Iliffe 2015.
| Methods | Study design: Cluster‐RCT Number of study arms: 3 Number of clusters: 42 Length of follow‐up: 18 months |
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| Participants | Setting: London and Nottingham, UK Number of participants: 1254 Number analysed: 709 Number lost to follow‐up: 545 Sample: community‐dwelling Age (years): mean 73 (range 65 ‐ 94) Sex: 62% female Inclusion criteria: ≥ 65 years, registered with participating general practices, living independently (not in residential or nursing homes), physically able to attend group exercise Exclusion criteria: ≥ 3 falls in the past year, ≥ 150 minutes of moderate‐vigorous physical activity a week, uncontrolled medical conditions and significant cognitive impairment |
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| Interventions | 1. Individual Otago Exercise Programme: leg strengthening, balance exercises and walking plan, 30 minute, 3 a week for 24 weeks 2. Group‐based FaME plus home training based on Otago Exercise Programme: leg and trunk strengthening, balance, flexibility, functional floor skills, walking plan, 1‐hour group session a week for 24 weeks + 30‐minute home exercises sessions, 2 a week for 24 weeks 3. Control group: no intervention |
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| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Health‐related quality of life 4. Number of people who died |
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| Duration of the study | 96 weeks | |
| Adherence | Adherence measured as home sessions completed, or class attendance 1. Individual Otago Exercise Programme: 149 (37%) participants reported they achieved ≥ 75% of the home exercise prescription (90 minutes a week) 2. Group‐based FaME plus home training based on Otago Exercise Programme: 150 participants (40%) attended 75% (or more) of classes |
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| Notes | Source of funding: Health Technology Assessment programme of the National Institute for Health Research Economic information: Mean cost per person (intervention) OEP London GBP 88, Nottingham GBP 117; FaME: London GBP 269, Nottingham GBP 218. Health service cost OEP GBP 404, FaME GBP 412, usual care GBP 367. Incremental cost per fall prevented/per QALY gained: no between‐group difference in QALY. Number of clusters allocated to OEP: 14; Number of clusters allocated to FaME: 14; number of clusters allocated to control: 14; number of clusters analysed (OEP): 14; number of clusters analysed (FaME): 14; number of clusters analysed (control): 14 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Treatments will be assigned…using computer generated random number tables, embedded in a computer programme for minimisation" |
| Allocation concealment (selection bias) | Low risk | Quote: "Practices were allocated to intervention or usual care, only after all participants had been recruited. The practices, their patients and the researchers undertaking baseline assessments were all blinded to allocation until this point" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel unblinded but impact of unblinding unknown |
| Blinding of outcome assessment (detection bias) Falls | High risk | Falls were measured using the same method in all groups. The researchers assessing outcomes were not blinded |
| Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Not applicable |
| Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Not applicable |
| Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants not blinded to group allocation |
| Incomplete outcome data (attrition bias) Falls and fallers | High risk | More than 20% of fall outcome data are missing (44%) at 18‐month follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
| Method of ascertaining falls (recall bias) | High risk | Self‐completed fall diaries (completed monthly during the 6‐month intervention period and every 3 months from 6 to 24 months follow‐up). Telephone contact with non‐responders and fallers |
| Cluster‐randomised trials | Low risk | After all participants from a practice had been recruited, the practice was individually allocated to a study arm by the London co‐ordinating centre; baseline comparability of clusters was not reported; missing outcomes for clusters or within clusters were not reported; accounted for the clustered design in the analysis; results comparable with individually randomised trials |