Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|---|---|---|---|
intake randomization | pre-Tx anamnestic and clinical data from blinded assessor | anamnestic and clinical data from clinician | post-Tx anamnestic and clinical data from blinded assessor | follow-up: anamnestic and clinical data from blinded assessor |
list of baseline reference items from investigator (based on data from assessor) | TDC from clinician, using list of investigator (data from assessor), and possibly based on added reference items from clinician | TDC from investigator based on assessor’s data; short-term outcome of RCT: if TDC ≤ -0.379 and no *application of discrepancy rule from anamnesis: Tx successful for short-term RCT-outcome, and patient continues to follow-up (stage 5); otherwise, Tx unsuccessful | TDC from investigator, based on assessor’s data; long-term outcome of RCT: if TDC ≤ -0.379 and no *application of discrepancy rule from anamnesis: Tx successful; otherwise, Tx unsuccessful | |
start of Tx by clinician | if TDC > -0.212 (after Tx-specific minimal Tx-duration), Tx ended unsuccessfully (insufficiently responsive patient), patient referred to blinded assessor (stage 4) | **if TDC from clinician > -0.379, while TDC from investigator ≤ -0.379 and no *application of discrepancy rule from anamnesis: Tx successful for short-term RCT-outcome, and patient continues on observation for follow-up (stage 5; TMD, not life-threatening) | ||
if TDC ≤ -0.379, at two successive visits (interval of 3-6 weeks) and no *application of discrepancy rule from anamnesis: Tx successful according to clinician, patient referred to blinded assessor (stage 4) | ||||
otherwise, Tx continued if the pre-set maximal treatment duration is not exceeded; then patient referred to blinded assessor (stage 4) |