|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
|
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
CATIEID, subjid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
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.
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
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 |
|
|
|
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
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
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
|
protocol |
String |
50
|
Recommended |
Protocol [Study] name |
|
|
|
Query
|
mat0 |
Integer |
|
Recommended |
Not done because patient has a guardian. |
0;1
|
0=No;1=Yes
|
|
Query
|
matu1a |
Integer |
|
Recommended |
Understanding-1a. Purpose of project |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat1 |
Query
|
matu1b |
Integer |
|
Recommended |
Understanding-1b. Duration of study |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat2 |
Query
|
matu1c |
Integer |
|
Recommended |
Understanding-1c. Daily medication |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat3 |
Query
|
matu1d |
Integer |
|
Recommended |
Understanding-1d. Monthly interviews |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat4 |
Query
|
matu2 |
Integer |
|
Recommended |
Understanding-2. Research study |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat5 |
Query
|
matu3a |
Integer |
|
Recommended |
Understanding-3a. Random assignment |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat6 |
Query
|
matu3b |
Integer |
|
Recommended |
Understanding-3b. Double blind |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat7 |
Query
|
matu3c |
Integer |
|
Recommended |
Understanding-3c. Medication changes |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat8 |
Query
|
matu4a |
Integer |
|
Recommended |
Understanding-4a. Societal benefit |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat9 |
Query
|
matu4b |
Integer |
|
Recommended |
Understanding-4b. Personal benefit |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat10 |
Query
|
matu4c |
Integer |
|
Recommended |
Understanding-4c.Risk of getting ineffective medicine |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat11 |
Query
|
matu4d |
Integer |
|
Recommended |
Understanding-4d. Side effects |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat12 |
Query
|
matu5 |
Integer |
|
Recommended |
Understanding-5. Rights to withdraw/receive ordinary care |
0::2
|
2 =Subject recalls the content of the item and offers a fairly clear version of it. A verbatim repetition of the interviewer's description is not required; in fact, paraphrase in the subject's own words is preferred; 1 = Subject shows some recollection of the item content, but describes it in a way that renders understanding uncertain, even after the clinician has made efforts to obtain clarification from the subject; 0=Subject (a) does not recall the content of the item; or (b) describes it in a way that is clearly inaccurate; or (c) describes it in a way that seriously distorts its meaning, even after the clinician has made efforts to obtain clarification from the patient; or offers a response that is unrelated to the question or unintelligible.
|
maccat13 |
Query
|
matu6 |
Integer |
|
Recommended |
Understanding total |
|
|
MATS1A, MATS2A, MATS3A, maccat_understanding |
Query
|
mata1 |
Integer |
|
Recommended |
Appreciation -1. Goal of recruitment is not to optimize subject's care or well-being |
0::2
|
2 =Subject acknowledges that he or she is being recruited for a valid reason unrelated to potential personal benefit from being in the study; 1=Subject acknowledges being recruited for reasons both related to and unrelated to potential personal benefit. OR Subject maintains he or she is being recruited for a reason related only to potential personal benefit, but has a plausible explanation for why this is the case; 0 = Subject maintains he or she is being recruited for a reason related only to potential personal benefit, but does not have a plausible explanation for why this is the case. OR Subject offers response that is unrelated to the question or unintelligible
|
maccat14 |
Query
|
mata2 |
Integer |
|
Recommended |
Appreciation -2. Research methods take precedence over individualized care |
0::2
|
2 = Subject provides response consistent with the idea that the research protocol, not personal needs, will determine the experimental condition to which he/she will be assigned; 1 = Subject is uncertain whether the research protocol or personal needs will determine the experimental condition to which he/she will be assigned. OR Subject believes that personal needs will determine assignment to experimental conditions, but has a plausible explanation for why this might be the case; 0 = Subject believes personal needs will determine assignment to experimental conditions, but does not have a plausible explanation for why this would be the case. OR Subject offers a response that is unrelated to the question or unintelligible
|
maccat15 |
Query
|
mata3 |
Integer |
|
Recommended |
Appreciation -3. Ability to decline or withdraw participation |
0::2
|
2 = Subject acknowledges that failure to participate or later withdrawal will not adversely affect him/her (in particular, in the context of a treatment setting, that subject can continue to receive ordinary care-assuming that this is the case); 1 = Subject is uncertain whether failure to participate or later withdrawal will adversely affect him/her OR Subject believes failure to participate or later withdrawal will adversely affect him/her and has a plausible explanation for why this is the case; 0 = Subject believes failure to participate or later withdrawal will adversely affect him/her and does not have a plausible explanation for why this is the case. OR Subject offers response that is unrelated to the question or unintelligible.
|
maccat16 |
Query
|
mata4 |
Integer |
|
Recommended |
Appreciation total |
|
|
MATS1B, MATS2B, MATS3B, maccat_appreciation |
Query
|
matr1 |
Integer |
|
Recommended |
Reasoning -1. Consequential reasoning |
0::2
|
2 = Subject mentions at least two specific consequences when explaining the choice. The consequences may be related to only one or both alternatives; 1 = Subject mentions only one specific consequence when explaining the choice; 0 = Subject mentions no specific consequences when explaining the choice, even after being asked directly whether there were any more specific reasons why that choice seems best.
|
maccat17 |
Query
|
matr2 |
Integer |
|
Recommended |
Reasoning -2. Comparative reasoning |
0::2
|
2= Subject offers at least one statement that is a comparison of the two options. The statement should include at least one specific difference; 1= Subject makes comparison statement, but does not include a statement of a specific consequence; 0= Subject makes no comparative statements
|
maccat18 |
Query
|
matr3 |
Integer |
|
Recommended |
Reasoning -3. Generating consequences |
0::2
|
2 =Subject must give at least two reasonable consequences; 1= Subject gives only one reasonable consequence; 0= Subject gives no reasonable consequences, even with adequate encouragement
|
maccat19 |
Query
|
matr4 |
Integer |
|
Recommended |
Reasoning -4. Logical consistency of final choice |
0::2
|
2= Subject's final choice (in Expressing a Choice) follows logically from the subject's own reasoning, as explained by the subject in response to the three previous subparts; 1= It is not clear whether the choice follows logically from the subject's own reasoning; 0= Subject's choice clearly does not follow logically from subject's own reasoning.
|
maccat21 |
Query
|
matr5 |
Integer |
|
Recommended |
Reasoning total |
|
|
MATS1C, MATS2C, MATS3C, maccat_reasoning |
Query
|
matc1 |
Integer |
|
Recommended |
Choice-1. Expressing a choice |
0::2
|
2= Subject states a choice; 1 =Subject states more than one choice, seems ambivalent; 0 =Subject does not state a choice.
|
maccat20 |
Query
|
matc2 |
Integer |
|
Recommended |
Choice total |
|
|
MATS1D, MATS2D, MATS3D |
Query
|
mats1e |
Integer |
|
Recommended |
Is this the final administration? (visit 1) |
0;1
|
0=No;1=Yes
|
|
Query
|
mats2e |
Integer |
|
Recommended |
Is this the final administration (visit 2) |
0;1
|
0=No;1=Yes
|
|
Query
|
mats3e |
Integer |
|
Recommended |
Is this the final administration? (visit 3) |
0;1
|
0=No;1=Yes
|
|
Query
|
maccattot |
Integer |
|
Recommended |
MacCAT Total Score |
|
|
|
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
|
baseline_score |
Float |
|
Recommended |
Percentage of baseline competency assessment score |
0::100
|
|
|