Weekes 2009.
Methods | Randomised controlled trial. Duration 12 months Six months intervention and follow‐up to 12 months. | |
Participants | Adults (n = 66; 35 males and 31 females) outpatients with severe COPD. Mean age 69 years. 66 randomised; 37 completed; 5 deaths in each group; all patients malnourished defined as unintentional weight loss and poor intake or BMI <18.5 kg/m2. 11% dropped out before baseline assessment. |
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Interventions | Dietary counselling to increase intake and advice on food fortification (n = 31) versus usual care (n = 28). | |
Outcomes | Survival*, weight*, BMI*, triceps skinfold*, MAC*, MAMC*, grip strength*, energy intake*, cost*, respiratory function, respiratory muscle function, QoL. | |
Notes | Usual care consisted of leaflet. Data have been obtained from the author. Paper submitted, awaiting decision re acceptance. Post hoc analysis of cost data will be available at the next update. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence. |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes. |
Blinding (performance bias and detection bias) Clinical outcomes | High risk | All assessments made by the lead investigator who was not blinded to group allocation. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | All assessments made by the lead investigator who was not blinded to group allocation. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | All assessments made by the lead investigator who was not blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 66 randomised; 37 completed; 5 deaths in each group; 11% dropped out before baseline assessment. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported but not as mean change (SD) at 6 months (end of intervention) for the outcomes of interest therefore not usable for meta‐analysis. Additional data and information obtained from the author. |
Other bias | Low risk | Baseline characteristics reported and no differences between groups. |