| Methods |
Randomised controlled trial with concurrent eligible patients outside of the RCT. The non‐RCT patients were not in the trial because the patients or their physician refused randomization, but consented to information extraction from medical records. High risk patients in major surgery. It is unclear but unlikely that there were any losses to follow up. |
| Data |
Characteristics of the non‐randomised patients compared to RCT patients who received the same treatment. RCT control patients were on average 69 (26 to 92) years, 245 men and 177 women. Non‐RCT control patients were on average 68 (30 to 93) years, 43 men and 45 women. |
| Comparisons |
Two RCT arms, the control arm patients were compared with non‐randomised patients who received similar treatment. Experimental: epidural block inserted preoperatively and maintained throughout and for 72 h after surgery, this in addition to general anesthetic during surgery. Control: general anesthetic during surgery and intravenous opioids. |
| Outcomes |
Outcomes were assessed in all patients. Patients were followed for 30 days postoperatively. Main outcome was 30 days mortality. |
| Notes |
The two RCT treatments were similarly effective. |
