Table 9:
GRADE Evidence Profile for Total Contact Casting Versus Therapeutic Shoes
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Percentage of Patients with a Healed Ulcer | |||||||
| 5 (RCTs)16,31,35,38,39 | No serious limitations | No serious limitations | Serious limitations (−1)a | No serious limitations | Undetected | None | ⊕⊕⊕ Moderate |
| Time to Healing (Kaplan-Meier Analysis) | |||||||
| 1 (RCT)38 | No serious limitations | Could not be evaluated | Serious limitations (−1)a | No serious limitations | Undetected | None | ⊕⊕⊕ Moderate |
| Patient Satisfaction With Treatment | |||||||
| 2 (RCTs)16,31 | No serious limitations | No serious limitations | Serious limitations (−1)a | Serious limitations (−1)b | Undetected | None | ⊕⊕ Low |
| Quality of Life | |||||||
| 1 (RCT)40 | No serious limitations | Could not be evaluated | Serious limitations (−1)a | Very serious limitations (−2)c | Undetected | None | ⊕ Very Low |
| Complications | |||||||
| 5 (RCTs)16,31,35,38,39 | No serious limitations | No serious limitations | Serious limitations (−1)a | Very serious limitations (−2)d | Undetected | None | ⊕ Very Low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial.
a
Different types of therapeutic shoes were used in the studies; the results with one type of shoe may not be applicable to other types.
b
Some of the studies did not find a statistically significant difference between study groups.
c
No statistically significant difference between groups. Only one small study (21 patients/study group) assessed the outcome.
d
Very few events reported in the studies, leading to very low statistical power to detect a difference between groups.