Table 8:
GRADE Evidence Profile for Comparison of HBOT and Standard Care on Minor Amputations
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| 4 (RCTs) | Serious limitations (−1)a | Serious limitations (−1)b | Serious limitations (−1)c,d | No serious limitations | Undetected | No other considerations | ⊕ Very Low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; HBOT, hyperbaric oxygen therapy; RCT, randomized controlled trial.
Unclear allocation concealment, unclear blinding, and a lack of intention-to-treat analyses.
No trend in estimates; some studies had more minor amputations in the HBOT group, and others had more minor amputations in the standard care group.
The interventions varied across studies in terms of how many sessions were given (35–60), how many sessions occurred daily (1 vs. 2), and whether treatment was given in a monoplace or multiplace hyperbaric chamber.
Standard care was not delivered to the control groups in the same way across studies, and several standard care treatment protocols did not meet standard wound care guidelines. Fedorko et al was not included because their definition of minor amputation was not consistent with that of other studies.