|
|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
candidateguid, guid, pseudo_guid, subject_key |
|
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
SUBJECT, abc_comm_src_subject, bid, case_id, catieid, cgi_subid, clinical_barcode, ibisid, id, newid, participant_id, pid, randid, record_id, subj_id, subject_id, subjectid, subjid |
|
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
CGIDate, abc_comm_interview_age, adate, admindate, bl_visit_date, bprs_doa, cgi_date, cgi_i_date_completed, cgiidt, cgis_date, consented_study, datacollecteddate, date_interview_ses, date_of_interview_contact, date_taken, date_time_cgi, intvdate, mg_rs_date, v10_cgii_date, v2_cgii_date, v3_cgii_date, v4_cgii_date, v5_cgii_date, v6_cgii_date, v7_cgii_date, v8_cgii_date, v9_cgii_date, visit_date, visit_date_pgii, visit_date_pgis |
|
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
age, age_m_consent, bslage, candidate_age_in_months, ch_age, globage, intvage, v10_cgii_age, v2_cgii_age, v3_cgii_age, v4_cgii_age, v5_cgii_age, v6_cgii_age, v7_cgii_age, v8_cgii_age, v9_cgii_age |
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
|
M = Male; F = Female; O=Other; NR = Not reported
|
ch_sex, demo_1, gender, sex |
| Query
|
cgi_si |
Integer |
|
Recommended |
Severity of Illness. Considering your total clinical experience with this particular population, how ill is the subject at this time? |
|
CGI: 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. CPEA STAART CGI: All of the above, plus: -7 = Don't know; -8 = Refused to answer; -9 = Does not apply
|
CGISI, bima_17, bprs_sev, cgi001, cgi1, cgi_01, cgi_1, cgi_2, cgi_overall, cgi_s, cgi_severity, cgi_soi, cgia1, cgis, cgis001, cgis_pdd, illness, severity_illness_si_score_si_row |
| Query
|
cgi_si2 |
Integer |
|
Recommended |
Severity of Social Communication Impairment version 2 |
1::7
|
Social communication scale:1 = Normal, no social communication impaired: In high levels of engagement with communication. 2 = Borderline social communication impairment: Easily enters coordinated joint engagement, occasionally slips into supported joint engagement. 3 = Mild social communication impairment: Can engage and communicate, but may be easily distracted, or need occasional adult support to re-engage. Communication attempts are difficult to understand, or predominantly about requests. 4 = Moderate social communication impairment: Needs consistent support to enter in to and/or maintain engagement, with inconsistent spontaneous communication; OR able to engage or communicate with ease but does not do both simultaneously. 5 = Marked social communication impairment: Can communicate about requests only, and does not comment. 6 = Severe social communication impairment: Rarely communicates, and is limited to requests. 7 = Most extreme social communication impairment: No engagement, no communication attemptsMental scale: 1 = Normal, not mentally ill 2 = Borderline mentally ill 3 = Mildly mentally ill 4 = Moderately mentally ill 5 = Markedly mentally ill 6 = Severely mentally ill 7 = Among the most extremely mentally ill
|
|
| Query
|
cgi_sii |
Integer |
|
Recommended |
Global Improvement. Rate the total improvement in the subject's overall function, whether or not, in your judgment, it is due entirely to treatment. Compared to the subject's condition at baseline, how much has the subject changed? |
|
CGI: 0 = Not assessed; 1 = Very much improved (at least 85% improvement); 2 = Much improved (at least 60% improvement); 3 = Improved (greater than 25% improvement); 4 = Minimally improved (at least 20-25% improvement); 5 = No change (between +/- 15% change); 6 = Minimally worse (at least 20-55% worse); 7 = Much worse (at least 60% worse); 8 = Very much worse (at least 80% worse). CPEA STAART CGI: 0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse; -7 = Don't know; -8 = Refused to answer; -9 = Does not apply
|
bima_18, cgi2, cgi_2, cgi_3, cgi_global, cgi_global_imp, cgi_overall_improvement, cgia2, cgia_s, cgii, cgii001, cgii_pdd, cgiiq, cgiiscal, global_improvement_gi_score_gi_row, improve, improvement, v2_cgii |
| Query
|
cgi_siii |
Integer |
|
Recommended |
Select the terms which best describe the degrees of therapeutic effect and side effects |
1::16
|
0 = Not assessed; 1 = No Interference/Marked Improvement; 2 = Slight Interference/Marked Improvement; 3 = Significant Interference/Marked Improvement; 4 = Nullify Therapeutic Effect/Marked Improvement; 5 = No Interference/Moderate Improvement; 6 = Slight Interference/Moderate Improvement; 7 = Significant Interference/Moderate Improvement; 8 = Nullify Therapeutic Effect/Moderate Improvement; 9 = No Interference/Minimal Improvement; 10 = Slight Interference/Minimal Improvement; 11 = Significant Interference/Minimal Improvement; 12 = Nullify Therapeutic Effect/Minimal Improvement; 13 = No Interference/Unchanged or Worse; 14 = Slight Interference/Unchanged or Worse; 15 = Significant Interference/Unchanged or Worse; 16 = Nullify Therapeutic Effect/Unchanged or Worse
|
|
| Query
|
cgi_score_type |
Integer |
|
Recommended |
CGI Score Type |
1::3
|
1 = Scoring range 0 to 7; 2 = Scoring range 0 to 8; 3 = Scoring range 0 to 6
|
|
| Query
|
cgi_sii_0_6 |
Integer |
|
Recommended |
CGI SII 0 - 6 |
0::6
|
0 = Very much worse; 1 = Much worse; 2 = Minimally worse; 3 = No change; 4 = Minimally improved; 5 = Much improved; 6 = Very much improved
|
|
| Query
|
cgi_sii_0_7 |
Integer |
|
Recommended |
CGI SII 0 - 7 Improvment/change |
0::7; 9
|
0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse; 9=NA
|
cgi002, cgi_3, v10_cgii_change, v3_cgii_change, v4_cgii_change, v5_cgii_change, v6_cgii_change, v7_cgii_change, v8_cgii_change, v9_cgii_change |
| Query
|
bafinfo |
Integer |
|
Recommended |
Check if the Assessment was not done. |
0::2
|
0=No; 1=Yes; 2=Unverified
|
CGIINFO, cgi_clinical_global_impression_complete |
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
CGICOM, cgi_si_comments, cgiicmt, cgiicmts, cgiscmts |
| Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
cgi_visit, int1, interval, timept, visit_name, visitlabel, visitnum, vistlabel, vtypbima, vtypbprs |
| Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
CGICODE, cgi_ie_id, cgii_completed_by, cgis_completed_by, mg_rs |
| Query
|
visit_tad |
Integer |
|
Recommended |
SOFTAD visit Note: BSI-Adolescent Self-report missing for TADS assessments. |
1::7
|
1 = Visit 1; 2 = Visit 2; 3 = Visit 3; 4 = Visit 4; 5 = Visit 5; 6 = Visit 6; 7 = Visit 7
|
|
| Query
|
asstyp |
Integer |
|
Recommended |
Assessment type |
1::20
|
1=TADS GATE A; 2=TADS GATE B; 3 = TADS Gate C; 4 = TADS Week 6; 5 = TADS Week 12; 6 = TADS Week 18; 7 = TADS Week 24; 8 = TADS Week 30; 9 = TADS Week 36; 10 = TADS F/U Mo 3; 11 = TADS F/U Mo 6; 12 = TADS F/U Mo 9; 13 = TADS F/U Mo 12; 14 = SOFTAD month 6; 15 = SOFTAD month 12; 16 = SOFTAD month 18; 17 = SOFTAD month 24; 18 = SOFTAD month 30; 19 = SOFTAD month 36; 20 = SOFTAD month 42
|
|
| Query
|
stage |
Integer |
|
Recommended |
Study stage |
|
0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;
|
|
| Query
|
cgimo |
Float |
|
Recommended |
Months from Time 0 to assessment |
|
|
globmo, monfol |
| Query
|
cgistm |
Float |
|
Recommended |
Months from SOFTAD enrollment to asst. |
|
|
globstm |
| Query
|
cgiicat |
Integer |
|
Recommended |
CGI-I Treatment Response Indicator |
0;1
|
0 = CGI-I non-responder 1 = CGI-I responder
|
resp |
| Query
|
cgim |
Integer |
|
Recommended |
CGI. Improvement since the end of treatment |
1::7
|
1 = Very much improved 2 = Much improved 3 = Improved 4 = Unchanged 5 = Worse 6 = Much worse 7 = Very much worse
|
|
| Query
|
cgisu |
Integer |
|
Recommended |
Clinical Global Imprsn.Subst. (CGI-SU) |
1::7
|
1 = Normal, not ill 2 = Borderline ill 3 = Mildly ill4 = Moderately ill 5 = Markedly ill 6 = Severely ill7 = Extremely ill
|
|
| Query
|
bsit0 |
Float |
|
Recommended |
Weeks from Time 0/baseline to assessment |
|
|
cgast0, cgastt0, cgi_week, cgiwksbtw, globt0 |
| Query
|
trttyp |
Integer |
|
Recommended |
Treatment type |
1::3
|
1 = CBT; 2 = PT; 3 = PT and CBT
|
|
| Query
|
sesstyp |
Integer |
|
Recommended |
Session Type |
1;2
|
1 = Office; 2 = Phone
|
|
| Query
|
cgiitrlo |
Integer |
|
Recommended |
ITT Version of Clinical Global Impressions Improvement (LOCF) treatment responder indicatorDerivation Logic: If the patient was missing the Week 6 CGII data then the patient was assigned as a non-responder. If the patient was missing the Week 12 CGII data, the Week 6 CGII LOCF treatment response data was used as the Week 12 response.Similar logic was used to populate the remaining visits out to Month 12. |
1;0
|
1 = CGII treatment responder 0 = CGII treatment non-responder
|
|
| Query
|
cgiilocf |
Integer |
|
Recommended |
ITT Version of Clinical Global Impressions -Improvement (LOCF)Derivation Logic: If the patient was missing the Week 6 CGII data then the patient was assigned with missing data. If the patient was missing the Week 12 CGII data, the Week 6 CGII LOCF data was used as the Week 12 response. Similar logic was used to populate the remaining visits out to Month 12. |
1::7
|
1 = Very much improved 2 = Much improved 3 = Minimally improved 4 = No change 5 = Slightly worse 6 = Much worse 7 = Very much worse
|
|
| Query
|
cgasrat |
Integer |
|
Recommended |
CGAS Clinical Global Assessment Scale Rating |
1::100; -9
|
1 - 10: Needs constant supervision (24-hour care); 11 -20: Needs considerable supervision; 21- 30: Unable to function in almost all areas; 31 - 40: Major impairment in functioning; 41 - 50: Moderate degree of interference in functioning; 51 - 60: Variable functioning with sporadic difficulties; 61-70: Some difficulty in a single area; 71- 80: No more than slight impairment in functioning; 81-90: Good functioning in all areas; 91-100: Superior functioning in all areas; -9=incomplete
|
c_gas_current, cgas_current_range, cgas_score, cgastrat, functioning_score, hp1 |
| Query
|
cgascat |
Integer |
|
Recommended |
CGAS Rating categorized into functional groupings |
1::10
|
1 = 1 � 10; 2 = 11 � 20; 3 = 21 � 30; 4 = 31 � 40; 5 = 41 � 50; 6 = 51 � 60; 7 = 61 � 70; 8 = 71 � 80; 9 = 81 � 90; 10 = 91 � 100
|
cgas1, cgastcat |
| Query
|
pesqcrit |
Float |
|
Recommended |
Adolescent age: 19-year criterion |
0;1
|
0 = Under 19.0; 1 = 19.0 or older
|
|
| Query
|
gafrat |
Float |
|
Recommended |
GAF rating |
1::100; -9
|
Rating Notes: 1-10: Persistent danger of severely hurting self or others; 11-20: Some danger of hurting self or others; 21-30: Inability to function in almost all areas; 31-40: Major impairment in several areas; 41-50: Serious symptoms; 51-60: Moderate symptoms 61-70: Some mild symptoms; 71-80: No more than slight impairment; 81-90: Absent or minimal symptoms; 91 100: Superior functioning;-9=missing
|
c_gaf_current, gaf_01, gaf_score, gafc |
| Query
|
gafcat |
Integer |
|
Recommended |
GAF category |
1::10
|
1 = 1-10; 2 = 11-20; 3 = 21-30; 4 = 31-40; 5 = 41-50; 6 = 51-60; 7 = 61-70; 8 = 71-80; 9 = 81-90; 10 = 91-100
|
|
| Query
|
glob_fm |
Integer |
|
Recommended |
Global functioning form |
1::3
|
1=CGAS; 2=GAF; 3=Both
|
|
| Query
|
globrat |
Float |
|
Recommended |
Global functioning rating (CGAS/GAF) |
1::100
|
|
|
| Query
|
globcat |
Integer |
|
Recommended |
Global functioning category (CGAS/GAF) |
1::10
|
1 = 1-10; 2 = 11-20; 3 = 21-30; 4 = 31-40; 5 = 41-50; 6 = 51-60; 7 = 61-70; 8 = 71-80; 9 = 81-90; 10 = 91-100
|
|
|
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_no, site_uid, siteid |
|
|
dsmvers |
String |
10
|
Recommended |
version/name of assessment |
|
|
form_name |
|
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
| Query
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid, session |
| Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
cgi_complete, formcomp, frmcomp, tststfld |
| Query
|
cgi_efficacy_te |
Float |
|
Recommended |
Efficacy Index - Therapeutic Effect: Rate this item on the basis of drug effect only. Select the terms that best describe the degrees of therapeutic effect and side effects |
0 :: 4
|
0=Not Assessed; 1=Marked - Vast improvement. Complete or nearly complete remission of all symptoms; 2=Moderate - Decided improvement. Partial remission of all symptoms; 3=Minimal - slight improvement which doesn't alter status of care of subject; 4=Unchanged or worse
|
cgi_ther_eect |
| Query
|
cgi_efficacy_se |
Integer |
|
Recommended |
Efficacy Index - Side Effects: Rate this item on the basis of drug effect only. Select the terms that best describe the degrees of therapeutic effect and side effects |
0 :: 4
|
0=Not Assessed; 1=None; 2=Dos not significanly interfere with subject's functioning; 3=Significanly interfere with subject's functioning; 4=Outweighs therapeutic effect
|
|
| Query
|
trt_grp |
String |
10
|
Recommended |
Treatment Group Assignment |
1;1AO;1CT;2; 3;4;5;6;7;8;9;10;11;12; O; P; CCA; GCT; TCT; TAU; CGC; ESDM; NA; EG
|
1=Group 1 first 8 weeks; 2=Group 2; 3=Group 3; 4 =active; 5=sham; 6=none; 7=ESDM High intensity; 8=ESDM Low intensity; 9=EIBI High intensity; 10=EIBI Low intensity; ESDM = Early Start Denver Model; EIBI = Early and Intensive Behavioral Intervention; 11 = Navigator; 12 = Care manager; 13=Waitlist Control; 14=Treatment; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; O=Oxytocin; P=Placebo; CCA=Community Control Arm; GCT=Generalized Cognitive Training; TCT=Targeted Cognitive Training; TAU=Treatment as Usual; CGC = Computer Games Control; NA=not assigned to treatment group; EG= Experimental Group
|
|
| Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
bsldays, cgidays, cgidaysbtw, gafdays |
| Query
|
etype |
String |
10
|
Recommended |
Rating Period |
BSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16
|
BSL=Baseline; WK1-WK16=Weeks 1-16
|
|
| Query
|
respond_detail_oth_spec |
String |
255
|
Recommended |
Respondent details |
|
|
informnt |
| Query
|
relationship |
Integer |
|
Recommended |
Relationship of respondent to individual |
|
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 90=Other; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent; 94 = Co-worker
|
infrmnt2 |
| Query
|
cgimania1 |
Integer |
|
Recommended |
Severity of Mania during the past week |
1::7
|
1=normal-not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=very severely ill
|
cgi_manic, cgi_s_mania, pgi_s_mania |
| Query
|
cgidepr1 |
Integer |
|
Recommended |
Severity of depression during the past week |
1::7
|
1=normal-not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=very severely ill
|
cgi_depressive, cgi_s_depression, pgi_s_depression |
| Query
|
cgioverall1 |
Integer |
|
Recommended |
Severity of overall bipolar illness during the past week |
1::7
|
1=normal-not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=very severely ill
|
cgi_s_overall_bipolar_illness, pgi_s_overall_bipolar |
| Query
|
cgimania2 |
Integer |
|
Recommended |
Change from baseline week - mania |
1::8
|
1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
|
cgi_i_mania, pgi_i_mania, pgi_i_overall_bipolar |
| Query
|
cgidepr2 |
Integer |
|
Recommended |
Change from baseline week - depression |
1::8
|
1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
|
cgi_i_depression, pgi_i_depression |
| Query
|
cgioverall2 |
Integer |
|
Recommended |
Change from baseline week - overall bipolar illness |
1::8
|
1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
|
cgi_i_overall_bipolar_illness |
| Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
| Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
cgia0b, daycgi |
| Query
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
redcap_event_name, vers |
|
|
subject_description |
String |
4,000
|
Recommended |
Subject related information (e.g the affection, phenotype, disease information, etc.). |
|
|
|
| Query
|
blcgis |
Integer |
|
Recommended |
baseline clinical global impressions severity |
1;2;3;4;5;6
|
1=Normal, not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill
|
|
| Query
|
chcgis |
Integer |
|
Recommended |
Change from baseline in Clinical Global Impressions Severity |
-10::10
|
|
|
| Query
|
cgicw |
Integer |
|
Recommended |
Substantial deterioration on CGI scale |
0;1
|
0=No; 1=Yes
|
|
| Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
studyday, visitdt |
| Query
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
| Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
| Query
|
cgis_adh |
Integer |
|
Recommended |
Symptoms of ADHD significant |
0;1
|
0=No; 1=Yes
|
|
| Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
| Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
| Query
|
last1 |
Integer |
|
Recommended |
Flag Last Phase 1/1A Visit |
|
1=Yes for all records meeting this criteria
|
|
| Query
|
last2 |
Integer |
|
Recommended |
Flag Last Phase 2 Visit |
|
1=Yes for all records meeting this criteria
|
|
| Query
|
last3 |
Integer |
|
Recommended |
Flag Last Phase 3 Visit |
|
1=Yes for all records meeting this criteria
|
|
| Query
|
lastoc |
Integer |
|
Recommended |
Flag Last Open Choice Phase Visit |
1
|
1=Yes for all records meeting this criteria
|
|
| Query
|
base1 |
Integer |
|
Recommended |
Flag Baseline Phase 1/1A Visit |
|
1=Yes for all records meeting this criteria
|
|
| Query
|
base2 |
Integer |
|
Recommended |
Flag Baseline Phase 2 Visit |
|
1=Yes for all records meeting this criteria
|
|
| Query
|
base3 |
Integer |
|
Recommended |
Flag Baseline Phase 3 Visit |
|
1=Yes for all records meeting this criteria
|
|
| Query
|
baseoc |
Integer |
|
Recommended |
Flag Baseline Open
Choice Phase Visit |
1
|
1=Yes for all records meeting this criteria
|
|
| Query
|
phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
|
|
|
| Query
|
cgicresp |
Integer |
|
Recommended |
CGIC Response |
0;1
|
1= when cgi_sii is 1, 2, or 4; 0= when cgi_sii is 5, 6, 7, or 8; blank= when cgi_sii is missing
|
|
| Query
|
visnum |
Float |
|
Recommended |
Numeric Visit Number |
|
-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
|
cgii_visit_number, cgis_visit_number, pggii_visit_number, pgis_visit_number, visitnumber |
| Query
|
b2_cgic |
Integer |
|
Recommended |
Phase 2 Baseline CGIC |
|
|
|
| Query
|
b2_resp |
Integer |
|
Recommended |
Phase 2 Baseline CGIC Response |
|
|
|
| Query
|
boc_cgic |
Integer |
|
Recommended |
Phase 4 Baseline CGIC |
|
|
|
| Query
|
boc_resp |
Integer |
|
Recommended |
Phase 4 Baseline CGIC Response |
|
|
|
| Query
|
b3_cgic |
Integer |
|
Recommended |
Phase 3 Baseline CGIC |
|
|
|
| Query
|
b3_resp |
Integer |
|
Recommended |
Phase 3 Baseline CGIC Response |
|
|
|
| Query
|
cgither |
Integer |
|
Recommended |
Role of Therapist Completing Clinical Global Impressions |
0::2
|
0 = IE (Independent Evaluator);1 = PT (Pharmacotherapist);2 = CBT (Cognitive Behavioral Therapist)
|
|
| Query
|
cgi_exresp |
Integer |
|
Recommended |
Excellent Response |
0;1
|
0 = responder (CGI-I =1);1 = nonresponder (CGI-I > 1)
|
|
| Query
|
resp36 |
Integer |
|
Recommended |
treatment responder status based on CGI-I <=2 |
0;1
|
0 = non-responder; 1 = responder
|
|
| Query
|
imputation |
Integer |
|
Recommended |
Indicator noting imputed data set number |
1::20
|
|
|
| Query
|
gafyear |
Integer |
|
Recommended |
GAF score past year |
0::100
|
Rating Notes: 1-10: Persistent danger of severely hurting self or others; 11-20: Some danger of hurting self or others; 21-30: Inability to function in almost all areas; 31-40: Major impairment in several areas; 41-50: Serious symptoms; 51-60: Moderate symptoms 61-70: Some mild symptoms; 71-80: No more than slight impairment; 81-90: Absent or minimal symptoms; 91 100: Superior functioning;
|
gaf_02 |
| Query
|
dataquality |
Integer |
|
Recommended |
Data quality |
0::5
|
0=No data (cancelled); 1=Data entered but only once, has missing data; 2=Data entered but only once, no missing data; 3=Double entered; 4=Data frozen for cleaning; 5=Data clean/locked
|
|
| Query
|
elig_inclusion_check |
Integer |
|
Recommended |
Checks for a pass/fail on Elig for Inclusion |
0::3
|
0=Failed (Ineligible); 1=Passed (Eligible); 2=In screening; 3=NA
|
|
| Query
|
subjecttype |
String |
20
|
Recommended |
Subject Type |
Control;Prodromal; Enhanced; Non-Enhanced
|
|
|
| Query
|
gaf1a |
Integer |
|
Recommended |
Participant report-Symptom Scale Score |
|
|
|
| Query
|
gaf1b1 |
Integer |
|
Recommended |
Participant report-Occupational Functioning Scale Score |
|
|
|
| Query
|
gaf1b2 |
Integer |
|
Recommended |
Participant report-Occupation |
1::3
|
1 = Worker;2 = Student;3 = Homemaker
|
|
| Query
|
gaf1c |
Integer |
|
Recommended |
Participant report-Social Functioning Scale Score |
|
|
|
| Query
|
gaf2a |
Integer |
|
Recommended |
Participant and clinician report-Symptom Scale Score |
|
|
mg_ss, overall_gaf |
| Query
|
gaf2b1 |
Integer |
|
Recommended |
Participant and clinician report-Occupational Functioning Scale Score |
|
|
mg_os2, mg_os3, mg_os4, occupational_gaf |
| Query
|
gaf2b2 |
Integer |
|
Recommended |
Participant and clinician report-Occupation |
1::3
|
1 = Worker;2 = Student;3 = Homemaker
|
mg_os1 |
| Query
|
gaf2c |
Integer |
|
Recommended |
Participant and clinician report-Social Functioning Scale Score |
|
|
mg_sf, social_gaf |
| Query
|
gaf3 |
Integer |
|
Recommended |
Currently in remission |
0;1
|
0=No; 1=Yes
|
|
| Query
|
gaf3a |
Integer |
|
Recommended |
Duration of remission |
|
Months
|
|
| Query
|
intrt |
Integer |
|
Recommended |
Treatment Status Code |
0::2
|
0=Baseline; 1=In Treatment; 2=In Follow-up
|
|
| Query
|
trtgrp_p |
Integer |
|
Recommended |
Treatment Group |
1;2
|
1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
|
|
| Query
|
days_visit1 |
Integer |
|
Recommended |
Days from Visit 1 |
|
|
dav1bima, dav1bprs |
| Query
|
trtgroup |
String |
2
|
Recommended |
Treatment Group |
N1;N2;R1;R2;R3
|
N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
|
|
| Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
| Query
|
sitedatasource_1 |
Integer |
|
Recommended |
Source of Data: Site |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrcr |
| Query
|
sitedatasource_phone |
Integer |
|
Recommended |
Source of Data: Telephone |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infoscrct |
| Query
|
sitedatasource_physician |
Integer |
|
Recommended |
Source of Data: Physician |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infoscrp |
| Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
enrolled |
| Query
|
confidence_lvl |
Integer |
|
Recommended |
Confidence Level |
1::4
|
1=Very Confident;2=Somewhat confident;3=Some reservations;4=Severe reservations
|
cgiconf |
| Query
|
comments |
String |
4,000
|
Recommended |
Comments about assessment |
|
|
cgi_notesexpanded, cgi_sii_comments |
| Query
|
cgi_worstmania |
Integer |
|
Recommended |
CGI- Change from worst phase of illness, mania |
1::8
|
1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
|
|
| Query
|
cgi_worstdepr |
Integer |
|
Recommended |
CGI- Change from worst phase of illness, depression |
1::8
|
1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
|
|
| Query
|
cgi_worstoverall |
Integer |
|
Recommended |
CGI- Change from worst phase of illness, overall bipolar |
1::8
|
1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
|
|
| Query
|
sideeffect |
Integer |
|
Recommended |
Side effects |
1;2
|
1=Present; 2=Not present
|
|
|
|
medication_name |
String |
255
|
Recommended |
Name of medication |
|
|
|
| Query
|
assessment_type |
Integer |
|
Recommended |
Assessment Type |
1::3
|
1 = Admission; 2 = Acute; 3 = Prophylactic
|
|
| Query
|
mood_trialentry |
Integer |
|
Recommended |
Mood State at Trial Entry |
1::5
|
1 = Depressed; 2 = Euthymic; 3 = Dysphoric Mania; 4 = Euphoric Mania; 5 = Cycling
|
|
|
|
moodstate_length |
String |
20
|
Recommended |
Length of time in mood state |
|
|
|
| Query
|
saps_ad10 |
Integer |
|
Recommended |
Rater number |
|
|
|
| Query
|
vis_scale_change |
Integer |
|
Recommended |
Visual
Scale
of
Participant
Change |
|
90=Very much better: Pt is very much more interactive or is much less inappropriate, may have many fewer or less concerning problem behaviors, functioning is much better than at week 0, usually in multiple settings.; 75=Much better: Pt is markedly more interactive or less socially inappropriate, problem behaviors may be clearly better, functioning in at least one setting is significantly better than at week 0. May consider reducing supports or increasing demands.; 50=Somewhat better: Pt is somewhat more interactive or less inappropriate on multiple occasions, problem behaviors may be modestly better in some settings, & functioning at times is clearly better than at week 0.; 25=Slightly better: Pt is sometimes slightly more interactive or less inappropriate or clearly better on 1 or 2 minor occasions, problem behaviors might be slightly better on a few occasions. Overall functioning is not meaningfully different from week 0.; 0=No meaningful changes: Variations in interaction and problem behaviors are within typical range for pt.; -25=Slightly worse: Pt is sometimes slightly less interactive or more inappropriate or notably worse on 1 or 2 occasions, problem behaviors might be slightly worse infrequently. Overall functioning is not meaningfully different from week 0.; -50=Somewhat worse: Pt is somewhat less interactive or more inappropriately interactive on multiple occasions, problem behaviors may be more frequent or intense in some settings, & functioning at times is clearly less good than at week 0. ; -75=Much worse: Pt is markedly less interactive or more inappropriately interactive, problem behaviors may be significantly worse , more support would be helpful, functioning in at least one setting is significantly worse than at week 0; -90=Very much worse: Pt is very much less interactive or extremely more inappropriately interactive, may have significantly worse problem behaviors, and urgently needs higher levels of support to function as at week 0
|
participant_change_value_mm |
| Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|
| Query
|
cgi_3s |
Integer |
|
Recommended |
Domain: Occupation/Education CGI-Severity |
0::7; -999
|
0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients; -999=missing
|
|
| Query
|
cgi_3i |
Integer |
|
Recommended |
Domain: Occupation/Education CGI-Improvement |
0::7;-999
|
0= Not assessed; 1=Very much improved; 2= Much improved; 3=Minimally improved; 4= No change; 5= Minimally worse; 6=Much worse; 7= Very much worse; -999=missing
|
|
| Query
|
cgi_4s |
Integer |
|
Recommended |
Domain: Social/Peer CGI-Severity |
0::7; -999
|
0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients; -999=missing
|
|
| Query
|
cgi_4i |
Integer |
|
Recommended |
Domain: Social/Peer CGI-Improvement |
0::7;-999
|
0= Not assessed; 1=Very much improved; 2= Much improved; 3=Minimally improved; 4= No change; 5= Minimally worse; 6=Much worse; 7= Very much worse; -999=missing
|
|
| Query
|
cgi_5s |
Integer |
|
Recommended |
Domain: Independent Living/Daily Functioning CGI-Severity |
0::7; -999
|
0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients; -999=missing
|
|
| Query
|
cgi_5i |
Integer |
|
Recommended |
Domain: Independent Living/Daily Functioning CGI-Improvement |
0::7;-999
|
0= Not assessed; 1=Very much improved; 2= Much improved; 3=Minimally improved; 4= No change; 5= Minimally worse; 6=Much worse; 7= Very much worse; -999=missing
|
|
| Query
|
monthsbl |
Float |
|
Recommended |
Actual number of months from Baseline |
|
|
|
| Query
|
gafhigh |
Integer |
|
Recommended |
GAF Highest past level since last follow-up |
1::100; 999
|
1-10 = Persistent danger of severely hurting self or others (e.g., recurrent violence) OR persistent inability to maintain minimal personal hygiene OR serious suicidal act with clear expectation of death.; 11-20 = Some danger of hurting self or others (e.g., suicide attempts without clear expectiation of death; frequently violent; manic excitement) OR occasionally fails to maintain minimal personal hygiene (e.g., smears feces) OR gross impairment in communication (e.g., largely incoherent or mute).; 21-30 = Behavior is considerably influenced by delusions or hallucinations OR serious impairment in communication or judgment (e.g., sometimes incoherent, acts grossly inappropriately, suicidal preoccupation) OR inability to function in almost all areas (e.g., stays in bed all day, no job, home, or friends).; 31-40 = Some impairment in reality testing or communication (e.g., speech is at times illogical, obscure, or irrelevant) OR major impairment in several areas, such as work or school, family relations, judgment, thinking, or mood (e.g., depressed man avoids friends, neglects family, and is unable to work; child frequently beats up younger children, is defiant at home, and is failing at school).; 41-50 = Serious symptoms (e.g., suicidal ideation, severe obsessional rituals, frequent shoplifting) OR any serious impairment in social, occupational, or school functioning (e.g., no friends, unable to keep a job).; 51-60 = Moderate symptoms (e.g., flat affect and circumstantial speech, occasional panic attacks) OR moderate difficulty in social, occupational, or school functioning (e.g., few friends, conflicts with peers or co-workers).; 61-70 = Some mild symptoms (e.g., depressed mood and mild insomnia) OR some difficulty in social, occupational, or school functioning (e.g., occasional truancy, or theft within the household), but generally functioning pretty well, has some meaningful interpersonal relationships.; 71-80 = If symptoms are present, they are transient and expectable reactions to psychosocial stressors (e.g., difficulty concentrating after family argument); no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).; 81-90 = Absent or minimal symptoms (e.g., mild anxiety before an exam), good functioning in all areas, interested and involved in a wide range of activities, socially effective, generally satisfied with life, no more than everyday problems or concerns (e.g., an occasional argument with family members.; 91-100 = Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. No symptoms.; 999 = Missing
|
|
| Query
|
me2 |
Integer |
|
Recommended |
Status |
0;1
|
0 = Past [Inactive]; 1 = Active
|
|
| Query
|
cgi_parent |
Integer |
|
Recommended |
Global Severity: Considering your total experience with this child, how much difficulty is he or she experiencing at this time? |
0::7
|
0=Not Assessed; 1=No Difficulties; 2=Minimal Difficulties; 3=Mild Difficulties; 4=Moderate Difficulties; 5=Marked Difficulties; 6=Severe Difficulties; 7=Very Severe Difficulties
|
|
| Query
|
msp1 |
Integer |
|
Recommended |
CGAS Rating: Most severe past episode |
1::100
|
1-10 = Needs constant supervision (24-hour care) due to severely aggressive or self-destructive behavior or gross impairment in reality testing, communication, cognition, affect, or personal hygiene.; 11-20 = Needs considerable supervision to prevent hurting others or self, e.g., frequently violent repeated suicide attempts OR gross impairment in all forms of communication, e.g., severe abnormalities in verbal and gestural communication, marked social aloofness, stupor, etc.; 21-30 = Unable to function in almost all areas, e.g., stays at home, in ward or in bed all day without taking part in social activities OR severe impairment in communication (e.g., sometimes incoherent or inappropriate).; 31-40 = Major impairment in functioning in several areas and unable to function in one of those areas, i.e., disturbed at home, at school, with peers, or in the society at large, e.g., persistent aggression without clear instigation; markedly withdrawn and isolated behavior due to either mood or thought disturbance; suicidal attempts with clear lethal intent. Such children are likely to require a special schooling and/or hospitalization or withdrawal from school (but this is not a sufficient criterion for inclusion in this category).; 41-50 = Moderate degree of interference in functioning in most social areas or severe impairment of functioning in one area, such as might result from, for example, suicidal preoccupations and ruminations, school refusal, and other forms of anxiety, obsessive rituals, major conversion symptoms, frequent anxiety attacks, frequent episodes of aggressive or other anti-social behavior with some preservation of meaningful social relationships.; 51-60 = Variable functioning with sporadic difficulties or symptoms in several but not all social areas. Disturbance would be apparent to those who encounter the child in a dysfunctional setting or time but not to those who see the child in other settings.; 61-70 = Some difficulty in a single area, but generally functioning pretty well (e.g., sporadic or isolated antisocial acts, such as occasionally playing hooky or petty theft; consistent minor difficulties with school work, mood changes of brief duration; fears and anxieties which do not lead to gross
avoidance behavior, self-doubts). Has some meaningful interpersonal relationships. Most people who do not know the child well would not consider him/her deviant but those who do know him/her might well express concern.; 71-80 = No more than slight impairment in functioning at home, at school, or with peers. Some disturbance of
behavior or emotional distress may be present in response to life stresses (e.g., parental separations, deaths, birth of a sib) but these are brief and interference with functioning is transient. Such children are only minimally disturbing to others and are not considered deviant by those who know them.; 81-90 = Good functioning in all areas. Secure in family, school and with peers. There may be transient difficulties and "everyday" worries that occasionally get out of hand (e.g., mild anxiety associated with
an important exam, occasionally "blow-up" with siblings, parents or peers).; 91-100 = Superior functioning in all areas (at home, at school and with peers), involved in a range of activities and has many interests (e.g., has hobbies or participates in extracurricular activities or belongs to an organized group such as Scouts, etc.) Likeable, confident, "everyday" worries never get out of hand. Doing well in school. No symptoms.
|
c_gas_msp, num_severe_cgas |
| Query
|
cur1 |
Integer |
|
Recommended |
CGAS Rating: Past year highest level of functioning |
1::100
|
1-10 = Needs constant supervision (24-hour care) due to severely aggressive or self-destructive behavior or gross impairment in reality testing, communication, cognition, affect, or personal hygiene.; 11-20 = Needs considerable supervision to prevent hurting others or self, e.g., frequently violent repeated suicide attempts OR gross impairment in all forms of communication, e.g., severe abnormalities in verbal and gestural communication, marked social aloofness, stupor, etc.; 21-30 = Unable to function in almost all areas, e.g., stays at home, in ward or in bed all day without taking part in social activities OR severe impairment in communication (e.g., sometimes incoherent or inappropriate).; 31-40 = Major impairment in functioning in several areas and unable to function in one of those areas, i.e., disturbed at home, at school, with peers, or in the society at large, e.g., persistent aggression without clear instigation; markedly withdrawn and isolated behavior due to either mood or thought disturbance; suicidal attempts with clear lethal intent. Such children are likely to require a special schooling and/or hospitalization or withdrawal from school (but this is not a sufficient criterion for inclusion in this category).; 41-50 = Moderate degree of interference in functioning in most social areas or severe impairment of functioning in one area, such as might result from, for example, suicidal preoccupations and ruminations, school refusal, and other forms of anxiety, obsessive rituals, major conversion symptoms, frequent anxiety attacks, frequent episodes of aggressive or other anti-social behavior with some preservation of meaningful social relationships.; 51-60 = Variable functioning with sporadic difficulties or symptoms in several but not all social areas. Disturbance would be apparent to those who encounter the child in a dysfunctional setting or time but not to those who see the child in other settings.; 61-70 = Some difficulty in a single area, but generally functioning pretty well (e.g., sporadic or isolated antisocial acts, such as occasionally playing hooky or petty theft; consistent minor difficulties with school work, mood changes of brief duration; fears and anxieties which do not lead to gross
avoidance behavior, self-doubts). Has some meaningful interpersonal relationships. Most people who do not know the child well would not consider him/her deviant but those who do know him/her might well express concern.; 71-80 = No more than slight impairment in functioning at home, at school, or with peers. Some disturbance of
behavior or emotional distress may be present in response to life stresses (e.g., parental separations, deaths, birth of a sib) but these are brief and interference with functioning is transient. Such children are only minimally disturbing to others and are not considered deviant by those who know them.; 81-90 = Good functioning in all areas. Secure in family, school and with peers. There may be transient difficulties and "everyday" worries that occasionally get out of hand (e.g., mild anxiety associated with
an important exam, occasionally "blow-up" with siblings, parents or peers).; 91-100 = Superior functioning in all areas (at home, at school and with peers), involved in a range of activities and has many interests (e.g., has hobbies or participates in extracurricular activities or belongs to an organized group such as Scouts, etc.) Likeable, confident, "everyday" worries never get out of hand. Doing well in school. No symptoms.
|
num_year_cgas |
| Query
|
gaf7 |
Integer |
|
Recommended |
GAF Functioning: for week of POOREST functioning in past month |
0::100
|
90 - 81: Good functioning in all areas, no more than everyday problems or concerns; 80 - 71: No more than slight impairment in social/occupational/school functioning; 70 - 61: Some difficulty in social/occupational/school functioning; 60 - 51: Moderate difficulty in social/occupational/school functioning; 50 - 41: Any serious impairment in social/occupational/school functioning; 40 - 31: Major impairment in several areas; 30 - 21: Inability to function in almost all areas; 20 - 11: Some danger of hurting self or others, OR occasionally fails to maintain minimal personal hygiene, OR gross impairment in communication; 10 - 1: Persistent danger of severely hurting self or others OR persistent inability to maintain minimal personal hygiene
|
|
| Query
|
gaf8 |
Integer |
|
Recommended |
Overall GAF: for week of POOREST functioning in past month |
0::100
|
90 - 81: Absent or minimal symptoms (e.g., mild anxiety before an exam), good functioning in all areas; 80 - 71: If symptoms are present, they are transient and expectable reactions to psychosocial stressors (e.g., difficulty concentrating after family argument), no more than slight impairment; 70 - 61: Some mild symptoms (e.g., depressed mood and mild insomnia) OR some difficulty in social, occupational, or school functioning; 60 - 51: Moderate symptoms OR moderate difficulty in social/occupational/school functioning; 50 - 41: Serious symptoms OR any serious impairment in social/occupational/school functioning; 40 - 31: Some impairment in reality testing or communication OR major impairment in several areas (e.g., work, school, family, judgment, thinking, or mood); 30 - 21: Behavior is considerably influenced by delusions or hallucinations OR serious impairment in communication or judgment, OR inability to function in almost all areas; 20 - 11: Some danger of hurting self or others OR occasionally fails to maintain minimal personal hygiene, OR gross impairment in communication; 10 - 1: Persistent danger of severely hurting self or others, OR persistent inability to maintain minimal personal hygiene
|
|
| Query
|
gaf10 |
Integer |
|
Recommended |
GAF Functioning: for month of BEST functioning in past YEAR |
0::100
|
90 - 81: Good functioning in all areas, no more than everyday problems or concerns; 80 - 71: No more than slight impairment in social/occupational/school functioning; 70 - 61: Some difficulty in social/occupational/school functioning; 60 - 51: Moderate difficulty in social/occupational/school functioning; 50 - 41: Any serious impairment in social/occupational/school functioning; 40 - 31: Major impairment in several areas; 30 - 21: Inability to function in almost all areas; 20 - 11: Some danger of hurting self or others, OR occasionally fails to maintain minimal personal hygiene, OR gross impairment in communication; 10 - 1: Persistent danger of severely hurting self or others OR persistent inability to maintain minimal personal hygiene
|
|
| Query
|
num_two_weeks_severe |
Integer |
|
Recommended |
On a scale from 1-100, with 100 being the highest level of functioning, please rate the child's general functioning in the past two weeks |
1::100
|
100-91=Superior functioning in all areas; 90-81 = Good functioning in all areas; 80 -71 = No more than slight impairment in functioning at home, at school, or with peers; 70-61 = Some difficulty in a single area, but generally functioning pretty well; 60-51= Variable functioning with sporadic difficulties ; 50 -41= Moderate degree of interference in functioning in most social areas; 40-31 = Major impairment in functioning in several areas; 30-21 = Unable to function in almost all areas; 20 - 11= Needs considerable supervision to prevent hurting others and self; 10 - 1= Needs constant supervision
|
c_gaf_past2wk |
| Query
|
cgi_depressive_improvement |
Integer |
|
Recommended |
Level of depressive symptom improvement |
0::7
|
0= Not assessed; 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse
|
|
| Query
|
cgi_manic_improvement |
Integer |
|
Recommended |
Level of manic symptom improvement |
0::7
|
0= Not assessed; 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse
|
|
| Query
|
cgi_ther_eect_assess |
Integer |
|
Recommended |
Therapeutic effect assessment: |
0;1
|
0= Not Assessed; 1= Assessed
|
|
| Query
|
cgi_4 |
Integer |
|
Recommended |
Side effects (marked): |
0::3
|
0= None; 1= Do not significantly interfere with patient's functioning; 2= Significantly interferes with patient's functioning; 3= Outweighs therapeutic effect
|
|
| Query
|
cgi_5 |
Integer |
|
Recommended |
Side effects (moderate): |
0::3
|
0= None; 1= Do not significantly interfere with patient's functioning; 2= Significantly interferes with patient's functioning; 3= Outweighs therapeutic effect
|
|
| Query
|
cgi_6 |
Integer |
|
Recommended |
Side effects (minimal): |
0::3
|
0= None; 1= Do not significantly interfere with patient's functioning; 2= Significantly interferes with patient's functioning; 3= Outweighs therapeutic effect
|
|
| Query
|
cgi_7 |
Integer |
|
Recommended |
Side effects (unchanged or worse): |
0::3
|
0= None; 1= Do not significantly interfere with patient's functioning; 2= Significantly interferes with patient's functioning; 3= Outweighs therapeutic effect
|
|
|
|
globimp |
Integer |
|
Recommended |
Global Improvement 9-point scale |
1::9
|
1 = Very much improved 2 = Much improved; 3 = Moderately improved; 4 = Minimally improved; 5 = No change; 6 = Minimally worse; 7 = Moderately worse; 8 = Much worse 9 = Very much worse
|
bprs_glob |
|
|
c_gas_msp_dep |
Integer |
|
Recommended |
CGAS Clinical Global Assessment Scale Rating - Most Severe Past for Depressive episodes |
1::100;-999;777;888
|
1 - 10= Needs constant supervision (24-hour care); 11 -20= Needs considerable supervision; 21- 30= Unable to function in almost all areas; 31 - 40= Major impairment in functioning; 41 - 50= Moderate degree of interference in functioning; 51 - 60= Variable functioning with sporadic difficulties; 61-70= Some difficulty in a single area; 71- 80= No more than slight impairment in functioning; 81-90= Good functioning in all areas; 91-100= Superior functioning in all areas; -999= N/A ; 777= Refused ; 888= Missing
|
|
|
|
c_gas_msp_manic |
Integer |
|
Recommended |
CGAS Clinical Global Assessment Scale Rating - Most Severe Past for Manic episodes |
1::100;-999;777;888
|
1 - 10= Needs constant supervision (24-hour care); 11 -20= Needs considerable supervision; 21- 30= Unable to function in almost all areas; 31 - 40= Major impairment in functioning; 41 - 50= Moderate degree of interference in functioning; 51 - 60= Variable functioning with sporadic difficulties; 61-70= Some difficulty in a single area; 71- 80= No more than slight impairment in functioning; 81-90= Good functioning in all areas; 91-100= Superior functioning in all areas; -999= N/A ; 777= Refused ; 888= Missing
|
|
|
|
c_gaf_msp_dep |
Integer |
|
Recommended |
Global Assessment of Functioning (GAF) Scale - Most Severe Past for Depressive episodes |
1::100;-999;777;888
|
1 - 10: Persistent danger of severely hurting self or others (e.g., recurrent violence); 11 - 20: Some danger of hurting self or others; 21 - 30: Behavior is considerably influenced by delusions or hallucinations; 31 - 40: Some impairment in reality testing or communication; 41 - 50: Serious symptoms; 51 - 60: Moderate symptoms; 61 - 70: Some mild symptoms; 71 - 80: If symptoms are present, they are transient and expectable reactions to psychosocial stressors; 81 - 90: Absent or minimal symptoms; 91 - 100: Superior functioning in a wide range of activities,; -999= N/A ; 777= Refused ; 888= Missing;
|
|
|
|
c_gaf_msp_manic |
Integer |
|
Recommended |
Global Assessment of Functioning (GAF) Scale - Most Severe Past for Manic episodes |
1::100;-999;777;888
|
1 - 10: Persistent danger of severely hurting self or others (e.g., recurrent violence); 11 - 20: Some danger of hurting self or others; 21 - 30: Behavior is considerably influenced by delusions or hallucinations; 31 - 40: Some impairment in reality testing or communication; 41 - 50: Serious symptoms; 51 - 60: Moderate symptoms; 61 - 70: Some mild symptoms; 71 - 80: If symptoms are present, they are transient and expectable reactions to psychosocial stressors; 81 - 90: Absent or minimal symptoms; 91 - 100: Superior functioning in a wide range of activities,; -999= N/A ; 777= Refused ; 888= Missing;
|
|
|
|
c_gaf_msp |
Integer |
|
Recommended |
Global Assessment of Functioning (GAF) Scale - Most Severe Past |
1::100;-999;777;888
|
1 - 10: Persistent danger of severely hurting self or others (e.g., recurrent violence); 11 - 20: Some danger of hurting self or others; 21 - 30: Behavior is considerably influenced by delusions or hallucinations; 31 - 40: Some impairment in reality testing or communication; 41 - 50: Serious symptoms; 51 - 60: Moderate symptoms; 61 - 70: Some mild symptoms; 71 - 80: If symptoms are present, they are transient and expectable reactions to psychosocial stressors; 81 - 90: Absent or minimal symptoms; 91 - 100: Superior functioning in a wide range of activities,; -999= N/A ; 777= Refused ; 888= Missing;
|
|
|
|
c_gas_past2wk |
Integer |
|
Recommended |
CGAS Clinical Global Assessment Scale Rating - Past 2 Weeks |
1::100;-999;777;888
|
1 - 10= Needs constant supervision (24-hour care); 11 -20= Needs considerable supervision; 21- 30= Unable to function in almost all areas; 31 - 40= Major impairment in functioning; 41 - 50= Moderate degree of interference in functioning; 51 - 60= Variable functioning with sporadic difficulties; 61-70= Some difficulty in a single area; 71- 80= No more than slight impairment in functioning; 81-90= Good functioning in all areas; 91-100= Superior functioning in all areas; -999= N/A ; 777= Refused ; 888= Missing
|
|
|
|
area4_explain |
String |
255
|
Recommended |
Employment situation? Explain briefly |
|
|
occupation |
|
|
time_point |
Integer |
|
Recommended |
Assessment time point |
|
1=Baseline (STARD); 2=Level exit (STARD); 3= Quarterly follow up (STARD);5= Screening; 10= Baseline; 21, 22, 23 = Mid-point 1, 2, 3; 30= End-of-treatment; 41, 42, 43= Follow-up1, 2, 3 etc.; 601 = 6 Month Reassessment ; 602 = 12 Month Reassessment ; 603 = 18 Month Reassessment
|
assessment |
|
|
gafoccupationscore |
Integer |
|
Recommended |
Assign score based on participant's average level of occupational functioning during the month prior to administration of the tool. |
0::100
|
|
|
|
|
socialfunctiscore |
Integer |
|
Recommended |
Social GAF |
0::100
|
|
|
|
|
gafsymptomscore |
Integer |
|
Recommended |
Assign score based on participant's worst level of functioning during the month prior to the date that the measure is administered |
0::100
|
|
|
|
|
socialscale |
Integer |
|
Recommended |
Please rate the patient''s most impaired level of social functioning in the past month. Rate actual functioning regardless of etiology of social problems. |
0::10
|
10 = Superior social/interpersonal functioning ; 9 = Above average social/interpersonal functioning; 8 = Good social/interpersonal functioning; 7 = Mild problems in social/interpersonal functioning; 6 = Moderate impairment in social/interpersonal functioning; 5 = Serious impairment in social/interpersonal functioning; 4 = Major impairment in social and interpersonal functioning; 3 = Marginal ability to function socially; 2 = Inability to function socially ; 1 = Extreme social isolation
|
|
|
|
retrorating_soc |
Integer |
|
Recommended |
Check here if this is a retrospective rating. |
0;1
|
0 = Unchecked ; 1 = Checked
|
|
|
|
providerdate_soc |
Date |
|
Recommended |
Date when Provider last saw client |
|
MM/DD/YYYY
|
|
|
|
providerrole_soc |
String |
50
|
Recommended |
Role of Provider giving rating |
|
|
|
|
|
rolescale |
Integer |
|
Recommended |
Please rate the patient''s most impaired level of functioning in occupational, educational, and/or homemaker roles, as appropriate, in the past month. Rate actual functioning regardless of etiology of occupational/educational problems. |
0::10
|
10 = Superior role functioning; 9 = Above-average role functioning; 8 = Good role functioning; 7 = Mild impairment in role functioning; 6 = Moderate impairment in role functioning; 5 = Serious Impairment in Role Functioning; 4 = Major impairment in social and interpersonal functioning; 3 = Marginal ability to function; 2 = Inability to function; 1 = Extreme role dysfunction
|
|
|
|
retro_rating_role |
Integer |
|
Recommended |
Check here if this is a retrospective rating. |
0;1
|
0 = Unchecked ; 1 = Checked
|
|
|
|
cgi_efficacy_oa |
Float |
|
Recommended |
Efficacy Index-Overall |
0.25; 0.33; 0.50; 0.67; 0.75; 1.50; 1.00; 2.00; 3.00; 4.00
|
4.00; 3.00; 2.00; 1.50; 1.00; 0.75; 0.67; 0.50; 0.33; 0.25
|
|
|
|
name_study |
String |
50
|
Recommended |
Name of initial study |
|
|
|
|
|
cgiassessing |
Integer |
|
Recommended |
The area this CGI is assessing |
1;2
|
1=Overall Function; 2=Language/Communication
|
|
|
|
severity |
Integer |
|
Recommended |
Severity of clinical disorder |
0::8
|
0 = Not severe; 8 = Most severe
|
|
|
|
global_severity |
Integer |
|
Recommended |
Global Severity Score |
1::8
|
1 = No pathology; 2 = Minimal pathology; 3 = Mild pathology; 4 = Moderate pathology; 5 = Mod-severe pathology; 6 = Severe pathology; 7 = Extreme pathology; 8 = Not assessed
|
|
|
|
global_improvement |
Integer |
|
Recommended |
Global improvement (Past Month): |
0::4;6;7
|
0 = Asymptomatic; 1 = Considerable improvement; 2 = Moderate improvement; 3 = Slight improvement; 4 = No improvement; 6 = Insufficient information; 7 = Not Applicable
|
|
|
|
alcohol_severity |
Integer |
|
Recommended |
Alcohol Severity Score |
1::8
|
1 = No pathology; 2 = Minimal pathology; 3 = Mild pathology; 4 = Moderate pathology; 5 = Mod-severe pathology; 6 = Severe pathology; 7 = Extreme pathology; 8 = Not assessed
|
|
|
|
alcohol_improvement |
Integer |
|
Recommended |
Alcohol Improvement Score |
1::8
|
1 = Abstinent occasional slips; 2 = 75% reduction; 3 = Some reduction <75%; 4 = Little or no change; 5 = Some increase <75%; 6 = 75% increase; 7 = >75% increase; 8 = Not assessed
|
|
|
|
alcohol_global_severity |
Integer |
|
Recommended |
Alcohol Global Severity. At this time, overall, how would you rate yourself for alcohol use and alcohol-related problems? |
1::7
|
1 = No problems; 2 = Borderline problems; 3 = Mild problems; 4 = Moderate problems; 5 = Marked problems; 6 = Severe problems; 7 = Extreme problems
|
|
|
|
alcohol_global_improvement |
Integer |
|
Recommended |
Alcohol Global Improvement. How would you rate yourself for changes in alcohol use and alcohol-related problems since the beginning of this study? |
1::7
|
1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse
|
|
