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]

Table 1 SPIRIT table for study procedure

	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	T1^a	T2^b	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

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
T1^a randomisation was triggered by the intervention clinician at the first clinical visit using the online system
T2^bfor customised FO group, manufacture required an additional fitting appointment approximately 2 weeks following clinical visit 1