Campbell 2008.
Methods | Randomised controlled trial. Duration 12 weeks. | |
Participants | Adults (n = 62) with stage 4 chronic kidney disease, 56 started study, male n = 34, female n = 22, intervention group mean age 69.5 (SD 11.7) years; control mean age 70.9 (SD 11.6) years. Nutritional status assessed using SGA, intervention group 24% malnourished (SGA B), control group 11% malnourished (SGA B). 50 patients completed the study. |
|
Interventions | Dietary counselling to increase energy intake, maintain protein intake and information on appropriate nutritional choices for renal patients (n = 24) versus usual care (generic information on nutrition, n = 26). | |
Outcomes | Dietary intake*, body weight*, nutritional status (SGA), body composition (total body potassium), survival * biochemistry. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated number sequence. |
Allocation concealment (selection bias) | Low risk | Described as concealed to recruiting officer until after baseline assessment. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 62 participants randomised in the study: 6 participants did not receive the intervention; 6 were lost to follow; 4 deaths ( all in the intervention group); 2 participants received dialysis. |
Selective reporting (reporting bias) | Low risk | Data on mortality, change in weight and energy intake were used in this review. The data are reported in the paper but the weight data is presented as a mean (SD) at baseline and at 12 weeks and therefore the mean change with SD has been obtained from the authors. The energy intake data reported in kJ/kg, mean change (SD) in kcals obtained from the author. |
Other bias | Unclear risk | Baseline variables stated, groups similar at baseline apart from amounts of malnutrition (see above). |