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

Ciaschini 2009.

Study characteristics
Methods RCT
Participants Setting: Algoma District (including Sault Ste Marie), Ontario, Canada
N = 201
Sample: community‐dwelling people at risk of a fall‐related fracture (94% women)
Age (years): mean 72 (SD 8.4)
Inclusion criteria: community‐dwelling; > 55 years old; able to consent; at risk of fracture (non‐pathological fracture in past year with T‐score < 2.0; attended ED with a fall, self referred, or referred by health professional and at high risk of falls (TUG test > 14 sec))
Exclusion criteria: if already receiving therapy for osteoporosis as per Osteoporosis Canada guidelines
Interventions 1. Multifactorial falls risk assessment by nurse + counselling and referral for PT and OT and interventions, plus recommendations for osteoporosis therapy targeting physicians and their patients
2. Control: usual care until 6 months, then same as intervention group
Outcomes 1. Number of people falling
2. Number of sustaining a fracture
Other outcomes reported but not included in this review: primary outcome implementation of appropriate falls risk management by 6 months
Duration of the study 6 months
Notes 12‐month study but 6‐month data used in review analysis as control group participants were offered the intervention after 6 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Eligible patients were randomized using a computer generated randomization scheme under supervision of the study biostatistician, into an immediate intervention protocol (IP) group or to a delayed intervention protocol (DP) group".
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement (see above)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "The patients, treating physicians and outcomes collectors could not be blinded to the intervention status." but impact of non‐blinding unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Outcome collection stated not to be blind to allocation
Blinding of outcome assessment (detection bias)
Fractures Low risk Probably low risk as fractures ascertained in both groups from patient records
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Falls and falls‐related injuries were obtained from electronic medical records as well as patient diaries."
Quote: "the number of falls and fractures as recorded in monthly patient diaries. Followup telephone calls every 3 months were used to obtain this data and completed patient diaries were mailed to the investigators at study end."