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. 2018 Oct 31;2018(10):CD001023. doi: 10.1002/14651858.CD001023.pub3

Rosemurgy 2012.

Methods Randomised clinical trials
Participants Country: USA
Number randomised: 132 participants
Intention‐to‐treat analysis
Mean age 54 ± 14 years for H‐shunt and 55 ± 12 years for TIPS
Maximal duration of follow‐up: 18 years
Inclusion criteria
Child‐Pugh A, B, C cirrhosis and portal hypertension with variceal or portal gastropathy bleeding who have failed or not candidates for endoscopic therapy. Median MELD score 13
Exclusion criteria
Participants with unfavourable anatomy or unlikely to survive because of profound ill‐health or hepatic dysfunction were excluded.
Interventions TIPS (66), H‐graft shunt 8mm (66)
Intervention performed as a definitive procedure, never as a bridge to transplantation
Outcomes Mortality, variceal rebleeding, shunt occlusion, liver failure requiring transplantation, inability to accomplish shunting, ascites, and encephalopathy
Notes Shunt failure was referred to as mortality, variceal rebleeding, irreversible shunt occlusion, liver failure requiring transplantation, and inability to accomplish shunting.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised randomisation by parallel allocation
Allocation concealment (selection bias) Low risk Computer generated sequential allocation
Blinding of participants and personnel (performance bias) 
 All‐cause mortality; serious adverse events, variceal rebleed‐related mortality, variceal rebleeding, non‐serious adverse events. Unclear risk Participants were blinded to the intervention received. The surgeon was only blinded to the type of shunt to be assigned. Given the nature of the interventions, it was unrealistic to blind participants to the intervention received
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Personnel were blinded to the intervention received. "A senior faculty hepatologist/gastroenterologist was "blinded" to the intervention received and evaluated participants for encephalopathy during the clinic visits".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat principle used for data analysis
Selective reporting (reporting bias) Low risk Trial protocol was not found but predetermined outcomes in methods section were all reported
Other bias Low risk Trial supported by institutional grant