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Table 3 Study performance and data element assessment scheme

From: Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

Assessment (domain) and specific measurement Weeks 2–4 Acute treatment phase Follow-up phase
4–11 weeks 24 weeks
End of session numbera Taper Follow up
5 10 15 20 [25] [30] 1 2 3 4 8 12 16 20 24
Consent S*                
Screening S                
Randomization B*                
Baseline S                
Medical history S                
Physical exam S       x          
Laboratory measurements S                
SCID-I S                
Current/past ATHF S                
Lifetime drinking history B                
CAPS B       x          x
THQ B                
LSC-R B                
BOMC S                
Medication use S x x x x x x x x x x x x x x x
rTMS treatment log   x x x x x x          
rTMS taper log         x x x       
HRSD and MADRS Sb x x x x x x     x x x x x x
BDI B x x x x x x     x x x x x x
QIDS-C16 B x x x x x x     x x x x x x
C-SSRS S                
C-SSRS follow up   x x x x x x x x x x x x x x x
BSS S x x x x x x x x x x x x x x x
BHS S x x x x x x x x x x x x x x x
VR-36 B       x          x
Neuropsychological battery B       x          x
DAST S       x          x
PCL B       x          x
MAST S       x          x
STAXI-2 S x x x x x x x x x x x x x x x
Urine toxicology screen and alcohol test S   x   x   X   x   x   x   x  
Protocol deviation As required
AE/SAE/UADE As required
  1. Note, for primary analyses and descriptive statistics total scores are used. Abbreviations: SCID Structured Clinical Interview for DSM Disorders, ATHF Antidepressant Treatment History Form, CAPS Clinician Administered PTSD Scale, THQ Trauma History Questionnaire, LSC-R Life Stressor Checklist-revised, BOMC Six-Item Blessed Orientation-Memory-Concentration, rTMS Repetitive transcranial magnetic stimulation, HRSD Hamilton Rating Scale for Depression, MADRS Montgomery-Asberg Depression Rating Scale, BDI Beck Depression Inventory, QIDS-C16 Quick Inventory of Depressive Symptomatology, C-SSRS Columbia Suicide Severity Rating Scale, BSS Beck Scale for Suicide Ideation, BHS Beck Hopelessness Scale, VR-36 Veterans RAND 36-Item Health Survey, DAST Drug Abuse Screening Test, PCL Posttraumatic Stress Disorder Checklist, MAST Michigan Alcohol Screening Test, STAXI-2 State Trait Anger Expression Inventory-2, AE adverse events, SAE serious adverse events
  2. *B Baseline
  3. *S Screening
  4. aSessions 21–25 and 26 − 30 may not be required if patient goes into remission earlier
  5. bMust be conducted within 7 days prior to randomization