GRADE evidence profile: real foot orthoses compared with sham 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 | 325 27 50 | Serious limitations* | Serious inconsistency † | No serious indirectness | Serious imprecision ‡ | Undetected | 103 | 70 | SMD −0.13 (−0.94 to 0.68) | Very low |
Medium term | 325–27 | No serious limitations | No serious inconsistency | No serious indirectness | Serious imprecision § | Undetected | 173 | 106 | SMD −0.27 (−0.51 to −0.02) | Moderate |
Longer term | 225 26 | No serious limitations | Serious inconsistency ¶ | Serious indirectness ** | Serious imprecision ‡ | Undetected | 127 | 83 | SMD −0.23 (−0.82 to 0.37) | Very low |
Function | ||||||||||
Short term | Nil | – | – | – | – | – | – | – | – | – |
Medium term | 325–27 | No serious limitations | No serious inconsistency | No serious indirectness | Serious imprecision ‡ | Undetected | 158 | 99 | SMD −0.17 (−0.41 to 0.08) | Moderate |
Longer term | 225 26 | No serious limitations | No serious inconsistency | Serious indirectness ** | Serious imprecision ‡ | Undetected | 127 | 83 | MD −0.21 (−0.49 to 0.07) | Low |
*>25% of the participants from trials at high risk of bias.
†CIs show no overlap.
↵‡Wide confidence intervals with the upper and lower boundaries representing different conclusions regarding the true effect.
↵§The upper and lower boundaries represent different conclusions regarding the true effect.
↵¶Point estimates vary with high I2.
↵**Trial endpoints vary with one trial ending at 24 weeks and the other 52 weeks.
GRADE, Grading Recommendations, Assessment, Development and Evaluation; MD, mean difference; SMD, standardised mean difference.