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Table 3 Procedure of a randomized controlled trial with variable treatment duration, for myogenous TMD

From: The index ‘Treatment Duration Control’ for enabling randomized controlled trials with variation in duration of treatment of chronic pain patients

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)   
  1. Stage 3, period of treatment (Tx) with a Tx-specific range of possible Tx-duration. Stage 5, follow-up, half a year and a year respectively following the end of a treatment that is successful in the short-term (stage 4). TDC, the index ‘Treatment Duration Control’. TMD, Temperomandibular Disorders. *application of discrepancy rule from anamnesis: if overall TDC ≤ -0.379 (successful Tx) while TDC solely based on anamnestic items >-0.212 (Tx with insufficient effect according to the patient), Tx was considered as being unsucessful. **this rule needed not to be applied in the present study as a discrepancy did not occur between a TDC-based outcome on treatment success from the clinician and the investigator (based on the assessor’s data). For further explanation, see text.