Hu 1998.
Methods | Randomised clinical trial, USA | |
Participants | 40 hospitalised adults admitted for 2‐stage anterior and posterior spinal reconstructive surgery, at nutritional risk due to major surgery Male:Female = 9:31 Mean age = 50.5 Exclusion criteria: Poorly‐controlled diabetes or had other medical contraindications |
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Interventions | Experimental group: TPN through a subclavian Hone catheter. It was started on the 1st postoperative day at 40 ml/hr and increased until calculated nutritional needs were achieved. Weaning began when they could consume 50% of their daily requirements orally. (n = 20) Control group: Standard intravenous fluids (n = 20) |
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Outcomes | Operative time, blood loss, transfusion requirements, all complications, length of hospital stay, albumin, pre‐albumin, weight, triceps skinfold, total lymphocyte count | |
Study dates | May 1994 to June 1997 | |
Notes | We contacted the authors on 23rd August 2015 by email: shu3@stanford.edu, and obtained additional information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The trial used a random‐number list for the sequence generation. |
Allocation concealment (selection bias) | Unclear risk | The trial was described as randomised, but it was unclear how the allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Only the experimental group had placement of a catheter. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was unclear how the outcome was assessed. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1 of the participants was transferred from the experimental group to the control group due to not receiving the intervention. There was also over 5% dropouts not accounted for with proper methodology. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report all‐cause mortality or serious adverse events properly. |
For‐profit bias | Unclear risk | It was unclear how the trial was funded. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |