| Methods |
Randomised controlled trial with stratification. No blinding reported. 60 patients, 31 HBOT, 29 control. Inclusion depended on availability of hyperbaric chamber. |
| Participants |
Patients with closed head injury and coma. Stratified in 9 subgroups of severity and pathology. |
| Interventions |
HBOT 2.5 ATA for 1 hour daily for 10 days, followed by 4 days rest and repeat if not responding. Standard care included hyperventilation and frusemide. |
| Outcomes |
Death, unfavourable outcome, adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described in the text: "Afterwards, the patient was selected randomly.... for OHP therapy or standard therapy". |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated, although quite probable given the methodology: "Once he was admitted to the study, a patient was assigned to one of nine subgroups.....Afterwards, the patient was selected randomly.... for OHP therapy or standard therapy". |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not described and appears unlikely. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No losses to follow‐up. |
| Selective reporting (reporting bias) |
Unclear risk |
Outcomes for consideration were not clearly stated. |
| Other bias |
High risk |
60 of a potential 185 patients were entered. Entry to study depended on availability of the chamber. |
