Table 4:
GRADE Evidence Profile for Comparison of HBOT and Standard Care on Ulcers Healed
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| 4 (RCTs) | Serious limitations (−1)a | No serious limitationsb | Serious limitations (−1)c,d | No serious limitationse | Undetected | No other considerations | ⊕⊕ Low |
| 1 (NRCT)34 | No serious limitations | No serious limitations | No serious limitations | No serious limitations | Undetected | No other considerations | ⊕⊕ Low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; HBOT, hyperbaric oxygen therapy; NRCT, nonrandomized controlled trial; RCT, randomized controlled trial.
Unclear allocation concealment, unclear blinding, and a lack of intention-to-treat analyses.
Including Duzgun et al29 makes the I2 value jump from 0% to 80%.
The interventions varied across studies in terms of how many sessions were given (20–60), 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.
The overall result may be inflated as one study (Duzgun et al29) reported no ulcers healed in the standard care group, which may not be accurate.