Summary of findings 4. Custom foot orthoses compared to shoes in children with juvenile idiopathic arthritis and flat feet.
| Custom foot orthoses compared to shoes in children with juvenile idiopathic arthritis andflat feet | ||||||
| Patient or population: children with juvenile idiopathic arthritis (JIA) and flat feet Setting: outpatient rheumatology clinics Intervention: custom foot orthoses (CFO) Comparison: shoes | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| With shoes (N = 13) | With CFOs (N = 15) | Difference | ||||
|
Pain
(measured on 0 to 10‐point VAS; lower = less pain) follow‐up: 3 months № of participants: 28 (1 RCT) |
The mean pain with shoes was 2.82 points | The mean pain with CFOs was 1.32 points | MD 1.5 points lower (2.78 points lower to 0.22 points lower) | ⊕⊝⊝⊝ Very lowa,b,c | CFOs likely results 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: 28 (1 RCT) |
The mean FFI score with shoes was 34.15 points | The mean FFI score with CFOs was 15.6 points | MD 18.55 points lower (34.42 points lower to 2.68 points lower) | ⊕⊕⊝⊝ Lowa,b | CFOs may result in a clinically important improvement 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: 25 (1 RCT) |
The mean child‐rated PedQL score with shoes was 59.78 points | The mean child‐rated PedQL score with CFOs was 47.68 points | MD 12.1 points higher (1.6 points lower to 25.8 points higher) | ⊕⊕⊝⊝ Lowa,c | CFOs may result in a clinically important 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 № of participants: 26 (1 RCT) |
The mean parent‐rated PedQL score with shoes was 55.95 points | The mean parent‐rated PedQL score with CFOs was 46.94 points | MD 9.01 points higher (4.08 points lower to 22.1 points higher) | ⊕⊕⊝⊝ Lowa,c | CFOs may result in a clinically important improvement in parent‐rated QoL. | |
|
Treatment success (measured on the 50FTW (seconds)) follow‐up: 3 months № of participants: 28 (1 RCT) |
The mean time for the 50FTW with shoes was 8.36 seconds | The mean time for the 50FTW with CFOs was 7.03 seconds | MD 1.33 seconds less (2.77 seconds less to 0.11 seconds more) | ⊕⊕⊝⊝ Lowa,c | CFOs likely result in little to no difference in timed walking. | |
|
Withdrawal due to adverse events
follow‐up: № of participants: 28 (1 study) |
RR 0.58 (0.11 to 2.94) | 23.1% | 13.4% (2.5% to 67.8%) | absolute difference 9.7% fewer (20.5% fewer to 44.8% more) |
⊕⊕⊝⊝ Lowa,c | CFOs likely result in little to no difference in withdrawals due to adverse events. Absolute reduction 9.7% (20.5 % fewer to 44.8% 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; 50FTW: 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 indirectness; only short‐term outcomes (3 months); FFI not validated in children; PedsQL has no foot‐related data cDowngraded for imprecision; small sample size and wide CI including both an increase and decrease in the effect estimate