Summary of findings 3. Custom foot orthoses compared to prefabricated foot orthoses for children with asymptomatic flat feet.
| Custom foot orthoses compared to prefabricated foot orthoses for children with asymptomatic flat feet | ||||||
| Patient or population: children with asymptomatic flat feet Setting: outpatient clinics Intervention: customised 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 = 54) | With CFOs (N = 54) | Difference (absolute) | ||||
|
Pain
(measured as proportion with pain) follow‐up: 12 months № of participants: 108 (1 RCT) |
RR 0.93 (0.73 to 1.18) | 74% | 68% (51.9% to 85.2%) | 7.4% fewer (22.2% fewer to 11.1% more) | ⊕⊕⊝⊝ Lowa,b | CFOs likely results in little to no difference in the proportion of children reporting pain. Absolute reduction 7.4% (22.2 % fewer to 11.1 % more) |
| Function or disability | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
| Quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
| Treatment success | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
|
Withdrawal due to adverse events
follow up: 12 months № of participants: 118 (1 RCT) |
RR 1.00 (0.90 to 1.12) | 91.5% | 91.5% (82.4% to 100%) | 0.0% fewer (9.2% fewer to 11% more) | ⊕⊕⊝⊝ Lowa,b | The evidence suggests that CFOs do not increase or reduce withdrawal due to adverse events. |
| 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; RR: Risk ratio | ||||||
| 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, (performance, other bias), participants, parents, and examiners not blinded; pain only assessed post hoc, as subgroup analysis bDowngraded for imprecision; wide 95% CI for CFO as intervention