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." |