Johansen 2004.
Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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Participants |
Inclusion criteria: NRS‐2000 score > 3 on admission to hospital Exclusion criteria: predicted admission < 4 days; < 18 years old; < 1 month expected survival; ability to understand Danish; previously included participants; patients next to another participant; pregnant and lactating; psychiatric disorder; haemodialysis; patients receiving or planned to receive EN or PN Diagnostic criteria: varied |
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Interventions | Received daily attention from the nutrition team (nurse and dietitian); motivation of participant and staff; daily monitoring and adjustment of nutrition care plan; secured supply of ordered food Number of trial centres: 3 hospitals in Denmark Treatment before trial: not described |
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Outcomes | Outcomes reported in abstract of publication: length of stay; nutrition discharge index; health‐related quality of life (Short Form ‐36 health survey) | |
Study details |
Run‐in period: no Was trial terminated early: no |
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Publication details |
Language of publication: English Funding: non‐commercial funding ‐ Danish Ministry of Health + participating Hospitals Publication status: peer review journal |
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Stated aim for study | Quote from publication: "To evaluate the clinical benefits of nutritional intervention in a random sample of all patients at nutritional risk according to Nutritional Risk Score ‐2002 from three different hospital levels" | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote from paper: participants selected "by a random numbers system" Comment: suggests that random sequence appropriate |
Allocation concealment (selection bias) | Unclear risk | Comment: not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: assessment of complications undertaken by a member of the investigation team blinded to allocation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: clearly described in the results; intention‐to‐treat analysis undertaken, however they do not report which group participants dropped out of |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes specified in the methods fully reported |
Other bias | Low risk | Comment: baseline characteristics fully described; intervention and usual cares comparable |