Huang 2010.
Methods | Study design: Cluster RCT Number of study arms: 2 Number of clusters: 4 (2 clusters included in this review) Length of follow‐up: 5 months | |
Participants | Setting: Taipei, Taiwan Number of participants: 115 Number analysed: 78 Number lost to follow‐up: 37 Sample: people registered as living in 4 randomly‐selected villages Age (years): mean 71.5 (SD 0.6) in people not lost to follow‐up Sex: 30% female Inclusion criteria: aged > 65 years; living in a non‐organised community of Taiwan Exclusion criteria: immobile; living outside registered living area |
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Interventions | Randomised into 4 groups: 3 intervention groups (1 group‐based Tai Chi, 1 education group, 1 Tai Chi plus education group) and 1 control group. Only group‐based Tai Chi and control groups included in this review 1. Group‐based Tai Chi: 13 simple movements, 40‐minute sessions, 3 a week for 20 weeks 2. Control group: usual care |
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Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) 2. Health‐related quality of life |
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Duration of the study | 20‐72 weeks | |
Adherence | Not reported | |
Notes | Source of funding: The National Science Council, Taiwan
Economic information: not reported Reported results not adjusted for clustering. Raw data at 5 months used in the review and adjusted for clustering. No raw data for 18 months so not possible to adjust for clustering. Number of clusters allocated to intervention: 1; number of clusters allocated to control: 1; number of clusters analysed (intervention): 1; number of clusters analysed (control): 1 Email communication regarding fall data, response received, data not included in review |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The three intervention groups and one control group were then assigned randomly to one each of the four selected villages." |
Allocation concealment (selection bias) | High risk | Individual participant recruitment was undertaken after group allocation of the 4 villages. There was no mention of active blinding of research team members recruiting participants |
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 | Unclear risk | Insufficient information to determine how falls were monitored in each group or whether assessors were blinded |
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) | High risk | Participants were not blinded to group allocation |
Incomplete outcome data (attrition bias) Falls and fallers | High risk | More than 20% of fall outcome data are missing (32%). Loss of fall data was unbalanced in the Tai Chi (n = 34) and control (n = 3) groups, with the reasons for withdrawal not clear |
Selective reporting (reporting bias) | High risk | Falls measured, but number of falls not reported. Adverse events not reported |
Method of ascertaining falls (recall bias) | Unclear risk | No mention of how falls were monitored Quote: "The fall or non‐fall situation was checked at preintervention, postintervention and at one and half year later with the aim of examining the effectiveness of the interventions" |
Cluster‐randomised trials | Unclear risk | Individuals were recruited to the trial after the clusters were randomised and personnel recruiting participants were not blind to cluster; clusters were not comparable at baseline for gender or education level; missing outcomes for clusters or within clusters were not reported; did not account for clustering in analysis; results comparable with individually randomised trials |