Ali 2016.
Methods | Parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 10 participants Number analysed: 10 participants Pantoprazole
Placebo
Inclusion criteria
Exclusion criteria: ‐ Baseline imbalances: ‐ |
|
Interventions |
Pantoprazole
Placebo
Adherence to regimen: ‐ Duration of trial: ‐ Duration of follow‐up: ‐ |
|
Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
|
|
Notes |
Setting: ICU Source of funding: ‐ Conflicts of interest: ‐
Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: ‐ |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: mentioned only that participants were randomised to treatment. Not enough information on method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Comment: no information about allocation concealment reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: mentioned only that the trial was double‐blind. No information about the method of blinding |
Blinding (detection bias) Clinically important upper GI bleeding | Low risk | Comment: mentioned that outcome assessment was done blinded to intervention. Presence of 1 or more macroscopic abnormalities (erythema or oedema, erosions, ulcerations, and nasogastric tube lesions) and GI bleeding was assessed, blinded to intervention, at endoscopy by a single experienced gastroenterologist Quote: "assessed, blinded to intervention, at endoscopy by a single experienced gastroenterologist" |
Blinding (detection bias) Nosocomial pneumonia | Unclear risk | Comment: The outcome was not addressed in this trial |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Low risk | Comment: mentioned that outcome assessment was done blinded to intervention |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Conference abstract reports about 10 participants from a larger prospective trial. Those who received > 5 doses of pantoprazole or placebo (n = 84) were eligible for the endoscopy substudy, but unclear why data from only 10 participants are reported |
Selective reporting (reporting bias) | Low risk | Comment: Outcomes reported in Methods section are also reported in Results section |
Other bias | Unclear risk | Comment: not enough information reported in conference abstract to assess other biases |