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. 2019 Jan 31;2019(1):CD012424. doi: 10.1002/14651858.CD012424.pub2

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
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
Outcomes 1. Number of people who experienced 1 or more falls (risk of falling)
2. Health‐related quality of life
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
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