Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino

a 21-items scale, which was proposed by the MS Council for Clinical Practice Guidelines as a shortened version of the previous 40-items Fatigue Impact Scale (21). The patient gives a score from 0 to 4 at each item, to express how every item best describes the personal experience, where 0 is "never" and 4 is "almost always"; the final score is the sum of the 21 items. The cut-off score beyond whom the subject can be considered fatigued is 38. The administration time is approximately 5-10 minutes. The MFIS is a structured, reliable, self-report questionnaire that the patient can generally complete easily, with little or no intervention from an interviewer. It provides a multidimensional assessment of fatigue, considering its impact on physical (9 items), cognitive (10 items) and phychosocial (2 items) functioning in daily life. It has a good reproducibility and a strong correlation with FSS results

a validated questionnaire specifically developed for MS (22). It is a 20-items scales that allows graduation of fatigue severity, and separate evaluation of motor (10 items) and cognitive (10 items) fatigue components. The response pattern for each item consists in a five-point Likert scale; a total score higher than 43 indicates the presence of mild fatigue and the score increases proportionally to the severity of fatigue (> 53: moderate; >63 severe); the cut-off for both the cognitive and the motor subscales is 22. FSMC provides good reliability and correlates with both FSS and MFIS scores

a simple and quick measure of the patient's instant perception of fatigue on him/herself. It is a measurement of the impression at the moment of the interview. It consists of a graphic 10 cm wide line with "no fatigue" at one end and "very severe fatigue" on the other and the subject is asked to place a cross at the point that best express his/her answer to the question "how do you feel in this moment?"

it objectively explores somnolence in terms of ability to remain awake in sleep- promoting environmental conditions. It has to be performed after a nocturnal PSG recording because the knowledge of the previous sleep is essential for MWT interpretation. Recordings include only EEG, EMG and EOG from the previous PSG and are carried out in a dim room, with slight illumination. Patients are instructed to stay awake as long as possible. Four sessions are recorded every two hours, each lasting until the patient falls asleep or for 40 minutes of continuous awake state. The sleep latency is assessed in each of the four recordings and it is defined by the elapse time in minutes on each trial before sleep onset: the patient is considered asleep after three 30 seconds EEG epochs of stage N1 of non-REM sleep, or one 30-second epoch of any other sleep stage.

a self-administered questionnaire with 8 questions, which provide a measure of a subject's general level of daytime sleepiness (26). Subjects are required to indicate their chance to fall asleep in 8 different situations on a rating scale from 0 to 3, where 0 means no chance and 3 big chance. The total score is the sum of the eight items, and a score higher that 10 suggests an excessive daytime sleepiness, whose severity increases proportionally to the score. Most people can answer the questions with no assistance in less than 5 minutes.

a simple and quick measure of the patient's instant perception of somnolence on him/herself. It is a measurement of the impression at the moment of the interview. It consists of a graphic 10 cm wide line with "no sleepiness" at one end and "very severe sleepiness" on the other and the subject is asked to place a cross at the point that best express his/her answer to the question "how do you feel in this moment?".

a 21-item self-report of depressive symptomatology for individuals aged 13 to 80 years (32). It was developed to have clinical sensitivity for assessing depression criteria reported in the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) and intends to assess symptoms experienced in the 2 weeks prior to assessment, such as intense sadness, crying, or changes in sleep, appetite, or sexual interest. Items are on a 4-point scale ranging from 0 to 3, with a maximum score of 63. Higher total scores indicate more severe depression symptoms. Administration of the scale takes about 10 minutes.

is a 10-items questionnaire that is used to measure the core symptoms and cognitive features of clinical depression (33). An higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The subject has to be interviewed by a trained psychologist or psychiatrist.

is a measure of attention and processing speed. It presents a series of nine symbols, each of which is paired with a single digit, labelled 1-9, in a key at the top of a sheet. The remainder of the page has a pseudorandomized sequence of the symbols and the subject must respond with the digit associated with each of these as quickly as possible. The score is the number of correct answers in 90 seconds.

is another measure of sustained attention and speed of information processing. The subject hears a series of single digit number from CD that are presented at the rate of one every 3 seconds in the first part of the test (PASAT 3"), or at the rate of one every 2 seconds in the second part (PASAT 2"). The subject is asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part and each part has a maximum of 60 correct answers.

evaluates sustained attention and some aspects of executive functions, such as the ability to elaborate relevant and irrelevant dimensions in parallel and to inhibit an automatic response while performing a task based on conflicting stimuli. The procedure comprised of three trials. In the first trial, the subject is instructed to read a list of word indicating colours printed in black ink as quickly as possible; in the second trial the subject is instructed to name the colour of strings of dots as quickly as possible; in the third trial (interference condition), the subject has to name the colours of the ink of words indicating conflicting colours as quickly as possible. Performance will assess by calculating the time required to name the items and the number of the errors.