Summary of findings 2. Prefabricated foot orthoses compared to shoes in children with asymptomatic flat feet.
Prefabricated foot orthosescompared to shoes in children with asymptomatic flat feet | ||||||
Patient or population: children with asymptomatic flat feet Setting: outpatient hospital clinic 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 = 52) | With PFOs (N = 54) | Difference (absolute) | ||||
Pain
(measured as proportion with pain) follow‐up: 12 months № of participants: 106 (1 RCT) |
RR 0.94 (0.76 to 1.16) | 78.8% | 74.1% (59.9 to 91.5) | 4.7% fewer (18.9% fewer to 12.6% more) | ⊕⊕⊝⊝ Lowa,b | PFOs likely result in little to no difference in the proportion of children reporting pain, absolute reduction 4.7% (18.9% fewer to 12.6% 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: 338 (4 RCTs) |
RR 0.99 (0.79 to 1.23) | 72.3% | 71.6% (57.1% to 88.9%) | 0.7% fewer (15.2% fewer to 16.6% more) | ⊕⊝⊝⊝ Very lowa,b,c | We are uncertain of the effects of PFOs on withdrawal due to adverse events. Absolute reduction 0.7% (15.2 fewer to 16.6 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; 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, attrition, other bias), participants, parents, and examiners not blinded; pain only assessed post hoc, as subgroup analysis; high attrition in some trials (notably Gould 1989) bDowngraded for imprecision; wide 95% CI for intervention cDowngraded for indirectness; variably aged participant samples between studies