Haran 2010.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: Sydney and Illawarra regions, New South Wales, Australia N = 606 Sample: sample from electoral roll; residents of retirement villages; outpatients and inpatients discharged from rehabilitation and orthopaedic ward; responders to advertising etc (65% women) Age (years): mean 80 (SD 6.6) Inclusion criteria: community‐dwelling; at a relatively high risk of falls (≥ 80 years, or 65 to 79 and TUG test ≥ 15 sec and/or ≥ 1 fall in past 12 mo); using bifocal, trifocal, or progressive lens glasses ≥ 3 x per wk when walking outdoors; reviewed by an optometrist or ophthalmologist in previous 24 months; "quite or very confident" that they could comply with the study recommendations Exclusion criteria: using single lens distance glasses; residing in high‐care residential facility; cognitive impairment (MMSE < 24); severe visual impairment (MET < 16 dB); insufficient English language skills; ophthalmic surgery planned in the next 12 months; unstable medical condition | |
Interventions | 1. Optometrist examination; prescribed single lens distance glasses for use in most walking or standing activities and given advice on use of their glasses 2. Control: used their multifocal glasses in their usual manner (no advice) All participants received an optometry assessment and updated multifocal glasses (if required) at baseline | |
Outcomes | 1. Rate of falls 2. Number of people falling 3. Number sustaining fall‐related fractures Other outcomes reported but not included in this review |
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Duration of the study | 13 months | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Each stratum was randomly allocated in permuted blocks of 10 generated externally (by JS)" a professor of statistics |
Allocation concealment (selection bias) | Low risk | Quote: "by using sequentially numbered opaque sealed envelopes containing group assignment" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Both groups received an intervention, i.e. an optometrist examination and updated multifocal lens prescription if required. The intervention group were prescribed a pair of single lens distance glasses and advice. |
Blinding of outcome assessment (detection bias) Falls and fallers | Low risk | Monthly calendars and follow‐up telephone calls as required. Research personnel who received the calendars and made the calls were blinded to group allocation. |
Blinding of outcome assessment (detection bias) Fractures | High risk | Injurious falls were defined as those that resulted in fractures, dislocations, and organ and soft tissue trauma. These were collected as self report from the monthly calendars and telephone calls and not verified from primary source. |
Incomplete outcome data (attrition bias) Falls | Low risk | SeeAppendix 3 for method of assessment |
Incomplete outcome data (attrition bias) Fallers | Low risk | SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls | Low risk | Daily diaries returned monthly with a follow‐up phone call if not returned |