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. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3

Clemson 2004.

Study characteristics
Methods RCT. Randomised in blocks of 4 stratified by sex and number of falls in previous 12 months
Participants Setting: Sydney, Australia
N = 310
Sample: volunteer community‐dwelling men and women recruited by various strategies (74% women)
Age (years): mean 78 (SD 5)
Inclusion criteria: aged ≥ 70; community‐dwelling; fallen in past year or felt themselves to be at risk of falling. Exclusion criteria: dementia (> 3 errors on Short Portable Mental Status Questionnaire); homebound; unable to independently leave home; unable to speak English
Interventions Both groups received baseline assessment at home before randomisation
1. Stepping On programme. Multifaceted small‐group (N = 12) learning environment to encourage self efficacy, behaviour change, and reduce falls using decision‐making theory and a variety of learning strategies. Facilitated by OT. 2 hours per wk, for 7 wks; taught exercises and practised in classes. OT home visit within 6 wks of final programme session; booster session 3 months after final session.
2. Control: at least 2 social visits from student OT with no discussion of falls or fall prevention
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 14 months
Notes Details of programme in Appendix A of Clemson 2004: risk appraisal, exercise, moving safely, home hazards, community safety, footwear, vision and falls, vitamin D, hip protectors, medication management, mobility mastery, review and plan
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomised by researcher not involved in subject screening or assessment". Method not described.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Study participants and personnel not blinded, but staff visiting control group instructed not to discuss falls or fall prevention
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk All participants used monthly calendar; telephone contact if not returned in 2 weeks. Blinding of study personnel recording data from the calendars not described. 
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Monthly falls postcard calendar.