformed according to the provided table into an interval score, which reflects the impact of dyspnea more accurately. The original DALS-15 showed excellent psychometric properties and has been already validated for Turkish language. The aim of this study is to validate the Polish-language version of DALS-15.
Study Type
OBSERVATIONAL
Enrollment
120
Convergent Validity - Modified Borg Dyspnea Scale upright
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in upright position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Time frame: Through study completion, an average of 1 year.
Convergent Validity - Modified Borg Dyspnea Scale supine
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in supine position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Time frame: Through study completion, an average of 1 year.
Reliability
Reliability will be tested by calculating the correlation between Polish language version of DALS-15 scores from the 1st and 2nd administration in the randomly selected subgroup of patients. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Time frame: Through study completion, an average of 1 year.
Internal Consistency
Consistency between particular items of Polish language version of DALS-15 will be evaluated using Cronbach alfa test. The score of the Polish language version of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Time frame: Through study completion, an average of 1 year.
Convergent Validity - ALSFRS-r
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Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of the respiratory part (items 10-12) of Polish-language version of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of the respiratory part of ALSFRS-R ranges between 0 and 12 with higher scores meaning a better outcome.
Time frame: Through study completion, an average of 1 year.
Impact of fatigue on quality of life - index
Correlation between DALS-15 and the index score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The index score of EQ-5D-5L questionnaire ranges between -0.59 to 1 with higher scores indicating better outcome.
Time frame: Through study completion, an average of 1 year.
Impact of fatigue on quality of life - visual analogue scale
Correlation between DALS-15 and the visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire ranges between 0 to 100 with higher scores indicating better outcome.
Time frame: Through study completion, an average of 1 year.