Methods |
Randomised controlled trial.
Duration 12 months. |
Participants |
Adults (n = 30, average age 66 years) with COPD, average FEV1 0.81 (range 0.4 ‐ 1.51), average body weight 52 kg (range 38 ‐ 68 kg), comment on use of cut‐off <90% IBW in introduction. 20 participants completed the study, there were 5 deaths. |
Interventions |
Nutritional counselling to use a high calorie diet using a variety of methods including nutritional supplements if required (n = 15) versus no individual nutritional counselling (n = 14). Participants may have attended a group session where diet was discussed. |
Outcomes |
Body weight*, 4‐site skinfolds (summed), survival*, energy intake*, respiratory function (FEV1* and 6‐minute walking distance). |
Notes |
Additional data and information on quality obtained from authors. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Information obtained from author, randomisation performed using a table of random numbers. |
Allocation concealment (selection bias) |
Low risk |
Information from the author, a person not involved in the study administered the random allocation. |
Blinding (performance bias and detection bias)
Clinical outcomes |
Low risk |
Information obtained from author confirmed blind assessment of outcomes. |
Blinding (performance bias and detection bias)
Functional outcomes |
Low risk |
Information obtained from author confirmed blind assessment of outcomes. |
Blinding (performance bias and detection bias)
Nutritional outcomes |
Low risk |
Information obtained from author confirmed blind assessment of outcomes. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
20 participants completed the study, there were 5 deaths, 3 in the intervention group and 2 in the control group. |
Selective reporting (reporting bias) |
Unclear risk |
All outcomes reported but not in a format suitable for entry into meta‐analysis. Data on mortality obtained from the author as the detail in the paper was unclear. Data on mean change for weight are reported without a SD and therefore the original data have been obtained from the authors. Data on energy intake are reported as mean and range with no SD at baseline and end of follow‐up. Data requested from authors but no detail available. |
Other bias |
High risk |
Baseline variables not given, don't know if groups similar at baseline. |