Comparison of the Kurtkze Expanded Disability Status Scale and the Functional Independence Measure:...

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2013 http://informahealthcare.com/dre ISSN 0963-8288 print/ISSN 1464-5165 online Disabil Rehabil, Early Online: 1–8 ! 2013 Informa UK Ltd. DOI: 10.3109/09638288.2013.766269 RESEARCH ARTICLE Comparison of the Kurtkze Expanded Disability Status Scale and the Functional Independence Measure: measures of multiple sclerosis-related disability Meheroz H. Rabadi 1,2 and Andrea S. Vincent 3 1 Oklahoma City VA Medical Center, Oklahoma City, OK, USA, 2 Department of Neurology, Oklahoma University, Oklahoma City, OK, USA, and 3 Cognitive Science Research Center, University of Oklahoma at Norman, OK, USA Abstract Background: Multiple sclerosis (MS) is a disease which has a variable clinical presentation followed by a variable clinical course. Therefore, accuracy of clinical rating scales to measure disability at initial clinical presentation and during follow-up visits is essential to accurately capture the variability inherent in this disease. This is particularly vital when attempting to identify the efficacy of interventions. Objective: This observational study in veterans with MS compared the Kurtkze Expanded Disability Status Scale (EDSS) and the Total Functional Independence Measure (TFIM) scale as measures of MS-related disability. Methods: We retrospectively reviewed the electronic charts of 76 veterans with MS who are regularly followed in our VA MS clinic. Local Institutional Review Board approval was obtained for the protocol. Data were analyzed using SAS (SAS System for Windows, version 9.2, SAS Institute Inc., Cary, NC, USA). Chi-square and Fisher exact tests were used to assess categorical variables. Kruskal–Wallis tests evaluated the relationships between MS types [relapsing–remitting MS (RR), secondary progressive MS (SP), primary progressive MS (PP) and clinical isolated syndrome (CIS)] and the initial TFIM, EDSS and Impairment Index (II) scores. Results: The EDSS score accurately measured MS-related impairment at initial evaluation and follow-up relative to an II. However, the EDSS score did not change over time, compared to the TFIM suggesting reduced sensitivity of the EDSS for detecting change in MS-related disability over time. Conclusions: This suggests TFIM scale is a more sensitive measure of MS-related disability than EDSS for use in future MS clinical trials. ä Implications for Rehabilitation This study highlights that given the paucity of scales to which EDSS has been compared, TFIM is a valuable adjunct to EDSS in measuring MS-related disability. TFIM is able to accurately measure the severity of MS-related disability and help provide for services patients with MS-related disability would need. TFIM is an easy to administer and a sensitive scale to measure the change in MS-related disability following interventions. Keywords Disability, Functional Independence Measure, Kurtkze EDSS scale, multiple sclerosis, rehabilitation History Received 16 April 2012 Revised 20 December 2012 Accepted 10 January 2013 Published online 19 April 2013 Introduction Multiple sclerosis (MS) is a disease which has a variable clinical presentation followed by a variable clinical course. Therefore, accuracy of clinical rating scales to measure disability at initial clinical presentation and during follow-up visits is essential to accurately capture the variability inherent in this disease. This is particularly vital when attempting to identify the efficacy of interventions. Kurtkze in 1955 described a new scale to assess MS-related disability called the Disability Status Scale (DSS) [1]. This scale was expanded in 1983 with the addition of eight Functional System (FS), into what is now called the Expanded Disability Status Scale (EDSS) [2]. The EDSS is now the most commonly used scale to record the neurological status of patients with MS, assess disease progression and monitor response to treatment. It is considered the ‘‘gold standard’’ in MS clinical trials. The EDSS score is based on a detailed neurological examination that combines impairment and disability in a 10-step ordinal scale, ranging from 0 (normal) to 10 (death). Thus, higher scores indicate increased levels of disability. The EDSS is scored in increments of 0.5 points and includes the scores of eight FS items: pyramidal, cerebellar, brain-stem, sensory, bowel and bladder, visual, mental and other functions (Appendix 1A and 1B). Address for correspondence: Meheroz H. Rabadi, MD, MRCPI, FAAN, Veterans Affairs Medical Center, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Tel: (405)456-5298. Fax: (405)456-1504. E-mail: [email protected] Disabil Rehabil Downloaded from informahealthcare.com by University of Regina on 05/20/13 For personal use only.

Transcript of Comparison of the Kurtkze Expanded Disability Status Scale and the Functional Independence Measure:...

2013

http://informahealthcare.com/dreISSN 0963-8288 print/ISSN 1464-5165 online

Disabil Rehabil, Early Online: 1–8! 2013 Informa UK Ltd. DOI: 10.3109/09638288.2013.766269

RESEARCH ARTICLE

Comparison of the Kurtkze Expanded Disability Status Scale andthe Functional Independence Measure: measures of multiplesclerosis-related disability

Meheroz H. Rabadi1,2 and Andrea S. Vincent3

1Oklahoma City VA Medical Center, Oklahoma City, OK, USA, 2Department of Neurology, Oklahoma University, Oklahoma City, OK, USA, and3Cognitive Science Research Center, University of Oklahoma at Norman, OK, USA

Abstract

Background: Multiple sclerosis (MS) is a disease which has a variable clinical presentationfollowed by a variable clinical course. Therefore, accuracy of clinical rating scales to measuredisability at initial clinical presentation and during follow-up visits is essential to accuratelycapture the variability inherent in this disease. This is particularly vital when attempting toidentify the efficacy of interventions. Objective: This observational study in veterans with MScompared the Kurtkze Expanded Disability Status Scale (EDSS) and the Total FunctionalIndependence Measure (TFIM) scale as measures of MS-related disability. Methods: Weretrospectively reviewed the electronic charts of 76 veterans with MS who are regularlyfollowed in our VA MS clinic. Local Institutional Review Board approval was obtained for theprotocol. Data were analyzed using SAS (SAS System for Windows, version 9.2, SAS Institute Inc.,Cary, NC, USA). Chi-square and Fisher exact tests were used to assess categorical variables.Kruskal–Wallis tests evaluated the relationships between MS types [relapsing–remitting MS(RR), secondary progressive MS (SP), primary progressive MS (PP) and clinical isolated syndrome(CIS)] and the initial TFIM, EDSS and Impairment Index (II) scores. Results: The EDSS scoreaccurately measured MS-related impairment at initial evaluation and follow-up relative to an II.However, the EDSS score did not change over time, compared to the TFIM suggesting reducedsensitivity of the EDSS for detecting change in MS-related disability over time. Conclusions: Thissuggests TFIM scale is a more sensitive measure of MS-related disability than EDSS for use infuture MS clinical trials.

� Implications for Rehabilitation

� This study highlights that given the paucity of scales to which EDSS has been compared, TFIMis a valuable adjunct to EDSS in measuring MS-related disability.

� TFIM is able to accurately measure the severity of MS-related disability and help provide forservices patients with MS-related disability would need.

� TFIM is an easy to administer and a sensitive scale to measure the change in MS-relateddisability following interventions.

Keywords

Disability, Functional Independence Measure,Kurtkze EDSS scale, multiple sclerosis,rehabilitation

History

Received 16 April 2012Revised 20 December 2012Accepted 10 January 2013Published online 19 April 2013

Introduction

Multiple sclerosis (MS) is a disease which has a variable clinicalpresentation followed by a variable clinical course. Therefore,accuracy of clinical rating scales to measure disability at initialclinical presentation and during follow-up visits is essential toaccurately capture the variability inherent in this disease. This isparticularly vital when attempting to identify the efficacy ofinterventions.

Kurtkze in 1955 described a new scale to assess MS-relateddisability called the Disability Status Scale (DSS) [1]. This scalewas expanded in 1983 with the addition of eight FunctionalSystem (FS), into what is now called the Expanded DisabilityStatus Scale (EDSS) [2]. The EDSS is now the most commonlyused scale to record the neurological status of patients with MS,assess disease progression and monitor response to treatment. It isconsidered the ‘‘gold standard’’ in MS clinical trials. The EDSSscore is based on a detailed neurological examination thatcombines impairment and disability in a 10-step ordinal scale,ranging from 0 (normal) to 10 (death). Thus, higher scoresindicate increased levels of disability. The EDSS is scored inincrements of 0.5 points and includes the scores of eight FS items:pyramidal, cerebellar, brain-stem, sensory, bowel and bladder,visual, mental and other functions (Appendix 1A and 1B).

Address for correspondence: Meheroz H. Rabadi, MD, MRCPI, FAAN,Veterans Affairs Medical Center, 921 NE 13th Street, Oklahoma City, OK73104, USA. Tel: (405)456-5298. Fax: (405)456-1504. E-mail:[email protected]

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The EDSS has been found to have a bi-modal distribution in validcross-sectional studies [3] and has a fair to substantial inter-raterreliability (�¼ 0.32–0.76) [4], with a two-point change con-sidered a reliable indicator of the patient’s response to treatment[5]. It has been found to have better reliability at higher scores dueto its over-emphasis on ambulation. Though EDSS is animpairment scale, it has been commonly used as a disabilityscale in terms of ambulation, despite a number of limitationswhen used as an outcome measure of disability [6,7]. Theselimitations include (i) lack of precision in defining FS grades dueto its use of subjective terms (e.g. mild, moderate and severe),(ii) inadequate assessment of cognitive and visual components,(iii) failure to measure common MS symptoms (e.g. fatigue andpain), (iv) cumbersome administration, (v) poor correlation withActivities of Daily Living (ADL) [8] and (vi) strong emphasis onambulation status.

Given these limitations of the EDSS scale, the current studyexplored the potential of the Total Functional IndependenceMeasure (TFIM) to serve as an alternative to the EDSS forassessing MS-related disability. The TFIM is a reliable [9] andvalid [10] functional assessment instrument that is widely used inmany rehabilitation settings [11] to measure degree of disability[12]. The TFIM has 18 items; each item is scored on an ordinalscale ranging from 1 (‘‘total assist’’: patient performs 525% oftask) to 7 (‘‘complete independence’’). The resulting TFIM scoreindicates the level of assistance needed to achieve independenceand ranges from 18 (totally dependent) to 126 (independent).Thus, more disability is shown by a lower score. The TFIMincludes both cognitive (five items) and motor (13 items)subscales. This structure allows clinicians to calculate a cognitiveFIM sub-score (range, 5–35) that is independent from the motorFIM sub-score (range, 13–91) (Appendix 2). The cognitive FIMsub-score is based on observations of the patient’s behaviors andis less affected by language disorders as is the Mini-Mental StateExamination.

Since few attempts have been made to compare the EDSS withother disability scales [13], we set out to compare the EDSS to theTFIM scale as an effective measure of MS-related disability andto determine which of the two scales is more responsive to clinicalchange following treatment.

Method

Participants and procedures

This retrospective study obtained data via chart review (VAelectronic record or paper chart for non-VA facilities) for 76veterans with MS who are regularly followed in our VA MS clinicat 3, 6, and 12 months after initial presentation since 2008. Therewere no inclusion/exclusion criteria. Patients who had relapsing–remitting MS continued taking their disease-modifying medica-tion, and was changed in 3 patients who had increased plaque loadon follow-up MRI of the brain. None of these patients were activein rehabilitation. Since 2008, a concerted effort has been made todecrease MS-related complications such as fatigue, pain andurinary incontinence. This study was approved by the InstitutionalReview Board for Human Subjects Research and the localVeterans Affairs Research and Development Committee.

Data recorded included basic demographics (age, gender andethnicity) and relevant clinical variables including age of onset,clinical MS subtype (relapsing–remitting MS (RR), secondaryprogressive MS (SP), primary progressive MS (PP) and clinicalisolated syndrome (CIS)) [14], disease duration and presentingfeatures such as visual complaint, motor weakness, balancedisorder and sensory complaint at the time of their initial clinicalpresentation. In addition to these clinical variables, the MS-related impairment severity was measured by the Impairment

Index (II). The II classifies impairment severity with a higherscore indicating more neurological deficits [15–17]. The II wascalculated for each patient separately on initial evaluation and12-month follow-up and included the following variables: Mini-Mental Status Examination (MMSE) for cognition, the MedicalResearch Council scale (MRC; 0¼ no strength to 5¼ normalstrength) for muscle strength in the upper and lower limbs andpresence/absence of visual complaints and peripheral sensorymodalities (e.g. light touch, pin-prick, vibration and propriocep-tion). Scores for these variables were categorized according to thefollowing criteria and then summed to get the II score: (a) 0 forMMSE score of 26–30, 1 for score of 20–25, 2 for a score of10–19 and 3 for a score of 0–9; (b) absence of visual and sensorycomplaints¼ 0 and presence¼ 1 point; and (c) 0 for an MRCscore of 5, 1 for score of 3–4 and 2 for 0–2 for UE/LE motorweakness. The II was calculated to verify the accuracy of theEDSS score in describing MS-related impairment. The EDSS andTFIM scores were documented by a Board and FIM certifiedneurologist on initial and 1-year follow-up in the MS clinic. Othervariables collected included ambulatory distance (feet) and use ofany ambulatory device (e.g. cane, walkers or electric wheelchair).

Statistical analysis

Data were analyzed using SAS (SAS System for Windows,version 9.2; SAS Institute Inc., Cary, NC). Chi-square and Fisherexact tests were used to assess categorical variables. Kruskal–Wallis tests evaluated the relationships between MS types (RR,SP, PP and CIS) and the initial TFIM, EDSS and II scores.Follow-up examination results were assessed using the Kruskal–Wallis Multiple Comparisons test [18] with a Bonferroni correc-tion. Changes in EDSS and TFIM scores from initial evaluation to1-year follow-up were assessed using t-test. Spearman’s correl-ation coefficient (rs) was used to assess the relationship betweenEDSS and TFIM scores at the initial clinical presentation and atthe follow-up examinations. Significance was set at p� 0.05 forall analyses.

Responsiveness to change in EDSS and TFIM scores over timewas assessed by the standard response mean (SRM) for eachassessment. SRM was calculated as the mean change in the scoredivided by the standard deviation (SD) of the change score. TheSRM assessed the clinically meaningful change over time for thediagnostic test being performed. However, at present, there is noconsensus about how best to assess responsiveness to change [19].Cohen’s rule of thumb for interpreting the effect size was appliedto the SRM: a value of 0.2 is small, 0.5 is moderate and 0.8 islarge [20,21].

Results

Table 1 presents the demographics of the study sample. Eighty-three percent were males and 86% were non-Hispanic whites. Themean age (in years) of our patient population was 53.6� 10.9 SD(range, 27–75 years). The average age of MS onset was35.6� 10.8 years and duration of MS insult 19.6� 12.3 years.The MS type was mainly RR (51%) followed by SP (30%) and PP(14%). The mean EDSS and TFIM scale scores were 4.5� 2.8 and90.1� 21.5, respectively, on initial evaluation. Consistent withprevious studies [3], the distribution of EDSS scores in thissample was bimodal (see Figure 1). When patients werecategorized according to their disability level using the standardEDSS cut-points: 33% of moderately (EDSS score between 3 and5.5) and 67% of severely (EDSS� 6) disabled patients were inpowered mobility.

A significant negative correlation observed for Concurrentvalidity of the EDSS scale for assessing MS-related disability atinitial evaluation was established by examining the correlations

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with TFIM and II scores. A negative correlation was observedbetween the TFIM and EDSS scores (rs¼�0.69, p50.001). Thiscorrelation remained significant when age, disease duration,gender, race and MS type (variables known to influence MS-related disability) were controlled, r¼�0.58, p50.0001.Likewise, a significant negative correlation was observed forTFIM and II (rs¼�0.51, p50.00010), while the EDSS and IIscores were positively correlated (rs¼ 0.63, p50.0001).

The results of the Kruskal–Wallis test showed that the numberof complaints (none, single, multiple) on the initial clinicalpresentation significantly co-related to both the EDSS and IIscores (EDSS: �2(2)¼ 6.39, p¼ 0.04; II: �2(2)¼ 7.43, p¼ 0.02)but not to the TFIM scores (�2(2)¼ 1.76, p¼ 0.42). Additionally,as shown in Table 2, a difference in TFIM scores was foundaccording to MS type, (�2(3)¼ 7.88, p¼ 0.049), but pairwisedifferences in the mean scores between the MS types did not reachsignificance. Similar differences were found for the EDSS scoresby MS type, (�2(3)¼ 31.28, p50.0001), with significant differ-ences in mean scores between the RR and the SP and PP groups.RR scores did not differ from CIS and PP did not differ from SP.Differences in II scores by MS type, (�2(3)¼ 13.41, p¼ 0.004)were also found, with a significant difference in mean scoresbetween the RR and the SP groups.

An examination of change in MS-related disability showed thatonly the TFIM score reflected significant change at follow-upfrom initial evaluation values. There was an 11.1% increase inTFIM scores (D¼ 9.98� 18.97, p¼ 0.0002) suggesting decreaseddisability at follow-up. In contrast, neither the EDSS nor II scoresshowed significant change from initial evaluation (EDSS: 5.4%increase, D¼ 0.25� 1.67, p¼ 0.21; II: 1.5% increase, D¼ 0.03� 1.74, p¼ 0.90) and the direction of change was suggestive ofincreased disability. Sensitivity to change, as measured by SRM,was 0.15 for the EDSS and 0.53 for TFIM scores. The SRMfigures for EDSS and TFIM scores did not correlate (R2¼ 0.04,p¼ 0.15). When functional impairment was defined as a TFIMscore of 18–90, the sensitivity and specificity of the EDSS was68% and 69%, respectively, using a cut-point of scores greaterthan or equal to 3.5.

Discussion

Accurate identification and measurement of MS-related disabil-ities in veterans is essential for determining who may benefit frominterventions to improve mobility and ADL function and forassessing the effects of these interventions. The EDSS hastraditionally been used for this purpose, but the findings of thisstudy suggest that the TFIM scale may be a better measure.Rehabilitation interventions initiated soon after diagnosis havebeen shown to improve ADL functions and mobility in patientswith mild to moderately severe MS [22,23].

We found the initial EDSS and TFIM scores were significantlynegatively correlated (p50.001) due to the scale characteristics.Less disability in ADLs was associated with lower EDSS andhigher TFIM scores, while a higher degree of disability was foundat a higher EDSS and lower TFIM scores. A similar correlationbetween the two scale scores was found by Sharrack et al. [24].Another study found a curvilinear relationship when Activities ofDaily Living assessed by the ADL scale was compared to theEDSS score. The ADL scale scores increased marginally withincreasing EDSS scores until the EDSS score exceeded 5, atwhich point the ADL scale score increased dramatically [8].Confounding variables known to influence MS-related disabil-ity such as age, disease duration, gender, race and MS typeplayed a minor role in the correlation between FIM and EDSSscores (r¼�0.58) compared to a simple bivariate correlationwithout these confounding variables included in the analyses(r¼�0.69).

Of the scales examined, only the TFIM scale showedsensitivity to clinical change as measured by SRM; this was amoderate effect size in measuring change in functional disabilityat 12-month follow-up. This helps to explain a previous findingthat showed the physical rehabilitation program improved func-tion in hospitalized patients with MS when they were assessedusing the TFIM scale compared to the EDSS scale [25]. EDSSappeared to be less sensitive and specific for assessing functionaldisability in comparison to TFIM. Factors such as fatigue, painand urinary incontinence greatly impact MS-related disability.When these are appropriately treated, the functional state in MSpatients is greatly improved. The EDSS with its main emphasis onambulation is less able to reflect the functional change whencompared to TFIM scale, as it incorporates ambulation plusactivities of daily living and cognition. TFIM also provides theadded benefit that it measures and informs the care-provider thedegree of care-giver burden to be expected for that particularpatient. Since the TFIM provides information on a wider range ofessential functions that help define MS-related disability, it servesas a useful adjunct to the EDSS.

In this study, neurologically based II scores verified the EDSSto be an appropriate measure of MS-related impairment on initial

Table 1. Demographic variables of 76 MS patients [mean� SD or n (%)where applicable].

Grouping variables Sample

Age (years) 53.6� 10.9Sex (M:F) 63:13Ethnicity (White/Black/Native American/Unknown) 65/7/2/2Age of MS onset in years 35.6� 10.8Duration of MS in years 19.6� 12.3MS types

Relapsing remitting 39 (51%)Secondary progressive 23 (30%)Primary progressive 11 (14%)Clinical isolated syndrome 3 (4%)Radiological isolated syndrome 0 (0%)

Initial complaint on MS diagnosisVisual (n¼ 39) 38 (97%)Weakness (n¼ 47) 46 (98%)Balance/in-coordination (n¼ 24) 24 (100%)Sensory (n¼ 32) 32 (100%)

MS severityMMSE (n¼ 74) 28.0� 2.9Visual (n¼ 69) 16 (23%)Upper limb muscle strength (n¼ 73) 4.4� 0.7Lower limb muscle strength (n¼ 73) 3.9� 1.4Sensory complaints (yes; n¼ 71) 37 (52%)Cerebellar complaints (yes; n¼ 71) 33 (46%)

GaitNormal 44 (45%)Ataxic 11 (15%)Spastic 13 (18%)Unable 16 (26%)Unknown 3 (4%)Neurogenic bowel (n¼ 68) 33 (51%)

Neurogenic bladder (n¼ 73) 51 (70%)EDSS scale score, initial (n¼ 73) 4.5� 2.8EDSS scale score, follow-up (n¼ 76) 4.7� 3.0a

TFIM score, initial (n¼ 64) 90.1� 21.5TFIM score, follow-up (n¼ 70) 100.2� 27.4b

Impairment Index, initial (n¼ 76) 2.0� 1.5Impairment Index, follow-up (n¼ 76) 2.1� 2.0c

EDSS, Expanded Disability Status Scale; TFIM, Total FunctionalIndependence Measure.

aNo change from initial EDSS score (p¼ 0.21).bSignificant increase from initial TFIM score (p¼ 0.0002).cNo change from initial Impairment Index score (p¼ 0.90).

DOI: 10.3109/09638288.2013.766269 MS, EDSS, TFIM 3

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evaluation and follow-up. The initial EDSS score had a bimodaldistribution, due to a lack of mid-range scores, and wasinfluenced by the initial clinical presentation. Sharrack et al. intheir study of 64 adult MS patients have previously reportedsimilar findings [24,26].

Recently, there has been a concerted effort to use a new scalecalled the Multiple Sclerosis Functional Composite Scale(MSFCS) in MS clinical trials in order to overcome limitationsperceived in the use of EDSS. The total MSFCS score is derivedfrom the combination of results from three performance tests: theTimed 8-meter Walk (t-8 m) to assess lower limb function(ambulation), the Nine-Hole Peg Test (9HPT) to assess upperlimb function and the 3-second version of the Paced AuditorySerial Addition Test (PASAT) to assess cognition. Tests resultsare converted to z-score [27]. Its advantages include it beingreliable, efficient and reproducible [28,29]. However, it iscumbersome to use in everyday clinical practice for the followingreasons: complaints such as dysarthria affects PASAT perform-ance; visual disturbance affects 9HPT; no measure for vision;calculation and clinical interpretation of z-scores are difficult; and

finally, there is a practice effect with tests repetition especially forthe PASAT.

The conclusion of this study should be viewed with caution asit has several limitations. First, this study is limited to primarilymale veteran population; thus, it is difficult to generalize to thegeneral population of MS patients. Second, the sample size israther small and may preclude detecting important differencesbetween groups. Third, some may question the reliability of theclinical information provided by veterans with MS who werediagnosed years ago. However, this problem was mitigated byreviewing their initial paper chart documentation, where possible.Despite these limitations, this finding of this study helps clinicianin choosing the most sensitive scale when assessing the efficacyof their interventions in MS-disease related disability.

Conclusion

Our study suggests that the EDSS scale continues to be betterscale at measuring MS-related impairment, while the TFIM scaleis a better measure of MS-related disability. The TFIM is more

Figure 1. Histogram of patients graded according to EDSS.

Table 2. Initial and follow-up EDSS, TFIM and Impairment Index scores by MS type [Median (IQR)].

MS type

Variable RR SP PP CIS p

N 39 23 11 3Initial EDSS scoreb 2 (5) 6.5 (2) 6.5 (2) 1 (1.5) 50.0001Follow-up EDSS scoreb 2 (5) 7.5 (1.5) 7.5 (2.5) 0 (1.0) 50.0001Change in the EDSS score 0 (0) 0 (0.5) 0.3 (1) 0 (1.5) 0.233Initial TFIM 98 (22) 83.5 (22.5) 82 (14) 97 (26) 0.049Follow-up TFIM 120 (17) 89 (36.5)a 80 (53)a 124 (16) 50.0001Change in the TFIM score 17.5 (24.5) �1 (22) 0 (9.5) 21 (42) 0.065Initial Impairment Index 1 (3) 3 (2)a 3 (1) 2 (2) 0.004Follow-up Impairment Index 0 (2) 3 (3)a 3 (4)a 1 (3) 0.0001Change in the Impairment Index score 0 (1) 0 (2) 1 (3) 0 (2) 0.080

aAll pair wise comparisons different at adjusted a¼ 0.004 except RR does not differ from CIS and PP does not differ from SP.bDiffers from relapsing remitting at adjusted a¼ 0.004.

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sensitive to clinical change over time than the EDSS scale andwould be a better measure to use in MS clinical trials.

Declaration of interest

The authors report no conflict of interest and have not received anyfunding for this study.

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28. Cohen JA, Fischer JS, Bolibrush DM, et al. Intrarater and interraterreliability of the MS functional composite outcome measure.Neurology 2000;54:802–6.

29. Hobart J, Kalkers N, Barkhof F, et al. Outcome measures formultiple sclerosis clinical trials: relative measurement precision ofthe Expanded Disability Status Scale and Multiple SclerosisFunctional Composite. Mult Scler 2004;10:41–6.

Appendix 1A: Functional systems

Pyramidal functions

0. Normal.1. Abnormal signs without disability.2. Minimal disability.3. Mild or moderate paraparesis or hemiparesis; severe monoparesis4. Marked paraparesis or hemiparesis; moderate quadriparesis; or monoplegia.5. Paraplegia, hemiplegia, or marked quadriparesis.6. Quadriplegia.V. Unknown.

Cerebellar functions

0. Normal.1. Abnormal signs without disability.2. Mild ataxia.3. Moderate truncal or limb ataxia.4. Severe ataxia, all limbs.5. Unable to perform coordinated movements due to ataxia.V. Unknown.X. Is used throughout after each number when weakness (grade 3 or more on pyramidal) interferes with testing.

DOI: 10.3109/09638288.2013.766269 MS, EDSS, TFIM 5

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Brain stem functions

0. Normal.1. Signs only.2. Moderate nystagmus or other mild disability.3. Severe nystagmus, marked extraocular weakness, or moderate disability of other cranial nerves.4. Marked dysarthria or other marked disability.5. Inability to swallow or speak.V. Unknown.

Sensory functions (revised 1982)

0. Normal.1. Vibration or figure-writing decrease only, in one or two limbs.2. Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure

writing) decrease alone in three or four limbs.3. Moderate decrease in touch or pain or position sense, and/or essentially lost vibration in one or two limbs; or mild decrease in

touch or pain and/or moderate decrease in all proprioceptive tests in three or four limbs.4. Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch

or pain and/or severe proprioceptive decrease in more than two limbs.5. Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of

the body below the head.6. Sensation essentially lost below the head.V. Unknown.

Bowel and bladder functions (revised 1982)

0. Normal.1. Mild urinary hesitancy, urgency, or retention.2. Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence.3. Frequent urinary incontinence.4. In need of almost constant catheterization.5. Loss of bladder function.6. Loss of bowel and bladder function.V. Unknown.

Visual (or optic) functions

0. Normal.1. Scotoma with visual acuity (corrected) better than 20/30.2. Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/59.3. Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/99.4. Worse eye with marked decrease of fields and maximal visual acuity (corrected) of 20/100 to 20/200; grade 3 plus maximal acuity

of better eye of 20/60 or less.5. Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less.6. Grade 5 plus maximal visual acuity of better eye of 20/60 or less.V. Unknown.X. Is added to grades 0 to 6 for presence of temporal pallor.

Cerebral (or mental) functions

0. Normal.1. Mood alteration only (Does not affect DSS score).2. Mild decrease in mentation.3. Moderate decrease in mentation.4. Marked decrease in mentation (chronic brain syndrome-moderate).5. Dementia or chronic brain syndrome-severe or incompetent.V. Unknown.

Other functions

0. None.1. Any other neurologic findings attributed to MS.V. Unknown.

6 M. H. Rabadi and A. S. Vincent Disabil Rehabil, Early Online: 1–8

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Appendix 1B: Kurtzke Expanded Disability Status Scale (EDSS)

Appendix 2: Total Functional Independence Measure (FIM)

0 Normal neurological exam (all grade 0 in Functional Systems (FS); cerebral grade 1 acceptable).1 No disability, minimal signs in one FS (i.e. one grade 1 excluding cerebral grade 1).1.5 No disability, minimal signs in more than one FS (more than one grade 1 excluding cerebral grade 1).2.0 Minimal disability in one FS (one FS grade 2, others 0 or 1).2.5 Minimal disability in two FS (two FS grade 2, others 0 or 1).3.0 Moderate disability in one FS (one FS grade 3, others 0 or 1), or mild disability in three or four FS (three-four FS grade 2, others 0 or 1).3.5 Fully ambulatory but with moderate disability in one FS (one grade 3 and one or two FS grade 2) or two FS grade 3, others 0 or 1, or five

FS grade 2, others 0 or 1.4.0 Fully ambulatory without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability consisting of one FS

grade 4 (others 0 or 1), or combinations of lesser grades exceeding limits of previous steps. Able to walk without aid or rest some500 m (0.3 miles).

4.5 Fully ambulatory without aid, up and about much of the day, able to work a full day, may otherwise have some limitation of full activityor require minimal assistance; characterized by relatively severe disability, usually consisting of one FS grade 4 (others 0 or 1) orcombinations of lesser grades exceeding limits of previous steps. Able to walk without aid or rest for some 300 m (975 ft).

5.0 Ambulatory without aid or rest for about 200 m (650 feet); disability severe enough to impair full daily activities (e.g., to work full daywithout special provisions). (Usual FS equivalents are one grade 5 alone, others 0 or 1; or combinations of lesser grades usuallyexceeding specifications for step 4.0)

5.5 Ambulatory without aid or rest for about 100 m (325 ft); disability severe enough to impair full daily activities. (Usual FS equivalents areone grade 5 alone, others 0 or 1; or combinations of lesser grades usually exceeding specifications for step 4.0)

6.0 Intermittent or constant unilateral assistance (cane, crutch, brace) required to walk about 100 m (325 ft) with or without resting. (Usual FSequivalents are combinations with more than two FS grade 3þ)

6.5 Constant bilateral assistance (canes, crutches, braces) required to walk about 20 m (65 ft). (Usual FS equivalents are combinations withmore than two FS grade 3þ)

7.0 Unable to walk beyond about 5 m (16 ft) even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair a full dayand transfers alone; up and about in wheelchair some 12 hours a day. Usual FS equivalents are combinations with more than one FSgrade 4þ; very rarely pyramidal grade 5 alone.

7.5 Unable to take more than a few steps; restricted to wheelchair; may need aid in transfers, wheels self but cannot carry on in standardwheelchair a full day; may require motorized wheelchair; usual FS equivalents are combinations with more than one FS grade 4þ

8.0 Essentially restricted to bed or chair or perambulated in wheelchair; but may be out of bed much of the day; retains many self-carefunctions; generally has effective use of arms. Usual FS equivalents are combinations, generally grade 4þ in several systems.

8.5 Essentially restricted to bed for much of the day; has some effective use of arm(s); retains some self-care functions. Usual FS equivalentsare combinations, generally grade 4þ in several systems.

9.0 Helpless bed patient; can communicate and eat. Usual FS equivalents are combinations, mostly grade 4.9.5 Totally helpless bed patient; unable to communicate effectively or eat/swallow. Usual FS equivalents are combinations, almost all

grade 4þ10 Death due to MS.

Activities

Self-careA. Eating _________B. Grooming _________C. Bathing _________D. Dressing – upper body _________E. Dressing – lower body _________F. Toileting _________Sphincter controlG. Bladder management _________H. Bowel management _________TransferI. Bed, chair, wheelchair _________J. Toilet _________K. Tub, shower _________LocomotionL. Walk/wheelchair _________M. Stairs _________CommunicationN. Comprehension _________O. Expression _________Social cognitionP. Social interaction _________Q. Problem solving _________R. Memory _________

TOTAL FIM _________

DOI: 10.3109/09638288.2013.766269 MS, EDSS, TFIM 7

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Levels for scoring the FIM

7 Complete independence (timely, safely) No helper6 Modified independence (device)

Modified dependence Helper5 Supervision4 Minimal assist (Subject¼ 75%þ)3 Moderate assist (Subject¼ 50%þ)

Complete dependence2 Maximal assist (Subject¼ 25%)1 Total assist (Subject¼ 0%þ)

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