Liu‐Ambrose 2008.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Vancouver, Canada Number of participants: 74 Number analysed: 59 Number lost to follow‐up: 15 Sample: people attending a falls clinic after presenting at ED or to GP with a fall or fall‐related injury (41/59 completing baseline assessment) Age (years): mean 82.2 (SD 6.3) (in 59 participants completing baseline assessment) Sex: 71% female Inclusion criteria: aged ≥ 70; community‐dwelling; attending 1 of 2 falls clinics (criteria for attending clinic: history of a fall and considered at risk for further falls); able to walk at least 3 m; 1 additional non‐syncopal fall in previous year (if index fall was suspected to be due to carotid sinus syndrome); at risk of further falls (TUG test > 15 seconds or PPA z‐score of ≥ 1) Exclusion criteria: progressive neurological condition (e.g. Parkinson's disease); life expectancy < 12 months; cognitively impaired (MMSE score < 24) |
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Interventions | 1. Individual Otago Exercise Programme: 30 minutes, 3 a week for 6 months plus walking for ≥ 2 a week 2. Control: no exercise intervention; semi‐structured interview about presenting fall and experience seeking care for the fall at ED Both groups received falls risk factor assessment and comprehensive geriatric assessment followed by 'Guideline Care' through falls clinic |
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Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Number of people who died |
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Duration of the study | 52 weeks | |
Adherence | Adherence measured by programme completion 1. Individual Otago Exercise Programme: 7/28 (25%) completed programme ≥ 3 a week. 16/28 (57%) completed programme ≥ 2 a week. 19/28 (68%) completed programme at ≥ 1 a week |
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Notes | Source of funding: Canadian Institutes of Health Research Economic information: Mean cost per person (intervention) CAD 14,285. Incremental cost per fall prevented/per QALY gained: CAD 247 per fall prevented Cost‐effectiveness analysis reported in Davis 2009 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization sequence was computer generated (www.randomization.com)" |
Allocation concealment (selection bias) | Low risk | Quote: "The Family Practice Research Coordinator at the University of British Columbia held this sequence independently and remotely" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blind to allocated group but impact of non‐blinding unclear |
Blinding of outcome assessment (detection bias) Falls | High risk | Falls self‐reported and Quote: "A research assistant who was not blinded to treatment group" phoned participants at the end of each month |
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) | Unclear risk | Not applicable |
Incomplete outcome data (attrition bias) Falls and fallers | High risk | More than 20% of fall outcome data are missing (30%) |
Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
Method of ascertaining falls (recall bias) | Low risk | Quote: "Ascertainment of falls ... documented on monthly calendars that were returned in prepaid preaddressed envelopes at the end of each month." "A research assistant who was not blinded to treatment group but was unaware of the study hypotheses made three attempts by telephone to contact participants at the end of each month. The purpose of each phone call was to inquire about falls (both groups) ... for all participants regardless of whether the calendar was returned." |