Informationen:
Fehler:
ID
43862
Beschreibung
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®
Link
https://clinicaltrials.gov/ct2/show/NCT01515423
Stichworte
Versionen (2)
- 21.05.17 21.05.17 -
- 20.09.21 20.09.21 -
Hochgeladen am
20. September 2021
DOI
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Lizenz
Creative Commons BY 4.0
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Visit 2 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Visit 2 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
Ähnliche Modelle
Visit 2 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
ECG reference number
Item
ECG reference number
integer
C1623258 (UMLS CUI [1,1])
C3274661 (UMLS CUI [1,2])
C3274661 (UMLS CUI [1,2])
Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Pulse at rest
Item
Supine after 5 minutes rest: Pulse
integer
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,2])
SBP at rest
Item
Supine after 5 minutes rest: Systolic Blood Pressure
integer
C2039694 (UMLS CUI [1])
DBP at rest
Item
Supine after 5 minutes rest: Diastolic Blood Pressure
integer
C2183311 (UMLS CUI [1])
Pulse while standing
Item
Standing after 2 minutes: Pulse
integer
C2029905 (UMLS CUI [1])
SBP standing
Item
Standing after 2 minutes: Systolic Blood Pressure
integer
C1303018 (UMLS CUI [1])
DBP standing
Item
Standing after 2 minutes: Diastolic Blood Pressure
integer
C1303019 (UMLS CUI [1])
CL Item
Standing (1)
CL Item
Sitting (2)
CL Item
Supine (3)
Item Group
PK Blood Sample: Paliperidone
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
Specimen taken
Item
Specimen taken
boolean
C1277698 (UMLS CUI [1])
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
C2826726 (UMLS CUI [1,2])
Comment, blood specimen
Item
Specimen comments, if any
text
C0947611 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
C2826726 (UMLS CUI [1,2])
Item
Was the Dipstick Pregnancy Test performed?
integer
C0430056 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (postmenopausal females) (3)
Reason for no pregnancy test
Item
If No, please provide a reason:
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
Urine drug screen collected
Item
Was urine drug screen (dipstick) collected?
boolean
C0202274 (UMLS CUI [1,1])
C2922935 (UMLS CUI [1,2])
C2922935 (UMLS CUI [1,2])
Reason for no urine drug screen
Item
If No, please provide a reason:
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,3])
CL Item
Skin (1)
CL Item
Eyes (2)
CL Item
Ears, Nose, Throat (3)
CL Item
Head, Neck, Thyroid (4)
CL Item
Heart (5)
CL Item
Lung (6)
CL Item
Chest (inc. Breasts) (7)
CL Item
Abdomen (8)
CL Item
Genitalia (9)
CL Item
Anorectal (10)
CL Item
Lymph nodes (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
Item
Status
integer
C0449438 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0460002 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Abnormality specification
Item
If 'Abnormal,' please describe the abnormality:
text
C1704258 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Abnormal Involuntary Movement Scale
C0450978 (UMLS CUI-1)
Item
Facial and oral movements: Muscles of facial expression
integer
C3640439 (UMLS CUI [1])
Code List
Facial and oral movements: Muscles of facial expression
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Facial and oral movements: Lips and perioral area
integer
C3640440 (UMLS CUI [1])
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Extremity movements: Upper (arms, wrists, hands, fingers)
integer
C3640443 (UMLS CUI [1])
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Extremity movements: Lower (legs, knees, ankles, toes)
integer
C3640444 (UMLS CUI [1])
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Trunk movements: Neck, shoulders, hip
integer
C3640445 (UMLS CUI [1])
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Global Judgements: Severity of abnormal movements
integer
C3640446 (UMLS CUI [1])
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Global Judgements: Incapacitation due to abnormal movements
integer
C3640447 (UMLS CUI [1])
Code List
Global Judgements: Incapacitation due to abnormal movements
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Global Judgements: Subject´s awareness of abnormal movements
integer
C3640448 (UMLS CUI [1])
Code List
Global Judgements: Subject´s awareness of abnormal movements
CL Item
0: No awareness (1)
CL Item
1: Awareness, no distress (2)
CL Item
2: Awareness, mild distress (3)
CL Item
3: Awareness, moderate distress (4)
CL Item
4: Awareness, severe distress (5)
Item
Dental Status: Current problems with teeth and/or dentures
integer
C3640449 (UMLS CUI [1])
Code List
Dental Status: Current problems with teeth and/or dentures
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
AIMS: Does the subject usually wear dentures?
Item
Dental Status: Does the subject usually wear dentures?
boolean
C3640450 (UMLS CUI [1])
CL Item
0: Normal, occasional fidgety movements of the limbs (1)
CL Item
1: Presence of characteristic restless movements: shuffling or tramping movements of the legs/feet, or swinging of one leg while sitting, and/or rocking from foot to foot or “walking on the spot” when standing, but movements present for less than half the time observed (2)
CL Item
2: Observed phenomena, as described in (1) above, which are present for at least half the observation period (3)
CL Item
3: Patient is constantly engaged in characteristic restless movements, and/or has the inability to remain seated or standing without walking or pacing, during the time observed (4)
Item
Subjective: Awareness of restlessness
integer
C3640452 (UMLS CUI [1])
CL Item
0: Absence of inner restlessness (1)
CL Item
1: Non-specific sense of inner restlessness (2)
CL Item
2: The patient is aware of an inability to keep the legs still, or a desire to move the legs, and/or complains of inner restlessness aggravated specifically by being required to stand still (3)
CL Item
3: Awareness of intense compulsion to move most of the time and/or reports strong desire to walk or pace most of the time (4)
Item
Subjective: Reported distress related to restlessness
integer
C3640453 (UMLS CUI [1])
Code List
Subjective: Reported distress related to restlessness
CL Item
0: No distress (1)
CL Item
1: Mild (2)
CL Item
2: Moderate (3)
CL Item
3: Severe (4)
Item
Global clinical rating of akathisia
integer
C3640454 (UMLS CUI [1])
CL Item
0: Absent. No evidence of awareness of restlessness. Observation of characteristic movements of akathisia in the absence of a subjective report of inner restlessness or compulsive desire to move the legs should be classified as pseudoakathisia. (1)
CL Item
1: Questionable. Non-specific inner tension and fidgety movements. (2)
CL Item
2: Mild akathisia. Awareness of restlessness in the legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements of akathisia not necessarily observed. Condition causes little or no distress. (3)
CL Item
3: Moderate akathisia. Awareness of restlessness as described for mild akathisia above, combined with characteristic restless movements such as rocking from foot to foot when standing. Patient finds the condition distressing. (4)
CL Item
4: Marked akathisia. Subjective experience of restlessness includes a compulsive desire to walk or pace. However, the patient is able to remain seated for at least five minutes. The condition is obviously distressing. (5)
CL Item
5: Severe akathisia. The patient reports a strong compulsion to pace up and down most of the time. Unable to sit or lie down for more than a few minutes. Constant restlessness which is associated with intense distress and insomnia. (6)
Item Group
Simpson Angus Rating Scale
C0030569 (UMLS CUI-1)
C0450973 (UMLS CUI-2)
C0450973 (UMLS CUI-2)
CL Item
0 Normal (1)
CL Item
1 Diminution in swing while the patient is walking (2)
CL Item
2 Marked diminution in swing with obvious rigidity in the arm (3)
CL Item
3 Stiff gait with arms held rigidly before the abdomen (4)
CL Item
4 Stooped shuffling gait with propulsion and retropulsion (5)
CL Item
0 Normal, free fall with loud slap and rebound (1)
CL Item
1 Fall slowed slightly with less audible contact and little rebound (2)
CL Item
2 Fall slowed, no rebound (3)
CL Item
3 Marked slowing, no slap at all (4)
CL Item
4 Arms fall as though against resistance; as though through glue (5)
Item
3 Shoulder shaking
integer
C0037004 (UMLS CUI [1,1])
C1883023 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C1883023 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
CL Item
0 Normal (1)
CL Item
1 Slight stiffness and resistance (2)
CL Item
2 Moderate stiffness and resistance (3)
CL Item
3 Marked rigidity with difficulty in passive movement (4)
CL Item
4 Extreme stiffness and rigidity with almost a frozen shoulder (5)
Item
4 Elbow rigidity
integer
C0013769 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
CL Item
0 Normal (1)
CL Item
1 Slight stiffness and resistance (2)
CL Item
2 Moderate stiffness and resistance (3)
CL Item
3 Marked rigidity with difficulty in passive movement (4)
CL Item
4 Extreme stiffness and rigidity with almost a frozen elbow (5)
Item
5 Wrist rigidity
integer
C0043262 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
CL Item
0 Normal (1)
CL Item
1 Slight stiffness and resistance (2)
CL Item
2 Moderate stiffness and resistance (3)
CL Item
3 Marked rigidity with difficulty in passive movement (4)
CL Item
4 Extreme stiffness and rigidity with almost frozen wrist (5)
Item
6 Leg pendulousness
integer
C1140621 (UMLS CUI [1,1])
C4068836 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C4068836 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
CL Item
0 The legs swing freely (1)
CL Item
1 Slight diminution in the swing of the legs (2)
CL Item
2 Moderate resistance to swing (3)
CL Item
3 Marked resistance and damping of swing (4)
CL Item
4 Complete absence of swing (5)
Item
7 Head dropping
integer
C0018670 (UMLS CUI [1,1])
C1705648 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
C1705648 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
CL Item
0 The head falls completely with a good thump as it hits the table (1)
CL Item
1 Slight slowing in fall, mainly noted by lack of slap as head meets the table (2)
CL Item
2 Moderate slowing in the fall quite noticeable to the eye (3)
CL Item
3 Head falls stiffly and slowly (4)
CL Item
4 Head does not reach the examining table (5)
CL Item
0 0-5 blinks (1)
CL Item
1 6-10 blinks (2)
CL Item
2 11-15 blinks (3)
CL Item
3 16-20 blinks (4)
CL Item
4 21 and more blinks (5)
CL Item
0 Normal (1)
CL Item
1 Mild finger tremor, obvious to sight and touch (2)
CL Item
2 Tremor of hand or arm occurring spasmodically (3)
CL Item
3 Persistent tremor of one or more limbs (4)
CL Item
4 Whole body tremor (5)
CL Item
0 Normal (1)
CL Item
1 Excess salivation to the extent that pooling takes place if the mouth is open and the tongue raised (2)
CL Item
2 When excess salivation is present and might occasionally result in difficulty speaking (3)
CL Item
3 Speaking with difficulty because of excess salivation (4)
CL Item
4 Frank drooling (5)
Item Group
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version
C3641328 (UMLS CUI-1)
SSRS: Wish to be dead
Item
Suicidal Ideation: Wish to be dead
boolean
C3641578 (UMLS CUI [1])
SSRS: Description of wish to be dead
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641579 (UMLS CUI [1])
SSRS: Non-specific active suicidal thoughts
Item
Suicidal Ideation: Non-specific active suicidal thoughts
boolean
C3641580 (UMLS CUI [1])
SSRS: Description of Non-Specific Active Suicidal Thoughts
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641581 (UMLS CUI [1])
SSRS: Active suicidal ideation with any methods (not plan) without intent to act
Item
Suicidal Ideation: Active suicidal ideation with any methods (not plan) without intent to act
boolean
C3641582 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641583 (UMLS CUI [1])
SSRS: Active suicidal ideation with some intent to act, without specific plan
Item
Suicidal Ideation: Active suicidal ideation with some intent to act, without specific plan
boolean
C3641605 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641606 (UMLS CUI [1])
SSRS: Active suicidal ideation with specific plan and intent
Item
Suicidal Ideation: Active suicidal ideation with specific plan and intent
boolean
C3641607 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641584 (UMLS CUI [1])
Item
Intensity of Ideation: Most Severe Ideation
integer
C3641585 (UMLS CUI [1])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
SSRS: Description of Ideation
Item
Intensity of Ideation: Description of Most Severe Ideation
text
C3641586 (UMLS CUI [1])
Item
Intensity of Ideation: Frequency of Most Severe Ideation
integer
C3641587 (UMLS CUI [1])
CL Item
1 Less than once a week (1)
CL Item
2 Once a week (2)
CL Item
3 2-5 times in week (3)
CL Item
4 Daily or almost daily (4)
CL Item
5 Many times each day (5)
Item
Intensity of Ideation: Duration of Most Severe Ideation
integer
C3641588 (UMLS CUI [1])
CL Item
1 Fleeting - few seconds or minutes (1)
CL Item
2 Less than 1 hour/some of the time (2)
CL Item
3 1-4 hours/a lot of time (3)
CL Item
4 4-8 hours/most of day (4)
CL Item
5 More than 8 hours/persistent or continuous (5)
Item
Intensity of Ideation: Controllability of Most Severe Ideation
integer
C3641589 (UMLS CUI [1])
CL Item
1 Easily able to control thoughts (1)
CL Item
2 Can control thoughts with little difficulty (2)
CL Item
3 Can control thoughts with some difficulty (3)
CL Item
4 Can control thoughts with a lot of difficulty (4)
CL Item
5 Unable to control thoughts (5)
CL Item
0 Does not attempt to control thoughts (6)
Item
Intensity of Ideation: Deterrents to Most Severe Ideation
integer
C3641590 (UMLS CUI [1])
CL Item
1 Deterrents definitely stopped you from attempting suicide (1)
CL Item
2 Deterrents probably stopped you (2)
CL Item
3 Uncertain that deterrents stopped you (3)
CL Item
4 Deterrents most likely did not stop you (4)
CL Item
5 Deterrents definitely did not stop you (5)
CL Item
0 Does not apply (6)
Item
Intensity of Ideation: Reasons for Most Severe Ideation
integer
C3641591 (UMLS CUI [1])
CL Item
1 Completely to get attention, revenge or a reaction from others (1)
CL Item
2 Mostly to get attention, revenge or a reaction from others (2)
CL Item
3 Equally to get attention, revenge or a reaction from others and to end/stop the pain (3)
CL Item
4 Mostly to end or stop the pain (you couldn’t go on living with the pain or how you were feeling) (4)
CL Item
5 Completely to end or stop the pain (you couldn’t go on living with the pain or how you were feeling) (5)
CL Item
0 Does not apply (6)
SSRS: Actual Suicide Attempt
Item
Suicidal Behavior: Actual attempt
boolean
C3641592 (UMLS CUI [1])
SSRS: Number of Actual Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of attempts:
integer
C3641593 (UMLS CUI [1])
SSRS: Description of Actual Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641594 (UMLS CUI [1])
SSRS: Non-suicidal self-injurious behavior
Item
Suicidal Behavior: Non-suicidal self-injurious behavior
boolean
C3641595 (UMLS CUI [1])
SSRS: Interrupted Suicide Attempt
Item
Suicidal Behavior: Interrupted attempt
boolean
C3641596 (UMLS CUI [1])
SSRS: Number of Interrupted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of interrupted attempts:
integer
C3641597 (UMLS CUI [1])
SSRS: Description of Interrupted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641598 (UMLS CUI [1])
SSRS: Aborted Suicide Attempt
Item
Suicidal Behavior: Aborted attempt
boolean
C3641599 (UMLS CUI [1])
SSRS: Number of Aborted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of aborted attempts:
integer
C3641600 (UMLS CUI [1])
SSRS: Description of Aborted Suicide Attempt
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641601 (UMLS CUI [1])
SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: Preparatory acts or behavior toward suicide attempt
boolean
C3641602 (UMLS CUI [1])
SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641603 (UMLS CUI [1])
SSRS: Suicidal Behavior
Item
Suicidal Behavior
boolean
C3641604 (UMLS CUI [1])
SSRS: Completed suicide
Item
Completed suicide
boolean
C3641338 (UMLS CUI [1])
SSRS: Most Lethal Suicide Attempt Date
Item
Suicidal Behavior - Actual Attempts: Most lethal attempt date
date
C3641339 (UMLS CUI [1])
Item
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
integer
C3641340 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
CL Item
0 No physical damage or very minor physical damage (e.g., surface scratches). (1)
CL Item
1 Minor physical damage (e.g., lethargic speech; first-degree burns; mild bleeding; sprains). (2)
CL Item
2 Moderate physical damage; medical attention needed (e.g., conscious but sleepy, somewhat responsive; second-degree burns; bleeding of major vessel). (3)
CL Item
3 Moderately severe physical damage; medical hospitalization and likely intensive care required (e.g., comatose with reflexes intact; third-degree burns less than 20% of body; extensive blood loss but can recover; major fractures). (4)
CL Item
4 Severe physical damage; medical hospitalization with intensive care required (e.g., comatose without reflexes; third-degree burns over 20% of body; extensive blood loss with unstable vital signs; major damage to a vital area). (5)
CL Item
5 Death (6)
Item
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality
integer
C3641341 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality
CL Item
0 Behavior not likely to result in injury (1)
CL Item
1 Behavior likely to result in injury but not likely to cause death (2)
CL Item
2 Behavior likely to result in death despite available medical care (3)
Item Group
Investigator Evaluation of lnjection site
C0035173 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Swelling
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Induration
integer
C0332534 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item Group
Subject Evaluation of lnjection site
C0030705 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Injection pain
Item
Injection pain
boolean
C0151828 (UMLS CUI [1])
Item Group
Positive and Negative Syndrome Scale for Schizophrenia
C4086747 (UMLS CUI-1)
C0036341 (UMLS CUI-2)
C0036341 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P02 Conceptual disorganization
integer
C4086687 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P03 Hallucinatory behavior
integer
C4086696 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P06 Suspiciousness/persecution
integer
C4087067 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N02 Emotional withdrawal
integer
C4086692 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N04 Passive/apathetic social withdrawal
integer
C4086702 (UMLS CUI [1])
Code List
Negative subscale: N04 Passive/apathetic social withdrawal
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N05 Difficulty in abstract thinking
integer
C4086689 (UMLS CUI [1])
Code List
Negative subscale: N05 Difficulty in abstract thinking
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N06 Lack of spontaneity and flow of conversation
integer
C4086699 (UMLS CUI [1])
Code List
Negative subscale: N06 Lack of spontaneity and flow of conversation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N07 Stereotyped thinking
integer
C4086708 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G01 Somatic concern
integer
C4086707 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G03 Guilt feelings
integer
C4086695 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G05 Mannerisms and posturing
integer
C4086700 (UMLS CUI [1])
Code List
General psychopathology subscale: G05 Mannerisms and posturing
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G06 Depression
integer
C4086688 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G07 Motor retardation
integer
C4086701 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G09 Unusual thought content
integer
C4086711 (UMLS CUI [1])
Code List
General psychopathology subscale: G09 Unusual thought content
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G10 Disorientation
integer
C4086690 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G11 Poor attention
integer
C4086703 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G12 Lack of judgment and insight
integer
C4086698 (UMLS CUI [1])
Code List
General psychopathology subscale: G12 Lack of judgment and insight
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G13 Disturbance of volition
integer
C4086691 (UMLS CUI [1])
Code List
General psychopathology subscale: G13 Disturbance of volition
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G14 Poor impulse control
integer
C4086704 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G15 Preoccupation
integer
C4086706 (UMLS CUI [1])
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G16 Active social avoidence
integer
C4086684 (UMLS CUI [1])
Code List
General psychopathology subscale: G16 Active social avoidence
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Calculated total PANSS score
Item
Calculated total PANSS score
integer
C4086747 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
Item Group
Clinical Global Impression - Severity
C3639708 (UMLS CUI-1)
Rater´s initials
Item
Rater´s initials
text
C3166278 (UMLS CUI [1])
Item
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
integer
C3698629 (UMLS CUI [1])
Code List
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
CL Item
normal, not at all ill (1)
CL Item
borderline mentally ill (2)
CL Item
mildly ill (3)
CL Item
moderately ill (4)
CL Item
markedly ill (5)
CL Item
severely ill (6)
CL Item
among the most extremely ill patients (7)
Item Group
Personal and Social Performance Scale
C0450973 (UMLS CUI-1)
C0037397 (UMLS CUI-2)
C0037397 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Domain of functioning: Socially useful activities, including work and study
integer
C3641834 (UMLS CUI [1])
Code List
Domain of functioning: Socially useful activities, including work and study
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Personal and social relationships
integer
C0021797 (UMLS CUI [1])
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Disturbing and aggressive behaviors
integer
C0001807 (UMLS CUI [1])
Code List
Domain of functioning: Disturbing and aggressive behaviors
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Total score
Item
Total score
integer
C2964552 (UMLS CUI [1])
Item Group
Administration of trial medication
C3854006 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C3469597 (UMLS CUI-2)
Medication Kit Number
Item
Medication Kit Number
integer
C2981406 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
Dispensation Date
Item
Dispensation Date
date
C2826773 (UMLS CUI [1])
Study drug administrator's initials
Item
Study drug administrator's initials
text
C2986440 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
Date of injection
Item
Date of injection
date
C0011008 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,2])
Actual clock time of injection
Item
Actual clock time of injection
time
C0040223 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,2])
CL Item
Left Deltoid (1)
CL Item
Right Deltoid (2)
CL Item
Left Gluteus (3)
CL Item
Right Gluteus (4)
Item Group
Medication Preference Questionnaire
C3854006 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C0558295 (UMLS CUI-3)
C0030705 (UMLS CUI-2)
C0558295 (UMLS CUI-3)
Item
How important is each of the following statements? 1. I can get back to my favourite activities
integer
C0441655 (UMLS CUI [1])
Code List
How important is each of the following statements? 1. I can get back to my favourite activities
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
2. I feel like myself again
integer
C1527305 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
3. It makes my symptoms (such as hearing voices) go away
integer
C2678249 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0231221 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
4. I feel more healthy
integer
C3898900 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
5. I feel less confused
integer
C1527305 (UMLS CUI [1,1])
C0009676 (UMLS CUI [1,2])
C0009676 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
6. I feel my symptoms (such as hearing voices) will not suddenly come back
integer
C0700364 (UMLS CUI [1,1])
C2678249 (UMLS CUI [1,2])
C2678249 (UMLS CUI [1,2])
Code List
6. I feel my symptoms (such as hearing voices) will not suddenly come back
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
7. I feel more in control over the medicine I take
integer
C1290952 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
8. I have few side effects from my medicine
integer
C0205388 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
9. I don't have to think about taking my medicine
integer
C0039869 (UMLS CUI [1,1])
C1290952 (UMLS CUI [1,2])
C1290952 (UMLS CUI [1,2])
CL Item
Not important (1)
CL Item
Not sure (2)
CL Item
Important (3)
Item
Based on your experience with both pills and injections, which ONE do you prefer?
integer
C0558295 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0558295 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C1527415 (UMLS CUI [1,2])
C0558295 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Code List
Based on your experience with both pills and injections, which ONE do you prefer?
CL Item
Pills (1)
CL Item
Injections (2)
Item
A). Pills are easier for me
integer
C0994475 (UMLS CUI [1,1])
C0332219 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
B). Pills work better for my symptoms (such as hearing voices)
integer
C2678249 (UMLS CUI [1,1])
C0994475 (UMLS CUI [1,2])
C0994475 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
C). I have less side effects from my medicine
integer
C0994475 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
D). I feel more in control when taking pills
integer
C0994475 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
C2587213 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
E). I feel less pain when taking pills
integer
C0994475 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
F). I feel less embarrassed when taking pills
integer
C0994475 (UMLS CUI [1,1])
C0679112 (UMLS CUI [1,2])
C0679112 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
A). Injections are easier for me
integer
C0332219 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C1828121 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
B). Injections work better for my symptoms (such as hearing voices)
integer
C2678249 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C1828121 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
C). I have less side effects from my medicine
integer
C1828121 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
D). I don't have to think about taking my medicine
integer
C1828121 (UMLS CUI [1,1])
C0039869 (UMLS CUI [1,2])
C1290952 (UMLS CUI [1,3])
C0039869 (UMLS CUI [1,2])
C1290952 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
E). I don't worry about sudden symptoms from my illness
integer
C1828121 (UMLS CUI [1,1])
C2678249 (UMLS CUI [1,2])
C1276802 (UMLS CUI [1,3])
C0233481 (UMLS CUI [1,4])
C2678249 (UMLS CUI [1,2])
C1276802 (UMLS CUI [1,3])
C0233481 (UMLS CUI [1,4])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Specification preference drug administration route
Item
If you have other reasons why you prefer pills or injections, please describe them:
text
C2348235 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0558295 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Item
Based on all of your experiences in this research study, which injection site would you prefer?
integer
C2700396 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
Code List
Based on all of your experiences in this research study, which injection site would you prefer?
CL Item
Arm (1)
CL Item
Buttock (2)
Item
A). Arm injections are easier for me
integer
C1293234 (UMLS CUI [1,1])
C0332219 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
B). Arm injections work better for my symptoms (such as hearing voices)
integer
C1293234 (UMLS CUI [1,1])
C2678249 (UMLS CUI [1,2])
C2678249 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
C). It is faster than a buttock injection
integer
C1293234 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
D). I have less side effects from arm injections
integer
C1293234 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
E). I feel less pain from arm injections
integer
C1293234 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
F). I feel less embarrassed by arm injections
integer
C1293234 (UMLS CUI [1,1])
C0679112 (UMLS CUI [1,2])
C0679112 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
A). Buttock injections are easier for me
integer
C2700396 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,3])
C0006497 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
B). Buttock injections work better for my symptoms (such as hearing voices)
integer
C2700396 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C2678249 (UMLS CUI [1,3])
C0006497 (UMLS CUI [1,2])
C2678249 (UMLS CUI [1,3])
Code List
B). Buttock injections work better for my symptoms (such as hearing voices)
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
C). It is faster than an arm injection
integer
C2700396 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0006497 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
D). I have less side effects from buttock injections
integer
C2700396 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,3])
C0006497 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
E). I feel less pain from buttock injections
integer
C2700396 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0006497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
F). I feel less embarrassed by buttock injections
integer
C2700396 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C0679112 (UMLS CUI [1,3])
C0006497 (UMLS CUI [1,2])
C0679112 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Specification, preference, injection site
Item
If you have other reasons why you prefer arm or buttock injections, please describe them:
text
C2348235 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0558295 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Would you prefer to receive your medication every day, every month, or every 3 months?
integer
C1290952 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,2])
Code List
Would you prefer to receive your medication every day, every month, or every 3 months?
CL Item
Every Month (1)
CL Item
Every 3 Months (2)
CL Item
Every Day (3)
CL Item
No Preference (4)
Item
Injections every month: I like to have injections more often because if l have a problem, my dose can be changed.
integer
C0332177 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,3])
Code List
Injections every month: I like to have injections more often because if l have a problem, my dose can be changed.
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every month: I am used to injections every month and don't mind them
integer
C0332177 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1298805 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C1298805 (UMLS CUI [1,3])
Code List
Injections every month: I am used to injections every month and don't mind them
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every month: I like to see the doctor more often
integer
C0332177 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C3259401 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C3259401 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every month: I don't like taking that much medication at once
integer
C0332177 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0021485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every month: Taking my medicine every month means less conflict or talking with my family or caregivers about medicines
integer
C0332177 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0233542 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0021485 (UMLS CUI [1,2])
C0233542 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Code List
Injections every month: Taking my medicine every month means less conflict or talking with my family or caregivers about medicines
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every 3 months: I like to have fewer injections
integer
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0205388 (UMLS CUI [2,1])
C0021485 (UMLS CUI [2,2])
C0021485 (UMLS CUI [1,2])
C0205388 (UMLS CUI [2,1])
C0021485 (UMLS CUI [2,2])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every 3 months: It is less painful to have fewer injections
integer
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every 3 months: I don't have to see my doctor as often
integer
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C3259401 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C3259401 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every 3 months: Fewer injections means fewer reminders about my illness
integer
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1709896 (UMLS CUI [1,3])
C0221423 (UMLS CUI [1,4])
C0021485 (UMLS CUI [1,2])
C1709896 (UMLS CUI [1,3])
C0221423 (UMLS CUI [1,4])
Code List
Injections every 3 months: Fewer injections means fewer reminders about my illness
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every 3 months: There is less conflict or talking about my medicine with my family or caregivers
integer
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0233542 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0021485 (UMLS CUI [1,2])
C0233542 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Code List
Injections every 3 months: There is less conflict or talking about my medicine with my family or caregivers
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Item
Injections every 3 months: There are fewer problems with transportation
integer
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C3830421 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,2])
C3830421 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Not sure (2)
CL Item
Yes (3)
Reason for preference monthly or trimonthly injections
Item
If you have other reasons why you prefer injections every month or 3 months, please tell us:
text
C0332179 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0332177 (UMLS CUI [2,1])
C0021485 (UMLS CUI [2,2])
C0566251 (UMLS CUI [3,1])
C0558295 (UMLS CUI [3,2])
C0021485 (UMLS CUI [1,2])
C0332177 (UMLS CUI [2,1])
C0021485 (UMLS CUI [2,2])
C0566251 (UMLS CUI [3,1])
C0558295 (UMLS CUI [3,2])
Item Group
Involvement Evaluation Questionnaire (Baseline)
C1321106 (UMLS CUI-1)
C1531735 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0034394 (UMLS CUI-4)
C1531735 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0034394 (UMLS CUI-4)
Age
Item
1.What is your age?
integer
C0001779 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Single (1)
CL Item
Married/in a long-term partnership (2)
CL Item
Divorced (3)
CL Item
Widowed (4)
CL Item
I live alone (1)
CL Item
I live with my spouse/partner and/or children (2)
CL Item
I live with my parents and/or sisters/brothers (3)
CL Item
I live with other relatives (4)
CL Item
I live with other friends (5)
CL Item
Other (6)
Specification housing
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1,1])
C0020056 (UMLS CUI [1,2])
C0020056 (UMLS CUI [1,2])
Household, quantity
Item
5.How many people, including yourself, are there in your household?
integer
C0015578 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Item
6.Is your relative/friend currently receiving help for his/her mental health problems?
integer
C0004936 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,2])
Code List
6.Is your relative/friend currently receiving help for his/her mental health problems?
CL Item
I do not know (1)
CL Item
No professional help (2)
CL Item
Yes, from a GP/family doctor (3)
CL Item
Yes, from a social worker (4)
CL Item
Yes, from an occupational therapist (5)
CL Item
Yes, at a community mental health centre/form the community mental health team (6)
CL Item
Yes, from a psychologist or cognitive-behavioural therapist (7)
CL Item
Yes, as an out-patient at a psychiatric hospital or the psychiatric department (8)
CL Item
Yes, in a psychiatric day hospital (9)
CL Item
Yes, as an in-patient in a psychiatric hospital department (10)
CL Item
Yes, living in supported housing (11)
CL Item
Yes, other (12)
Specification help for mental health
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,3])
Item
7.What is your precise relationship with your relative/friend? I am his/her:
integer
C0439849 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
CL Item
Mother/father (step, foster and adoptive parents included) (1)
CL Item
Daughter/Son (2)
CL Item
Sister/Brother (3)
CL Item
Other relative (4)
CL Item
Spouse, partner or girl/boyfriend (5)
CL Item
Friend (6)
CL Item
Neighbour (7)
CL Item
Colleague/fellow student (8)
CL Item
Other (9)
Specification relationship
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Patient part of household
Item
8.Is your relative/friend part of your household?
boolean
C0681850 (UMLS CUI [1,1])
C1292711 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
C1292711 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
Item
9.How many days have you and your relative/friend lived together at the same address during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1883357 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C1883357 (UMLS CUI [1,3])
Code List
9.How many days have you and your relative/friend lived together at the same address during the past 4 weeks?
CL Item
None (1)
CL Item
Some days (2)
CL Item
The full 4 weeks (3)
Specification quantity days together
Item
If "Some days", specify how many:
integer
C2348235 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C1883357 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C1883357 (UMLS CUI [1,4])
Item
10.What has been your average weekly telephone or personal contact with your relative/friend over the past 4 weeks?
integer
C0449238 (UMLS CUI [1,1])
C3812666 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2,1])
C0302186 (UMLS CUI [2,2])
C3812666 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2,1])
C0302186 (UMLS CUI [2,2])
Code List
10.What has been your average weekly telephone or personal contact with your relative/friend over the past 4 weeks?
CL Item
Less than 1 hour per week (1)
CL Item
1-4 hours a week (2)
CL Item
5-8 hours a week (3)
CL Item
9-16 hours a week (4)
CL Item
17-32 hours a week (5)
CL Item
More than 32 hours a week (6)
Item
11.How often during the past 4 weeks have you encouraged your relative/friend to take proper care of her/himself ( e.g. washing, bathing, brushing teeth, dressing, combing hair, etc.)?
integer
C3898838 (UMLS CUI [1,1])
C0548205 (UMLS CUI [1,2])
C0548205 (UMLS CUI [1,2])
Code List
11.How often during the past 4 weeks have you encouraged your relative/friend to take proper care of her/himself ( e.g. washing, bathing, brushing teeth, dressing, combing hair, etc.)?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
12.How often during the past 4 weeks have you helped your relative/friend to take proper care of her/himself ( e.g. washing, bathing, brushing teeth, dressing, combing hair, etc.)?
integer
C3898838 (UMLS CUI [1,1])
C3827269 (UMLS CUI [1,2])
C3827269 (UMLS CUI [1,2])
Code List
12.How often during the past 4 weeks have you helped your relative/friend to take proper care of her/himself ( e.g. washing, bathing, brushing teeth, dressing, combing hair, etc.)?
CL Item
Nevero (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
13.How often during the past 4 weeks have you encouraged your relative/friend to eat enough?
integer
C3898838 (UMLS CUI [1,1])
C0510754 (UMLS CUI [1,2])
C0510754 (UMLS CUI [1,2])
Code List
13.How often during the past 4 weeks have you encouraged your relative/friend to eat enough?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
14.How often during the past 4 weeks have you encouraged your relative/friend to undertake some kind of activity (e.g. go for a walk, have a chat, hobbies, household chores)?
integer
C3898838 (UMLS CUI [1,1])
C2922556 (UMLS CUI [1,2])
C2922556 (UMLS CUI [1,2])
Code List
14.How often during the past 4 weeks have you encouraged your relative/friend to undertake some kind of activity (e.g. go for a walk, have a chat, hobbies, household chores)?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
15.How often during the past 4 weeks have you accompanied your relative/friend on some kind of outside activity, because he/she did not dare to go alone?
integer
C3898838 (UMLS CUI [1,1])
C0441655 (UMLS CUI [1,2])
C1883357 (UMLS CUI [1,3])
C0441655 (UMLS CUI [1,2])
C1883357 (UMLS CUI [1,3])
Code List
15.How often during the past 4 weeks have you accompanied your relative/friend on some kind of outside activity, because he/she did not dare to go alone?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
16.How often during the past 4 weeks have you ensured that your relative/friend has taken the required medicine?
integer
C3898838 (UMLS CUI [1,1])
C1290952 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,3])
C1290952 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,3])
Code List
16.How often during the past 4 weeks have you ensured that your relative/friend has taken the required medicine?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
CL Item
Not relevant: relative/friend has no medicines (6)
Item
17.How often during the past 4 weeks have you guarded your relative/friend from committing dangerous acts (i.e. setting something alight, leaving the gas on, forgetting to stub cigarettes out, etc.)?
integer
C3898838 (UMLS CUI [1,1])
C0010967 (UMLS CUI [1,2])
C0010967 (UMLS CUI [1,2])
Code List
17.How often during the past 4 weeks have you guarded your relative/friend from committing dangerous acts (i.e. setting something alight, leaving the gas on, forgetting to stub cigarettes out, etc.)?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
18.How often during the past 4 weeks have you guarded your relative/friend from self-inflicted harm (i.e. cutting him/herself, excessive medication intake, burning, suicide attempt, etc.)?
integer
C3898838 (UMLS CUI [1,1])
C0085271 (UMLS CUI [1,2])
C0085271 (UMLS CUI [1,2])
Code List
18.How often during the past 4 weeks have you guarded your relative/friend from self-inflicted harm (i.e. cutting him/herself, excessive medication intake, burning, suicide attempt, etc.)?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
19.How often during the past 4 weeks have you ensured your relative/friend received sufficient sleep?
integer
C3898838 (UMLS CUI [1,1])
C0547106 (UMLS CUI [1,2])
C0547106 (UMLS CUI [1,2])
Code List
19.How often during the past 4 weeks have you ensured your relative/friend received sufficient sleep?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
20.How often during the past 4 weeks have you guarded your relative/friend from drinking too much alcohol?
integer
C3898838 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
C0442802 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
Code List
20.How often during the past 4 weeks have you guarded your relative/friend from drinking too much alcohol?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
21.How often during the past 4 weeks have you guarded your relative/friend from taking illegal drugs?
integer
C3898838 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,2])
Code List
21.How often during the past 4 weeks have you guarded your relative/friend from taking illegal drugs?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
22.How often during the past 4 weeks have you carried out tasks normally done by your relative/friend (household chores, financial matters, shopping, cooking, etc.)?
integer
C3898838 (UMLS CUI [1,1])
C0557462 (UMLS CUI [1,2])
C3540678 (UMLS CUI [1,3])
C0557462 (UMLS CUI [1,2])
C3540678 (UMLS CUI [1,3])
Code List
22.How often during the past 4 weeks have you carried out tasks normally done by your relative/friend (household chores, financial matters, shopping, cooking, etc.)?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
23.How often during the past 4 weeks have you encouraged your relative/friend to get up in the morning?
integer
C3898838 (UMLS CUI [1,1])
C1269765 (UMLS CUI [1,2])
C0442696 (UMLS CUI [1,3])
C1269765 (UMLS CUI [1,2])
C0442696 (UMLS CUI [1,3])
Code List
23.How often during the past 4 weeks have you encouraged your relative/friend to get up in the morning?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
24.How often during the past 4 weeks has your relative/friend disturbed your sleep?
integer
C3898838 (UMLS CUI [1,1])
C0037317 (UMLS CUI [1,2])
C0037317 (UMLS CUI [1,2])
Code List
24.How often during the past 4 weeks has your relative/friend disturbed your sleep?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
25.How often during the past 4 weeks has the atmosphere been strained between you both, as a result of your relative/friend's behaviour?
integer
C3898838 (UMLS CUI [1,1])
C0425168 (UMLS CUI [1,2])
C0425168 (UMLS CUI [1,2])
Code List
25.How often during the past 4 weeks has the atmosphere been strained between you both, as a result of your relative/friend's behaviour?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
26.How often during the past 4 weeks has your relative/friend caused a quarrel?
integer
C3898838 (UMLS CUI [1,1])
C0680226 (UMLS CUI [1,2])
C0680226 (UMLS CUI [1,2])
Code List
26.How often during the past 4 weeks has your relative/friend caused a quarrel?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
27.How often during the past 4 weeks have you been annoyed by your relative/friend's behaviour?
integer
C3898838 (UMLS CUI [1,1])
C3831378 (UMLS CUI [1,2])
C0004927 (UMLS CUI [1,3])
C3831378 (UMLS CUI [1,2])
C0004927 (UMLS CUI [1,3])
Code List
27.How often during the past 4 weeks have you been annoyed by your relative/friend's behaviour?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
28.How often during the past 4 weeks have you heard from others that they have been annoyed by your relative/friend's behaviour?
integer
C3898838 (UMLS CUI [1,1])
C1546930 (UMLS CUI [1,2])
C3831378 (UMLS CUI [1,3])
C0004927 (UMLS CUI [1,4])
C1546930 (UMLS CUI [1,2])
C3831378 (UMLS CUI [1,3])
C0004927 (UMLS CUI [1,4])
Code List
28.How often during the past 4 weeks have you heard from others that they have been annoyed by your relative/friend's behaviour?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
29.How often during the past 4 weeks have you felt threatened by your relative/friend?
integer
C3898838 (UMLS CUI [1,1])
C0562573 (UMLS CUI [1,2])
C0562573 (UMLS CUI [1,2])
Code List
29.How often during the past 4 weeks have you felt threatened by your relative/friend?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
30.How often during the past 4 weeks have you thought of moving out, as a result of your relative/friend's behaviour?
integer
C3898838 (UMLS CUI [1,1])
C0588450 (UMLS CUI [1,2])
C0004927 (UMLS CUI [1,3])
C0588450 (UMLS CUI [1,2])
C0004927 (UMLS CUI [1,3])
Code List
30.How often during the past 4 weeks have you thought of moving out, as a result of your relative/friend's behaviour?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
31.How often during the past 4 weeks have you been able to persue your own activities and interests ( e.g. work, school, hobbies, sports, visits to family and friends)?
integer
C3898838 (UMLS CUI [1,1])
C2947996 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2947996 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
Code List
31.How often during the past 4 weeks have you been able to persue your own activities and interests ( e.g. work, school, hobbies, sports, visits to family and friends)?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
32.How often during the past 4 weeks have you worried about your relative/friend's safety?
integer
C4084900 (UMLS CUI [1,1])
C0036043 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,2])
Code List
32.How often during the past 4 weeks have you worried about your relative/friend's safety?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
33.How often during the past 4 weeks have you worried about the kind of help/treatment your relative/friend is receiving?
integer
C4084900 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,2])
Code List
33.How often during the past 4 weeks have you worried about the kind of help/treatment your relative/friend is receiving?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
34.How often during the past 4 weeks have you worried about your relative/friend's general health?
integer
C4084900 (UMLS CUI [1,1])
C0424575 (UMLS CUI [1,2])
C0424575 (UMLS CUI [1,2])
Code List
34.How often during the past 4 weeks have you worried about your relative/friend's general health?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
35.How often during the past 4 weeks have you worried about how your relative/friend would manage financially if you were no longer able to help?
integer
C4084900 (UMLS CUI [1,1])
C0549106 (UMLS CUI [1,2])
C0549106 (UMLS CUI [1,2])
Code List
35.How often during the past 4 weeks have you worried about how your relative/friend would manage financially if you were no longer able to help?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
36.How often during the past 4 weeks have you worried about your relative/friend's future?
integer
C4084900 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0016884 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,2])
C0016884 (UMLS CUI [1,3])
Code List
36.How often during the past 4 weeks have you worried about your relative/friend's future?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
37. How often during the past 4 weeks have you worried about your own future?
integer
C4084900 (UMLS CUI [1,1])
C1519021 (UMLS CUI [1,2])
C0016884 (UMLS CUI [1,3])
C1519021 (UMLS CUI [1,2])
C0016884 (UMLS CUI [1,3])
Code List
37. How often during the past 4 weeks have you worried about your own future?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
38. To what extent have your relative/friend's mental problems been a burden to you during the past 4 weeks?
integer
C1446377 (UMLS CUI [1,1])
C2828008 (UMLS CUI [1,2])
C2828008 (UMLS CUI [1,2])
Code List
38. To what extent have your relative/friend's mental problems been a burden to you during the past 4 weeks?
CL Item
No burden at all (1)
CL Item
A slight burden (2)
CL Item
A fairly heavy burden (3)
CL Item
A heavy burden (4)
CL Item
A very heavy burden (5)
Item
39. Have you got used to your relative/friend having mental health problems?
integer
C1446377 (UMLS CUI [1,1])
C0009967 (UMLS CUI [1,2])
C0009967 (UMLS CUI [1,2])
Code List
39. Have you got used to your relative/friend having mental health problems?
CL Item
No (1)
CL Item
A little (2)
CL Item
Fairly well (3)
CL Item
Very well (4)
CL Item
Completely (5)
Item
40. How often have you felt able to cope with your relative/friend's mental health problems?
integer
C3898838 (UMLS CUI [1,1])
C2364069 (UMLS CUI [1,2])
C1446377 (UMLS CUI [1,3])
C2364069 (UMLS CUI [1,2])
C1446377 (UMLS CUI [1,3])
Code List
40. How often have you felt able to cope with your relative/friend's mental health problems?
CL Item
Never (1)
CL Item
Sometimes (2)
CL Item
Regularly (3)
CL Item
Often (4)
CL Item
(almost) Always (5)
Item
41. Has your relationship with your relative/friend changed since the onset of the mental health problems?
integer
C2045651 (UMLS CUI [1,1])
C1446377 (UMLS CUI [1,2])
C1446377 (UMLS CUI [1,2])
Code List
41. Has your relationship with your relative/friend changed since the onset of the mental health problems?
CL Item
No (1)
CL Item
A little (2)
CL Item
Rather a lot (3)
CL Item
A lot (4)
CL Item
A great deal (5)
Item
42.What is your highest education level?
integer
C0013658 (UMLS CUI [1])
CL Item
Did not complete secondary school or Less than High School (1)
CL Item
Secondary School or High School Diploma (2)
CL Item
Some College or University (3)
CL Item
Apprenticeship (4)
CL Item
College or University Degree (5)
CL Item
Graduate Degree (6)
CL Item
Full time employment (1)
CL Item
Part time employment (2)
CL Item
Casual employment (3)
CL Item
Sheltered work (4)
CL Item
Unpaid work (Volunteer) (5)
CL Item
Unemployed, seeking work (6)
CL Item
Unemployed, NOT seeking work (7)
CL Item
Retiredo Housewife or dependent spouse (8)
CL Item
Student (9)
Item
44.What part of your family's income is spent on the subject's medical bills?
integer
C1292711 (UMLS CUI [1,1])
C0021162 (UMLS CUI [1,2])
C0085552 (UMLS CUI [1,3])
C0021162 (UMLS CUI [1,2])
C0085552 (UMLS CUI [1,3])
Code List
44.What part of your family's income is spent on the subject's medical bills?
CL Item
None (1)
CL Item
A small part (2)
CL Item
A moderate part (3)
CL Item
A lot (4)
CL Item
A great deal (5)
CL Item
Prefer not to state (6)
quantity, care provider for the subject
Item
45.How many people, not including yourself, provide care for the subject?
integer
C1265611 (UMLS CUI [1,1])
C1531735 (UMLS CUI [1,2])
C1531735 (UMLS CUI [1,2])
Number of children
Item
46.If you are a parent, how many children do you have?
integer
C2229974 (UMLS CUI [1])
how many hours spent on caregiving
Item
47.How many hours did you spend on caregiving activities (for the subject) during the past 7 days?
integer
C0556976 (UMLS CUI [1,1])
C4062067 (UMLS CUI [1,2])
C4062067 (UMLS CUI [1,2])
Item
48.If you are employed (full time employment, part time employment, casual employment, sheltered employment, unpaid (volunteer) work or gainfully self-employed) did you miss any work or school days related to caregiving for the subject in the past 4 weeks?
integer
C2977596 (UMLS CUI [1,1])
C4054769 (UMLS CUI [1,2])
C4054769 (UMLS CUI [1,2])
Code List
48.If you are employed (full time employment, part time employment, casual employment, sheltered employment, unpaid (volunteer) work or gainfully self-employed) did you miss any work or school days related to caregiving for the subject in the past 4 weeks?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
specification of missed working day because of caregiving
Item
If "yes", please record the number of working days missed:
integer
C2348235 (UMLS CUI [1,1])
C0559457 (UMLS CUI [1,2])
C2977596 (UMLS CUI [1,3])
C0559457 (UMLS CUI [1,2])
C2977596 (UMLS CUI [1,3])
impact of caregiving activities on leisure activities
Item
49.How many days was your ability to participate in leisure activities impacted by caregiving activities in the past 4 weeks?
integer
C0556971 (UMLS CUI [1,1])
C2977596 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0023292 (UMLS CUI [1,4])
C2977596 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0023292 (UMLS CUI [1,4])
Quantity of General practitioner visits
Item
50.1 How many times did you visit/or were visited by a General/Family doctor for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0017319 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0017319 (UMLS CUI [1,3])
Quantity of Specialist physician visits
Item
50.2 How many times did you visit/or were visited by a Specialist doctor (e.g. psychiatrist) for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C2348234 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C2348234 (UMLS CUI [1,3])
Quantity of Psychiatric nurse visits
Item
50.3 How many times did you visit/or were visited by a Psychiatric nurse for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0033870 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0033870 (UMLS CUI [1,3])
Quantity of Psychologist visits
Item
50.4 How many times did you visit/or were visited by a Psychologist for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0033908 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0033908 (UMLS CUI [1,3])
Quantity of Social worker visits
Item
50.5 How many times did you visit/or were visited by a Social worker for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0037444 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0037444 (UMLS CUI [1,3])
Quantity of Other medical specialists visits
Item
50.6 How many times did you visit/or were visited by a Other medical specialist for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1271040 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C1271040 (UMLS CUI [1,3])
Quantity of Emergency Room visits
Item
50.7 How many times did you visit an Emergency Room for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C4291935 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C4291935 (UMLS CUI [1,3])
Quantity of Other visits
Item
50.8 How many times did you visit/or were visited by a ... (please specify) for a medical condition of your own during the past 4 weeks?
integer
C1265611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specification other
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
days hospitalized in past 4 weeks
Item
51.How many days have you been hospitalized in the past 4 weeks?
integer
C0701159 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
Item Group
Resource Use Questionnaire A Hospitalisation (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0019993 (UMLS CUI-3)
C0034394 (UMLS CUI-2)
C0019993 (UMLS CUI-3)
Hospitalization
Item
Has the subject been in hospital during the last 12 months? (new hospitalisations as well as continuation of a hospitalisation starting more than 12 months before study entry)
boolean
C0019993 (UMLS CUI [1])
CL Item
I University Hospital (1)
CL Item
II Psychiatric/mental Hospital (2)
CL Item
III General/regional Hospital (3)
CL Item
IV Long-term-care/rehabilitation facility (4)
CL Item
V Other (5)
CL Item
A Psychiatry (1)
CL Item
B General/internal medicine (2)
CL Item
C Intensive care (3)
CL Item
D Surgery (4)
CL Item
E Other (5)
CL Item
1 Management of relapse (as defined in protocol) (1)
CL Item
2 Other psychiatric reason (2)
CL Item
3 Social reason (e.g., caregiver away or unavailable) (3)
CL Item
4 Other medical reason (4)
Hospitalization started before 12 months
Item
Hospitalization started before 12 months
boolean
C0019993 (UMLS CUI [1,1])
C3842282 (UMLS CUI [1,2])
C3842282 (UMLS CUI [1,2])
hospitalization start date
Item
If hospitalization started less than 12 months ago, date of beginning:
date
C0019993 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Hospitalization ongoing
Item
Hospitalization ongoing
boolean
C0019993 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
hospitalization end date
Item
If hospitalization is not longer ongoing, date of end:
date
C0019993 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item Group
Resource Use Questionnaire B Emergency room visits without hospitalisation (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C4291935 (UMLS CUI-3)
C0034394 (UMLS CUI-2)
C4291935 (UMLS CUI-3)
Emergency room visit
Item
Has the subject visited the emergency room during the last three months? (any type of ad hoc treatment at a hospital or by an emergency team without a subsequent inpatient stay)
boolean
C4291935 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
Date of visit in ER
Item
Date of visit
boolean
C1320303 (UMLS CUI [1,1])
C4291935 (UMLS CUI [1,2])
C4291935 (UMLS CUI [1,2])
Item
Reason
integer
C0566251 (UMLS CUI [1,1])
C4291935 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C4291935 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
CL Item
1 Management of relapse (as defined in protocol) (1)
CL Item
2 Other psychiatric reason (2)
CL Item
3 Social reason (e.g., caregiver away or unavailable) (3)
CL Item
4 Other medical reason (4)
Item Group
Resource Use Questionnaire C Day clinic (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C3838685 (UMLS CUI-3)
C0034394 (UMLS CUI-2)
C3838685 (UMLS CUI-3)
Day clinic visit
Item
Has the subject required the service of a day clinic during the last three months? (new services as well as continuation of a service ongoing at 3 months before study entry)
boolean
C3838685 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
CL Item
I University Hospital (1)
CL Item
II Psychiatric/mental Hospital (2)
CL Item
III General/regional Hospital (3)
CL Item
IV Long-term-care/rehabilitation facility (4)
CL Item
V Other (5)
Day care clinic visits on x days/week
Item
Frequency/week (enter number of days/week)
integer
C3838685 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0677547 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0677547 (UMLS CUI [1,3])
Item
Reason
integer
C0566251 (UMLS CUI [1,1])
C3838685 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C3838685 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
CL Item
1 Management of relapse (as defined in protocol) (1)
CL Item
2 Other psychiatric reason (2)
CL Item
3 Social reason (e.g., caregiver away or unavailable) (3)
CL Item
4 Other medical reason (4)
Day clinic started before 3 months
Item
Day clinic started before 3 months
boolean
C3838685 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1442461 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C1442461 (UMLS CUI [1,3])
Day clinic start date
Item
If day clinic started less than 3 months ago, date of beginning:
date
C3838685 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Day clinic ongoing
Item
Day clinic ongoing
boolean
C3838685 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
Day clinic end date
Item
If day clinic is not longer ongoing, date of end:
date
C3838685 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item Group
Resource Use Questionnaire D Night clinic (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0240526 (UMLS CUI-3)
C0442592 (UMLS CUI-4)
C0034394 (UMLS CUI-2)
C0240526 (UMLS CUI-3)
C0442592 (UMLS CUI-4)
Night clinic visit
Item
Has the subject required the service of a night clinic during the last three months? (new services as well as continuation of a service ongoing at 3 months before study entry)
boolean
C0240526 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
CL Item
I University Hospital (1)
CL Item
II Psychiatric/mental Hospital (2)
CL Item
III General/regional Hospital (3)
CL Item
IV Long-term-care/rehabilitation facility (4)
CL Item
V Other (5)
Night clinic visits on x days/week
Item
Frequency/week (enter number of days/week)
integer
C0545082 (UMLS CUI [1,1])
C0677547 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,4])
C0677547 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,4])
Item
Reason
integer
C0566251 (UMLS CUI [1,1])
C0240526 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0240526 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
CL Item
1 Management of relapse (as defined in protocol) (1)
CL Item
2 Other psychiatric reason (2)
CL Item
3 Social reason (e.g., caregiver away or unavailable) (3)
CL Item
4 Other medical reason (4)
Night clinic started before 3 months
Item
Night clinic started before 3 months
boolean
C0240526 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1442461 (UMLS CUI [1,4])
C0442592 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1442461 (UMLS CUI [1,4])
Night clinic start date
Item
If night clinic started less than 3 months ago, date of beginning:
date
C0240526 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Night clinic ongoing
Item
Night clinic ongoing
boolean
C0240526 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,3])
Night clinic end date
Item
If night clinic is not longer ongoing, date of end:
date
C0240526 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Resource Use Questionnaire E Outpatient treatment (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0002423 (UMLS CUI-3)
C0034394 (UMLS CUI-2)
C0002423 (UMLS CUI-3)
Outpatient consultation
Item
Has the subject had an outpatient consultation during the last three months? (related to the disease and/or treatment in this trial, but excluding trial visits)
boolean
C0002423 (UMLS CUI [1])
CL Item
Psychiatrist or neurologist (please exclude trial visits) (1)
CL Item
Psychologist (2)
CL Item
Psychiatric nurse (3)
CL Item
General practitioner (4)
CL Item
Social worker (5)
CL Item
Therapist (e.g., psycho-, physio-, occupational) (6)
CL Item
Other (7)
Specification health professional
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1,1])
C1704312 (UMLS CUI [1,2])
C1704312 (UMLS CUI [1,2])
Number of consultations
Item
Number of consultations
integer
C1265611 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
C0009818 (UMLS CUI [1,2])
Item Group
Resource Use Questionnaire F Daily living (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0020056 (UMLS CUI-3)
C0034394 (UMLS CUI-2)
C0020056 (UMLS CUI-3)
CL Item
A At home, alone (1)
CL Item
B At home, with family or friends (2)
CL Item
C Homelesso (3)
CL Item
D Psychiatric institution (4)
CL Item
E Sheltered living (5)
CL Item
F Prison (6)
CL Item
G Other (7)
Item Group
Resource Use Questionnaire G Productivity of subject (Baseline Assessment)
C3858749 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0557390 (UMLS CUI-3)
C0034394 (UMLS CUI-2)
C0557390 (UMLS CUI-3)
Item
What was the subject's occupational status at trial entry?
integer
C0014006 (UMLS CUI [1])
CL Item
Full-time employment or gainfully self-employed (1)
CL Item
Part time employment (2)
CL Item
Casual employment (3)
CL Item
Sheltered work (4)
CL Item
Unpaid work (e.g. volunteer work) (5)
CL Item
Unemployed, but seeking work (6)
CL Item
Unemployed, but not seeking work (7)
CL Item
Retired (8)
CL Item
Housewife or dependent husband (9)
CL Item
Student (10)
Item
What was the reason for this occupational status?
integer
C0566251 (UMLS CUI [1,1])
C0014006 (UMLS CUI [1,2])
C0014006 (UMLS CUI [1,2])
CL Item
Psychiatric disease (1)
CL Item
Other (2)
Item
If the subject is employed (full time employment, part time employment, casual employment, sheltered employment, unpaid (volunteer) work) or gainfully self-employed, did he or she lose any working days related to the disease and/or treatment under study during the last three months? (Note that lost working days due to study visits must not be included)
integer
C0559457 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
Code List
If the subject is employed (full time employment, part time employment, casual employment, sheltered employment, unpaid (volunteer) work) or gainfully self-employed, did he or she lose any working days related to the disease and/or treatment under study during the last three months? (Note that lost working days due to study visits must not be included)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Specification number days off work
Item
If "yes", please record the number of working days lost:
integer
C2348235 (UMLS CUI [1,1])
C0559457 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0559457 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Item
If the subject is still completing an educational degree, did he/she lose any days at an educational institution related to the disease and/or treatment under study during the last three months? (Note that days at an educational institution lost due to study visits must not be included)
integer
C0013652 (UMLS CUI [1,1])
C0559294 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0559294 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Code List
If the subject is still completing an educational degree, did he/she lose any days at an educational institution related to the disease and/or treatment under study during the last three months? (Note that days at an educational institution lost due to study visits must not be included)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Number of educational days lost
Item
If "yes", please record the number of educational days lost:
integer
C2230086 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
Item Group
Medication Kit Dispensation
C0013227 (UMLS CUI-1)
C1880359 (UMLS CUI-2)
C1690540 (UMLS CUI-3)
C1880359 (UMLS CUI-2)
C1690540 (UMLS CUI-3)
Date medication kit assigned
Item
Date medication kit assigned
date
C0011008 (UMLS CUI [1,1])
C1516050 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C1690540 (UMLS CUI [1,4])
C1516050 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C1690540 (UMLS CUI [1,4])
Medication kit number
Item
Medication kit number
integer
C2981406 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])