Multiple Sclerosis and Related Disorders

Italian translation and validation of the ABILHAND-26 and its correlation with upper
limb objective and subjective measures in multiple sclerosis subjects
--Manuscript Draft--

Manuscript Number:

Article Type: Original Article

Keywords: Upper Limb; Patient Reported Outcome Measures; Multiple Sclerosis; correlations;
Italian translation

Corresponding Author: Davide Marengo, Ph.D.

University of Turin
Torino, ITALY

First Author: Erica Grange, OT, MSc

Order of Authors: Erica Grange, OT, MSc

Davide Marengo, PhD

Rachele Di Giovanni, OT, MSc

Margit Mueller, PT

Giampaolo Brichetto, MD

Andrea Tacchino, PhD

Rita Bertoni, PT, PhD

Francesco Patti, MD

Angelo Pappalardo, MD

Luca Prosperini, MD,PhD

Letizia Castelli, PT, PhD

Rosalba Rosato, PhD

Davide Cattaneo, PT, PhD

Claudio Solaro, MD

Abstract: BACKGROUND

Upper limb (UL) function is affected in about 50% of people with MS (PwMS). In the
last decade, Patient Reported Outcome Measures (PROM) are playing an important
role in clinical trial and practice. ABILIHAND-26 is a PROM that assess self-perceived
manual ability defined as the capacity to manage daily activities using the upper limbs.

The aim of the study is to translate the ABILHAND-26 into Italian, to explore its
psychometric properties examining the associations with demographics, clinical
variables, 9-Hole Peg Test (9-HPT) and Manual Ability Measures-36 (MAM-36).

MATERIALS and METHODS

Subjects were recruited in five Italian neurological centers. They were evaluated
through ABILHAND-26, 9-HPT and MAM-36. Confirmatory factor analysis and Rasch
analysis were adopted to investigate the psychometric properties of the ABILHAND-26.

RESULTS

Two hundred and forty-five patients were recruited. Rasch analyses showed adequate
functioning and supported the unidimensionality of the scale. ABILHAND-26 showed
negative correlations with age and disease duration, moderate negative correlation
with EDSS and the 9-HPT scores for both arms and strong positive associations (ρ ≥
.84) with the MAM-36. Difference in ABILHAND scores only emerged when comparing

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 patients with higher disability (EDSS ≥ 6) with both the other groups (p < .01)

CONCLUSION

The Italian version of the ABILHAND-26 in now available. It shows adequate reliability
of the score, good convergent validity, moderate criterion validity and strong
convergent validity. ABILHAND-26 could represent a valid assessment for self-
perceived ability to perform manual activity, especially for PwMS with moderate-to-high
level of disability.

Suggested Reviewers: Maria Grazia Grasso

mg.grasso@hsantalucia.it
Expert in the field

François Béthoux
bethouf@ccf.org
Expert in the field

Opposed Reviewers:

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Cover Letter

Moncrivello, 12th April 2021

I am pleased to submit the manuscript " Italian translation and validation of the ABILHAND-
26 and its correlation with upper limb objective and subjective measures in multiple sclerosis
subjects", co-authored by Grange Erica, Marengo Davide, Di Giovanni Rachele, Mueller Margit, Brichetto
Giampaolo, Tacchino Andrea, Bertoni Rita, Patti Francesco, Pappalardo Angelo, Prosperini Luca, Castelli
Letizia, Rosalba Rosato, Cattaneo Davide to be evaluated for publication in Multiple Sclerosis and
Related Disorders.

The aim of the study is to translate the ABILHAND-26 into Italian and to explore its psychometric
properties examining the associations with demographics, clinical variables, 9-Hole Peg Test and Manual
Ability Measures-36

Our results highlighted that ABILHAND-26 showed negative correlations with age and disease duration,
moderate negative correlation with disability level and manual dexterity for both arms and strong positive
associations with another Upper Limb Patient Reported Outcome Measure. Difference in ABILHAND
scores only emerged when comparing patients with higher disability (EDSS ≥ 6) with both the other groups.
The Italian version of the ABILHAND-26 in now available. It shows adequate reliability of the score, good
convergent validity, moderate criterion validity and strong convergent validity.
ABILHAND-26 could represent a valid assessment for self-perceived ability to perform manual activity,
especially for PwMS with moderate-to-high level of disability

I hope that you will find our manuscript interesting and suitable for publication in the Journal.

All authors have read and approved the submitted manuscript and believe that the manuscript represents
honest work. The manuscript has not been published elsewhere in whole or in part. All authors have no
conflict of interest.

Looking forward to hearing from you

Best regards.
Manuscript Click here to view linked References

Italian translation and validation of the ABILHAND-26 and its correlation with upper limb objective and
1 subjective measures in multiple sclerosis subjects
2
1
3 Grange Erica, 2 Marengo Davide, 1 Di Giovanni Rachele, 3 Mueller Margit, 3,4 Brichetto Giampaolo, 3 Tacchino Andrea,
4
5
5 Bertoni Rita, 6 Patti Francesco, 7 Pappalardo Angelo, 8Prosperini Luca, 9Castelli Letizia, 2 Rosalba Rosato, 4, 10
Cattaneo
6
7 Davide, 1 Solaro Claudio
8
9
10
11
12
1.CRRF “Mons. Luigi Novarese”, Moncrivello (VC);
13
14
15 2.Department of Psychology, University of Turin.
16
17 3.Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genova;
18
19 4. Rehabilitation Centre, Italian Multiple Sclerosis Society
20
21 5. IRCSS Fondazione Don Carlo Gnocchi, Milan, Italy
22
23
24 6.MS Center Institute of Neurological Sciences - University of Catania;
25
26 7. Centro Disabilità Cronica Neurologica, Presidio Ambulatoriale, Azienda Sanitaria Provinciale Catania, Catania
27
28 8. S. Camillo-Forlanini Hospital, Rome, Italy; and Psychiatry, Sapienza University, Rome;
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30 9. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome
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32
10. Department of Physiopathology and Transplants, University of Milan, Milan, Italy
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34
35
36
37 Grange Erica and Marengo Davide contributed equally to the manuscript.
38
39 Corresponding author:
40
41 Marengo Davide
42 Department of Psychology, University of Turin, Turin, Italy
43
44 ph: 0116702793
45 mail: davide.marengo@unito.it
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47
48
49 ORCID
50
51 Grange Erica: 0000-0001-5114-9276
52 Marengo Davide: 0000-0002-7107-0810
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54 Di Giovanni Rachele: 0000-0003-4723-9302
55
56 Mueller Margit
57
Brichetto Giampaolo: 0000-0003-2026-3572
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59 Tacchino Andrea: 0000-0002-2263-7315
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61 Bertoni Rita: 0000-0001-9533-5716
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 Patti Francesco: 0000-0002-6923-0846
1 Pappalardo Angelo: 0000-0002-0710-5492
2
3 Prosperini Luca: 0000-0003-3237-6267
4
5 Castelli Letizia: 0000-0001-9455-3789
6
7 Rosalba Rosato: 0000-0002-4921-374X
8 Cattaneo Davide: 0000-0003-4251-1856
9
10 Solaro Claudio: 0000-0002-6713-4623
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12
13
ACKNOWLEDGMENTS
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15 The authors would thank Italian Multiple Sclerosis Foundation (FISM) to support the study
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 1 ABSTRACT
1
22 BACKGROUND
3
43 Upper limb (UL) function is affected in about 50% of people with MS (PwMS). In the last decade, Patient Reported
5
64 Outcome Measures (PROM) are playing an important role in clinical trial and practice. ABILIHAND-26 is a PROM
7
85 that assess self-perceived manual ability defined as the capacity to manage daily activities using the upper limbs.
9
10 6 The aim of the study is to translate the ABILHAND-26 into Italian, to explore its psychometric properties examining
11
12 7 the associations with demographics, clinical variables, 9-Hole Peg Test (9-HPT) and Manual Ability Measures-36 (
13
14 8 MAM-36).
15
16 9 MATERIALS and METHODS
17
1810 Subjects were recruited in five Italian neurological centers. They were evaluated through ABILHAND-26, 9-HPT and
19
2011 MAM-36. Confirmatory factor analysis and Rasch analysis were adopted to investigate the psychometric properties of
21
2212 the ABILHAND-26.
23
2413 RESULTS
25
2614 Two hundred and forty-five patients were recruited. Rasch analyses showed adequate functioning and supported the
27
2815 unidimensionality of the scale. ABILHAND-26 showed negative correlations with age and disease duration, moderate
29
3016 negative correlation with EDSS and the 9-HPT scores for both arms and strong positive associations (ρ ≥ .84) with the
31
3217 MAM-36. Difference in ABILHAND scores only emerged when comparing patients with higher disability (EDSS ≥ 6)
33
3418 with both the other groups (p < .01)
35
3619 CONCLUSION
37
3820 The Italian version of the ABILHAND-26 in now available. It shows adequate reliability of the score, good convergent
39
4021 validity, moderate criterion validity and strong convergent validity. ABILHAND-26 could represent a valid assessment
41
4222 for self-perceived ability to perform manual activity, especially for PwMS with moderate-to-high level of disability.
43
4423
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4624
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48
25 KEYWORDS
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50
26 Upper Limb, Patient Reported Outcome Measures, Multiple Sclerosis, correlations, Italian translation
51
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 1 1. Background
1
22 Multiple Sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system that can lead
3
43 to a wide range of neurological symptoms, characterized by chronic disease progression. [1] Upper limb (UL)
5
64 dysfunction has often been considered less debilitating than lower limb impairment; however, it is associated with a loss
7
85 of independence in activities of daily living, reduced quality of life and participation restrictions. [2-4]
9
10 6 As result of a revision on clinical tools to measure objective UL function in MS, the Nine Hole Peg Test (9-HPT) has
11
12 7 been considered the gold standard for UL assessment [3] and one of the best proxies for measuring UL capacity in
13
14 8 MS;[3] however, it does not assess subjects’ perceived ability in performing manual activity of daily living (ADL) and
15
16 9 it is not known the correlation with the level of independence [5].
17
1810 In the last decade, Patient Reported Outcome Measures (PROMs) have been introduced in clinical practice and
19
2011 scientific trials [6]to overcome this issue. A recent review reported [3] as the most used PROMs for UL perceived
21
2212 function in MS are the Manual Ability Measure-36 [7] (MAM-36), the ABILHAND [8] and the Disability of Arm,
23
2413 Shoulder and Hand (DASH) [9]. In addition, a new specific PRO for measuring arm function in MS, the Arm Function
25
2614 in Multiple Sclerosis Questionnaire (AMSQ) was developed [10].
27
2815 The Italian translation and validation of the MAM-36 [7] and AMSQ [11] in people with MS (PwMS) has been
29
3016 published in the last year, while the Italian version of the ABILHAND is not available yet.
31
3217 The ABILIHAND was proposed by Penta et al [12] to evaluate self-perceived manual ability defined as the capacity to
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3418 manage daily activities using the upper limbs, regardless of the strategies involved, in rheumatoid arthritis subjects with
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3619 wrist arthrodesis. They selected 46 items related to UL function from an original core set of 54 items, including both
37
3820 bimanual and unimanual activities. Later, a 23-item ABILHAND version [13] was proposed in stroke survivors,
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4021 including only bimanual activities due to the unilateral nature of the deficit while, a 26-items version of ABILHAND
41
4222 [14] was developed for subjects with systemic sclerosis, a disease with bilateral UL involvement. Having in mind the
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4423 bilateral asymmetric UL dysfunction in MS, we implemented the ABILHAND-26, which includes both bimanual and
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4624 unimanual activities, in a large sample of PwMS.
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4825 The aim of the study was to translate the ABILHAND-26 into Italian, to explore the psychometric properties in a large
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26 sample of PwMS and to investigate construct validity by examining its’ association with demographics, clinical, UL
51
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27 PROM (MAM-36) and UL objective measure (9-HPT).
53
54
55
5628 2. Materials and Methods
57
5829 2.1 Translation and adaptation of the ABILHAND-26
59
6030 The ABILHAND-26 includes 26 items assessing the difficulty a person may experience in performing
61
6231 unimanual and bimanual ADLs unrespecting of the arm used and independent of the adaptive strategies adopted.
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64
65
 1 The first step consisted in a foreword-backward translation procedure of the ABILHAND-26. Initially, the
1
22 questionnaire was translated from English to Italian by a professional translator aware of the concepts of the scale then,
3
43 a panel of expert evaluated the translated version in order to ensure semantic equivalence and acceptability. A list of
5
64 possible alternatives for the controversial items stems and response choices was developed and translated into Italian
7
85 from the original version. Finally, the panel determined the definitive translated version. The questionnaire was fulfilled
9
10 6 by 5 MS subjects followed by a second experts meeting and then back translated from Italian into English to compare
11
12 7 this version with the original one.
13
14 8 2.2 Subjects
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16 9 Participants were a consecutive sample of subjects followed at five MS outpatient clinics: “Department of
17
1810 Rehabilitation, Mons. Luigi Novarese Hospital” of Moncrivello; “Department of Neurology, University of Catania”;
19
2011 “Don Gnocchi Foundation” of Milan, “Rehabilitation Service of Liguria of the Italian Multiple Sclerosis Society
21
2212 (AISM)” of Genoa; and “Sant’Andrea Hospital” of Rome. The ethical committee of each participating centre allowed
23
2413 the ethical approval for this study (P.R.196REG2015). Signed informed consent was obtained from each subject prior to
25
2614 enrolment in the study according to the Declaration of Helsinki.
27
2815 Inclusion criteria were a minimum age of 18, diagnosis of MS according to McDonald revised criteria [15], stable
29
3016 disease course without worsening more than 1 EDSS [16] point over the last 3 months, relapse free at the time of
31
3217 enrolment, completed ABILHAND-26 and capable of understanding and providing signed informed consent. Exclusion
33
3418 criteria were presence of bilateral plegia, orthopaedic or neurological diseases other than MS. For each subject, we
35
3619 collected demographic (age, gender) and clinical characteristics (EDSS, and disease course and duration) along with the
37
3820 9-HPT, MAM-36 and ABILHAND-26 scores.
39
4021 2.3 Assessment
41
4222 Nine Hole Peg Test (9-HPT) [17]: is a quantitative test to assess fine manual dexterity. It consists in picking up
43
4423 9 pegs one at a time as quickly as possible, puts them in the nine holes, and removes them again as quickly as possible
45
4624 one at a time. Two consecutive trials with the dominant hand are followed by two consecutive trials with the non-
47
4825 dominant hand. For the purpose of the present study, the time taken to complete each trial was recorded, with a
49
50
26 maximum time of 180 seconds, and for each arm the average time of the trials represents the final score.
51
52
27 ABILHAND-26 [14]: includes 26 items assessing the difficulty a patient may experience in performing unimanual and
53
54
55
28 bimanual ADLs unrespecting of the arm used and independent of the adaptive strategies adopted. Items are rated on a 3-
56
5729 level scale, where 0= impossible, 1=difficult, 2= easy. A fourth response is possible for activities not usually performed,
58
5930 with or without hand impairment, which is scored 0. A total score can be computed by taking the sum of responses to
60
6131 the items
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 1 Manual Ability Measure-36 (MAM-36) [7]: consists of 36 items investigating subjects’s perceived ability in performing
1
22 common tasks (e.g. eating, dressing, buttoning clothes) using one’s hands, excluding the use of adaptive equipment.
3
43 Each item is rated on a 4-point scale ranging from 1 (cannot do it) to 4 (easy). Tasks that are almost never performed,
5
64 with or without hand impairment, are scored 0. For the purpose of the present study, instead of using the raw score, the
7
85 MAM-36 was scored by calibrating the Rasch rating-scale model anchoring the item and structure parameters as
9
10 6 reported in the Italian version validation study of the MAM-36 in a large MS population. [7].
11
12 7 2.4 Strategy of Analyses
13
14 8 First, we computed descriptive statistics for the study measures. Next, we investigate the psychometric
15
16 9 properties of the ABILHAND-26 scale following a two-step approach, including both confirmatory factor analysis
17
1810 (CFA) and Rasch analysis. More specifically, in order to test the unidimensionality of the scale, we implemented a one-
19
2011 factor CFA model using the weighted least squares estimator. We evaluated model fit using the comparative fit (CFI),
21
2212 the Tucker-Lewis (TLI), and the root mean square error of approximation (RMSEA) indexes. We considered values of
23
2413 CFI > 0.95, TLI > 0.95, and RMSEA < 0.05 as indication of good model fit, while CFI and TLI > 0.90, and RMSEA <
25
2614 0.08, as indication of acceptable fit [18]. Significant standardized item loadings > 0.70 were considered indicating good
27
2815 convergent validity, while value equal or below 0.70, but exceeding 0.50 were considered acceptable [18]. Values of
29
3016 Average variance extracted (AVE) ≥ 0.50 and omega (𝜔) composite reliability coefficient ≥ 0.70 were considered
31
3217 further evidences of convergent validity of the item set [19-21]. CFA analyses were performed using MPLUS version 8.
33
3418 Next, we implemented the Rasch rating scale model [22] to examine the functioning of the ABILHAND-26 scale.
35
3619 Adequate functioning of the 4-point rating scale was established if results met the following criteria: 1) a minimum of
37
3820 ten responses in each rating category, 2) rating category measures increasing monotonically, and 3) Outfit mean square
39
4021 values for each rating category sitting below 2.0 [23]. Adequate item fit was determined by Infit and Outfit mean square
41
4222 values sitting in a range of 0.6 to 1.4 [24], while items showing values sitting beyond this range but not exceeding 2.0
43
4423 were considered unproductive for measurement, but not degrading [25]. Reliability of person scores was determined
45
46
24 using the Rasch reliability index, assuming values ≥ 0.90 as appropriate for clinical applications [26]. Additionally, we
47
48
25 computed the person separation index and used it to determine the number of statistically distinguishable ability groups
49
50
26 (i.e., person strata [27]). The dimensionality of the scale was examined by performing a Principal Component Analysis
51
52
27 (PCA) on Rasch residuals. Unidimensionality was established if Rasch measures explained ≥ 40% variance of the data,
53
54
5528 and the first contrast had an eigenvalue lower than or equal to 2.0 and accounted for both less than 5% total variance,
56
5729 and less than 10% of unexplained variance [28,29]. Rasch analyses were performed using Winsteps 3.68.2
58
5930 We also examined ceiling and floor effects of the ABILHAND-26 score, which we considered significant if we found
60
6131 more than 15% of patients reporting either minimum or maximum extreme scores. Next, criterion validity of the Rasch
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 1 and raw score for the ABILHAND-26 was investigated by examining its association with patients’ demographic and
1
22 clinical variables, and 9-HPT scores for both arms. The association of the scores with age, disease duration, EDSS, 9-
3
43 HPT, and MAM-36 scores was examined using Spearman’s rank correlation coefficient. Gender differences on the
5
64 scores were examined using Mann–Whitney U test.
7
85 In order to further investigate the discriminative ability of the ABILHAND-26 in distinguishing patients by level of
9
10 6 disability, we group participants into three groups according to their EDSS score (Mild Disability: EDSS ≤ 3; Moderate:
11
12 7 3.5 ≤ EDSS ≤ 5.5; Severe: EDSS ≥ 6) and use the Kruskal-Wallis test (with Dunn’s post-hoc test) to investigate
13
14 8 between-group differences in the distribution of the scale. We also provide a visualization of the distribution of both the
15
16 9 raw and Rasch scores in the different EDSS groups. Similarly, association between ABILHAND-26 Rasch and raw
17
1810 scores and disease course was also examined using Kruskal-Wallis test (with Dunn’s post-hoc test). Convergent validity
19
2011 was assessed by examining association with an alternative PROM of upper limb functionality in daily activities, the
21
2212 MAM-36. Except where indicated, analyses were performed in SPSS, version 23.
23
2413 3. Results
25
2614 Two hundred and forty-five subjects were recruited. Descriptive statistics for subjects’ demographic and
27
2815 clinical characteristics are reported in Table 1.
29
3016 Table 1 Descriptive statistics for recruited subjects
31
3217 3.1 Psychometric properties of the ABILHAND-26
33
3418 Results of the investigation of the psychometric properties of the ABILHAND-26 are reported in Table 2-3. As
35
3619 regards CFA analyses, results showed the one-factor model had acceptable model fit based on recommended thresholds
37
3820 (CFI = 0.98, TLI = 0.98, RMSEA = 0.04). Standardized loadings were ≥ 0.74 (see Table 3), resulting in an AVE of
39
4021 0.69, and excellent composite reliability (𝜔 = 0.98).
41
4222 Based on Rasch analyses, the ABILHAND-26 rating scale met all the criteria for adequate functioning, as 1) responses
43
4423 were greater than 10 for each category, 2) Rasch step measures increased monotonically, and 3) Infit and Outfit mean-
45
46
24 square statistics were within suggested thresholds (Table 2). Figure 1 provides a visualization of the category
47
48
25 probability curves as estimated in our sample. Item difficulty and fit statistics are reported in Table 3. Item difficulty
49
50
26 ranged from -1.70 to 2.80; Item 1 (“Threading a needle”) was the most difficult item, while item 10 (“Turning off a
51
52
27 tap”) was the easiest. In our sample, the distribution of person ability ranged from −2.93 to 5.26 logit, with a mean of
53
54
5528 3.32 logit (SD = 2.32) standing about 3 logit above the mean item difficulty (Mean = 0.00 logit, SD = 1.12), meaning
56
5729 that most of the activity described in the items were perceived by patients to be easy. Figure 2 provides a visualization
58
5930 of the distribution of person ability relative to the items’ location on the logit continuum. Rasch person separation
60
6131 reliability was 0.81, indicating good but not excellent reliability. Person separation index was 2.03, resulting in a person
62
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64
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 1 strata value of 3.04, which indicate approximately three distinct ability groups can be identified using the ABILHAND-
1
22 26.
3
43 As regards item functioning, four items showed Outfit mean-square values sitting below the lower limit (Item 3:
5
64 “Cutting meat”; Item 4: “Handling scissors”, Item 26: “Butting up trousers”) for productive measurement. Because Infit
7
85 and Outfit statistics for all the items did not exceed the 2.0 threshold, we decided not to drop any item from the scale.
9
10 6 Results of the PCA performed on Rasch residuals indicated the Rasch dimensions explained 52.9% of the variance in
11
12 7 the data. The eigenvalue for the first contract was 2.1, thus revealing a minor disturbance in unidimensionality due to a
13
14 8 secondary dimension in the data with roughly the strength of two items. However, because the first contrast accounted
15
16 9 for only 3.9% and 8.2% respectively of the total and unexplained variance, which are both below suggested criteria,
17
1810 indicating no substantial violation of scale unidimensionality.
19
2011 Table 2 ABILHAND-26 response categories: number of responses, estimated Rasch measure, and fit statistics
21
2212 Table 3 ABILHAND-26: One-factor CFA loadings, Rasch difficulty parameters and fit statistics
23
2413 Figure 1 Rating scale functioning: Category probability curves for the ABILHAND-26
25
2614 Figure 2 Distribution of person ability relative to item difficulty for the ABILHAND-26
27
2815 3.2 Distribution of the ABILHAND-26 SCORE
29
3016 In our sample, the ABILHAND-26 raw score scale had a mean value of 42.36 (SD = 10.47; Skewness = -1.56),
31
3217 a median value of 46, with an observed range of 0-52. We found indication of significant ceiling effect (but no floor
33
3418 effect), as more than 15% of the patients (17.1% of patients, N=42) had the highest possible score on the scale. As for
35
3619 the Rasch score for the ABILHAND-26, in our sample we had a mean value of 3.32 logit (SD = 2.32), with a median
37
3820 value of 3.09, and ranging -6.27 to 6.55.
39
4021 3.3 Criterion and convergent validity of the ABILHAND-26
41
4222 Results of correlations are shown in Table 4. Overall, both the Rasch and raw scores for the ABILHAND-26
43
4423 showed a similar pattern of associations. Both scores showed small negative correlations with age and disease duration,
45
4624 and moderate negative correlation with EDSS and the 9-HPT scores for both arms. Both the Rasch and raw scores for
47
4825 the ABILHAND-26 showed strong positive associations (ρ ≥ .84) with the MAM-36 total score, indicating good
49
50
26 convergent validity. There was no significant association between the ABILHAND-26 scores and gender (Rasch score:
51
52
27 U = 7321.5, p = .36; Raw score: U = 6768.5, p = .90).
53
54
55
28 A visualization of the distribution of both raw and Rasch scores by EDSS level and disease course is provided in Figure
56
5729 3. When we grouped participants according to their disability level, results indicated significant between-group
58
5930 differences existed in ABILHAND-26 raw scores (EDSS ≤ 3: M = 46.48; 3.5 ≤ EDSS ≤ 5.5: M = 46.49; EDSS ≥ 6:
60
6131 36.78; KW [2] = 53.48, p < .001 ), and Rasch scores (EDSS ≤ 3: M = 4.39; 3.5 ≤ EDSS ≤ 5.5: M = 4.07; EDSS ≥ 6:
62
63
64
65
 1 2.05; KW [2] = 55.22, p < .001 ). For both the Rasch and raw scores, post-hoc analyses showed, significant pairwise
1
22 difference only emerged when comparing patients with higher disability (EDSS ≥ 6) with both the other groups (p <
3
43 .01). Results also indicated significant differences existed in ABILHAND-26 Rasch scores between patients with
5
64 different disease course (Relapsing-remitting: M=3.76; Secondary progressive: M=2.82; Primary progressive: M=3.09,
7
85 KW [2] = 16.410, p < .001); a similar effect was found on ABILHAND-26 raw scores (Relapsing-remitting: M=44.45;
9
10 6 Secondary progressive: M=37.73; Primary progressive: M=40.87, KW [2] = 17.673, p < .001). For both the Rasch and
11
12 7 raw scores, post-hoc analyses showed that only Relapsing-remitting and secondary progressive PwMS were statistically
13
14 8 different (p < .01).
15
16 9 Table 4 Correlation between ABILHAND-26 Rasch and raw scores and study measures
17
1810 Figure 3 Frequency distribution of ABILHAND-26 raw and Rasch scores by EDSS level and disease course
19
2011 Discussion
21
2212 The present study aims to provide evidences about the psychometric properties of a 26 items version of the
23
2413 ABILHAND [14] in a sample of PwMS. Using a combination of CFA and Rasch analyses, we investigated the
25
2614 functioning of the questionnaires’ rating scale and items, as well its compliance to the requirement of
27
2815 unidimensionality. Ceiling and floor effects, reliability and targeting to our sample of PwMS were also explored.
29
3016 Finally, we examined construct validity of the ABILHAND-26 scores by inspecting their association with demographic
31
3217 and clinical criteria, as well as patients’ performance on the 9-HPT [17], and another PROM of UL functionality in
33
3418 ADL, the MAM-36 [7].Overall, results of CFA and Rasch analyses both supported the unidimensionality of the scale
35
3619 and adequate reliability of the score meaning that the scale measures a single ability, i.e. the self-perceived manual
37
3820 ability that can be represented by a single scale total score and that the scale have a good internal consistency.
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4021 Additionally, Rasch analyses did not reveal significant malfunctioning of the item set, and of items’ response categories
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4222 (Figure 1) confirming that the categories (Impossible, Difficult, and Easy) have three decreasing level of difficulty.
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4423 The scale showed a significant ceiling effect, meaning the lacking of ability to stratify subjects with low disability,
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4624 while the scale seems more suitable to score subjects with high level of disability, and those with progressive disease
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4825 courses. Note that indications of problematic targeting emerged also for MAM36, suggesting the assessment of upper
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26 limb perceived manual ability is challenging in early diagnose subjects with MS and that scores should be used with
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27 caution to measure manual ability pre and post upper limb interventions. Future studies are warranted to develop tools
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28 better covering the whole spectrum of manual disability in MS.
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5729 As a final step, we explored the construct validity of the ABILHAND-26. Both the Rasch and raw scores showed
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5930 moderate criterion validity with respect of EDSS score and 9-HPT scores for both arms and, not surprising, a strong
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6131 convergent validity with the MAM-36 score.
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 1 Due to the high correlation found between MAM-36 and ABILHAND-26, the moderate association reported between
1
22 ABILHAND-26 and 9-HPT is not surprising. In fact, our result confirms a similar correlation between the same
3
43 objective measure (9-HPT) and another UL PROM (MAM-36) reported in previous study [7]. Moreover, the
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64 correlation found between the two UL PROMs can also support that both ABILHAND-23 and MAM-36 [7] are more
7
85 suitable to assess subjects with high level of disability.
9
10 6 A recent study reporting the correlation between MAM-36 and the 23-item version of ABILHAND, showed a slightly
11
12 7 smaller correlation compared to our findings, probably owing to the smaller sample size and higher disability level and
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14 8 older age of the sample included in this study [30].
15
16 9 The different correlation found between MAM-36 and the two versions of ABILHAND can be also explained by the
17
1810 dissimilar nature of the item contained. Indeed, ABILHAND-23 was developed for stroke survivors, starting from a 56
19
2011 item set of both unimanual and bimanual activities, through a Rasch model which retained only bimanual items on the
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2212 basis of the response functioning. In contrast, in the present study, the Rasch model confirms the functioning of
23
2413 ABILHAND-26 item set, highlighting the importance of evaluating both unimanual and bimanual activities when
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2614 assessing self-perceived UL function in PwMS.
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2815 Overall, our findings indicate that the Italian version of the ABILHAND-26 provides a reliable and valid assessment of
29
3016 the self-perceived impact of upper limb impairment in performing ADL, in particular in PwMS with a moderate-to-high
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3217 level of disability.
33
3418
35
3619 DECLARATION
37
3820 Funding Grant FISM R20/2014
39
4021 Conflicts of interest/Competing interests Authors declare no conflicts of interest
4122 Availability of data and material The data that support the findings of this study are available on request from the
42
4323 corresponding author. The data are not publicly available due to privacy or ethical restrictions.
44
4524 Authors' contributions
4625 Conceptualization: Claudio Solaro, Giampaolo Brichetto, Luca Prosperini, Davide Cattaneo
4726 Methodology: Claudio Solaro, Erica Grange, Andrea Tacchino, Rosalba Rosato
4827 Formal analysis: Davide Marengo
4928 Investigation: Rachele Di Giovanni, Erica Grange, Margit Mueller, Rita Bertoni, Letizia Castelli
50
29 Writing - original draft preparation: Claudio Solaro, Rachele Di Giovanni, Erica Grange, Davide Marengo, Davide
51
5230 Cattaneo
5331 Writing - review and editing: Giampaolo Brichetto, Andrea Tacchino, Francesco Patti, Angelo Pappalardo, Luca
5432 Prosperini, Rosalba Rosato
5533 Funding acquisition: Claudio Solaro
5634 Supervision: Claudio Solaro, Francesco Patti, Angelo Pappalardo, Luca Prosperini, Davide Cattaneo
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58
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35 Ethics approval The ethical committee of each participating centre allowed the ethical approval for this study
6036 (P.R.196REG2015)
6137
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2315 26. Bland JM, Altman DG. Cronbach's alpha. BMJ. 1997 Feb 22;314(7080):572.
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2516 27. Fisher WJ. Reliability, separation, strata statistics. Rasch Meas Trans. 1992; 6:328.
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2717 28. Linacre, JM. Data variance explained by Rasch measures. Rasch Measurement Transactions. 2006; 20(1),
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19 29. Smith EV Jr. Detecting and evaluating the impact of multidimensionality using item fit statistics and principal
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3220 component analysis of residuals. J Appl Meas. 2002; 3(2):205-31.
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3421 30. Prada V, Tacchino A, Podda J, Pedullá L, Konrad G, Battaglia MA, Brichetto G, Monti Bragadin M. Mam36
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 Table 1. Descriptive statistics for recruited subjects.
1
2
Subjects characteristics
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5 Number of subjects 245
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7 Gender (Female) N = 159 (64.9%)
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9 Age years, mean (SD); median (range) 48.95 (14.51); 49 (17 -85)
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11 MS subtype
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13 Relapsing remitting N = 154 (62.9%)
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15 Primary progressive N = 32 (24.1%)
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17 Secondary progressive N = 59 (13.1%)
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19 Disease duration (years), mean (SD); median (range) 14.02 (10.87); 11 (0 - 59)
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21 EDSS, mean (SD); median (range) 4.41 (2.12); 5 (0 – 8.00)
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23 EDSS ≥ 3 N = 84 (34.3%)
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25 3.5 ≤ EDSS ≤ 5.5 N = 57 (23.2%)
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27 EDSS ≥ 6 N = 104 (42.5%)
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29 ABILHAND-26 Raw score, mean (SD); median (range) 42.36 (10.47); 46 (0 – 52)
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31 MAM-36 Total score, mean (SD); median (range) 125.95 (19.07); 131 (39 – 144)
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33 MAM-36 Rasch score, mean (SD); median (range) 3.17 (2.20); 2.75 (-2.04 – 6.65)
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35 9-HPT seconds (Right), mean (SD); median (range) 30.99 (23.88); 24 (11.00 – 180.00)
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37 9-HPT seconds (Left), mean (SD); median (range) 35.23 (30.34); 25.06 (12.00 – 180.00)
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39 Note. Sample size for 9-HPT scores is N = 243.
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 Table 2. ABILHAND-26 response categories: number of responses, estimated Rasch measure, and fit statistics
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Response category Step Measure SE Number of respones Infit Oufit
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5 0 Impossible* - 328 1.07 1.27
6
7 1 Difficult -1.36 0.08 1243 0.95 0.84
8
9 2 Easy 1.36 0.04 3272 1.05 1.05
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11 * Reference category
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26 Figure 1. Rating scale functioning: Category probability curves for the ABILHAND-26
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 Table 3. ABILHAND-26: One-factor CFA loadings, Rasch difficulty parameters and fit statistics
1
2 One-factor CFA Rasch model
3 b
Order Item Loading SE Difficulty SE Infit Outfit
4
5 1 Threading a needle 0.79 0.03 2.80 0.14 1.00 0.98
6 Passare il filo in un ago
7 9 Wiping windows 0.76 0.04 2.54 0.14 1.26 1.20
8
9 Pulire le finestre
10 25 Shelling hazel nuts 0.9 0.02 1.51 0.15 0.77 0.75
11 Aprire una nocciola
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13 7 Cutting one's nails 0.86 0.03 1.06 0.15 1.04 0.87
14 Tagliarsi le unghie
15 17 Opening a screw-topped jar 0.79 0.04 0.93 0.15 1.01 0.96
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17 Aprire un vasetto
18 16 Peeling potatoes with a knife 0.91 0.02 0.78 0.15 0.84 0.67
19 Pelare le patate con un coltello
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5 Taking the cap off a bottle 0.77 0.04 0.59 0.16 1.18 1.17
21
22 Togliere il tappo ad una bottiglia
23 2 Putting on a piece of jewelry 0.84 0.04 0.56 0.16 1.07 1.16
24
Indossare un gioiello
25
26 11 Lacing shoes 0.83 0.03 0.44 0.16 1.05 1.06
27 Allacciarsi le scarpe
28 14 Peeling onions 0.89 0.03 0.22 0.17 0.98 0.76
29
30 Pelare le cipolle
31 3 Cutting meat 0.91 0.02 0.02 0.17 0.73 0.59
32 Tagliare la carne
33
34 26 Buttoning up trousers 0.92 0.02 0.02 0.17 0.69 0.51
35 Abbottonare i pantaloni
36 12 Handling a stapler 0.85 0.04 -0.15 0.19 1.26 0.96
37
38 Usare una cucitrice
39 22 Tearing open a package of chips 0.82 0.03 -0.24 0.18 0.96 0.88
40 Aprire un sacchetto di patatine
41
18 Fastening the zipper of a jacket 0.81 0.04 -0.33 0.18 1.03 0.88
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43 Chiudere la cerniera di un giubbotto
44 4 Handling scissors 0.93 0.02 -0.41 0.19 0.75 0.57
45 Usare le forbici
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47 24 Fastening a snap-fastener (e.g., bag, jacket) 0.84 0.03 -0.49 0.19 0.90 0.87
48 Chiudere un bottone automatico (es. camicia, borsa)
49 6 Taking a coin out of a pocket 0.77 0.05 -0.75 0.20 1.12 1.29
50
51 Prendere una moneta da una tasca
52 20 Spreading butter on a slice of bread 0.89 0.03 -0.78 0.20 0.77 0.69
53 Spalmare del burro su una fetta di pane
54
55 15 Winding up a wristwatch 0.78 0.04 -0.80 0.20 1.18 1.04
56 Mettersi un orologio
57 23 Brushing one's hair 0.77 0.05 -0.93 0.21 1.15 1.18
58
Spazzolarsi i capelli
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60 13 Opening mail 0.80 0.04 -1.00 0.21 1.02 1.19
61 Aprire la posta
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 21 Putting cream on one's body 0.82 0.05 -1.14 0.22 1.28 0.81
1 Spalmare una crema per il corpo
2
8 Unwrapping a chocolate bar 0.79 0.05 -1.16 0.22 1.18 1.14
3
4 Scartare una tavoletta di cioccolato
5 19 Cleaning vegetables 0.81 0.06 -1.59 0.25 1.06 1.19
6 Lavare le verdure
7
8 10 Turning off a tap 0.74 0.06 -1.70 0.24 1.35 1.22
9 Chiudere un rubinetto
10 Note. a Standardized loadings are reported. b Items are reported in decreasing difficulty order.
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40 Figure 2. Distribution of person ability relative to item difficulty for the ABILHAND-26
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 Table 4. Correlation between ABILHAND-26 Rasch and raw scores and study measures
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3
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ABILHAND-26
5
6 Rasch score Raw score
7 Age -.166** -.165**
**
8 Disease duration -.242 -.237**
**
9 EDSS -.500 -.495**
**
10 9-HPT (Right) -.395 -.411**
**
11 9-HPT (Left) -.376 -.412**
**
12 MAM-36 Rasch score .847 .836**
13 Note. ** p<.01. Sample size for 9-HPT scores is N = 243.
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 Figure 3. Frequency distribution of ABILHAND-26 raw and Rasch scores by EDSS level and disease course
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Conflict of Interest/ Role of Funding Source

Declaration of interests

☒ The authors declare that they have no known competing financial interests or personal relationships
that could have appeared to influence the work reported in this paper.

☐The authors declare the following financial interests/personal relationships which may be considered
as potential competing interests:
Figure 1 Click here to access/download;Figure;Figure 1.png
Figure 2 Click here to access/download;Figure;Figure 2.png
Figure 3 Click here to access/download;Figure;Figure 3.png
Table 1 Click here to access/download;Table;Table 1.docx

Table 1. Descriptive statistics for recruited subjects.

Subjects characteristics

Number of subjects 245

Gender (Female) N = 159 (64.9%)

Age years, mean (SD); median (range) 48.95 (14.51); 49 (17 -85)

MS subtype

Relapsing remitting N = 154 (62.9%)

Primary progressive N = 32 (24.1%)

Secondary progressive N = 59 (13.1%)

Disease duration (years), mean (SD); median (range) 14.02 (10.87); 11 (0 - 59)

EDSS, mean (SD); median (range) 4.41 (2.12); 5 (0 – 8.00)

EDSS ≥ 3 N = 84 (34.3%)

3.5 ≤ EDSS ≤ 5.5 N = 57 (23.2%)

EDSS ≥ 6 N = 104 (42.5%)

ABILHAND-26 Raw score, mean (SD); median (range) 42.36 (10.47); 46 (0 – 52)

MAM-36 Total score, mean (SD); median (range) 125.95 (19.07); 131 (39 – 144)

MAM-36 Rasch score, mean (SD); median (range) 3.17 (2.20); 2.75 (-2.04 – 6.65)

9-HPT seconds (Right), mean (SD); median (range) 30.99 (23.88); 24 (11.00 – 180.00)

9-HPT seconds (Left), mean (SD); median (range) 35.23 (30.34); 25.06 (12.00 – 180.00)

Note. Sample size for 9-HPT scores is N = 243.

Table 2 Click here to access/download;Table;Table 2.docx

Table 2. ABILHAND-26 response categories: number of responses, estimated Rasch measure, and fit statistics

Response category Step Measure SE Number of respones Infit Oufit

0 Impossible* - 328 1.07 1.27

1 Difficult -1.36 0.08 1243 0.95 0.84

2 Easy 1.36 0.04 3272 1.05 1.05

* Reference category
Table 3 Click here to access/download;Table;Table 3.docx

Table 3. ABILHAND-26: One-factor CFA loadings, Rasch difficulty parameters and fit statistics

One-factor CFA Rasch model

b
Order Item Loading SE Difficulty SE Infit Outfit
1 Threading a needle 0.79 0.03 2.80 0.14 1.00 0.98
Passare il filo in un ago
9 Wiping windows 0.76 0.04 2.54 0.14 1.26 1.20
Pulire le finestre
25 Shelling hazel nuts 0.9 0.02 1.51 0.15 0.77 0.75
Aprire una nocciola
7 Cutting one's nails 0.86 0.03 1.06 0.15 1.04 0.87
Tagliarsi le unghie
17 Opening a screw-topped jar 0.79 0.04 0.93 0.15 1.01 0.96
Aprire un vasetto
16 Peeling potatoes with a knife 0.91 0.02 0.78 0.15 0.84 0.67
Pelare le patate con un coltello
5 Taking the cap off a bottle 0.77 0.04 0.59 0.16 1.18 1.17
Togliere il tappo ad una bottiglia
2 Putting on a piece of jewelry 0.84 0.04 0.56 0.16 1.07 1.16
Indossare un gioiello
11 Lacing shoes 0.83 0.03 0.44 0.16 1.05 1.06
Allacciarsi le scarpe
14 Peeling onions 0.89 0.03 0.22 0.17 0.98 0.76
Pelare le cipolle
3 Cutting meat 0.91 0.02 0.02 0.17 0.73 0.59
Tagliare la carne
26 Buttoning up trousers 0.92 0.02 0.02 0.17 0.69 0.51
Abbottonare i pantaloni
12 Handling a stapler 0.85 0.04 -0.15 0.19 1.26 0.96
Usare una cucitrice
22 Tearing open a package of chips 0.82 0.03 -0.24 0.18 0.96 0.88
Aprire un sacchetto di patatine
18 Fastening the zipper of a jacket 0.81 0.04 -0.33 0.18 1.03 0.88
Chiudere la cerniera di un giubbotto
4 Handling scissors 0.93 0.02 -0.41 0.19 0.75 0.57
Usare le forbici
24 Fastening a snap-fastener (e.g., bag, jacket) 0.84 0.03 -0.49 0.19 0.90 0.87
Chiudere un bottone automatico (es. camicia, borsa)
6 Taking a coin out of a pocket 0.77 0.05 -0.75 0.20 1.12 1.29
Prendere una moneta da una tasca
20 Spreading butter on a slice of bread 0.89 0.03 -0.78 0.20 0.77 0.69
Spalmare del burro su una fetta di pane
15 Winding up a wristwatch 0.78 0.04 -0.80 0.20 1.18 1.04
Mettersi un orologio
23 Brushing one's hair 0.77 0.05 -0.93 0.21 1.15 1.18
Spazzolarsi i capelli
13 Opening mail 0.80 0.04 -1.00 0.21 1.02 1.19
Aprire la posta
 21 Putting cream on one's body 0.82 0.05 -1.14 0.22 1.28 0.81
Spalmare una crema per il corpo
8 Unwrapping a chocolate bar 0.79 0.05 -1.16 0.22 1.18 1.14
Scartare una tavoletta di cioccolato
19 Cleaning vegetables 0.81 0.06 -1.59 0.25 1.06 1.19
Lavare le verdure
10 Turning off a tap 0.74 0.06 -1.70 0.24 1.35 1.22
Chiudere un rubinetto
Note. a Standardized loadings are reported. b Items are reported in decreasing difficulty order.
Table 4 Click here to access/download;Table;Table 4.docx

Table 4. Correlation between ABILHAND-26 Rasch and raw scores and study measures

ABILHAND-26
Rasch score Raw score
Age -.166** -.165**
**
Disease duration -.242 -.237**
**
EDSS -.500 -.495**
**
9-HPT (Right) -.395 -.411**
**
9-HPT (Left) -.376 -.412**
**
MAM-36 Rasch score .847 .836**
Note. ** p<.01. Sample size for 9-HPT scores is N = 243.
Credit Author Statement

Credit Author Statement

Conceptualization: Claudio Solaro, Giampaolo Brichetto, Luca Prosperini, Davide Cattaneo

Methodology: Claudio Solaro, Erica Grange, Andrea Tacchino, Rosalba Rosato

Formal analysis: Davide Marengo

Investigation: Rachele Di Giovanni, Erica Grange, Margit Mueller, Rita Bertoni, Letizia Castelli

Writing - original draft preparation: Claudio Solaro, Rachele Di Giovanni, Erica Grange, Davide Marengo,
Davide Cattaneo

Writing - review and editing: Giampaolo Brichetto, Andrea Tacchino, Francesco Patti, Angelo Pappalardo,
Luca Prosperini, Rosalba Rosato

Funding acquisition: Claudio Solaro

Supervision: Claudio Solaro, Francesco Patti, Angelo Pappalardo, Luca Prosperini, Davide Cattaneo