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

Reinsch 1992.

Methods RCT (cluster‐randomised by senior centre. 2 x 2 factorial design)
Study design: Cluster‐RCT
Number of study arms: 2
Number of clusters: 16
Length of follow‐up: 12 months
Participants Setting: Los Angeles County and Orange County, California, USA
Number of participants: 230
Number analysed: 230
Number lost to follow‐up: 0
 Sample: recruited from 16 senior centres
 Age (years): mean 74.2 (SD 6.0)
Sex: 80% female
 Inclusion criteria: aged > 60
 Exclusion criteria: none listed
Interventions Randomised into 4 groups: 3 intervention groups (1 group‐based balance and strength training, 1 cognitive‐behavioural training, 1 exercise and cognitive training) and 1 control group (discussion group). Only the group‐based balance and strength training and control group were included in this review
1. Group‐based balance and strength training: no special equipment used; 1 hour, 3 a week for 52 weeks
 2. Control group: health and interest discussion group, 1 hour, 1 a week for 52 weeks
Outcomes 1. Number of people who experienced 1 or more falls (risk of falling)
Duration of the study 52 weeks
Adherence Dropout/noncompliance defined as missing ⅓ or more of the classes taught at their centre
1. Group‐based balance and strength training: 13/57 noncompliance (44/57 compliance)
2. Control group: 8/50 noncompliance (42/50 compliance)
Notes Source of funding: NIH, AARP Andrus Foundation, Roosevelt Warm Springs Foundation
Economic information: not reported
MacRae paper includes a subset of results for only 2 arms of the study, in Los Angeles county only
Number of clusters allocated to intervention: 4; number of clusters allocated to control: 4; number of clusters analysed (intervention): 4; number of clusters analysed (control): 4
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned to treatments"
Allocation concealment (selection bias) High risk Quote:" A biostatistician not involved in the study randomized general practices into the intervention or control group by using computer‐generated random numbers. After the randomization, the general practitioners enrolled patients for the study according to the inclusion and exclusion criteria". The method of concealment is not described and assume the recruiting general practitioners were unblinded and may have had knowledge of participant characteristics
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants and personnel implementing the intervention not blinded to allocated group, but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias) 
 Falls Unclear risk Falls reported by participants who were aware of their group allocation. Blinding of research assistant not described
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 Method for recording medical attention and adverse events was unclear. Appears to be self‐report
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) High risk Falls were measured, but number of falls was not reported
Method of ascertaining falls (recall bias) Low risk Prospective. Monthly diaries plus weekly phone calls or visits
Cluster‐randomised trials Unclear risk Individual participant recruitment was undertaken after group allocation. The method of concealment is not described and it is likely that recruitment was undertaken by a person who was unblinded and may have had knowledge of participant characteristics; baseline characteristics of clusters were not reported; missing outcomes for clusters or within clusters were not reported; did not account for the clustered design in the analysis; results comparable with individually‐randomised trials