Booker 2000.
Study characteristics | ||
Methods | Study design: parallel‐group RCT | |
Participants | Country: USA Setting: multi‐center; medical and surgical ICU Inclusion criteria: receiving nutritional support through a gastric feeding tube with anticipated duration of tube feeding > 48 hours Exclusion criteria: not reported Baseline characteristics
|
|
Interventions | Intervention arm
Control arm
Loss to follow‐up: 17 participants withdrew from the trial: death (n = 2); transfer from ICU before completion of 3 days (n = 6); early removal of feeding tube (n = 5); missing data (n = 4). There was no mention of which arm these 17 participants belonged to. Duration of follow‐up: 3 days Duration of trial: September 1995 to June 1997 |
|
Outcomes | Volume aspirated from stomach | |
Notes | Funding source: Sigma Theta Tau, Delta Lambda Chapter, St Louis University Conflict of interest: unknown Clinical trial registration: unknown Duration of follow‐up was changed from 7 days due to serious numbers of missing data. Any disease severity scores of participants were not reported. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | People who consented were assigned to treatment group randomly. Details of randomization methods not provided. |
Allocation concealment (selection bias) | Unclear risk | Multi‐center (3 centers) study and often for such a study design, a centralized allocation method would be performed. However, for this study there were no further details on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded. For subjective outcomes, such as pneumonia and adverse events, the risk of detection bias would be high; for objective outcome measures, such as mortality, the risk of detection of bias would be low. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data for 17 participants were omitted from analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Lack of full‐time clinical research monitoring by study investigators. |