GRADE evidence profile: customised foot orthoses compared with prefabricated foot orthoses
| Quality assessment | Limitations | Inconsistency | Indirectness | Imprecision | Publication bias | Summary of findings | Effect size (95% CI) | GRADE | ||
| Outcome | No of trials | Participants | ||||||||
| Foot orthoses | Sham | |||||||||
| Pain | ||||||||||
| Short term | 227 38 | Very serious limitations* | No serious inconsistency | No serious indirectness | Serious imprecision † | Undetected | 97 | 93 | SMD −0.04 (−0.33 to 0.24) | Very low |
| Medium term | 426 27 38 44 | Serious limitations‡ | No serious inconsistency | No serious indirectness | Serious imprecision † | Undetected | 214 | 199 | SMD −0.07 (−0.26 to 0.12) | Low |
| Longer term | 126 | No serious limitations | Serious inconsistency § | No serious indirectness | Very serious imprecision ¶ | Undetected | 46 | 44 | SMD 0.04 (−0.38 to 0.45) | Very low |
| Function | ||||||||||
| Short term | Nil | – | – | – | – | – | – | – | – | – |
| Medium term | 226 27 | Serious limitations‡ | No serious inconsistency | No serious indirectness | Serious imprecision † | Undetected | 62 | 59 | SMD −0.06 (−0.39 to 0.27) | Low |
| Longer term | Nil | – | – | – | – | – | – | – | – | – |
*All participants from trials at high risk of bias.
↵†CIs are narrow; however, the upper and lower boundaries represent different conclusions regarding the true effect.
↵‡>25% of participants from trials at high risk of bias.
↵§Point estimates vary with high I2.
↵¶Recommendation from one trial and CIs represent different conclusions regarding the true effect.
GRADE, Grading Recommendations Assessment, Development and Evaluation; SMD, standardised mean difference.