Fuenzalida 1990.
Study characteristics | ||
Methods | RCT. Parallel design with 2 treatment arms. Duration: 42 days total (21 days in hospital and 21 days at home). Location: single centre in the USA. |
|
Participants |
Inclusion criteria: adults with COPD with FEV1 30% ‐ 50% of predicted and more than 5% weight loss, mean (SD) % IBW at study entry 78.5% (9.6%). Exclusion criteria: not living in the area of the study, medical problems confounding thier nutritional or lung status, home oxygen therapy, cancer, use of oral corticosteroids, alcoholism, previous lobectomy, dementia, azotemia, CVD, liver disease, nonambulatory, chemotherapy use, interstitial lung disease, pneumonia in the past month, diabetes, malabsorption, use of ONS, and intestinal resection. Number randomised: 9 participants (intervention group, n = 4, control group, n = 5). Gender split: all males. Age: mean (SD) 62.4 (5.6) years. Nutritional status: per cent (SD) loss of usual weight in previous year 8.3 (1.54) %. |
|
Interventions |
Intervention: participants received dietary advice and ONS in the form of individually planned diet and 1080 kcal of a nutritional supplement. Control: participants received dietary advice alone in the form of individualised diet planned by dietitian to provide 100% of recommended daily intake. |
|
Outcomes | Survival*, weight*, BMI*, TSF*, MAMC*, MUAC*, energy intake*, measures of pulmonary function (FEV1*), measures of immune function. | |
Publication details |
Language: English. Funding: grant from the National Institute of Arthritis, Metabolism, Kidney and Digestive Diseases and grant from the National Institutes of Health. Publication status: peer‐reviewed journal. |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised but method not stated. |
Allocation concealment (selection bias) | Unclear risk | Method not stated. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Not reported, but must have been an unblinded trial due to the nature of the intervention. However, this is unlike to have influenced clinical outcomes. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Not reported, but must have been an unblinded trial due to the nature of the intervention. Functional outcomes could have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not reported, but must have been an unblinded trial due to the nature of the intervention. Nutritional outcomes could have been influenced by lack of blinding. |
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 | Unclear risk | Judged to be unclear as low risk for clinical outcomes and high risk for functional and nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses occurred during the study. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. Outcomes reported not in a format suitable for direct entry into a meta‐analysis. Data in the paper on weight have been used to derive mean change (SD). Information on study quality obtained from authors. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |