Tsui 2010.
| Methods | Secondary data analysis of a single‐centre RCT | |
| Participants | 99 adult male patients undergoing radical prostatectomy and bilateral lymphadenectomy for adenocarcinoma of the prostate | |
| Interventions | Intraoperative general anaesthesia + epidural analgesia vs general anaesthesia alone (IV morphine) | |
| Outcomes | Clinical evidence or biochemical recurrence of prostate cancer (defined as PSA > 0.2 ng/mL) | |
| Notes | 102 participants randomly assigned in prospective single‐centre trial; 99 completed the protocol | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Based on a computer‐generated table of random numbers, participants were block randomly assigned (block size = 10) |
| Allocation concealment (selection bias) | Low risk | Blinded study envelopes, which were opened immediately before surgery. Then, treatment allocation is predictable towards the end of a block of 10 if block size is known |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and caregivers were not blinded. Likely no influence on outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Treatment allocation was temporarily removed from the data set during the censoring process in an attempt to make it as non‐informative as possible |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 102 participants were randomly assigned, 51 to each group. It was not possible to site the epidural catheter for two participants in the epidural group, and one participant with renal failure was recruited to the control group in violation of protocol. These 3 participants were excluded from the study (no data available) In 22 cases (14 participants in the study group and eight in the control group), outcome data (PSA) were not available after hospital discharge. These participants were effectively removed from the analysis by right‐censoring on the day of hospital discharge Missing outcome data are unlikely to be related to survival outcomes |
| Selective reporting (reporting bias) | Unclear risk | Published article uses 'survival,' 'disease‐free survival' and 'recurrence' to describe outcomes. It remains unclear whether these terms are used interchangeably or if 'survival' as used in the methods section was a predefined outcome that then was not reported |
| Other bias | Unclear risk | Progress of participants through the trial flow chart (Figure 1) is inconsistent in terms of numbers of included patients. The breakdown of the general anaesthesia group (n = 50) calculates to 54 participants, and it is unclear how this mismatch might influence data analysis Outcome definition does not match any of the standardized outcomes used for this review. The wording appears to come closest to our outcome of 'time to tumour progression (TTP)' = time elapsed between surgery and tumour progression, with the difference that prostate cancer–related deaths were considered to show tumour progression. However, only one participant in each group died of prostate cancer and was included in the calculation of TTP |
RCT = randomized controlled trial.
ASA = American Society of Anesthesiologists physical status classification.
IV = intravenous.
IM = intramuscular.
PSA = prostate‐specific antigen.
TTP = time to progression.
TTR = time to recurrence