Coda 2014.

Study characteristics
Methods	Randomised controlled two‐arm parallel trial, single blinded, multi‐centre
Participants	60 children with JIA Ages ‐ 11.17(3.51) control PFOs, 10.64(3.84) fitted PFOs Genders: control PFOs 6M/23F; fitted PFOs 9M/22F Setting: Paediatric Rheumatology hospital clinics Location: Scotland, UK Inclusion criteria: diagnosed with juvenile idiopathic arthritis (JIA; any subtype) according to International League of Associations for Rheumatology criteria, lower extremity joint involvement with disease onset ranging from 5 to 18 years, previous failure of orthotic management in which the child has not worn any foot orthoses for at least 3 months, ability to walk a minimum of 15 metres or more without assistive devices, at least 6 months after start of disease modifying antirheumatic drug therapy Exclusion criteria: inability to walk barefoot or shod, concomitant musculoskeletal disease, central or peripheral nerve disease and endocrine disorders, previous foot surgery, currently using foot orthoses, supply of foot orthoses is contraindicated Baseline characteristics: CPFO group had higher VAS, 14 versus 6.5 in PFO group (NS); CPFO group had 65% oligoarthritis versus PFO 44.8%
Interventions	1. Fitted PFOs, customised in clinic (N = 31) 2. Control PFOs (N = 29) Both PFO types had same black covers to assist blinding
Outcomes	Baseline, 3 and 6 month outcomes ‐ VAS ‐ PedsQL
Source of funding	Queen Margaret University, Edinburgh ‐ PhD scholarship
Notes	Foot posture was not defined Validated outcome measures used
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“After obtaining informed consent, children were randomised in blocks of 10 each by an online computer random number generator (www.randomization.com).”
Allocation concealment (selection bias)	Unclear risk	No specific mention of allocation concealment. Insufficient information to permit judgement of high or low risk
Blinding of participants and personnel (performance bias) All outcomes	High risk	low ‐ ‘The control FOs was made with leather board (1 mm) without corrections. Both FOs had the same black‐ethylene vinyl acetate (EVA) top cover (0.75 mm) to allow for blinding and monitoring the level of adherence to wearing the FOs.’ high ‐ study did not blind investigators to the intervention, and the outcome may be influenced by lack of blinding
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function)	Low risk	Pain measured by participants HRQoL measured by participants and parents/carers Participants and their parents/carers are blinded
Blinding of outcome assessment (detection bias) ‐ objective outcomes	Unclear risk	N/A
Incomplete outcome data (attrition bias) All outcomes	Low risk	‘Overall, 179 out of a possible 180 assessments were completed (99.4%) and accounted for statistical analysis.’ No reason for missing data given and it was not clear from which group and time point the data were missing.
Selective reporting (reporting bias)	Unclear risk	No reference to study protocol. Insufficient information to permit judgement of low risk or high risk.
Other bias	Unclear risk	It is not clear how the orthoses in this study were funded.