Day 2002.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 18 months | |
| Participants | Setting: Melbourne, Australia Number of participants: 272 Number analysed: 272 Number lost to follow‐up: 0 Sample: community‐dwelling men and women identified from electoral roll Age (years): mean 76.1 (SD 5.0) Sex: 60% female Inclusion criteria: aged ≥ 70; community‐dwelling and able to make modifications; expected to remain in area for 2 years (except for short absences); have approval of family physician Exclusion criteria: undertaken regular to moderate exercise with a balance component in previous 2 months; unable to walk 10 to 20 m without rest or help or having angina; severe respiratory or cardiac disease; psychiatric illness prohibiting participation; dysphasia; recent major home modifications; education and language adjusted score > 4 on the short portable mental status questionnaire |
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| Interventions | Randomised into 8 groups: only 1 intervention group (group‐based balance and strength) and 1 control group included in this review 1. Group‐based balance and strength, plus daily home exercises tailored by physiotherapist: 1‐hour class a week, 15 weeks 2. Control group: no intervention. Received brochure on eye care for over‐40‐year olds |
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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 experienced 1 or more falls requiring medical attention |
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| Duration of the study | 18 months | |
| Adherence | Adherence measured by class attendance, frequency of home programme 1. Group‐based balance and strength group: 401/541 participants started a class; mean number of sessions attended, 10 (SD 3.8); 328/401 attended > 50% of their sessions; mean number of additional home exercise sessions, 9 a month |
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| Notes | Source of funding: Australian National Health and Medical Research Council, Victorian Department of Human Services (Aged Care), City of Whitehorse, Victorian Health Promotioin Foundation, Rotary, National Safety Council Economic information: Mean cost per person (intervention) AUD 52, AUD 33 for exercise group, AUD 39 for control group. Incremental cost per fall prevented/per QALY gained: ICER per fall prevented AUD 652, injurious fall prevented AUD 1176, fracture prevented AUD 26,236, QALY AUD 51,483 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised by "adaptive biased coin" technique, to ensure balanced group numbers |
| Allocation concealment (selection bias) | Low risk | Computer‐generated by an independent third party contacted by telephone |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blinded to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | Low risk | All participants used monthly falls diary, with telephone contact from a researcher blinded to group allocation if not returned in 5 days |
| 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 | Low risk | No missing fall data |
| 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 | Falls reported using monthly postcard to record daily falls. Telephone follow‐up if calendar not returned within 5 working days of the end of each month, or reporting a fall |