MSBase Data-entry Software (MDS) Data Dictionary · 1.20 Patient Code String 50 Yes 1.21 Doctor in charge Select Yes [Lookup local users] 1.22 Deceased Select Yes No; Yes Y 1.23 Deceased

MSBase Data-entry Software (MDS)

Data Dictionary A comprehensive list of fields

used in MDS

Patient Profile - Patient Identification

1.1. Description The Identification form captures basic demographic details, for example the Age and Sex and demographic details of the patient.

1.2. Rules and Constraints • The minimum dataset consists of Last Name, First

Name, Gender and Date of Birth.

• Patient cannot be saved unless mandatory fields arepopulated.

• Patient cannot be saved if there is another patientwith the same identical minimum dataset

1.3. Functions • Add a patient – You can enter basic information about

the patient, once saved, the patient now exists inMDS.

• Edit a patient – You can edit data about the patient.

1.4. Data Fields

Ref Field Type Len Data Format Nullable Validation/check Allowed Values Sent to

Registry Comments

1.01 Patient ID String Mandatory Y Unique, the ID for the patient.

Calculated

1.02 Birth Date Date dd/mm/yyyy Mandatory Y Day removed, to Month

precision when sent to Registry

1.03 Last Name String 50 Mandatory

1.04 First name String 50 Mandatory

1.05 Gender Select Mandatory Female; Male Y Biological sex of patient

1.06 Maiden

Name String 50 Yes

Available where

Gender = Female

1.07 Birth City String 20 Yes Y Birth city of patient

1.08 Birth

Country Select Yes

Afghanistan; Albania; Algeria; Andorra; Angola; Argentina; Armenia; Australia; Austria; Azerbaijan; Bahamas; Bahrain;

Bangladesh; Barbados; Belarus; Belgium; Belize; Benin; Bermuda; Bhutan; Bolivia; Bosnia And Herzegowina; Botswana;

Brazil; Brunei Darussalam; Bulgarie; Burkina Faso; Burundi; Cambodia; Cameroon; Canada; Cape Verde; Central African

Republic; Chad; Chile; China; Colombia; Congo; Costa Rica; Cote D'Ivoire; Croatia; Cuba; Cyprus; Czech Republic; Denmark;

Djibouti; Dominica; Dominican Republic; East Timor; Ecuador; Egypt; El Salvador; Equatorial Guinea; Eritrea; Estonia;

Ethiopia; Finland; France; Gabon; Gambia; Georgia; Germany; Ghana; Gibraltar; Greece; Greenland; Grenada; Guadeloupe;

Guatemala; Guinea; Guinea-Bissau; Guyana; Haiti; Honduras; Hong Kong; Hungary; Iceland; India; Indonesia; Iran; Iraq;

Ireland; Israel; Italy; Jamaica; Japan; Jordan; Kazakhstan; Kenya; Kuwait; Kyrgyzstan; Laos; Latvia; Lebanon; Lesotho; Liberia;

Libya; Liechtenstein; Lithuania; Luxembourg; Macedonia; Madagascar; Malawi; Malaysia; Maldives; Mali; Malta;

Mauritania; Mauritius; Mexico; Moldova; Monaco; Mongolia; Morocco; Mozambique; Namibia; Nepal; Netherlands; New

Caledonia; New Zealand; Nicaragua; Niger; Nigeria; North Korea; Norway; Oman; Pakistan; Palestine; Panama; Paraguay;

Peru; Philippines; Poland; Portugal; Puerto Rico; Qatar; Romania; Russian Federation; Rwanda; Samoa; San Marino; Saudi

Arabia; Senegal; Serbia; Seychelles; Sierra Leone; Singapore; Slovakia; Slovenia; Somalia; South Africa; South Korea; Spain;

Sri Lanka; Sudan; Suriname; Swaziland; Sweden; Switzerland; Syria; Taiwan, Republic Of China; Tajikistan; Tanzania;

Thailand; Togo; Tonga; Tunisia; Turkey; Turkmenistan; Uganda; Ukrainian Ssr; United Arab Emirates; United Kingdom;

United States; Uruguay; Uzbekistan; Venezuela; Vietnam; Western Sahara; Yemen; Zaire; Zambia; Zimbabwe

Y Birth country

1.09,

1.10 Address String 50 Yes

1.11 City String 50 Yes

1.12 Zip Code String 10 Yes

1.13 State String 20 Yes

1.14 Country Select Yes

Afghanistan; Albania; Algeria; Andorra; Angola; Argentina; Armenia; Australia; Austria; Azerbaijan; Bahamas; Bahrain;

Bangladesh; Barbados; Belarus; Belgium; Belize; Benin; Bermuda; Bhutan; Bolivia; Bosnia And Herzegowina; Botswana;

Brazil; Brunei Darussalam; Bulgarie; Burkina Faso; Burundi; Cambodia; Cameroon; Canada; Cape Verde; Central African

Republic; Chad; Chile; China; Colombia; Congo; Costa Rica; Cote D'Ivoire; Croatia; Cuba; Cyprus; Czech Republic; Denmark;

Djibouti; Dominica; Dominican Republic; East Timor; Ecuador; Egypt; El Salvador; Equatorial Guinea; Eritrea; Estonia;

Ethiopia; Finland; France; Gabon; Gambia; Georgia; Germany; Ghana; Gibraltar; Greece; Greenland; Grenada; Guadeloupe;

Guatemala; Guinea; Guinea-Bissau; Guyana; Haiti; Honduras; Hong Kong; Hungary; Iceland; India; Indonesia; Iran; Iraq;

Ireland; Israel; Italy; Jamaica; Japan; Jordan; Kazakhstan; Kenya; Kuwait; Kyrgyzstan; Laos; Latvia; Lebanon; Lesotho; Liberia;

Libya; Liechtenstein; Lithuania; Luxembourg; Macedonia; Madagascar; Malawi; Malaysia; Maldives; Mali; Malta;

Mauritania; Mauritius; Mexico; Moldova; Monaco; Mongolia; Morocco; Mozambique; Namibia; Nepal; Netherlands; New

Caledonia; New Zealand; Nicaragua; Niger; Nigeria; North Korea; Norway; Oman; Pakistan; Palestine; Panama; Paraguay;

Peru; Philippines; Poland; Portugal; Puerto Rico; Qatar; Romania; Russian Federation; Rwanda; Samoa; San Marino; Saudi

Arabia; Senegal; Serbia; Seychelles; Sierra Leone; Singapore; Slovakia; Slovenia; Somalia; South Africa; South Korea; Spain;

Sri Lanka; Sudan; Suriname; Swaziland; Sweden; Switzerland; Syria; Taiwan, Republic Of China; Tajikistan; Tanzania;

Thailand; Togo; Tonga; Tunisia; Turkey; Turkmenistan; Uganda; Ukrainian Ssr; United Arab Emirates; United Kingdom;

United States; Uruguay; Uzbekistan; Venezuela; Vietnam; Western Sahara; Yemen; Zaire; Zambia; Zimbabwe

Y Country of residence

1.15 Home

Phone String 20 Yes

1.16 Work Phone String 20 Yes

1.17 Other

Number String 20 Yes

1.18 Email String 100 Yes

1.19 Status Select Yes Active File; Inactive File

1.20 Patient

Code String 50 Yes

1.21 Doctor in

charge Select Yes [Lookup local users]

1.22 Deceased Select Yes No; Yes Y

1.23 Deceased

Date Date dd/mm/yyyy Yes

Only available if

Deceased = Yes Y Must be populated with a date

1.24

Death

Related

Cause

Sub-

Report Yes

Captured in Medical Events,

aggregated in this view.

1.25 Cause of

Death String 50 Yes

Only available if

Deceased = Yes Y

1.26 Health

Insurance String 20 Yes

1.27 Insurance

Reference String 20 Yes

1.28 Study code String 20 Yes

1.29 Keyword String 50 Yes

1.30 Education Select Yes College; Elementary; High School; University Y Education level

Medical History

2.1. Description The Medical History captures information about the patient’s medical history and family medical history.

2.2. Rules and Constraints • Medical History for family members does not need to be

MS Related.

2.3. Functions • Enter/Edit Data – You can enter disease and medical

history for patient

• Enter and Delete Medical Condition – You can add/editMedical Event and Delete Medical Event

• Enter and Delete Family History – You are able to addand remove family member disease history.

2.4. Data Fields

Ref Field Type Len Data Format Nullable Validation/check Allowed Values

Sent to

Registry Comments

2.01 Date Date dd/mm/yyyy Mandatory

Date must be >

Birthdate Y Clinic entry/First Seen

2.02 Ethnic Origin Select Yes [Lookup Reference Data] Y Ethnic origin

2.03 Referred by Select Yes [List of Care Professionals] Y

2.04 Visit frequency planned Select Yes

1 month; 3 months; 6 months; 9 months; 1 year; 1.5 year; 2

years ; 3 years; 4 years Y Measure in months

2.05 Dominant Hand Select Yes Left; Right, Unknown Y

2.06 # Previous relapses Number NNN Yes Y Number of relapses since first symptoms

2.07

Diseases and Medical

conditions

Sub-

report Yes

Captured in Medical Events, aggregated in this

view

2.08 Family MS History Select Yes No; Unknown; Yes Y Refer to Section Family History

2.09 Family Disease History

Sub-

report Yes Y

2.10 Remarks Memo Yes

Family History

3.1. Description This Family History form is an important utility to capture familial medical conditions. A family member may already exist in MDS, in which case the family member may be selected from the drop-down list and their details will be pre-populated. However, in the likely scenario that the family member is not in MDS then this data may be entered manually. This screen will only appear when initiated from the Medical History page.

3.2. Rules and Constraints • Relationship type is a mandatory field

3.3. Functions • Enter Data – User enters disease and medical history for

patient

• Enter, Edit and Delete Medical Condition – User able to add Medical Event and Delete Medical Event

• Enter and Delete Family History – User able to add and remove family member disease history.

3.4. Data Fields


Sent to

Registry Comments

2.01 Date Date dd/mm/yyyy Mandatory

Date must be >

Birthdate Y Clinic entry/First Seen

2.02 Ethnic Origin Select Yes [Lookup Reference Data] Y Ethnic origin

2.03 Referred by Select Yes [List of Care Professionals] Y

2.04 Visit frequency planned Select Yes

1 month; 3 months; 6 months; 9 months; 1 year; 1.5 year; 2

years ; 3 years; 4 years Y Measure in months

2.05 Dominant Hand Select Yes Left; Right, Unknown Y

2.06 # Previous relapses Number NNN Yes Y Number of relapses since first symptoms

2.07

Diseases and Medical

conditions

Sub-

report Yes

Captured in Medical Events, aggregated in this

view

2.08 Family MS History Select Yes No; Unknown; Yes Y Refer to Section Family History

2.09 Family Disease History

Sub-

report Yes Y


MS Diagnosis

4.1. Description The diagnosis form allows the user to enter information about the MS diagnosis of the patient. It is in this section that the MS Course of the patient is calculated (also allows a RIS or NMO diagnosis). Refer to the User Guide for the MS Course calculation information.

4.2. Rules and Constraints • Disease Course is automatically calculated.

• Date of onset should be before the date of the first relapse. If not, the MS Course will not calculate.

4.3. Functions • Enter/edit Data – You can enter data about the patient’ss

diagnosis.

• You can determine a patients MS Course using the calculator.

4.4. Data Fields


Sent to

Registry Comments

4.01 RIS Onset Date Date dd/mm/yyyy Yes Y

4.02 Date of onset Date dd/mm/yyyy Yes

Date must be >

Birthdate Y

4.03 First Symptoms Supratentorial Select Yes False; True Y

4.04 First Symptoms Optic Pathways Select Yes False; True Y

4.05 First Symptoms Brainstem Select Yes False; True Y

4.06 First Symptoms Spinal Cord Select Yes False; True Y

4.07 Progression from onset Select Yes False; True

4.08 First Symptoms Other String 40 Yes Y

4.09 Start of progression Date dd/mm/yyyy Yes

Available if

"Progression from

Onset" = No, Date

must be > Onset

Date Y

4.10 Confirmed MS Diagnosis Date dd/mm/yyyy Yes Y

4.11 Confirmed by Clinical Findings Select Yes False; True Y

4.12 Confirmed by CSF Select Yes False; True Y

4.13 Confirmed by MRI Select Yes False; True Y

4.14 Confirmed by Evoke Potentials Select Yes False; True Y

4.15 Confirmed By Other String 50 Yes Y

4.16 McDonald classification Select Yes MS; Not MS; Possible MS Y

4.17 Poser classification Select Yes

Clinically Definite A1; Clinically Definite A2; Clinically Probable C1; Clinically Probable C2;

Clinically Probable C3; Clinically Definite A1; Clinically Definite A2; Laboratory Definite B1;

Laboratory Definite B2; Laboratory Definite B3; Laboratory Supported Definite B1; Laboratory

Supported Definite B2; Laboratory Supported Definite B3; Laboratory Supported Probable D1 Y

4.18 NMO classification Select Yes Definite NMO; Not NMO Y

4.19 Ms Course 1 Date Select Yes

Automatically

Populated Clinically Isolated syndrome; Primary Progressive Y Calculated

4.20 Ms Course 1 Date Date dd/mm/yyyy Yes

Automatically

Populated Y Calculated

4.21 Ms Course 2 Select Yes

Automatically

Populated Primary Relapsing; Relapse Remitting; Secondary progressive Y Calculated


Automatically


4.23 Ms Course 3 Select Yes

Automatically

Populated Secondary progressive Y Calculated


Automatically


Flexifields

5.1. Description Flexifields that have been created can be found in the Patient Profile Flexifield section. By default, the Centre Flexifields will be shown. If the patient belongs to a sub-study where flexifields have been added, then they will also appear in this section as an additional tab. For further information refer to the User Guide.

5.2. Rules and Constraints • Flexifields must be specified in the Preferences.

5.3. Functions • Enter/Edit Data – You can enter data into Flexifields

5.4. Data Fields


Sent to

Registry Comments

N/A Flexifield Text Text 1000 Yes Defined by the user

N/A Flexifield Number Number Yes Defined by the user

N/A Flexifield Date Date dd/mm/yyyy Yes Defined by the user

N/A Text Area - Memo Memo Yes Defined by the user

N/A Dropdown Dropdown Yes Defined by the user

N/A Checkbox Checkbox Yes Defined by the user

N/A Header Header Yes Defined by the user

Notes

6.1. Description The Notes section allows the user to enter general notes about the patient, upload documents and provide links to WWW resources. None of this data is sent to the MSBase Registry.

6.2. Rules and Constraints • Documents to be copied from origin directory to shared

network location

6.3. Functions • Enter Data - User enters general notes about the patient

• Add Link - User links to local document, this document is then copied to shared area so that other users have it available

• Add URL - User links to WWW resources. The link is active, and no downloading of the site occurs.

6.4. Data Fields


Sent to

Registry Comments

N/A Notes Text area Yes

N/A

URL WWW

link Yes

Link to WWW resource

N/A

Document Local Link

Yes

UNC path to local

document

Basic Details

7.1. Description The Visits section captures the status of the patient on a specific date. A patient can have many Visits.

7.2. Rules and Constraints • Visit must be after date of birth, and prior to date of

death.

• Once someone has a Visit indicating they are a smoker, they are unable to be set to “Never Smoked”

• Where the previous visit has either a marital or employment status, then those values will automatically be carried across and the user notified.

7.3. Functions • Create 1 or more visits

• Delete 1 or more visits

• Enter/edit data – You can enter/edit data about the visit

7.4. Data Fields


Sent to

Registry Comments

5.01 Date of Visit Date dd/mm/yyyy Mandatory Y

5.02 Status – First Visit Select Yes False; True Y

5.03 Status - Administrative Select Yes False; True Y

5.04 Status – Routine Select Yes False; True Y

5.05

Status – Suspected

Relapse Select Yes False; True Y

5.06 Status – Phone Select Yes False; True Y

5.07 Status – Retrospective Select Yes False; True Y

5.08 Status -Other Select Yes False; True

5.09 Smoking History Select Yes Unknown; Never Smoked; Current Smoker; Past Smoker Y

5.10

Smoking – Number per

day Number NNN Yes Y

5.11 Smoking – Age Started Number NNN Yes Y

5.12 Smoking – Age Stopped Number NNN Yes Y

5.13 McDonald classification String Yes Y Calculated

5.14 Poser classification String Yes Y Calculated

5.15 Disease Course Select Yes

<null>; Clinically Isolated Syndrome; Primary Progressive; Primary

Progressive; Relapse Remitting; Secondary progressive Y MSCourse at visit - MSCourse at visit - Calculated

5.16 Days missed work Number NNN.NN Yes Y Number of days missed work

5.17 Days in rehabilitation Number NNN.NN Yes Y Number of days in rehabilitation

5.18 Days in hospital Number NNN.NN Yes Y Number of days in hospital

5.19

Number of ambulatory

visits Number NNN.NN Yes Y Number of ambulatory visits

5.20 Examined By Select Yes [Lookup local users]

5.21 Marital Status Select Yes

Cohabiting; Divorced; Married; Separated; Single (Never Married);

Unknown/No Answer; Widowed Y

5.22 Employment Status Select Yes

Employed; Employed (full-time), Employed (part-time), Retired;

Student; Unemployed; Domestic Duties, Disability Pensioner,

Unknown/No Answer Y

5.23 EDSS Number NN.N Yes Y Dropdown selected values only

5.24 Ambulation index Number NN Yes Y

5.25

Time to walk 8 m. (sec.) -

Attempt 1 Number NNN.NN Yes Y

5.26

Time to walk 8 m. (sec.) -

Attempt 2 Number NNN.NN Yes Y

5.27

Nine-hole peg test (sec.) -

Attempt 1 - Right Number NNN.N Yes Y

5.28


Attempt 2 - Right Number NNN.N Yes Y

5.29


Attempt 1 - Left Number NNN.N Yes Y

5.30


Attempt 2 - Left Number NNN.N Yes Y

5.31 Dominant Hand Select Yes Y Calculated

5.32 PASAT Test Number NN Yes

PASAT test must be

<60 Y

5.33 Height Number NNN.N Yes Y

5.34 Height - Unit Select Yes cm; Foot Inch Y

5.35 Weight - Unit Select Yes kg; lb Y

5.36 Weight Number NNN.NN Yes Y

5.37 Blood Pressure - Systolic Number NNN Yes Y

5.38 Blood Pressure - Diastolic Number NNN Yes Y

5.39 Pulse Number NNN Yes Y


Symptoms

8.1. Description This symptoms page allows the user to enter any symptoms being experienced by the patient for that visit.

8.2. Functions • Enter data – User identifies patient symptoms specific to

that visit.

8.3. Data Fields Ref Field Type Len Data Format Nullable Validation/check Allowed Values Sent to Registry Comments

6.01 Blurred vision Select Yes False; True Y

6.02 Field defect / scotoma Select Yes False; True Y

6.03 Oscillopsia Select Yes False; True Y

6.04 Diplopia / gaze paresis Select Yes False; True Y

6.05 Dysphagia Select Yes False; True Y

6.06 Dysarthria Select Yes False; True Y

6.07 Vertigo Select Yes False; True Y

6.08 Hearing loss Select Yes False; True Y

6.09 Trigeminal nerve involvement Select Yes False; True Y

6.10 Neuralgia Select Yes Available if "Trigeminal nerve involvement" = Yes False; True Y

6.11 typical pain Select Yes Available if "Trigeminal nerve involvement" = Yes False; True Y

6.12 Paresthesiae Select Yes Available if "Trigeminal nerve involvement" = Yes False; True Y

6.13 Hypoesthesiae Select Yes Available if "Trigeminal nerve involvement" = Yes False; True Y

6.14 Facial palsy Select Yes False; True Y

6.15 Myokymia Select Yes False; True Y

6.16 Motor weakness: upper extremities Select Yes False; True Y

6.17 Motor weakness: lower extremities Select Yes False; True Y

6.18 Ataxia: upper extremities Select Yes False; True Y

6.19 Ataxia: lower extremities Select Yes False; True Y

6.20 Gait disturbance: paresis Select Yes False; True Y

6.21 Gait disturbance: ataxia Select Yes False; True Y

6.22 Gait disturbance: spasticity Select Yes False; True Y

6.23 Tremor Select Yes False; True Y

6.24 Paresthesiae Select Yes False; True Y

6.25 Dysaesthesiae Select Yes False; True Y

6.26 Pain, headache Select Yes False; True Y

6.27 Lhermitte's sign Select Yes False; True Y

6.28 Micturition Select Yes False; True Y

6.29 Defecation problems Select Yes False; True Y

6.30 Sexual functions problems Select Yes False; True Y

6.31 Mood problems Select Yes False; True Y

6.32 Cognition problems Select Yes False; True Y

6.33 Fatigue Select Yes False; True Y

6.34 Extrapyramidal symptoms Select Yes False; True Y

6.35 nystagmus Select Yes False; True Y

6.36 Seizures Select Yes False; True Y

6.37 Hemiplegia Select Yes False; True Y

6.38 Hemispasm Select Yes False; True Y

6.39 Remarks1 Memo Yes

EDSS

9.1. Description The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in MS. This section allows the neurologist to enter the scores for each functional system. MDS will then estimate an EDSS score for you for you to confirm.

9.2. Rules and Constraints • Score based on Neurostatus EDSS score.

• All fields must be complete to calculate score

• EDSS Score is calculated and suggested but does not automatically update the field. EDSS score must be manually entered by user.

9.3. Functions • Enter data – Uses enters data about wellbeing of patient.

• MDS updates and highlights as user interacts


7.01 Visual Select N Yes ?;1;2;3;4;5;6 Y Dropdown selected values only

7.02 Temporal Pallor Select Yes False; True Y

7.03 Brainstem Select N Yes ?;1;2;3;4;5 Y Dropdown selected values only

7.04 Pyramidal Select N Yes ?;1;2;3;4;5;6 Y Dropdown selected values only

7.05 Cerebellar Select N Yes ?;1;2;3;4;5 Y Dropdown selected values only

7.06 Pyramidal Weakness Select Yes False; True Y

7.07 Sensory Select N Yes ?;1;2;3;4;5;6 Y Dropdown selected values only

7.08 Bowel/Bladder Select N Yes ?;1;2;3;4;5;6 Y Dropdown selected values only

7.09 Mental Select N Yes ?;1;2;3;4;5 Y Dropdown selected values only

7.10 Ambulation Select NN Yes ?;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15 Y Dropdown selected values only

7.11 EDSS Score Select Yes 0.0; 1.0; 1.5; 2.0; 2.5; 3.0; 3.5; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 8.5; 9.0; 9.5; 10.0 Y

MusiQOL

10.1. Description The Multiple Sclerosis International Quality of life questionnaire (MusiQoL) is a self-administered and multidimensional questionnaire. There are 31 questions over 9 dimensions, with a final score being an average of these 9 dimensions.

10.2. Rules and Constraints • A minimum of 50% of questions for each the dimensions

need to be complete for that dimension to receive a score.

10.3. Functions • You can respond to each of the 31 questions.

10.4. Data Fields

Ref Field Type Len

Data

Format Nullable Validation/check Allowed Values

Sent to

Registry Comments

8.01 MusiQOL01 Select Yes

Not applicable; Never/Not at all; Rarely/A little;

Sometimes/Somewhat; Often/A lot; Always/Very Y 1. Had difficulty walking or moving outside?



Sometimes/Somewhat; Often/A lot; Always/Very Y 2. Had difficulty with outdoor activities: i.e. shopping, going out to a movie ...?



Sometimes/Somewhat; Often/A lot; Always/Very Y 3. Had difficulty walking or moving around at home?



Sometimes/Somewhat; Often/A lot; Always/Very Y 4. Been troubled by your balance or walking problems?



Sometimes/Somewhat; Often/A lot; Always/Very Y 5. Had difficulty with leisure activities at home: i.e. do-it-yourself, gardening...?



Sometimes/Somewhat; Often/A lot; Always/Very Y

6. Had difficulty with your occupational activities: i.e. integration, interruption,

limitation...?



Sometimes/Somewhat; Often/A lot; Always/Very Y 7. Been quickly tired?



Sometimes/Somewhat; Often/A lot; Always/Very Y 8. Been short of energy?



Sometimes/Somewhat; Often/A lot; Always/Very Y 9. Felt anxious?



Sometimes/Somewhat; Often/A lot; Always/Very Y 10. Felt depressed or gloomy?



Sometimes/Somewhat; Often/A lot; Always/Very Y 11. Felt like crying?



Sometimes/Somewhat; Often/A lot; Always/Very Y 12. Felt nervous or irritated by a few things or situations?



Sometimes/Somewhat; Often/A lot; Always/Very Y 13. Been troubled by loss of memory?




14. Had difficulty concentrating: i.e. when reading, watching a film, following a

discussion...?



Sometimes/Somewhat; Often/A lot; Always/Very Y 15. Been troubled by your vision: worsened or unpleasant?



Sometimes/Somewhat; Often/A lot; Always/Very Y 16. Experienced unpleasant feelings: i.e. hot, cold...?



Sometimes/Somewhat; Often/A lot; Always/Very Y 17. Talked with your friends?



Sometimes/Somewhat; Often/A lot; Always/Very Y 18. Felt understood by your friends?



Sometimes/Somewhat; Often/A lot; Always/Very Y 19. Felt encouraged by your friends?



Sometimes/Somewhat; Often/A lot; Always/Very Y 20. Talked with your spouse/partner or your family?



Sometimes/Somewhat; Often/A lot; Always/Very Y 21. Felt understood by your spouse/partner or your family?



Sometimes/Somewhat; Often/A lot; Always/Very Y 22. Felt encouraged by your spouse/partner or your family?



Sometimes/Somewhat; Often/A lot; Always/Very Y 23. Felt satisfied with your love life?



Sometimes/Somewhat; Often/A lot; Always/Very Y 24. Felt satisfied with your sex life?



Sometimes/Somewhat; Often/A lot; Always/Very Y 25. Felt that your situation is unfair?



Sometimes/Somewhat; Often/A lot; Always/Very Y 26. Felt bitter?



Sometimes/Somewhat; Often/A lot; Always/Very Y 27. Been upset by the stares of other people?



Sometimes/Somewhat; Often/A lot; Always/Very Y 28. Been embarrassed when in public?




29. Been satisfied with the information on your disease or the treatment given by the

doctors, nurses, psychologists...taking care of your MS?



Sometimes/Somewhat; Often/A lot; Always/Very Y 30. Felt understood by the doctors, nurses, psychologists...taking care of your MS?



Sometimes/Somewhat; Often/A lot; Always/Very Y 31. Been satisfied with your treatments?

8.32 Exact Time Start Time hh:mm Yes Check if time Y

8.33 Exact Time End Time hh:mm Yes Check if time Y

Flexifields

11.1. Description Centre specified Flexifields for Visits are in this section.


11.3. Functions • Enter/Edit Data – You can enter/edit data for flexifields.


N/A Flexifield Text Text 1000 Yes Defined by the user

N/A Flexifield Number Number Yes Defined by the user

N/A Flexifield Date Date dd/mm/yyyy Yes Defined by the user

N/A Text Area - Memo Memo Yes Defined by the user

N/A Dropdown Dropdown Yes Defined by the user

N/A Checkbox Checkbox Yes Defined by the user

N/A Header Header Yes Defined by the user

Safety

12.1. Description The safety page allows the user to report changes in the medical conditions of the patient, such as malignancies, adverse reactions or event.

12.2. Functions • Enter/Edit Safety data – You can add/edit the safety data

• View/Add/Delete Medical conditions – You can add/edit the Medical Conditions of the patient.

12.3. Data Fields

Ref Field Type Len

Data


Sent to

Registry Comments

9.01 Malignancy Developed Select Yes

No; Unknown/No

Answer; Yes Y Has the patient developed a malignancy (excluding NMSC) since the last visit ?

9.02

Non-Melanoma Cancer

Developed Select Yes

No; Unknown/No

Answer; Yes Y Has the patient developed a NMSC since the last visit ?

9.03 Herpes Zoster Developed Select Yes

No; Unknown/No

Answer; Yes Y Has the patient developed a herpes zoster (shingles) since the last visit ?

9.04

Immunosuppression


No; Unknown/No

Answer; Yes Y Has the patient developed an immunosuppression-associated or severe infection since the last visit ?

9.05

Significant Condition


No; Unknown/No

Answer; Yes Y Has the patient developed any other significant medical condition since the last visit ?

9.06

Disease and Medical

conditions

Sub-

Report Yes Captured in Medical Events, aggregated in this view

Notes

13.1. Description Visit specific Notes section where the user can upload documents and refer to URL.

13.2. Rules and Constraints • Documents are not stored within MDS, they are linked to

a drive location.

13.3. Functions • Enter Data – You can enter notes about the visit

• Add Link – You can link to a local document

• Add URL – You can link to WWW resources.


N/A Notes Text area Yes

N/A URL WWW link Yes Link to WWW resource

N/A Document Local Link Yes UNC path to local document

Relapses

14.1. Description This section captures the date and details of MS Relapse events.

14.2. Rules and Constraints • The only medication that can be linked to a Relapse is a

corticosteroid. These are symptomatic treatments that have been specified in the preferences as Corticosteroid.

14.3. Functions • Add/Delete relapse – You can Add/Delete Relapse for

patient

• Add/Delete Corticosteroid – You can Add/Delete Corticosteroid schedule


10.01 Onset Date Date dd/mm/yyyy Mandatory Y

10.02 Duration Number NNN.N Yes Y

10.03 ADL Impact Select Yes No; Unknown; Yes Y

10.04 Recovery Select Yes Complete; None; Partial; Unknown Y

10.05 Severity Select Yes Mild; Moderate; Severe; Unknown Y

10.06 Pyramidal tract Select Yes False; True Y

10.07 Cerebellum Select Yes False; True Y

10.08 Brainstem Select Yes False; True Y

10.09 Sensory functions Select Yes False; True Y

10.10 Bowel bladder Select Yes False; True Y

10.11 Visual functions Select Yes FALSE; TRUE Y

10.12 Neuropsycho. Functions Select Yes False; True Y

10.13 FS - Other Select Yes False; True Y

10.14 Other Detailed String 50 Yes Y

10.15 Corticosteroids Select Yes Only Available if Treatment = Ambulatory or Hospital No; Unknown; Yes Y


10.17 Steroid Prescription Select Yes [List of Corticosteroids] Y When added, fields to contain start/end date

10.18 Treatment Select Yes Ambulatory; Hospital; None; Unknown Y

Malignancy

15.1. Description The Malignancy section allows you to record occurrences and details of malignancy.

15.2. Rules and Constraints • Date of event must be after date of birth and prior to

date of death.

15.3. Functions • Add/Delete Malignancy – You can add/delete malignancy

event

• Add/Edit – You can add/edit details of the malignancy.


11.01 Date of diagnosis Date dd/mm/yyyy Mandatory Y

11.02 MedDRA Classification Select Yes MedDRA LLT Y MedDRA LLT code

11.03 Primary Cancer Site Memo Yes Y

11.04 Histological diagnosis Memo Yes Y

11.05 Diagnosis Stage Select Yes I; II; III; IV Y

11.06 Treatment - No Treatment Select Yes False; True Y

11.07 Treatment - Chemotherapy Select Yes False; True Y

11.08 Treatment - Radiotherapy Select Yes False; True Y

11.09 Treatment - Surgery Select Yes False; True Y

11.10 Treatment - Other Select Yes False; True Y

11.11 Outcome Select Yes Death; Ongoing; Remission; Unknown Y

11.12 Treatment Modality Other String 100 Yes Y

11.13 Outcome End Date Date dd/mm/yyyy Yes Only available if Outcome = Recovery or Death Y


11.15 Death Outcome Select Yes Immediate; Underlying Y

NMSC

16.1. Description The NMSC section allows the user to record occurrences and details of NMSC.


date of death.

16.3. Functions • Add/Delete NMSC – You can add/delete NMSC event

• Add/Edit – You can add/edit details of the NMSC.


12.01 Date of diagnosis Date dd/mm/yyyy Mandatory Y

12.02 MedDRA Classification Select Yes MedDRA LLT Y MedDRA LLT code

12.03 Primary Cancer Site Memo Yes Y

12.04 Histological diagnosis Memo Yes Y

12.05 Diagnosis Stage Select Yes I; II; III; IV Y

12.06 Treatment - No Treatment Select Yes False; True Y

12.07 Treatment - Chemotherapy Select Yes False; True Y

12.08 Treatment - Radiotherapy Select Yes False; True Y

12.09 Treatment - Surgery Select Yes False; True Y

12.10 Treatment - Other Select Yes False; True Y


12.12 Treatment Modality Other String 100 Yes Y

12.13 Outcome Decease Date Date dd/mm/yyyy Yes Only available if Outcome = Recovery or Death Y



Herpes Zoster

17.1. Description The Herpes Zoster section allows the user to record occurrences and details of Herpes Zoster


date of death.

17.3. Functions • Add/Delete Herpes Zoster – You can add/delete Herpes

Zoster event

• Add/Edit – You can add/edit details of the Herpes Zoster.



13.02 Treatment Modality Memo Yes Y

13.03 Outcome Select Yes Death; Ongoing; Recovery; Unknown Y




Immuno-suppression-associated

18.1. Description The Immuno-Suppression Associated section allows the user to record occurrences and details of infection.


date of death.

18.3. Functions • Add/Delete Immuno-Suppression Associated – You can

add/delete Immuno-Suppression Associated event

• Add/Edit – You can add/edit details of the Immuno-Suppression Associated event.



14.02 Immunosuppression Type String 100 Mandatory Y

14.03 MedDRA classification Select Yes MedDRA LLT Y MedDRA LLT code

14.04 Treatment Modality Memo Yes Y





Pregnancy

19.1. Description The Pregnancy section allows the user to record occurrences and details of pregnancy.

19.2. Rules and Constraints • Pregnancy page only visible if user female

• Birthdate and Termination/Miscarriage dates cannot both be recorded, only one.

19.3. Functions

• Add/Delete Pregnancy – You can add/delete Pregnancy event

• Add/Edit – You can add/edit details of the Pregnancy event.


15.01 Begin Date Date dd/mm/yyyy Mandatory Y

15.02 Date of diagnosis Date dd/mm/yyyy Yes Y

15.03 Date of last menstruation Date dd/mm/yyyy Yes Y

15.04 Positive Pregnancy Test Select Yes No; Yes Y

15.05 Pregnancy Complications Memo Yes Y

15.06 Birth Date Date dd/mm/yyyy Yes Y

15.07 Children born Number NN Yes Y Number of children born from this pregnancy

15.08 Total children Number NN Yes Y

15.09 Delivery Select Yes <null>; Normal; Pre-term Y

15.10 Abnormality Reported Memo Yes Y

15.11 Breast Feeding Select Yes <null>; No; Yes Y

15.12 Breast Feeding Start Date dd/mm/yyyy Yes Y

15.13 Breast Feeding Stop Date dd/mm/yyyy Yes Y

15.14 Termination/Miscarriage Select Yes <null>; Abortion; Miscarriage Y

15.15 Termination/Miscarriage Date Date dd/mm/yyyy Yes Cannot have Date of Birth and Date of Termination Y

15.16 Abortion Stage of pregnancy Number NN Yes Y

15.17 Reason String 20 Yes Y

Other Events

20.1. Description This section captures other medical events.

20.2. Rules and Constraints • Medical Conditions can be selected from existing

MedDRA terms. OR

• Medical Conditions can be selected from the list of reference data terms.

• The start date of the related treatment must occur on or before the date of the adverse condition.

20.3. Functions • Add/Delete Other Events – You can add/delete Other

Events

• Add/Edit – You can add/edit details of the Other Events

20.4. Data Fields

Ref Field Type Len

Data


Sent to

Registry Comments

16.01

Condition Type/MedDRA

LLT Select Mandatory MedDRA LLT Y MedDRA LLT code


16.03 Severity Select Yes Life Threatening; Mild; Moderate; Severe Y

16.04 Outcome Select Yes Fatal; Ongoing; Resolved Y


16.06 Condition Decease Date Date dd/mm/yyyy Yes

Only available if Outcome =

Recovery or Death Y

16.07 Drug Relationship Select Yes Not Related; Related Y

16.08 Treatment Select Yes [List MS Specific Treatments or Symptomatic Treatments assigned to that user] Y

16.09 Result in death Select Yes

Congenital anomaly/birth defect; Is life-threatening; Other Medical Important Condition;

Permanent/serious disability incapacity; Requires/prolongs hospitalisation; Result in death Y

16.10 Is life threatening Select Yes



16.11

Permanent/serious

disability incapacity Select Yes



16.12

Require/prolongs

hospitalisation Select Yes



16.13

Congenital anomaly/birth

defect Select Yes



16.14

Other medically important

condition Select Yes




16.16 Serious Adverse Event Select Yes



MRI

21.1. Description The MRI section allows user to record Magnetic Resonance Imaging (MRI) scan details.

21.2. Rules and Constraints • MRI images are stored in the MDS database.

• Quantitative tab can only be populated by MSBase Registry API through selected providers.

• Images not sent to the MSBase Registry

21.3. Functions • Add/Delete MRI – You can add/delete MRI event details

for a patient.

• Attach image/s – You can browse to a local file and upload so that other users can see image.

• Add and/or Delete MRI Calendar Event – You can add/delete Calendar Event

• View and Zoom images – You can view, zoom and pan MRI images.


17.01 Exam Date Date dd/mm/yyyy Mandatory Must be greater than birthdate Y

17.02 CNS region Select Mandatory Brain; Cervical Cord; Thoracic Cord; Whole Spinal Cord Y

17.03 T1 Select Yes FALSE; TRUE Y

17.04 T1 Type Select Yes T1 must be set to Yes <null>; Abnormal MS Atypical; Abnormal MS Typical; Normal Y

17.05 T1 lesion count Number NNNNNN Yes T1 must be set to Yes Y

17.06 T1 + Gadolinium Select Yes False; True Y

17.07 T1 + Gadolinium type Select Yes T1 + Gandolinium must be set to Yes <null>; Abnormal MS Atypical; Abnormal MS Typical; Normal Y

17.08 Gd lesion count Number NNNNNN Yes T1 + Gandolinium must be set to Yes Y

17.09 T2 Select Yes False; True Y

17.10 T2 Type Select Yes T2 Type must be set to Yes <null>; Abnormal MS Atypical; Abnormal MS Typical; Normal Y

17.11 T2 lesion count Number NNNNNN Yes T2 Type must be set to Yes Y

17.12 New lesions Number NNNNNN Yes T2 Type must be set to Yes Y

17.13 Gadolinium administration Select Yes <null>; 0; 1+ Y

17.14 T1+Gd enh lesions Select Yes Gadolinium administration must be set to Yes <null>; 0; 1-2; 3-8; 9+ Y

17.15 T2 hyperintensive lesions Select Yes <null>; 0; 1+ Y

17.16 Infratentorial lesions Select Yes <null>; 0; 1+ Y

17.17 Juxtacortical lesions Select Yes <null>; 0; 1-2; 3+ Y

17.18 Periventricular lesions Select Yes <null>; No; Yes Y


17.20 Contiguous lesion Select Yes ?; No; Yes Y

CSF This section provides details on the collection of Cerebral Spinal Fluid (CSF).

22.1. Rules and Constraints • NA

22.2. Functions • Add/Delete CSF – You can add/delete CSF event details

for a patient.

• Add and/or Delete CSF Calendar Event – You can add/delete Calendar Event.

22.3. Data Fields


Sent to

Registry Comments

18.01 CSF Collection Date Date dd/mm/yyyy Mandatory Y

18.02 Collection Type Select Yes Abnormal MS-Atypical; Abnormal MS-Typical; Normal; Traumatic Y

18.03 Total Protein Number NNNNNNNNN Yes Y

floating

decimal

18.04 Glucose Number NNNNNNNNN Yes Y

floating

decimal

18.05 Albumin Number NNNNNNNNN Yes Y

floating

decimal

18.06 Q Albumin Number NNNNNNNNN Yes Y

floating

decimal

18.07 IgG Number NNNNNNNNN Yes Y

floating

decimal

18.08 IgG Index Number NNNNNNNNN Yes Y

floating

decimal

18.09 Other String 100 Yes Y

18.10 JC Virus in CSF Select Yes Done; Not Done Y

18.11 Result Select Yes Only available if JC Virus in CSF = Done Negative; Positive Y

18.12 White Cell Count Number NNNNNNNNN Yes Y

floating

decimal

18.13 Lymphocytes (%) Number NNNNNNNNN Yes

Only available if White Cell Count is

populated Y

floating

decimal

18.14 Granulocytes (%) Number NNNNNNNNN Yes


populated Y

floating

decimal

18.15 Plasma cells (%) Number NNNNNNNNN Yes


populated Y

floating

decimal

18.16 Erythrocytes (/mm3) Number NNNNNNNNN Yes


populated Y

floating

decimal

18.17 Oligoclonal Bands Select Yes Not Done; OCB absent in CSF; OCB detected in CSF Y

18.18

Oligoclonal band

count Number NNNNNNNNN Yes

Only available if Oligoclonal = OCB detected

in CSF Y

floating

decimal

18.19 Serum Match Select Yes

Only available if Oligoclonal = OCB detected

in CSF

<null>; Matched OCB detected in serum; No matched OCB in serum; Serum

sample not done Y


Evoked Potentials

23.1. Description This section records details about the Evoked Potential exam, measuring rate of conduction and amplitude of the nerve impulses.


23.3. Functions • Add/Delete EP –You can add/delete EP event details for a

patient.

• Add and/or Delete EP Calendar Event – You can add/delete Calendar Event


19.01 Exam Date Date dd/mm/yyyy Mandatory Y

19.02 VEP Right - Type Select Yes Abnormal; Normal; Unknown Y

19.03 VEP Right - Amplitude Number NNNNNN.NN Yes Y

19.04 VEP Right - P100 latency Number NNNNNN Yes Y

19.05 Normal Range Low Number NNNNN Yes Must be less than Normal Range High (warning only) Y Normal range for latency (msec)

19.06 VEP Left - Type Select Yes Abnormal; Normal; Unknown Y

19.07 VEP Left - Amplitude Number NNNNNN.NN Yes Y

19.08 VEP Left - P100 latency Number NNNNNN Yes Y

19.09 Normal Range High Number NNNNN Yes Must be less than Normal Range Low (warning only) Y

19.10 BAEP Right Select Yes Abnormal; Normal; Unknown Y

19.11 BAEP Left Select Yes Abnormal; Normal; Unknown Y

19.12 SEP - Right - Upper Extremity Select Yes Abnormal; Normal; Unknown Y

19.13 SEP - Right - Lower Extremity Select Yes Abnormal; Normal; Unknown Y

19.14 SEP - Left - Upper Extremity Select Yes Abnormal; Normal; Unknown Y

19.15 SEP - Left - Lower Extremity Select Yes Abnormal; Normal; Unknown Y

19.16 MEP - Right - Upper Extremity Select Yes Abnormal; Normal; Unknown Y

19.17 MEP - Right - Lower Extremity Select Yes Abnormal; Normal; Unknown Y

19.18 MEP - Left - Upper Extremity Select Yes Abnormal; Normal; Unknown Y

19.19 MEP - Left - Lower Extremity Select Yes Abnormal; Normal; Unknown Y


Laboratory Tests -> Haematology

24.1. Description The haematology section, part of the broader Laboratory Tests, enables the user to enter data from exams and comment where the test value is abnormal.


24.3. Functions • Add/Delete Lab test – You can add/delete Lab test

details for a patient.

• Add/Delete Lab test Calendar Event – You can add/delete Calendar Event


20.01 White cell count Number NNNNNN.NN Yes Y

20.02 White cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.03 White cell abnormal Select Yes Abnormal; Normal Y

20.04 White cell comments String 100 Yes

20.05 Red cell count Number NNNNNN.NN Yes Y

20.06 Red cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.07 Red cell abnormal Select Yes Abnormal; Normal Y

20.08 Red cell comments String 101 Yes

20.09 Lymphocyte Count Number NNNNNN.NN Yes Y

20.10 Lymphocyte Count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.11 Lymphocyte abnormal Select Yes Abnormal; Normal Y

20.12 Lymphocyte comments String 102 Yes

20.13 Lymphocyte Count lower limit Number NNNNNN.NN Yes Y

20.14 T cell count Number NNNNNN.NN Yes Y

20.15 T cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.16 T cell abnormal Select Yes Abnormal; Normal Y

20.17 T cell comments String 103 Yes

20.18 CD4 T cell count Number NNNNNN.NN Yes Y

20.19 CD4 T cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.20 CD4 T cell abnormal Select Yes Abnormal; Normal Y

20.21 CD4 T cell comments String 104 Yes

20.22 CD8 T cell count Number NNNNNN.NN Yes Y

20.23 CD8 T cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.24 CD8 T cell abnormal Select Yes Abnormal; Normal Y

20.25 CD8 T cell comments String 105 Yes

20.26 CD19 B cell count Number NNNNNN.NN Yes Y

20.27 CD19 B cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.28 CD19 B cell abnormal Select Yes Abnormal; Normal Y

20.29 CD19 B cell comments String 106 Yes

20.30 NK cell count Number NNNNNN.NN Yes Y

20.31 NK cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.32 NK cell abnormal Select Yes Abnormal; Normal Y

20.33 NK cell comments String 107 Yes

20.34 Neutrophil count Number NNNNNN.NN Yes Y

20.35 Neutrophil count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.36 Neutrophil abnormal Select Yes Abnormal; Normal Y

20.37 Neutrophil comments String 108 Yes

20.38 Monocyte count Number NNNNNN.NN Yes Y

20.39 Monocyte count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.40 Monocyte abnormal Select Yes Abnormal; Normal Y

20.41 Monocyte comments String 109 Yes

20.42 Eosinophil count Number NNNNNN.NN Yes Y

20.43 Eosinophil count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.44 Eosinophil abnormal Select Yes Abnormal; Normal Y

20.45 Eosinophil comments String 110 Yes

20.46 Basophil count Number NNNNNN.NN Yes Y

20.47 Basophil count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.48 Basophil abnormal Select Yes Abnormal; Normal Y

20.49 Basophil comments String 111 Yes

20.50 Platelet count Number NNNNNN.NN Yes Y

20.51 Platelet count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.52 Platelet abnormal Select Yes Abnormal; Normal Y

20.53 Platelet comments String 112 Yes

20.54 Haemoglobin count Number NNNNNN.NN Yes Y

20.55 Haemoglobin count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

20.56 Haemoglobin abnormal Select Yes Abnormal; Normal Y

20.57 Haemoglobin comments String 113 Yes

20.58 Exam Date Date dd/mm/yyyy Mandatory Y

Laboratory Tests -> Blood Chemistry

25.1. Description The Blood Chemistry section, part of the broader Laboratory Tests, enables the user to enter data from exams and comment where the test value is abnormal.


25.3. Functions • Add/Delete Lab test – You can add/delete Lab test details

for a patient.



21.01 Total Protein count Number NNNNNN.NN Yes Y

21.02 Total Protein count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.03 Total Protein abnormal Select Yes Abnormal; Normal Y

21.04 Total Protein comments String 114 Yes

21.05 Albumin count Number NNNNNN.NN Yes Y

21.06 Albumin count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.07 Albumin abnormal Select Yes Abnormal; Normal Y

21.08 Albumin comments String 115 Yes

21.09 SGOT / AST count Number NNNNNN.NN Yes Y

21.10 SGOT / AST count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.11 SGOT / AST abnormal Select Yes Abnormal; Normal Y

21.12 SGOT / AST comments String 116 Yes

21.13 SGPT / ALT count Number NNNNNN.NN Yes Y

21.14 SGPT / ALT count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.15 SGPT / ALT abnormal Select Yes Abnormal; Normal Y

21.16 SGPT / ALT comments String 117 Yes

21.17 Gamma-GT count Number NNNNNN.NN Yes Y

21.18 Gamma-GT count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.19 Gamma-GT abnormal Select Yes Abnormal; Normal Y

21.20 Gamma-GT comments String 118 Yes

21.21 Bilirubin count Number NNNNNN.NN Yes Y

21.22 Bilirubin count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.23 Bilirubin abnormal Select Yes Abnormal; Normal Y

21.24 Bilirubin comments String 119 Yes

21.25 Alkaline phosphatase count Number NNNNNN.NN Yes Y

21.26 Alkaline phosphatase count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.27 Alkaline phosphatase abnormal Select Yes Abnormal; Normal Y

21.28 Alkaline phosphatase comments String 120 Yes

21.29 Calcium count Number NNNNNN.NN Yes Y

21.30 Calcium count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.31 Calcium abnormal Select Yes Abnormal; Normal Y

21.32 Calcium comments String 121 Yes

21.33 Urea count Number NNNNNN.NN Yes Y

21.34 Urea count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.35 Urea abnormal Select Yes Abnormal; Normal Y

21.36 Urea comments String 122 Yes

21.37 Uric acid count Number NNNNNN.NN Yes Y

21.38 Uric acid count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.39 Uric acid abnormal Select Yes Abnormal; Normal Y

21.40 Uric acid comments String 123 Yes

21.41 Creatinine count Number NNNNNN.NN Yes Y

21.42 Creatinine count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.43 Creatinine abnormal Select Yes Abnormal; Normal Y

21.44 Creatinine comments String 124 Yes

21.45 Amylase count Number NNNNNN.NN Yes Y

21.46 Amylase count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.47 Amylase abnormal Select Yes Abnormal; Normal Y

21.48 Amylase comments String 125 Yes

21.49 Lipase count Number NNNNNN.NN Yes Y

21.50 Lipase count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

21.51 Lipase abnormal Select Yes Abnormal; Normal Y

21.52 Lipase comments String 126 Yes

Laboratory Tests -> Thyroid Function

26.1. Description The Thyroid Function section, part of the broader Laboratory Tests, enables the user to enter data from exams and comment where the test value is abnormal.


26.3. Functions • Add/Delete Lab test – You can add/delete Lab test

details for a patient.


26.4. Data Fields


Sent to

Registry Comments

22.01

Anti-microsomal antibodies

count Number NNNNNN.NN Yes Y

22.02


count unit Select Yes

%; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L;

mmol/L; nmol/L; pmol/L; U/L; umol/L Y

22.03


abnormal Select Yes Abnormal; Normal Y

22.04


comments String 127 Yes

22.05

Anti-thyroglobulin

antibodies count Number NNNNNN.NN Yes Y

22.06

Anti-thyroglobulin

antibodies count unit Select Yes

%; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L;


22.07

Anti-thyroglobulin

antibodies abnormal Select Yes Abnormal; Normal Y

22.08

Anti-thyroglobulin

antibodies comments String 128 Yes

22.09 T3 count Number NNNNNN.NN Yes Y

22.10 T3 count unit Select Yes

%; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L;


22.11 T3 abnormal Select Yes Abnormal; Normal Y

22.12 T3 comments String 129 Yes

22.13 T4 count Number NNNNNN.NN Yes Y

22.14 T4 count unit Select Yes

%; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L;


22.15 T4 abnormal Select Yes Abnormal; Normal Y

22.16 T4 comments String 130 Yes

22.17 TSH count Number NNNNNN.NN Yes Y

22.18 TSH count unit Select Yes

%; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L;


22.19 TSH abnormal Select Yes Abnormal; Normal Y

22.20 TSH comments String 131 Yes

Laboratory Tests -> Serological Tests

27.1. Description The Serological Tests section, part of the broader Laboratory Tests, enables the user to enter data from exams and comment where the test value is abnormal.



for a patient.



23.01 Anti JC virus results Number NNNNNN.NN Yes Y

23.02 Anti JC virus Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.03 Anti JC virus Normal Select Yes Abnormal; Normal Y

23.04 Anti JC virus comments String 132 Yes

23.05 Urine JC Virus DNA results Number NNNNNN.NN Yes Y

23.06 Urine JC Virus DNA Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.07 Urine JC Virus DNA Normal Select Yes Abnormal; Normal Y

23.08 Urine JC Virus DNA comments String 133 Yes

23.09 HBV antigen results Number NNNNNN.NN Yes Y

23.10 HBV Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.11 HBV Normal Select Yes Abnormal; Normal Y

23.12 HBV antigen comments String 134 Yes

23.13 Anti HCV results Number NNNNNN.NN Yes Y

23.14 Anti HCV Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.15 Anti HCV Normal Select Yes Abnormal; Normal Y

23.16 Anti HCV comments String 135 Yes

23.17 Anti-HIV results Number NNNNNN.NN Yes Y

23.18 Anti-HIV Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.19 Anti-HIV Normal Select Yes Abnormal; Normal Y

23.20 Anti-HIV comments String 136 Yes

23.21 Anti Varicella results Number NNNNNN.NN Yes Y

23.22 Anti Varicella Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.23 Anti Varicella normal Select Yes Abnormal; Normal Y

23.24 Anti Varicella comments String 137 Yes

23.25 Quantiferon gold test results Number NNNNNN.NN Yes Y

23.26 Quantiferon gold test Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.27 Quantiferon gold Normal Select Yes Abnormal; Normal Y

23.28 Quantiferon gold test comments String 138 Yes

23.29 Mantoux test results Number NNNNNN.NN Yes Y

23.30 Mantoux test Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.31 Mantoux test Normal Select Yes Abnormal; Normal Y

23.32 Mantoux test comments String 139 Yes

23.33 Neutralising Anti-IFN results Number NNNNNN.NN Yes Y

23.34 Neutralising Anti-IFN Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.35 Neutralising Anti-IFN Normal Select Yes Abnormal; Normal Y

23.36 Neutralising Anti-IFN comments String 140 Yes

23.37 Neutralising Anti-natalizumab results Number NNNNNN.NN Yes Y

23.38 Neutralising Anti-natalizumab Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.39 Neutralising Anti-natalizumab Normal Select Yes Abnormal; Normal Y

23.40 Neutralising Anti-natalizumab comments String 141 Yes

23.41 Pregnancy test results Number NNNNNN.NN Yes Y

23.42 Pregnancy test Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

23.43 Pregnancy test Normal Select Yes Abnormal; Normal Y

23.44 Pregnancy test comments String 142 Yes

23.45 Lab performing test Memo Yes

Laboratory Tests -> Auto-antibody Tests

28.1. Description The Auto-antibody tests section, part of the broader Laboratory Tests, enables the user to enter data from exams and comment where the test value is abnormal.



for a patient.



24.01 NMO-IgG results Number NNNNNN.NN Yes Y

24.02 NMO-IgG Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.03 NMO-IgG Normal Select Yes Abnormal; Normal Y

24.04 NMO-IgG comments String 143 Yes

24.05 Anti-MOG results Number NNNNNN.NN Yes Y

24.06 Anti-MOG Unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.07 Anti-MOG Normal Select Yes Abnormal; Normal Y

24.08 Anti-MOG comments String 144 Yes

24.09 ANA count Number NNNNNN.NN Yes Y

24.10 ANA count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.11 ANA abnormal Select Yes Abnormal; Normal Y

24.12 ANA comments String 145 Yes

24.13 Anti-mitochindrial count Number NNNNNN.NN Yes Y

24.14 Anti-mitochindrial count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.15 Anti-mitochindrial abnormal Select Yes Abnormal; Normal Y

24.16 Anti-mitochindrial comments String 146 Yes

24.17 Anti parietal cell count Number NNNNNN.NN Yes Y

24.18 Anti parietal cell count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.19 Anti parietal cell abnormal Select Yes Abnormal; Normal Y

24.20 Anti parietal cell comments String 147 Yes

24.21 ASMA count Number NNNNNN.NN Yes Y

24.22 ASMA count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.23 ASMA abnormal Select Yes Abnormal; Normal Y

24.24 ASMA comments String 148 Yes

24.25 Anti-Ro count Number NNNNNN.NN Yes Y

24.26 Anti-Ro count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.27 Anti-Ro abnormal Select Yes Abnormal; Normal Y

24.28 Anti-Ro comments String 149 Yes

24.29 La count Number NNNNNN.NN Yes Y

24.30 La count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.31 La abnormal Select Yes Abnormal; Normal Y

24.32 La comments String 150 Yes

24.33 Sm count Number NNNNNN.NN Yes Y

24.34 Sm count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.35 Sm abnormal Select Yes Abnormal; Normal Y

24.36 Sm comments String 151 Yes

24.37 RNP count Number NNNNNN.NN Yes Y

24.38 RNP count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.39 RNP abnormal Select Yes Abnormal; Normal Y

24.40 RNP comments String 152 Yes

24.41 Scl-70 count Number NNNNNN.NN Yes Y

24.42 Scl-70 count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.43 Scl-70 abnormal Select Yes Abnormal; Normal Y

24.44 Scl-70 comments String 153 Yes

24.45 Jo1 count Number NNNNNN.NN Yes Y

24.46 Jo1 count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.47 Jo1 abnormal Select Yes Abnormal; Normal Y

24.48 Jo1 comments String 154 Yes

24.49 Anti-DNA count Number NNNNNN.NN Yes Y

24.50 Anti-DNA count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.51 Anti-DNA abnormal Select Yes Abnormal; Normal Y

24.52 Anti-DNA comments String 155 Yes

24.53 ANCA count Number NNNNNN.NN Yes Y

24.54 ANCA count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.55 ANCA abnormal Select Yes Abnormal; Normal Y

24.56 ANCA comments String 156 Yes

24.57 Anti-LKM count Number NNNNNN.NN Yes Y

24.58 Anti-LKM count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.59 Anti-LKM abnormal Select Yes Abnormal; Normal Y

24.60 Anti-LKM comments String 157 Yes

24.61 Anti-cardiolipin count Number NNNNNN.NN Yes Y

24.62 Anti-cardiolipin count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.63 Anti-cardiolipin abnormal Select Yes Abnormal; Normal Y

24.64 Anti-cardiolipin comments String 158 Yes

24.65 LAC count Number NNNNNN.NN Yes Y

24.66 LAC count unit Select Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.67 LAC abnormal Select Yes Abnormal; Normal Y

24.68 LAC comments String 159 Yes

24.69 Anti-transglutaminase count Number NNNNNN.NN Yes Y

24.70 Anti-transglutaminase count unit Number NNNNNN.NN Yes %; ?; 10e12/L; 10e9/L; g/dL; g/L; L/L; mmol/L; nmol/L; pmol/L; U/L; umol/L Y

24.71 Anti-transglutaminase abnormal Select Yes Abnormal; Normal Y

24.72 Anti-transglutaminase comments String 160 Yes

Flexifields

29.1. Description User specified Flexifields for Paraclinical Tests are in this section.


29.3. Functions • Enter/Delete Data – You can enter/delete Flexifield data.

MS Specific

30.1. Description This section identifies MS Specific treatments

30.2. Rules and Constraints • MS Treatment must be present in the list of MS Specific

Treatments. Dose, unit, period populated with default values and may be modified.

• Concurrent MS Specific Treatments are possible, but where concurrent treatments are initiated MDS will attempt to close the existing treatment at the start date of the new treatment. MDS will prompt and ask whether you wish to continue.

• Changing the dosage of an ongoing MS Specific Treatment will be met with a confirmation prompt from MDS. In the instance where it is a valid change (for example an error) then you can ignore the prompt. Where it is a change to dosage, MDS will automatically end the existing treatment and start a new treatment with the new dosage.

30.3. Functions • Add/Remove MS Specific Treatment – User can add

treatment, modify data and delete treatment.

30.4. Data Fields


Sent to

Registry Comments

25.01

MS Specific

Treatment Select Mandatory [Lookup MS Specific Treatment] Y Treatment

25.02 Start date Date dd/mm/yyyy Mandatory

Must be less than Date of death, must

not have another MS Specific Treatment

be undergoing Y Starting on

25.03 Ending on Date dd/mm/yyyy Yes Must be greater than Start Date Y End date

25.04

Reason for

end Select Yes Must have Ending On populated

Adverse Event; Allergic Reaction; Convenience; Lack Of Improvement; Lack Of Tolerance; Mri

Activity; Non Adherence; Persistence Of Relapses; Pregnancy Confirmed; Pregnancy Planning;

Progression Of Disease; Progression Of Edss; Scheduled Stop; Treatment Stop Cause; Unknown Y

25.05

Posology

dose Number NNNNNN.NN Yes Y

25.06 Posology unit Select Yes g; mcg; mg; MIU; ml; MU; Other Y

25.07

Posology

period Select Yes

/ 2 Days; / 2 Hour; / 3 Days; / 3 Hour; / 3 Month; / 4 Hour; / 4 Week; / 5 Week; / 6 Week; / 7 Week; /

8 Week; / Day; / Hour; / Month; / Week; <null>; 2 / Day; 2 / Week; 3 / Day; 3 / Week; 4 / Day; Other Y

25.08

Posology

route Select Yes IM; IV; Oral; Other; SC Y


Symptomatic

31.1. Description This section identifies Symptomatic treatments

31.2. Rules and Constraints • Treatment must be present in the list of Symptomatic

Treatments. Dose, unit, period populated with default values and may be modified.

31.3. Functions • Add/Remove Symptomatic Treatment – User can add

treatment, modify data and delete treatment.

31.4. Data Fields


Sent to

Registry Comments

26.01

Symptomatic

Treatment Select Mandatory [Lookup Symptomatic Treatment] Y


Must be less than Date of

death, Must not have

another MS Specific

Treatment be undergoing Y

26.03 Ending on Date dd/mm/yyyy Yes

Must be greater than Start

Date Y

26.04

Reason for

end Select Yes

Must have Ending On

populated

Treatment Related Adverse Event, Allergic Reaction, Lack of efficacy, Lack of tolerance, Non adherence, Patient

Choice/Convenience, Persistence of relapses, Persisting MRI activity, Pregnancy confirmed, Pregnancy planning,

Progression of disease, Progression of EDSS, Scheduled Stop, Anti-JCV AB Positive / PML Risk, Other Y

26.05

Posology

dose Number NNNNNN.NN Yes Y

26.06 Posology unit Select Yes mcg, MU, mg, g, ml, MIU, Other, mg/kg, mg/m2 Y

26.07

Posology

period Select Yes

Other; 2 / Week; / Week; 2 / Day; 3 / Week; / 3 Hour; / 2 Hour; 3 / Day; / 3 Days; / 2 Days; / Hour; / Day; / 4 Hour; 4 /

Day; / Month; / 3 Month; / 4 Week; Single Dose; Daily for 5 days; Daily for 3 days; / 2 Week; / 6 Month; 5 Day

Course; 5 Day Course (Week 1 and Week 5); / 2 Week; / 6 Month; 5 Day Course; 5 Day Course (Week 1 and Week

5) Y

26.08

Posology

route Select Yes SC, IM, IV, Oral Y


Non-pharmacological

32.1. Description This section identifies non-pharmacological treatments.

32.2. Rules and Constraints • Treatment must be present in the list of non-

pharmacological treatments.

32.3. Functions • Add/Remove non-pharmacological Treatment – User can

add treatment, modify data and delete treatment.

32.4. Data Fields

Ref Field Type Len

Data


Sent to

Registry Comments

27.01

Non-pharmacological

treatment Select Mandatory

[Lookup non-Pharmacological

treatment] Y


Must be less than Date of death, Must not have another MS Specific Treatment be

undergoing Y

27.03 Ending on Date dd/mm/yyyy Yes Must be greater than Start Date Y
