The Movement Disorder Society Version of the Unified Parkinson's Disease Rating Scale MDS-UPDRS

Transcription

1 The Movement Disorder ociety Version of the Unified Parkinson's Disease ating cale Questionnaire upplement to the tudy Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by CDIC and National Institute of Neurological Disorders and trokes (NIND) Notes to eaders This implementation guide is intended to be used with other CDIC User Guides for specific Therapeutic/Disease Areas and follows the CDIC tudy Data Tabulation Model Implementation Guide for Human Clinical trials. evision History Date Version ummary of Changes The Movement Disorder ociety version of the Unified Parkinson's Disease ating cale () Draft

2 CDIC DTM Questionnaire upplement (Version.0) Introduction This document describes the CDIC implementation of the questionnaire, a standard questionnaire administered on a CF that is typically used in clinical trials. contains data elements about non-motor and motor features of Parkinson's disease, it is the new version of the sponsored by the MD. The CF preceded the CDIC CDAH CF standards and based on its copyright status, cannot be modified to CDAH standards. The representation of data collected for this questionnaire is based on the tudy Data Tabulation Model Implementation Guide (DTMIG) Q domain table, which can be found at the CDIC website at These implementation details for this specific questionnaire are meant to be used in conjunction with the DTMIG, but are recorded separately since this questionnaire may be used in many different therapeutic area implementations. All questionnaire documentation can be found on the CDIC web site ( The CDIC Intellectual Property Policy can be found on the CDIC web site at: ( epresentations and Warranties, Limitations of Liability, and Disclaimers This document is a supplement to the tudy Data Tabulation Model Implementation Guide for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the DTMIG for a complete version of this material. 2 Copyright tatus CDIC has obtained permission to include the questionnaire as part of CDIC Data tandards. This means that CDIC developed QTETCD and QTET for each question based on the actual question text on the questionnaire. The instrument itself was not changed. The CDIC documentation of this instrument consists of: () controlled terminology, (2) standard database structure with examples and (3) case report forms annotated with the CDIC DTMIG submission values. This is a separate document bundled with the documentation. CDIC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder. CDIC acknowledges the Movement Disorder ociety (MD) for the agreement to include the scale in the CDIC data standards. Copyright information for the scale is the Movement Disorder ociety (MD), All ight eserved. 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 2 August 9, 202

3 CDIC DTM Questionnaire upplement (Version.0) The author s consent ensures that the data captured using this instrument will be done so in a standardized manner thereby facilitating collection, database storage, reporting and regulatory review of that data. CDIC wants to emphasize that the existing copyright status as well as the existing procedures for licensing fees and using the instrument will remain exactly as they have been. Please follow the instrument owner s own mechanisms for permissions and licenses if you have a need to use this questionnaire. 3 The Q Domain Model 3. Assumptions for the Questionnaire Domain Model All assumptions for the Q domain from the DTMIG apply for this supplemental implementation guide including those referenced in the CDIC notes. Additionally, the following assumptions apply to the Movement Disorder ociety version of the Unified Parkinson's Disease ating cale: The Movement Disorder ociety version of the Unified Parkinson's Disease ating cale (): The has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). Part I has two components: IA concerns a number of behaviors that are assessed by the investigator with all pertinent formation from patients and caregivers, and IB is completed by the patient with or without the aid of the caregiver, but independently of the investigator. These sections can, however, be reviewed by the rater to ensure that all questions are answered clearly and the rater can help explain any perceived ambiguities. Part II is designed to be a self-administered questionnaire like Part IB, but can be reviewed by the investigator to ensure completeness and clarity. Of note, the official versions of Part IA, Part IB and Part II of the do not have separate on or off ratings. However, for individual programs or protocols the same questions can be used separately for on and off. Part III has instructions for the rater to give or demonstrate to the patient; it is completed by the rater. Part IV has instructions for the rater and also instructions to be read to the patient. This part integrates patient-derived information with the rater s clinical observations and judgments and is completed by the rater. The time period of evaluation is populated in the QEVLINT field in IO 860 format when the evaluation interval can be precisely described as duration. pecific points in time should use the QDTC field. In cases where the evaluation interval cannot be precisely described as an IO 860 duration, the evaluation period should be represented using the upplemental Qualifier EVLINTTX. The evaluator of the questionnaire is stored in QEVAL and for the form the selection of the evaluator is based on each section of the form as follows: Part I QEVAL= Part IB QEVAL=UBJECT Part II QEVAL=UBJECT Part III QEVAL= Part IV QEVAL= Terminology: o QCAT, QTETCD and QTET are approved CDIC controlled terminology. 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 3 August 9, 202

4 CDIC DTM Questionnaire upplement (Version.0) o A full list of value sets for QOE, QTEC and QTEN fields is provided in ection 4: Mapping trategy. o UPPQ is used for additional data standardization with those data items listed in ection 5: upplemental Qualifiers. 3.2 Example for the MOVEMENT DIODE OCIETY VEION of the UNIFIED PAKINON DIEAE ATING CALE Domain Model The example below shows the terminology for QCAT, QTET, QTETCD and QOE that is utilized for this scale. 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 4 August 9, 202

5 CDIC DTM Questionnaire upplement (Version.0) Example: The Movement Disorder ociety version of the Unified Parkinson's Disease ating cale () This example shows data from one subject collected at one visit for a questionnaire. The example uses standard controlled terminology for QTETCD, QTET, QCAT, QCAT and QOE for the measure. QEVAL is used for the rater response in sections IA, IB, II, II and IV. ows -72: epresent the 72 questions from the. All original results are represented with the standard terminology in QOE. This result is then transformed into a tandard Numeric score in QTEN. TUDYID=TUDY0, DOMAIN=Q and UUBJID=2324-P00 are not shown in the example due to the foot print of the table. qs.xpt o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD20 UPD202 UPD203 UPD204 UPD2-Cognitive Impairment Part A: Non- Living (nm- Part A: Non- Living (nm- UPD2- Hallucinations and Psychosis UPD2-Depressed Mood UPD2-Anxious Mood Part A: Non- Living (nm- Part A: Non- Normal: No cognitive impairment light: Illusions or non-formed hallucinations, but patient recognizes them without loss of insight Mild: Depressed mood that is sustained over days, but without interference with normal activities and social interactions Moderate: Anxious feelings interfere with, but do not QOE U QTE C QTE N 0 0 QEVAL VIITNU M QEVLIN T -PW -PW -PW -PW 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 5 August 9, 202

6 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE 5 5 UPD205 UPD2-Apathy 6 6 UPD UPD UPD UPD UPD20 UPD2-Ftrs Dopa Dysregulationyn d UPD2 UPD2- leep Problems UPD2-Daytime leepiness UPD2-Pain and other ensations UPD2-Urinary Problems Part B: Non- Living (nm- Part B: Non- Living (nm- Part A: Non- Living (nm- Part A: Non- Living (nm- Part B: Non- Living (nm- Part B: Non- Living (nm- preclude, the patient s ability to carry out normal activities and social interactions evere: Passive and withdrawn, complete loss of initiative light: Problems are present but usually do not cause any difficulties for the patient or family/caregive r evere: I usually do not sleep for most of the night Mild: ometimes I fall asleep when alone and relaxing. For example, while reading or watching TV Normal: No uncomfortable feelings Moderate: Urine problems cause a lot of QOE U QTE C QTE N QEVAL VIITNU M QEVLIN T -PW -PW UBJECT -PW UBJECT -PW 0 0 UBJECT -PW UBJECT -PW 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 6 August 9, 202

7 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD2 UPD22 UPD2- Constipation Problems Part B: Non- Living (nm- Part B: Non- Living (nm- Part B: Non- Living (nm- UPD2- Lightheadedness on tanding 3 3 UPD23 UPD2-Fatigue UPD220 UPD2-peech 5 5 UPD UPD UPD2204 UPD2-aliva and Drooling UPD2-Chewing and wallowing UPD2-Eating Tasks Part II: Living (M- Part II: Living (M- Part II: Living (nm- Part II: Living (M- difficulties with my daily activities, including urine accidents Mild: Constipation causes me to have some troubles doing things or being comfortable Moderate: Dizzy or foggy feelings cause me to sit or lie down to avoid fainting or falling Normal: No fatigue Mild: My speech causes people to ask me to occasionally repeat myself, but not everyday light: I have too much saliva, but do not drool Moderate. I choked at least once in the past week Normal: Not at all (No QOE U QTE C QTE N QEVAL VIITNU M QEVLIN T UBJECT -PW UBJECT -PW 0 0 UBJECT -PW UBJECT -PW UBJECT -PW UBJECT -PW 0 0 UBJECT -PW 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 7 August 9, 202

8 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE 8 8 UPD2205 UPD2-Dressing 9 9 UPD2206 UPD2-Hygiene UPD2207 UPD UPD2209 Living (M- Part II: Living (M- Part II: Living (M- Part II: Living (M- Part II: Living (M- Part II: Living (M- Part II: Living (M- Part II: Living (M- Part II: UPD2- Handwriting UPD2-Doing Hobbies/Other Activities UPD2-Turning in Bed UPD220 UPD2-Tremor UPD UPD222 UPD2-Get Out of Bed/Car/Deep Chair UPD2-Walking and Balance problems) light: I am slow but I do not need help Normal: Not at all (no problems) Mild: ome words are unclear and difficult to read Moderate: I have major problems doing these activities, but still do most evere: I am unable to turn over without help from someone else Normal: Not at all. I have no shaking or tremor Normal: Not at all (no problems) light: I am slightly slow or QOE U QTE C QTE N QEVAL VIITNU M QEVLIN T UBJECT -PW 0 0 UBJECT -PW UBJECT -PW UBJECT -PW UBJECT -PW 0 0 UBJECT -PW 0 0 UBJECT -PW UBJECT -PW 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 8 August 9, 202

9 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD223 UPD2-Freezing UPD23A UPD23B UPD23C UPD23C 3 3 UPD UPD UPD2303A UPD2-Medication for PD UPD2-Clinical tate on Meds UPD2-Taking Levodopa UPD2-Minutes ince Levodopa Dose UPD2-peech Problems UPD2-Facial Expression UPD2-igidity Neck Living (M- Part II: Living (M- may drag a leg. I never use a walking aid Normal: Not at all (no problems) QOE U QTE C QTE N Yes ON: On is the typical functional state when patients are receiving medication and have a good response QEVAL VIITNU M QEVLIN T 0 0 UBJECT -PW No minute Mild: Loss of modulation, diction, or volume, with a few words unclear, but the overall sentences easy to follow Moderate: Masked facies with lips parted some of the time when the mouth is at rest Mild: igidity detected without the activation maneuver, but full range of -P0 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 9 August 9, 202

10 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD2303B UPD2303C UPD2303D UPD2303E UPD2304A UPD2304B UPD2-igidity T Upper Extremity UPD2-igidity Left Upper Extremity UPD2-igidity T Lower Extremity UPD2-igidity Left Lower Extremity UPD2-ight Finger Tapping UPD2-Left Finger Tapping QOE U QTE C QTE N motion is easily achieved light: igidity only detected with activation maneuver Normal: No rigidity 0 0 light: igidity only detected with activation maneuver evere: igidity detected without the activation maneuver and full range of motion not achieved Mild: Any of the following: a) 3 to 5 interruptions during tapping; b) mild slowing; c) the amplitude decrements midway in the 0-tap sequence Moderate: Any of the following: a) more than 5 interruptions during tapping or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) the amplitude decrements QEVAL VIITNU M QEVLIN T 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 0 August 9, 202

11 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD2305A UPD2305B UPD2306A UPD2306B 44 UPD2307A UPD2-ight Hand Movements UPD2-Left Hand Movements UPD2-Pron/up Movement of T Hand UPD2-Pron/up Movement of Left Hand UPD2-ight Toe Tapping starting after the st tap evere: Cannot or can only barely perform the task because of slowing, interruptions or decrements Moderate: Any of the following: a) more than 5 interruptions during the movement or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) the amplitude decrements starting after the st openand-close sequence Normal: No problems 0 0 QOE U QTE C QTE N light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the movement; b) slight slowing; c) the amplitude decrements near the end of the sequence Moderate: Any of the QEVAL VIITNU M QEVLIN T 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page August 9, 202

12 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD2307B UPD2308A UPD2308B UPD2309 UPD2-Left Toe Tapping UPD2-ight Leg Agility UPD2-Left Leg Agility UPD2-Arising from Chair following: a) more than 5 interruptions during the tapping movements or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) amplitude decrements after the first tap QOE U QTE C QTE N evere: Cannot or can only barely perform the task because of slowing, interruptions or decrements Normal: No problems 0 0 light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the movement; b) slight slowing; c) amplitude decrements near the end of the task light: Arising is slower than normal; or may need more than one attempt; or may need to QEVAL VIITNU M QEVLIN T 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 2 August 9, 202

13 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD230 UPD2-Gait UPD UPD232 UPD2-Freezing of Gait UPD2-Postural tability UPD233 UPD2-Posture UPD UPD235A UPD235B UPD2-Body Bradykinesia UPD2-Postural Tremor of ight Hand UPD2-Postural Tremor of left Hand move forward in the chair to arise. No need to use the arms of the chair QOE U QTE C QTE N Normal: No problems 0 0 light: Freezes on starting, turning or walking through doorway with a single halt during any of these events, but then continues smoothly without freezing during straight walking evere: Very unstable, tends to lose balance spontaneously or with just a gentle pull on the shoulders Normal: No problems 0 0 light: light global slowness and poverty of spontaneous movements Mild: Tremor is at least but less than 3 cm in amplitude Mild: Tremor is at least but less than 3 cm in amplitude QEVAL VIITNU M QEVLIN T -P0 -P UPD236A UPD2-Kinetic Moderate: 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 3 August 9, 202

14 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE UPD236B UPD237 A UPD237 B UPD237 C UPD237 D UPD237E UPD238 Tremor of ight Hand UPD2-Kinetic Tremor of Left Hand UPD2-est Tremor Amplitude UE UPD2-est Tremor Amplitude LUE UPD2-est Tremor Amplitude LE UPD2-est Tremor Amplitude LLE UPD2-est Tremor Amplitude Lip/Jaw UPD2- Consistency of est Tremor UPD UPD UPD UPD UPD UPD Tremor is at least 3 but less than 0 cm in amplitude Moderate: Tremor is at least 3 but less than 0 cm in amplitude QOE U QTE C QTE N Normal: No tremor 0 0 light.:< cm in maximal amplitude Mild: > cm but < 3 cm in maximal amplitude Moderate: 3-0 cm in maximal amplitude. light: < cm in maximal amplitude light: Tremor at rest is present < 25% of the entire examination period QEVAL VIITNU M QEVLIN T -P0 -P0 -P0 -P0 -P0 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 4 August 9, 202

15 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE DYKINEIA IMPACT ON PAT III ATING DYKINEIA IMPACT ON PAT III ATING UPD2DA UPD2DB UPDHY A. DYKINEIA [exclusive of OFF-state dystonia] A. DYKINEIA [exclusive of OFF-state dystonia] B. MOTO FLUCTUATION B. MOTO FLUCTUATION UPD240 UPD2402 UPD2403 UPD2404 UPD2- Dyskinesias During Exam UPD2- Movements Interfere atings UPD2-Hoehn and Yahr tage UPD2-Time pent with Dyskinesias UPD2- Functional Impact Dyskinesias UPD2-Time pent in the Off tate UPD2- Functional Impact Fluctuations UPD UPD UPD UPD UPD UPD UPD Part IV: Complication s Part IV: Complication s Part IV: Complication s Part IV: Complication s QOE U QTE C QTE N No 0 0 Yes Unilateral involvement only Mild: 26-50% of waking day Normal: No dyskinesias or no impact by dyskinesias on activities or social interactions Moderate: 5-75% of waking day evere: Fluctuations impact on function to the point that, during OFF, the patient usually does not perform most activities or QEVAL VIITNU M QEVLIN T PW PW PW PW 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 5 August 9, 202

16 CDIC DTM hort Form Questionnaire upplement (Version.0) o w QE Q QGPID QTETCD QTET QCAT QCAT QOE B. MOTO FLUCTUATION C. OFF DYTONIA UPD2405 UPD2406 UPD2- Complexity Fluctuations UPD2-Painful Off-state Dystonia UPD participate in most social interactions that are performed during ON periods Moderate: OFF times are predictable some of the time (26-50%) light: < 25% of time in OFF state UPD Part IV: Complication s Part IV: Complication s QOE U QTE C QTE N QEVAL VIITNU M QEVLIN T PW PD The primary source of information, details on Dyskinesia, details on OFF hours and details on Dystonia is to be populated in UPPQ as follows. The standard terminology for QNAM and QLABEL are listed below. TUDYID DOMAIN UUBJID IDVA IDVAVAL QNAM QLABEL QVAL QOIG QEVAL TUDY0 Q 2324-P000 QEQ PIMC Primary ource of Information PATIENT CF TUDY0 Q 2324-P000 QEQ 7 PIMC Primary ource of Information CAEGIVE CF TUDY0 Q 2324-P000 QEQ 67 TOTAWK Total Hours Awake 6 CF TUDY0 Q 2324-P000 QEQ 67 TOTDYK Total Hours with Dyskinesia 8 CF TUDY0 Q 2324-P000 QEQ 67 PCTDYK Percent Dyskinesia 50% CF TUDY0 Q 2324-P000 QEQ 69 TOTAWK Total Hours Awake 6 TUDY0 Q 2324-P000 QEQ 69 TOTHOFF Total Hours OFF 2 CF TUDY0 Q 2324-P000 QEQ 69 PCTHOFF Percent of Hours OFF 75% CF TUDY0 Q 2324-P000 QEQ 72 TOTHOFF Total Hours OFF 4 TUDY0 Q 2324-P000 QEQ 72 TOTOFDY Total Hours OFF with Dystonia CF TUDY0 Q 2324-P000 QEQ 72 PCTOFDY Percent of OFF with Dystonia 25% CF 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 6 August 9, 202

17 CDIC DTM Questionnaire upplement (Version.0) 4 DTM Mapping trategy specific mapping strategy: This section is used for reference with the annotated CF for further details on the CF data capture and to understand the alignment of the questionnaire to the DTM Q domain. It also provides guidance on how the result variables (QOE, QOEU, QTEC, QTEN, and QTEU) should be populated for each questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated. QTETCD= UPD20 QTET=UPD2-Cognitive Impairment Normal: No cognitive impairment 0 0 light: Impairment appreciated by patient or caregiver with no concrete interference with the patient s ability to carry out normal activities and social interactions Mild: Clinically evident cognitive dysfunction, but only minimal interference with the patient s ability to carry out normal activities and social interactions Moderate: Cognitive deficits interfere with but do not preclude the patient s ability to carry out normal activities and social interactions evere: Cognitive dysfunction precludes the patient s ability to carry out normal activities and social interactions QTETCD= UPD202 QTET=UPD2-Hallucinations and Psychosis Normal: No hallucinations or psychotic behaviour 0 0 light: Illusions or non-formed hallucinations, but patient recognizes them without loss of insight Mild: Formed hallucinations independent of environmental stimuli. No loss of insight Moderate: Formed hallucinations with loss of insight evere: Patient has delusions or paranoia QTETCD= UPD203 QTET=UPD2-Depressed Mood Normal: No depressed mood 0 0 light: Episodes of depressed mood that are not sustained for more than one day at a time. No interference with patient s ability to carry out normal activities and social interactions Mild: Depressed mood that is sustained over days, but without interference with normal activities and social interactions Moderate: Depressed mood that interferes with, but does not preclude, the patient s ability to carry out normal activities and social interactions evere: Depressed mood precludes patient s ability to carry out normal activities and social interactions QTETCD= UPD204 QTET=UPD2-Anxious Mood Normal: No anxious feelings Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 7 August 9, 202

18 CDIC DTM Questionnaire upplement (Version.0) light: Anxious feelings present but not sustained for more than one day at a time. No interference with patient s ability to carry out normal activities and social interactions Mild: Anxious feelings are sustained over more than one day at a time, but without interference with patient s ability to carry out normal activities and social interactions Moderate: Anxious feelings interfere with, but do not preclude, the patient s ability to carry out normal activities and social interactions evere: Anxious feelings preclude patient s ability to carry out normal activities and social interactions QTETCD= UPD205 QTET=UPD2-Apathy Normal: No apathy 0 0 light: Apathy appreciated by patient and/or caregiver, but no interference with daily activities and social interactions Mild: Apathy interferes with isolated activities and social interactions Moderate: Apathy interferes with most activities and social interactions evere: Passive and withdrawn, complete loss of initiative QTETCD= UPD206 QTET=UPD2-Ftrs Dopa Dysregulationynd Normal: No problems present 0 0 light: Problems are present but usually do not cause any difficulties for the patient or family/caregiver Mild: Problems are present and usually cause a few difficulties in the patient s personal and family life Moderate: Problems are present and usually cause a lot of difficulties in the patient s personal and family life evere: Problems are present and preclude the patient s ability to carry out normal activities or social interactions or to maintain previous standards in personal and family life QTETCD= UPD207 QTET=UPD2UPD2-leep Problems Normal: No problems 0 0 light: leep problems are present but usually do not cause trouble getting a full night of sleep Mild: leep problems usually cause some difficulties getting a full night of sleep Moderate: leep problems cause a lot of difficulties getting a full night of sleep, but I still usually sleep for more than half the night evere: I usually do not sleep for most of the night QTETCD= UPD208 QTET=UPD2-Daytime leepiness Normal: No daytime sleepiness 0 0 light: Daytime sleepiness occurs but I can resist and I stay awake Mild: ometimes I fall asleep when alone and relaxing. For example, while 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 8 August 9, 202

19 CDIC DTM Questionnaire upplement (Version.0) reading or watching TV Moderate: I sometimes fall asleep when I should not. For example, while eating or talking with other people evere: I often fall asleep when I should not. For example, while eating or talking with other people QTETCD= UPD209 QTET=UPD2-Pain and other ensations Normal: No uncomfortable feelings 0 0 light: I have these feelings. However, I can do things and be with other people without difficulty Mild: These feelings cause some problems when I do things or am with other people Moderate: These feelings cause a lot of problems, but they do not stop me from doing things or being with other people evere: These feelings stop me from doing things or being with other people QTETCD= UPD20 QTET=UPD2-Urinary Problems Normal: No urine control problems 0 0 light: I need to urinate often or urgently. However, these problems do not cause difficulties with my daily activities Mild: Urine problems cause some difficulties with my daily activities. However, I do not have urine accidents Moderate: Urine problems cause a lot of difficulties with my daily activities, including urine accidents evere: I cannot control my urine and use a protective garment or have a bladder tube QTETCD= UPD2 QTET=UPD2-Constipation Problems Normal: No constipation 0 0 light: I have been constipated. I use extra effort to move my bowels. However, this problem does not disturb my activities or my being comfortable Mild: Constipation causes me to have some troubles doing things or being comfortable Moderate: Constipation causes me to have a lot of trouble doing things or being comfortable. However, it does not stop me from doing anything evere: I usually need physical help from someone else to empty my bowels QTETCD= UPD22 QTET=UPD2-Lightheadedness on tanding Normal: No dizzy or foggy feelings 0 0 light: Dizzy or foggy feelings occur. However, they do not cause me troubles doing things Mild: Dizzy or foggy feelings cause me to hold on to something, but I do not need to sit or lie back down Moderate: Dizzy or foggy feelings cause me to sit or lie down to avoid fainting or falling 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 9 August 9, 202

20 CDIC DTM Questionnaire upplement (Version.0) evere: Dizzy or foggy feelings cause me to fall or faint QTETCD= UPD23 QTET=UPD2-Fatigue Normal: No fatigue 0 0 light: Fatigue occurs. However it does not cause me troubles doing things or being with people Mild: Fatigue causes me some troubles doing things or being with people Moderate: Fatigue causes me a lot of troubles doing things or being with people. However, it does not stop me from doing anything evere: Fatigue stops me from doing things or being with people QTETCD= UPD220 QTET=UPD2-peech Normal: Not at all (no problems) 0 0 light: My speech is soft, slurred or uneven, but it does not cause others to ask me to repeat myself Mild: My speech causes people to ask me to occasionally repeat myself, but not everyday Moderate: My speech is unclear enough that others ask me to repeat myself every day even though most of my speech is understood evere: Most or all of my speech cannot be understood QTETCD= UPD2202 QTET=UPD2-aliva and Drooling Normal: Not at all (no problems) 0 0 light: I have too much saliva, but do not drool Mild: I have some drooling during sleep, but none when I am awake Moderate: I have some drooling when I am awake, but I usually do not need tissues or a handkerchief evere: I have so much drooling that I regularly need to use tissues or a handkerchief to protect my clothes QTETCD= UPD2203 QTET=UPD2-Chewing and wallowing Normal: No problems 0 0 light: I am aware of slowness in my chewing or increased effort at swallowing, but I do not choke or need to have my food specially prepared Mild: I need to have my pills cut or my food specially prepared because of chewing or swallowing problems, but I have not choked over the past week Moderate. I choked at least once in the past week evere: Because of chewing and swallowing problems, I need a feeding tube QTETCD= UPD2204 QTET=UPD2-Eating Tasks Normal: Not at all (No problems) 0 0 light: I am slow, but I do not need any help handling my food and have not had food spills while eating 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 20 August 9, 202

21 CDIC DTM Questionnaire upplement (Version.0) Mild: I am slow with my eating and have occasional food spills. I may need help with a few tasks such as cutting meat Moderate: I need help with many eating tasks but can manage some alone evere: I need help for most or all eating tasks QTETCD= UPD2205 QTET=UPD2-Dressing Normal: Not at all (no problems) 0 0 light: I am slow but I do not need help Mild: I am slow and need help for a few dressing tasks (buttons, bracelets) Moderate: I need help for many dressing tasks evere: I need help for most or all dressing tasks QTETCD= UPD2206 QTET=UPD2-Hygiene Normal: Not at all (no problems) 0 0 light: I am slow but I do not need any help Mild: I need someone else to help me with some hygiene tasks Moderate: I need help for many hygiene tasks evere: I need help for most or all of my hygiene tasks QTETCD= UPD2207 QTET=UPD2-Handwriting Normal: Not at all (no problems) 0 0 light: My writing is slow, clumsy or uneven, but all words are clear Mild: ome words are unclear and difficult to read Moderate: Many words are unclear and difficult to read evere: Most or all words cannot be read QTETCD= UPD2208 QTET=UPD2-Doing Hobbies/Other Activities Normal: Not at all (no problems) 0 0 light: I am a bit slow but do these activities easily Mild: I have some difficulty doing these activities Moderate: I have major problems doing these activities, but still do most evere: I am unable to do most or all of these activities QTETCD= UPD2209 QTET=UPD2-Turning in Bed Normal: Not at all (no problems) 0 0 light: I have a bit of trouble turning, but I do not need any help Mild I have a lot of trouble turning and need occasional help from someone else Moderate: To turn over I often need help from someone else 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 2 August 9, 202

22 CDIC DTM Questionnaire upplement (Version.0) evere: I am unable to turn over without help from someone else QTETCD= UPD220 QTET=UPD2-Tremor Normal: Not at all. I have no shaking or tremor 0 0 light: haking or tremor occurs but does not cause problems with any activities Mild: haking or tremor causes problems with only a few activities Moderate: haking or tremor causes problems with many of my daily activities evere: haking or tremor causes problems with most or all activities QTETCD= UPD22 QTET=UPD2-Get Out of Bed/Car/Deep Chair Normal: Not at all (no problems) 0 0 light: I am slow or awkward, but I usually can do it on my first try Mild: I need more than one try to get up or need occasional help Moderate: I sometimes need help to get up, but most times I can still do it on my own evere: I need help most or all of the time QTETCD= UPD222 QTET=UPD2-Walking and Balance Normal: Not at all (no problems) 0 0 light: I am slightly slow or may drag a leg. I never use a walking aid Mild: I occasionally use a walking aid, but I do not need any help from another person Moderate: I usually use a walking aid (cane, walker) to walk safely without falling. However, I do not usually need the support of another person evere: I usually use the support of another person to walk safely without falling QTETCD= UPD223 QTET=UPD2-Freezing Normal: Not at all (no problems) 0 0 light: I briefly freeze but I can easily start walking again. I do not need help from someone else or a walking aid (cane or walker) because of freezing Mild: I freeze and have trouble starting to walk again, but I do not need someone s help or a walking aid (cane or walker) because of freezing Moderate: When I freeze I have a lot of trouble starting to walk again and, because of freezing, I sometimes need to use a walking aid or need someone else s help evere: Because of freezing, most or all of the time, I need to use a walking aid or someone s help 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 22 August 9, 202

23 CDIC DTM Questionnaire upplement (Version.0) QTETCD= UPD23A QTET=UPD2-Medication for PD No 0 0 Yes QTETCD= UPD23B QTET=UPD2-Clinical tate on Meds ON: On is the typical functional state when patients are receiving medication and have a good response OFF: Off is the typical functional state when patients have a poor response in spite of taking medications 0 0 QTETCD= UPD23C QTET=UPD2-Taking Levodopa No 0 0 Yes QTETCD= UPD230 QTET=UPD2-peech Problems Normal: No speech problems 0 0 light: Loss of modulation, diction or volume, but still all words easy to understand Mild: Loss of modulation, diction, or volume, with a few words unclear, but the overall sentences easy to follow Moderate: peech is difficult to understand to the point that some, but not most, sentences are poorly understood evere: Most speech is difficult to understand or unintelligible QTETCD= UPD2302 QTET=UPD2-Facial Expression Normal: Normal facial expression 0 0 light: Minimal masked facies manifested only by decreased frequency of blinking Mild: In addition to decreased eye-blink frequency, Masked facies present in the lower face as well, namely fewer movements around the mouth, such as less spontaneous smiling, but lips not parted Moderate: Masked facies with lips parted some of the time when the mouth is at rest evere: Masked facies with lips parted most of the time when the mouth is at rest QTETCD= UPD2303A UPD2303E QTET=UPD2-igidity Neck UPD2-igidity Left Lower Extremity Normal: No rigidity 0 0 light: igidity only detected with activation maneuver Mild: igidity detected without the activation maneuver, but full range of motion is easily achieved Moderate: igidity detected without the activation maneuver; full range of 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 23 August 9, 202

24 CDIC DTM Questionnaire upplement (Version.0) motion is achieved with effort evere: igidity detected without the activation maneuver and full range of motion not achieved QTETCD= UPD2304A UPD2304B QTET=UPD2-ight Finger Tapping UPD2- Left Finger Tapping Normal: No problems 0 0 light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the tapping movement; b) slight slowing; c) the amplitude decrements near the end of the 0 taps Mild: Any of the following: a) 3 to 5 interruptions during tapping; b) mild slowing; c) the amplitude decrements midway in the 0-tap sequence Moderate: Any of the following: a) more than 5 interruptions during tapping or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) the amplitude decrements starting after the st tap evere: Cannot or can only barely perform the task because of slowing, interruptions or decrements QTETCD= UPD2305A UPD2305B QTET=UPD2-ight Hand Movements UPD2-Left Hand Movements Normal: No problem 0 0 light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the movement; b) slight slowing; c) the amplitude decrements near the end of the task Mild: Any of the following: a) 3 to 5 interruptions during the movements; b) mild slowing; c) the amplitude decrements midway in the task Moderate: Any of the following: a) more than 5 interruptions during the movement or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) the amplitude decrements starting after the st open-andclose sequence evere: Cannot or can only barely perform the task because of slowing, interruptions or decrements QTETCD= UPD2306A UPD2306B QTET=UPD2-Pron/up Movement of T Hand UPD2-Pron/up Movement of Left Hand Normal: No problems 0 0 light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the movement; b) slight slowing; c) the amplitude decrements near the end of the sequence Mild: Any of the following: a) 3 to 5 interruptions during the movements; b) mild slowing; c) the amplitude decrements midway in the sequence Moderate: Any of the following: a) more than 5 interruptions during the movement or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing c) the amplitude decrements starting after the st supinationpronation sequence evere: Cannot or can only barely perform the task because of slowing, 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 24 August 9, 202

25 CDIC DTM Questionnaire upplement (Version.0) interruptions or decrements QTETCD= UPD2307A UPD2307B QTET=UPD2-ight Toe Tapping UPD2- Left Toe Tapping Normal: No problem 0 0 light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the tapping movement; b) slight slowing; c) amplitude decrements near the end of the ten taps Mild: Any of the following: a) 3 to 5 interruptions during the tapping movements; b) mild slowing; c) amplitude decrements midway in the task Moderate: Any of the following: a) more than 5 interruptions during the tapping movements or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) amplitude decrements after the first tap evere: Cannot or can only barely perform the task because of slowing, interruptions or decrements QTETCD= UPD2308A UPD2308B QTET=UPD2-ight Leg Agility UPD2-Left Leg Agility Normal: No problems 0 0 light: Any of the following: a) the regular rhythm is broken with one or two interruptions or hesitations of the movement; b) slight slowing; c) amplitude decrements near the end of the task Mild: Any of the following: a) 3 to 5 interruptions during the movements; b) mild slowness; c) amplitude decrements midway in the task Moderate: Any of the following: a) more than 5 interruptions during the movement or at least one longer arrest (freeze) in ongoing movement; b) moderate slowing in speed; c)amplitude decrements after the first tap evere: Cannot or can only barely perform the task because of slowing, interruptions or decrements QTETCD= UPD2309 QTET=UPD2-Arising from Chair Normal: No problems. Able to arise quickly without hesitation 0 0 light: Arising is slower than normal; or may need more than one attempt; or may need to move forward in the chair to arise. No need to use the arms of the chair Mild: Pushes self up from arms of chair without difficulty Moderate: Needs to push off, but tends to fall back; or may have to try more than one time using arms of chair, but can get up without help evere: Unable to arise without help QTETCD= UPD230 QTET=UPD2-Gait Normal: No problems 0 0 light: Independent walking with minor gait impairment Mild: Independent walking but with substantial gait impairment Moderate: equires an assistance device for safe walking (walking stick, 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 25 August 9, 202

26 CDIC DTM Questionnaire upplement (Version.0) walker) but not a person evere: Cannot walk at all or only with another person s assistance QTETCD= UPD23 QTET=UPD2-Freezing of Gait Normal: No freezing 0 0 light: Freezes on starting, turning or walking through doorway with a single halt during any of these events, but then continues smoothly without freezing during straight walking Mild: Freezes on starting, turning or walking through doorway with more than one halt during any of these activities, but continues smoothly without freezing during straight walking Moderate: Freezes once during straight walking evere: Freezes multiple times during straight walking QTETCD= UPD232 QTET=UPD2-Postural tability Normal: No problems: ecovers with one or two steps 0 0 light: 3-5 steps, but subject recovers unaided Mild: More than 5 steps, but subject recovers unaided Moderate: tands safely, but with absence of postural response; falls if not caught by examiner evere: Very unstable, tends to lose balance spontaneously or with just a gentle pull on the shoulders QTETCD= UPD233 QTET=UPD2-Posture Normal: No problems 0 0 light: Not quite erect, but posture could be normal for older person Mild: Definite flexion, scoliosis or leaning to one side, but patient can correct posture to normal posture when asked to do so Moderate: tooped posture, scoliosis or leaning to one side that cannot be corrected volitionally to a normal posture by the patient evere: Flexion, scoliosis or leaning with extreme abnormality of posture QTETCD= UPD234 QTET=UPD2-Body Bradykinesia Normal: No problems 0 0 light: light global slowness and poverty of spontaneous movements Mild: Mild global slowness and poverty of spontaneous movements Moderate: Moderate global slowness and poverty of spontaneous movements evere: evere global slowness and poverty of spontaneous movements QTETCD= UPD235A UPD235B QTET=UPD2-Postural Tremor of ight Hand UPD2-Postural Tremor of Left Hand Normal: No tremor Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 26 August 9, 202

27 CDIC DTM Questionnaire upplement (Version.0) light: Tremor is present but less than cm in amplitude Mild: Tremor is at least but less than 3 cm in amplitude Moderate: Tremor is at least 3 but less than 0 cm in amplitude evere: Tremor is at least 0 cm in amplitude QTETCD= UPD236A UPD236B QTET=UPD2-Kinetic Tremor of ight Hand UPD2-Kinetic Tremor of Left Hand Normal: No tremor 0 0 light: Tremor is present but less than cm in amplitude Mild: Tremor is at least but less than 3 cm in amplitude Moderate: Tremor is at least 3 but less than 0 cm in amplitude evere: Tremor is at least 0 cm in amplitude QTETCD= UPD237A UPD237D QTET=UPD2-est Tremor Amplitude UE UPD2-est Tremor Amplitude LLE Normal: No tremor 0 0 light.:< cm in maximal amplitude Mild: > cm but < 3 cm in maximal amplitude Moderate: 3-0 cm in maximal amplitude evere: > 0 cm in maximal amplitude QTETCD= UPD237E QTET=UPD2-est Tremor Amplitude Lip/Jaw Normal: No tremor 0 0 light: < cm in maximal amplitude Mild: > cm but < 2 cm in maximal amplitude Moderate: > 2 cm but < 3 cm in maximal amplitude evere: > 3 cm in maximal amplitude QTETCD= UPD238 QTET=UPD2-Consistency of est Tremor Normal: No tremor 0 0 light: Tremor at rest is present < 25% of the entire examination period Mild: Tremor at rest is present 26-50% of the entire examination period Moderate: Tremor at rest is present 5-75% of the entire examination period evere: Tremor at rest is present > 75% of the entire examination period QTETCD= UPD2DA UPD2DB QTET=UPD2-Dyskinesias During Exam UPD2-Movements Interfere atings No 0 0 Yes 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 27 August 9, 202

28 CDIC DTM Questionnaire upplement (Version.0) QTETCD= UPDHY QTET=UPD2-Hoehn and Yahr tage Asymptomatic 0 0 Unilateral involvement only Bilateral involvement without impairment of balance Mile to moderate involvement; some postural instability but physically independent; needs assistance to recover from pull test evere disability; still able to walk or stand unassisted Wheelchair bound or bedridden unless aided 5 5 QTETCD= UPD240 QTET=UPD2-Time pent with Dyskinesias Normal: No dyskinesias 0 0 light: 25% of waking day Mild: 26-50% of waking day Moderate: 5-75% of waking day evere: > 75% of waking day QTETCD= UPD2402 QTET=UPD2-Functional Impact Dyskinesias Normal: No dyskinesias or no impact by dyskinesias on activities or social interactions 0 0 light: Dyskinesias impact on a few activities, but the patient usually performs all activities and participates in all social interactions during dyskinetic periods Mild: Dyskinesias impact on many activities, but the patient usually performs all activities and participates in all social interactions during dyskinetic periods Moderate: Dyskinesias impact on activities to the point that the patient usually does not perform some activities or does not usually participate in some social activities during dyskinetic episodes evere: Dyskinesias impact on function to the point that the patient usually does not perform most activities or participate in most social interactions during dyskinetic episodes QTETCD= UPD2403 QTET=UPD2-Time pent in the Off tate Normal: No OFF time 0 0 light: 25% of waking day Mild: 26-50% of waking day Moderate: 5-75% of waking day evere: > 75% of waking day QTETCD= UPD2404 QTET=UPD2-Functional Impact Fluctuations Normal: No fluctuations or No impact by fluctuations on performance of activities or social interactions 0 0 light: Fluctuations impact on a few activities, but during OFF, the patient usually performs all activities and participates in all social interactions that 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 28 August 9, 202

29 CDIC DTM Questionnaire upplement (Version.0) typically occur during the ON state Mild: Fluctuations impact many activities, but during OFF, the patient still usually performs all activities and participates in all social interactions that typically occur during the ON state Moderate: Fluctuations impact on the performance of activities during OFF to the point that the patient usually does not perform some activities or participate in some social interactions that are performed during ON periods evere: Fluctuations impact on function to the point that, during OFF, the patient usually does not perform most activities or participate in most social interactions that are performed during ON periods QTETCD= UPD2405 QTET=UPD2-Complexity Fluctuations Normal: No motor fluctuations 0 0 light: OFF times are predictable all or almost all of the time (> 75%) Mild: OFF times are predictable most of the time (5-75%) Moderate: OFF times are predictable some of the time (26-50%) evere: OFF episodes are rarely predictable. (< 25%) QTETCD= UPD2406 QTET=UPD2-Painful Off-state Dystonia Normal: No dystonia O NO OFF TIME 0 0 light: < 25% of time in OFF state Mild: 26-50% of time in OFF state Moderate: 5-75% of time in OFF state evere: > 75% of time in OFF state 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 29 August 9, 202

30 CDIC DTM Questionnaire upplement (Version.0) 5 upplemental Qualifier Name Codes The following table contains an additional standard name codes for use in the upplemental Qualifiers for Questionnaires (UPPQ) special-purpose dataset. QNAM QLABEL Applicable Domains PIMC Primary ource of Information Q TOTAWK Total Hours Awake Q TOTDYK Total Hours with Dyskinesia Q PCTDYK Percent Dyskinesia Q TOTHOFF Total Hours OFF Q PCTHOFF Percent of Hours OFF Q TOTOFDY Total Hours OFF with Dystonia Q PCTOFDY Percent of OFF with Dystonia Q End of Document 202 Clinical Data Interchange tandards Consortium, Inc. All rights reserved Page 30 August 9, 202