Summary of findings 5. Prefabricated foot orthoses compared to shoes in children with juvenile idiopathic arthritis and flat feet.
| Prefabricated foot orthoses compared to shoes in children with juvenile idiopathic arthritis andflat feet | ||||||
| Patient or population: children with juvenile idiopathic arthritis and flat feet Setting: outpatient rheumatology clinics Intervention: prefabricated foot orthoses (PFO) Comparison: shoes | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| With shoes (N = 12) | With PFOs (N = 12) | Difference | ||||
|
Pain
(measured on 0 to 10‐point VAS; lower = less pain) follow‐up: 3 months № of participants: 25 (1 RCT) |
The mean pain with shoes was 2.82 points | The mean pain with PFOs was 2.84 points | MD 0.02 points higher (1.94 points lower to 1.98 points higher) | ⊕⊝⊝⊝ Very lowa,b,c | PFOs likely 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: 25 (1 RCT) |
The mean FFI score with shoes was 34.15 points | The mean FFI score with PFOs was 38.32 points | MD 4.17 points lower (24.4 points lower to 16.06 points higher) | ⊕⊕⊝⊝ Lowa,c | PFOs likely result in little to no difference in function or disability. | |
|
Quality of life (child‐rated) (measured on 0 to 100‐point PedsQL; higher score = better QoL) follow up: 3 months № of participants: 22 (1 RCT) |
The mean child‐rated PedQL score with shoes was 59.78 points | The mean child‐rated PedQL score with PFOs was 37.99 points | MD 3.84 points on PedsQL lower (19.01 lower to 11.33 higher) | ⊕⊕⊝⊝ LOW 1 3 | PFOs likely results in little to no difference in child‐rated QoL. | |
|
Quality of life (parent‐rated) (measured on 0 to 100‐point PedsQL; higher score = better QoL) follow‐up: 3 months № of participants: 22 (1 RCT) |
The mean parent‐rated PedQL score with shoes was 55.95 points | The mean parent‐rated PedQL score with PFOs was 56.59 points | MD 0.64 points lower (13.22 points lower to 11.94 points higher) | ⊕⊕⊝⊝ Lowa,c | PFOs likely results in little to no difference in parent‐rated QoL. | |
|
Treatment success (measured on the 50FWT (seconds)) follow‐up: 3 months № of participants: 25 (1 RCT) |
The mean time for the 50FWT with shoes was 8.36 seconds | The mean time for the 50FWT with PFOs was 7.98 seconds | MD 0.38 seconds lower (1.9 seconds lower to 1.14 seconds higher) | ⊕⊕⊝⊝ Lowa,c | PFOs likely results in little to no difference in timed walking. | |
|
Withdrawal due to adverse events
follow‐up: № of participants: 25 (1 study) |
RR 0.72 (0.14 to 3.61) | 23.1% | 16.6% (3.2% to 83.3%) | absolute difference 6.5% less (19.8% less to 60.2 % more) |
‐ | PFOs likely results in little to no difference in withdrawals due to adverse events. Absolute reduction 6.5% (19.8% fewer to 60.2% more) |
| Adverse events | ‐ | ‐ | ‐ | ‐ | ‐ | 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 their assessment of pain bDowngraded for indirectness; only short‐term outcomes (3 months); FFI not validated in children; PedsQL had no foot‐related data cDowngraded for imprecision; small sample size