Pighills 2011.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: affluent rural and deprived urban areas, Yorkshire, United Kingdom
N = 238
Sample: recruited from 13 GP lists in the Airedale NHS Trust (67% women)
Age (years): mean 79 (SD 6)
Inclusion criteria: community‐dwelling; aged ≥ 70; history of ≥ 1 fall in previous 12 months Exclusion criteria: living in nursing or residential care homes; receiving OT services; had fall‐specific OT intervention in past year |
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Interventions | 1. Environmental assessment provided by OT, recommendations sent to participant and referrals made for equipment and other input 2. As above, but provided by a trained non‐professionally qualified domiciliary support worker 3. Control: usual care from GP |
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Outcomes | 1. Rate of falls 2. Number of people falling Other outcomes reported but not included in this review | |
Duration of the study | 12 months | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The computer‐generated outcome of randomization was automatically e‐mailed to an independent person" |
Allocation concealment (selection bias) | Low risk | Quote: "The York Trials Unit independently and remotely conducted simple Web‐based randomization ... The computer‐generated outcome of randomization was automatically e‐mailed to an independent person who passed the participant's case notes on to the contact person for the group to which they had been randomized." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel carrying out the intervention were aware of group allocation |
Blinding of outcome assessment (detection bias) Falls and fallers | Low risk | Quote: "Calendars that were not returned within 2 weeks of the end of the month prompted a telephone contact from an independent, blinded interviewer to ascertain whether the participant had fallen." "All reported falls were followed up with a blinded, structured telephone interview to investigate the circumstances and consequences." "Staff of the York Trials Unit inputted questionnaire data which was checked twice for accuracy." |
Incomplete outcome data (attrition bias) Falls | Unclear 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 | Used postcard diary, mailed monthly. Followed up in 2 weeks if did not send. Participants also provided with toll‐free telephone number so that they could report falls contemporaneously of they sustained multiple falls or had difficulty recalling falls. |