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The Movement Disorder Society-Non-Motor Scale (MDS-NMS): Results From the Initial Phases of an International Validation K Ray Chaudhuri 1 , Daniel Weintraub 2 , Anette Schrag 3 , Pablo Martinez-Martin 4 on behalf of EUROPAR and the IPMDS Non-Motor PD Study Group. 1 Neurology and Clinical Neuroscience, King's College, King's College Hospital and University Hopsital Lewisham, London, UK. 2 Parkinson's Disease and Mental Illness Research, Education and Clinical Centers, Philadelphia Veterans Affairs Medical Center and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States; 3 Department of Clinical Neurosciences, UCL Institute of Neurology and Luton & Dunstable University Hospital, London, United Kingdom and 4 National Center of Epidemiology and CIBERNED, Carlos III Institute of Health, Madrid, Spain. A significant advancement in the recognition and study of NMS in Parkinson’s disease (PD) was the development of o the NMS questionnaire (NMS-Quest) 1 o the Non-Motor Symptoms Scale (NMSS) 2,3 NMSS is increasingly used in clinical trials, e. g. RECOVER (UCB), DUOGLOBE (Abbvie), PANDA (Mundipharma), TOLEDO (Britannia) WHY DO WE NEED NEW NMSS? To keep pace with the extensive developments that have taken place in the field of PD NMS since 2007 when NMSS was validated In the UPDRS and MDS-UPDRS each NMS disorder(s) is covered by a single item only with a 5-point rating, which provides limited data To revise the Non-Motor Symptom Scale (NMSS) and develop a new up to date version: 1. Consolidation, refinement and improvement in wording and scoring, including the anchors and scoring for each item 2. Clearer grouping of individual items into disorders or domains 3. Inclusion of symptoms/disorders not covered or covered in a limited fashion in the NMSS (e.g., multi-domain cognitive impairment, impulse control and related disorders (ICDs), non-motor fluctuations (NMFs), fatigue as a distinct syndrome, and some dysautonomia symptoms) 4. Ensuring that the instrument is appropriate for use as global NMS measure in future clinical trials CONCLUSIONS: The pvMDS-NMS showed satisfactory basic clinimetric attributes of the scale while some items and domains performed suboptimally. The definitive version of the MDS-NMS is now to be validated. Phase 1: A preliminary version of MDS-NMS (pvMDS-NMS) was developed including 15 domains with 63 items, each one scoring for: - frequency (0 - 4) - severity (0 - 4) - a total score (frequency x severity; 0 - 16) A higher score on an item indicates more severe symptoms Additionally, the scale includes an optional section for evaluating non-motor fluctuations (NMF) in 7 domains, scored 0 - 4 for each item (change from “on” to “off” period). Phase 2: A pilot study (UK and USA) was performed in 69 non demented PD patients and 19 healthy controls by 20 experienced neurologists using the neurologist-based pvMDS- NMS and questionnaires about the MDS-NMS for neurologists, patients and controls. Statistical analysis addressed data quality, missing values, scores distribution, and preliminary reliability. Both phases have been completed. This project was funded by the Movement Disorder Society. This poster presents independent research supported by the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre and Dementia Unit at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. We thank Alexandra Rizos for creating this poster. 1 KR Chaudhuri et al., Mov Disord Vol. 21, No. 7, 2006, pp. 916–923 2 KR Chaudhuri et al., Vol. 22, No. 13, 2007, pp. 1901– 1911 3 P Martinez-Martin et al., Neurology 2009;73: 1584–1591 Biomedical Research Centre and Dementia Unit at South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience King’s College London Endorsed by Graph 2: Feedback on provisional MDS-NMS from Neurologists/ Geriatricians & PD patients 85% 4% 88% 12% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Neurologists Patients Relevant Useful Comprehensive Too long Complicated wording Complicated scoring Percentage of YES responses to questions Graph 1: Provisional MDS-NMS Total mean score 0 20 40 60 80 100 120 140 160 180 200 PD Patients Controls 500 91.6 ± 100.5 28.5± 12.0 Mean (Standard deviation) The pvMDS-NMS scores were fully computable in 95.64%. Total mean score (±SD) in PD patients was 91.6±100.5 (range: 10–491). All domains, except Sleep and Wakefulness (7.2%) showed floor effect (low endorsement of symptoms) >15% (22.1–79.7%), but none had relevant ceiling effect (high endorsement of symptoms) (1.4–4.5%). Cronbach's alpha index was satisfactory for 9/15 domains. Inter-item and Item-total correlations were globally satisfactory, and the item homogeneity index (standard value, >0.30) was satisfactory for most domains, except for : (1) Impulse control and related disorders, (2) Other Neuropsychiatric symptoms, and (3) Other Symptoms The optional NMF section was completed by 71%, with similar findings in score distribution to the main pvMDS-NMS. BACKGROUND METHODS OBJECTIVES: RESULTS: REFERENCES ACKNOWLEDGEMENTS

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Page 1: and Neuroscience King’s College London The Movement ...parkinsons-london.co.uk/wp-content/uploads/2016/08/Poster-MDS-NM… · NMS and questionnaires about the MDS-NMS for neurologists,

The Movement Disorder Society-Non-Motor Scale (MDS-NMS): Results From the Initial Phases of an International Validation

K Ray Chaudhuri1, Daniel Weintraub2, Anette Schrag3, Pablo Martinez-Martin4 on behalf of EUROPAR and the IPMDS Non-Motor PD Study Group.

1Neurology and Clinical Neuroscience, King's College, King's College Hospital and University Hopsital Lewisham, London, UK. 2Parkinson's Disease and Mental Illness Research, Education and Clinical Centers, Philadelphia Veterans Affairs Medical Center and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States; 3Department of Clinical Neurosciences, UCL Institute of Neurology and Luton & Dunstable University Hospital, London, United Kingdom and 4National Center of

Epidemiology and CIBERNED, Carlos III Institute of Health, Madrid, Spain.

BACKGROUND:

• A significant advancement in the recognition and study of NMS in Parkinson’s disease (PD) was the development of o the NMS questionnaire (NMS-Quest)1 o the Non-Motor Symptoms Scale (NMSS) 2,3

• NMSS is increasingly used in clinical trials, e. g. RECOVER (UCB), DUOGLOBE (Abbvie), PANDA (Mundipharma), TOLEDO (Britannia)

WHY DO WE NEED NEW NMSS?

• To keep pace with the extensive developments that have taken place in the field of PD NMS since 2007 when NMSS was validated

• In the UPDRS and MDS-UPDRS each NMS disorder(s) is covered by a single item only with a 5-point rating, which provides limited data

RESULTS:

OBJECTIVES: To revise the Non-Motor Symptom Scale (NMSS) and develop a new up to date version:

1. Consolidation, refinement and improvement in wording and scoring, including the anchors and scoring for each item

2. Clearer grouping of individual items into disorders or domains

3. Inclusion of symptoms/disorders not covered or covered in a limited fashion in the NMSS (e.g., multi-domain cognitive impairment, impulse control and related disorders (ICDs), non-motor fluctuations (NMFs), fatigue as a distinct syndrome, and some dysautonomia symptoms)

4. Ensuring that the instrument is appropriate for use as global NMS measure in future clinical trials

CONCLUSIONS:

The pvMDS-NMS showed satisfactory basic clinimetric attributes of the scale while

some items and domains performed suboptimally.

The definitive version of the MDS-NMS is now to be validated.

METHODS: Phase 1: A preliminary version of MDS-NMS (pvMDS-NMS) was developed including 15 domains with 63 items, each one scoring for:

- frequency (0 - 4) - severity (0 - 4) - a total score (frequency x severity; 0 - 16)

A higher score on an item indicates more severe symptoms

Additionally, the scale includes an optional section for evaluating non-motor fluctuations (NMF) in 7 domains, scored 0 - 4 for each item (change from “on” to “off” period).

Phase 2: A pilot study (UK and USA) was performed in 69 non demented PD patients and 19 healthy controls by 20 experienced neurologists using the neurologist-based pvMDS-NMS and questionnaires about the MDS-NMS for neurologists, patients and controls.

Statistical analysis addressed data quality, missing values, scores distribution, and preliminary reliability.

Both phases have been completed.

ACKNOWLEGMENTS: This project was funded by the Movement Disorder Society. This poster presents independent research supported by the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre and Dementia Unit at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. We thank Alexandra Rizos for creating this poster.

REFERENCES: 1 KR Chaudhuri et al., Mov Disord Vol. 21, No. 7, 2006, pp. 916–923

2 KR Chaudhuri et al., Vol. 22, No. 13, 2007, pp. 1901– 1911 3 P Martinez-Martin et al., Neurology 2009;73: 1584–1591

Biomedical Research Centre and Dementia Unit at

South London and Maudsley NHS Foundation

Trust and the Institute of Psychiatry, Psychology

and Neuroscience King’s College London

Endorsed by

Graph 2: Feedback on provisional MDS-NMS from Neurologists/ Geriatricians & PD patients

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Relevant Useful

Comprehensive

Too long Complicated wording Complicated scoring

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Graph 1: Provisional MDS-NMS Total mean score

0

20

40

60

80

100

120

140

160

180

200

PD Patients Controls

500

91.6 ± 100.5

28.5± 12.0

Mea

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• The pvMDS-NMS scores were fully computable in 95.64%. • Total mean score (±SD) in PD patients was 91.6±100.5 (range: 10–491). • All domains, except Sleep and Wakefulness (7.2%) showed floor effect (low endorsement of symptoms) >15% (22.1–79.7%), but none had

relevant ceiling effect (high endorsement of symptoms) (1.4–4.5%). • Cronbach's alpha index was satisfactory for 9/15 domains. • Inter-item and Item-total correlations were globally satisfactory, and the item homogeneity index (standard value, >0.30) was satisfactory

for most domains, except for : (1) Impulse control and related disorders, (2) Other Neuropsychiatric symptoms, and (3) Other Symptoms • The optional NMF section was completed by 71%, with similar findings in score distribution to the main pvMDS-NMS.

BACKGROUND METHODS

OBJECTIVES:

RESULTS:

REFERENCES

ACKNOWLEDGEMENTS