| Study characteristics |
| Methods |
RCT (cluster‐randomised by household) |
| Participants |
Setting: USA
N = 3182 (N = 2509 households)
Sample: independently living members of HMO recruited by mail (62% women)
Age (years): mean 73 (SD 6)
Inclusion criteria: aged over 65; ambulatory; living within 20 miles of investigation site; consenting
Exclusion criteria: blind; deaf; institutionalised; housebound; non‐English speaking; severely mentally ill; terminally ill; unwilling to travel to research centre |
| Interventions |
1. Home visit, safety inspection (prior to randomisation), hazards booklet, repair advice, fall prevention classes (addressing environmental, behavioural, and physical risk factors), financial and technical assistance
2. Control: home visit, safety inspection (prior to randomisation), hazards booklet |
| Outcomes |
1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture |
| Duration of the study |
23 months |
| Notes |
Cost description reported in primary reference. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomly assigned" |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Participants and personnel not blind to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias)
Falls and fallers |
Low risk |
Falls self reported by postcard, which prompted telephone interview. Quote: "Fall interviewers were blind to group assignment and did not include anyone who had interacted with participants during intervention sessions." |
| Blinding of outcome assessment (detection bias)
Fractures |
Unclear risk |
Quote: "Fall interviewers were blind to group assignment and did not include anyone who had interacted with participants during intervention sessions." but "Fracture falls and hospitalised falls defined based on participant report" and not confirmed by the results of radiological examination or from primary care case records. |
| 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 |
Unclear risk |
SeeAppendix 3 for method of assessment. Insufficient information to permit judgement. |
| Risk of bias in recall of falls |
Low risk |
Prospective. Returned a postcard after each fall. Also recorded falls on monthly diaries, and received quarterly mail/telephone contacts. |
