Ganzoni 1994.
Study characteristics | ||
Methods | RCT. Parallel design with 2 treatment arms. Duration: 12 months. Location: Germany. |
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Participants |
Inclusion criteria: adults with COPD. Exclusion criteria: not reported/translated. Number randomised: 29 participants (intervention group, n = 15, control group, n = 14). 20 participants completed the study, there were 5 deaths (3 in the intervention group and 2 in the control group), 3 participants could not be followed up at 12 months and 1 participant did not have a baseline assessment completed (information provided by author). Gender split: not reported/translated. Age: average age 66 years. Nutritional status: body weight: average 52 kg (range 38 ‐ 68 kg); lung function (FEV1):average 0.81 (range 0.4 ‐ 1.51). |
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Interventions |
Intervention: participants (n = 15) received dietary advice plus ONS if required in the form of nutritional counselling to use a high‐calorie diet using a variety of methods including nutritional supplements if required. Control: participants (n = 14) received no dietary advice and no ONS in the form of no individual nutritional counselling. Participants may have attended a group session where diet was discussed. |
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Outcomes | Body weight*, 4‐site skinfold measurements (summed), survival*, energy intake*, respiratory function (FEV1* and 6‐minute walking distance). | |
Publication details |
Language: German. Funding: not declared. Publication status: peer‐reviewed journal. |
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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. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not described and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcome assessments were blinded. |
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 and an additional 4 participants had missing assessment information. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. 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 | Unclear risk | Baseline variables not given, and not known if groups similar at baseline. |