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Concomitant Treatment

1,483 Shared Subjects

N/A
Clinical Assessments
Treatment
12/29/2014
alltx01
04/18/2023
View Change History
01
Query Element Name Data Type Size Required Description Value Range Notes Aliases
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 patid, randid, 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
Query stage Integer Recommended Study stage
0::5; 51::53; 67; -888; -999
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 pmtgrp String 10 Recommended Premature Termination Category no;s1;s1s;s2;s3 no = no PMT; s1 = Stage 1 PMT; s1s = Stage 1 Switcher; s2 = Stage 2 PMT; s3 = Stage 3 PMT
Query drpgrp String 10 Recommended Study Drop Category no;s1;s2;s3 no = no Drop; s1 = Stage 1 Drop; s2 = Stage 2 Drop; s3 = Stage 3 Drop
Query tads_flx Integer Recommended Indicator of whether patient received a non-ASAP PT session during the stage (only counting sessions where it was clear the patient had been on drug on the session date).Note: This assumes that all PBO patients received FLX after Stage I PMT if PT sessions continued. 0;1 0 = No; 1 = Yes
Query tads_cbt Integer Recommended Indicator of whether patient received a non-ASAP CBT session during the stage. 0;1 0 = No; 1 = Yes
Query ntc_tt1 Integer Recommended First non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt2 Integer Recommended Second non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt3 Integer Recommended Third non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt4 Integer Recommended Fourth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt5 Integer Recommended Fifth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt6 Integer Recommended Sixth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt7 Integer Recommended Seventh non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_tt8 Integer Recommended Eighth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. 1::8 1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
Query ntc_adep Integer Recommended Indicator of whether any prescribed treatment in the stage was anti-depressant medication. 1 1 = Yes
Query ntc_stim Integer Recommended Indicator of whether any prescribed treatment in the stage was stimulant medication. 1 1 = Yes
Query ntc_aanx Integer Recommended Indicator of whether any prescribed treatment in the stage was anti-anxiety medication. 1 1 = Yes
Query ntc_neur Integer Recommended Indicator of whether any prescribed treatment in the stage was neuroleptic medication. 1 1 = Yes
Query ntc_mood Integer Recommended Indicator of whether any prescribed treatment in the stage was mood stabilizing medication. 1 1 = Yes
Query ntc_othm Integer Recommended Indicator of whether any prescribed treatment in the stage was a medication other than those already classified. 1 1 = Yes
Query ntc_cbt Integer Recommended Indicator of whether any prescribed treatment in the stage was cognitive behavioral therapy. 1 1 = Yes
Query ntc_othp Integer Recommended Indicator of whether any prescribed treatment in the stage was an other psychosocial therapy. 1 1 = Yes
Query c_iph Integer Recommended Indicator of whether patient used an inpatient unit in a psychiatric hospital during the stage. 1 1 = Yes
Query c_igh Integer Recommended Indicator of whether patient used an inpatient psychiatric unit in a general hospital during the stage. 1 1 = Yes
Query c_idrg Integer Recommended Indicator of whether patient used an inpatient alcohol or drug treatment or detox unit during the stage. 1 1 = Yes
Query c_iemo Integer Recommended Indicator of whether patient used a regular medical inpatient unit for emotional, behavior, or substance use problems during the stage. 1 1 = Yes
Query c_rest Integer Recommended Indicator of whether patient used a residential treatment center during the stage. 1 1 = Yes
Query c_grph Integer Recommended Indicator of whether patient used a group home during the stage. 1 1 = Yes
Query c_day Integer Recommended Indicator of whether patient used a day hospital/day treatment during the stage. 1 1 = Yes
Query c_fost Integer Recommended Indicator of whether patient used therapeutic foster care during the stage. 1 1 = Yes
Query c_odrg Integer Recommended Indicator of whether patient used an outpatient drug or alcohol unit during the stage. 1 1 = Yes
Query c_cman Integer Recommended Indicator of whether patient used case management coordination during the stage. 1 1 = Yes
Query c_home Integer Recommended Indicator of whether patient used in-home counseling or crisis services during the stage. 1 1 = Yes
Query c_pro Integer Recommended Indicator of whether patient used professional treatment during the stage. 1 1 = Yes
Query c_doc Integer Recommended Indicator of whether patient used a medical doctor during the stage. 1 1 = Yes
Query c_er Integer Recommended Indicator of whether patient used an emergency room during the stage. 1 1 = Yes
Query c_hot Integer Recommended Indicator of whether patient used a crisis hotline during the stage. 1 1 = Yes
Query c_oth Integer Recommended Indicator of whether patient used other services during the stage. 1 1 = Yes
Query ssrimed Integer Recommended Non-TADS SSRI use 0;1 0 = No; 1 = Yes
Query daysrz Integer Recommended days since randomization visitdt
Query study String 100 Recommended Study; The code for each individual study studyid
Query site String 101 Recommended Site Study Site siteid
Query visit String 60 Recommended Visit name int1, timept
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified formcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query pmtot Integer Recommended Total pages cttot
Query ctany Integer Recommended Treatments other than meds 0;1 0=No; 1=Yes
Query pmmednum Integer Recommended Medication/treatment number fi_dcode, trtnum
treatment_name String 200 Recommended treatment name ctname, fi_dname, fi_nname, treatment
Query cttae Integer Recommended Treatment for an AE 0;1 0=No; 1=Yes
Query aef001 Integer Recommended Adverse Event number -9=unknown ctaenum
Query pmstdt Integer Recommended Date medication/treatment began in days from the randomization date ctstdt, daystart_t
Query cmcont Integer Recommended Continuing at end of study? 1;2 1=Yes; 2=No ctcont
Query pmstop Integer Recommended Date medication/treatment stopped in days from the randomization date ctstop, dayend_t
Query visday Integer Recommended Number of days from study baseline to date of visit dayctl_t, vdaconm
Query slot_t Integer Recommended Slot on Concomitant Treatment Log form fi_drln, fi_ndrln
Query page_t Integer Recommended Page of Concomitant Treatment Log form
Query mh Integer Recommended Is Concomitant Treatment a mental health treatment? 0;1 0 = No;1 = Yes
indication String 50 Recommended Indication for which Concomitant Treatment used fi_dindi, fi_nindi
Query cont_t Integer Recommended Is Concomitant Treatment still being used? 0;1 0 = No;1 = Yes fi_dongo, fi_nongo
Query study_id Integer Recommended Study ID number 46=Acute Phase; 47=Stabilization Phase
procedure String 200 Recommended Concomitant Procedures
Query startdy Integer Recommended Start Day cdtstda, ndotstda, startdays
Query endday Integer Recommended Stop Day cdtspda, ndotspda, stopdays
Query fi_ckdrg Integer Recommended No concomitant medications 0;1 0 = No;1 = Yes
Query fi_ckndr Integer Recommended No concomitant non-drug treatment 0;1 0 = No;1 = Yes
Query saps_ad10 Integer Recommended Rater number
fi_freq String 35 Recommended Concomitant treatment frequency fi_nsess
q14_unit String 10 Recommended Dose: Unit In mg, tsp, pills, etc. fi_unit
Query q14_qty Float Recommended Dose: Quantity 0.0 :: 325; -7; -8; -9;999 -7 = Don't know; -8 = Refused to answer; -9 = Does not apply; 999 = Missing value fi_dose
route1 String 50 Recommended route 1
Query conmedno Integer Recommended Check if NO concomitant medications were used 0;1 0=No; 1=Yes
Query cntr_othrtrt Integer Recommended Received any treatments other than medic 1;2 1=Yes;2=No
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
Query anytrtmnt Integer Recommended Has the subject received medical treatment other than drugs 30 days prior to or during this study? 0;1 0 = No; 1 = Yes
cmind String 200 Recommended Indication
cmstrtdt Date Recommended Start Date
cmstpdt Date Recommended Stop Date
contamination01 Integer Recommended Have you received any sleep intervention, treatment or coaching since entering the study? 0; 1; -9 0 = No; 1 = Yes; -9 = Missing
contamination02b String 100 Recommended Have you received any sleep intervention, treatment or coaching since entering the study? - If yes, with who or which group have you been working on sleep?
contamination02a String 100 Recommended Have you received any sleep intervention, treatment or coaching since entering the study? - If yes, what sleep work have you been doing?
timepoint_label String 50 Recommended Timepoint/visit label timepoint
transcuse_01 Integer Recommended Are you still using Transdiagnostic Sleep and Circadian Intervention (TranS-C)? 0; 1; -9 0 = No; 1 = Yes; -9 = Missing
transcuse_02 String 1,000 Recommended If yes, what parts of Transdiagnostic Sleep and Circadian Intervention (TranS-C) are you still using?
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

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