Sherrington 2014.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Sydney, Australia Number of participants: 340 Number analysed: 340 Number lost to follow‐up: 0 Sample: community‐dwelling Age (years): mean 81.2 (SD 8.0) Sex: 74% female Inclusion criteria: aged 60 years and over and had been admitted to and subsequently discharged from 9 aged care, rehabilitation and orthopaedic wards at 4 public hospitals in Sydney, Australia Exclusion criteria: resided in a high‐care residential facility (nursing home); had cognitive impairment (a MMSE score < 24); had insufficient English language to understand procedures; were unable to walk more than 1 m even with an assistive device or the help of 1 person; or had a medical condition precluding a 12‐month home exercise program (e.g. unstable cardiac disease or progressive neurological disease) |
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Interventions | 1. Home‐based strength and balance programme: Weight‐bearing Exercise for Better Balance exercise programme + 32‐page education booklet about fall prevention, home programme of lower limb balance and strengthening exercises for 20 ‐ 30‐minute sessions, up to 6 a week for 12 months; home visits: 10 over 12 months 2. Control group: Usual care from health and community services + 32‐page education booklet about fall prevention | |
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 | 52 weeks | |
Adherence | Participants who actually exercised 1. Weight‐bearing Exercise group: 1 month: 90%, 3 months: 81%, 8 months: 66%, 12 months: 60% | |
Notes | Source of funding: Australian National Health and Medical Research Council, Australian National Health and Medical Research Council Research Fellowships Economic information: Mean cost per person (intervention): WEBB AUD 751. Healthcare service costs: WEBB AUD 12,029, usual care AUD 10,327. Incremental costs per fall prevented/per QALY gained: AUD 77,403 per QALY gained |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random‐number schedule with randomly‐ordered blocks of 2, 4, and 6 |
Allocation concealment (selection bias) | Low risk | Quote: “Ensure concealed randomisation to groups, the randomisation schedule was generated in advance by and only accessible to the first author who was not involved in participant recruitment, interviews or assessments” |
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 | Low risk | Same method used to ascertain falls in both groups. Blinded research assistants recorded and confirmed falls |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Method of ascertaining fractures not specified |
Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Low risk | Adverse events were monitored using the exercise diaries and recorded by blinded assessors |
Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants were not blinded to group allocation |
Incomplete outcome data (attrition bias) Falls and fallers | Low risk | No missing fall data |
Selective reporting (reporting bias) | Low risk | Falls, risk of falls and adverse events are reported and the trial protocol paper prespecifies the same fall outcomes as those in the trial report |
Method of ascertaining falls (recall bias) | Low risk | Monthly falls calendar. Participants who did not return calendars or who reported a fall were telphoned by blinded research assistants |