Logghe 2009.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: 2 industrial towns in the western Netherlands Number of participants: 269 Number analysed: 269 Number lost to follow‐up: 0 Sample: registered with participating 23 general practices Age (years): mean 77 (SD 4.6) Sex: 71% female Inclusion criteria: aged ≥ 70; community‐dwelling; high falls risk (1 or more falls in previous year or 2 or more risk factors for falling (disturbed balance, mobility problems, dizziness, using benzodiazepines or diuretics)) Exclusion criteria: none described |
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Interventions | 1. Group‐based Tai Chi: 1 hour, 2 a week for 13 weeks + fall‐prevention brochure 2. Control: fall‐prevention brochure | |
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 lesson attendance 1. Group‐based Tai Chi: 47% attended 80% of lessons |
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Notes | Source of funding: Netherlands Organization for Health Research and Development (ZonMw) Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An independent research assistant performed a prestratified block randomization using a computer‐generated randomization list" |
Allocation concealment (selection bias) | Low risk | Quote: "An independent research assistant performed ... randomization" |
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 | Falls self‐reported but Quote: "The blinded research assistant contacted the participant when forms were missing or incomplete, and they then completed the forms together over the telephone". Falls were recorded and confrimed using the same method in both groups |
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 | Quote: "At baseline, the participants received a falls calendar and the instruction to fill it out on a daily basis for 1 year ... The fall calendars were collected monthly by mail. The blinded research assistant contacted the participant when forms were missing or incomplete, and they then completed the forms together over the telephone" |