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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Rogers 1992.

Study characteristics
Methods RCT.
Parallel design with 2 arms.
Duration: 4 months.
Location: USA.
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) %.
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.
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.
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.