On 2013 Jun 23, Hilda Bastian commented:

This trial bears the predominant weight for safety concerns about single-session debriefing in a subsequent influential systematic review (Rose S, 2002, of which the lead trialist here is an author). Its results are potentially affected by multiple serious biases.

The trial had a high attrition rate (>22%): 23 lost to follow-up (p78 - participants) and 7 who left hospital before intervention (p78 - results). The number of events was low.

This trial report does not include an intention-to-treat analysis (ITT). ITT was imputed in the systematic review (Rose S, 2002), without description of the additional data or reporting the methods used, and whether or not sensitivity analyses were conducted.

The intervention group was at higher risk of the event at baseline (25% of the intervention arm had others involved in the trauma vs 4% in the control arm, p=0.01; percentage of the body burned, life threat and past significant trauma were also higher, although not significantly so).

There was a disproportionately large number in the intervention group (64 vs 46), due to the method of randomization and having stopped the trial early.

On 2013 Jun 23, Hilda Bastian commented:

This trial bears the predominant weight for safety concerns about single-session debriefing in a subsequent influential systematic review (Rose S, 2002, of which the lead trialist here is an author). Its results are potentially affected by multiple serious biases.

The trial had a high attrition rate (>22%): 23 lost to follow-up (p78 - participants) and 7 who left hospital before intervention (p78 - results). The number of events was low.

This trial report does not include an intention-to-treat analysis (ITT). ITT was imputed in the systematic review (Rose S, 2002), without description of the additional data or reporting the methods used, and whether or not sensitivity analyses were conducted.

The intervention group was at higher risk of the event at baseline (25% of the intervention arm had others involved in the trauma vs 4% in the control arm, p=0.01; percentage of the body burned, life threat and past significant trauma were also higher, although not significantly so).

There was a disproportionately large number in the intervention group (64 vs 46), due to the method of randomization and having stopped the trial early.