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. 2022 Jan 14;2022(1):CD006311. doi: 10.1002/14651858.CD006311.pub3

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 evidenceHigh 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