Summary of findings 7. Prefabricated foot orthoses compared to shoes in children with symptomatic flat feet.

Prefabricated foot orthoses compared to shoes in children with symptomatic flat feet
Patient or population: children with symptomatic 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 = 26)	With PFOs (N = 26)	Difference
Pain	‐	‐	‐	‐	‐	not reported
Function or disability (global function assessed with 0 to 100‐point PODCI; higher scores = better functioning) follow‐up: mean 12 weeks № of participants: 52 (1 RCT)		The mean PODCI score with shoes was 0.7 points	The mean PODCI score with PFOs was 3.7 points	MD 3 points higher (2.28 points higher to 3.72 points higher)	⊕⊕⊝⊝ Lowa.b	The evidence suggests that PFOs results in little to no difference in function
Quality of life (measured on 0 to 100‐point PedsQL; higher score = better QoL) follow‐up: mean 12 weeks № of participants: 52 (1 RCT)		The mean PedQL score with shoes was ‐1.1 points	The mean PedQL score with PFOs was 2.9 points	MD 1.8 points higher (1.07 points higher to 2.53 points higher)	⊕⊕⊝⊝ Lowa,b	The evidence suggests that PFOs results in little to no difference in quality of life
Treatment success	‐	‐	‐	‐	‐	not reported
Withdrawal due to adverse events	‐	‐	‐	‐	‐	not reported
Adverse effects	‐	‐	‐	‐	‐	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; MD: mean difference; PODCI: Pediatrics Outcomes Data Collection Instrument; 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 (participants and parents aware of treatment received; selective reporting of outcomes, as the published study included more outcomes than were listed in the trial registry (ClinicalTrials.gov NCT02414087))
^bDowngraded for imprecision due to small sample size, small effects across scaled outcome measures