Table 2 GRADE evidence profile
Quality assessment | № of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
№ of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | AFOs manufactured using 3D printing techniques | Traditionally manufactured AFOs | Relative (95% CI) | Absolute (95% CI) | ||
Walking ability (assessed by 3D gait analysis) | ||||||||||||
5 | observational studies 1,2,3,4,5 | serious a,b,c | not serious | serious 1,5,6,7 a,b | serious d | none | 20 | 11 | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Patient perceived comfort (assessed by interview) | ||||||||||||
2 | observational studies 2,8 | very serious e | not serious | serious a | serious d | none | Interview after use of AFO during gait | ⨁◯◯◯ VERY LOW | IMPORTANT | |||
Patient satisfaction (assessed with the QUEST) | ||||||||||||
2 | observational studies 4 | very serious f | not serious | not serious | serious d | none | 1 | 1 | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Bending stiffness (assessed by bench testing using custom stiffness testing device) | ||||||||||||
3 | observational studies 6,9,10 | serious a,c,g | not serious | serious a | serious d | none | 3 | 1 | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Energy Dissipation (assessed by bending testing and analysing the resulting acceleration-time trajectory) | ||||||||||||
1 | observational studies 6 | not serious | not serious | serious a | serious d | none | 1 | 1 | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Destructive Testing (assessed by benching testing using a hydraulic axial load cell) | ||||||||||||
1 | observational studies 4 | not serious | not serious | serious a | serious d | none | 1 | 1 | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Dimensional accuracy between CAD model and printed AFO (assessed by the FaroArm, fit with a 3 mm spherical tip) | ||||||||||||
1 | observational studies 8 | serious h | not serious | serious a | serious d | none | 2 | – | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Durability (assessed by mechanical stress test of 300,000 cycles) | ||||||||||||
1 | observational studies 4 | serious a | not serious | serious a | serious d | none | 2 | – | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Durability (follow up: 6 weeks; assessed by observation) | ||||||||||||
1 | observational studies 11 | serious d,e | not serious | not serious | serious d | none | 7 | 7 | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |
Material displacement (assessed by finite element analysis) | ||||||||||||
1 | observational studies 7 | serious h,i | not serious | serious a | serious d | none | 1 | – | – | – | ⨁◯◯◯ VERY LOW | IMPORTANT |