TABLE 2. Quality assessment of the overall literature pool by outcome categorya.
| Treatment | Number of participants completed (number of studies) | Confidence in estimate of effectb | Reported studies safety grade (number of studies)/overall safetyc | Strength of the recommendationd |
|---|---|---|---|---|
| Mild TBI | ||||
| Cognitive | ||||
| HBO2 vs sham | 183 (3) | A | +2(2)/0 overall | Weak recommendation against |
| HBO2 vs “standard care” | 72 (1) | B | +2(1) | No recommendation |
| Postconcussive symptom severity | ||||
| HBO2 vs sham | 133 (2) | A | +2(1)/0 overall | Weak recommendation against |
| HBO2 vs “standard care” | 72 (1) | B | +2(1) | No recommendation |
| Psychological | ||||
| HBO2 vs sham | 183 (3) | A | +2(2)/0 overall | Weak recommendation against |
| HBO2 vs “standard care” | 72 (1) | B | +2(1) | No recommendation |
| Moderate-to-severe TBI | ||||
| Alterations in the level of consciousness | ||||
| HBO2 vs “standard care” | 219 (4) | C | 0 | Weak recommendation in favor |
| Intracranial pressure | ||||
| HBO2 vs “standard care” | 237 (2) | B | 0 | No recommendation |
| Glasgow Outcome Scale and mortality | ||||
| HBO2 vs “standard care” | 357 (5) | C | 0 | Weak recommendation in favor |
Abbreviations: HBO2, hyperbaric oxygen; TBI, traumatic brain injury.
aThis analysis usually also incorporates overall effect size according to outcomes; because of the heterogeneity among the studies and poor reporting, this was not done.
bFurther research is very unlikely to change our confidence in the estimate of effect (A); further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate (B); further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate (C); any estimate of effect is very uncertain (D).
cSafety grade ranges from +2 appears safe with infrequent adverse events and interactions to −2 appears to have serious safety concerns that include frequent and serious adverse events and/or interactions.
dStrength of recommendation ranges from “strong recommendation in favor”—SME is very certain that benefits do outweigh risks and burdens—to “strong recommendation against”—SME is very certain that benefits do not outweigh the risks and burdens.