Summary of findings 6. Custom foot orthoses compared to prefabricated foot orthoses in children with juvenile idiopathic arthritis and flat feet.
| Custom foot orthoses compared to prefabricated foot orthoses in children with juvenile idiopathic arthritis andflat feet | ||||||
| Patient or population: children with juvenile idiopathic arthritis and flat feet Setting: outpatient rheumatology clinics Intervention: custom foot orthoses (CFO) Comparison: prefabricated foot orthoses (PFO) | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| With PFOs (N = 41) | With CFOs (N = 46) | Difference | ||||
|
Pain
(measured on 0 to 10‐point VAS; lower = less pain) follow‐up: 3 months to 6 months № of participants: 87 (2 RCTs) |
The mean pain with PFOs was 3.22 points | The mean pain with CFOs was 1.74 points | MD 1.48 points lower (3.23 points lower to 0.26 points higher) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in little to no difference in pain. | |
|
Function or disability (measured on 0 to 100‐point FFI; 0 = no disability) follow‐up: 3 months № of participants: 27 (1 RCT) |
The mean FFI score with PFOs was 29.9 points | The mean FFI score with CFOs was 15.6 points | MD 14.38 points lower (30.22 points lower to 1.46 points higher) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in little to no difference in function. | |
|
Quality of life (child‐rated) (measured on 0 to 100‐point PedsQL; higher score = better QoL) follow‐up: 3 months to 6 months № of participants: 83 (2 RCTs) |
The mean child‐rated PedQL score with PFOs was 55.94 points | The mean child‐rated PedQL score with CFOs was 64.58 points | MD 8.64 points higher (3.9 points lower to 21.18 points higher) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in a small improvement in child‐rated QoL. | |
|
Quality of life (parent‐rated) (measured on 0 to 100‐point PedsQL; higher score = better QoL) follow up: 3 months to 6 months № of participants: 84 (2 RCTs) |
The mean parent‐rated PedQL score with PFOs was 55.31 points | The mean parent‐rated PedQL score with CFOs was 58.25 points | MD 2.94 points higher (11 points lower to 16.88 points higher) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in little to no difference in parent‐rated QoL. | |
|
Treatment success (measured on the 50FWT (seconds)) follow‐up: 3 months № of participants: 27 (1 RCT) |
The mean time for the 50FWT with PFOs was 7.98 seconds | The mean time for the 50FWT with CFOs was 7.03 seconds | MD 0.95 seconds lower (1.88 seconds lower to 0.02 seconds lower) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in little to no difference in timed walking | |
|
Withdrawal due to adverse events Follow‐up: № of participants: 87 (2 RCTs) |
RR 0.80 (0.13 to 4.87) | 4.9% | 3.9% (0.6% to 23.8%) | 1.0% fewer (4.2% fewer to 18.9% more) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in little difference in withdrawals due to adverse events. |
| Adverse effects | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
| Serious adverse events | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; FFI: Foot Function Index; 50FWT: 50‐Foot Timed Walk; MD: mean difference; PedsQL: Pediatric quality of life inventory; RR: Risk ratio; VAS: visual analogue scale; QoL: quality of life | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded for bias; single blinded; children and their parents knew which treatment they had, which may have affected the assessment of pain bDowngraded for imprecision due to wide 95% CIs