ID

43862

Description

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

Keywords

  1. 5/21/17 5/21/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Visit 2 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Visit 2 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Date of visit
Description

Date of visit

Alias
UMLS CUI-1
C1320303
Visit date
Description

Date of visit

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1320303
dd.mm.yyyy
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
ECG reference number
Description

ECG reference number

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C3274661
Vital Signs with Weight, Waist and Temperature
Description

Vital Signs with Weight, Waist and Temperature

Alias
UMLS CUI-1
C0518766
Body Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist Circumference
Description

Waist Circumference

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Supine after 5 minutes rest: Pulse
Description

Pulse at rest

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0443144
beats/min
Supine after 5 minutes rest: Systolic Blood Pressure
Description

SBP at rest

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C2039694
mmHg
Supine after 5 minutes rest: Diastolic Blood Pressure
Description

DBP at rest

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C2183311
mmHg
Standing after 2 minutes: Pulse
Description

Pulse while standing

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
Standing after 2 minutes: Systolic Blood Pressure
Description

SBP standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C1303018
mmHg
Standing after 2 minutes: Diastolic Blood Pressure
Description

DBP standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C1303019
mmHg
Actual Position
Description

Patient position finding

Data type

integer

Alias
UMLS CUI [1]
C0449850
PK Blood Sample: Paliperidone
Description

PK Blood Sample: Paliperidone

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-3
C0753678
Specimen taken
Description

Specimen taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Accession number
Description

Accession number

Data type

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C2826726
Specimen comments, if any
Description

Comment, blood specimen

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0178913
Lab Sample Central Lab
Description

Lab Sample Central Lab

Alias
UMLS CUI-1
C3244292
Accession number
Description

Accession number

Data type

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C2826726
Urine Dipstick Pregnancy Test
Description

Urine Dipstick Pregnancy Test

Alias
UMLS CUI-1
C0430056
Was the Dipstick Pregnancy Test performed?
Description

Dipstick Pregnancy Test

Data type

integer

Alias
UMLS CUI [1]
C0430056
If No, please provide a reason:
Description

Reason for no pregnancy test

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
Dipstick Pregnancy Test Result
Description

Pregnancy Test Result

Data type

integer

Alias
UMLS CUI [1]
C0427777
Urine Drug Screen (Dipstick)
Description

Urine Drug Screen (Dipstick)

Alias
UMLS CUI-1
C0202274
Was urine drug screen (dipstick) collected?
Description

Urine drug screen collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C2922935
If No, please provide a reason:
Description

Reason for no urine drug screen

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0202274
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Body system
Description

Examined body system

Data type

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0031809
Status
Description

Status, body system, physical examination

Data type

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C0031809
If 'Abnormal,' please describe the abnormality:
Description

Abnormality specification

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2348235
Abnormal Involuntary Movement Scale
Description

Abnormal Involuntary Movement Scale

Alias
UMLS CUI-1
C0450978
Facial and oral movements: Muscles of facial expression
Description

AIMS: Muscles of facial expression

Data type

integer

Alias
UMLS CUI [1]
C3640439
Facial and oral movements: Lips and perioral area
Description

AIMS: Lips and perioral area

Data type

integer

Alias
UMLS CUI [1]
C3640440
Facial and oral movements: Jaw
Description

AIMS: Jaw

Data type

integer

Alias
UMLS CUI [1]
C3640441
Facial and oral movements: Tongue
Description

AIMS: Tongue

Data type

integer

Alias
UMLS CUI [1]
C3640442
Extremity movements: Upper (arms, wrists, hands, fingers)
Description

AIMS: Upper arm

Data type

integer

Alias
UMLS CUI [1]
C3640443
Extremity movements: Lower (legs, knees, ankles, toes)
Description

AIMS: Lower extremities

Data type

integer

Alias
UMLS CUI [1]
C3640444
Trunk movements: Neck, shoulders, hip
Description

AIMS: Neck, shoulders, hip

Data type

integer

Alias
UMLS CUI [1]
C3640445
Global Judgements: Severity of abnormal movements
Description

AIMS: Severity of abnormal movements

Data type

integer

Alias
UMLS CUI [1]
C3640446
Global Judgements: Incapacitation due to abnormal movements
Description

AIMS: Incapacitation due to abnormal movements

Data type

integer

Alias
UMLS CUI [1]
C3640447
Global Judgements: Subject´s awareness of abnormal movements
Description

AIMS: Subject´s awareness of abnormal movements

Data type

integer

Alias
UMLS CUI [1]
C3640448
Dental Status: Current problems with teeth and/or dentures
Description

AIMS: Current problems with teeth and/or dentures

Data type

integer

Alias
UMLS CUI [1]
C3640449
Dental Status: Does the subject usually wear dentures?
Description

AIMS: Does the subject usually wear dentures?

Data type

boolean

Alias
UMLS CUI [1]
C3640450
Barnes Akathisia Rating Scale
Description

Barnes Akathisia Rating Scale

Alias
UMLS CUI-1
C3541345
Objective
Description

BARS: Objective

Data type

integer

Alias
UMLS CUI [1]
C3640451
Subjective: Awareness of restlessness
Description

BARS: Awareness of restlessness

Data type

integer

Alias
UMLS CUI [1]
C3640452
Subjective: Reported distress related to restlessness
Description

BARS: Reported distress related to restlessness

Data type

integer

Alias
UMLS CUI [1]
C3640453
Global clinical rating of akathisia
Description

BARS: Global clinical rating of akathisia

Data type

integer

Alias
UMLS CUI [1]
C3640454
Simpson Angus Rating Scale
Description

Simpson Angus Rating Scale

Alias
UMLS CUI-1
C0030569
UMLS CUI-2
C0450973
1 Gait
Description

Gait

Data type

integer

Alias
UMLS CUI [1,1]
C0016928
UMLS CUI [1,2]
C0450973
2 Arm Dropping
Description

Arm dropping

Data type

integer

Alias
UMLS CUI [1,1]
C0231650
UMLS CUI [1,2]
C0450973
3 Shoulder shaking
Description

Shoulder shaking

Data type

integer

Alias
UMLS CUI [1,1]
C0037004
UMLS CUI [1,2]
C1883023
UMLS CUI [1,3]
C0450973
4 Elbow rigidity
Description

Elbow rigidity

Data type

integer

Alias
UMLS CUI [1,1]
C0013769
UMLS CUI [1,2]
C0858572
UMLS CUI [1,3]
C0450973
5 Wrist rigidity
Description

Wrist rigidity

Data type

integer

Alias
UMLS CUI [1,1]
C0043262
UMLS CUI [1,2]
C0858572
UMLS CUI [1,3]
C0450973
6 Leg pendulousness
Description

Leg pendulousness

Data type

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C4068836
UMLS CUI [1,3]
C0450973
7 Head dropping
Description

Head dropping

Data type

integer

Alias
UMLS CUI [1,1]
C0018670
UMLS CUI [1,2]
C1705648
UMLS CUI [1,3]
C0450973
8 Glabella tap
Description

Glabella tap

Data type

integer

Alias
UMLS CUI [1,1]
C0576550
UMLS CUI [1,2]
C0450973
9 Tremor
Description

Tremor

Data type

integer

Alias
UMLS CUI [1,1]
C0040822
UMLS CUI [1,2]
C0450973
10 Salivation
Description

Salivation

Data type

integer

Alias
UMLS CUI [1,1]
C0036104
UMLS CUI [1,2]
C0450973
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version
Description

Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version

Alias
UMLS CUI-1
C3641328
Suicidal Ideation: Wish to be dead
Description

SSRS: Wish to be dead

Data type

boolean

Alias
UMLS CUI [1]
C3641578
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of wish to be dead

Data type

text

Alias
UMLS CUI [1]
C3641579
Suicidal Ideation: Non-specific active suicidal thoughts
Description

SSRS: Non-specific active suicidal thoughts

Data type

boolean

Alias
UMLS CUI [1]
C3641580
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Non-Specific Active Suicidal Thoughts

Data type

text

Alias
UMLS CUI [1]
C3641581
Suicidal Ideation: Active suicidal ideation with any methods (not plan) without intent to act
Description

SSRS: Active suicidal ideation with any methods (not plan) without intent to act

Data type

boolean

Alias
UMLS CUI [1]
C3641582
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act

Data type

text

Alias
UMLS CUI [1]
C3641583
Suicidal Ideation: Active suicidal ideation with some intent to act, without specific plan
Description

SSRS: Active suicidal ideation with some intent to act, without specific plan

Data type

boolean

Alias
UMLS CUI [1]
C3641605
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan

Data type

text

Alias
UMLS CUI [1]
C3641606
Suicidal Ideation: Active suicidal ideation with specific plan and intent
Description

SSRS: Active suicidal ideation with specific plan and intent

Data type

boolean

Alias
UMLS CUI [1]
C3641607
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent

Data type

text

Alias
UMLS CUI [1]
C3641584
Intensity of Ideation: Most Severe Ideation
Description

SSRS: Most Severe Ideation

Data type

integer

Alias
UMLS CUI [1]
C3641585
Intensity of Ideation: Description of Most Severe Ideation
Description

SSRS: Description of Ideation

Data type

text

Alias
UMLS CUI [1]
C3641586
Intensity of Ideation: Frequency of Most Severe Ideation
Description

SSRS: Frequency

Data type

integer

Alias
UMLS CUI [1]
C3641587
Intensity of Ideation: Duration of Most Severe Ideation
Description

SSRS: Duration

Data type

integer

Alias
UMLS CUI [1]
C3641588
Intensity of Ideation: Controllability of Most Severe Ideation
Description

SSRS: Controllability

Data type

integer

Alias
UMLS CUI [1]
C3641589
Intensity of Ideation: Deterrents to Most Severe Ideation
Description

SSRS: Deterrents

Data type

integer

Alias
UMLS CUI [1]
C3641590
Intensity of Ideation: Reasons for Most Severe Ideation
Description

SSRS: Reasons for ideation

Data type

integer

Alias
UMLS CUI [1]
C3641591
Suicidal Behavior: Actual attempt
Description

SSRS: Actual Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641592
Suicidal Behavior: If ´Yes´, specify total number of attempts:
Description

SSRS: Number of Actual Suicide Attempts

Data type

integer

Alias
UMLS CUI [1]
C3641593
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Actual Suicide Attempts

Data type

text

Alias
UMLS CUI [1]
C3641594
Suicidal Behavior: Non-suicidal self-injurious behavior
Description

SSRS: Non-suicidal self-injurious behavior

Data type

boolean

Alias
UMLS CUI [1]
C3641595
Suicidal Behavior: Interrupted attempt
Description

SSRS: Interrupted Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641596
Suicidal Behavior: If ´Yes´, specify total number of interrupted attempts:
Description

SSRS: Number of Interrupted Suicide Attempts

Data type

integer

Alias
UMLS CUI [1]
C3641597
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Interrupted Suicide Attempts

Data type

text

Alias
UMLS CUI [1]
C3641598
Suicidal Behavior: Aborted attempt
Description

SSRS: Aborted Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641599
Suicidal Behavior: If ´Yes´, specify total number of aborted attempts:
Description

SSRS: Number of Aborted Suicide Attempts

Data type

integer

Alias
UMLS CUI [1]
C3641600
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Aborted Suicide Attempt

Data type

text

Alias
UMLS CUI [1]
C3641601
Suicidal Behavior: Preparatory acts or behavior toward suicide attempt
Description

SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641602
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt

Data type

text

Alias
UMLS CUI [1]
C3641603
Suicidal Behavior
Description

SSRS: Suicidal Behavior

Data type

boolean

Alias
UMLS CUI [1]
C3641604
Completed suicide
Description

SSRS: Completed suicide

Data type

boolean

Alias
UMLS CUI [1]
C3641338
Suicidal Behavior - Actual Attempts: Most lethal attempt date
Description

SSRS: Most Lethal Suicide Attempt Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C3641339
dd.mm.yyyy
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
Description

SSRS: Most Lethal Suicide Attempt Damage

Data type

integer

Alias
UMLS CUI [1]
C3641340
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality
Description

SSRS: Most Lethal Suicide Attempt Potential

Data type

integer

Alias
UMLS CUI [1]
C3641341
Investigator Evaluation of lnjection site
Description

Investigator Evaluation of lnjection site

Alias
UMLS CUI-1
C0035173
UMLS CUI-2
C0220825
UMLS CUI-3
C2700396
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Time of evaluation
Description

Time of evaluation

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C2700396
hh:mm
Redness
Description

Redness of injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Swelling
Description

Swelling of injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Induration
Description

Induration of injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C2700396
Subject Evaluation of lnjection site
Description

Subject Evaluation of lnjection site

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0220825
UMLS CUI-3
C2700396
Time of evaluation
Description

Time of evaluation

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C2700396
hh:mm
Injection pain
Description

Injection pain

Data type

boolean

Alias
UMLS CUI [1]
C0151828
Positive and Negative Syndrome Scale for Schizophrenia
Description

Positive and Negative Syndrome Scale for Schizophrenia

Alias
UMLS CUI-1
C4086747
UMLS CUI-2
C0036341
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Positive subscale: P01 Delusions
Description

PANSS: Delusions

Data type

integer

Alias
UMLS CUI [1]
C4087066
Positive subscale: P02 Conceptual disorganization
Description

PANSS: Conceptual disorganization

Data type

integer

Alias
UMLS CUI [1]
C4086687
Positive subscale: P03 Hallucinatory behavior
Description

PANSS: Hallucinatory behavior

Data type

integer

Alias
UMLS CUI [1]
C4086696
Positive subscale: P04 Excitement
Description

PANSS: Excitement

Data type

integer

Alias
UMLS CUI [1]
C4086693
Positive subscale: P05 Grandiosity
Description

PANSS: Grandiosity

Data type

integer

Alias
UMLS CUI [1]
C4086694
Positive subscale: P06 Suspiciousness/persecution
Description

PANSS: Suspiciousness/persecution

Data type

integer

Alias
UMLS CUI [1]
C4087067
Positive subscale: P07 Hostility
Description

PANSS: Hostility

Data type

integer

Alias
UMLS CUI [1]
C4086697
Negative subscale: N01 Blunted affect
Description

PANSS: Blunted affect

Data type

integer

Alias
UMLS CUI [1]
C4086686
Negative subscale: N02 Emotional withdrawal
Description

PANSS: Emotional withdrawal

Data type

integer

Alias
UMLS CUI [1]
C4086692
Negative subscale: N03 Poor rapport
Description

PANSS: Poor rapport

Data type

integer

Alias
UMLS CUI [1]
C4086705
Negative subscale: N04 Passive/apathetic social withdrawal
Description

PANSS: Passive/apathetic social withdrawal

Data type

integer

Alias
UMLS CUI [1]
C4086702
Negative subscale: N05 Difficulty in abstract thinking
Description

PANSS: Difficulty in abstract thinking

Data type

integer

Alias
UMLS CUI [1]
C4086689
Negative subscale: N06 Lack of spontaneity and flow of conversation
Description

PANSS: Lack of spontaneity and flow of conversation

Data type

integer

Alias
UMLS CUI [1]
C4086699
Negative subscale: N07 Stereotyped thinking
Description

PANSS: Stereotyped thinking

Data type

integer

Alias
UMLS CUI [1]
C4086708
General psychopathology subscale: G01 Somatic concern
Description

PANSS: Somatic concern

Data type

integer

Alias
UMLS CUI [1]
C4086707
General psychopathology subscale: G02 Anxiety
Description

PANSS: Anxiety

Data type

integer

Alias
UMLS CUI [1]
C4086685
General psychopathology subscale: G03 Guilt feelings
Description

PANSS: Guilt feelings

Data type

integer

Alias
UMLS CUI [1]
C4086695
General psychopathology subscale: G04 Tension
Description

PANSS: Tension

Data type

integer

Alias
UMLS CUI [1]
C4086709
General psychopathology subscale: G05 Mannerisms and posturing
Description

PANSS: Mannerisms and posturing

Data type

integer

Alias
UMLS CUI [1]
C4086700
General psychopathology subscale: G06 Depression
Description

PANSS: Depression

Data type

integer

Alias
UMLS CUI [1]
C4086688
General psychopathology subscale: G07 Motor retardation
Description

PANSS: Motor retardation

Data type

integer

Alias
UMLS CUI [1]
C4086701
General psychopathology subscale: G08 Uncooperativeness
Description

PANSS: Uncooperativeness

Data type

integer

Alias
UMLS CUI [1]
C4086710
General psychopathology subscale: G09 Unusual thought content
Description

PANSS: Unusual thought content

Data type

integer

Alias
UMLS CUI [1]
C4086711
General psychopathology subscale: G10 Disorientation
Description

PANSS: Disorientation

Data type

integer

Alias
UMLS CUI [1]
C4086690
General psychopathology subscale: G11 Poor attention
Description

PANSS: Poor attention

Data type

integer

Alias
UMLS CUI [1]
C4086703
General psychopathology subscale: G12 Lack of judgment and insight
Description

PANSS: Lack of judgment and insight

Data type

integer

Alias
UMLS CUI [1]
C4086698
General psychopathology subscale: G13 Disturbance of volition
Description

PANSS: Disturbance of volition

Data type

integer

Alias
UMLS CUI [1]
C4086691
General psychopathology subscale: G14 Poor impulse control
Description

PANSS: Poor impulse control

Data type

integer

Alias
UMLS CUI [1]
C4086704
General psychopathology subscale: G15 Preoccupation
Description

PANSS: Preoccupation

Data type

integer

Alias
UMLS CUI [1]
C4086706
General psychopathology subscale: G16 Active social avoidence
Description

PANSS: Active social avoidence

Data type

integer

Alias
UMLS CUI [1]
C4086684
Calculated total PANSS score
Description

Calculated total PANSS score

Data type

integer

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0449820
Clinical Global Impression - Severity
Description

Clinical Global Impression - Severity

Alias
UMLS CUI-1
C3639708
Rater´s initials
Description

Rater´s initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
Description

Clinical global impression of subject's psychotic disorder

Data type

integer

Alias
UMLS CUI [1]
C3698629
Personal and Social Performance Scale
Description

Personal and Social Performance Scale

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0037397
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Domain of functioning: Socially useful activities, including work and study
Description

Socially useful activities, including work and study

Data type

integer

Alias
UMLS CUI [1]
C3641834
Domain of functioning: Personal and social relationships
Description

Personal and social relationships

Data type

integer

Alias
UMLS CUI [1]
C0021797
Domain of functioning: Self-care
Description

Self-care

Data type

integer

Alias
UMLS CUI [1]
C0474417
Domain of functioning: Disturbing and aggressive behaviors
Description

Disturbing and aggressive behaviors

Data type

integer

Alias
UMLS CUI [1]
C0001807
Total score
Description

Total score

Data type

integer

Alias
UMLS CUI [1]
C2964552
Administration of trial medication
Description

Administration of trial medication

Alias
UMLS CUI-1
C3854006
UMLS CUI-2
C3469597
Medication Kit Number
Description

Medication Kit Number

Data type

integer

Alias
UMLS CUI [1,1]
C2981406
UMLS CUI [1,2]
C3854006
Dispensation Date
Description

Dispensation Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826773
dd.mm.yyyy
Study drug administrator's initials
Description

Study drug administrator's initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C3854006
Date of injection
Description

Date of injection

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021485
dd.mm.yyyy
Actual clock time of injection
Description

Actual clock time of injection

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0021485
hh:mm
Location
Description

Injection site

Data type

integer

Alias
UMLS CUI [1]
C2700396
Medication Preference Questionnaire
Description

Medication Preference Questionnaire

Alias
UMLS CUI-1
C3854006
UMLS CUI-2
C0030705
UMLS CUI-3
C0558295
How important is each of the following statements? 1. I can get back to my favourite activities
Description

Activities

Data type

integer

Alias
UMLS CUI [1]
C0441655
2. I feel like myself again
Description

Feelings, self

Data type

integer

Alias
UMLS CUI [1,1]
C1527305
UMLS CUI [1,2]
C0036588
3. It makes my symptoms (such as hearing voices) go away
Description

Schizophrenic symptoms go away

Data type

integer

Alias
UMLS CUI [1,1]
C2678249
UMLS CUI [1,2]
C0231221
4. I feel more healthy
Description

Feel healthy

Data type

integer

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C1527305
5. I feel less confused
Description

Feeling confused

Data type

integer

Alias
UMLS CUI [1,1]
C1527305
UMLS CUI [1,2]
C0009676
6. I feel my symptoms (such as hearing voices) will not suddenly come back
Description

Reappearance of schizophrenic symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C0700364
UMLS CUI [1,2]
C2678249
7. I feel more in control over the medicine I take
Description

Feel control over medication intake

Data type

integer

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C2587213
8. I have few side effects from my medicine
Description

Few adverse effects

Data type

integer

Alias
UMLS CUI [1,1]
C0205388
UMLS CUI [1,2]
C0041755
9. I don't have to think about taking my medicine
Description

Think about taking medication

Data type

integer

Alias
UMLS CUI [1,1]
C0039869
UMLS CUI [1,2]
C1290952
Based on your experience with both pills and injections, which ONE do you prefer?
Description

Oral route of drug administration, injection

Data type

integer

Alias
UMLS CUI [1,1]
C0558295
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0558295
UMLS CUI [2,2]
C1828121
A). Pills are easier for me
Description

Pills, easy

Data type

integer

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C0332219
B). Pills work better for my symptoms (such as hearing voices)
Description

Schizophrenic symptoms, pills

Data type

integer

Alias
UMLS CUI [1,1]
C2678249
UMLS CUI [1,2]
C0994475
C). I have less side effects from my medicine
Description

Pills, adverse effects

Data type

integer

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C0041755
D). I feel more in control when taking pills
Description

Pills, feel control

Data type

integer

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C2587213
UMLS CUI [1,3]
C1527305
E). I feel less pain when taking pills
Description

Pills, pain

Data type

integer

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C0030193
F). I feel less embarrassed when taking pills
Description

Embarrassed to take pills

Data type

integer

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C0679112
A). Injections are easier for me
Description

Injection, easy

Data type

integer

Alias
UMLS CUI [1,1]
C0332219
UMLS CUI [1,2]
C1828121
B). Injections work better for my symptoms (such as hearing voices)
Description

Schizophrenic symptoms, Injections

Data type

integer

Alias
UMLS CUI [1,1]
C2678249
UMLS CUI [1,2]
C1828121
C). I have less side effects from my medicine
Description

Adverse effects, injections

Data type

integer

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C0041755
D). I don't have to think about taking my medicine
Description

Injections, think about taking medication

Data type

integer

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C0039869
UMLS CUI [1,3]
C1290952
E). I don't worry about sudden symptoms from my illness
Description

Injections, worry about sudden symptoms from illness

Data type

integer

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C2678249
UMLS CUI [1,3]
C1276802
UMLS CUI [1,4]
C0233481
If you have other reasons why you prefer pills or injections, please describe them:
Description

Specification preference drug administration route

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0558295
UMLS CUI [1,3]
C0013153
Based on all of your experiences in this research study, which injection site would you prefer?
Description

Injection site preference

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0558295
A). Arm injections are easier for me
Description

Arm injection, easy

Data type

integer

Alias
UMLS CUI [1,1]
C1293234
UMLS CUI [1,2]
C0332219
B). Arm injections work better for my symptoms (such as hearing voices)
Description

Arm injection, schizophrenic symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1293234
UMLS CUI [1,2]
C2678249
C). It is faster than a buttock injection
Description

Arm injections, duration

Data type

integer

Alias
UMLS CUI [1,1]
C1293234
UMLS CUI [1,2]
C0449238
D). I have less side effects from arm injections
Description

Arm injection, adverse effects

Data type

integer

Alias
UMLS CUI [1,1]
C1293234
UMLS CUI [1,2]
C0041755
E). I feel less pain from arm injections
Description

Arm injections, pain

Data type

integer

Alias
UMLS CUI [1,1]
C1293234
UMLS CUI [1,2]
C0030193
F). I feel less embarrassed by arm injections
Description

Arm injections, feel embarrassed

Data type

integer

Alias
UMLS CUI [1,1]
C1293234
UMLS CUI [1,2]
C0679112
A). Buttock injections are easier for me
Description

Buttock injections, easy

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0006497
UMLS CUI [1,3]
C0332219
B). Buttock injections work better for my symptoms (such as hearing voices)
Description

Buttock injections, schizophrenic symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0006497
UMLS CUI [1,3]
C2678249
C). It is faster than an arm injection
Description

Buttock injections, duration

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0006497
UMLS CUI [1,3]
C0449238
D). I have less side effects from buttock injections
Description

Buttock injections, adverse effects

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0006497
UMLS CUI [1,3]
C0041755
E). I feel less pain from buttock injections
Description

Buttock injections, pain

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0006497
UMLS CUI [1,3]
C0030193
F). I feel less embarrassed by buttock injections
Description

Buttock injections, feel embarrassed

Data type

integer

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0006497
UMLS CUI [1,3]
C0679112
If you have other reasons why you prefer arm or buttock injections, please describe them:
Description

Specification, preference, injection site

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0558295
UMLS CUI [1,3]
C2700396
Would you prefer to receive your medication every day, every month, or every 3 months?
Description

Interval to receive medication

Data type

integer

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C1272706
Injections every month: I like to have injections more often because if l have a problem, my dose can be changed.
Description

Monthly injections, change of dose

Data type

integer

Alias
UMLS CUI [1,1]
C0332177
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1608430
Injections every month: I am used to injections every month and don't mind them
Description

Monthly injection, routine procedure

Data type

integer

Alias
UMLS CUI [1,1]
C0332177
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1298805
Injections every month: I like to see the doctor more often
Description

Monthly injection, doctor visit sequence

Data type

integer

Alias
UMLS CUI [1,1]
C0332177
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C3259401
Injections every month: I don't like taking that much medication at once
Description

Monthly injection, Quantity, Medication

Data type

integer

Alias
UMLS CUI [1,1]
C0332177
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0013227
Injections every month: Taking my medicine every month means less conflict or talking with my family or caregivers about medicines
Description

Monthly injection, family conflict, medication

Data type

integer

Alias
UMLS CUI [1,1]
C0332177
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C0233542
UMLS CUI [1,4]
C0013227
Injections every 3 months: I like to have fewer injections
Description

Trimonthly injection, fewer injections

Data type

integer

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [2,1]
C0205388
UMLS CUI [2,2]
C0021485
Injections every 3 months: It is less painful to have fewer injections
Description

Trimonthly injection, Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C0030193
Injections every 3 months: I don't have to see my doctor as often
Description

Trimonthly injection, doctor visit sequence

Data type

integer

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C3259401
Injections every 3 months: Fewer injections means fewer reminders about my illness
Description

Trimonthly injection, reminder about illness

Data type

integer

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1709896
UMLS CUI [1,4]
C0221423
Injections every 3 months: There is less conflict or talking about my medicine with my family or caregivers
Description

Trimonthly injection, family conflict, medication

Data type

integer

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C0233542
UMLS CUI [1,4]
C0013227
Injections every 3 months: There are fewer problems with transportation
Description

Trimonthly injection, problem with transportation

Data type

integer

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C3830421
If you have other reasons why you prefer injections every month or 3 months, please tell us:
Description

Reason for preference monthly or trimonthly injections

Data type

text

Alias
UMLS CUI [1,1]
C0332179
UMLS CUI [1,2]
C0021485
UMLS CUI [2,1]
C0332177
UMLS CUI [2,2]
C0021485
UMLS CUI [3,1]
C0566251
UMLS CUI [3,2]
C0558295
Involvement Evaluation Questionnaire (Baseline)
Description

Involvement Evaluation Questionnaire (Baseline)

Alias
UMLS CUI-1
C1321106
UMLS CUI-2
C1531735
UMLS CUI-3
C0220825
UMLS CUI-4
C0034394
1.What is your age?
Description

Age

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C0001779
years
2.What is your gender?
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
3.What is your civil status?
Description

Marital status

Data type

integer

Alias
UMLS CUI [1]
C0024819
4.Do you live alone or with others?
Description

Housing

Data type

integer

Alias
UMLS CUI [1]
C0020056
If "Other", please specify:
Description

Specification housing

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0020056
5.How many people, including yourself, are there in your household?
Description

Household, quantity

Data type

integer

Alias
UMLS CUI [1,1]
C0015578
UMLS CUI [1,2]
C1265611
6.Is your relative/friend currently receiving help for his/her mental health problems?
Description

Mental disorder, therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0039798
If "Other", please specify:
Description

Specification help for mental health

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0039798
7.What is your precise relationship with your relative/friend? I am his/her:
Description

Relationship

Data type

integer

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0681850
If "Other", please specify:
Description

Specification relationship

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0681850
8.Is your relative/friend part of your household?
Description

Patient part of household

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1292711
UMLS CUI [1,3]
C0020052
9.How many days have you and your relative/friend lived together at the same address during the past 4 weeks?
Description

Quantity, day, together

Data type

integer

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1883357
If "Some days", specify how many:
Description

Specification quantity days together

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C1883357
10.What has been your average weekly telephone or personal contact with your relative/friend over the past 4 weeks?
Description

Personal contact or telephone call duration

Data type

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C3812666
UMLS CUI [2,1]
C0449238
UMLS CUI [2,2]
C0302186
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.)?
Description

how often, encourage self-care

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0548205
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.)?
Description

how often help with self-care

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C3827269
13.How often during the past 4 weeks have you encouraged your relative/friend to eat enough?
Description

how often encourage to eat

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0510754
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)?
Description

How often encourage to undertake activity

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C2922556
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?
Description

How often activities together

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0441655
UMLS CUI [1,3]
C1883357
16.How often during the past 4 weeks have you ensured that your relative/friend has taken the required medicine?
Description

how often control of intake of medication

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C1290952
UMLS CUI [1,3]
C2587213
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.)?
Description

how often dangerous behaviour

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0010967
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.)?
Description

how often self-inflicted harm

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0085271
19.How often during the past 4 weeks have you ensured your relative/friend received sufficient sleep?
Description

how often ensure sufficient sleep

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0547106
20.How often during the past 4 weeks have you guarded your relative/friend from drinking too much alcohol?
Description

how often guarded from drinking too much alcohol

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0001948
21.How often during the past 4 weeks have you guarded your relative/friend from taking illegal drugs?
Description

how often illegal drug use

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0281875
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.)?
Description

how often help friend with tasks

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0557462
UMLS CUI [1,3]
C3540678
23.How often during the past 4 weeks have you encouraged your relative/friend to get up in the morning?
Description

how often encourage to get up

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C1269765
UMLS CUI [1,3]
C0442696
24.How often during the past 4 weeks has your relative/friend disturbed your sleep?
Description

how often sleep disturbed

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0037317
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?
Description

how often relationship problems

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0425168
26.How often during the past 4 weeks has your relative/friend caused a quarrel?
Description

how often caused a quarrel

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0680226
27.How often during the past 4 weeks have you been annoyed by your relative/friend's behaviour?
Description

how often annoyed by behaviour

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C3831378
UMLS CUI [1,3]
C0004927
28.How often during the past 4 weeks have you heard from others that they have been annoyed by your relative/friend's behaviour?
Description

how often others annoyed by behaviour

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C1546930
UMLS CUI [1,3]
C3831378
UMLS CUI [1,4]
C0004927
29.How often during the past 4 weeks have you felt threatened by your relative/friend?
Description

how often threatening behavior

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0562573
30.How often during the past 4 weeks have you thought of moving out, as a result of your relative/friend's behaviour?
Description

how often thought of moving out because of behavior

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C0588450
UMLS CUI [1,3]
C0004927
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)?
Description

how often persue own activities

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C2947996
UMLS CUI [1,3]
C0441655
32.How often during the past 4 weeks have you worried about your relative/friend's safety?
Description

how often worried about safety

Data type

integer

Alias
UMLS CUI [1,1]
C4084900
UMLS CUI [1,2]
C0036043
33.How often during the past 4 weeks have you worried about the kind of help/treatment your relative/friend is receiving?
Description

how often worried about treatment

Data type

integer

Alias
UMLS CUI [1,1]
C4084900
UMLS CUI [1,2]
C0039798
34.How often during the past 4 weeks have you worried about your relative/friend's general health?
Description

how often worried about general health

Data type

integer

Alias
UMLS CUI [1,1]
C4084900
UMLS CUI [1,2]
C0424575
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?
Description

how often worried about financial problems

Data type

integer

Alias
UMLS CUI [1,1]
C4084900
UMLS CUI [1,2]
C0549106
36.How often during the past 4 weeks have you worried about your relative/friend's future?
Description

how often worried about future

Data type

integer

Alias
UMLS CUI [1,1]
C4084900
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0016884
37. How often during the past 4 weeks have you worried about your own future?
Description

how often worried about personal future

Data type

integer

Alias
UMLS CUI [1,1]
C4084900
UMLS CUI [1,2]
C1519021
UMLS CUI [1,3]
C0016884
38. To what extent have your relative/friend's mental problems been a burden to you during the past 4 weeks?
Description

mental health problem, burden

Data type

integer

Alias
UMLS CUI [1,1]
C1446377
UMLS CUI [1,2]
C2828008
39. Have you got used to your relative/friend having mental health problems?
Description

used to mental health problem

Data type

integer

Alias
UMLS CUI [1,1]
C1446377
UMLS CUI [1,2]
C0009967
40. How often have you felt able to cope with your relative/friend's mental health problems?
Description

how often felt able to cope with health problems

Data type

integer

Alias
UMLS CUI [1,1]
C3898838
UMLS CUI [1,2]
C2364069
UMLS CUI [1,3]
C1446377
41. Has your relationship with your relative/friend changed since the onset of the mental health problems?
Description

change in relationship due to mental health problem

Data type

integer

Alias
UMLS CUI [1,1]
C2045651
UMLS CUI [1,2]
C1446377
42.What is your highest education level?
Description

Highest education level

Data type

integer

Alias
UMLS CUI [1]
C0013658
43.What is your current employment status?
Description

Employment status

Data type

integer

Alias
UMLS CUI [1]
C0242271
44.What part of your family's income is spent on the subject's medical bills?
Description

what part of income spent on health care costs

Data type

integer

Alias
UMLS CUI [1,1]
C1292711
UMLS CUI [1,2]
C0021162
UMLS CUI [1,3]
C0085552
45.How many people, not including yourself, provide care for the subject?
Description

quantity, care provider for the subject

Data type

integer

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C1531735
46.If you are a parent, how many children do you have?
Description

Number of children

Data type

integer

Alias
UMLS CUI [1]
C2229974
47.How many hours did you spend on caregiving activities (for the subject) during the past 7 days?
Description

how many hours spent on caregiving

Data type

integer

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0556976
UMLS CUI [1,2]
C4062067
hours
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?
Description

missed work related to caregiving

Data type

integer

Alias
UMLS CUI [1,1]
C2977596
UMLS CUI [1,2]
C4054769
If "yes", please record the number of working days missed:
Description

specification of missed working day because of caregiving

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0559457
UMLS CUI [1,3]
C2977596
days
49.How many days was your ability to participate in leisure activities impacted by caregiving activities in the past 4 weeks?
Description

impact of caregiving activities on leisure activities

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0556971
UMLS CUI [1,2]
C2977596
UMLS CUI [1,3]
C4049986
UMLS CUI [1,4]
C0023292
days
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?
Description

Quantity of General practitioner visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0017319
visits/4 weeks
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?
Description

Quantity of Specialist physician visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C2348234
visits/4 weeks
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?
Description

Quantity of Psychiatric nurse visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0033870
visits/4 weeks
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?
Description

Quantity of Psychologist visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0033908
visits/4 weeks
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?
Description

Quantity of Social worker visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0037444
visits/4 weeks
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?
Description

Quantity of Other medical specialists visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1271040
visits/4 weeks
50.7 How many times did you visit an Emergency Room for a medical condition of your own during the past 4 weeks?
Description

Quantity of Emergency Room visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C4291935
visits/4 weeks
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?
Description

Quantity of Other visits

Data type

integer

Measurement units
  • visits/4 weeks
Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0205394
visits/4 weeks
If "Other", please specify:
Description

Specification other

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0205394
51.How many days have you been hospitalized in the past 4 weeks?
Description

days hospitalized in past 4 weeks

Data type

integer

Measurement units
  • days/4 weeks
Alias
UMLS CUI [1,1]
C0701159
UMLS CUI [1,2]
C0556971
days/4 weeks
Resource Use Questionnaire A Hospitalisation (Baseline Assessment)
Description

Resource Use Questionnaire A Hospitalisation (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C0019993
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)
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Type of hospital
Description

Type of hospital

Data type

integer

Alias
UMLS CUI [1]
C0019994
Type of Ward
Description

Type of Ward

Data type

integer

Alias
UMLS CUI [1]
C1305702
Reason
Description

Reason for hospitalization

Data type

integer

Alias
UMLS CUI [1]
C1830395
Hospitalization started before 12 months
Description

Hospitalization started before 12 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C3842282
If hospitalization started less than 12 months ago, date of beginning:
Description

hospitalization start date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0808070
dd.mm.yyyy
Hospitalization ongoing
Description

Hospitalization ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C3174772
If hospitalization is not longer ongoing, date of end:
Description

hospitalization end date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0806020
dd.mm.yyyy
Resource Use Questionnaire B Emergency room visits without hospitalisation (Baseline Assessment)
Description

Resource Use Questionnaire B Emergency room visits without hospitalisation (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C4291935
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)
Description

Emergency room visit

Data type

boolean

Alias
UMLS CUI [1,1]
C4291935
UMLS CUI [1,2]
C0545082
Date of visit
Description

Date of visit in ER

Data type

boolean

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C4291935
Reason
Description

Reason for ER visit

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C4291935
UMLS CUI [1,3]
C0545082
Resource Use Questionnaire C Day clinic (Baseline Assessment)
Description

Resource Use Questionnaire C Day clinic (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C3838685
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)
Description

Day clinic visit

Data type

boolean

Alias
UMLS CUI [1,1]
C3838685
UMLS CUI [1,2]
C0545082
Type of hospital
Description

Type of hospital

Data type

integer

Alias
UMLS CUI [1]
C0019994
Frequency/week (enter number of days/week)
Description

Day care clinic visits on x days/week

Data type

integer

Measurement units
  • days/week
Alias
UMLS CUI [1,1]
C3838685
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0677547
days/week
Reason
Description

Reason for day clinic visit

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3838685
UMLS CUI [1,3]
C0545082
Day clinic started before 3 months
Description

Day clinic started before 3 months

Data type

boolean

Alias
UMLS CUI [1,1]
C3838685
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1442461
If day clinic started less than 3 months ago, date of beginning:
Description

Day clinic start date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C3838685
UMLS CUI [1,2]
C0808070
dd.mm.yyyy
Day clinic ongoing
Description

Day clinic ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C3838685
UMLS CUI [1,2]
C3174772
If day clinic is not longer ongoing, date of end:
Description

Day clinic end date

Data type

date

Measurement units
  • days
Alias
UMLS CUI [1,1]
C3838685
UMLS CUI [1,2]
C0806020
days
Resource Use Questionnaire D Night clinic (Baseline Assessment)
Description

Resource Use Questionnaire D Night clinic (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C0240526
UMLS CUI-4
C0442592
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)
Description

Night clinic visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0545082
Type of hospital
Description

Type of hospital

Data type

integer

Alias
UMLS CUI [1]
C0019994
Frequency/week (enter number of days/week)
Description

Night clinic visits on x days/week

Data type

integer

Measurement units
  • days/week
Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0677547
UMLS CUI [1,3]
C0240526
UMLS CUI [1,4]
C0442592
days/week
Reason
Description

Reason for night clinic visit

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0240526
UMLS CUI [1,3]
C0442592
UMLS CUI [1,4]
C0545082
Night clinic started before 3 months
Description

Night clinic started before 3 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C1442461
If night clinic started less than 3 months ago, date of beginning:
Description

Night clinic start date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0808070
dd.mm.yyyy
Night clinic ongoing
Description

Night clinic ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C3174772
If night clinic is not longer ongoing, date of end:
Description

Night clinic end date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0806020
dd.mm.yyyy
Resource Use Questionnaire E Outpatient treatment (Baseline Assessment)
Description

Resource Use Questionnaire E Outpatient treatment (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C0002423
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)
Description

Outpatient consultation

Data type

boolean

Alias
UMLS CUI [1]
C0002423
Health professional
Description

Health professional

Data type

integer

Alias
UMLS CUI [1]
C1704312
If "Other", please specify:
Description

Specification health professional

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C1704312
Number of consultations
Description

Number of consultations

Data type

integer

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0009818
Resource Use Questionnaire F Daily living (Baseline Assessment)
Description

Resource Use Questionnaire F Daily living (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C0020056
What is the subject's usual accommodation status?
Description

Housing

Data type

integer

Alias
UMLS CUI [1]
C0020056
Resource Use Questionnaire G Productivity of subject (Baseline Assessment)
Description

Resource Use Questionnaire G Productivity of subject (Baseline Assessment)

Alias
UMLS CUI-1
C3858749
UMLS CUI-2
C0034394
UMLS CUI-3
C0557390
What was the subject's occupational status at trial entry?
Description

Occupational status

Data type

integer

Alias
UMLS CUI [1]
C0014006
What was the reason for this occupational status?
Description

Reason for occupational status

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0014006
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)
Description

Days off work because of mental disorder or its treatment

Data type

integer

Alias
UMLS CUI [1,1]
C0559457
UMLS CUI [1,2]
C0004936
If "yes", please record the number of working days lost:
Description

Specification number days off work

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0559457
UMLS CUI [1,3]
C0004936
days
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)
Description

Could not attend to educational institution because of disease or its treatment

Data type

integer

Alias
UMLS CUI [1,1]
C0013652
UMLS CUI [1,2]
C0559294
UMLS CUI [1,3]
C0004936
If "yes", please record the number of educational days lost:
Description

Number of educational days lost

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C2230086
UMLS CUI [1,2]
C0004936
days
Medication Kit Dispensation
Description

Medication Kit Dispensation

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1880359
UMLS CUI-3
C1690540
Date medication kit assigned
Description

Date medication kit assigned

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1516050
UMLS CUI [1,3]
C3854006
UMLS CUI [1,4]
C1690540
dd.mm.yyyy
Medication kit number
Description

Medication kit number

Data type

integer

Alias
UMLS CUI [1,1]
C2981406
UMLS CUI [1,2]
C3854006

Similar models

Visit 2 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
ECG
C1623258 (UMLS CUI-1)
ECG reference number
Item
ECG reference number
integer
C1623258 (UMLS CUI [1,1])
C3274661 (UMLS CUI [1,2])
Item Group
Vital Signs with Weight, Waist and Temperature
C0518766 (UMLS CUI-1)
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])
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])
Item
Actual Position
integer
C0449850 (UMLS CUI [1])
Code List
Actual Position
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)
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])
Comment, blood specimen
Item
Specimen comments, if any
text
C0947611 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item Group
Lab Sample Central Lab
C3244292 (UMLS CUI-1)
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
Item Group
Urine Dipstick Pregnancy Test
C0430056 (UMLS CUI-1)
Item
Was the Dipstick Pregnancy Test performed?
integer
C0430056 (UMLS CUI [1])
Code List
Was the Dipstick Pregnancy Test performed?
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])
Item
Dipstick Pregnancy Test Result
integer
C0427777 (UMLS CUI [1])
Code List
Dipstick Pregnancy Test Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Urine Drug Screen (Dipstick)
C0202274 (UMLS CUI-1)
Urine drug screen collected
Item
Was urine drug screen (dipstick) collected?
boolean
C0202274 (UMLS CUI [1,1])
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])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C0460002 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Code List
Body system
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])
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])
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])
Code List
Facial and oral movements: Lips and perioral area
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: Jaw
integer
C3640441 (UMLS CUI [1])
Code List
Facial and oral movements: Jaw
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: Tongue
integer
C3640442 (UMLS CUI [1])
Code List
Facial and oral movements: Tongue
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])
Code List
Extremity movements: Upper (arms, wrists, hands, fingers)
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])
Code List
Extremity movements: Lower (legs, knees, ankles, toes)
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])
Code List
Trunk movements: Neck, shoulders, hip
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])
Code List
Global Judgements: Severity of 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: 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])
Item Group
Barnes Akathisia Rating Scale
C3541345 (UMLS CUI-1)
Item
Objective
integer
C3640451 (UMLS CUI [1])
Code List
Objective
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])
Code List
Subjective: Awareness of restlessness
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])
Code List
Global clinical rating of akathisia
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)
Item
1 Gait
integer
C0016928 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
1 Gait
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)
Item
2 Arm Dropping
integer
C0231650 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
2 Arm Dropping
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])
Code List
3 Shoulder shaking
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])
Code List
4 Elbow rigidity
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])
Code List
5 Wrist rigidity
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])
Code List
6 Leg pendulousness
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])
Code List
7 Head dropping
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)
Item
8 Glabella tap
integer
C0576550 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
8 Glabella tap
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)
Item
9 Tremor
integer
C0040822 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
9 Tremor
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)
Item
10 Salivation
integer
C0036104 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
10 Salivation
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])
Code List
Intensity of Ideation: Most Severe Ideation
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])
Code List
Intensity of Ideation: Frequency of Most Severe Ideation
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])
Code List
Intensity of Ideation: Duration of Most Severe Ideation
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])
Code List
Intensity of Ideation: Controllability of Most Severe Ideation
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])
Code List
Intensity of Ideation: Deterrents to Most Severe Ideation
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])
Code List
Intensity of Ideation: Reasons for Most Severe Ideation
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)
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])
Item
Redness
integer
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Code List
Redness
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])
Code List
Swelling
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])
Code List
Induration
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)
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
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)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Positive subscale: P01 Delusions
integer
C4087066 (UMLS CUI [1])
Code List
Positive subscale: P01 Delusions
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])
Code List
Positive subscale: P02 Conceptual disorganization
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])
Code List
Positive subscale: P03 Hallucinatory behavior
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: P04 Excitement
integer
C4086693 (UMLS CUI [1])
Code List
Positive subscale: P04 Excitement
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: P05 Grandiosity
integer
C4086694 (UMLS CUI [1])
Code List
Positive subscale: P05 Grandiosity
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])
Code List
Positive subscale: P06 Suspiciousness/persecution
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: P07 Hostility
integer
C4086697 (UMLS CUI [1])
Code List
Positive subscale: P07 Hostility
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: N01 Blunted affect
integer
C4086686 (UMLS CUI [1])
Code List
Negative subscale: N01 Blunted affect
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])
Code List
Negative subscale: N02 Emotional 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: N03 Poor rapport
integer
C4086705 (UMLS CUI [1])
Code List
Negative subscale: N03 Poor rapport
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])
Code List
Negative subscale: N07 Stereotyped 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
General psychopathology subscale: G01 Somatic concern
integer
C4086707 (UMLS CUI [1])
Code List
General psychopathology subscale: G01 Somatic concern
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: G02 Anxiety
integer
C4086685 (UMLS CUI [1])
Code List
General psychopathology subscale: G02 Anxiety
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])
Code List
General psychopathology subscale: G03 Guilt feelings
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: G04 Tension
integer
C4086709 (UMLS CUI [1])
Code List
General psychopathology subscale: G04 Tension
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])
Code List
General psychopathology subscale: G06 Depression
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])
Code List
General psychopathology subscale: G07 Motor retardation
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])
Code List
General psychopathology subscale: G08 Uncooperativeness
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])
Code List
General psychopathology subscale: G10 Disorientation
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])
Code List
General psychopathology subscale: G11 Poor attention
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])
Code List
General psychopathology subscale: G14 Poor impulse control
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])
Code List
General psychopathology subscale: G15 Preoccupation
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])
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)
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])
Code List
Domain of functioning: Personal and social relationships
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: Self-care
integer
C0474417 (UMLS CUI [1])
Code List
Domain of functioning: Self-care
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)
Medication Kit Number
Item
Medication Kit Number
integer
C2981406 (UMLS CUI [1,1])
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])
Date of injection
Item
Date of injection
date
C0011008 (UMLS CUI [1,1])
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])
Item
Location
integer
C2700396 (UMLS CUI [1])
Code List
Location
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)
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])
Code List
2. I feel like myself again
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])
Code List
3. It makes my symptoms (such as hearing voices) go away
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])
Code List
4. I feel more healthy
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])
Code List
5. I feel less confused
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])
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])
Code List
7. I feel more in control over the medicine I take
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])
Code List
8. I have few side effects from my medicine
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])
Code List
9. I don't have to think about taking my medicine
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])
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])
Code List
A). Pills are easier for me
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])
Code List
B). Pills work better for my symptoms (such as hearing voices)
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])
Code List
C). I have less side effects from my medicine
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])
Code List
D). I feel more in control when taking pills
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])
Code List
E). I feel less pain when taking pills
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])
Code List
F). I feel less embarrassed when taking pills
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])
Code List
A). Injections are easier for me
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])
Code List
B). 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). I have less side effects from my medicine
integer
C1828121 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Code List
C). I have less side effects from my medicine
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])
Code List
D). I don't have to think about taking my medicine
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])
Code List
E). I don't worry about sudden symptoms from my illness
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])
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])
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])
Code List
A). Arm injections are easier for me
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])
Code List
B). Arm 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 a buttock injection
integer
C1293234 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Code List
C). It is faster than a buttock injection
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])
Code List
D). I have less side effects from arm injections
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])
Code List
E). I feel less pain from arm injections
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])
Code List
F). I feel less embarrassed by arm injections
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])
Code List
A). Buttock injections are easier for me
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])
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])
Code List
C). It is faster than an arm injection
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])
Code List
D). I have less side effects from buttock injections
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])
Code List
E). I feel less pain from buttock injections
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])
Code List
F). I feel less embarrassed by buttock injections
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])
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])
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])
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])
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])
Code List
Injections every month: I like to see the doctor more often
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])
Code List
Injections every month: I don't like taking that much medication at once
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])
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])
Code List
Injections every 3 months: I like to have fewer injections
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])
Code List
Injections every 3 months: It is less painful to have fewer injections
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])
Code List
Injections every 3 months: I don't have to see my doctor as often
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])
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])
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])
Code List
Injections every 3 months: There are fewer problems with transportation
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])
Item Group
Involvement Evaluation Questionnaire (Baseline)
C1321106 (UMLS CUI-1)
C1531735 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0034394 (UMLS CUI-4)
Age
Item
1.What is your age?
integer
C0001779 (UMLS CUI [1])
Item
2.What is your gender?
integer
C0079399 (UMLS CUI [1])
Code List
2.What is your gender?
CL Item
Male (1)
CL Item
Female (2)
Item
3.What is your civil status?
integer
C0024819 (UMLS CUI [1])
Code List
3.What is your civil status?
CL Item
Single (1)
CL Item
Married/in a long-term partnership (2)
CL Item
Divorced (3)
CL Item
Widowed (4)
Item
4.Do you live alone or with others?
integer
C0020056 (UMLS CUI [1])
Code List
4.Do you live alone or with others?
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])
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])
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])
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])
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])
Code List
7.What is your precise relationship with your relative/friend? I am his/her:
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Code List
42.What is your highest education level?
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)
Item
43.What is your current employment status?
integer
C0242271 (UMLS CUI [1])
Code List
43.What is your current employment status?
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Specification other
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1,1])
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])
Item Group
Resource Use Questionnaire A Hospitalisation (Baseline Assessment)
C3858749 (UMLS CUI-1)
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])
Item
Type of hospital
integer
C0019994 (UMLS CUI [1])
Code List
Type of hospital
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)
Item
Type of Ward
integer
C1305702 (UMLS CUI [1])
Code List
Type of Ward
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)
Item
Reason
integer
C1830395 (UMLS CUI [1])
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])
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])
Hospitalization ongoing
Item
Hospitalization ongoing
boolean
C0019993 (UMLS CUI [1,1])
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])
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)
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])
Date of visit in ER
Item
Date of visit
boolean
C1320303 (UMLS CUI [1,1])
C4291935 (UMLS CUI [1,2])
Item
Reason
integer
C0566251 (UMLS CUI [1,1])
C4291935 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Code List
Reason
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)
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])
Item
Type of hospital
integer
C0019994 (UMLS CUI [1])
Code List
Type of hospital
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])
Item
Reason
integer
C0566251 (UMLS CUI [1,1])
C3838685 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Code List
Reason
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])
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])
Day clinic ongoing
Item
Day clinic ongoing
boolean
C3838685 (UMLS CUI [1,1])
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])
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)
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])
Item
Type of hospital
integer
C0019994 (UMLS CUI [1])
Code List
Type of hospital
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])
Item
Reason
integer
C0566251 (UMLS CUI [1,1])
C0240526 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Code List
Reason
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])
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])
Night clinic ongoing
Item
Night clinic ongoing
boolean
C0240526 (UMLS CUI [1,1])
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])
Item Group
Resource Use Questionnaire E Outpatient treatment (Baseline Assessment)
C3858749 (UMLS CUI-1)
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])
Item
Health professional
integer
C1704312 (UMLS CUI [1])
Code List
Health professional
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])
Number of consultations
Item
Number of consultations
integer
C1265611 (UMLS CUI [1,1])
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)
Item
What is the subject's usual accommodation status?
integer
C0020056 (UMLS CUI [1])
Code List
What is the subject's usual accommodation status?
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)
Item
What was the subject's occupational status at trial entry?
integer
C0014006 (UMLS CUI [1])
Code List
What was the subject's occupational status at trial entry?
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])
Code List
What was the reason for this occupational status?
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])
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])
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])
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])
Item Group
Medication Kit Dispensation
C0013227 (UMLS CUI-1)
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])
Medication kit number
Item
Medication kit number
integer
C2981406 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])

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