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Table 1 SPIRIT table for study procedure

From: A protocol for a randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: the FOCOS RA trial [Foot Orthoses – Customised v Off-the-Shelf in Rheumatoid Arthritis]

  Pre-study screening/consent Baseline Randomisation /Clinical visit 1 Clinical visit 2 Clinical visit 3 6 months follow up 12 months follow up
−1 0 T1a T2b T3 F1 F2
Enrolment
 Eligibility screen X       
 Informed consent X       
 Allocation    X     
Measurements
 FFI pain   X     X X
 FFI disability   X     X X
 FFI functional limitation   X     X X
 FIS-RA   X     X X
 EQ-5D-5 L   X     X X
 HAQ   X     X X
 DAS-28   X     X X
 CSRI       X X
Interventions
 Customised foot orthoses    X X X   
 Prefabricated foot orthoses    X   X   
  1. FFI Foot function index, FIS-RA Foot impact scale for rheumatoid arthritis, HAQ Health assessment questionnaire, DAS-28 disease activity score 28 joints, CSRI Client service receipt inventory
  2. T1a randomisation was triggered by the intervention clinician at the first clinical visit using the online system
  3. T2bfor customised FO group, manufacture required an additional fitting appointment approximately 2 weeks following clinical visit 1