Splett 2003.
| Methods |
Cluster‐randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: people entering residential care facilities with service provided by a dietitian Exclusion criteria: people entering a hospice or respite care programme or those expected to have a stay < 30 days Diagnostic criteria: varied |
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| Interventions |
Number of trial centres: 29 Treatment before trial: 57% intervention group and 61% usual care had previous dietary modification and 25% intervention and 35% control received help at mealtimes |
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| Outcomes | Outcomes reported in abstract of publication: rate of unintentional weight loss, weight status 90 days after admission and weight status 90 days after identification of unintentional weight loss | |
| Study details |
Run‐in period: none Was trial terminated early: no |
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| Publication details |
Language of publication: English Funding: not stated Publication status: peer review journal |
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| Stated aim for study | Quote from publication: "To assess the effectiveness of a new medical nutrition therapy protocol for the prevention and treatment of unintentional weight loss and describe nutrition assessment and intervention activities of dietitians" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: ".. facilities were randomly assigned to either the medical nutrition therapy protocol care group (MNTPC) or the usual care (UC) group using a random numbers table" |
| 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: not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: fully described |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |
| Other bias | High risk |
Assessment of risk of bias in cluster‐randomised trials (1) Recruitment bias: unclear (2) Baseline imbalance: number of diagnoses (3) Loss of clusters: unclear (4) Incorrect analysis: yes (5) Comparability with individually randomised trials/different types of clusters: unclear |