Campbell 1997.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 24 months | |
| Participants | Setting: Dunedin, New Zealand Number of participants: 233 Number analysed: 233 Number lost to follow‐up: 0 Sample: women identified from general practice registers Age (years): mean 84.1 (SD 3.1) Sex: 100% female Inclusion criteria: at least 80 years old; community‐living Exclusion criteria: cognitive impairment; not ambulatory in own residence; already receiving physiotherapy |
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| Interventions | 1. Individual Otago Exercise Programme: home‐based programme prescribed in 4 x 1‐hour visits in first 2 months, 30‐minute exercise, 3 a week plus walk outside home 3 a week. Regular phone contact after first 2 months 2. Control: social visit by research nurse x 4 in first 2 months. Regular phone contact | |
| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) | |
| Duration of the study | 52 weeks. 2‐year data reported in Campbell 1999 | |
| Adherence | Not reported | |
| Notes | Source of funding: Accident Rehabilitation and Compensation Insurance Corporation of New Zealand, Department of Veterns Affairs, USA
Economic information: Mean cost per person (intervention): NZD 173 in year 1, NZD 22 in year 2. Healthcare service costs: no difference between the 2 groups resulting from falls or for total healthcare costs, 27% hospital admission costs resulted from fall. Incremental cost per fall prevented/per QALY gained: at 1 year = NZD 314 (programme implementation costs only); at 2 years = NZD 265 (programme implementation costs only) Otago Exercise Programme manual can be obtained from www.cdc.gov/HomeandRecreationalSafety/Falls/compendium/1.2_otago.html. Cost‐effectiveness analysis reported (Robertson 2001ac). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocation schedule developed using computer‐generated numbers |
| Allocation concealment (selection bias) | Low risk | Assignment by independent person off‐site |
| 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 | High risk | Falls reported by participants who were aware of group allocation. Blinding of adjudicator reported, but researcher making telephone contact was aware of group allocation as she also did social visits (personal communication reported by Gillespie 2012) |
| 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 outcome data for falls |
| 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 recorded daily on postcard calendars, mail registration monthly by postcard, telephone follow‐up |