|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
candidateguid, guid, nimhid, pseudo_guid, subject_key, z1 |
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
CATIEID, bid, case_id, clinical_barcode, ibisid, id, ptid, randid, record_id, stepid, subj, subject_id, subjectid, subjid, subnum, z2 |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
ans_date, bl_visit_date, consented_study, date_interview_ses, date_vitals, date_vitals2_d6c, hwv_doa, intvdate, sdate, testdate, v10_avs_date, v1_avs_date, v2_avs_date, v3_avs_date, v4_avs_date, v5_avs_date, v6_avs_date, v7_avs_date, v8_avs_date, v9_avs_date, visit_date, vitaldt |
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0 :: 1260
|
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.
|
bslage, ch_age, dema1, intvage, v10_avs_age, v1_avs_age, v2_avs_age, v3_avs_age, v4_avs_age, v5_avs_age, v6_avs_age, v7_avs_age, v8_avs_age, v9_avs_age |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
|
M = Male; F = Female; O=Other; NR = Not reported
|
ch_sex, dema2, gender, sex |
|
bas_time |
String |
10
|
Recommended |
time of baseline exam |
|
|
|
Query
|
blood_ps_base |
Integer |
|
Recommended |
baseline systolic blood pressure |
|
999 = Missing
|
syst1, systolicbp, vsfa2, vssa4 |
Query
|
blood_pd_base |
Integer |
|
Recommended |
baseline diastolic blood pressure |
|
999 = Missing
|
dias1, diastolicbp, vsfa3, vssa5 |
Query
|
heart_rate_base |
Float |
|
Recommended |
Baseline heart rate (in bpm) |
0::480;999
|
999 = Missing
|
ch_hr_baseline, heart_rate_base1_3y, heart_rate_base1_5y, heart_rate_base1_7y, heart_rate_base2_3y, heart_rate_base2_5y, heart_rate_base2_7y, pulserate, vsfa4, vssa6 |
Query
|
temp_base |
Integer |
|
Recommended |
baseline temperature |
|
|
|
|
post_time_20min |
String |
10
|
Recommended |
time of 20 min post exam |
|
|
|
Query
|
blood_ps_20min |
Integer |
|
Recommended |
20 min post blood pressure systolic |
|
|
|
Query
|
blood_pd_20min |
Integer |
|
Recommended |
20 min post blood pressure diastolic |
|
|
|
Query
|
heart_rate_20min |
Integer |
|
Recommended |
20 min post heart rate |
|
|
|
Query
|
temp_20min |
String |
10
|
Recommended |
20 min post temperature |
|
|
|
|
debrief_time |
String |
10
|
Recommended |
time of debrief exam |
|
|
|
Query
|
blood_ps_debrief |
Integer |
|
Recommended |
debrief systolic blood pressure |
|
|
|
Query
|
blood_pd_debrief |
Integer |
|
Recommended |
debrief diastolic blood pressure |
|
|
|
Query
|
heart_rate_debrief |
Integer |
|
Recommended |
debrief heart rate |
|
|
|
Query
|
temp_debrief |
Integer |
|
Recommended |
debrief temperature |
|
|
|
|
vital_compdt |
Date |
|
Recommended |
Date Assessment Completed |
|
|
|
Query
|
vital_collect |
Integer |
|
Recommended |
Was any data collected for this form? |
|
1 = Yes; 0 = No
|
vitaldon |
Query
|
height_met |
Float |
|
Recommended |
Height - Metric Unit |
|
999 = Missing; -999 = No Data
|
Vital_Ht, c_height, ch_height_baseline, height, ht_cm, hwb_cm, hwv_height_cm, svshght, v10_avs_height, v1_avs_height, v2_avs_height, v3_avs_height, v4_avs_height, v5_avs_height, v6_avs_height, v7_avs_height, v8_avs_height, v9_avs_height, vs_htm, vssa2a, vtl003 |
Query
|
weight_met |
Float |
|
Recommended |
Weight - Metric Unit |
|
999 = Missing; -999 = No Data
|
Vital_Wt, blvswght, c_weight, ch_weight_baseline, hwb_kg, hwv_weight_kg, svswght, v10_avs_weight, v1_avs_weight, v2_avs_weight, v3_avs_weight, v4_avs_weight, v5_avs_weight, v6_avs_weight, v7_avs_weight, v8_avs_weight, v9_avs_weight, vs_wtk, vsfa1, vssa1, vtl002, weight, wt_kg, wtkg |
Query
|
temperature |
Float |
|
Recommended |
Temperature (degrees Fahrenheit) |
0::300
|
|
Vital_Temper, hwv_temp_f, temp, temp_f, vstemp, vtl001, vtl005 |
Query
|
vital_sysbp |
Float |
|
Recommended |
Blood Pressure (sitting for 3 minutes)mmHg (systolic) |
0::500; 999
|
999=NK/missing
|
SYS, sbpsit, sitbpsys, systolic, systsit, vs_bpsyssit, vtl002a, vtl005a |
Query
|
vital_diabp |
Integer |
|
Recommended |
Blood Pressure (sitting for 3 minutes)mmHg (diastolic) |
0::500
|
|
DIA, diastolic, diastsit, dpbsit, sitbpdia, vs_bpdiasit, vtl002b, vtl005b |
Query
|
vital_pulse |
Integer |
|
Recommended |
Pulse (sitting for 3 minutes)beats/min |
0 :: 300
|
|
hrsit, hwv_pulse, sitpuls, vs_pulsesit, vtl005c |
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
|
|
phase |
Query
|
bmi |
Float |
|
Recommended |
body mass index of subject |
|
-9 = Missing
|
blbmi, c_bmi, ch_bmi_baseline, current_bmi, hwb_ckbmilb, hwv_bmi_m, hwv_bmi_nm, scrnbmi, vs_bmi, vssa3 |
Query
|
waist |
Float |
|
Recommended |
5. Waist |
|
inches
|
ch_wc_baseline, hwv_waist_circum_inch, vsfa5a, vsfa6a, vssa7a |
Query
|
hips |
Float |
|
Recommended |
6. Hips |
|
inches; 999=Legitimately skipped
|
vsfa7a, vssa8a |
Query
|
wh_ratio |
Float |
|
Recommended |
7. Waist/Hip Ratio |
|
|
waist_height_ratio |
Query
|
base1b_a |
Integer |
|
Recommended |
Flag Baseline Phase 1B Visit - All Vital |
0;1
|
0=No;1=Yes
|
|
Query
|
base2_a |
Integer |
|
Recommended |
Flag Baseline Phase 2 Visit - All Vitals |
0;1
|
0=No;1=Yes
|
|
Query
|
base3_a |
Integer |
|
Recommended |
Flag Baseline Phase 3 Visit - All Vitals |
0;1
|
0=No;1=Yes
|
|
Query
|
last1_a |
Integer |
|
Recommended |
Flag Last Phase 1/1A Visit - All Vitals |
0;1
|
0=No;1=Yes
|
|
Query
|
last1b_a |
Integer |
|
Recommended |
Flag Last Phase 1B Visit All Vitals |
0;1
|
0=No;1=Yes
|
|
Query
|
last2_a |
Integer |
|
Recommended |
Flag Last Phase 2 Visit - All Vitals |
0;1
|
0=No;1=Yes
|
|
Query
|
last3_a |
Integer |
|
Recommended |
Flag Last Phase 3 Visit - All Vitals |
0;1
|
0=No;1=Yes
|
|
Query
|
b1_wt |
Integer |
|
Recommended |
Phase 1/1A Baseline Weight |
|
value for assessment at phase-specific baseline; retained across all records for that assessment.
|
weight |
Query
|
b1b_wt |
Integer |
|
Recommended |
Phase 1B Baseline Weight |
|
value for assessment at phase-specific baseline; retained across all records for that assessment.
|
|
Query
|
b2_wt |
Integer |
|
Recommended |
Phase 2 Baseline Weight |
|
value for assessment at phase-specific baseline; retained across all records for that assessment.
|
|
Query
|
b3_wt |
Integer |
|
Recommended |
Phase 3 Baseline Weight |
|
value for assessment at phase-specific baseline; retained across all records for that assessment.
|
|
Query
|
c_wt |
Integer |
|
Recommended |
Phase-Specific CFB Weight |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
p_gain |
Float |
|
Recommended |
Phase Specific Percent Wt Gain |
|
Phase-specific percent weight gain (100 * C_WT / phase- specific baseline weight)
|
|
Query
|
bmi_cat |
Integer |
|
Recommended |
Body Mass Index Categorized |
1::6
|
1 = Underweight (BMI < 18.5); 2 = Normal (BMI 18.5-24.9); 3 = Overweight (BMI 25-29.9); 4 = Obesity I (BMI 30-34.9); 5 = Obesity II (BMI 35-39.9); 6 = Obesity III (BMI >=40)
|
|
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
eventname, int1, session, visit_name, visitnum, vtypvs |
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
vsfa0b |
Query
|
base1 |
Integer |
|
Recommended |
Flag Baseline Phase 1/1A Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
base1b |
Integer |
|
Recommended |
Flag Baseline Phase 1B 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
|
last1 |
Integer |
|
Recommended |
Flag Last Phase 1/1A Visit |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last1b |
Integer |
|
Recommended |
Flag Last Phase 1B 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
|
heart_rate |
Integer |
|
Recommended |
heart rate |
|
|
HEART, heart_rate2_bd6, hr |
Query
|
height_std |
Float |
|
Recommended |
Height - Standard Unit |
|
-1 = Not known; 999 = Missing
|
HEIGHT, current_height, height, height_in_inches, heightin, ht, ht_cm, vsfa1a, vssa1a, vtl011 |
Query
|
weight_std |
Float |
|
Recommended |
Weight - Standard Unit |
|
-1 = Not known; 999 = Missing
|
WEIGHT, current_weight, vsfa2a, vssa2d, weight, weight_in_lbs, weight_in_lbs2_311, wt, wt_kg |
Query
|
vtl004a |
Integer |
|
Recommended |
Standing Systolic Blood pressure (mm/Hg) |
0::300
|
|
stnbpsys, syststand, vs_bpsysstand, vsstbp1, vtl007a, vtl008a |
Query
|
vtl004b |
Integer |
|
Recommended |
Standing Diastolic Blood pressure (mm/Hg) |
0::200
|
|
diaststand, stnbpdia, vs_bpdiastand, vsstbp2, vtl007b, vtl008b |
Query
|
vtl004c |
Integer |
|
Recommended |
Standing Pulse (bpm) |
0::300
|
|
hrstand, stnpuls, vs_pulsestand, vtl008, vtl009 |
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
hwv_notes, vitals_comment, vtl006 |
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
bsldays, dayvital |
Query
|
assbdic |
String |
5
|
Recommended |
Assessment Point |
D;14;E;24;LB;36;72;96;120; 9; B; 3; 7; 144; 168;192; C
|
D=MTA baseline assessment; 14=MTA 14 month assessment; E=MTA early termination assessment; B = MTA Pre-Baseline Screening Assessment (579/579); 09 = MTA 9 Month Assessment (530/530); 24=MTA 24 month assessment; LB=LNCG baseline assessment; 36=MTA and LNCG 3 year assessment; 72=MTA and LNCG 6 year assessment; 96=MTA and LNCG 8 year assessment; 03 = MTA 3 Month Assessment (438/687);120=MTA and LNCG 10 year assessment; 7= 7th Grade Assessment (221/276); 144 = MTA & LNCG 12 Month Assessment (578/578); 168 = MTA & LNCG 14 Month Assessment (585/585); 192 = MTA & LNCG 16 Month Assessment (505/505); C = MTA Pre-Baseline Screening Assessment (78/78)
|
assvital |
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, relvital |
Query
|
actbdic |
Integer |
|
Recommended |
Active status |
0::5
|
0=Inactive-Data collected after the 14 month treatment phase/after early termination from treatment phase/prior to treatment phase; 1=Active-Data collected during the 14 month treatment phase while subject received originally assigned treatment regardless of degree of compliance; 2=Active-This is the last active assessment for subjects who were about to violate treatment arm by receiving alternate treatment; 3=Active-This is the last active assessment for subjects who were about to leave the study by moving away;4=Yes, Active; 5=No, Not Active
|
actvital |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_no, site_uid, siteid, sitenum |
Query
|
sjtyp |
Integer |
|
Recommended |
Subject type |
1;2
|
1=MTA randomized trial subject; 2=Local normative comparison group (LNCG) subject
|
|
|
age |
String |
20
|
Recommended |
Age (years: months: days) |
|
|
|
Query
|
respct |
Float |
|
Recommended |
Respirations per minute |
|
|
respiration, respiratoryrate |
Query
|
cough |
Integer |
|
Recommended |
Cough |
1;2
|
1=No; 2=Yes
|
|
Query
|
wheeze |
Integer |
|
Recommended |
Wheeze |
1;2
|
1=No; 2=Yes
|
|
Query
|
othresp |
Integer |
|
Recommended |
Other respiratory abnormality |
1;2
|
1=No; 2=Yes
|
|
Query
|
tics5 |
Integer |
|
Recommended |
Count of tics per 5 minutes |
|
0=Tics present but less than one in 5 minutes
|
|
Query
|
vocal |
Integer |
|
Recommended |
Vocal tic |
1;2
|
1=No; 2=Yes
|
|
Query
|
motor |
Integer |
|
Recommended |
Motor tic |
1::3
|
1=No; 2=Yes; 3=Current
|
|
Query
|
simple |
Integer |
|
Recommended |
Simple tic |
1;2
|
1=No; 2=Yes
|
|
Query
|
complex |
Integer |
|
Recommended |
Complex tic |
1;2
|
1=No; 2=Yes
|
|
Query
|
single |
Integer |
|
Recommended |
Single tic |
1;2
|
1=No; 2=Yes
|
|
Query
|
mult |
Integer |
|
Recommended |
Multiple tics |
1;2
|
1=No; 2=Yes
|
|
Query
|
facial |
Integer |
|
Recommended |
Movement Severity Score-facial and oral |
|
Created variable with 20% missing data rule applied: Sum of AIMS01-AIMS04
|
|
Query
|
othtic |
Integer |
|
Recommended |
Other location of tic |
1;2
|
1=No; 2=Yes
|
|
Query
|
ptawar |
Integer |
|
Recommended |
Is patient aware of tic? |
1;2
|
1=No; 2=Yes
|
|
Query
|
parawar |
Integer |
|
Recommended |
Is parent aware of tic? |
1;2
|
1=No; 2=Yes
|
|
Query
|
ticsev |
Integer |
|
Recommended |
Tic severity |
1::4
|
1=Clinically insignificant; 2=Bothersome; 3=Impairing; 4=Handicapping
|
|
Query
|
eyer |
Float |
|
Recommended |
Visual acuity right eye 20/_ |
|
|
|
Query
|
eyel |
Float |
|
Recommended |
Visual acuity left eye 20/_ |
|
|
|
Query
|
earr |
Integer |
|
Recommended |
Hearing right ear |
1;2
|
1=Normal; 2=Impaired
|
|
Query
|
earl |
Integer |
|
Recommended |
Hearing left ear |
1;2
|
1=Normal; 2=Impaired
|
|
Query
|
heent |
String |
10
|
Recommended |
Heent exam |
normal; abnormal; other
|
|
|
Query
|
endo |
Integer |
|
Recommended |
Endocrine exam |
1::3
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only
|
|
Query
|
card |
Integer |
|
Recommended |
Cardiac/circulatory exam |
1::3
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only
|
|
Query
|
abdom |
Integer |
|
Recommended |
Abdomen/gastrointestinal exam |
1::3
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only
|
|
Query
|
skin |
Integer |
|
Recommended |
Skin exam |
0::5
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only; 0=Not done; 4=Normal; 5=Abnormal
|
|
Query
|
musc |
Integer |
|
Recommended |
Musculoskeletal exam |
1::3
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only
|
|
Query
|
neur |
Integer |
|
Recommended |
Neurological exam |
1::3
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only
|
|
Query
|
respir |
Integer |
|
Recommended |
Respiratory exam |
1::3
|
1=Wide range of normal variability; 2=Abnormal by exam; 3=Abnormal by history only
|
resp |
Query
|
alc_breath |
Float |
|
Recommended |
Alcohol Breathalyzer Reading |
|
|
breathalyzer |
Query
|
carbon_mon_breath |
String |
25
|
Recommended |
Carbon Monoxide Breathalyzer Reading |
|
|
|
Query
|
positive_drugs0 |
Integer |
|
Recommended |
Positive for No elicit drugs |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs1 |
Integer |
|
Recommended |
Positive for Cotinine |
0 :: 1
|
0 = No; 1 = Yes
|
urine_uds___4 |
Query
|
positive_drugs2 |
Integer |
|
Recommended |
Positive for COC |
0 :: 1
|
0 = No; 1 = Yes
|
urine_uds___2 |
Query
|
positive_drugs3 |
Integer |
|
Recommended |
Positive for AMP |
0 :: 1
|
0 = No; 1 = Yes
|
urine_uds___1 |
Query
|
positive_drugs4 |
Integer |
|
Recommended |
Positive for mAMP |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs5 |
Integer |
|
Recommended |
Positive for THC |
0 :: 1
|
0 = No; 1 = Yes
|
urine_uds___5 |
Query
|
positive_drugs6 |
Integer |
|
Recommended |
Positive for MTD |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs7 |
Integer |
|
Recommended |
Positive for OPI |
0 :: 1
|
0 = No; 1 = Yes
|
urine_uds___6 |
Query
|
positive_drugs8 |
Integer |
|
Recommended |
Positive for PCP |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs9 |
Integer |
|
Recommended |
Positive for BAR |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs10 |
Integer |
|
Recommended |
Positive for BZO |
0 :: 1
|
0 = No; 1 = Yes
|
urine_uds___3 |
Query
|
current_medication |
String |
300
|
Recommended |
subject's current medications |
|
|
medications |
Query
|
bp |
String |
25
|
Recommended |
Blood Pressure |
|
|
blood_pressure, blood_pressure2_1e7, bpressure, ch_bp_baseline |
Query
|
pulse |
Float |
|
Recommended |
Pulse |
|
|
vs_pulse |
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
|
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
|
|
|
respond_detail_oth_spec |
String |
255
|
Recommended |
Respondent details |
|
|
informnt |
Query
|
hwb_bmipct |
Float |
|
Recommended |
BMI percentile |
|
|
bmi_perc_baseline |
Query
|
hwb_bslkg |
Float |
|
Recommended |
Baseline weight (kg) |
|
Same as "Today's weight" at baseline
|
blwtkg, wght1 |
Query
|
hwb_ckgainkg |
Float |
|
Recommended |
Weight gain |
|
|
|
Query
|
hwb_pct_gain |
Float |
|
Recommended |
Calculated percent weight gain |
|
Between baseline and this rating period
|
|
|
hwb_bp1_hwb_bp2 |
String |
25
|
Recommended |
Blood pressure - right arm after sitting for 1 minute |
|
|
|
Query
|
hwb_pulse |
Float |
|
Recommended |
Pulse - right arm after sitting for 1 minute |
|
|
|
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
|
vssa2b |
Float |
|
Recommended |
Repeat standing height measurement to confirm |
0::150
|
in inches
|
|
Query
|
vssa2c |
Float |
|
Recommended |
Computed average height |
0::150
|
in inches
|
|
Query
|
vssa7b |
Float |
|
Recommended |
Repeat waist measurement to confirm |
0::150
|
in inches
|
vsfa5b, wstcirc2 |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_id, form_name, formid, vers |
Query
|
vsfa5 |
Integer |
|
Recommended |
Is this a quarterly follow-up (with labs) or discontinuation visit? |
0;1
|
0=No; 1=Yes
|
|
Query
|
vsfa6b |
Float |
|
Recommended |
Repeat waist measurement to confirm |
0::1000
|
|
|
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
date, visitdt, vsfa0ba, vssa0b |
Query
|
blwt |
Float |
|
Recommended |
Baseline weight in pounds |
|
|
hwv_weight_lbs |
Query
|
chwt |
Float |
|
Recommended |
Change from baseline in weight in lbs |
|
|
|
Query
|
chwtkg |
Float |
|
Recommended |
Change from baseline in weight in kg |
|
|
|
Query
|
pchwtkg |
Float |
|
Recommended |
Percent change in weight |
|
|
|
Query
|
bsln_bmi |
Float |
|
Recommended |
Baseline BMI |
|
|
|
Query
|
chng_bmi |
Float |
|
Recommended |
change from baseline in bmi |
|
|
|
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp, tstst |
Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
Query
|
q19_a2c |
Float |
|
Recommended |
Head circumference: Centimeters |
|
|
head_circumference, head_circumfrence, vit_q06 |
Query
|
caffcoff |
Integer |
|
Recommended |
Cups coffee |
|
|
|
Query
|
cafftea |
Float |
|
Recommended |
Cups tea |
|
|
|
Query
|
caffsoda |
Integer |
|
Recommended |
Soda (12-oz) |
|
|
|
Query
|
caffchoc |
Integer |
|
Recommended |
Chocolate (1-oz) |
|
|
|
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid, session |
Query
|
vshgtcm |
Float |
|
Recommended |
Vital Signs Height in centimeters for BMI |
|
|
|
Query
|
vsstbpsi |
Float |
|
Recommended |
Initial Blood Pressure Systolic Standing |
|
|
|
Query
|
vsstbpdi |
Float |
|
Recommended |
Initial Blood Pressure Diastolic Standing |
|
|
|
Query
|
vssubpsi |
Float |
|
Recommended |
Initial Blood Pressure Systolic Supine |
|
|
|
Query
|
vssubpdi |
Float |
|
Recommended |
Initial Blood Pressure Diastolic Supine |
|
|
|
Query
|
vssthri |
Float |
|
Recommended |
Initial Heart Rate Standing |
|
|
|
Query
|
vssuhri |
Float |
|
Recommended |
Initial Heart Rate Supine |
|
|
|
Query
|
vssubp1 |
Float |
|
Recommended |
Blood Pressure Systolic Supine |
|
|
vs_bpsysly |
Query
|
vssubp2 |
Float |
|
Recommended |
Blood Pressure Diastolic Supine |
|
|
vs_bpdialy |
Query
|
vssthr |
Float |
|
Recommended |
Heart Rate Standing |
|
|
|
Query
|
vssuhr |
Float |
|
Recommended |
Heart Rate Supine |
|
|
|
Query
|
stbps15 |
Float |
|
Recommended |
15 minute Blood Pressure Systolic Standing |
|
|
|
Query
|
stbpd15 |
Float |
|
Recommended |
15 minute Blood Pressure Diastolic Standing |
|
|
|
Query
|
subps15 |
Float |
|
Recommended |
15 minute Blood Pressure Systolic Supine |
|
|
syst2 |
Query
|
subpd15 |
Float |
|
Recommended |
15 minute Blood Pressure Diastolic Supine |
|
|
dias2 |
Query
|
vssthr15 |
Float |
|
Recommended |
15 minute Heart Rate Standing |
|
|
|
Query
|
vssuhr15 |
Float |
|
Recommended |
15 minute Heart Rate Supine |
|
|
|
Query
|
stbps30 |
Float |
|
Recommended |
30 minute Blood Pressure Systolic Standing |
|
|
|
Query
|
stbpd30 |
Float |
|
Recommended |
30 minute Blood Pressure Diastolic Standing |
|
|
|
Query
|
subps30 |
Float |
|
Recommended |
30 minute Blood Pressure Systolic Supine |
|
|
syst3 |
Query
|
subpd30 |
Float |
|
Recommended |
30 minute Blood Pressure Diastolic Supine |
|
|
dias3 |
Query
|
vssthr30 |
Float |
|
Recommended |
30 minute Heart Rate Standing |
|
|
|
Query
|
vssuhr30 |
Float |
|
Recommended |
30 minute Heart Rate Supine |
|
|
|
Query
|
positive_drugs11 |
Integer |
|
Recommended |
Positive for OXY |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs12 |
Integer |
|
Recommended |
Positive for MDMA |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
positive_drugs13 |
Integer |
|
Recommended |
Positive for PPX |
0 :: 1
|
0 = No; 1 = Yes
|
|
Query
|
c_waist |
Float |
|
Recommended |
Waist (cm) |
|
|
hwv_waist_circum_cm, v10_avs_waistcircum, v2_avs_waistcircum, vs_waistcirc, wstcirc1 |
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
|
visit_number_vitals |
Query
|
lastoc |
Integer |
|
Recommended |
Flag Last Open Choice Phase Visit |
1
|
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
|
boc_wt |
Integer |
|
Recommended |
Open choice Baseline Weight |
|
value for assessment at phase-specific baseline; retained across all records for that assessment.
|
|
Query
|
vtl004 |
Integer |
|
Recommended |
Respiratory Rate sitting (breaths/min) |
0::60; -9
|
-9=Unknown
|
|
Query
|
vtl010 |
Integer |
|
Recommended |
Respiratory Rate standing (breaths/min) |
|
|
|
|
vtlq1 |
String |
10
|
Recommended |
Time Vital Signs taken |
|
|
bp12, bp16, bp20, bp24, bp28, bp32, bp36, bp4, bp40, bp44, bp48, bp52, bp56, bp60, bp64, bp68, bp72, bp76, bp8, bp80, hwv_time |
Query
|
vtl007 |
Float |
|
Recommended |
Height in inches |
|
|
height, hwv_height_inch, vs_ht |
Query
|
mhf_23 |
Integer |
|
Recommended |
Checks if physical exam was administered |
0;1
|
0=No; 1=Yes
|
exam |
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
Query
|
vis_type |
Integer |
|
Recommended |
Visit type |
0::2
|
1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview
|
phone |
Query
|
blood_ps |
Integer |
|
Recommended |
systolic blood pressure |
|
|
bp1, bp13, bp17, bp21, bp25, bp29, bp33, bp37, bp41, bp45, bp49, bp5, bp53, bp57, bp61, bp65, bp69, bp73, bp77, bp9, bp_syst, bpsystolic, hwv_bp_systolic, sys_bp, vs_sbp |
Query
|
blood_pd |
Integer |
|
Recommended |
diastolic blood pressure |
|
|
bp10, bp14, bp18, bp2, bp22, bp26, bp30, bp34, bp38, bp42, bp46, bp50, bp54, bp58, bp6, bp62, bp66, bp70, bp74, bp78, bp_dias, bpdiastolic, dias_bp, diastoli, hwv_bp_diastolic, vs_dbp |
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
Query
|
vsfa7b |
Float |
|
Recommended |
Repeat hip measurement to confirm |
|
999=Legitimately skipped
|
vssa8b |
|
vstmpth |
String |
10
|
Recommended |
Time Point Hours |
|
|
timehh |
|
vstmptm |
String |
10
|
Recommended |
Time Point Minutes |
|
|
timemm |
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 |
|
|
dav1vs |
Query
|
premorbidweight |
Integer |
|
Recommended |
Premorbid body weight (Baseline only) lbs |
|
|
|
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
|
subj_pos |
String |
20
|
Recommended |
Position of subject |
|
Sitting; Supine; Prone; Standing
|
bpposit |
|
cardio_respratecount |
String |
50
|
Recommended |
Respiratory Rate - Count |
|
|
respiration, resprate |
|
arith_temperature_ct |
String |
50
|
Recommended |
Temperature |
|
|
temp, temp_count |
Query
|
tempunit |
String |
20
|
Recommended |
Temperature Unit |
|
|
hwv_temp_unit |
Query
|
attend |
Integer |
|
Recommended |
Attended Evaluation |
0;1;-9
|
1=Yes; 0=No; -9=Unknown
|
|
Query
|
body_temp_f |
Float |
|
Recommended |
Body Temperature Fahrenheit |
|
|
|
Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
|
Query
|
sitedatasource_1 |
Integer |
|
Recommended |
Source of Data: Site |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
|
Query
|
sitedatasource_phone |
Integer |
|
Recommended |
Source of Data: Telephone |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
|
Query
|
sitedatasource_physician |
Integer |
|
Recommended |
Source of Data: Physician |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
|
|
comments |
String |
4,000
|
Recommended |
Comments about assessment |
|
|
|
|
doa_futdt |
String |
20
|
Recommended |
Future date entered (Assessment) |
|
|
hwv_doa_futdt |
|
dode |
String |
10
|
Recommended |
Date of Data Entry |
|
|
hwv_dode |
|
dode_futdt |
String |
20
|
Recommended |
Future date entered (Data Entry) |
|
|
hwv_dode_futdt |
Query
|
form_completed |
Integer |
|
Recommended |
Was the form completed? |
1::4
|
1=Yes; 2=No; 3=Unverified; 4 = N/A-Not in age range
|
hwv_form_complete |
Query
|
form_explain |
Integer |
|
Recommended |
Why was this form not completed? |
86::99
|
99=Participant unable to complete due to cognitive impairment; 98=Participant unable to complete due to physical impairment; 97=Participant refused to begin/finish; 96=Participant completed but with less than best effort; 95=Participant unable to be contacted; 94=Participant deceased; 93=Participant withdrew consent; 92=Time constraints; 91=Rater forgot to administer; 90=Missed appointment; 89=Participant was terminated from study; 88=Other;87 = Not Done (reason unspecified); 86 = Not Applicable
|
hwv_explain |
|
other_reason_nc |
String |
100
|
Recommended |
Other reason form was not completed |
|
|
hwv_other_reason_nc |
Query
|
assessment_complete |
Integer |
|
Recommended |
Complete? |
0::2
|
0=Incomplete; 1=Unverified; 2=Complete
|
heightweightvitals_complete |
Query
|
monthsbl |
Float |
|
Recommended |
Actual number of months from Baseline |
|
|
|
Query
|
fatmass |
Float |
|
Recommended |
Fat Mass, % |
|
|
|
Query
|
fatpct |
Float |
|
Recommended |
Fat percentage, % |
|
|
|
Query
|
v1_avs_1st_systolic |
Integer |
|
Recommended |
First Reading Systolic BP (mmHg) |
|
|
systolic, v10_avs_1st_systolic, v2_avs_1st_systolic, v3_avs_1st_systolic, v4_avs_1st_systolic, v5_avs_1st_systolic, v6_avs_1st_systolic, v7_avs_1st_systolic, v8_avs_1st_systolic, v9_avs_1st_systolic |
Query
|
v1_avs_1st_diastolic |
Integer |
|
Recommended |
First Reading Diastolic BP (mmHg) |
|
|
v10_avs_1st_diastolic, v2_avs_1st_diastolic, v3_avs_1st_diastolic, v4_avs_1st_diastolic, v5_avs_1st_diastolic, v6_avs_1st_diastolic, v7_avs_1st_diastolic, v8_avs_1st_diastolic, v9_avs_1st_diastolic |
Query
|
v1_avs_1st_pulserate |
Integer |
|
Recommended |
First Reading Pulse Rate (beats/min) |
|
|
pulse1, v10_avs_1st_pulserate, v2_avs_1st_pulserate, v3_avs_1st_pulserate, v4_avs_1st_pulserate, v5_avs_1st_pulserate, v6_avs_1st_pulserate, v7_avs_1st_pulserate, v8_avs_1st_pulserate, v9_avs_1st_pulserate |
Query
|
v1_avs_2ndt_systolic |
Integer |
|
Recommended |
Second Reading Systolic BP (mmHg) |
|
|
v10_avs_2nd_systolic, v2_avs_2nd_systolic, v3_avs_2nd_systolic, v4_avs_2nd_systolic, v5_avs_2nd_systolic, v6_avs_2nd_systolic, v7_avs_2nd_systolic, v8_avs_2nd_systolic, v9_avs_2nd_systolic |
Query
|
v1_avs_2nd_diastolic |
Integer |
|
Recommended |
Second Reading Diastolic BP (mmHg) |
|
|
v10_avs_2nd_diastolic, v2_avs_2nd_diastolic, v3_avs_2nd_diastolic, v4_avs_2nd_diastolic, v5_avs_2nd_diastolic, v6_avs_2nd_diastolic, v7_avs_2nd_diastolic, v8_avs_2nd_diastolic, v9_avs_2nd_diastolic |
Query
|
v1_avs_2nd_pulserate |
Integer |
|
Recommended |
Second Reading Pulse Rate (beats/min) |
|
|
pulse2, v10_avs_2nd_pulserate, v2_avs_2nd_pulserate, v3_avs_2nd_pulserate, v4_avs_2nd_pulserate, v5_avs_2nd_pulserate, v6_avs_2nd_pulserate, v7_avs_2nd_pulserate, v8_avs_2nd_pulserate, v9_avs_2nd_pulserate |
Query
|
v1_avs_3rd_systolic |
Integer |
|
Recommended |
Third Reading Systolic BP (mmHg) |
|
|
v10_avs_3rd_systolic, v2_avs_3rd_systolic, v3_avs_3rd_systolic, v4_avs_3rd_systolic, v5_avs_3rd_systolic, v6_avs_3rd_systolic, v7_avs_3rd_systolic, v8_avs_3rd_systolic, v9_avs_3rd_systolic |
Query
|
v1_avs_3rd_diastolic |
Integer |
|
Recommended |
Third Reading Diastolic BP (mmHg) |
|
|
v10_avs_3rd_diastolic, v2_avs_3rd_diastolic, v3_avs_3rd_diastolic, v4_avs_3rd_diastolic, v5_avs_3rd_diastolic, v6_avs_3rd_diastolic, v7_avs_3rd_diastolic, v8_avs_3rd_diastolic, v9_avs_3rd_diastolic |
Query
|
v1_avs_3rd_pulserate |
Integer |
|
Recommended |
Third Reading Pulse Rate (beats/min) |
|
|
pulse3, v10_avs_3rd_pulserate, v2_avs_3rd_pulserate, v3_avs_3rd_pulserate, v4_avs_3rd_pulserate, v5_avs_3rd_pulserate, v6_avs_3rd_pulserate, v7_avs_3rd_pulserate, v8_avs_3rd_pulserate, v9_avs_3rd_pulserate |
Query
|
v1_avs_average_sysbp |
Integer |
|
Recommended |
Average Systolic Blood Pressure (mmHg) |
|
|
systmean, v10_avs_average_sysbp, v2_avs_average_sysbp, v3_avs_average_sysbp, v4_avs_average_sysbp, v5_avs_average_sysbp, v6_avs_average_sysbp, v7_avs_average_sysbp, v8_avs_average_sysbp, v9_avs_average_sysbp |
Query
|
v1_avs_average_diasbp |
Integer |
|
Recommended |
Average Diastolic Blood Pressure (mmHg) |
|
|
diastmean, v10_avs_average_diasbp, v2_avs_average_diasbp, v3_avs_average_diasbp, v4_avs_average_diasbp, v5_avs_average_diasbp, v6_avs_average_diasbp, v7_avs_average_diasbp, v8_avs_average_diasbp, v9_avs_average_diasbp |
Query
|
v1_avs_average_pulserate |
Integer |
|
Recommended |
Average Pulse Rate (beats/min) |
|
|
pulsemean, v10_avs_average_pulserate, v2_avs_average_pulserate, v3_avs_average_pulserate, v4_avs_average_pulserate, v5_avs_average_pulserate, v6_avs_average_pulserate, v7_avs_average_pulserate, v8_avs_average_pulserate, v9_avs_average_pulserate |
Query
|
c_hip |
Float |
|
Recommended |
Hip circumference, cm |
|
|
v10_avs_hipcircum, v2_avs_hipcircum, vs_hipcircum |
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
vitalsf_u_collected_by |
Query
|
visualacuity |
Integer |
|
Recommended |
Visual acuity (both eyes) |
|
|
|
Query
|
vs_sftricep |
Float |
|
Recommended |
mean tricep skinfold thickness(mm) |
|
|
|
Query
|
vs_sfsubscap |
Float |
|
Recommended |
mean subscapular skinfold thickness (mm) |
|
|
|
Query
|
htdzy |
Integer |
|
Recommended |
Heart: Dizziness on standing |
0;1
|
0=No; 1=Yes
|
vs_dizziness |
Query
|
vs_pulsely |
Float |
|
Recommended |
pulse lying |
|
|
|
Query
|
me2 |
Integer |
|
Recommended |
Status |
0;1
|
0 = Past [Inactive]; 1 = Active
|
|
Query
|
lineno |
Integer |
|
Recommended |
Line number (lines per participant) |
0::150
|
|
|
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|
Query
|
armused |
Integer |
|
Recommended |
Which arm was used? (Note: right arm should be used as the default) |
1;2
|
1= Right; 2=Left
|
arm, ch_arm_baseline |
Query
|
cuffsize |
Integer |
|
Recommended |
What cuff size was used |
1::4
|
1= Small; 2= Medium; 3= Large; 4= Thigh
|
|
Query
|
wstdiff |
Integer |
|
Recommended |
Are waist measurment 1 and measurement 2 >0.5cm apart? |
0;1
|
0= No; 1= Yes
|
|
Query
|
wstcirc3 |
Integer |
|
Recommended |
Waist circumference (in centimeters) measurement 3 |
|
|
|
Query
|
t1bmizy |
Float |
|
Recommended |
BMI z-score |
|
|
bmi_z_score, bmi_zscore |
Query
|
vtl010a |
Integer |
|
Recommended |
Has there been a change in orthostatic vitals from sitting to standing that excludes the subject from the study? |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
timept |
Integer |
|
Recommended |
Time Point |
|
888 = not applicable; 999 = missing
|
timepoint |
Query
|
heart_rate_cogchal1_3y |
Integer |
|
Recommended |
cognitive challenge heart rate |
|
|
heart_rate_cogchal2_3y, heart_rate_cogchal_5y, heart_rate_cogchal_7y |
Query
|
heart_rate_cogcont_3y |
Integer |
|
Recommended |
cognitive control heart rate |
|
|
heart_rate_cogcont_5y, heart_rate_cogcont_7y |
Query
|
heart_rate_emotechal_3y |
Integer |
|
Recommended |
emotional challenge heart rate |
|
|
heart_rate_emotechal_5y, heart_rate_emotechal_7y |
Query
|
heart_rate_emotecont_3y |
Integer |
|
Recommended |
emotional control heart rate |
|
|
heart_rate_emotecont_5y, heart_rate_emotecont_7y |
Query
|
heart_rate_phychal_3y |
Integer |
|
Recommended |
physical challenge heart rate |
|
|
heart_rate_phychal_5y, heart_rate_phychal_7y |
Query
|
heart_rate_phycont_3y |
Integer |
|
Recommended |
physical control heart rate |
|
|
heart_rate_phycont_5y, heart_rate_phycont_7y |
Query
|
heart_rate_socchal_5y |
Integer |
|
Recommended |
social challenge heart rate |
|
|
heart_rate_socchal_7y |
Query
|
heart_rate_soccont1_5y |
Integer |
|
Recommended |
social control heart rate |
|
|
heart_rate_soccont1_7y, heart_rate_soccont2_5y, heart_rate_soccont2_7y |
Query
|
visual_acuity |
Integer |
|
Recommended |
Smallest size that they were able to read correctly. |
1::9
|
1=4.0 m/160 in; 2=2.0 m/80 in; 3=1.4 m/56 in; 4=1.2 m/48 in; 5=1.0 m/40 in; 6=80 cm/32 in; 7=60 cm/24 in; 8=50 cm/20 in; 9=40 cm/16 in
|
|
|
wk_heart_rate_com |
String |
250
|
Recommended |
Heart rate. Comments |
|
|
hr_follow_up_comments, hr_screening_comments |
Query
|
regmense |
Integer |
|
Recommended |
Regular menstrual periods |
0;1; 999
|
0=No;1=Yes; 999=NA
|
lmp, lmp_follow_up |
|
mnstrdt |
Date |
|
Recommended |
Date of Last Menstrual Period |
|
|
lmp_date, lmp_follow_up_date |
|
mchq_18 |
String |
500
|
Recommended |
Do you have regular menstrual cycles. If no, explain |
|
|
no_lmp_follow_up_comments |
Query
|
bp_screening_status |
Integer |
|
Recommended |
Blood Pressure Results |
1;2
|
1= Normal; 2= Abnormal
|
|
|
bp_screening_comments |
String |
200
|
Recommended |
Blood Pressure Comments |
|
|
|
Query
|
hr_screening_status |
Integer |
|
Recommended |
Heart Rate Results |
1;2
|
1= Normal; 2= Abnormal
|
|
|
no_lmp_why |
String |
200
|
Recommended |
If no last menstrual period, please explain why |
|
|
|
|
laba5 |
Float |
|
Recommended |
Hdl Cholesterol (Mg/Dl) |
|
-9=Unknown
|
hdl |
|
rsptc_no |
Float |
|
Recommended |
Blood value - Total Cholesterol (mg/dL) |
|
-9=Unknown
|
cholesterol |
|
scq_02_a |
Integer |
|
Recommended |
High Blood pressure treatment |
|
0=No; 1=Yes
|
hypertension |
|
smoke_past |
Integer |
|
Recommended |
Child ever smoked? |
|
1 = Yes; 0 = No; 9 = Unknown
|
smoking |
|
cr2 |
Integer |
|
Recommended |
Diabetes Mellitus |
|
0 = No current diabetes or random BS < 220;1 = Diagnosis of diabetes or random BS >220
|
diabetes |
|
risk_total |
Integer |
|
Recommended |
10-Year Risk of Heart Attack Total |
0 :: 500
|
|
|
|
vascular_age |
Integer |
|
Recommended |
Heart/Vascular Age in years |
0 :: 100
|
|
|
|
hr_time2 |
Float |
|
Recommended |
heart rate (bpm) at time point 2 |
|
|
|
|
hr_time3 |
Float |
|
Recommended |
heart rate (bpm) at time point 3 |
|
|
|
|
hr_time4 |
Float |
|
Recommended |
heart rate (bpm) at time point 4 |
|
|
|
|
moi |
Integer |
|
Recommended |
Method of Injury |
1::8
|
1= Motor Vehicle Crash; 2= Gun Shot; 3= Stab; 4= Fall; 5= Pedestrian Struck; 6= Motorcycle Crash; 7= Crush Injury; 8= Other
|
|
|
moi_other |
String |
200
|
Recommended |
Method of Injury: Specify other |
|
|
|
|
injusry_ss |
Integer |
|
Recommended |
Injury Severity Score |
|
|
|
|
blooddtm |
String |
25
|
Recommended |
Date and Time of Blood Draw |
|
|
|
|
blood_draw_4 |
Integer |
|
Recommended |
Was re-draw needed? |
0;1
|
0= No; 1= Yes
|
|
|
activ_level |
Integer |
|
Recommended |
Activity Level During Hospitalization |
1::3
|
1= Bedridden; 2= Ambulatory with Help; 3= Ambulatory Independently
|
|
|
nida_y_tobaco_type |
Float |
|
Recommended |
Smoking status |
0;1;2;2.1;2.2;2.3;2.31;3
|
0 = Never smoker; 1 = Non-Smoker; 2 = Smoker; 2.1 = Current Every-Day Smoker ; 2.2 = Current Some-Day Smoker ; 2.3 = Former Smoker ; 2.31 = Former Smoker Heavier Past Exposure; 3= Other/Unknown
|
|
|
resp_source |
Integer |
|
Recommended |
Respondent Source |
1::6
|
1= subject; 2= parent; 3= clinician; 4= teacher; 5= trainer; 6= fidelity reviewer
|
source |
|
validity |
String |
13
|
Recommended |
Validity rating |
Yes;No;Questionnable
|
|
|
|
temp_site |
Integer |
|
Recommended |
Temperature Site |
1;2
|
1= Ear; 2= Oral
|
|
|
participant_target_hr_50 |
Float |
180
|
Recommended |
Target HR range (50%) |
|
|
|
|
target_hr_range_60 |
Float |
175
|
Recommended |
Target HR range (60%) |
|
|
|
|
pre004 |
Integer |
|
Recommended |
Pregnancy Test Result |
1;2;9;-9
|
1=Positive; 2=Negative; 9=Equivocal; -9=Unknown
|
pregnancy_status |
|
upreg |
Integer |
|
Recommended |
Pregnant - Urine test |
1::3; 9
|
1=Positive; 2=Negative; 3=Not done; 9=Equivocal (Must retest)
|
pregnancy_test_result |
|
comqother |
String |
255
|
Recommended |
Respondent - Other (text) |
|
|
|
|
bp_stand |
String |
15
|
Recommended |
Blood Pressure Standing (for at least 1 minute), Systolic/Diastolic |
|
|
bp_standing |
|
bp3 |
Float |
|
Recommended |
Mean Arterial Pressure (MAP) |
|
|
bp11, bp15, bp19, bp23, bp27, bp31, bp35, bp39, bp43, bp47, bp51, bp55, bp59, bp63, bp67, bp7, bp71, bp75, bp79 |
|
cuff_size |
Integer |
|
Recommended |
Cuff Size |
1::6;-999
|
1 = Infant; 2 = Child; 3 = Small adult; 4 = Regular adult; 5 = Large adult; 6 = Thigh; -999 = No information
|
|
|
code |
Integer |
|
Recommended |
Research code in the system |
|
|
|
|
handedness_01 |
Integer |
|
Recommended |
Handedness based on self report. |
1::3;-999
|
1 = Right; 2 = Left; 3 = Both; -999 = N/A or missing
|
handedness |
|
time_vitals |
Integer |
|
Recommended |
At which time point were the vitals conducted? |
0::9
|
0= At Arrival; 1= Resting Baseline; 2= 0 minutes post-IV bolus infusion; 3= 15 minutes; 4= 30 minutes; 5= 60 minutes; 6= 120 minutes; 7= 180 minutes; 8= 240 minutes; 9= 300 minutes
|
|
|
vital_sysbp_sit |
Integer |
|
Recommended |
What is the Sitting Blood Pressure (sitting for at least 5 minutes)? |
0::500; 999
|
in mmHg (systolic); 999=NK/missing
|
|
|
vital_diabp_sit |
Integer |
|
Recommended |
What is the Sitting Heart Blood Pressure (sitting for at least 5 minutes)? |
0::500
|
in mmHg (diastolic)
|
|
|
heart_rate_sit |
Integer |
|
Recommended |
What is the Sitting Heart Rate (sitting for at least 5 minutes)? |
|
|
|
|
vital_sysbp_stand |
Integer |
|
Recommended |
What is the Standing Blood Pressure (standing for 30 seconds)? |
0::500; 999
|
in mmHg (systolic); 999=NK/missing
|
|
|
vital_diabp_stand |
Integer |
|
Recommended |
What is the Standing Blood Pressure (standing for 30 seconds)? |
0::500
|
in mmHg (diastolic)
|
|
|
heart_rate_stand |
Integer |
|
Recommended |
What is the Standing Heart Rate (standing for 30 seconds)? |
|
|
|
|
puls_ox |
String |
250
|
Recommended |
What does the Pulse Oximeter read? |
|
|
|
|
same_vitals8 |
String |
1,000
|
Recommended |
Neck if abnormal, please specify |
|
|
|
|
same_vitals9 |
Integer |
|
Recommended |
Lymph Nodes Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals10 |
String |
1,000
|
Recommended |
Lymph Nodes if abnormal, please specify |
|
|
|
|
same_vitals11 |
Integer |
|
Recommended |
Chest Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals12 |
String |
1,000
|
Recommended |
Chest if abnormal, please specify |
|
|
|
|
same_vitals13 |
Integer |
|
Recommended |
Heart Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals14 |
String |
1,000
|
Recommended |
Heart if abnormal, please specify |
|
|
|
|
same_vitals15 |
String |
250
|
Recommended |
Other, specify |
|
|
|
|
same_vitals16 |
Integer |
|
Recommended |
Other Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals17 |
String |
1,000
|
Recommended |
Other if abnormal, please specify |
|
|
|
|
same_vitals1 |
Integer |
|
Recommended |
General Appearance Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals2 |
String |
1,000
|
Recommended |
General Appearance if abnormal, please specify |
|
|
|
|
same_vitals3 |
Integer |
|
Recommended |
Skin Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals4 |
String |
1,000
|
Recommended |
Skin if abnormal, please specify |
|
|
|
|
same_vitals5 |
Integer |
|
Recommended |
Head, Eyes, Ears, Nose, Throat Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
same_vitals6 |
String |
1,000
|
Recommended |
Head, Eyes, Ears, Nose, Throat if abnormal, please specify |
|
|
|
|
same_vitals7 |
Integer |
|
Recommended |
Neck Findings |
1::3
|
1 = Normal; 2 = Abnormal; 3 = Not done
|
|
|
alc_dose |
Float |
|
Recommended |
Alcohol dose given |
0::1.1
|
alcohol dose in ml/kg
|
|
|
site_reaction4 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: Itching/Pruritus |
0;1
|
0=No; 1=Yes
|
|
|
site_reaction5 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: Pain or tenderness |
0;1
|
0=No; 1=Yes
|
|
|
site_reaction6 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: Discoloration |
0;1
|
0=No; 1=Yes
|
|
|
site_reaction7 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: None of the above |
0;1
|
0=No; 1=Yes
|
|
|
vital_ae_post |
Integer |
|
Recommended |
Did the subject experience any reactions or adverse events after the 30-minute post-dose observation period? |
0;1
|
0=No; 1=Yes
|
|
|
vital_ae_post_text |
String |
4,000
|
Recommended |
Did the subject experience any reactions or adverse events after the 30-minute post-dose observation period? If yes, explain |
|
|
|
|
timepoint_label |
String |
50
|
Recommended |
Timepoint/visit label |
|
|
|
|
vital_sigfind |
Integer |
|
Recommended |
Vitals: Were there any significant findings? |
0;1
|
0=No; 1=Yes
|
|
|
vital_sigfind_text |
String |
4,000
|
Recommended |
Vitals: Specify significant findings |
|
|
|
|
fast_12hrs_pre |
Integer |
|
Recommended |
Has the subject been fasting for 12 hours or more prior to blood sampling? |
0;1
|
0=No; 1=Yes
|
|
|
tremfya_dose |
Integer |
|
Recommended |
Guselkumab (Tremfya) dose administered |
1::3
|
1=30mg; 2=70mg; 3=100mg
|
|
|
site_reaction1 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: Redness/Erythema |
0;1
|
0=No; 1=Yes
|
|
|
site_reaction2 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: Swelling |
0;1
|
0=No; 1=Yes
|
|
|
site_reaction3 |
Integer |
|
Recommended |
Injection Site Reaction Assessment - Indicate presence of: Induration |
0;1
|
0=No; 1=Yes
|
|
|
demeanor |
Integer |
|
Recommended |
Subject''s demeanor during collection of blood pressure |
1;2
|
1=Calm; 2=Agitated
|
|
|
drug_opi |
Integer |
|
Recommended |
Opiates (OPI) urine drug screen |
0::2
|
0 = Negative; 1 = Positive; 2 = Not readable
|
|
|
uri_8 |
Integer |
|
Recommended |
Urine Drug Screen: Benzodiazepines (BZO) |
1::4;9
|
1=Positive; 2=Negative; 3=Not available; 4=Not readable; 9=Missing
|
drug_bzo |
|
urine_uds___7 |
Integer |
|
Recommended |
Positive for K2 |
0;1
|
0 = No; 1 = Yes
|
|
|
drug_k2 |
Integer |
|
Recommended |
K2 urine drug screen |
0::2
|
0 = Negative; 1 = Positive; 2 = Not readable
|
|
|
urine_uds___8 |
Integer |
|
Recommended |
Positive for ethyl glucuronide (EtG) |
0;1
|
0 = No; 1 = Yes
|
|
|
urineetg_assay |
Integer |
|
Recommended |
Ethyl glucuronide (EtG) assay result, detectable limit 100-499 ng/mL |
0::2
|
0 = BDL (Below Detection Limit); 1 = ADL (Above Detection Limit); 2 = Value available
|
|
|
urineetg_value |
Float |
|
Recommended |
Ethyl glucuronide (EtG) value ng/mL |
|
|
|
|
urinecbd_value |
Float |
|
Recommended |
CBD value ng/mL |
|
|
|
|
cdt_assay |
Float |
|
Recommended |
CDT assay result % |
|
|
|
|
peth_assay |
Float |
|
Recommended |
Phosphatidylethanol (PEth) Assay Result |
|
|
|
|
stopbang_weigh |
Integer |
|
Recommended |
Weight in pounds |
|
|
vs_wt |
|
vs_ht_entry |
Float |
|
Recommended |
Height in inches at Entryway |
|
|
|
|
lmp_days |
Integer |
|
Recommended |
Days since starting date of last menstrual period |
|
Calculate: visit date - LMP date
|
|
|
etoh_reading |
Float |
|
Recommended |
Alcohol (ETOH) reading |
|
|
|
|
co_reading |
Float |
|
Recommended |
Carbon Monoxide (CO) reading |
|
|
|
|
urine_uds___9 |
Integer |
|
Recommended |
Urine drug screen all negative |
0;1
|
0 = No; 1 = Yes
|
|
|
drug_cot |
Integer |
|
Recommended |
Cotinine (COT) urine drug screen |
0::2
|
0 = Negative; 1 = Positive; 2 = Not readable
|
|
|
uri_7 |
Integer |
|
Recommended |
Urine Drug Screen: Cocaine (COC) |
1::4;9
|
1=Positive; 2=Negative; 3=Not available; 4=Not readable; 9=Missing
|
drug_coc |
|
uri_11 |
Integer |
|
Recommended |
Urine Drug Screen: Amphetamine (AMP) |
1::4;9
|
1=Positive; 2=Negative; 3=Not available; 4=Not readable; 9=Missing
|
drug_amp |
|
uri_9 |
Integer |
|
Recommended |
Urine Drug Screen: Cannabis (THC) |
1::4;9
|
1=Positive; 2=Negative; 3=Not available; 4=Not readable; 9=Missing
|
drug_thc |
|
eda_total_nsscr |
Float |
|
Recommended |
Total skin conductance responses (SCRs) |
|
Number of responses
|
|
|
ncttsk |
String |
250
|
Recommended |
Name of task. |
|
|
|
|
meanetco2 |
Float |
|
Recommended |
Mean end tidal CO2 (ETCO2) |
|
In mmHg
|
|
|
hrv_rmssd_mean |
Float |
|
Recommended |
Mean root mean square of successive differences (RMSSD) between normal heartbeats |
|
In msec
|
|
|
hrv_sdsd_mean |
Float |
|
Recommended |
Mean standard deviation of successive RR interval differences (SDSD) |
|
In msec
|
|
|
hrv_pnn50 |
Float |
|
Recommended |
Mean number of times in which the change in successive NN intervals exceeds 50ms (pNN50) |
|
In percentage
|
|
|
hrv_hr |
Float |
|
Recommended |
Mean heart rate |
|
BPM
|
|
|
eda_scl |
Float |
|
Recommended |
Mean skin conductance level |
|
In microsiemens
|
|
|
vo2_max |
Float |
|
Recommended |
VO2 max (also maximal oxygen consumption, maximal oxygen uptake or maximal aerobic capacity) is the maximum rate of oxygen consumption attainable during physical exertion. |
0::200
|
mL/(kg?min)
|
|