Skip to main content
. 2016 Dec 20;2016(12):CD009840. doi: 10.1002/14651858.CD009840.pub2

Johansen 2004.

Methods Parallel randomised controlled clinical trial
Randomisation ratio: 1:1
Superiority design
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
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
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
Publication details Language of publication: English
Funding: non‐commercial funding ‐ Danish Ministry of Health + participating Hospitals
Publication status: peer review journal
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