| Paquet 2014 |
High risk of bias |
‐Seems to be alternate allocation rather than truly random. Quote: "The patients were randomized alternatively in one of two groups", "successive randomized TEN patients"
‐Illness auxiliary scores at admission are similar. No other baseline characteristics are described per group. |
Some concerns |
No mention of blinding of carers. Quote: "Each drug was administered intravenously (IV). NAC diluted in 5% glucose solution was administered at decreasing doses over a 20‐h period [...] In addition, IV infliximab was administered at a 5 mg/kg dosage as a single IV shot over a 2‐h period."
No evidence to suggest any deviations from the intended intervetion because of the trial context.
All participants analysed according to the group to which they were randomised and all participants received allocated intervention. |
Low risk of bias |
‐Data are available for all participants for the outcome of disease‐specific mortality. |
Low risk of bias |
‐Outcome is mortality so it would be measured the same way regardless of intervention group.
‐Mortality is unlikely to have been influenced if outcome assessors were aware of group allocation. |
Low risk of bias |
‐No pre‐specified analysis plan was reported ; however, the only outcome used from this study was mortality rate which is reasonable to assume was an important outcome identified a priori as it is the most significant outcome for SJS‐TEN |
High risk of bias |
The study is judged to be at high risk of bias in at least one domain for this result. |
