Table 3.
Entry | Judgement | Support for judgement |
---|---|---|
Random sequence generation (selection bias) | Low risk |
Quote: “The randomization codes were generated by a computer using a random mixing box” Comment: Probably done |
Allocation concealment (selection bias) | Unclear risk |
Quote: “Concealed in envelops” Comment: Insufficient details to allow definite judgement: Were the envelops sealed and/or sequentially numbered? |
Blinding of participants and personnel (performance bias) | High risk | Comment: No blinding mentioned in terms of allocated interventions (the group of patients), and the lack of blinding is likely to influence the outcomes |
Blinding of outcome assessment (detection bias) (patient-reported outcomes) | Unclear risk |
Quote: “The concealed randomization code was opened by an investigator who was blinded to the treatment results” Comment: Probably referring to the treatment results of the biliary drainage and not the outcomes of the study |
Blinding of outcome assessment (detection bias) (mortality) | High risk | Comment: No blinding mentioned in terms of outcome assessment (the group of patients), and the lack of blinding is likely to influence the outcomes |
Incomplete outcome data addressed (attrition bias) | Low risk | Comment: No missing outcomes reported. Probably true, especially with the low patient number |
Selective reporting (reporting bias) | High risk | Comment: An outcome listed in methods is not described in detail: the overall morbidity and mortality related to acute cholangitis |