Lin 2011.
| Methods |
Cluster‐ and cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants | 29 participants; mean age 82.9 (SD 6.0) years; 17 male: 12 female with dementia in care home. Appear to be identical to participants in Group 2 in Lin 2010; No response from study author Inclusion criteria: diagnosis of dementia ; > 2 Edinburgh Feeding Evaluation in Dementia scale (EdFed); MMSE score = 10‐23 Exclusion criteria: not stated Diagnostic criteria: dementia |
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| Interventions | Montessori intervention including sensory stimulation, procedural movements (e.g. hand eye co‐ordination) and extension and conclusion activities Number of trial centres: 2 Treatment before trial: none |
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| Outcomes | Outcomes reported in abstract of publication: EdFed score; Eating Behaviours score; MNA score; self‐feeding frequency and self‐feeding time | |
| Study details |
Run‐in period: 2‐week wash out between cross‐over Was study terminated early: no |
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| Publication details | Language of publication: English Funding: non‐commercial funding ‐ National Health Research Inistitute (Taiwan) Publication status: peer review journal |
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| Stated aim for study | Quote from publication: "To investigate the efficacy of a Montessori intervention in improving the eating ability and nutritional status of residents with dementia in long term care facilities" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from paper: "To avoid contamination among participants ......the two demential special care units were randomly assigned....." Comment: insufficient information provided to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: described as not blinded, lack of blinding therefore may have influenced participant responses |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors blind to allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: not described |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes fully reported |
| Other bias | High risk |
Comment: baseline data suggest considerable variation in length of institutionalisation and length of time diagnosed with dementia Assessment of risk of bias in cluster‐randomised trials (1) Recruitment bias: no (2) Baseline imbalance: frail status (3) Loss of clusters: no (4) Incorrect analysis: no (5) Comparability with individually randomised trials/different types of clusters: different types of clusters |