Munk 2014.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants | 84 people newly admitted to hospital; mean age intervention 75 (SD 10) years; control 74 (SD 11) years; 47 female, 34 male (data on those that completed the study) Inclusion criteria:new admissions to hospital, > 18 years old and at nutritional risk according to NRS‐2002, able to eat orally, anticipated length of stay > 3 days, sufficient language proficiency Exclusion criteria: dysphagia, food allergy or intolerance, anatomical obstruction preventing food intake, receiving enteral or parenteral nutrition, judged to be terminally ill Diagnostic criteria: admitted to oncology, orthopaedics or urology wards |
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| Interventions | An a la carte menu of small dishes enriched with natural energy‐dense ingredients and supplemented with protein powder Number of trial centres: 1 Treatment before trial: not stated |
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| Outcomes | Outcomes reported in abstract of publication: percent reaching their calculated energy and protein requirements, mean energy and protein intake, body weight, handgrip strength, LOS, mortality | |
| Study details |
Run‐in period: 5 weeks to ensure optimal staff training. Recruitment started at the end of the run‐in Was trial terminated early: no |
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| Publication details |
Language of publication: English Funding: commercial funding ‐ protein powder donated by Toft Care System, Copenhagen, Denmark. Study funded by Herlev University Hospital Research Unit Publication status: peer review journal |
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| Stated aim for study | Quote "to investigate whether a novel food service concept with protein supplementation would increase protein and energy intake in hospitalised patients at nutritional risk". | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from paper: "The allocation sequence was generated by a secretary who was not otherwise involved in the trial" |
| Allocation concealment (selection bias) | Low risk | Quote from paper: "using sealed opaque envelopes, with a total of 9 blocks each with 10 envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants and study personnel were not blinded to group allocation. Blinding of participants would not be possible due to the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: data assessors were not blinded to group allocation. Blinding of the assessors was judged by the authors to be difficult as participants were likely to reveal their group allocation. The analyses were conducted blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: three participants did not receive the intervention and so not included in the study |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes specified in the methods reported |
| Other bias | Low risk | Comment: baseline characteristics fully reported; control and intervention groups comparable at baseline |