Rogers 1992.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: 4 months. Location: USA. |
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Participants |
Inclusion criteria: adults with COPD and weight < 90% of IBW and FEV1/FVC < 0.6. Exclusion criteria: recent (within 8 weeks) exacerbation of COPD, diabetes, thyroid dysfunction, malabsorption, alcoholism, myopathic disease or neoplastic disease, received nutritional supplements in the previous 3 months, corpulmonale, congestive heart failure. Number randomised: 28 participants (intervention group, n = 15; control group, n = 12). Attrition: 1 withdrawal in the control (no advice) group. Gender split: not reported. Age: mean (SE), 62 (2.0) years. Nutritional status: mean (SE) % IBW, intervention 77.8 (1.6) %; control 78.6 (2.0) %. |
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Interventions |
Intervention: participants received dietary advice plus ONS if required in the form of nutritional counselling to achieve a balanced meal plan plus supplements as needed; advice provided during 4‐week inpatient phase and then at each outpatient visit. Control: participants received no dietary advice and no ONS in the form of no dietary advice. |
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Outcomes | Weight*, TSF*, MUAC*, grip strength*, respiratory function*, QoL* (Sickness Impact Profile (SIP)). | |
Publication details |
Language: English. Funding: the National Heart, Lung and Blood Institute, the American Lung Association of Southwestern Pennsylvania, Clinical Research Unit of Presbyterian‐University Hospital and Ross Laboratories. Publication status: peer‐reviewed journal. |
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Notes | Additional data and information awaited from authors. No data on QoL was presented, only that the difference was not significant. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, method not stated. |
Allocation concealment (selection bias) | Unclear risk | Method not stated. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | The study was unblinded. However, this is unlikely to influence clinical outcomes. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | The study was unblinded. Functional outcomes could have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | No nutritional outcomes reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded 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 outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 withdrawal in the no advice group. Reason not given. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. All specified outcomes were reported in a format not suitable for entry into meta‐analysis. Change in weight, TSF, MAMC and handgrip strength are reported as mean (SD) at the start and end of intervention with a P value. No data obtained from authors therefore mean change (SD) derived using data in the paper. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |