Table 2.
GRADE evidence profile.
| Quality Assessment | Nº of Patients/Participants | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nº of Studies | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Other Considerations | Customized AM AFO | Traditional Thermoformed Polypropylene AFO |
Relative (95% CI) | Absolute (95% CI) | ||
| Walking ability through biomechanical tests (kinematics, kinetics, EMG) | ||||||||||||
| 12 | Observational studies [15,22,23,26,28,29,30,31,32,33,34,35] | serious a,b | not serious | Serious a | not serious | none | 66 g | 9 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
| Durability through a mechanical test | ||||||||||||
| 5 | Observational studies [15,19,20,21,22] | not serious | not serious | serious a,c | serious d | none | 16 | 2 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
| Durability through observation after trial | ||||||||||||
| 2 | Observational studies [27,36] | very serious e | not serious | not serious | serious d | none | 8 | 7 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
| Patient satisfaction assessed with the QUEST | ||||||||||||
| 2 | Observational studies [15,28] | serious f | not serious | not serious | serious a,d | none | 2 | 1 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
| Comfort through participant/patient feedback | ||||||||||||
| 6 | Observational studies [19,22,24,25,26,27] | very serious b,e | not serious | serious a | serious d | none | 17 | 1 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
| Dimensional accuracy through FaroArm (fit with a 3 mm spherical tip) | ||||||||||||
| 1 | Observational studies [25] | not serious | not serious | serious a | serious d | none | 1 | 0 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
| Material strength and AFO behavior simulation assessed by FEM analysis | ||||||||||||
| 3 | Observational studies [19,21,23] | serious d | not serious | serious a | serious d | none | 3 | 1 | -- | -- | ⨁◯◯◯ VERY LOW |
Important |
CI Confidence Interval. a Not all studies compared to traditionally thermoformed polypropylene AFOs; b Differences in type of Participants/Patients conditions; c Differences in type of AM/Traditional AFO assessed; d Participants/Patients number assessed low; e No quantitative assessment; f No blinding of AFOs; g Sarma et al. [23] does not reference the exact number of participants, so the value of 1 element was considered.