Wee 2013.
Methods | Parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: ‐ Number analysed: ‐ Famotidine
Pantoprazole
Inclusion criteria: each patient admitted to ICU/CCM Exclusion criteria: ‐ Baseline imbalances: Both groups had similar baseline characteristics including risk factors for SRMB (2.7 vs 2.7, P = 0.50); however, the pantoprazole group had higher APACHE‐II scores (23.9 vs 20.1; :P < 0.01) |
|
Interventions |
Famotidine
Pantoprazole
Adherence to regimen: ‐ Duration of trial: December 2012 to April 2013 Duration of follow‐up: until discharge |
|
Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought in review and not reported in trial
Outcomes reported in trial, but not used in review ‐ |
|
Notes |
Setting: ICU/CCU, Kingsbrook Jewish Medical Center, Brooklyn, NY 11203, USA, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USA Sponsorship source: ‐ Conflicts of interest: ‐ Comments: 2 conference abstracts reporting on 1 study Ethical approval: Quote: "Expedited IRB approval was granted" Informed consent: Quote: "Informed consent was not required" Sample size calculation: ‐ Clinical trials registration: ‐ |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized" Comment: not enough details reported |
Allocation concealment (selection bias) | Unclear risk | Comment: no information reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: no information on blinding reported. Lack of blinding is unlikely to introduce bias to outcome measures and outcomes |
Blinding (detection bias) Clinically important upper GI bleeding | Unclear risk | Comment: not enough details described |
Blinding (detection bias) Nosocomial pneumonia | Unclear risk | Comment: Study did not address this outcome |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Unclear risk | Comment: no information on blinding of outcome assessors reported. Lack of blinding might potentially introduce bias |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: conference abstracts. Not enough information reported to assess incomplete outcome data |
Selective reporting (reporting bias) | Unclear risk | Comment: Secondary outcomes listed in the Methods sections of the two abstracts differ slightly. Not enough information reported to assess selective outcome reporting |
Other bias | Unclear risk | Comment: not enough information reported to assess other sources of bias |