10072 2012 1112 author

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ArticleTitle Validation of the Italian version of the Movement Disorder Society—Unified Parkinson’s Disease RatingScale

Article Sub-Title

Article CopyRight Springer-Verlag(This will be the copyright line in the final PDF)

Journal Name Neurological Sciences

Corresponding Author Family Name AntoniniParticle

Given Name AngeloSuffix

Division

Organization Department for Parkinson’s disease, IRCCS San Camillo

Address Via Alberoni 70, Venice, Italy

Email [email protected]

Author Family Name AbbruzzeseParticle

Given Name GiovanniSuffix

Division Department of Neurosciences, Ophthalmology and Genetics

Organization Centre for Movement Disorders, University of Genoa

Address Genoa, Italy

Email

Author Family Name Ferini-StrambiParticle

Given Name LuigiSuffix

Division

Organization Università Vita-Salute San Raffaele

Address Milan, Italy

Email

Author Family Name TilleyParticle

Given Name BarbaraSuffix

Division

Organization University of Texas Health Science Center School of Public Health at Houston

Address Houston, USA

Email

Author Family Name HuangParticle

Given Name JingSuffix

Division

Organization University of Texas Health Science Center School of Public Health at Houston

Address Houston, USA

Email

Author Family Name StebbinsParticle

Given Name Glenn T.Suffix

Division Department of Neurological Services

Organization Rush University Medical Center

Address Chicago, IL, USA

Email

Author Family Name GoetzParticle

Given Name Christopher G.Suffix

Division Department of Neurological Services

Organization Rush University Medical Center

Address Chicago, IL, USA

Email

Author Family Name BaroneParticle

Given Name PaoloSuffix

Division Neurodegenerative Diseases Center

Organization University of Salerno, Salerno, and IDC-Hermitage-Capodimonte

Address Naples, Italy

Email

Schedule

Received 11 February 2012

Revised

Accepted 2 May 2012

Abstract The Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) has been available in English since 2008. As part of this process, the MDS-UPDRS organizing teamdeveloped guidelines for development of official non-English translations. We present here the formal processfor completing officially approved non-English versions of the MDS-UPDRS and specifically focus on thefirst of these versions in Italian. The MDS-UPDRS was translated into Italian and tested in 377 native-Italianspeaking PD patients. Confirmatory and exploratory factor analyses determined whether the factor structurefor the English-language MDS-UPDRS could be confirmed in data collected using the Italian translation. Tobe designated an ‘Official MDS translation,’ the Comparative Fit Index (CFI) had to be ≥0.90 relative to theEnglish-language version. For all four parts of the Italian MDS-UPDRS, the CFI, in comparison with theEnglish-language data, was ≥0.94. Exploratory factor analyses revealed some differences between the twodatasets, however these differences were considered to be within an acceptable range. The Italian version ofthe MDS-UPDRS reaches the criterion to be designated as an Official Translation and is now available foruse. This protocol will serve as outline for further validation of this in multiple languages.

Keywords (separated by '-') Parkinson’s disease - MDS-UPDRS - Unified Parkinson’s Disease Rating Scale - Rating scales

Footnote Information The members of the MDS-UPDRS Italian Validation Study Group are given in the Appendix.Electronic supplementary material The online version of this article (doi:10.1007/s10072-012-1112-z)contains supplementary material, which is available to authorized users.

Metadata of the article that will be visualized in OnlineAlone

Electronic supplementarymaterial

Below is the link to the electronic supplementary material.MOESM1: Supplementary Material (PDF 434 kb).

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Journal: 10072

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ORIGINAL ARTICLE1

2 Validation of the Italian version of the Movement Disorder

3 Society—Unified Parkinson’s Disease Rating Scale

4 Angelo Antonini • Giovanni Abbruzzese • Luigi Ferini-Strambi •

5 Barbara Tilley • Jing Huang • Glenn T. Stebbins • Christopher G. Goetz •

6 Paolo Barone • MDS-UPDRS Italian Validation Study Group

7 Received: 11 February 2012 / Accepted: 2 May 20128 � Springer-Verlag 2012

9 Abstract The Movement Disorder Society-sponsored

10 revision of the Unified Parkinson’s Disease Rating Scale

11 (MDS-UPDRS) has been available in English since 2008.

12 As part of this process, the MDS-UPDRS organizing team

13 developed guidelines for development of official non-

14 English translations. We present here the formal process

15 for completing officially approved non-English versions of

16the MDS-UPDRS and specifically focus on the first of

17these versions in Italian. The MDS-UPDRS was translated

18into Italian and tested in 377 native-Italian speaking PD

19patients. Confirmatory and exploratory factor analyses

20determined whether the factor structure for the English-

21language MDS-UPDRS could be confirmed in data col-

22lected using the Italian translation. To be designated an

23‘Official MDS translation,’ the Comparative Fit Index

24(CFI) had to be C0.90 relative to the English-language

25version. For all four parts of the Italian MDS-UPDRS, the

26CFI, in comparison with the English-language data, was

27C0.94. Exploratory factor analyses revealed some differ-

28ences between the two datasets, however these differences

29were considered to be within an acceptable range. The

30Italian version of the MDS-UPDRS reaches the criterion to

31be designated as an Official Translation and is now avail-

32able for use. This protocol will serve as outline for further

33validation of this in multiple languages.

34

35Keywords Parkinson’s disease � MDS-UPDRS �

36Unified Parkinson’s Disease Rating Scale � Rating scales

37Introduction

38After its introduction in the 1980s, the Unified Parkinson’s

39Disease Rating Scale (UPDRS) has become the gold

40standard clinical rating scale for Parkinson’s disease (PD)

41[1, 2]. In 2008, a new Movement Disorder Society (MDS)-

42sponsored revision of the UPDRS, known as the MDS

43UPDRS, successfully passed clinimetric testing with high

44internal consistency and reliable factor structures for each

45part of the scale [3].

46The new MDS-UPDRS comprises four parts: Part I

47evaluates non-motor experiences of daily living

A1 The members of the MDS-UPDRS Italian Validation Study Group are

A2 given in the Appendix.

A3 Electronic supplementary material The online version of thisA4 article (doi:10.1007/s10072-012-1112-z) contains supplementaryA5 material, which is available to authorized users.

A6 A. Antonini (&)

A7 Department for Parkinson’s disease, IRCCS San Camillo,

A8 Via Alberoni 70, Venice, Italy

A9 e-mail: [email protected]

A10 G. Abbruzzese

A11 Department of Neurosciences, Ophthalmology and Genetics,

A12 Centre for Movement Disorders, University of Genoa,

A13 Genoa, Italy

A14 L. Ferini-Strambi

A15 Universita Vita-Salute San Raffaele, Milan, Italy

A16 B. Tilley � J. Huang

A17 University of Texas Health Science Center School of Public

A18 Health at Houston, Houston, USA

A19 G. T. Stebbins � C. G. Goetz

A20 Department of Neurological Services,

A21 Rush University Medical Center,

A22 Chicago, IL, USA

A23 P. Barone

A24 Neurodegenerative Diseases Center, University of Salerno,

A25 Salerno, and IDC-Hermitage-Capodimonte, Naples, Italy

123Journal : Large 10072 Dispatch : 12-5-2012 Pages : 5

Article No. : 1112h LE h TYPESET

MS Code : NEUS2171 h CP h DISK4 4

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48 (nM-EDL), Part II evaluates motor experiences of daily

49 living (motor-EDL), Part III evaluates motor function, and

50 Part IV evaluates motor fluctuations and dyskinesia. As

51 with the previous version, scores are rated by a mix of both

52 the physician and patient. Six of the 13 items in Part I

53 (those dealing with complex behaviors) and all items in

54 Part IV covering fluctuations and dyskinesia involve rater-

55 led interviews of the patient or caregiver. The remaining

56 questions in Part I and all items in Part II are answered with

57 a patient/caregiver questionnaire without direct input from

58 the rater, and Part III involves objective examination by the

59 rater for all items [3]. The MDS-UPDRS was specifically

60 designed to be less ambiguous than its predecessor and the

61 significant patient/caregiver involvement means that it is

62 vital that they understand the questions asked of them,

63 preferably in their mother tongue. In order to establish a

64 successful translation and designate non-English language

65 versions as an ‘Official MDS translation,’ the MDS has set

66 a strict protocol and criteria for testing. We present here the

67 Italian version of the MDS-UPDRS.

68 Methods

69 Translation of the MDS-UPDRS

70 The MDS-UPDRS was translated into Italian by a team of

71 PD expert investigators in Italy and was then back-trans-

72 lated by colleagues fluent in English and Italian and not

73 involved in the original translation. This back-translation

74 was then reviewed by a team of US experts (Glenn Steb-

75 bins, Christopher Goetz, Nancy LaPelle, and Barbara

76 Tilley) who had been involved in the development of the

77 original American version.

78 Cognitive pretesting

79 Cognitive pretesting using a structured interview format

80 was performed to evaluate specific items of the MDS-

81 UPDRS in terms of task difficulty for examiner and

82 respondent, and respondent interest, attention span, dis-

83 comfort, and comprehension. Items were selected for

84 cognitive pretesting when the observed differences were

85 between the back-translated Italian version and the English

86 version. In addition, questions that were identified in cog-

87 nitive testing of the American version were also tested [4].

88 Questions included in cognitive pretesting were MDS-

89 UPDRS Parts 1.2 Hallucinations and Psychosis; 1.6 Fea-

90 tures Of Dopamine Dysregulation Syndrome; 1.10 Urinary

91 Problems; 2.13 Freezing; 3.12 Postural Stability; 3.17 Rest

92 Tremor Amplitude; 4.1 Time Spent With Dyskinesias; and

93 4.2 Functional Impact Of Dyskinesias. Based on the results

94 of the initial cognitive pretesting, other round(s) of

95translation and back translation and cognitive pretesting

96could be required. Once any issues identified during cog-

97nitive pretesting were addressed, the final translation was

98obtained.

99Testing of the Italian version

100A total of 17-experienced Italian movement disorder spe-

101cialists were recruited to examine native-Italian speaking

102PD patients who had provided informed consent. Data

103without patient names or medical record numbers were

104transferred to the analytic team via a secure website. The

105patient sample size for the translation study was based on

106the statistical need for a minimum of five subjects per item

107of the questionnaire [5]. Thus, as there are 65 items on the

108MDS-UPDRS, a sample of at least 325 patients was

109required. Any participants with missing values within a

110part were deleted from analysis of that part only.

111Factor analysis

112Confirmatory and exploratory factor analyses were per-

113formed using M-plus, Version 6.1 (for categorical analy-

114ses). An unweighted least squares (ULS) approach to factor

115estimation that minimizes the sum of squared differences

116between observed and estimated correlation matrices not

117counting diagonal elements was used. In addition, an

118orthogonal VARIMAX rotation that constrains the factors

119to be uncorrelated was used to assist in interpretation of

120factors. For Part III, Factor 6, all factor loadings for the

121Italian data were negative (in the American data, Factor 2

122had negative signs for all factor loadings). This is an arti-

123fact of the quadrant of the rotation. A factor analysis using

124a standardized CF-VARIMAX rotation, equivalent to the

125VARIMAX rotation, gave similar results but without the

126minus signs. Since the VARIMAX rotation is more widely

127used, we report the VARIMAX rotation without the (-)

128signs.

129A confirmatory factor analysis (CFA) was used to

130determine if the factor structure for the English language

131MDS-UPDRS [3] could be confirmed in data collected

132using the Italian translation. The CFA was conducted

133separately for MDS-UPDRS Parts I–IV with the Italian

134data constrained to fall into the factors defined in the

135English language data and the CFA results were evaluated

136based on the Comparative Fit Index (CFI). To establish a

137successful translation and to designate that translation as an

138‘Official MDS translation’ of the MDS-UPDRS, the CFI

139for each Part (I–IV) of the translated MDS-UPDRS had to

140be 0.90 or greater relative to the English language version.

141In the original factor structure report, three dopamine

142dysregulation syndromes (DDSs) had an item loading of

1430.49 on Factor 1 of Part I. However, in the re-running of

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144 the analysis for the current program, the same item had an

145 item factor loading of only 0.19, falling outside the

146 acceptable range to be identified with any factor in the

147 scale. Therefore, the CFIs for the Italian translation versus

148 the English language version were calculated both with and

149 without the DDS item.

150 An exploratory factor analysis (EFA) for the Italian

151 version of MDS-UPDRS Parts I–IV using the same factor

152 analytic approach as for the confirmatory factor analysis

153 but without constraining the factors to follow a pre-speci-

154 fied factor structure was also performed. Separate SCREE

155 plots were used in addition to the assessment of clinical

156 interpretability of remaining factors to choose the cut-off

157 for the number of factors to retain for each MDS-UPDRS

158 part. The screen plot is a scatter plot of eigenvalues ranked

159 against the amount of scale variance accounted for by each

160 eigenvector. The number of factors can be defined by the

161 number of eigenvectors that independently account of a

162 significant amount of variance [6]. Once the factors were

163 chosen, an item was retained in a factor if the factor

164 loading for the item was C0.40.

165 Results

166 Cognitive pretesting

167 A total of 10 PD patients were interviewed as part of the

168 cognitive pretesting step. One of the 10 patients inter-

169 viewed had difficulty comprehending one item on Part 1 of

170 the Italian MDS-UPDRS (question 1.2 ‘‘Hallucinations and

171 psychosis’’). Neither patients nor their examiners identified

172 other difficulties. A second round of cognitive pre-testing

173 was completed by three PD patients after a modification of

174 the Italian version of the latter question. No difficulties

175 were identified with question 1.2 (Hallucinations and psy-

176 chosis) or any other item on this second round of testing.

177 The modified version of the scale was approved as the

178 Official Working Draft of the Italian MDS-UPDRS for

179 testing in a larger group of patients with PD.

180 Testing of the Italian version of the MDS-UPDRS

181 In total, 377 native Italian-speaking PD patients were

182 examined by 16-experienced movement disorder special-

183 ists using the Italian translation of the MDS-UPDRS. All

184 patients fulfilled Brain Bank diagnostic criteria for proba-

185 ble PD. Patient demographic characteristics are given in

186 Table 1.

187 For all four parts of the Italian MDS-UPDRS, the CFI,

188 in comparison with the English-language version, was 0.94

189 or greater and thus the pre-specified factor structure was

190 confirmed in the Italian data set (Table 2). Moreover, the

191overall CFIs for the English language version and the

192Italian version with or without the DDS item reached the

193criterion of CFI C0.90, showing that the Italian version of

194the MDS-UPDRS meets the requirements for designation

195as an Official Translation.

196Exploratory factor analyses revealed some differences

197between the Italian and English language datasets. For Part

198I, in contrast to the English language version of the MDS-

199UPDRS, Cognitive impairment loaded on Factor 2 instead

200of Factor 1. In Part II, 3 of 13 items loaded differently in

201the Italian version in comparison to the English version. In

202Part III, 3 of 33 items loaded differently between the two

203versions. Given the variability of factor estimates and the

204smaller sample size used in the Italian version, the analytic

205team considered these differences within an acceptable

206range.

207Discussion

208In order for the MDS-UPDRS to fully replace its prede-

209cessor, the UPDRS version 3, [2] as the international gold

210standard tool for the assessment of PD patients, it is vital

211that properly tested translations are made available for use

212in non-English speaking countries. The Italian version of

213the MDS-UPDRS presented here reaches the criterion to be

214designated as an Official translation of the MDS-UPDRS

215and as such is now available for use in clinical studies.

216The Italian dataset shared a common factor structure

217with the English language dataset based on the high CFIs

218for all Parts of the MDS-UPDRS. Isolated item differences

219in factor loadings were identified, but the overall factor

220structure of the Italian version was consistent with that of

221the English language version confirming its suitability for

222use. Since this study was conducted, a DVD-based teaching

223program that covers the four parts of the scale has become

224available with visual and verbal (English language)

225instructions for the uniform application [7]. It is planned

Table 1 Baseline characteristics

Patients (n = 378)

Ethnicity (%)

Non-hispanic white 100

Other –

Gender (%)

Male 59.8

Female 40.2

Age (years, mean ± SD) 64.5 ± 10.3

H&Y stage 2.1 ± 0.7

Years since PD diagnosis (mean ± SD) 7.1 ± 5.6

Years of education (mean ± SD) 9.6 ± 4.4

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226 that this teaching program will also be translated into dif-

227 ferent languages and that this will further encourage

228 international consistency of rating with this important new

229 tool.

230 The Italian version of the MDS-UPDRS is the first offi-

231 cially approved non-English translation. The global program

232 now includes two other completed translations (Spanish and

233 Estonian) in statistical review and other language teams are

234 organized for Chinese, Dutch, French, German, Hebrew,

235 Japanese, Korean, Russian, Slovakian and Thai versions.

236 Other language teams are encouraged to organize and par-

237 ticipate (email contact: CG Goetz, [email protected]).

238 Large-scale clinical trials using the MDS-UPDRS will

239necessarily recruit centers in countries where official trans-

240lations are available, so this effort has very practical impli-

241cations for future patient and research programs.

242Acknowledgments The authors wish to acknowledge all the243investigators and patients who took part in this translation. Editorial244assistance (editing and referencing) was provided by Anita Chadha-245Patel PhD, who was supported by an unrestricted grant from the246Neureca Foundation for movement disorders, Milan, Italy.

247Appendix

248See Table 3

Table 2 Confirmatory factor analysis model fit

Part I: Non-motor aspects of experiences of daily living (a 2-factor model)

Italian CFI = 0.94, RMSEA = 0.07 (374 patients)

English language CFI = 0.96, RMSEA = 0.06 (849 patients)

Part II: Motor aspects of experience of daily living (a 3-factor model)



Part III: Motor examination (a 7-factor model)



Part IV: Motor complications (a 2-factor model)



CFI comparative fit index, RMSEA root mean square error of approximation

Table 3 MDS-UPDRS Italian Validation Study Group

Investigators Affiliation

Monica Bandettini di

Poggio

Department of Neurosciences, Ophthalmology and Genetics, Centre for Movement Disorders, University of Genoa,

Genoa, Italy

Giovanni Fabbrini Department of Neurology and Psychiatry, Sapienza University of Rome

Flavio Di Stasio Department of Neurology and Psychiatry, Sapienza University of Rome

Michele Tinazzi Dipartimento di Scienze Neurologiche, Neuropsicologiche, Morfologiche e Motorie, Universita di Verona

Tommaso Bovi Dipartimento di Scienze Neurologiche, Neuropsicologiche, Morfologiche e Motorie, Universita di Verona

Silvia Ramat Department of Neurosciences, University of Florence

Sara Meoni Department of Neurosciences, University of Florence

Gianni Pezzoli Parkinson Institute, Istituti Clinici di Perfezionamento, Milan, Italy

Margherita Canesi Parkinson Institute, Istituti Clinici di Perfezionamento, Milan, Italy

Paolo Martinelli Dipartimento Scienze Neurologiche Universita di Bologna Italy

Cesa Lorella Maria

Scaglione

Dipartimento Scienze Neurologiche Universita di Bologna Italy

Aroldo Rossi Azienda Ospedaliera - Universita di Perugia, Perugia (Italy)

Nicola Tambasco Azienda Ospedaliera - Universita di Perugia, Perugia (Italy)

Gabriella Santangelo Department of Psychology, Second University of Naples, Caserta and IDC Hermitage Capodimonte, Naples

Marina Picillo Department of Psychology, Second University of Naples, Caserta and IDC Hermitage Capodimonte, Naples

Letterio Morgante Dipartimento di Neuroscienze, Scienze Psichiatriche ed Anestesiologiche, Universita’ di Messina

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249250 References

251 1. Fahn S, Elton RL. Unified Parkinson’s Disease Rating Scale. In:252 Recent developments in Parkinson’s disease: MacMillan Health-253 care Information, 1987:153–164254 2. Movement Disorder Society Task Force on Rating Scales for255 Parkinson’s Disease (2003) The Unified Parkinson’s Disease256 Rating Scale (UPDRS): status and recommendations. Mov Disord257 18:738–750258 3. Goetz CG, Tilley BC, Shaftman SR et al (2008) Movement259 Disorder Society-sponsored revision of the Unified Parkinson’s260 Disease Rating Scale (MDS-UPDRS): scale presentation and261 clinimetric testing results. Mov Disord 23:2129–2170

2624. Goetz CG, Fahn S, Martinez-Martin P et al (2006) Movement263Disorder Society-sponsored revision of the Unified Parkinson’s264Disease Rating Scale (MDS-UPDRS): Process, format, and265clinimetric testing plan. Mov Disord 22(1):41–472665. Hatcher L (1994) A step-by-step approach to using the SAS system267for factor analysis and structural equation modeling. SAS Institue,268Cary2696. Gorsuch R (1983) Factor analysis, 2nd edn. Lawrence Erlbaum270Associations, Hillsdale2717. Goetz CG, Stebbins GT, Chmura TA, Fahn S, Poewe W, Tanner272CM (2010) Teaching program for the Movement Disorder Society-273sponsored revision of the Unified Parkinson’s Disease Rating274Scale: (MDS-UPDRS). Mov Disord 25:1190–1194

275

Table 3 continued

Investigators Affiliation

Francesca

Morgante

Dipartimento di Neuroscienze, Scienze Psichiatriche ed Anestesiologiche, Universita’ di Messina

Rocco Quatrale Neurology Unit University Hospital S.Annna Ferrara, Italy

MariaChiara Sensi Neurology Unit University Hospital S.Annna Ferrara, Italy

Manuela Pilleri Department for Parkinson disease, IRCCS San Camillo Venezia

Roberta Biundo Department for Parkinson disease, IRCCS San Camillo Venezia

Giampietro

Nordera

Casa di Cura Villa Margherita, Arcugnano (Vicenza) Italy

Antonella Caria Casa di Cura Villa Margherita, Arcugnano (Vicenza) Italy

Claudio Pacchetti Parkinson’s Dis. and Mov. Dis. Unit, Fondazione Istituto Neurologico Nazionale ‘‘C. Mondino’’, IRCCS,

Roberta Zangaglia Parkinson’s Dis. and Mov. Dis. Unit, Fondazione Istituto Neurologico Nazionale ‘‘C. Mondino’’, IRCCS,

Leonardo Lopiano Universita degli Studi di Torino, Dipartimento di Neuroscienze, SCDU Neurologia 4

Maurizio Zibetti Universita degli Studi di Torino, Dipartimento di Neuroscienze, SCDU Neurologia 4

Mario Zappia Dipartimento di Neuroscienze U.O.C. di Neurologia - Clinica Neurologica dell’Universita degli Studi di Catania, Catania

(Italy)

Alessandra

Nicoletti

Dipartimento di Neuroscienze U.O.C. di Neurologia - Clinica Neurologica dell’Universita degli Studi di Catania, Catania

(Italy)

Aldo Quattrone Dipartimento di Scienze Mediche dell’Universita degli Studi Magna Graecia, Catanzaro

Maria Salsone Dipartimento di Scienze Mediche dell’Universita degli Studi Magna Graecia, Catanzaro

Gianni Cossu S.C. di Neurologia - A.O. ‘‘G. Brotzu’’ Cagliari

Daniela Murgia S.C. di Neurologia - A.O. ‘‘G. Brotzu’’ Cagliari

Alberto Albanese Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano

Francesca Del

Sorbo

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano

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