Table 1 Shortened version of Questionnaire 1. Answers are expressed as a percentage of all responses. Cut-off level to reach consensus: two-thirds (67%) of agreement of effective answers
%4. How many of your patients have Motricity problems? / 0-30 / 15.38
40-60 / 43.27
70-100 / 41.35
5. How many of your patients have Mobility problems? / 0-30 / 39.60
40-60 / 41.58
70-100 / 18.81
6. How many of your patients have the following symptoms?
a Spasticity / 0-25 / 20.39
26-50 / 51.46
51-75 / 27.18
76-100 / 0.97
Median Value / 39.68
b Fatigue / 0-25 / 0.98
26-50 / 20.59
51-75 / 50.00
76-100 / 28.43
Median Value / 63.97
c Coordination disturbances / 0-25 / 37.86
26-50 / 51.46
51-75 / 9.71
76-100 / 0.97
Median Value / 30.95
d Hyposthenia / 0-25 / 7.84
26-50 / 50.98
51-75 / 35.29
76-100 / 5.88
Median Value / 47.30
e Equilibrium disturbances / 0-25 / 27.72
26-50 / 54.46
51-75 / 15.84
76-100 / 1.98
Median Value / 35.52
f Ambulation problems / 0-25 / 13.59
26-50 / 49.51
51-75 / 27.18
76-100 / 9.71
Median Value / 45.75
g Other symptoms / 0-25 / 20.93
26-50 / 48.84
51-75 / 27.91
76-100 / 2.33
Median Value / 45.75
7. Which of the following symptoms are most frequently mentioned by MS patients suffering from ambulation or impaired mobility?
a Lower limb weakness / 17.36
b Disturbances of sensitivity, e.g. numbness inthe lower limbs / 11.84
c Slow motion / 10.26
d Unable to walk long distances / 16.32
e Lack of equilibrium / coordination / 13.48
f Fatigue / 18.27
g Tendency to stumble, dragging feet / 11.79
i Other symptoms / 0.67
8. In your experience, after how many years do motricity problems become detectable?
a 0-5 years / 33.65
b 6-10 years / 51.92
c10-15 years / 12.50
d >15 years / 1.92
9. In your experience, after how many years do mobility problems become detectable?
a 0-5 years / 14.42
b 6-10 years / 37.50
c 10-15 years / 40.38
d >15 years / 7.69
10. Is the management of MS patients in your center the result of an integrated, multidisciplinary and multiprofessional approach? / Yes / 97.03
No / 2.97
11. How important do you consider motricity problems in MS patients on a scale from 0 (not important) to 9 (very important)? / 0-4 / 1%
5-9 / 99%
12. How important do you consider mobility problems in MS patients on a scale from 0 (not important) to 9 (very important)? / 0-4 / 1%
5-9 / 99%
13. How many months elapse in your institution between two evaluations of motricity and mobility in MS patients? / Weeks / Mean: 6.00
Months / Mean: 3.76
14. How often do you consider it appropriate to evaluate mobility in MS patients? / At each visit / 87.25
Depending on the patient / 11.76
Only at the first visit / 0.00
Other / 0.98
15. How often do you monitor the following symptoms in your clinical practice on a scale from 0 (never) to 9 (always)?
a Altered sensitivity / 0-4 / 4.9
5-9 / 95.1
b Loss visual acuity / 0-4 / 16.5
5-9 / 83.5
c Difficulty speaking / 0-4 / 16.0
5-9 / 84.0
d Equilibrium / coordination disturbances / 0-4 / 2.9
5-9 / 87.1
e Loss of muscular strength / 0-4 / 1.0
5-9 / 99.0
f Cognitive disturbances / 0-4 / 16.3
5-9 / 83.7
g Emotional disturbances / 0-4 / 16.8
5-9 / 83.2
h Sphincter disturbances / 0-4 / 7.7
5-9 / 92.3
i Mobility problems / 0-4 / 1.0
5-9 / 99.0
j Fatigue / 0-4 / 1.0
5-9 / 99.0
17. In your clinical practice do you use specific tests to evaluate ambulation in MS patients? / Yes / 91.91
No / 8.09
If yes, which of the following tests do you use?
a T25FW test
- Never
- Rarely
- Often
- Always
b 6MW test
- Never
- Rarely
- Often
- Always
c 2MW test
- Never
- Rarely
- Often
- Always
d EDSS / 3.77
- Never
- Rarely
- Often
- Always
e MSWS-12
- Never
- Rarely
- Often
- Always
f Others
- Never
- Rarely
- Often
- Always
If not, why?
- Space limitations
- Time limitations
- Others
18. Are you satisfied with the tests to evaluate ambulation in MS patients? Please indicate the degree of satisfaction on a scale from 0 (totally unsatisfied) to 9 (fully satisfied) / 0-4 / 36
5-9 / 64
19. It is estimated that the indirect costs and loss of productivity account for at least 2/3 of total annual spending for each MS patient. In your experience, do you agree with this estimate on a scale from 0 (totally disagree) to 9 (fully agree)? / 0-4 / 4.9
5-9 / 95.1
20. In your experience, from which EDSS range do the indirect costs increase significantly? / 0-4 / 0.00
4-6 / 70.30
> 6 / 29.70
21. In your experience, does an integrated therapeutic approach (pharmacological, rehabilitative, occupational, etc.) aimed at improving motricity and mobility, lead to direct and indirect cost savings? Please indicate your agreement with this statement on a scale from 0 (totally disagree) to 9 (fully agree) / 0-4 / 2.9
5-9 / 97.1
24. Considering all of your MS patients, for how many of these doesimpaired mobility represent a problem in their social life? / Median % values
a Every day / 32.5
b Several times / week / 20.0
c Once, twice / month / 15.0
d More rarely / 15.0
25. To what extent do you think that mobility problems impact on each of the following aspects of the patient’s life? Please use a scale from 0 (little impact) to 9 (great impact).
a Work / 0-4 / 0.0
5-9 / 100.0
b Social life / 0-4 / 1.0
5-9 / 99.0
c Family life / 0-4 / 9.6
5-9 / 90.4
26. To what extent does the data reported in the following reflect your personal experience? Please use a scale from 0 (not at all) to 9 (completely)
a 72% of the patients state that mobility problems impact heavily on working activities. / 0-4 / 2.9
5-9 / 97.1
b 64% have reported a significant reduction in income due to mobility problems / 0-4 / 3.8
5-9 / 96.2
c 45% declare having lost friends due to mobility problems / 0-4 / 13.3
5-9 / 86.7
27.1 How many of your MS patients with mobility / motricity problems do you treat with one of the following classes of drugs (sum can exceed 100)? / Median % values
a Symptomatic drugs / 55.00
b Rehabilitative therapy / 60.00
c Occupational therapy / 10.00
d Symptomatic drugs + rehabilitative therapy / 60.00
27.2 In your experience what is the approximate percentage of symptomatic drugcosts charged to patients? / Mean / 30.00
28. In your experience, indicate to what extent rehabilitative approaches contribute to the improvement of ambulation deficits. / Little / 8.65
Moderately / 40.38
Much / 50.96
29. In your experience, do you think that the use of aids and orthosis can improve the ambulatory performance of MS patients? / Little / 11.65
Moderately / 43.69
Much / 44.66
30. Which drugs do you use to treat mobility deficits? (if you use more than one drug, assign a score, with 1 being the most frequently used7 the least frequently used, and 0 the one that is not used). Values are % patients that most frequently use the indicated drug.
a Extended-release fampridine / 6.68
b 4-aminopiridine / 18.53
c Tizanidine / 17.83
d Baclofen / 29.63
e Botulinum toxin / 19.45
f Cannabinoids / 5.21
g Other drugs / 2.67
31. Which drugs do you use to treat ambulation deficits? (if you use more than one drug, assign a score, with 1 being the most frequently used, 7 the least frequently used, and 0 the one that is not used). Values are % frequency of use of each drug by the experts.
a Extended-release fampridine / 7.99
b 4-aminopiridine / 18.16
c Tizanidine / 17.24
d Baclofen / 29.01
e Botulinum toxin / 18.93
f Cannabinoids / 5.08
g Other drugs / 3.58
32. How satisfied are you with the drugs that are presently available for the treatment of ambulation deficits? Please use a scale from 0 (not at all satisfied) to 9 (fully satisfied). / 0-4 / 53.0
5-9 / 47.0
33. In your experience, please indicate to what extent treatment with extended-release fampridine is useful for improving ambulation in terms of efficacy, safety, and ease of use.
a Efficacy / Little / 14.93
Moderately / 68.66
Much / 16.42
b Safety / Little / 3.08
Moderately / 67.69
Much / 29.23
c Ease of use / Little / 6.15
Moderately / 58.46
Much / 35.38
34. In your experience, please indicate to what extent treatment with immediate-release fampridine is useful for improving ambulation in terms of efficacy, safety, and ease of use.
a Efficacy / Little / 32.81
Moderately / 60.94
Much / 6.25
b Safety / Little / 30.65
Moderately / 54.85
Much / 14.52
c Ease of use / Little / 40.32
Moderately / 43.55
Much / 16.13
35. In your experience, please indicate to what extent treatment with baclofen is useful for improving ambulation in terms of efficacy, safety, and ease of use.
a Efficacy / Little / 43.14
Moderately / 47.06
Much / 9.80
b Safety / Little / 6.93
Moderately / 62.38
Much / 30.69
c Ease of use / Little / 19.80
Moderately / 53.47
Much / 26.73
36. In your experience, please indicate to what extent treatment with botulinum toxin is useful for improving ambulation in terms of efficacy, safety, and ease of use.
a Efficacy / Little / 33.00
Moderately / 54.00
Much / 13.00
b Safety / Little / 8.16
Moderately / 69.39
Much / 22.45
c Ease of use / Little / 47.96
Moderately / 39.80
Much / 12.24
37. Which of the following properties do you consider to be most relevant for improving ambulation in MS patients? Please use a scale from 1, most important, to 5, least important. % values express the number of experts that have indicated each category as the most important property
a Rapid identification of responders. / 17.45
b Rapidity of onset of action. / 15.33
c Efficacy over time. / 25.92
d Good safety profile / 24.74
e Possibility of combination with DMTs. / 16.57
38. In your experience, for patients under pharmacological treatment to improve ambulation, which scale and/or parameter do you consider most useful for evaluating patient’s response?
a Standard neurological examination / 21.56
b T25FW test. / 25.88
c MSWS-12. / 14.49
d EDSS / 18.53
e Mechanistic evaluation of gait. / 19.96
f Others / 2.58
Table 2 Shortened version of Questionnaire 2. Answers are expressed as a percentage of all responses. Cut-off level to reach consensus: two-thirds (67%) of agreement of effective answers.
1. The time interval between two visits for the evaluation of motricity and mobility in the absence of complications, should be no more than / %1 month / 2.3
2 months / 2.3
3 months / 43.2
6 months / 52.3
Other / 0.0
2. Given that the EDSS scale derives from an interpolation of different components, do you deem appropriate evaluating each of the following components individually? Please use a scale from 0 (totally disagree) to 9 (fully agree).
2.a Alteration of sensitivity / 0-4 / 4.6
5-9 / 95.4
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 0.00
b. Evaluation of this variable is not considered of particular relevance / 66.67
c. Others / 33.33
2.b Mobility problems / 0-4 / 1.2
5-9 / 98.8
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 0.00
b. Evaluation of this variable is not important enough / 0.00
c. Others / 100.00
2.c Loss of muscular strength / 0-4 / 2.3
5-9 / 97.7
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 0.00
b. Evaluation of this variable is not important enough / 50.00
c. Others / 50.00
2.d Fatigue / 0-4 / 11.9
5-9 / 88.1
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 76.92
b. Evaluation of this variable is not important enough / 50.00
c. Others / 23.08
2.e Equilibrium / coordination disturbances / 0-4 / 3.4
5-9 / 96.6
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 0.00
b. Evaluation of this variable is not important enough / 50.00
c. Others / 50.00
2.f Sphincter disturbances / 0-4 / 4.6
5-9 / 95.4
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 33.33
b. Evaluation of this variable is not important enough / 33.33
c. Others / 33.33
2.g Decreased visual acuity / 0-4 / 5.7
5-9 / 94.3
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 75.00
b. Evaluation of this variable is not important enough / 00.00
c. Others / 25.00
2.h Cognitive disturbances / 0-4 / 9.3
5-9 / 90.7
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 57.14
b. Evaluation of this variable is not important enough / 00.00
c. Others / 52.86
2.i Psychic disturbances / 0-4 / 15.1
5-9 / 84.9
If not (answers 0-4), please indicate why
a. Instruments to evaluate this variable are not available / 66.67
b. Evaluation of this variable is not important enough / 8.33
c. Others / 25.00
4. In clinical practice, the EDSS scale is one of the most widely used. Which approach do you follow in the neurological evaluation with EDSS in current clinical practice?
1. Subjective approach, derived from patient considerations. / 1.2
2. Objective approach, derived from evaluation of functional systems. / 45.9
3. Both / 52.9
5. Since the EDSS scale is widely used for defining the MS patient status, would you deem it useful to have other tests to evaluate the following aspects more accurately? / % No/Yes
a. Alteration of sensitivity. / 83.6/16.4
b. Mobility problems. / 33.3/66.7
c. Loss of muscular strength. / 71.6/28.4
d. Fatigue. / 32.9/67.1
e. Equilibrium/coordination disturbances. / 77.8/22.8
f. Sphincter disturbances. / 45.3/54.7
g. Loss of visual acuity. / 52.6/47.4
h. Cognitive disturbances. / 19.5/80.5
i. Psychic disturbances / 42.1/57.9
6. Considering your clinical experience, please quantify your agreement with the following statement: the EDSS scale, which is based on the ambulation in the range from 4 to 7, has a reduced sensitivity in detecting significant clinical changes that are important for gait performance. Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 10.7
5-9 / 89.3
7. Considering your clinical experience, please quantify your agreement with the following statement: The increase in the T25FW value is more sensitive than EDSS in detecting worsening of gait performance. Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 5.9
5-9 / 94.1
8. Considering your clinical experience, please quantify your agreement with the following statement: T25FW is an objective scale that delivers a continuous, validated measure for the determination of gait performance in MS. Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 8.4
5-9 / 91.6
9. Considering your clinical experience, please quantify your agreement with the following statement: The MSWS12 subjective scale, which is correlated to T25FW and addresses elements that are not considered during the check up at the doctor’s office (e.g. climbing up or down the stairs), is sensitive to variations in ambulation conditions. Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 2.5
5-9 / 97.5
10. In order to evaluate gait performance in a patient, how do you quantify the usefulness of the MSWS12 subjective scale? Please use a scale from 0 (not useful) to 9 (very useful). / 0-4 / 2.5
5-9 / 97.5
11. Do you agree that a T25FW of more than 11 seconds correlates with a progressive reduction of working activity? Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 19.8
5-9 / 80.2
12. In order to start treating ambulation problems, scientific literature indicates a cut-off of 1 m/s based on the 10 m test. The T25FW test measures the speed of ambulation over 8 meters. Do you agree with the statement that a T25FW that detects a walking speed of 1 m/s can be used as a reference cut-off to start treating ambulation problems? Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 17.9
5-9 / 82.1
13. Do you agree that there is a correlation between T25FW and daily life activities? Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 9.6
5-9 / 90.4
14. In clinical practice, what is the T25FW walking speed value that signals that MS patients start facing negative consequences in their working activity (e.g. loss of a full-time job)?
a. <11 seconds / 3.90
b. 11-21 seconds / 50.25
c. >21 seconds / 42.86
15. Which is the model of assistance that you consider most appropriate for MS patients with mobility problems?
a. Formal assistance, to be paid / 1.8
b. Formal assistance, delivered by the National Health Service / 46.8
c. Domestic / 10.8
d. Domestic, integrated / 30.6
e. Family / 7.2
f. Informal, to be paid / 1.8
16. For how many patients did you prescribe one of the following drugs in 2012?
a. Extended-release fampridine
> 100 / 0.0
< 50 / 11.8
> 25 / 40.8
None / 47.4
b. 4-aminopiridine
> 100 / 4.0
< 50 / 32.0
> 25 / 42.7
c. Tizanidine
> 100 / 1.4
< 50 / 20.3
> 25 / 36.5
None / 41.9
d. Baclofen
> 100 / 35.0
< 50 / 30.0
> 25 / 32.5
None / 2.5
e. Botulinum toxin
> 100 / 1.3
< 50 / 23.4
> 25 / 61.0
None / 14.3
f. Cannabinoids
> 100 / 0.0
< 50 / 1.4
> 25 / 21.6
None / 77.0
g. Other drugs
> 100 / 13.0
< 50 / 17.4
> 25 / 21.7
None / 47.8
17. Do you agree that a pharmacological treatment that improves motor autonomy could reduce the cost of patient assistance? Please use a scale from 0 (totally disagree) to 9 (fully agree). / 0-4 / 3.6
5-9 / 96.4
18. Among the available drugs for the treatment of alterations of motricity / mobility / ambulation, which do you think is the most appropriate?
a. Extended-release fampridine / 40.5
b. 4-aminopiridine / 12.9
c. Tizanidine / 3.4
e. Baclofen / 25.9
f. Botulinum toxin / 12.1
g. Cannabinoids / 4.3
h. Other drugs / 0.9
19. For the treatment of alterations in motricity / mobility / ambulation, how often do you use the drug that you consider most appropriate? Please use a scale from 0 (never) to 9 (always). / 0-4 / 28.2
5-9 / 71.8
20. In the treatment of alterations of motricity / mobility / ambulation, what is the main reason that may lead to not always use the most appropriate drug?
a. Problems of tolerability / side effects. / 34.4
b. Problems of cost / lack of reimbursement / 58.3
c. Choice of the patient / 3.1
d. Other reasons / 4.2
1